OPIATE MDL 2804 RICO CLAIMS STAY IN BELLWETHER TRIAL NEXT MONTH: Opinion /s/Dan Aaron Polster September 10, 2019

“TRIPLE DAMAGES AND ATTORNEYS FEES NOW PART OF DEFENSE TRIAL PREP”

 

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF OHIO

EASTERN DIVISION

 

IN RE: NATIONAL PRESCRIPTION OPIATE LITIGATION

 THIS DOCUMENT RELATES TO:

 All Cases

MDL 2804

)     Case No. 1:17-md-2804

)     Judge Dan Aaron Polster

)     OPINION AND ORDER REGARDING

)     DEFENDANTS’ SUMMARY

)     JUDGMENT MOTIONS ON RICO AND OCPA

 

Before the Court are two related motions for summary judgment filed by Defendants regarding Plaintiffs’ claims under the Racketeer Influenced and Corrupt Organizations (RICO) Act 18 U.S.C. § 1961 et seq. and Ohio’s Corrupt Practices Act (OCPA),1 Ohio Rev. Code § 2923.31 et seq.. They are: (1) Distributors’ Motion for summary judgment on Plaintiffs’ RICO and OCPA Claims, (Doc. #: 1921); and (2) Manufacturers’ Motion for summary judgment on Plaintiffs’ RICO, OCPA, and Conspiracy Claims. (Doc. #: 1930). Only the RICO and OCPA portions of these motions are addressed in this opinion and order.2 Plaintiffs filed an omnibus response (Doc. #: 2182) and Manufacturers and Distributors each filed a Reply (Doc. ##: 2533 and 2547, respectively). Plaintiffs’, with leave of the Court, filed a Sur-Reply (Doc. #: 2500). For the reasons set forth below, Defendants’ summary judgment motions are DENIED.

1 “Ohio’s RICO statute, O.R.C. § 2923.31 et seq., is patterned after the federal RICO statute. Thus, courts “have found that the elements for an [Ohio RICO] violation are the same as those for a [federal] RICO claim.” Robins v. Glob. Fitness Holdings, LLC, 838 F. Supp. 2d 631, 651 (N.D. Ohio 2012) (citing Foster v. D.B.S. Collection Agency, 463 F.Supp.2d 783, 811 (S.D.Ohio 2006)).

2 The Manufacturers’ arguments regarding Civil Conspiracy are addressed in a separate opinion. (Doc. #: 2562).

1.

The Court hereby incorporates the legal standards set forth in the Court’s Opinion and Order regarding Plaintiffs’ Summary Judgment Motions Addressing the Controlled Substances Act, see Doc. #: 2483.

II.

Under the RICO statute, it is “unlawful for any person employed by or associated with any enterprise . . . to conduct or participate, directly or indirectly, in the conduct of such enterprise’s affairs through a pattern of racketeering activity.” 18 U.S.C.A. § 1962. Defendants articulate two principal arguments for summary judgment on Plaintiffs’ RICO and OCPA claims: (1) no evidence of any enterprise and (2) no evidence of causation. Distributors also advance a threshold argument regarding their alleged racketeering activity, which the Court addresses first below.

The RICO statute expressly lists those violations that constitute predicate acts of racketeering activity. See 18 U.S.C.A. § 1961(1). Distributors assert, in a footnote,3 that the Magistrate   Judge’s   Report   &   Recommendation—finding   that   a   violation   of   21 U.S.C.

  • 843(A)(4)(a) can constitute a predicate act—is “wrong as a matter of law.” Dist. MSJ on RICO at 16 n.14 (Doc. #: 1921-1). No party objected to the Magistrate’s finding and it was subsequently adopted by the Court. See Dec. 19, 2018 Order re MTD Summit (Doc. #: 1203). Although the Magistrate Judge expressed that “whether § 842, § 843, or neither was violated is ultimately an issue of fact that cannot be resolved  on  a  motion  to  dismiss,”  Summit  R&R  at  46-47  (Doc. #: 1025), Distributors here do not meaningfully develop any factual bases that convince the Court either to conclude as a matter of law that Distributors did not violate § 843, or to revisit itsprior legal conclusion (that such a violation, if committed, can constitute racketeering activity). In fact, Distributors acknowledge they drafted their summary judgment motion based on the assumption that “the failure to report a suspicious order can constitute a predicate act of racketeering  for  purposes  of  RICO  and  the  OCPA.”  Dist.  MSJ  on  RICO  at  16  n.14  (Doc. #: 1921-1) (emphasis added). Thus, the Court reaffirms its legal conclusion that a violation of 21 U.S.C. § 843(A)(4)(a) can constitute a predicate act under 18 U.S.C. § 1961(1)(D); and the Court further concludes that, at a minimum, Distributors have failed to demonstrate there is no genuine dispute of material fact regarding whether they violated § 842, § 843.

3 It appears that Distributors only raise this argument in a footnote as an aside to their primary argument that, to the extent their alleged failure to report suspicious orders constitutes a racketeering activity, it did not cause Plaintiffs’ injuries. The broader causation elements of Distributors’ argument are addressed further below.

Distributors also imply for the first time in their reply brief that, because Plaintiffs argue in opposition to summary judgment that “Distributor Defendants flatly failed in their obligation not to ship suspicious orders” pursuant to 21 U.S.C. § 823(b), that Plaintiffs abandoned their prior assertions of various categories of racketeering activity including mail fraud, wire fraud, and failure to report suspicious orders (as a potential violation of § 843). Pls. Opp. Resp. re RICO & Civ. Con. at 114 (Doc. #: 2182) (emphasis in original). As stated above in footnote 3, Distributors’ arguments regarding the viability of Plaintiffs’ assertions of predicate acts was made in the broader context of their proximate causation arguments. Thus, Plaintiffs response, which was intended to address proximate cause and not predicate acts, was appropriate under the circumstances. The Court does not construe Plaintiffs’ opposition response as disclaiming any assertion of predicate acts previously made and argued.

A.  The Existence of An Enterprise

“[A]n association-in-fact enterprise is ‘a group of persons associated together for a common purpose of engaging in a course of conduct.’” Boyle v. United States, 556 U.S. 938, 946 (2009) (quoting United States v. Turkette, 452 U.S. 576, 583 (1981)). To satisfy the enterprise requirement, “an association-in-fact enterprise must have at least three structural features: a purpose, relationships among those associated with the enterprise, and longevity sufficient to permit these associates to pursue the enterprise’s purpose.” Id. The concept of an enterprise is intended to be broad and “[s]uch a group need not have a hierarchical structure or a ‘chain of command’; decisions may be made on an ad hoc basis and by any number of methods.” Summit R&R at 36 (Doc. #: 1025) (citing Boyle, 556 U.S. at 944). The Court has previously observed that “[a]n enterprise includes any group of individuals associated together for a common purpose of engaging in a course of unlawful conduct.” Robins, 838 F. Supp. 2d at 651.

Of course, just because an enterprise’s common purpose may include unlawful conduct does not mean the enterprise’s common purpose must be unlawful. In fact, both the Supreme Court and the Sixth Circuit have made clear that the purpose of the enterprise need only be common to its members, and “must be separate from the pattern of racketeering activity in which it engages.” Frank v. D’Ambrosi, 4 F.3d 1378, 1386 (6th Cir. 1993) (citing Turkette, 452 U.S. at 583). That is, if a group of individuals associate together for the common purpose of committing a series of unlawful acts (and those unlawful acts are also RICO predicate acts), the common purpose is not separate from the pattern of racketeering activity, and there is no RICO violation (there is likely just a conspiracy to commit a crime). If, however, the series of unlawful acts is not the ultimate goal of the group of individuals, but instead merely an unlawful method to achieve that goal, then the enterprise can be described as “separate from the pattern of racketeering activity in which it engages,” and may constitute a RICO violation. Id. There is no requirement, however, that the ultimate goal also be unlawful.

Defendants assert there is no evidence of coordination sufficient to form an association in fact. The Court has already concluded, however, that Plaintiffs have produced sufficient evidence for a reasonable jury to conclude that all Defendants, which includes RICO Marketing Enterprise Defendants and RICO Supply Chain Enterprise Defendants, associated together for the common purpose of expanding the prescription opioid market. See Order Re Civ. Con. (Doc. #: 2562). Plaintiffs have produced evidence to raise genuine issues regarding whether and to what extent the various Defendants coordinated (relationship prong) with one another to expand the opioid market and protect the supply chain (common purpose prong), and that it has been going on long enough to pursue the common purpose (longevity prong). Id. at 6-10. Thus, Defendants have not shown an absence of any essential element as described in Turkette and Boyle such that no reasonable jury could find the existence of an enterprise.

Defendants also assert there is no evidence that they directed or controlled the enterprise. The Supreme Court has said that, “[i]n order to ‘participate, directly or indirectly, in the conduct of such enterprise’s affairs,’ one must have some part in directing those affairs.” Reves v. Ernst & Young, 507 U.S. 170, 179 (1993). The Sixth Circuit further clarified that, “[a]lthough Reves does not explain what it means to have some part in directing the enterprise’s affairs, subsequent decisions from our sister circuits have persuasively explained that it can be accomplished either by making decisions on behalf of the enterprise or by knowingly carrying them out.” United States

  1. Fowler, 535 F.3d 408, 418 (6th Cir. 2008). Thus, in order to show that a Defendant “conduct[s] or participate[s], directly or indirectly, in the conduct of such enterprise’s affairs,” Plaintiffs must show that Defendants made decisions or knowingly carried out acts that helped to further the common purpose of the enterprise. 18 U.S.C.A. § 1962(c).

In its September 3, 2019 Opinion and Order regarding Civil Conspiracy, the Court reviewed the evidence produced by Plaintiffs and determined that various decisions made and actions taken by Manufacturers and Distributors ‒ which, again, include the Marketing Enterprise and Supply Chain Defendants ‒ are sufficient to create a genuine issue of material fact as to whether these Defendants conspired with one another to expand the opioid market and protect the opioid supply chain. See Order re Civ. Con. at 6-10 (Doc. #: 2562). The Court now concludes that these same facts create a genuine issue as to whether Marketing Enterprise and Supply Chain Enterprise Defendants participated in the conduct of these enterprises’ affairs. Defendants have failed to demonstrate that no reasonable juror could conclude, based on the evidence, that they did not.

B.  Causation

 Defendants also assert Plaintiffs have produced no evidence that the alleged predicate acts are causally tied to Plaintiffs alleged RICO injuries. The Court has addressed Defendants causation arguments at some length. See Summit R&R at 24-36 (Doc. #: 1025); Order re MTD Summit at 7-10 (Doc. #: 1203); Order re Causation (Doc. #: 2561). In all instances, the Court has concluded that Plaintiffs will be allowed to test their aggregate theory of causation and have produced enough evidence to raise a genuine dispute  of  material  fact.  See  generally,  Order  re  Causation  (Doc. #: 2561).

C.  Other Arguments

 Manufacturers also assert that RICO damages are not available, as a matter of law, for the marketing of their branded products. Manufacturers assert their marketing was independent, competitive behavior and not the conduct of the enterprise. This argument appears to confuse the alleged common purpose of the enterprise with the alleged pattern of racketeering activity. Plaintiffs have alleged that the purpose of the Marketing Enterprise was to expand the opioid market and that the pattern of racketeering activity by which they accomplished this goal was the use of mail and wire communications in the fraudulent marketing of prescription opioids. Defendants’ argue that their alleged unlawful conduct (fraudulent marketing of opioids), cannot— at the same time—benefit both them individually (increasing market share) and the enterprise collectively (expanding the opioid market). Defendants, however, cite no case law that persuades the Court that racketeering conduct cannot serve both the member and the enterprise at the same time.

Finally, Manufacturers assert Plaintiffs have not done enough to demonstrate that their alleged RICO damages do not flow from the personal injuries of their citizens. In its Opinion and Order adopting the Magistrate Judge’s R&R on the motions to dismiss, the Court concluded that Plaintiffs had sufficiently alleged “categories of costs . . . that cannot be said to arise directly out of Plaintiffs’ residents’ personal injuries.” Order re MTD Summit at 16-17 (Doc. #: 1203). Defendants’ argument now urges the Court to reconsider its supposedly too-broad application of Jackson v. Sedgwick Claims Mgmt. Servs., Inc., 731 F.3d 556 (6th Cir. 2013).4 The Court declines to do so.

Accordingly, Distributors’ Motion for summary judgment on Plaintiffs’ RICO and OCPA Claims, (Doc. #: 1921); and Manufacturers’ Motion for summary judgment on Plaintiffs’ RICO, OCPA, and Conspiracy Claims (Doc. #: 1930) are both DENIED.

IT IS SO ORDERED.

  

/s/Dan Aaron Polster September 10, 2019

DAN AARON POLSTER

UNITED STATES DISTRICT JUDGE

 

 

 

 

 

 

 

 

 

 

 

 

4 Notably, Manufacturers do not assert that the Court’s application is incorrect; merely that it is broad. See Man. MSJ on RICO & Civ. Con. at 27 (Doc. #: 1930-1).

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Opioid MDL 2804 Class Settlement: Judge Polster tells state AGs to come up with a better model

 

Their response: “The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

By Mark A. York (August 8, 2019)

(MASS TORT NEXUS MEDIA) Opiate drugmaker stocks fell sharply after Bloomberg reported that a coalition of state attorneys general had demanded $45 billion from the three leading drug distributors in the U.S. to settle litigation over opioids.

According to Bloomberg, the counteroffer came after the distributors proposed a $10 billion settlement. The reported offers were made in negotiations between the National Association of Attorneys General andMcKesson (ticker: MCK), Cardinal Health (CAH), and AmerisourceBergen(ABC).

The report appears to be spooking investors. Shares of Cardinal were down 6.4% in afternoon trading, McKesson fell 5.9%, and AmerisourceBergen declined 6.1%.

Generic drugmakers also suffered large drops – . Teva Pharmaceutical Industries(TEVA) was down 8.7%, Mylan (MYL) was down 6.6%, and Endo International(ENDP) and Mallinckrodt (MNK)—which both released earnings Tuesday—were down 19% and 11.7%, respectively.

Those amounts appear to be far higher than investors expected. In a note Tuesday, Evercore ISI analyst Ross Muken wrote that investors he had spoken with had expected the distributors to pay $5 billion.

“Ohio Attorney General letter to Opiate MDL Judge Pollster citing caselaw”

The motion excludes state attorneys general, some of whom have brought lawsuits in state courts across the country, and sets up a procedure in which 24,500 cities, counties and other smaller governments could resolve their claims. It comes two days after Alabama Attorney General Steve Marshall voluntarily dismissed the state’s case in federal court and as Oklahoma Attorney General Mike Hunter is in the midst of the first opioid trial in the nation against manufacturer Johnson & Johnson.

Ohio AG Response

The Ohio AG wrote a letter to Federal Judge Dan Polster, where he challenged the legitimacy of the strategy pursued by private plaintiff attorneys, some of them veterans of the 1997 settlement between the states and the tobacco industry, who have signed up thousands of individual cities and counties as clients to try to pressure opioid manufacturers and distributors into a multibillion-dollar settlement. Private lawyers reaped some $14 billion in fees from the $260 billion tobacco settlement.

Yost criticized “the self-admitted power grab being made by unelected private attorneys to control the distribution of public moneys within the States.”

“The proposed negotiating class, and perhaps this very litigation, threatens the sovereignty of the States like nothing else in recent history,” he wrote. “It seeks to represent not a single political subdivision asserting parens patriae standing, but all of them. In other words, this motion seeks to permit the class to stand in the shoes of the States — nothing short of usurpation.”

