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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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.

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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 reference materials from CBS, ABC, NBC US Department of Ju

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Fosamax Ruling: “A Small Win for Defense, A Big Win for Plaintiffs”

SCOTUS Fosamax Ruling (May 20, 2019)

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning

Small Win for Defendants

Defendants Won the argument that a Judge not a jury is the proper authority to decide impossibility preemption arguments arising under the FDCA (Food and Drug Cosmetics Act, Title 21). However, the win on this one issue is a hollow victory for defendants considering the entirety of SCOTUS order and opinion.

SCOTUS ruled that judges not juries are the proper authority to decide the issue however, SCOTUS also placed significant limits on what those lower court judges could and could not consider when ruling on impossibility pre-preemption arguments like those raise by Merck in the Fosamax Case.

JUSTICE THOMAS SUMMARY OF RULING

JUSTICE THOMAS, concurring:

I join the Court’s opinion and write separately to explain my understanding of the relevant pre-emption principles and how they apply to this case.

“Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law”

Big Win for Plaintiffs

SCOTUS ruled that Judges decide however, SCOTUS went much further and defined limits on what facts and information could be considered by lower court judges when making decisions related to impossibly preemption arguments like those raised by Merck in Fosamax.

SCOTUS opinion limits the clear and convincing evidence standards to OFFICAL Acts taken by the FDA which would in general rise1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

2. If the defendant did not ask to make the specific label change (which plaintiffs allege was needed) having provided the FDA all relevant information, and the FDA OFFICIALLY denied the label change, then no pre-emption exists.

Arguments that postulate “hypotheticals” (absent either of the above official actions (facts)) are not to be considered. Communications between the defendant and the FDA, Statements by the FDA that do not constitute an official act under the law, are not to be considered.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court heard arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse event being that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referred solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

SCOTUS RULED 9-0

Additional Concurring Opinion on the judgment only (Jury vs Judge only) from Justices Cavanaugh, Alito’s  and Chief Justice Roberts could be interpreted as allowing lower court Judges to consider other Official acts by the FDA other than those delineated above however, the additional opinion did not define what official acts other than the two discussed could be considered and inasmuch as these two official actions are constitute the limit of the powers relevant to such matters, delegated to the FDA by Congress, it is doubtful that a defendant could show a lower court Judge any other document (without posing hypotheticals) that would constitute an official action taken by the FDA that would have prevented the defendant from meeting its State Law duties (impossibility preemption).

In that the only powers delegated to the FDA by Congress (powers under the law) are those defined in the two types of actions listed above, relevant to the type of impossibility preemption arguments that were raised in Fosamax, based on unofficial actions, communications and statements from the FDA (and that defendants hoped to raise in numerous other cases) the Fosamax ruling taken in its entity, is a major blow to defendants hoping to open major cracks in Wyeth v Levine.

The central issue in this case concerns federal preemption, which as relevant here, takes place when it is “‘impossible for a private party to comply with both state and federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated with drugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulates the information that appears on brand-name prescription drug labels. The alleged conflict between state and federal law in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certain associated risks.

FOSAMAX HISTORY

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

MERCK SHARP & DOHME CORP. v. ALBRECHT Opinion of the Court(excerpt)

III

We turn now to what is the determinative question before us:

Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a question of law, normally for a judge to decide without a jury?

The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize its considered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agency action”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questions respecting the . . . terms of any agency action” and its “application” are “questions of law”). To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law. Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.

We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drug consumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision), the litigants may dispute whether the drug manufacturer submitted all material information to the FDA.

But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury. Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiary factual disputes” that are part and parcel of the broader legal question.  Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewhere between a pristine legal standard and a simple historical fact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circumstances, “‘the fact/law distinction at times has turned on a determination that, as a matter of the sound administration of justice, one judicial actor is better positioned than another to decide the issue in question.’” Markman, 517 U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.

 IV

Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards we have described in Part II of our opinion, we vacate its judgment and remand the case to that court for further proceedings consistent with this opinion.

It is so ordered.

____________________________________________________________

How Big Pharma’s cadre of lobbyists and congressional insiders attempt to reap major dividends, as we address the Fosamax ruling remains to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is paying off very well.

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Bayer/Monsanto and Roundup Verdict of $2 Billion = Settlement

  • Pilliod v. Monsanto Co. RG17862702, California Superior Court, County of Alameda (Oakland)

 

(MASS TORT NEXUS MEDIA) Combine the $2 billion verdict of May 13, 2019 and the two previous jury awards of $159 million in damages and you get major legal and financial issues for Bayer and the board of directors.