Yost also criticized the allocation mechanism the lawyers have proposed. According to an “Allocation Map” the lawyers have placed online, Coshocton County, Ohio, would get $1.99 per capita or a total of $73,265 out of a $1 billion settlement, after lawyers claimed $100 million in fees.

“Distributing a few thousand dollars to local communities is meaningless.”  Ohio was among 27 states, including Texas and California, that filed a letter in June asking Judge Polster to delay any decision on a class.

See OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION

The motion also comes as U.S. District Judge Dan Polster of the Northern District of Ohio has pushed for global settlement talks while setting the first trial in the MDL for Oct. 21. In a brief supporting their motion a settlement class, which included 40 class representatives, including counties in California, Florida, Georgia, New Jersey and New York, and major cities such as Atlanta, Chicago, Denver, Los Angeles and San Francisco.

“This precise vehicle has never been used before, but we are very confident that this is a valid use of the procedure and that the court will, we are hopeful, welcome this as an opportunity to move the resolution of these cases forward,” said co-lead plaintiffs attorney Paul Hanly of Simmons Hanly Conroy in New York.

The federal litigation link is, Opiate Prescription MDL 2804, US District Court of Ohio link.

The move is also designed to provide some assurances to defendants—manufacturers and distributors of the prescription painkillers, as well as pharmacies—about the total scope of lawsuits that are out there.

The federal judge overseeing multidistrict litigation against opioid manufacturers and distributors left little doubt he supports a plan developed by private lawyers to assemble an unprecedented “negotiating class” consisting of every city and county in the U.S.

Rejecting complaints that the proposal would violate federal law and trample on states’ rights, U.S. District Judge Dan Aaron Polster repeatedly said “there has to be a vehicle” for resolving the nearly 2,000 cases by cities and counties that have been concentrated in his court. Along with hundreds of lawsuits still in state court and litigation by individual states, Indian tribes and other entities such as healthcare agencies and pension funds, Judge Polster said, the mass of litigation must be settled somehow.

“Everyone knows that trying 2,500 cases would sink the state and federal judiciaries, but also the amount of private resources would also be staggering and no one would want that,” the judge told lawyers for both sides during 1.5-hour hearing in Cleveland Tuesday morning.

A majority of state attorneys general as well as defendants including drug distributors are opposed to the proposal, under which Judge Polster would certify a procedure that specifying how funds from an opioid settlement are distributed to individual counties before any money is on the table. In filings with the court in late July, Ohio AG Dave Yost called the plan a “power grab” by private lawyers who represent most of the cities and counties in the litigation.

August 6, 2019 Development

“The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

Among other objections, critics of the plan say it would violate Rule 23 of the Federal Rules of Civil Procedure, which governs class actions, and U.S. Supreme Court decisions requiring class action lawyers to fairly represent both their own clients and so-called “absent” class members who aren’t participating in settlement negotiations or may not even be aware of the litigation.

In a back-and-forth exchange with Sonja Winner, a Covington Burling attorney representing McKesson, the judge dismissed the idea the proposal might violate the most important Supreme Court precedent, Amchem v. Windsor. In that 1997 decision, the court said any class action must satisfy Rule 23 requirements, including that the claims are typical across the entire class and the interests of absent class members are represented.

Winner said the proposed mechanism for allocating money under a settlement only reaches as far as the counties, leaving cities to negotiate their share of the money with the counties that theoretically represent them in the class. The conflict between the two groups would be fatal under Amchem, she said.

“I’m not worried about the Supreme Court — the issue is what I will do,” Judge Polster responded.

“I’ve got 2,000 cases. There has to be a vehicle for solving them as a group.”

According to a calculator the plaintiff lawyers have put online, Fremont County in Wyoming would get $98,000 of a hypothetical $1 billion settlement, while the town of DuBois would get nothing because its $98 payout would fall below a $500 minimum. Winner said that was typical of the uneven results that individual cities and counties might not be aware of before they are asked to decide whether to sign off on the settlement procedure or opt out.

The judge also brushed aside objections from other AG’s, who stated that the complex allocation formula would intrude on the power of the states to allocate money among their political subdivisions as they see fit. Judge Polster said he wouldn’t approve any language undermining state sovereignty, but went on to say he also won’t approve any settlement that directs all of the money into state treasuries, as some politicians demand.

He cited the 1997 tobacco settlement, in which little of the money paid over by cigarette companies actually went toward treating smoking-related disease. He said it was a “problem” that “in a number of states any money that the state AG obtains …goes into the general fund.”

Because the litigation in his court “encompasses the cities and counties,” any settlement “has to account for the matter of putting money into state general funds,” the judge said. “Because that idea isn’t going to fly.”

Clearly Judge Polster’s views on the opioid litigation have evolved since the early days, when he envisioned a swift settlement that included significant changes in how the industry does business. He repeatedly agreed with defendant companies that they have no incentive to settle unless plaintiff lawyers can offer them global peace, and that is impossible without the participation of the states and possibly even the federal government.

“Everybody understands no defendant is going to settle with the states alone and not the cities and counties,” or vice versa, he said. “That would be lunacy.”

The judge also told critics, including defendant companies, to come up with a better solution if they don’t like the one the plaintiff lawyers have proposed.

“Nobody has a monopoly on good ideas,” he said. “The more ideas floated, the better.”

He did recognize one glaring conflict of interest in the current proposal: Some of the same lawyers, most prominently Motley Rice, represent states and hundreds of members of the proposed class of cities and counties. He barred those lawyers from participating in the hearing or arguing in favor of the proposal.

“Those lawyers have a conflict at the moment because all or most of the state attorneys general are opposing this motion,” he said.

The judge also said that if he approves the mechanism, which seemed likely from his comments, he will appoint an independent representative on behalf of the tens of thousands of cities and counties that haven’t sued but could belong in the class. He also said he would limit settlement releases to claims under federal law and would have 13 nationwide “families” of defendants.

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

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FDA – Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma: Who Knew and When?

A Litigation Review by Mass Tort Nexus

July 30, 2019

https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

By Mark A. York 

(Mass Tort Nexus Media) The  Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

What is the connection between textured breast implants and cancer?

Studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not a breast cancer but a cancer of the immune system. Plastic surgeons have identified at least 688 cases of BIA ALCL worldwide, as of February 2019. The FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia has placed the risk as high as 1 in 1,000.

While the vast majority of BIA ALCL cases occur in patients with textured implants, the FDA has identified at least 24 in patients with smooth-surfaced implants.

Breast Implants Can Cause Cancer

There is now a link between cancer and breast implants emerging in scientific and medical circles. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants. French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

 

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

 Silicone Breast Implant Lawsuit Not Preempted, Case to Proceed USDC ND Illinois Ruling

As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of “ALCL” or other spelling variations (for example, “anaplastic lymphoma,” or “anaplastic”) in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.

The tables below summarize unique BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of July 6, 2019.

Table 1: Summary of US and Global Deaths Reported in MDRs Received as of July 6th, 2019 (N = 33)

https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs submitted to the FDA.  We excluded apparent duplicates. The data is stratified by factors that we considered in our analysis.

ALCL Deaths from MDRs and Literature reported as MDRs* Deaths through 7/6/29 (n=33)
n %a
Age at time of diagnosis (years) Median 52
Range 37-83
Not specified (# of reports) 13 39
Time from the last implant to diagnosis (years) Median 9
Range 1-20
Not specified (# of reports) 23 70
Implant Surface Textured 15 48
Smooth* history of textured 1 3
Not specified 17 48
Implant Fill Silicone 14 42
Saline 8 24
Not specified 11 33
Reason for Implant Reconstruction 5 15
Augmentation 17 52
Not specified 11 33
Clinical presentation (breast)b Seroma 6 18
Breast swelling/pain 3 9
Capsular contracture 1 3
Peri-implant mass/lump 13 39
Others 7 21
Not specified 7 21
Anaplastic lymphoma kinase (ALK) Positive 0  0
Negative 12 36
Not specified 21 64
CD30 Statusc Positive 12 36
Negative 0 0
Not specified 21 64
Implant manufacturer Allergan 12 36
Mentor 1 3
Unknown 20 61
Reporter country: US or OUSd US 12 36
OUS 21 64
Not specified 0 0

a Percentage in terms of the total 33 deaths. There are no reports of deaths associated with tissue expanders.
b MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
c CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
d US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form.
* Includes 1 case of B-Cell Lymphoma

Table 2: Summary of US and Global Data as of July 6, 2019 (N=573)

These data are a tabulation of US and global BI-ALCL cases reported to the FDA in MDRs.  We excluded apparent duplicates.  The data is stratified by factors we considered in our analysis.

Unique ALCL cases1 Cases through 9/30/18
(n=457)
Cases through 7/6/19
(n=573)
n %a n %b
Age at time of diagnosis (years) Median 53 53
Range 27-90 27-90
Not specified (# of reports) 111 24 161 28
Time from the last implant to diagnosis (years) Median 9 8
Range 0-34 0-34
Not specified (# of reports) 110 24 169 29
Implant surface Textured 310 68 385 67
Smooth 24 5 26c 5
Not specified 123 27 162 28
Implant fill Silicone 274 60 343 60
Saline 183 40 197 34
Not specified 0 0 33 6
Reason for implant Reconstruction 108 24 115 20
Augmentation 104 23 111 19
Not specified 245 54 347 61
Clinical presentation (breast)d Seroma 266 58 302 53
Breast swelling/pain 135 30 150 26
Capsular contracture 69 15 73 13
Peri-implant mass/lump 82 18 94 16
Others 43 9 56 10
Not specified 105 23 147 26
Anaplastic lymphoma kinase (ALK) Positive 0  0 0 0
Negative 229 50 255 45
Not specified 228 50 318 55
CD30 statuse Positive 215 47 246 43
Negative 0  0 0 0
Not specified 242 53 327 57
Implant manufacturer Allergan* includes McGhan, Inamed 386 84 481 84
Mentor 36 8 38 7
Sientra 2 0.4 6 1
Other Manufacturerf 5 1 6 1
Unknown Manufacturer 28 6 42 7
Reporter country: US or OUSg US 276 48 320 56
OUS 181 32 253 44
Not specified 0 0 0 0

1Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
a Percentage in terms of the total 457 MDRs.
b Percentage in terms of the total 573 MDRs.
c In the 26 cases of smooth implants, 12 have unknown prior history of implants, 7 have a history of textured implants, and 7 have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
e CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
f Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed
g US/OUS is counted as the recorded reporter’s country in the MedWatch form, or if the event was noted to be from a foreign source in box G3 of the MedWatch form. Please note that the reporter country may not reflect the country where the event occurred or the country where the device is marketed.

History of Adverse Events Has Been Known 

The FDA has  coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Breast implant lawsuits are underway as of October 2016. In March 2017, the FDA issued a warning confirming that breast implants cause ALCL cancer. Lawsuits for ladies with BIA-ALCL are currently being organized. In April 2017, a bipartisan bill called the Medical Device Safety Act H.R. 2164 was introduced and needs your help in being passed to hold the manufacturers accountable for the harm they have caused. In January 2018, a Mentor MemoryGel Silicone Breast Implant case was able to in part pass preemption.

Background:

In the early 2000s, Allergan and Mentor were approved for premarket Investigational Device Exempt (IDE) studies where a limited number of plastic surgeons were allowed to use silicone breast implants, accordingly they were supposed to inform women of the study and follow up on them. In November 2006, Mentor and Allergan silicone breast implants were conditionally approved and six postmarket studies were to be conducted, see Mentor Approval Order and Allergan (formerly Inamed) Approval Order. The manufacturer premarket and postmarket studies have overall failed to follow up on women and provide real statistics on health problems that arise.

Presently, in 2018, there are over 50,000 women in breast implant illness Facebook support groups. Similar to the Dow times, the manufacturers have again pushed a campaign marketing the safety and inertness of implants rather than disclosing the truth of lack of real statistics and follow ups, the adjuvant immunologic effects of silicone, and the numerous heavy metals and chemicals used in manufacturing. With the lack of awareness on the matter, there is currently a public health crisis as the medical community at large has failed to help women identify breast implants as playing a role in their symptoms and has led to many misdiagnoses, unnecessary medications and treatments, and body parts being removed (thyroid, gall bladder, uterus, etc.). History is repeating itself and the manufacturers need to be held accountable for the alleged lack of informed consent and toxicity caused by saline and silicone breast implants.

Current Breast Implant Lawsuits:

Silicone

  • Weber v. Allergan (2012)
  • Ebrahimi v. Mentor (2016)
  • Mize v. Mentor Nguyen v. Mentor (Spouse Plaintiff) (2017)
  • Gravitt v. Mentor Gravitt v. Mentor (Spouse Plaintiff) (2017)
  • Skelton v. Allergan – BIA-ALCL (2018)
  • Cashen v. Mentor | Cashen v. Mentor (Spouse Plaintiff) – BIA-ALCL (2018)
  • Rea v. Allergan – BIA-ALCL (2018)
  • Vieira et al v. Mentor Worldwide, LLC et al (2018)
  • Sewell et al v. Mentor (2018)

Saline

  • Laux v. Mentor (2015)
  • Allergan Saline Lawsuits (2016)

Mentor Silicone Breast Implant Lawsuits:

Lawsuit Filed Against Mentor Worldwide Over Mentor MemoryGel Silicone Breast Implants 

(September 28, 2016)

A Seattle woman, Sara Ebrahimi, has filed suit against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging the defective manufacturing of Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that Mentor and its parent company, Johnson & Johnson, repeatedly failed to follow the requirements imposed by the Food and Drug Administration (“FDA”) in connection with the approval of Mentor’s premarket approval application. It is further alleged that the companies failed to warn the FDA and women receiving the implants of the devices’ known dangerous propensities. The lawsuit — Ebrahimi v. Mentor Worldwide LLC, et al. (case no. 2:16-cv-07316-DMG) — was filed in the Central District of California in Los Angeles, where Mentor is headquartered.

Mentor develops, manufactures, and markets products for surgical and non-surgical procedures, including Mentor MemoryGel™ Silicone Breast ImplantsThe lawsuit alleges that chemicals Mentor used in the manufacturing process bled through the implants, and into Ms. Ebrahimi’s body, causing her to suffer serious medical problems. It is alleged that Mentor and Johnson & Johnson knew that their devices were defective, yet allowed them to be surgically implanted in Ms. Ebrahimi and other unsuspecting women. It is further alleged that Mentor and Johnson & Johnson failed to warn the FDA of these risks by not providing adequate follow-through studies.

Mentor MemoryGel™ Silicone Breast Implants are regulated medical devices under the Food, Drug and Cosmetic Act that require FDA approval. As a condition of approval, the FDA required that Mentor conduct six post-approval studies to demonstrate, over time, that its silicone implants were safe and effective. The lawsuit alleges that Mentor failed to design effective studies and, as a result, failed to provide the FDA with the longitudinal studies that were required as a condition to the devices’ approval. It is alleged that:

It was Mentor’s obligation to design and execute a study where women were able to access internet forms that are easily understood and provide a working forum to report their experience with implants. Mentor intentionally and systematically failed to make this happen which is a violation of the FDA’s conditions for approval. Data collection was sparse and potential serious side effects and harmful complications were downplayed and under-reported due to inadequate sample size.

This lawsuit influenced a new wave of breast implant litigation. Its research and structure are being used as a model being replicated by the following lawsuits below.

Rexina Mize, et al. v. Mentor Worldwide LLC

(February 2nd, 2017)

The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles). In March 2017, the case was transferred and reassigned to the federal judge handling Ebrahimi v. Mentor and the case number was changed to CV 17-1747 DMG (KSx). In August 2017, the case was remanded back to state court.

Her husband, Spouse Plaintiff Minh Nguyen, is also suing Mentor on loss of consortium.

From the article, Johnson & Johnson Unit Sued Over Leaking Breast Implants:

Catherine Gravitt, et al. v. Mentor Worldwide LLC

(July 25th, 2017)

The case is Gravitt et al v. Mentor Worldwide LLC, No. 1:2017cv05428, Illinois Northern District Court (Chicago). Catherine Gravitt and her husband Travis Gravitt are the plaintiffs who filed against Mentor, see Complaint. She was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010 and in 2016 she discovered a rupture. Health complications included abnormal thyroid levels, swollen lymph nodes, severe and random skin rashes, blackouts and periods of disorientation, extreme fatigue and weakness, muscle soreness, frequent flu like symptoms, anxiety, depression, and more. Additionally it is alleged she gave birth to a son and daughter who both developed defects related to the toxic materials leaking from her breast implants. See the docket and the news article, “Couple’s lawsuit faults California breast implant maker.

In January 2018, U.S. District Judge Gary Feinerman allowed the case to in part pass federal preemption, see Memorandum Opinion and Order. This is a significant court ruling for all breast implant cases. See the news article, “Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge.”

Renee Cashen, et. al v. Mentor Worldwide LLC, Ethicon, and Johnson & Johnson 

(April 27th, 2018)

The case is Cashen et al v. Mentor Worldwide LLC, filed in the Superior Court of New Jersey. Renee Cashen and her husband Richard Cashen are plaintiffs. In February 2008, she was implanted with textured Mentor MemoryGel Siltex Round Moderate Gel Breast Implants. After implantation, she was discharged from the post-market study she had been enrolled in. In 2016, she noticed a lump under her right armpit. A month later a biopsy was done and ALCL was discovered but it took several weeks later until her doctors associated it with her Mentor breast implants. In May 2016, Mrs. Cashen had explant surgery and six lymph nodes removed. In July 2017, she began chemotherapy treatments. The Defendants allegedly failed to comply with their post-approval surveillance obligation.

They are represented by Ross Feller Casey, LLP and McEldrew Young, both in Philadelphia, Pennsylvania.

Vieira et al v. Mentor Worldwide, LLC et al

(June 27th, 2018)

Nicole Vieira and Emilia Barozzi filed complaints in Los Angeles County Superior Court, Case No. BC711663. Plaintiffs were implanted with Mentor MemoryGel Silicone Breast Implants and afterwards they “experienced various medical complications, including fatigue, weakness, memory loss, and nausea.” After explantation it was discovered that the implants’ silicone gel had bled. The complaint alleges mistakes in Mentor’s manufacturing of the implants and defects in the silicone used. These resulted in silicone gel to bleed and therefore triggered the medical complications.

In July the case was moved to Federal Court, Case No. 2:18-cv-06502, and in September it was remanded back to Los Angeles Superior Court.

Allergan Silicone Breast Implant Lawsuits:

Nicole Weber v. Allergan No. 13-17017 (9th Circuit 2015)

The case was filed in 2012 and is moving to trial in early 2018.

“Weber appealed the district court’s dismissal of Weber’s diversity action brought against Allergan Inc, asserting strict product liability and negligence, and alleging that Allergan’s Natrelle Style 20 [silicone] breast implants are dangerous.” (Sept 21, 2015). See youtube video on her 9th Circuit court hearing. (The opposing attorney talks at 37:00)

Her amended claim was found to adequately state parallel state law claims (Oct. 23, 2015).

“Weber has identified to the extent possible without discovery, the standards she believes the manufacture of her implants violated, adequately stating parallel state-law claims.” the court said.

Vivian Skelton v. Allergan – BIA-ALCL

The case was filed as Skelton v. Allergan, No. BC696400 in Los Angeles County Superior Court. It was transferred to California Central District Court and the case number was changed to 2:18-cv-02617. She was diagnosed with breast implant-associated anaplastic large cell lymphoma, this is an Allergan BIA-ALCL Lawsuit.

Rhea v. Allergan – BIA-ALCL

(May 8th, 2018)

Michele Rea and Carl Rea from Fairfax, Virginia filed in the Superior Court of New Jersey in May 2018, see case here.

From Ross Feller Casey in ‘Another Lawsuit Alleges Breast Implants Cause A Rare Cancer‘:

Rea underwent reconstructive surgery for a partial mastectomy in 2011. About five years later, she was diagnosed with anaplastic large cell lymphoma, which was caused by a Natrelle Style 410 [highly cohesive silicone gel] implant made by Allergan, Inc., the suit alleges.

Allergan Saline Lawsuits:

In Jacksonville, Florida, the law firm of Terrell Hogan is filing hundreds of lawsuits against two local plastic surgeons – Dr. Loren Clayman and Dr. Mark Clayman. There are also allegations of fraud, as well as a lawsuit against Allergan.

“I represent about 150 women,” said Attorney Chris Shakib.

Shakib, the lead attorney in the case, called his findings unbelievable.

For further information, see articles on this here (June 1st, 2016) and here (November 29th, 2016).

Mentor Saline Lawsuits:

Anita Laux v. Mentor Worldwide LLC

(December 29, 2015)

The case is Laux v. Mentor Worldwide LLC, No. 2:16-cv-01026-ODW(AGR), filed in Ventura County Superior Court and moved to federal court. She is represented by Robert A. Zeman (Law Offices of Robert A. Zeman) and Alan C. Milstein (Sherman Silverstein Kohl Rose and Podolsky).

Breast implants are categorized as Class III medical devices (along with hip implants, pacemakers, cardiac stents, etc) and are very difficult to sue due to the 2008 Supreme Court case, Riegel v Medtronic which gave broad federal protection to manufacturers. To sue a manufacturer, one would need a product liability case and these are generally governed by state laws under theories of negligence, strict liability, and breach of warranty. The Supreme Court ruling with Riegel created a precedent for preemption of state laws, essentially citing that Class III medical devices are solely accountable to the regulations and surveillance of the FDA. After Riegel, the only way to sue is to assert parallel state law claims where one must prove the manufacturer deviated from a guideline they were approved by (a violation of a federal requirement, such as a FDA guideline), the violation of an identical state law, and how that violation of that federal requirement caused injury.

BIA-ALCL

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system caused by breast implants. It is generally found in fluid collection in between the implant and capsule, in a seroma, or in a nodule in the capsule. Physical signs are effusion, swelling, pain, inflammation, mass, ulceration, and others. The overwhelming symptoms in a majority of patients is a delayed seroma, persistent swelling, and pain. While even more rare some patients may present skin changes, lymphadenopathy, capsular contracture, or a potentially palpable mass.1 CD30 is the diagnostic test being used to distinguish ALCL. It is found to occur at a much higher rate in textured breast implants, however there have been some smooth surfaced breast implant cases as well.

Risks:

“[S]tudies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.” – FDA Update 3/21/18

Medical Device Reports (FDA)

Update: As of July 2017, Dr. Mark Clemens states that worldwide there have been 464 adverse event reports in relation to BIA-ALCL and 12 deaths. See PSEN Breast Implant Associated Anapestic Large Cell Lymphoma.

As of February 2017, the FDA has received a total of 359 medical device reports (MDRs) of breast-implant-associated ALCL, including nine deaths. Out of those 359 total reports, only 64% (231 reports) listed data on the surface at the time of reporting:

  • 87% (203 out of the 231 report) were with textured surfaces
  • 12% (28 out of the 231 reports) were with smooth surfaces

Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants.

Sample of the FDA Adverse Event Reports on BIA-ALCL:

Note: Parentheses represent redacted information to protect privacy.

  1. Company rep reported right side anaplastic large-cell lymphoma and “subcutaneous nodules and lymph nodes. ” the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013. (Reported in 2013, Allergan silicone) Link.
  2. Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an (b)(6) report written in aesthetic plastic surgery 2013 reports alcl, seroma, pain. Additional information noted in article anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an italian report written in aesthetic plastic surgery 2013 article notes in regards to the right side, “necrosis and chronic inflammation signs are present” and “skin above the implant became red and painful and the patient had febrile episodes. ” treatment noted for the event of seroma as “a broad-spectrum antibiotic. ” (Reported in 2013, Allergan silicone) Link.
  3. Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: “the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin’s lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin’s lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ” (Reported in 2013, Allergan saline) Link.
  4. Pt is a female who underwent left mastectomy in 1996, for ductal carcinoma in situ with tissue expanders and saline implant reconstruction. She presented in 2010, with a peri-implant hematoma, though possibly post-traumatic. She underwent evacuation of the hematoma and change to a silicone gel implant. All pathology specimens were negative for tumor. She again presented in 2012, with a spontaneous hematoma and at surgery multiple biopsies revealed anaplastic large cell lymphoma (alcl) limited to the periprosthetic capsule and hematoma fluid. After an extensive hematologic and metastatic workup which was negative, she underwent removal of the implant and total periprosthetic capsulectomy. Capsular pathology showed alcl. (Reported in 2012, Mentor silicone) Link.
  5. On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 – (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy – diagnosis lymphoma. (b)(6) 2010: surgical biopsy – diagnosis alcl. (b)(6) 2010: surgical biopsy – diagnosis alcl. (Reported in 2011, Allergan saline) Link.
  6. The original purchase date of this device was (b)(6)2004. In (b)(6) 2006, the pt was implanted with mentor siltex saline devices during a revision augmentation procedure. In (b)(6) 2008, the devices were replaced with mentor smooth saline devices due to a left device deflation. In (b)(6) 2010, the pt had both implants removed due to recurring fluid accumulation in the right breast. On (b)(6)2010, the pt was diagnosed with alcl (t-cell lymphoma). No further info is available at this time. (Reported in 2010, Mentor saline) Link.
  7. It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient’s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal. (Reported in 2017, Mentor Memory Shape Silicone) Link.

Above is only a sample of six reports to the FDA. As of July 2017, Dr. Mark Clemens states the FDA has received 464 adverse event reports in relation to BIA-ALCL and 12 deaths. Join the Facebook group ALCL in Women with Breast Implants BIA-ALCL to view reports by country.

BIA-ALCL Causation Theories:

The cause is still unknown but is actively being studied. Some researchers have theorized that biofilm contributes to lymphoma and others have thought the chemicals in the implants irritate the immune system. Both theories rely on the presence of persistent inflammation, which means chronic activation of immune cells and particularly the T lymphocytes, which are white blood cells involved with ALCL.

Throughout the body, there are many diverse populations of bacteria that are both beneficial and harmful. In recent years, there has been an increased focus in characterizing bacteria and analyzing patterns of bacteria to understand the possible correlation between normal versus infectious/cancerous scenarios – especially in relation to breast cancer. What has been discovered is that similar to how the gut has its own microbiome of good and bad bacteria, the normal breast tissue and human milk also have their own microbiology that over time is influenced by factors such as dietary and sugar changes. The article “Microbiota of the Human Breast Tissue” delves into the various specific bacteria that were found in human breasts. Since breasts are not sterile, if a foreign object is placed inside the body, it will be colonized and infected.

Biofilm is bacteria that adheres to the surfaces of medical devices. It can result in a low grade chronic bacterial infection, chronic inflammation, and capsular contracture. Some bacteria produce acid as they grow and this reduces the pH of the surrounding environment. In the closed off space between the surface of the implant and the inner capsule surface, the bacteria coating the implant could form an acidic environment that contributes potentially to the breakdown of silicone. Australian researchers found that biofilm from capsular contracture cases was different from the biofilm identified on 26 implants from lymphoma patients. This brings biolfim to light as “a possible infectious contributing cause” for the lymphoma.

The chemicals used in the manufacturing process, which are neurotoxic and carcinogenic, are also believed to be playing a role in the development of lymphoma. The majority of ALCL cases have been found with textured implants, the roughness of the surface is triggering chronic inflammation. Textured implants were designed to keep the implants in place, thus, the capsules embed themselves on and around the textured surface. This creates an intimate, hand in hand connection between the scar tissue and chemically abrasive textured surface. Over time, this can lead to a direct abrasive irritation of the immune system, significantly affecting T cells.

It is interesting to note the connection between polyurethane coated implants and textured implants. Polyurethane coated implants were the first type of breast implant linked to cancer, and textured implants have now become the second type of breast implant linked to cancer – what they both have in common is a chemically abrasive fuzzy surface. Polyurethane implants were in production from about 1980 to when the manufacturer voluntarily withdrew them in 1991 due to significant safety concerns. These implants were the precursors to the textured breast implants since the textured surface was thought to be important in reducing capsular contracture and firmness, but the implant manufacturers could not use polyurethane so instead they created the textured surface currently manufactured today (since the mid-1990’s). This textured surface is also linked to an increased occurrence of forming double capsules (scar tissue surrounding the implants) and seromas, thereby going against its intended purpose.1,2

Protocol: 

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer case worldwide were probably not reported, and noted that doctors and patients may not be aware the ACCL risks. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

BIA-ALCL and Mammograms:

There have been cases reported in the BIA-ALCL FB Support Group where mammograms have triggered breast swelling and led to BIA-ALCL diagnoses.

Resources:

Government Health Agencies and Other Sources

Science and Medical: 

Please see the Scientific Articles page for over 200+ references to breast implant related scientific articles. They are organized into eight categories: 1. General, 2. Researchers, 3. Saline Implants & Mold, 4. Ruptured Silicone Implants, 5. Biofilm & Infections, 6. Breast Feeding with Implants and Effects on Children, 7. Biomaterials, and 8. ALCL (cancer).

Current Experts:

Dr. Pierre Blais (chemist and biocompatibility expert – Canada), Dr. Arthur Brawer (rheumatologist and silicone toxicity expert – Long Branch, NJ), Dr. Yehuda Shoenfeld (physician and autoimmunity researcher – Israel), Dr. Cohen Tervaert (rheumatologist – Edmonton, Canada), Dr. Henry Dijkman (pathologist – Netherlands), Dr. Diana Zuckerman (President of National Center of Health Research), Dr. Sarah Myhill (UK), Dr. Lu-Jean Feng (plastic surgeon – Cleveland, OH), Dr. Victor Urzola (plastic surgeon – Costa Rica), Dr. H. Jae Chun (plastic surgeon – Newport Beach, CA), Dr. Matthew G. Stanwix (plastic surgeon – Henrico, VA), Dr. Susan Kolb (plastic surgeon – Atlanta, GA), Dr. Edward Melmed (plastic surgeon – Dallas, TX), Dr. Rita Kappel (plastic surgeon – Netherlands), Dr. Michael Harbut (environmental medicine specialist – Detroit, MI), Dr. S V Maharaj (silicone breast implants and platinum expert). See here for some of their publications.

Educational Links:

What You Need to Know About Breast Implants (National Center For Health Research)

Breast Implant Illnesses: What’s the Evidence? (National Center For Health Research)

Safety – Junk Science, ‘New’ Cohesive Gel, and Toxicity for Silicone and Saline Implants

Breast Implants and Cancer (BIA-ALCL) and BIAALCL.com

Dr. Myhill –

Silicone Breast Implants and Injections

Chemical Poisoning – Diagnosis

Detoxification

Dr. Urzola –

Breast Implant Illness

“Over the past year and 8 months I have learned and researched a lot about this condition. After explanting over 100 patients and seeing the extraordinary post operative reports with over 85% of patients reporting complete remission of their symptoms or at least an important improvement, we are committed to starting a scientific investigation with the purpose of validating BII as a syndrome and getting the medical community to recognize it as a problem affecting thousands of women around the world.” (2017)

Dr. Feng –

Breast Implant Removal: Basics I

Topic: Linda L. Haas, Feng Clinic CEO, answers basic scheduling questions from patients who have just started researching breast implant removal. Videos: Part I and Part II.