The Monsanto Roundup MDL 2741 May trial, initially set for next week was stopped by Judge Chhabria, who vacated the May 20, 2019 bellwether trial date, in the case of, Stevick v. Monsanto  where plaintiff Elaine Stevick, asserts that Roundup caused non-Hodgkin lymphoma. Federal Judge Vince Chhabria is overseeing thousands of Roundup lawsuits and has deemed Hardeman’s case and two others “bellwether trials” in ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California).

The numbers being discussed between Bayer corporate and their now very concerned board of directors for a global settlement are between $3 billion and $5 billion, which may be a low number after the $2 billion Pilliod jury award.

Here is the breakdown of the Pilliod vs. Monsanto trial verdict in the Alameda County Superior Court, Oakland, CA

$2.055 billion total verdict

 $55,206,172.80 compensatory damages and $2 billion punitive damages

Alva Pilliod

Compensatory:

Past economic – $47,296.01

Past non-economic loss – $8M

Future non-economic loss – $10M

——————————————-

$18,047,296.10

Punitive damages – $1 billion

Alberta Pilliod

Compensatory:

Past economic – $201,166.76

Past non-economic – $8M

Future economic  – $2,957,710

Future non-economic – $26M

——————————————-

$37,158,876.70

Punitive damages – $1 billion

 Monsanto Hit with Historic $2.055 Billion Verdict Losing Third Roundup Trial

Baum Hedlund Firm Press Conference on Verdict:  https://www.facebook.com/BaumHedlund/

 May 13, 2019  An Alameda jury in the case of Pilliod et al. v. Monsanto Company (Case No. RG17862702, JCCP No. 4953) returned a verdict today of $2.055 billion in favor of a husband and wife with non-Hodgkin lymphoma, ordering Monsanto to pay $55 million in compensatory damages and $2 billion in punitive damages ($1 billion each for Mr. and Mrs. Pilliod) for failing to warn consumers that exposure to Roundup weed killer causes non-Hodgkin lymphoma (NHL).

The verdict is the third in a row against Monsanto (now Bayer). Combined with the first two legal defeats (the Johnson v. Monsanto verdict of $289.2M and the Hardeman v. Monsanto verdict of $80M), verdicts against Monsanto in the Roundup cancer litigation now stand at $2.424 billion with 13,400 cases still pending in state and federal courts. (Johnson’s verdict was later reduced to $78.5M but his verdict is on appeal.)

A press conference on today’s landmark verdict will be held at the offices of Audet & Partners in San Francisco at 4:30 p.m. Plaintiffs Alva and Alberta Pilliod and their legal team will give statements on the verdict. A Q&A with the attorneys will follow. Details can be found below. We will also live stream this from our Facebook page.

Monsanto Loses Third Straight Roundup Cancer Trial

Alva and Alberta Pilliod, a Livermore, California couple in their 70s, used Monsanto’s Roundup weed killer together for more than 30 years to landscape their home and other properties. They were both diagnosed with the same type of NHL, diffuse large B-cell lymphoma (DLBCL), associated with Roundup exposure. In 2011, Alva was diagnosed with systemic NHL in many of his bones, which spread to his pelvis and spine. Alberta was diagnosed with NHL brain cancer in 2015.

In their Roundup cancer lawsuit, the couple attributed their cancer diagnoses on exposure to Roundup and its active ingredient, glyphosate, and accused Monsanto of fraudulently representing that Roundup is safe despite scientific evidence linking exposure to NHL.

At trial, attorneys for the Pilliods, Michael Miller of the Miller Firm and R. Brent Wisner of Baum, Hedlund, Aristei & Goldman, showed jurors a trove of internal Monsanto documents they say demonstrate the agrochemical giant’s manipulation of scientific literature, including ghostwriting several review papers on glyphosate published in scientific journals and cited in Environmental Protection Agency (EPA) regulatory reviews.

The jury also saw documents showing Monsanto’s efforts to influence EPA and other regulatory agencies, as well as evidence that Monsanto ran a public relations campaign to plant favorable stories in Reuters and other media outlets to defend its products and discredit scientists who determined glyphosate was linked to cancer.

During closing arguments, Wisner told the jury that Roundup was “born in fraud” because the agrochemical received EPA approval in 1974 based on studies conducted at Industrial Bio-Test Laboratories (IBT). A subsequent EPA review of the data found that IBT routinely falsified data. Three IBT executives were later convicted of fraud. According to Wisner, from that point on, Monsanto repeatedly refused to conduct studies on glyphosate and Roundup, even after the EPA and its own toxicologist told Monsanto that it needed to conduct more studies to address safety concerns.