Breast Implant Removal: Basics II

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Mass Tort Nexus “CLE Immersion Course”

September 13-16, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Anne Marie Kopek at 954.837.3423 or AnneMarie@masstortnexus.com

  1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
  2. To obtain our free newsletters that contains real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

Note: (Excerpts within this article include other online media sources)

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Additional Resources On Breast Implant Complications and Adverse Events

Topics: pathology, mold/microorganisms, detoxification, coinfections/diseases, selecting a surgeon, silicone vs. saline, capsule removal, lymph node removal, hormones and symptoms of BII. Videoand Transcript.

Breast Implant Removal: Basics III

Topics: the aesthetics of the breast, muscle repair, mastopexies or breast lifts, fat transfer and who is a candidate. Video and Transcript.

Breast Implant Removal IV: Detoxification

Topic: An in-depth discussion of detoxification before and after breast implant removal. Video.

Will I recover from breast implant illness without lymph node removal? (Video)

Is There A Connection Between Lyme Disease and Breast Implant Illness? (Video)

MTHFR and breast implants (Video)

Dr. Feng Webinars I-IV and YouTube Channel

Research articles and studies

Dr. Chun –

“Many patients suffer from BII(Breast Implant Illness) from their saline or silicone breast implants.” – Dr. Chun’s Breast Implant Removal Page

YouTube Channel – with videos on explantation, ruptured implants, difficulty associated with detecting ruptured silicone, and an en bloc capsulectomy explant (graphic).

Instagram where you can see Dr. Chun’s meticulous skill and expertise in doing perfect en bloc explants.

FDA Testimony

Dr. Kolb –

If something is of use to women affected by breast implant illness, it will be provided on this website regardless of politics.

Doctors, are you listening?

Immune Protocol

Silicone Immune Treatment Protocol

Inositol for Silicone Detoxification Provided by Dr. Douglas Shanklin

Videos: Dr. Susan Kolb discusses silicone breast implants and saline breast implants

Book: The Naked Truth About Breast Implants: From Harm to Healing

Note: There are currently four pending medical malpractice lawsuits filed against this plastic surgeon.

Dr. Blais –

Breast Feeding

Truth on ‘Cohesive’ Gel Implant

Technology and composition of silicone breast implants

How do implants rupture and cause injury

Testimony to the FDA (2000) 

All articles on breast implants by Dr. Pierre Blais, click here. Topics include: rupture, cancer, breast feeding, polyurethane, saline implants, cohesive gel, explant problems etc.

Dr. Blais is a chemist and expert in the biocompatibility of implant materials. He has been analyzing breast implants and conducting breast implant failure analyses for over 40+ years. There is currently a backlog due to the high demand and he is not accepting any new breast implants. Dr. Blais is a significant resource, he is a wealth of information on most breast implant matters.

Dr. Brawer –

Case Report: Silicone is not fun in the sun (2018)

ASIA vs. the mechanisms of silicone toxicity (2017)

Vague Syndromes (2017)

Mechanisms of Breast Implant Toxicity (2017)

Autoinflammatory Syndrome Induced by Adjuvants (ASIA) Syndrome is Misguided (2017)

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity (2017)

Breast Implant Toxicity (2016)

Bones, Groans, and Silicone (2012)

Amelioration of Systemic Disease after Removal of Silicone Gel-filled Breast Implants (2000)

Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity (1998)

Chronology of systemic disease development in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Clinical features of local breast phenomena in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Dr. Schoenfeld

Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis (2018)

The ASIA syndrome: basic concepts (2017)

Autoimmune/Inflammatory syndrome induced by adjuvants (ASIA) and thyroid autoimmunity (2017)

Sjörgen’s Syndrome and Environmental Factors (2016)

Silicone and Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA). (2015)

Silicone implant incompatibility syndrome (SIIS). A frequent cause of ASIA (Schoenfeld’s syndrome). (2013)

Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum (2013)

The spectrum of ASIA: ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (2012)

’ASIA’ – Autoimmune/inflammatory syndrome induced by adjuvants (2010)

Fibrosarcoma after silicone breast augmentation: is there a connection? (1998)

Light and electron microscopic study of an invasive cribriform carcinoma with extensive microcalcification developing in a breast with silicone augmentation (1994)

Breast carcinoma occurring in association with silicone augmentation (1993)

Doctors Speak Out –

Dr. Bernard PattenDr. Al LevinDr. Robert Goldwyn,

Dr. Frank Vasey (the “Dark” side of silicone breast implants)

Dr. Stephen Edelson (goes into symptom mechanisms)

Dr. Britta Ostermeyer (on dangers of silicone implants)

Other Educational Videos –

Breast Implant Illness – Dr. Faria

Integrative en-block treatment – Dr. Hovsepian

Capsular contracture – ruptured breast implants – Dr. Cassileth

Silicone Toxicity and Detoxification – Dr. Jennings

Immune Response to Silicone (skip to 5:38 for the effects on children)

Dr. Urzola’s Live Feed on Breast Implant Illness (2017)

Other links:

National Birth Defect Registry

  • Did you have breast implants while pregnant?
  • Did you breastfeed with breast implants?
  • Was your child born with a birth defect? Was your child born with a birth defect?

The National Birth Defect Registry might be able to help us research any possible link between breast implants and birth defects. If you’d like to help, please go to their website and register. Click here for more info.

***Search here if a doctor is receiving payments from a manufacturer and here (such as fees in research, consulting, speaker, sponsor, etc).

Petitions –

Breast Implant Petition

Request FDA Hearing

Medical Device Safety Act H.R. 2164

Surveys –

Dr. Victor Urzola’s Breast Implant Illness Data Collection Database

Dr. Yehuda Shoenfeld’s ASIA survey

PIP Implants Survey – if you have or had PIP, please fill out this survey

Concerns for estrogenicy of silicone breast implants

Allergan manufacturing patent

Method of making textured surface implants patent (Mentor)

UK MHRA PIP Implant Ingredient Analyses

Dr. Harbut response to FDA on platinum toxicity

Dr. Maharaj and Dr. Lykissa responses to FDA on platinum toxicity

Facebook Support Groups:

US: Breast Implant Illness – The Ticking Time Bomb

Breast Implant Illness and Breast Cancer Survivors Home

Canada: Breast Implant Failure and Illness – Canada

Australia: Breast Implant Illness – (Australia & New Zealand) Healing and Support

UK: UK Breast Implant Illness and Healing Support Group

ALCL: ALCL in Women with Breast Implants (BIA-ALCL)

For all medical devices: Medical Device Problems

Mothers: Breast Implants and Children

There are over 160+ breast implant illness support groups and awareness pages on Facebook where women share their experiences.

Personal Stories and Videos:

The Naked Truth // My Life with Breast Implants

Personal stories

Alex Chafen – Breast Implants, a Husband’s Perspective

Andrea Conti Cowder (Video and BII Story)

Pursuing Explantation – My path to health after breast implant illness

Beth Maturevich – Breast Implant Illness (Saline) Video

Raylene Hollrah – Diagnosed with ALCL, story

Implant Illness Awareness – Breast implants are not safe. We are the proof.

Mybreastimplantillness WordPress 

nothappywithmentor.blogspot.com

The faces of breast implant illness – Video

Jamee Cook –

Pursuing Explantation – My path to health after breast implant illness

YouTube channel on breast implant illness

Advocacy Groups:

US:

Canada:

Australia:

Netherlands:

UK:

Scotland:

Ireland FB Group: PIP Ireland

France:

Italy FB Page: Protesi PIP and Blog

Sweden:

Switzerland: Informationen zu Brustimplantaten

Venezuela FB Group: Protesis Mamarias PIP

Brasil: Breast Implants Illness (Doença Prótese Mamária) Brasil

Singapore FB Page: Implant Illness and Detox Singapore

South Africa: Breast Implant Illness – South Africa

Breast Implant Illness Websites:

Breast Implant Victim Advocacy (BIVA)

Breast Implant Failure

BIA-ALCL

BIA-ALCL Awareness –  Just Call Me Ray Foundation  (Non-Profit)

Breast Implant Info (Non-Profit)

No Grit No Pearls.org (Non-Profit)

Toxic Discovery (Non-Profit)

Life Since Explant Club

Reversing Breast Implant Illness

Healing Breast Implant Illness

Discover Breast Implant Illness

Miss Diagnosed

BII Aware

Prothese Mammaire Danger

Fake Breasts Real Women

Breast implant illness websites and forums have been around since the late 90s and early 2000s:

Silicone Poison Report

Silicone Holocaust

Implant Information Network (founded in 2004)

Breast Implant Awareness – Humantics Foundation (founded in 2001)

Silicone Implants Survivors (forum since around 1999) and PS List

Silicone Hypersensitivity (owner passed away)

In addition, there were Yahoo support groups and breastimplantsupport.org was another popular forum but now is no longer running.

Breast Implant Manufacturer FDA Information:

Recalls

Allergan Natrelle Silicone & Allergan Silicone Timeline 

Allergan Natrelle 410 Cohesive Anatomical Silicone & Allergan Silicone Timeline

Mentor MemoryGel Silicone & Mentor Silicone Timeline

Mentor MemoryShape Silicone & Mentor Silicone Timeline

Sientra Silicone & FDA Timeline

Allergan Natrelle Saline & Saline Timeline

Mentor Saline & Saline Timeline

Ideal Saline & Saline Timeline

For more information on breast implant FDA links and how to do more FDA research, click here.

Books:

The Naked Truth About Breast Implants: From Harm to Healing by Dr. Susan Kolb

The D.I.R.T. Committee by Gail Hamilton

  • Must read, especially if you had Dow
  • D.I.R.T = Document Investigation & Review Team

The Boobie Trap: Silicone, Scandals, and Survival by Barbara Stanistreet

Informed Consent by John A. Byrne

Dr. Andrew Hall Cutler:

Dr. Cutler has a PhD in chemistry from Princeton University and has extensive study in biochemistry and medicine. He himself got mercury poisoning from amalgam fillings and created these books to provide guidance for detoxification.

Movies: Two Small VoicesBreast Men, Absolutely Safe

Press Articles & News:

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Mother feels she is dying after her 32E breast implants ‘poisoned’ her

Dr. Britta Ostermeyer testifies to FDA in 2000 on the dangers of silicone breast implants.

Safety of breast implants under review in South Korea after silicone gel found in breast milk

FDA panels put silicone breast implants back under microscope (2011)

The silicone implant scandal (2012)

Breast Implants: America’s Silent Epidemic

Breast Implant Illness by Maya

Sara-Jane Fitness Cover Story

The Troubled History of PIP’s Implant Man in America **Implant manufacturers all operate in relatively similar ways and this article provides a glimpse of the dirty and corrupt business.

The “Dark” Side of Silicone Breast Implants

Toxic Moldy Breast Implants

Breast Implant Toxicity – on the radio with Danielle Delaney & Alex Charfen

The Ill Effects of Breast Implants

Why are celebrities removing their breast implants?

Explant Breast Surgery: Why women are getting their breast implants removed

Devoted mother-of-four dies from heart failure after implants trigger dormant TB

46 cases of ALCL diagnosed in Australia & New Zealand

Australia’s health regulator has confirmed that women with breast implants have a much higher risk of cancer (7 News Sydney – Video)

Patients accuse breast implant manufacturer of fraud (2016 – Allergan)

Breast implant illness conference – Texas (7/16/16)

News Segment on a lady with breast implant illness & saline implants

Monsters Inside of Me – Discovery Channel on saline implants with mold

Mold and Breast Implant Illness – The Doctors (TV show)

2017 – Important Year for Breast Implant News –

Breast implant illness gains nationwide coverage and becomes a movement:

French court says German firm must compensate for faulty breast implants

Woman who beat breast cancer once says breast implants caused cancer again

Johnson & Johnson Unit Sued Over Leaking Breast Implants

Johnson & Johnson, Mentor Worldwide LLC Senior staff target Support Groups

Former Playboy Models Get Their Breast Implants Removed Believing They Caused Illness

Mother-of-two is left with ROTTING breasts after silicone implants leaked into her blood stream – as cosmetic procedures fall to a ten-year low in the UK 

Can implants kill you?

Phoenix Valley women speak out on breast implant illness: ‘I just had to get them out’

Doctor’s Breast Implant Illness Denial Elicits Strong Response

Breast Implants Cause Rare Form of Cancer, FDA says

9 deaths linked to rare cancer form breast implants

In the News: Breast Implants Linked to Rare Cancer (Diana Zuckerman)

Former Women’s IFBB Pro Jackie Paisley dies after long battle with illness (silicone toxicity)

Breast Implant Survey Suggests Doctors Divided on Safety

Nicola Robinson’s Deepest Regret (silicone breast implants)

Breast Implant Illness + 6 Other Breast Implant Dangers (Dr. Axe)

Playboy Models Claim Implants Caused Health Problems (The Doctors, show)

Former Playmate of the Year on removing breast implants: ‘I literally thought I was dying’ (AZ Family News)

Women complain that their breast implants made them sick (West Palm Beach – WPTV News)

Her Hidden Dangers (Illinois – 23WIFR News)

Breast implant patient’s life ‘could have been saved’ – Hairdresser Kandi du Cros died after breast implant operation flared up rare existing disease (BBC News)

2 Massachusetts Women, Thousands Nationwide Say Breast Implants Made Them Sick (CBS Boston News)

Women concerned about implants after learning they may be linked to rare cancer (Fox 59 Indianapolis News)

Caldwell woman diagnosed with cancer from her breast implants, insurance won’t pay to remove them (KIVI 6 On Your Side – ABC Idaho)

A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’ (NY Times)

DeLauro Statement on Breast Implants Connected to Lymphoma (United States Representative Rosa DeLauro)

Swedish breast implant illness news story: Johanna, 31, varnar andra: “Implantaten gjorde mig jättesjuk”

Danish: Johanna fik opereret brysterne større – aldrig har hun fortrudt noget så meget

Woman reveals danger of implants, horror of lawsuits – silicone poisoning brings on 20 year suit with Dow Chemicals (UB Media Biz)

Conflict of Interest: The FDA & Big Pharma – Does the FDA Work for Big Pharma? (Drug Watch)

Breast prostheses: For a national registry of complications (Dr. José Budo)

Colorado women claim breast implants made them sick (Denver 7 News)

Did breast implants make Valley woman sick? (ABC15 Arizona)

9 Investigates health concerns with silicone breast implants (WFTV9 Orlando, FL)

Brit Boob Implant Cancer Bombshell – Two breast surgery patients die from a ‘bombshell’ cancer linked to implants

Rare cancer reignites debate over breast implants’ safety

Silicone Breast Implants are back – This Time the Issue is Cancer

Sydney mother’s dire warning after breast implants almost ruined her life. (Australia News)

Dr. Robert Whitfield MD, FACS describes breast implant-related illness (The Plastic Surgery Channel)

The Explant Phenomenon (Huffington News)

Former ‘Playboy’ playmates have ‘toxic’ breast implants removed after they make them sick (Inside Edition)

Women say breast implants caused unexplained illness for years (WSB-TV Atlanta, GA)

Why scores of women are having their implants removed (Tucson News, AZ)

More Canadian women having their breast implants removed, surgeons say (CTV News)

2018

Women battling illness after breast implants urge awareness, education (CBS Miami)

The breast implants that may be linked to blood cancer: Linzy was baffled by her symptoms but doctors solved the mystery in time for her to make a full recovery (Daily Mail UK)

South Florida Woman: Breast implants ruined my life (West Palm Beach – WPTV News)

CBS 5 Investigates: Chemist claims breast implants make some women sick (CBS Arizona)

Why Kiwi women are getting their breast implants removed (New Zealand)

I spent the last five years managing my health so my body could cope with these toxic bags’: Why more women are having their breast implants REMOVED following debilitating complications (Daily Mail Australia)

Facing unexplainable symptoms, metro women argue silicone breast implants made them sick (Fox 4 Kansas)

Arkansas women want doctors, FDA to recognize seriousness of ‘Breast Implant Illness’ (THV11 Arkansas)

My breast implants were killing me – how I took my life back (Elephant Journal)

Calls to ban textured breast implants after two die and 23 develop same type of cancer (My Vue News – UK)

Kiwi woman says seven-year illness caused by breast implants (Stuff – New Zealand)

Perth mum Ricci Jess reveals painful truth behind fake boobs (Perth Now – Australia) 

Explants: breast implants removal surgery grows among Perth women (Perth Now – Australia)

My breast implants nearly destroyed my life: how S Club 7’s Hannah Spearritt was left in agony following the boob job she craved (Daily Mail UK)

After 17 years with breast implants, Princeton woman leads calls for more education, safety (WFAA 8 ABC – North Texas)

Mount Pleasant woman says breast implants caused serious health problems (4News – Mount Pleasant, South Carolina)

Breast Implant Illness: What we don’t know can hurt us (Swaay)

Glamour model who got a boob job at 18 shares her plastic surgery nightmare that destroyed her kidneys and has left her on dialysis (Daily Mail Australia)

Facing health issues, Georgia woman has breast implants removed (Fox5 – Atlanta, Georgia)

Breast Implant Illness: Two metro women say implants caused years of complications (13 WHOtv – Iowa)

Breast Implant Illness: Woman claims implants made her sick (7 WJHG – Panama City Beach, Florida)

Former local 4 reporter says breast implants caused years of chronic fatigue, depression, hair loss (Click On Detroit – Michigan)

Auckland woman ‘s painful lesson about the dangers of breast implants (News Hub – NZ) 

What this yoga teacher learned from her mistake with breast implants (Charlotte Five)

Biocell textured breast implants under scrutiny as women complain of pain (CBC – Canada)

Breast implants reveal problems in tracking device safety (AP News) 

Breast Implant Injuries Kept Hidden As New Health Threats Surface (ICIJ)

Under the skin of ICIJ’s Implant Files (ICIJ)

Breast implants study reveals serious safety concerns (The Guardian)

The Implant Files reveal how breast implants linked to rare cancer set off alarm bells (ABC – Australia)

The Implant Files: Faulty breast implants leave women in limbo (Financial Review – Australia) 

Bare dager etter at hun opererte inn silikon i brystet, merket Karin Wenke Osthaug at noe var galt (Aftenpolten – Norway)

Cancer lié aux prothèses mammaires (LAGC) : l’inertie des autorités sanitaires (France Culture)

Temor, burocracia y dolor: hablan tres argentinas damnificadas por implantes mamarios (Perfil – Argentina)

British women are hit by new breast implant cancer scare seven years after PIP scandal as concerns grow over most commonly-used implant banned in France but still allowed in UK (Daily Mail – UK)

Rare form of Blood Cancer Linked to Certain Type of Breast Implants Used by Thousands of Women (People)

Breast Implants May Increase Your Risk of A Rare Type Of Cancer (Women’s Health)

Some medical devices deemed unsafe in other nations still sold in U.S. (NBC News)

Breast-implant-related complications, including cancer, kept secret thanks to broken reporting system (The Star)

My Breast Implants Made Me Sick – and Nobody Believed Me (Cosmopolitan)

Hidden dangers: patients, doctors not informed of defective implants (ICIJ)

Many Women Getting Breast Implants Removed In Light Of Health Concerns (CBS Philly)

Mother, 34, who was left ‘slowly dying’ by her ‘toxic’ C-cup breast implants has them removed after four years of agony (Daily Mail and The Sun)

Richmond woman warns of breast implant illness (K12 – Virginia)

As the Allergan breast implants disaster explodes, isn’t it time women say enough is enough? (Huffington Post – UK)

Allergan’s textured breast implants recalled by French authorities (NBC News)

 

 

 

Read More

ALLERGAN BREAST IMPLANTS RECALLED WORLDWIDE TODAY JULY 24, 2019

“Textured implants linked to rare form of cancer per FDA”

By Mark A. York (July 24, 2019)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) A worldwide recall of breast implants by Allergan Inc. was issued Wednesday for textured models because of a link to a rare form of cancer. The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems. The FDA had ruled earlier this year the implants could stay on the market.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC

Sientra, Inc.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

https://www.cbsnews.com/news/breast-implant-recall-allergan-recalls-textured-implant-linked-to-rare-cancer-today-2019-07-24/

Nine deaths from a rare form of cancer have been linked to breast implants, the Food and Drug Administration announced in 2017.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. Such models account for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface.

Health authorities first linked textured implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.

As recently as May, the FDA said that the danger did not warrant a national ban on the devices. But the FDA said Wednesday that new data show a direct link to cancer with Allergan’s implants not seen with other textured implants.

“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action,” said FDA deputy commissioner Amy Abernethy in a statement.

The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.

The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.

There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.

Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.

“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.

In May, the country’s three largest breast implant manufacturers — Allergan, Sientra and Mentor — told CBS News textured implants have been extensively tested for safety and comply with FDA monitoring and that patient safety is their top priority.

___________________________________________________________

March 20, 2019   FDA NOTICE ON TEXTURED IMPLANTS

 

 

FDA News Release March 20, 2019

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

For Immediate Release

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California.  Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.  Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.

Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate.

The FDA’s actions today are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agency’s commitment to take more aggressive actions against manufacturers who fail to comply.

In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updatesto the public regarding BIA-ALCL.

Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA’s headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s MedWatch Adverse Event Reporting program.  The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

End

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  1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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Note: (Excerpts within this article include network broadcast and print materials and other o

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WILL JOHNSON & JOHNSON FACE “OPIOID CRISIS LEGAL JUSTICE” IN OKLAHOMA VERDICT?

Florida, Texas, Nevada, North Carolina, North Dakota, Tennessee, Massachusetts and others have their own Opioid Litigation in state courts across the country

By Mark A. York (July 15, 2019)

Live-video-opening-statements-for-oklahoma-opioid-trial vs. Johnson & Johnson

J&J defense-rests-in-opioid-trial-closing-arguments-set-for-July 15th

(MASS TORT NEXUS MEDIA) The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, fit in to the “opioid litigation solution” and if they will actually receive treatment services and assistance on a substantive level.

Johnson & Johnson used promotional gimmicks for its opioid painkillers that are similar to how criminal drug dealers try to boost sales, a pharmaceutical-industry critic told a judge hearing Oklahoma’s claim that the company helped fuel a crisis of addiction.

J&J’s use of coupons allowing patients to get free Duragesic pain patches was improper, said Andrew Kolodny, a Brandeis University professor and opioid researcher who testified at the trial Wednesday on behalf of the state, which says the company is liable under public-nuisance laws.

Closing arguments are underway today, July 15, 2019 in Oklahoma’s case against Johnson & Johnson alleging the consumer products giant and its subsidiaries helped fuel the state’s opioid crisis.

Each side had about two hours Monday to make their cases to Cleveland County District Judge Thad Balkman, who is expected to issue his ruling at a later date.

See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

https://kfor.com/2019/07/12/defense-rests-in-opioid-trial-closing-arguments-set-for-July 15th

Oklahoma Attorney General Mike Hunter has described consumer products giant Johnson & Johnson as the “kingpin” company that helped fuel the state’s opioid crisis during closing arguments in the state’s case against the drugmaker.

Oklahoma claims that J&J aggressively marketed opioids in the state in a way that overstated their effectiveness to treat chronic pain and understated the addiction risks.

For a look at the Federal Opiate Litigation MDL 2804 see “OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION” where counties, cities, indian tribes as well as unions, hospitals and individuals have filed more than 2000 lawsuits against the opioid industry as a whole.

Bad Conduct of Opioid Big Pharma Outlined

In a June 2017 memo to Purdue officials, titled “Confidential Program Recommendation,” Matt Well, a founding partner of the Washington, D.C.-based public relations firm The Herald Group, details a campaign that included attacks on undisclosed attorneys general. The attacks were intended to deter other states from suing the company.

Link to Purdue Pharma Opioid Marketing Campaign Documents

“Our goal is to make state attorneys general think twice about joining the litigation,” Well wrote in the proposal.

Other recommendations included targeting outside law firms hired to help in the cases by calling into question the attorneys’ credibility and personal profit motive.

The final recommendation included working with journalists and placing stories in specific publications to tell what the firm labeled “the anti-story”. The anti-story refers to the public relations firm finding legal experts to talk to reporters or write op-eds for publications that slam lawsuits filed by states and shift the blame for the epidemic to victims in an attempt to sway public opinion to the company’s favor.

At one point, the opiate industry attempted to raise arguments stating that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous – a central question in any litigation, which was quickly denied and seems to show that Opiate Big Pharma is once again attempting to hide behind the FDA shield.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

KEY POINTS AT OKLAHOMA TRIAL 

  • Lawyers for the state, including Attorney General Mike Hunter, told a judge in Norman, Oklahoma that J&J knew opioids were addictive yet played down their dangers when promoting them, leading to an oversupply of pills that caused overdose deaths.
  • The case is one of around 2,000 actions by state and local governments accusing drug manufacturers of contributing to the opioid epidemic.
  • J&J denies causing the epidemic. Its lawyers have argued that its products made up a small share of opioids prescribed in Oklahoma and carried U.S. Food and Drug Administration-approved labels that warned of the addictive risks.

Lawyers for the state of Oklahoma on Monday urged a judge to hold Johnson & Johnson responsible for fueling the U.S. opioid epidemic, as the first trial nationally in litigation over the drug crisis came to an end.

Attorney General Mike Hunter, told a judge in Norman, Oklahoma that J&J knew opioids were addictive yet played down their dangers when promoting them, leading to an oversupply of pills that caused overdose deaths.

“This company went out and sponsored lies,” Brad Beckworth, a lawyer for the state, said in his closing argument.” They went out and said the risk of addiction was less than 1%.”

He urged Judge Thad Balkmanm, who presided over the multibillion-dollar nonjury trial, to find Johnson & Johnson liable for creating a public nuisance.

The case is one of around 2,000 actions by state and local governments accusing drug manufacturers of contributing to the opioid epidemic. Opioids were linked to a record 47,600 overdose deaths in 2017, according to the U.S. Centers for Disease Control and Prevention.

The Oklahoma trial is being closely watched by plaintiffs in other opioid lawsuits, particularly in 1,900 cases pending before a federal judge in Ohio who has been pushing for a settlement ahead of an October trial.

At trial, lawyers for Oklahoma argued that J&J, which sold the painkillers Duragesic and Nucynta, had since the 1990s marketed opioids as “safe and effective for everyday pain” while downplaying their addictive qualities.

The state has accused J&J of acting as the “kingpin” behind the epidemic and says the company was motivated to boost prescriptions not only because it sold painkillers but because it also grew and imported raw materials that opioid manufacturers like OxyContin maker Purdue Pharma LP used.

J&J denies causing the epidemic. Its lawyers have argued that its products made up a small share of opioids prescribed in Oklahoma and carried U.S. Food and Drug Administration-approved labels that warned of the addictive risks.

J&J, whose lawyers were expected to deliver their own closing arguments later on Monday, argues the state is seeking to stretch the bounds of a public nuisance statute in order to force J&J to pay up to $17.5 billion to remedy the crisis.

Purdue and Teva Pharmaceutical Industries Ltd were originally also defendants in the case. Purdue reached a $270 million settlement with the state in March and Teva settled for $85 million in June. Both deny wrongdoin

One contributing factor behind the opioid epidemic is the increase in the use of prescription painkillers nationally. From 1991 to 2011, the number of opioid prescriptions dispensed by U.S. pharmacies tripled from 76 million to 219 million.[4] This increase in the use of opioids is unique to America. The United States represents less than 5 percent of the world’s population but consumes roughly 80 percent of the world’s supply of opioid drugs.[5] There is also wide variation from one state to another in opioid-prescribing rates. In 2012 twelve states had more opioid prescriptions than people: Alabama (142.9 per 100 people), Tennessee (142.8), West Virginia (137.6), Kentucky (128.4), Oklahoma (127.8), Mississippi (120.3), Louisiana (118), Arkansas (115.8), Indiana (109.1), Michigan (107), South Carolina (101.8), and Ohio (100.1).[6]

The impact of the opioid epidemic touches every aspect of our public safety and judicial system. Drug-related arrests involving opioids are skyrocketing. In many communities, court dockets and probation caseloads are filled with individuals with opioid-use disorders. Access to treatment, particularly medication-assisted treatment combined with cognitive behavioral interventions, is limited—particularly in rural communities. This epidemic also comes at a price. In 2015 the Ohio Department of Mental Health and Addiction Services began providing substance-abuse treatment in Ohio’s prisons, spending an estimated $30 million per year on drug treatment in prisons, $4 million on housing for individuals in recovery, and $1 million over two years for naloxone to reverse drug overdoses. The Ohio State Highway Patrol spent over $2 million to expand and improve their crime lab to keep up with substance testing.

UP TO $500 BILLION SETTLEMENT?

The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.

INSURERS ARE FIGHTING BACK

In 2018 ravelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul  opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see  California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.

To access the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

September 13-16, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Anne Marie Kopek at 954.837.3423 or AnneMarie@masstortnexus.com

  1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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Note: (Excerpts within this article include reference materials from CBS, ABC, NBC US Department of Ju

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FDA BANS THE USE OF PELVIC MESH PRODUCTS – How Will This Affect The TVM Litigation?

Will this move by the FDA re-ignite the mass tort engine in TVM litigation or possibly force settlement in Ethicon TVM MDL 2327?

By Mark A. York (April 17, 2019)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Manufacturers of pelvic synthetic surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday. The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  The key issue with the product for many years is the fact that its made from polypropylene, basically the same material as fishing line.

The FDA said it “has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

The FDA said its April 16, 2019 action to remove surgical mesh products from the market is part of its commitment to ensuring the safety of medical devices. In a November statement, the agency said that it “regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide.”

FDA Release January 4, 2019

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

Summary: The U.S. Food and Drug Administration issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

FDA Finally Takes Action

Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina. In the 1990s, gynecologists began implanting surgical mesh for the transvaginal repair of the condition and in 2002, the first mesh device specifically for this purpose was cleared for use by the FDA, according to the agency’s statement.

“We couldn’t assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

For years, medical device companies have stated that the products they are developing and placing into the marketplace are safe and helping patients in the USA and worldwide. That is often not the case and people around the world are suffering.

Medical device makers and compensated doctors have touted FDA approved implants and other devices as the surgical cure for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief and many other afflictions.

2017 Pelvic Mesh Study in England Showed High Number of Adverse Events:

Scientific Reports Volume 7, Article number: 12015 (2017) |

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

Conclusions

Summary: This is the largest study to date of surgical mesh insertions for SUI. It includes all NHS patients in England over an 8-year period. We estimate that 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally, within 30-days or within 5 years of the initial mesh insertion procedure. This is likely a lower estimate of the true incidence. Given concerns about the safety of these procedures, this study provides robust data to inform both individual decision-making and national guidance.