After approximately 7 weeks of trial proceedings, the jury found that exposure to Roundup caused the Pilliods to develop NHL and that Monsanto failed to warn of this severe health hazard. Importantly, the jury also found that Monsanto acted with malice, oppression or fraud and should be punished for its conduct.

Since the Monsanto acquisition last summer and two negative jury verdicts, Bayer has lost more than $30 billion in shareholder value.

Monsanto Co. continues to refuse to warn consumers of the dangers of its multi-billion-dollar product Roundup despite the world’s foremost authority on cancer—the International Agency for Research on Cancer (IARC)—listing glyphosate as a probable carcinogen in 2015.

Monsanto Bad Conduct Is Revealed

* Monsanto never conducted epidemiology studies for Roundup and its other formulations made with the active ingredient glyphosate to evaluate the cancer risks for users.

* Monsanto was aware that the surfactants in Roundup were much more toxic than glyphosate alone.

* Monsanto spent millions of dollars on covert public relations campaigns to finance ghostwritten studies and articles aimed at discrediting independent scientists whose work found dangers with Monsanto’s herbicides.

* When the US Agency for Toxic Substances and Disease Registry sought to evaluate glyphosate toxicity in 2015, Monsanto engaged the assistance of EPA officials to delay that review.

* Monsanto enjoyed a close relationship with certain officials within the Environmental Protection Agency (EPA), who have repeatedly backed Monsanto’s assertions about the safety of its glyphosate products.

* The company internally had worker safety recommendations that called for wearing a full range of protective gear when applying glyphosate herbicides, but did not warn the public to do the same.

Pilliod v. Monsanto Trial Transcripts

Pilliod v. Monsanto Trial Exhibits

Pilliod v. Monsanto Jury Instructions

Attorneys React to Verdict Against Monsanto

After the verdict, co-lead trial counsel R. Brent Wisner thanked the jury for dutifully listening to scientific evidence and testimony over the course of several weeks. “They were given an incredibly difficult task having to analyze the highly-complex scientific issues in this case,” said Wisner. “They took detailed notes, asked incredibly thoughtful questions and in the end, came to understand that the science shows there are serious health hazards associated with Roundup and that Monsanto did nothing to warn people about the risk.”

“The jury saw for themselves internal company documents demonstrating that, from day one, Monsanto has never had any interest in finding out whether Roundup is safe,” Wisner said. “Instead of investing in sound science, they invested millions in attacking science that threatened their business agenda.”

Wisner also thanked everyone on the trial team, calling the victory a “true team effort that would not have been possible without the tenacity and resolve of everyone who worked on the case.”

Michael Miller, who served with Wisner as co-lead trial counsel added: “Unlike the first two Monsanto trials, where the judges severely limited the amount of plaintiffs’ evidence, we were finally allowed to show a jury the mountain of evidence showing Monsanto’s manipulation of science, the media and regulatory agencies to forward their own agenda despite Roundup’s severe harm to the animal kingdom and humankind.”

Roundup Cancer Attorneys in Pilliod v. Monsanto

A team of attorneys from three law firms represented the Pilliods in this trial: Michael Miller, Curtis G. Hoke, David J. Dickens and Jeffrey Travers of The Miller Firm of Orange, Virginia; R. Brent Wisner, Michael L. Baum and Pedram Esfandiary of Baum, Hedlund, Aristei & Goldman of Los Angeles, California; and Mark Burton of Audet & Partners of San Francisco, California.

The Miller Firm and Baum, Hedlund, Aristei & Goldman co-tried the case of Dewayne “Lee” Johnson v. Monsanto Co., the first Monsanto Roundup lawsuit to proceed to trial. The case resulted in a $289.2 million jury verdict last August. The judge later upheld the jury’s verdict but reduced the punitive damages award, bringing the total award to $78.5 million.

Baum Hedlund partner, R. Brent Wisner, was also part of the Hardeman trial team (the second Roundup trial) conducted by Aimee Wagstaff of Andrus Wagstaff and Jennifer Moore of Moore Law in U.S. District Court for the Northern District of California (federal court). Mr. Wisner presented one of the key fact witnesses (Dr. Christopher Portier) and he cross-examined most of the corporate witnesses in Hardeman v. Monsanto Co. Wisner is also administrator and co-lead counsel for the Roundup Products Cases JCCP 4953 (known as the Roundup Judicial Council Coordination Proceedings or simply Roundup JCCP) before the California Superior Court for the County of Alameda (where he Pilliod trial occurred).