Why Device Makers Tout FDA Approvals

  1. “Medtronic receives FDA clearance for two heart devices”
  2. “FDA approves device to help curb cluster headaches”
  3. MRI approved for young infants in intensive care

Manufacturer headlines like these instill consumer confidence that medical devices are safe and effective. After all, they have the FDA’s stamp of approval, right? NO!

The reality is, the FDA seldom requires rigorous evidence that a device works well–and safely–before allowing it onto the market. Medical devices are the diverse array of non-drug products used to diagnosis and treat medical conditions, from bandages to MRI scanners to smartphone apps to artificial hips.

This low standard of evidence applies to even the highest risk devices such as those that are implanted in a person’s body. Surgical mesh, pacemakers and gastric weight loss balloons are just a few examples of devices that have had serious safety problems.

Devices are subject to weaker standards than drugs because they’re regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA’s approval.

In 2011, an Institute of Medicine panel recommended that the “flawed” system be replaced, because it does not actually establish safety and effectiveness. At the time the FDA said it disagreed with the group’s recommendations.

Defective devices cleared through this system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market. .J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

The FDA forcing mesh manufacturers to stop the use of synthetic mesh is long overdue, and how this action results in renewed interest by mass tort firms across the country, remains to be seen. Regardless, it would seem that Ethicon and the other defendants in the pending TVM litigation that have been unwilling to discuss settlement, may now be forced to deal with the catastrophic consequences of manufacturing and marketing medical devices that have injured untold thousands of patients around the world.

To access the most current TVM case status and other real time information on Mass Torts  sign up for:

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  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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False Narratives Opioids and Xarelto

Mass Tort Nexus is compiling an evidentiary package for law firms who intend to reject the current Xarelto settlement offer and prepare for trial. This article represents an extremely small segment of what any firm who prepares for trial will have at their disposal; however, we believe most everyone involved in Mass Torts might find the following topic interesting.

It is well known how Big Pharma allegedly promoted a false narrative regarding Opioids and the risk posed by these highly addictive drugs. Despite the fact that thousands of people were dying every year from opioid overdose, doctors seemed unaware that the narrative they had bought into was false.

What might the death toll ultimately be for the new anticoagulants?

We are aware that both the Xarelto primary defendants are also accused of being party to the opioid false narrative conspiracy in opioid litigation complaints.  If Big Pharma can keep doctors prescribing opioids like skittles for decades, despite the rising death toll, how hard could it be to keep doctors prescribing an anticoagulant with a few tweaks to the truth?

Why Did Doctors Prescribe Xarelto and Why do they Continue to Prescribe Xarelto?

The clinical trials for Xarelto did not prove the drug to be superior in efficacy to Warfarin, only “non inferior.” It was not a better drug from an efficacy stand point. Doctors had no reason to switch patients to Xarelto because it “worked better” than Warfarin.

Xarelto is exponentially more expensive that Warfarin, so doctors had to reason to switch patients to Xarelto based on cost.

What were the makers of Xarelto able to claim about their new (unproven in the general patient population) to convince them to switch patients to Xarelto?

  1. No Routine Blood Testing (monitoring.)
  2. No Dietary Restrictions.

What if these claims were false, patients do need routine blood monitoring while on Xarelto?

What if patients taking Xarelto do need to restrict their diet (not consume certain food products?)

Would doctors keep prescribing Xarelto? Probably not, if the arguably false narrative first presented to them was corrected (warned) as having been false. That said, once a claim is made, people, including doctors, are not likely to realize that the claim is no longer being made once they have bought into the claim, unless they are specifically informed that the claim might have been false.

The following will explain why the makers of Xarelto may have stopped claiming (in their television and print ads,) that patients taking Xarelto did not need routine blood testing nor adhere to any dietary restrictions.

We will first review Xarelto television spots beginning in 2013 and more recent ads. Then we will explain why the makers of Xarelto quit claiming that users of their product stopped claiming that:

  1. No Routine Blood Testing (monitoring) was needed.
  2. No dietary restrictions.

You may view a larger selection of ads than those provided below at: https://www.ispot.tv/brands/ISA/xarelto

2013: Xarelto Bob Ad  (both “no routine monitoring” and “no dietary restrictions claims made”.)

 

 

 

 

 

 

 

https://www.ispot.tv/ad/7dJt/xarelto-bob

Start at 16 Seconds, “Bob took Wafarin and made a monthly trip to the clintic to get his blood tested but not anymore.”

Start at  36 Seconds,   “Xarelto is the first and only once per day prescription blood thinner… That does not require rountine Blood Monitoring.”

Start at 57 Seconds, “and there’s no dietary restrictions…Bob can eat the health foods he likes. ”

2014 Mary Ad (both “no routine monitoring” and “no dietary restrictions claims made.”)

 

 

 

 

 

 

https://www.ispot.tv/ad/7pGC/xarelto-mary-song-by-arturo-cardelus

Start at 12 Seconds  “Which required monthly testing, but that’s history.”

Start at 56 Seconds “Plus with no Known Dietary Restrictions.”

2015  Arnold Palmer (they did not specifically say no routine testing and dietary restrictions, but they  implied the claims. )

 

 

 

 

 

 

https://www.ispot.tv/ad/AYGi/xarelto-game-plan-feat-chris-bosh-arnold-palmer-brian-vickers

Start at 29 Seconds (claims worked into general conversation)

article link: https://www.masstortnexus.com/News/366/Did-Xarelto-the-Drug-Arnold-Palmer-Promoted-Lead-to-His-Death?

2016: Jerry West (neither of the claims were made in this ad.)

 

 

 

 

 

 

https://www.ispot.tv/ad/ARh_/xarelto-high-risk-of-stroke-featuring-jerry-west

2017  Xarelto “Protect Themselves” ad feature authority figures  (neither of the claims were made in this ad.)

 

 

 

 

 

 

 

 

https://www.ispot.tv/ad/wtdp/xarelto-protect-themselves

2018  “Learn all you can ad” (we do not think irony was intended), (neither of the claims were made in this ad)

 

 

 

 

 

 

https://www.ispot.tv/ad/wPmP/xarelto-learn-all-you-can

So Why Did the Makers of Xarelto Quit Making Their “Claims to Fame?”

We will first address why the makers of Xarelto most likely stopped making the “no rountine blood testing (monitoring claim.) This answer to this one is easy; Because the FDA warned them about making this claim.

It is difficult to understand why the makers of Xarelto did not unilaterally determine (and warn that their original messaging no routine blood monitoring needed) might have been misleading based solely on the number of adverse events reported to the FDA since the product’s introduction.

______________________________________________________________________________________________________

 

 

Food and Drug Administration

Silver Spring, MD 20993

Roxanne McGregor-Beck, Director

Johnson & Johnson International, Inc.

1000 Route 202 South

P.O. Box 300

Raritan, New Jersey 08869-0602

 

RE: NDA #202439

XARELTO (rivaroxaban) tablets

MA #215

Dear Ms. McGregor-Beck:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer (DTC) print advertisement (K02XS121040 AF) (Print Ad) for XARELTO (rivaroxaban) tablets (Xarelto) submitted by Johnson & Johnson International, Inc. (Johnson & Johnson) on behalf of Janssen Pharmaceuticals, Inc. under cover of Form FDA 2253 and observed during routine surveillance in the January/February 2013 issue of WebMD magazine. The Print Ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Thus, the Print Ad misbrands Xarelto in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix).

Background:

Below is the indication and summary of the most serious and most common risks associated with the use of Xarelto.1 According to its FDA-approved product labeling (PI), in pertinent part:

Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

 The PI for Xarelto contains Boxed Warnings regarding increased risk of stroke after discontinuation in patients with nonvalvular atrial fibrillation and the risk of spinal/epidural

hematoma. The PI also contains Contraindications regarding active pathological bleeding and severe hypersensitivity reaction to Xarelto, as well as Warnings and Precautions regarding the risk of bleeding, use in patients with renal impairment and hepatic impairment, use with P-gp and strong CYP3A4 inhibitors or inducers, and risk of pregnancy related hemorrhage. The most common adverse reactions with Xarelto were bleeding complications.

Minimization of Risk Information

 Promotional materials are false or misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug. Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. The Print ad prominently presents various efficacy claims for Xarelto, such as, but not limited to, the following, that are presented in large, bolded and/or colorful text and graphics (emphasis original):

• “If you have atrial fibrillation (AFib)”

• “Ready to break your AFib routine?”

• “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce

the risk of stroke—without routine blood monitoring.”

• “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal. Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”

In contrast, the risk information is presented on the preceding adjacent page without any of the emphasis (i.e. color scheme, borders, layout, and graphics) used with the efficacy claims. The result is a presentation which appears unconnected to the efficacy claims and is therefore not likely to draw readers’ attention. This overall presentation misleadingly  minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims. We note that the Print Ad contains the statement, “Please see accompanying Medication Guide on the following pages” (emphasis original) at the bottom of the page, and that risk information is presented on an adjacent page, but this is not sufficient to mitigate the overall misleading presentation.

Misleading Claim

 The Print Ad includes the following claim (emphasis original):

• “And there are no dosage adjustments…”

The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto. However, according to the DOSAGE AND ADMINISTRATION section of the PI, the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a CrCL of 15 to 50 mL/min. In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….” Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy.

Conclusion and Requested Action

For the reasons discussed above, the Print Ad misbrands Xarelto in violation of the FD&C Act, 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix). OPDP requests that Johnson & Johnson immediately cease the dissemination of violative promotional materials for Xarelto such as those described above. Please submit a written response to this letter on or before June 20, 2013, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Xarelto that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to the undersigned at the Food and Drug Administration,

Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 or by facsimile at (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA# 215 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Xarelto comply with each applicable requirement of the FD&C Act and FDA implementing regulations.

Sincerely,

{See appended electronic signature page}

Zarna Patel, Pharm.D.

Regulatory Review Officer

Office of Prescription Drug Promotion

{See appended electronic signature page}

Amy Toscano, Pharm.D., RAC, CPA

Team Leader

Office of Prescription Drug Promotion

____________________________________________________________________________________

It is difficult to understand why the makers of Xarelto did not unilaterally determine (and warn that their original messaging (no routine blood monitoring needed) might have been misleading bases solely on the number of adverse events reported to the FDA since the products introduction.

 

 

 

 

 

https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/59a37af8-d2bb-4dee-90bf-6620b1d5542f/state/analysis

 

 

 

 

 

 

https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/59a37af8-d2bb-4dee-90bf-6620b1d5542f/state/analysis

Having not corrected their prior claims (warned) related to the need for routine blood testing (monitoring) the makers of Xarelto did add the words underlined (below) to the label for Xarelto NDA -022406 in November of 2018. This statement in no way corrects the arguably false prior statements related to “No Routine Blood Testing” needed.  This statement simply warns that many of the common “blood monitoring tests used” are not recommended for individuals using Xarelto. A more accurate statement might have been: “These tests have no diagnostic value for individuals on Xarelto,” as the drug skews the test, and not in a predictable fashion, which would allow for adjustment of the test results.

Do these two statements seem the same to you?

  1. No Routine Blood Monitoring Needed with Xarelto.
  2. The test routinely used for anticoagulation monitoring has no diagnostic value for individuals taking Xarelto.

Which of the above two statements would likely increase revenues from the drug and which one would likely have the opposite effect?

11/07/2018 (SUPPL-29)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Bleeding

Reversal of Anticoagulant Effect

Additions and/or revisions underlined:

… anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=287

“Now We Turn to “No Dietary Restrictions Necessary”

 06/28/2017 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Bleeding

(additions underlined)

(excerpts)

5.6 Use with P-gp and Strong CYP3A4 Inhibitors or Inducers

(additions underlined)

Avoid concomitant use of XARELTO with known combined P-gp and strong CYP3A4 inhibitors.

Avoid concomitant use of XARELTO with drugs that are known combined P-gp and strong CYP3A4 inducers.

7 Drug Interactions

7.1 General Inhibition and Induction Properties

(additions underlined)

Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters. Combined P-gp and strong CYP3A4 inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A4 inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events.

7.2 Drugs that Inhibit Cytochrome P450 3A4 Enzymes and Drug Transport Systems

Interaction with Combined P-gp and Moderate CYP3A4 Inhibitors in Patients with Renal Impairment

XARELTO should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A4 inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk.

End excerpt

What is the significance of the above?

The inducers make the user more susceptible to clots (ischemic stroke, DVT, PE, etc.)

The inhibitors make the user more likely to bleed.

On a side note, the GI tract is significant to the actions of CYPE4A as well as P-gp. And if you remember from above, what was the most reported AE with Xarelto:

 

So what does the use of Strong and Moderate CYP34A and P-gp Inhibitors and Inducers have to do with dietary restrictions?

Most everyone is familiar with the fact that some drugs carry a warning about restricting grapefruit juice from your diet while on the given drug (i.e. statins).

The relation to the above and the “no dietary restrictions” claim, that the makers of Xarelto use to promote their drug (and then stopped making but did not correct the narrative) is simple. There are numerous foods which are CYP34A, and P-gp inhibitors and/or inducers. We provide a small sampling of foods and dietary supplements below.

The dietary restrictions associated with Warfarin restricted foods high in Vitamin K, like Kale (yummy Kale).

Xarelto Potential Food Restrictions

It is worth nothing that due to genetic differences, the strength of a given CYP34A and P-gp Inhibitor or Inducer necessary to interfere with a drug is not the same for everyone. Women as a general rule are more susceptible to the effects of CYP34A and P-gp Inhibitors or Inducers than men.

Grape Fruit Juice: Inhibits CYP34A and P-gp Seville Orange Juice CYP34A and P-gp
Lime Juice Inhibits CYP34A Lemon Juice Inhibits CYP34A
Pomegranate Juice Inhibits CYP34A Star Fruit Juice Inhibits CYP34A
Kiwi Juice Inhibits CYP34A Passion Fruit Juice Inhibits CYP34A
 St. John’s wort Induction of P-gp Ginkgo Biloba Induces P-gp

 In addition to food interactions Approximately 50% of prescription drugs either induce or inhibit CYP34A or P-gp.

While many drugs are deactivated by CYP3A4, there are also some drugs which are activated by the enzyme. Some substances, such as grapefruit juice and some drugs, interfere with the action of CYP3A4. These substances will therefore either amplify or weaken the action of those drugs that are modified by CYP3A4.

https://en.wikipedia.org/wiki/CYP3A4

So, what the Xarelto label (warnings) universally adequate in 2015, 2016 or today?

We think not!

Read More

Mass Tort Nexus: Xarelto Settlement Update

Xarelto Settlement: Power in Numbers

(April 23, 2019) As stated in previous Mass Tort Nexus articles, we are of the opinion that the current proposed Xarelto Settlement is “dead on arrival.” Based on our conversations with non-leadership firms, we are of the belief that there is an implacable intention to reject or recommend that their clients reject the current settlement offer.

Numerous additional firms have contacted Mass Tort Nexus since our first article was published related to the proposed settlement last week. Since that release, Mass Tort Nexus has received ongoing inquiries from firms asking the same basic question:

Do the leadership firms control enough of the client cases in the Xarelto litigation, to reach a settlement participation level acceptable to the defendant under the current proposal, without regard to the number of non-leadership firms that might reject the offer?

In order to provide an informed answer to this question Mass Tort Nexus conducted an analysis:

Mass Tort Nexus accessed the JMPL and the USDC ED Louisiana ECF links to determine how many cases are pending in MDL 2592. For this analysis we are not considering cases filed in other venues; however, there is no cause to believe that cases in other venues would be of sufficient volume to skew these findings.

According to the JPML, there are 23,866 cases pending in Xarelto MDL 2592 as of 04/15/2019. We believe no major change in these numbers has occurred in the three days that have elapsed between the latest JPML report and this analysis.

We will assume for arguments sake, that all the PSC members are going to accept the proposed Xarelto settlement. From a pure business perspective, the PSC members will be paid according to the work their firms have performed for the “common benefit”, which for many PSC firms may be a more significant sum than the fees they would earn from the clients they represent. Based on this reasoning, we will assume that all of the PSC member firms will accept the current settlement offer.

Mass Tort Nexus accessed Pacer to determine how many cases were on file for the Plaintiff Steering Committee (PSC) members.

The following are the result of that review:

PSC Member Firm MDL Cases
Ferrer Poirot 1,679
Beasley Allen 1,466
Morgan & Morgan 800
Levin Papantonio 650
Aylstock Witkin Kreis Overholtz 515
Schlicter, Bogard & Denton 118
Seeger Weiss 100
Nast Law 90
Ross Feller Casey 70
Levine Fishbein & Berman 50
Weitz & Luxenberg P.C. 81
Goza & Honnold, L.L.C. 310
Total Client MDL Cases PSC Members 5,929 24.82%
Total Client Cases MDL Non-PSC Members 17,937 75.18%
Xarelto MDL 2592 23866
http://www.laed.uscourts.gov/case-information/mdl-mass-class-action/xarelto/contacts/plaintiffs-steering-committee
https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-April-15-2019.pdf

Based on the results of our findings, of cases filed by PSC members, “Leadership” represents 5,929 (24.82%) of the 23,866 Xarelto MDL 2592 cases on file, while non leadership firms represent 17,937 (75.18%) of the cases on file.

Therefore, the answer to the question “does leadership directly control enough of total number of Xarelto cases to meet the participation requirements by the defendant is NO, based on this informed analysis.

Based on information received from reliable sources, the “Participation Level” defendants require to “go through” with the current offer is 90%. Of course, the defendants would have the option of going through with the settlement at a participation level of less than 90% however, it would not make sense for a defendant in any mass litigation to move forward with a settlement, that left several thousand cases moving towards trial. The number of cases left unsettled is more important than the representation of that number as a percentage.

Note: Mass Tort Nexus’ analysis of the number of cases under the direct control of leadership did not include any cases filed by other firms, which may have subsequently been referred to leadership firms. Therefore, leadership may have direct control over a larger number of cases that cannot be confirmed through our analytical methodology. Without regard to the foregoing, Mass Tort Nexus was able to verify the number of cases on file by firms who have expressed an implacable intent to reject the current offer, and therefore, the conclusions reached through our analysis would not  impact the unknown variable arising from cases filed by non-leadership firms, that have been subsequently referred to leadership firms.

To complete our analysis, we calculated the number of cases that could reject the settlement offer and overall participation still reach a given percentage participation level.

 

Participation Level (PL) Maximum Rejections to Achieve PL
95% 1,193.3
90% 2,386.6
85% 3,579.9
80% 4,773.2
75% 5,966.5
70% 7,159.8
65% 8,353.1
60% 9,546.4
55% 10,739.7
50% 11933

 

Based on conversations with numerous firms with “small” to “large” dockets, in the Xarelto MDL (also verified in the same manner as MTN verified leaderships client numbers), Mass Tort Nexus is of the following opinion:

Firms that have expressed their position to be in absolute rejection of the current offer, (nothing can convince them to change their minds), that the hold outs from these firms along will prevent the participation level in the settlement from reaching 80%.

Firms that are leaning toward rejection but could possibly change their minds (if they split down the middle on their final decision, half going one way and half going the other) would likely prevent the settlement acceptance level form reaching 70%.

If additional firms that have not communicated with Mass Tort Nexus also add to the “implacable rejectors” count, reaching a participation percentage acceptable to defendants becomes even less probable.

Mass Tort Nexus would like to clarify past comments, as well as comments made in this article, and those that may be forthcoming in future coverage of the proposed Xarelto settlement. Our coverage of this issue is not intended to be a disparagement of the firms in leadership in the Xarelto MDL. Leadership did not make the current settlement offer, the defendants made the offer. When a defendant approaches leadership wishing to discuss settlement, leadership engages in the discussion. When defendants make an offer, leadership presents that offer to the non-leadership firms involved in the litigation (becoming the messenger.)  If the offer does not result in a consummated settlement, leadership will have to “go back to the table” with the defendants. Leadership can not be seen to have been the cause of the previous settlement offer “falling through” and retain the credibility with the defendants needed for additional rounds of negotiations.  It is never our intent to “shoot the messenger” even when our opinions differ from the message.

https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-April-15-2019.pdf

 

Read More

Analysis of Proposed Xarelto Settlement Discount Rates – Debunking Defendants Rationale

 

 

Analysis of Proposed Xarelto Settlement Discount Rates

Debunking Defendants Rationale

 This is a follow up to the Mass Tort Nexus article “Xarelto Settlement: Dead on Arrival” – link: Xarelto-Settlement-Dead-on-Arrival? April 15, 2019

 

(MASS TORT NEXUS MEDIA) This article is intended to address the Xarelto defendants’ contentions that certain settlement offer “discounts” are justified for client cases arising in 2015 and 2016 due to changes in the FDA label,  which the defendant contends brought warnings contained in the label into adequacy. This paper will also address defendant’s contention that cases arising under the laws of the States of Texas and Michigan merit a massive discount in settlement value (offers).

We will focus on the Xarelto label change from 11/07/2018, AND an additional label change was made on 01/15/2019 related to Eosinophilia, which could be relevant to many of the Xarelto cases already filed as well as give rise to a Xarelto Litigation II, that could involve more injured individuals than the current Xarelto Litigation. The relevance and significance of the 01/15/2019 “Eosinophilia” label change will be addressed by Mass Tort Nexus in the near future.

Mass Tort Nexus has also received information that there is an ongoing investigation related to Xarelto potentially causing kidney injury, which may or not be related to Eosinophilia. We will continue to provide more information related to this subject in future articles. Given the new Eosinophilia warning and the investigation related to Kidney injury, and the 11/07/2018 label change related to anticoagulation tests (and the possible impact on future Xarelto case trials) Mass Tort Nexus understands why the defendants might be eager to reach a settlement sooner rather than later. Conversely, there is no reason why plaintiffs’ firms should believe the defendants to be in a superior negotiating position, nor be willing to accept subpar settlements for their existing cases.

It is worth nothing that the 11/07/2018 label change (admission) by the defendant that the most commonly used anticoagulation tests are “not recommended” (in reality likely have no diagnostic value) would make it far more difficult for the defendants to prevail in future trials under the Learned Intermediary Doctrine, as doctors would be less likely to testify that, “they would still do everything exactly as they did when originally prescribing Xarelto.” Had the defendant revealed the foregoing before the prior bellwether trials, the outcome of those trials may have been very different.  It is not surprising that the defendants are eager to settled Xarelto cases without having to face another trial post the 11/07/2018 and 01/15/2019 label changes.

Had the defendants revealed the information related to the most common anticoagulation tests used as “not being recommended” prior to the bellwether trials, doctors testifying in support of a defendants “Learned Intermediary Defense” would likely face questions like these:

 Plaintiffs’ Counsel:  So, Dr. Smith, I see that you performed an INR test to make sure that my client was correctly anticoagulated, that their blood was not to thick or too thin, is that right?

Dr. Smith: Yes

Plaintiffs’ Counsel:  Were you aware that as of 11/07/2018 the defendants recommend that this test not be used and in fact, the literature shows that this test provides no diagnostic value when a person is taking Xarelto?

Dr. Smith: It unlikely that Dr. Smith will say he knew the above when he prescribed Xarelto as he would essentially be admitting to medical malpractice.

Plaintiffs’ Counsel:  So, Dr. Smith, would you still today, follow the same protocol when prescribing Xarelto and use an INR test to make sure the dose of Xarelto did not have the patient’s blood to thick (likely to clot) or too thin (likely to bleed).

Dr. Smith: Unlikely that Dr. Smith would say he would still do what the defendant now recommends he not do.

Plaintiffs’ Counsel:  Dr. Smith, just out of curiosity, do you think the words “No Routine Blood Testing Needed” mean the same thing as “The blood test routinely used don’t work”?

The same line of questioning could be used for doctors that treated a Xarelto bleed or clot.

The contention that any label change could render a product adequately warned for all circumstances and facts relevant to every possible client injury scenario is somewhat preposterous; however, we will address and rebut the defendant’s contentions more directly. Although the Xarelto warning label has been changed numerous times since 2016, we only need to review the label change made on 11/07/2018 (see below) to conclude that the label was not adequate in any clients case in which the referenced anticoagulation tests were used in the “dosing” of Xarelto or the treatment of any Xarelto related injury 11/07/2018.

 11/07/2018 Xarelto Label Change

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s029lbl.pdf

 5.0 Warnings and Precautions

 5.2 Risk of Bleeding

Reversal of Anticoagulant Effect

Additions and/or revisions underlined:

… anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

Mass Tort Nexus Comment: The highlighted language above was added to the Xarelto FDA (U.S) 0n 11/07/2018, indicating that the use of PT, INR, aPTT anti-factor Xa (FXa) is not recommended. A more accurate statement (warning) would be that these tests have no diagnostic value and should not be used when evaluating dosing for individual patients nor treating bleeds and other conditions related to Xarelto, while the patient has Xarelto in their system.

 We will first address the 11/07/2018 label change as it related to the defendants contentions that the Xarelto label “adequately warned”  of the risks associated with label changes made in 2015 and 2016 as well as the justification (or lack thereof) for any discounts to base settlement offers arising therefrom.

Mass Tort Nexus opinion is as follows:

  1. At minimum, no discount is justified in any case arising before 11/07/2018, in which any of the anticoagulation tests now “not recommended” for use, where used by the prescribing physician immediately before and or any time after prescribing Xarelto, for use by the specific client. The doctor nor the patient were adequately warned with regard to these tests providing any diagnostic value that could serve to mitigate the risks associated with the use of Xarelto.  Additionally, for any client that presented at a medical facility (prior to 11/07/2018), with a Xarelto related injury which resulted in the use of the tests in the process of treating that injury, the warning label was not sufficient to mitigate the risks associated with the use of tests which the defendant now recommends not be used.
  2.  Today the warning label remains inadequate and no discount based on a contention that the warning label was brought into adequacy at any point in the past, is warranted. Until the defendants make further changes to the label including, but not limited to, giving the “anticoagulation” test “warning” greater prominence on the label as well as changing the “not recommended” portion of the statement to reflect a more truthful representation, that is less likely to be overlooked or misunderstood by prescribing physicians. An adequate warning would include information as to why the tests are not recommended (they likely have no diagnostic value).
  3.  It would be difficult for the defendants to argue that the fact that the most commonly used anticoagulation tests “are not recommended” for use in dosing Xarelto or treating a Xarelto injury, would not likely have impacted some doctors decision to prescribe the drug had they been previously warned prior to 11/07/2018. In reality, given the lack of prominence of the 11/07/2018 label change and the fact that no additional educational efforts are being made by defendants (that we are aware of), to insure that doctors are now aware that these tests are “not recommended” and in fact, likely have no diagnostic value, it is probable that the 11/07/2018 warning has not significantly decreased the risk posed Xarelto users, related to this new “warning.

 Before addressing Texas 82.007 and Michigan 600.2946, it is important to point out that one of the most Signiant claims made by the makers of Xarelto, in their effort to establish their product as being superior to Warfarin was that “no routine blood testing (anticoagulation tests) was needed” for patients using Xarelto. Patients taking Warfarin and other VKA’s (Vitamin K Antagonists) do require routine monitoring to insure their anticoagulation levels remain in a therapeutic range.

The “No Routine Blood Testing Needed” claim of the makers of Xarelto, made to the FDA and the public appears to have been very misleading. Mass Tort Nexus has yet to determine how the makers of Xarelto concluded that No Routine Blood Testing was needed for patients taking Xarelto. The 101,743 adverse event reports filed with the FDA related to Xarelto since 2011, is one indicator that “Routine Blood Testing” is needed to insure Xarelto user’s safety. If no Routine Blood Testing was needed, then why have Xarelto patients experienced such a high volume of bleeding and clotting events? The FDA warning letter sent to the makers of Xarelto (provided at the end of this document), is highly relevant to this topic.

If Xarelto was so well designed that a doctor could just assume that patients would be maintained with a therapeutic range (not too thin and likely to bleed or too thick and likely to clot), then why has the FDA received Xarelto 101,753 adverse event reports since 2011, many involving bleeding or clotting that might have been prevented with “routine testing’?

 

Texas and Michigan Cases

To the best of our knowledge, the defendant has yet to raise a defense under Texas 82.007 and Michigan 600.2946 in any case, much less prevail in arguments arising under these laws.

Neither Texas 82.007 nor Michigan 600.294 provide an absolute defense for drug manufacturers. Both state’s laws have language which provide a plaintiff with means, by which to overcome the presumption that these laws provide immunity for a given defendant. We will refer to the language in both States laws as the “savings clause” in the remainder of this article. We will also address each law separately with regard to the burden plaintiffs would face, in overcoming a defense raised under either Texas 82.007 or Michigan 600.294.

First, We Will review the “savings clause” for both Texas 82.007 and Michigan 600.2946 available to plaintiffs to overcome the presumption of drug manufacturer immunity arising under the two laws. See the relevant savings clauses and links to the entire statutes below:

Texas   82.007

(2)(b)  The claimant may rebut the presumption in Subsection (a) as to each defendant by establishing that:

(1)  the defendant, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury;

(3)(A) the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the United States Food and Drug Administration;

(B)  the product was used as recommended, promoted, or advertised;  

Michigan 600.2946

(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller. However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval. This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:

(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301 to 321, 331 to 343-2, 344 to 346a, 347, 348 to 353, 355 to 360, 360b to 376, and 378 to 395, and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted

http://www.legislature.mi.gov/(S(5z3q41uoys1lzoajegixoc5p))/mileg.aspx?page=GetObject&objectname=mcl-600-2946

As a preliminary point, if any discount was justified arising under Texas 82.007or Michigan 600.2946, it should be minimal in light of the fact that the defendant has neither raised a defense in any individual case (to the best of our knowledge), nor prevailed in such a defense. A small discount might be warranted to allow plaintiffs to avoid the cost of litigating any matter raised by defense in the unlikely event that the defendants are willing to incur the cost of litigating the matter themselves.

Secondly, if any discount arising under Texas 82.007 and Michigan 600.2946 was justified, cases arising under Texas 82.007 would warrant a less significant discount than those arising under Michigan 600.2946, for reasons we will address below.

It is worth noting that the defendants must affirmatively raise a defense under Texas 82.007 or Michigan 600.2946 and doing so may expose their clinical trials, communications with the FDA, (including warning letters related to their advertising, one of which we have included at the end of this document), to discovery and scrutiny they may wish to avoid. Mass Tort Nexus would be interested in any internal communications, as well as third party communications the defendants engaged in related to the death of Arnold Palmer (including communications with his family) as we have long held the opinion that Xarelto may have caused or contributed to the death of Xarelto’s most famous spokesperson.