Baum Hedlund managing partner, Michael Baum, and a team working under him assisted the Hardeman trial team as members of the MDL Executive Committee by presenting and preparing experts, corporate testimony and documents for Hardeman v. Monsanto Co. Mr. Baum is also a member of the Executive Committee for the Monsanto Roundup MDL (federal multi-district litigation). Mr. Miller is a co-leader of the Roundup MDL Executive Committee.

Pilliod v. Monsanto Docket History and Links

Alva and Alberta Pilliod v. Monsanto Co. (Case No. RG17862702, JCCP No. 4953) is the first Roundup non-Hodgkin lymphoma lawsuit from the California Roundup Judicial Council Coordination Proceedings (JCCP) to go to trial. Hundreds of lawsuits filed in California state courts are consolidated in the Roundup JCCP before Judge Winifred Smith for the Superior Court of Alameda County.

Pilliod v. Monsanto Co. is the third Roundup cancer case to go before a jury. The first Monsanto Roundup trial, Dewayne “Lee” Johnson v. Monsanto Co., resulted in a $289.2 million jury verdict last August. The judge later upheld the jury’s verdict but reduced the punitive damages award, bringing the total award to $78.5 million. The second case, Edwin Hardeman v. Monsanto Co., resulted in an $80 million jury verdict against the agrochemical company.

Plaintiffs in the litigation against Monsanto (now Bayer) allege that exposure to Roundup weed killer caused them to develop non-Hodgkin lymphoma.

Quick link to Pilliod trial transcripts

Quick link to Pilliod trial exhibits

Quick link to Pilliod trial press release

Jury Instructions

Alberta Pilliod verdict form

Alva Pilliod verdict form

Looking for unsealed Monsanto emails, communications, studies and other memoranda? Visit the Monsanto Papers page.

Alva Pilliod and his wife, Alberta, are in their 70s and have been married for nearly 50 years. They started using Roundup in the 1970s and continued using the weed killer until only a few years ago. The Livermore couple has two children and four grandchildren.

Alva suffers from non-Hodgkin lymphoma in his bones that spread to his pelvis and spine. He was diagnosed in 2011. Alberta was diagnosed with non-Hodgkin lymphoma brain cancer in 2015.

Attorneys for the Pilliods asked Judge Ioana Petrou (the previous presiding judge who has since been appointed to the First District Court of Appeal) to expedite the trial due to their advanced ages and cancer diagnoses. Judge Petrou granted their trial preference. The presiding judge for this trial is now Judge Winifred Smith.

The Miller Firm senior partner Michael J. Miller and Baum, Hedlund, Aristei & Goldman attorney R. Brent Wisner are co-lead trial counsel for the Pilliods. The Miller Firm and Baum, Hedlund, Aristei & Goldman co-tried the Johnson case last year.

Pilliod v. Monsanto Company Trial Transcripts

Day 1: 3/28/2019 – Plaintiff opening statement by R. Brent Wisner. Defense opening statement by Tarek Ismail.

Day 2: 4/2/2019 – Dr. Christopher Portier 402 Hearing (short hearing out of the presence of the jury to determine the admissibility of evidence). Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner.

Dr. Christopher Portier testimony (jury present). Direct examination by R. Brent Wisner.

Dr. Portier holds a Ph.D. in Biostatistics (with a minor in Epidemiology). For over three decades, Dr. Portier held prominent leadership positions in the U.S. government that combined the disciplines of toxicology, statistics and epidemiology, including:

  • Associate Director of the National Institute of Environmental Health Sciences (NIEHS) National Toxicology Program and thus the nation’s chief toxicologist, among other roles at NIEHS.
  • Director of the National Center for Environmental Health, Center for Disease and Prevention.
  • Director of the Agency for Toxic Substances and Disease Registry (ATSDR).

Expert Report of Dr. Portier

Day 3: 4/3/2019 – Dr. Christopher Portier testimony (continued). Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner.

Day 4: 4/4/2019 – Dr. Charles Jameson testimony. Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner. Recross-examination by Tarek Ismail.

Dr. Jameson worked for the National Institutes of Health’s National Cancer Institute (NCI) as a senior chemist for the NCI’s Rodent Bioassay Program where he served as chief chemist, directing all chemistry activities and participating in the development of all two-year rodent bioassays while also serving as secretary for the NCI’s Chemical Selection Working Group. He also served as program leader for the National Toxicology Program at the NIH’s National Institute of Environmental Health Sciences (NIEHS) for 12 years.