Comment: Texas 82.007, does not require a showing that any information that may have been withheld or misrepresentation made to the FDA was “intentional.” Texas 82.007 does not require a plaintiff to plead nor show that the FDA would, and the drug would not have been approved, or the United States Food and Drug Administration would have withdrawn approval for the drug if the information were accurately submitted. Michigan 600.2946, does require plaintiffs to show and plead that any misrepresentations or withholding of information and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.

Michigan 600.2946 obviously places a far more significant burden on a plaintiff seeking to rebut the presumption of immunity than does Texas 82.007. Pleading that a drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted, can be problematic in light of the SCOTUS decision Buckman v. Plaintiff Legal Committee: https://www.loc.gov/item/usrep531341/

The foregoing should not be interpreted as presenting an impossible burden for plaintiffs to overcome under Michigan 600.2946 as was shown in the Second Circuit decision in DESIANO v. WARNER-LAMBERT & CO. https://caselaw.findlaw.com/us-2nd-circuit/1209786.html. Also see TAYLOR v. SMITHKLINE BEECHAM Michigan Supreme Court decision https://caselaw.findlaw.com/mi-supreme-court/1355001.html. These two well-reasoned rulings and opinions make it clear that 1. Plaintiffs can meet the requirements set forth in Michigan 600.2946 to overcome the presumption of immunity without running afoul of Buckman. 2. Plaintiffs can prevail in overcoming a defense raised under Michigan 600.2946 as they did in DESIANO.

Notwithstanding the foregoing, the burden placed un plaintiffs under Michigan 600.2946 is still far greater than that placed on plaintiffs by Texas 82.007.  It appears that any defendant has a better chance of prevailing in raising a defense under Michigan 600.2946 than one raised under Texas 82.007 however, given the fact that Michigan has a population of 9,996,000,(3.05% percent of the U.S. population) while Texas has a population of 27,700,000 (8.45% percent of the U.S. population), would the defendants be willing to undertake the time and expense (and continued concern from the market) involved in raising a defense under Michigan 600.2946, which would not dispose of a significant number of cases, if they prevail given that there is no reason to believe that a disproportionate number of the total Xarelto cases on file arise under Michigan law. Additionally, would the defendant be likely to undertake the time and expense (and continued concern from the market) involved in raising a defense under Texas 82.007, with a far less likelihood of prevailing than in Michigan.

The plaintiff’s burden with overcoming a defense raised under Texas  82.007 is obviously less arduous that than the burden over overcoming a defense raised under Michigan 600.2946. Due to the foregoing, the defendant’s application of the same discount (if any is justified) to cases arising under Texas law to those arising under Michigan Law, is not justified.

 

Michigan and Texas Law and the 11/07/2018 Label Change

Texas 82.007 and Michigan 600.2946:

Texas 82.007: The defendants’ statements in the 11/07/2018 label change “not recommending” these tests are still arguably misleading given that the test apparently have no diagnostic value when a patient is taking Xarelto and more importantly represent important information previously withheld from the FDA and/or mispresenting to the FDA. A strict interpretation of C would not require a plaintiff to show that that the actions or inactions of the defendant were intentional. Arguably, the 11/07/2018 label change related to these tests could be rebut the presumption that the protection provided from Texas 82.007 is available to the defendant.

Michigan 600.2946: The same reasoning applied to the analysis of Texas  82.007 applies to Michigan 600.2946 in this matter with one exception, Michigan 600.2946 requires a showing that the defendants actions or inactions were intentional and a showing that the FDA would not have approved or would have withdrawn the approval for the product if not for the information withheld or misrepresentations made. MTN provides an analysis below aimed at showing what the defendants knew and when they knew it relevant to the warnings they neglected to add to their label until 11/07/2018.

Analysis

The following analysis is more relevant to Michigan 600.2946 than to Texas 82.007. There is a high degree of confidence that Plaintiffs would prevail in any defense raised under Texas 82.007.

In that overcoming a defense raised under Michigan 600.2946 requires a showing that the defendant intentionally made misrepresentations the FDA or intentionally withheld information from the FDA. Additionally, under Michigan 600.2946   plaintiffs must make a colorable argument that the FDA would not have approved the drug or would have later withdrawn approval, absent the misrepresentations or withheld information. The 11/07/2018 FDA label change related to anticoagulant testing would be an example of evidence plaintiffs might present to meet the requirements of Michigan 600.2946. In that Michigan’s law require plaintiffs show the offending actions or inactions of the defendant were intentional, demonstrating what the defendants knew (relevant to the referenced anticoagulation tests) and when they knew it would be important in overcoming a defense raised under Michigan 600.2946.

It should be noted that a defense raised under Michigan 600.2946 or Texas 82.007 exposes the defendant to broad discovery, through which plaintiffs would likely discover far more evidence to support their rebuttal arguments than can be discovered in the public domain.  For our instant purpose however, we will focus on determining when the defendant knew or should have known that the anticoagulation tests listed in the 11/07/2018 label change provide no diagnostic value for patients on Xarelto.

Mass Tort Nexus has conducted a review of the publicly available literature in order to establish what the defendant knew or should have know and when, related to anticoagulation testing with commonly used modalities and methods. We will not present a chronological listing (not exhaustive) of information in the public domain relevant to this topic.

 It should be noted that any information or data published in clinical literature must be developed over time (before it is reported). We can safely assume that any information reported in the medical literature in 2012 was known to the defendant at the time they sought the initial FDA approval for Xarelto, granted in July of 2011. If the defendants were to raise a defense under Michigan 600.2946 or Texas 82.007, plaintiffs would likely be allowed broad discovery which would reveal that the defendants possessed or should have possessed the information related to anticoagulation tests that they withheld from the FDA and prescribing physicians until 11/07/2018.

 No Exhaustive Review of the Literature

2012

The data below was taken from a presentation from Ohio Society of Pharmacist Association in 2012. Given the fact that the information below was reliant on clinical observations prior to the presentation of the below, it is likely that the defendant was aware of the issue related to INR testing, prior to seeking U.S. FDA approval (granted July 1, 2011)

Summary
• Dabigatran
– aPTT
• Appears to be a useful measure in hemorrhagic emergency
• Therapeutic ranges have not yet been established
– Ecarin clotting time
• Also useful in hemorrhagic emergency, but not widely available.
• Rivaroxaban and Apixaban
– Prothrombin time, but not INR
• Appears to be useful in hemorrhagic emergency
• Therapeutic ranges have not yet been established
– HepTest, PiCT, and chromagenic assay all appear to be
useful, but not commonly available

https://cdn.ymaws.com/www.ohioshp.org/resource/resmgr/annualmeetinghandouts/effects_of_new_oral_anticoag.pdf

 May 2012

Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories.

RXA plasma levels can be quantified accurately and precisely by a chromogenic anti-FXa assay on different coagulometers in different laboratories. Ingestion of 10mg RXA results in significant alterations of both PT- and aPTT-based coagulation assays.

https://www.ncbi.nlm.nih.gov/pubmed/21840043?dopt=Abstract

July 2012 Rivaroxaban: A practical Guide

INR testing should be preformed just before the next intake of Rivaroxaban on the INR measurement

http://www.uclmontgodinne.be/files/RivaroxabanPracticalGuide06072012.pdf

Thrombosis Journal 2013

https://thrombosisjournal.biomedcentral.com/articles/10.1186/1477-9560-11-11

Because rivaroxaban and other target-specific oral anticoagulants have different mechanisms of action from traditional anticoagulant agents, laboratory tests used for these traditional agents (such as PT/international normalized ratio [INR] or activated partial thromboplastin time) are not suitable for target-specific oral anticoagulants

Pub Med   May 2017

https://www.ncbi.nlm.nih.gov/pubmed/28476405

Direct factor Xa inhibitors such as rivaroxaban or apixaban may prolong prothrombin time (PT) and elevate international normalized ratio (INR). However, these tests are not reliable for assessing the anticoagulation effects of these agents such as rivaroxaban or apixaban may prolong prothrombin time (PT) and elevate international normalized ratio (INR). However, these tests are not reliable for assessing the anticoagulation effects of these agents.

See the warning letter sent from the FDA to the makers of Xarelto. Mass Tort Nexus believes more warning letters like this one exist and will continue our efforts to discover all relevant FDA communications. This warning letter is highly relevant to the prior subject matter of this article.

(FDA Link to June 6, 2013 Warning Letter to Johnson & Johnson Re: Xarelto Label is Below)

NDA 202439 XARELTO (rivaroxaban) tablets   

June 6, 2013

Johnson & Johnson International, Inc.

 

 

______________________________________________________________________________________________________

 

 

Food and Drug Administration

Silver Spring, MD 20993

Roxanne McGregor-Beck, Director

Johnson & Johnson International, Inc.

1000 Route 202 South

P.O. Box 300

Raritan, New Jersey 08869-0602

 

RE: NDA #202439

XARELTO (rivaroxaban) tablets

MA #215

Dear Ms. McGregor-Beck:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer (DTC) print advertisement (K02XS121040 AF) (Print Ad) for XARELTO (rivaroxaban) tablets (Xarelto) submitted by Johnson & Johnson International, Inc. (Johnson & Johnson) on behalf of Janssen Pharmaceuticals, Inc. under cover of Form FDA 2253 and observed during routine surveillance in the January/February 2013 issue of WebMD magazine. The Print Ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Thus, the Print Ad misbrands Xarelto in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix).

Background:

Below is the indication and summary of the most serious and most common risks associated with the use of Xarelto.1 According to its FDA-approved product labeling (PI), in pertinent part:

Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

 The PI for Xarelto contains Boxed Warnings regarding increased risk of stroke after discontinuation in patients with nonvalvular atrial fibrillation and the risk of spinal/epidural

hematoma. The PI also contains Contraindications regarding active pathological bleeding and severe hypersensitivity reaction to Xarelto, as well as Warnings and Precautions regarding the risk of bleeding, use in patients with renal impairment and hepatic impairment, use with P-gp and strong CYP3A4 inhibitors or inducers, and risk of pregnancy related hemorrhage. The most common adverse reactions with Xarelto were bleeding complications.

Minimization of Risk Information

 Promotional materials are false or misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug. Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. The Print ad prominently presents various efficacy claims for Xarelto, such as, but not limited to, the following, that are presented in large, bolded and/or colorful text and graphics (emphasis original):

• “If you have atrial fibrillation (AFib)”

• “Ready to break your AFib routine?”

• “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce

the risk of stroke—without routine blood monitoring.”

• “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal. Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”

In contrast, the risk information is presented on the preceding adjacent page without any of the emphasis (i.e. color scheme, borders, layout, and graphics) used with the efficacy claims. The result is a presentation which appears unconnected to the efficacy claims and is therefore not likely to draw readers’ attention. This overall presentation misleadingly  minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims. We note that the Print Ad contains the statement, “Please see accompanying Medication Guide on the following pages” (emphasis original) at the bottom of the page, and that risk information is presented on an adjacent page, but this is not sufficient to mitigate the overall misleading presentation.

Misleading Claim

 The Print Ad includes the following claim (emphasis original):

• “And there are no dosage adjustments…”

The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto. However, according to the DOSAGE AND ADMINISTRATION section of the PI, the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a CrCL of 15 to 50 mL/min. In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….” Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy.

Conclusion and Requested Action

For the reasons discussed above, the Print Ad misbrands Xarelto in violation of the FD&C Act, 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix). OPDP requests that Johnson & Johnson immediately cease the dissemination of violative promotional materials for Xarelto such as those described above. Please submit a written response to this letter on or before June 20, 2013, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Xarelto that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to the undersigned at the Food and Drug Administration,

Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 or by facsimile at (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA# 215 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Xarelto comply with each applicable requirement of the FD&C Act and FDA implementing regulations.

Sincerely,

{See appended electronic signature page}

Zarna Patel, Pharm.D.

Regulatory Review Officer

Office of Prescription Drug Promotion

{See appended electronic signature page}

Amy Toscano, Pharm.D., RAC, CPA

Team Leader

Office of Prescription Drug Promotion

 

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Xarelto Settlement: Dead on Arrival?

April 15, 2019

(Mass Tort Nexus Media) Bayer and Johnson & Johnson both issued press releases on March 25th indicating to the public, as well as stockholders and analysts, that the companies had reached a settlement to resolve approximately 25,000 claims related to Xarelto. This announcement was arguably highly misleading, in that the agreement reached has not actually resulted in the settlement of a single Xarelto lawsuit (to the best of our knowledge) and certainly not 25,000 cases.

This was the headline in Reuters:  Bayer, J&J settle U.S. Xarelto litigation for $775 million,see Reuters.com/article/us-bayer-xarelto/bayer-jj-settle-us-xarelto-litigation-for-$775-million

At the time of press release, in which Bayer and Johnson & Johnson led the public and the market to believe they had resolved (settled) 25,000 pending Xarelto lawsuits, the overwhelming majority of firms representing those 25,000 clients had yet to receive significant details related to the proposed settlement, and of course had yet to present any offer to their individual clients, who would have to accept any offer made before a case could actually be settled.

Law Firms attending the Mass Torts Made Perfect conference in Las Vegas last week received more details related to the defendants proposed settlement and the reaction was not positive.

Large Scale Rejection of Proposed Settlement?

Mass Tort Nexus has spoken with a great a number of firms who were in attendance at MTMP, as well as numerous others since that time, and the clear indication that we have received would lead us to the conclusion that it is highly unlikely that the defendants proposed settlement will be accepted by enough firms (or rather their clients), to make going forward with the current proposed settlement anything other than a waste of time.

Law Firms that have been in contact with Mass Tort Nexus have indicated that they will fulfill their duty to present any offer made by defendants for their cases to the individual clients; however, they will not likely recommend that clients accept the offers made under the proposed settlement scheme. Many of the firms made colorful comments that we will not publish; however, there was a common theme among the comments:

“I would feel like I was selling out my clients if I recommend they accept the current offer the defendants have made.”

Others went as far as to say:

“I think it would be malpractice to recommend that clients accept the final amounts likely to be offered in this settlement scheme”

Dilemma for Bayer and Johnson & Johnson

The premature and arguably misleading public announcement, which would likely be considered official stock holder guidance, may create additional problems for the corporations already plagued by legal woes, which pose risks to their respective stock prices and stock holder value. If the proposed Xarelto settlement does fall through, as it appears will likely be the case, the companies will be faced with having to walk back previous positive news  “We have resolved the risk associated with the Xarelto litigation” to “not only have we not resolved the risk associated with the Xarelto litigation, but that risk may now be more significant than it was before we proposed a settlement, and many plaintiffs firms see it as more of an insult than an offer.”

If the proposed settlement was even close to something plaintiffs might except in significant numbers, Bayer and J&J might have been in a position to “tweak the settlement” and avoid having to deliver bad news to their stockholders and the public. Unfortunately for Bayer and J&J, the proposed settlement seems to be so far from “acceptable” that their only option may be to scrap the current proposed settlement and come back with another proposal, that will not be received with such strong resistance. If the two corporate giants have any hope of salvaging their messaging to the market, they will need to act quickly.

Proposed Settlement Appears to be a “Non-Starter” 

      

For now, it appears that there is no amount of lipstick that would make the proposed Xarelto settlement scheme attractive.  Most of the firms Mass Tort Nexus has spoken to have indicated that the defendants offer is not even a starting point.

 

 

 

 

MTN will provide more information in future articles about the proposed settlement, as well as the reasons a large number of firms do not feel the settlement is fair and just to their clients. At this point in time; however, it seems likely that the proposed Xarelto settlement is:

The Industry Comment

       XARELTO SETTLEMENT

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