Expert Report of Dr. Jameson

Day 5: 4/8/2019 – Dr. Beate Ritz, Chair of the Epidemiology Department at UCLA, direct examination by Michael Miller. Cross-examination by Kelly Evans. Redirect examination by Michael Miller. Recross-examination by Kelly Evans. Further redirect examination by Michael Miller.

Mark Martens video testimony (taken on April 7, 2017 in Washington, D.C.).  Mr. Martens is a former Monsanto executive, Toxicology Agriculture Research & Development Director for Monsanto Europe.

Dr. Ritz is a professor of Epidemiology at the University of California, Los Angeles. She holds doctoral degrees in Medicine and Epidemiology and is the author of numerous toxicology publications, lectures and presentations. Dr. Ritz engaged in a systematic review of the literature in this case, utilized the Bradford Hill Criteria and concluded that “to a reasonable degree of scientific certainty, glyphosate causes NHL. Furthermore, to a reasonable degree of scientific certainty, glyphosate-based formulations, including Roundup, cause NHL.”

Dr. Ritz Expert Report

Day 6: 4/9/2019 – Dr. Dennis Weisenburger direct examination by Michael Miller. Cross-examination by Tarek Ismail.

Dr. Weisenburger specializes in the studies of the hematopoietic and immune systems, with a special interest in non-Hodgkin lymphoma. His study of the pathological mechanisms by which NHL develops began in the 1980s when he was directing large epidemiologic studies related to NHL.

Over the last four decades, Dr. Weisenburger has published over 300 papers on NHL in peer-reviewed journals, and over 50 papers on the epidemiology of NHL, including studies on glyphosate and NHL. In his expert report, Dr. Weisenburger concluded that to “a reasonable degree of medical certainty that glyphosate and GBFs [glyphosate-based formulations] (including Roundup) can cause NHL in humans exposed to these chemicals in the workplace or environment.”

Dr. Weisenburger Expert Report

Day 7: 4/10/2019 – Dr. Dennis Weisenburger cross-examination by Tarek Ismail (resumed). Redirect examination by Michael Miller. Recross-examination by Tarek Ismail. Further re-direct examination by Michael Miller. Further recross-examination by Tarek Ismail.

Mark Martens video testimony (resumed).

William Reeves video testimony. Mr. Reeves is Global Health and Safety Issues Management Lead at Bayer Crop Science.

Day 8: 4/11/2019 – Dr. William Robert Sawyer, toxicologist, direct examination by Brent Wisner. Cross-examination by Kelly Evans. Redirect examination by Brent Wisner.

William Reeves video testimony (resumed)

Day 9: 4/15/19 – William Reeves video testimony (resumed)

William Heydens video testimony (Monsanto Regulatory Product Safety Assessment Lead)

Michael Koch video testimony (Product Safety Team Lead, Bayer Crop Science)

Day 10: 4/16/19 – Michael Koch video testimony (resumed)

William Pease, direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr. Redirect examination by Brent Wisner.

Dr. Pease, toxicologist and assistant adjunct professor at the School of Public Health, University of California at Berkeley. In the early 90s he was a Research Toxicologist at UC Berkeley, where he coordinated the school’s Environmental Health Policy Program and conducted research on the impacts of pesticide use in California. Dr. Pease served as the co-chair of the Human Health Committee of CalEPA’s Comparative Risk Project, organizing its risk assessment and risk ranking process.

Michael Koch video testimony (resumed)

Aaron Blair video testimony. Dr. Blair currently serves as an advisor on the Chlordecone Scientific Committee (Institute National du Cancer, France), Pesticide Advisory Committee (Carex Canada), and Independent Advisory Board for Exposure Assessment (Institute of Occupational Medicine, Scotland). He has authored/coauthored more than 500 papers on occupational and environmental causes of cancer, other diseases, and epidemiologic methodology.

Daniel Goldstein video testimony. Dr. Goldstein works for Monsanto as Monsanto Lead Medical Sciences and Outreach.

Day 11: 4/17/2019 – Charles Benbrook, scientist and agricultural economist, direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr. Redirect by Brent Wisner.

Kavitha Raj video testimony. Dr. Kavitha Raj is the treating physician for Mr. and Mrs. Pilliod.

Day 12: 4/18/2019 – Kavitha Raj video testimony (resumed)

Alberta Pilliod direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr.

Alva Pilliod direct examination by Brent Wisner

Michael Pilliod direct examination by Michael Miller

Alberta and Alva Pilliod are the plaintiffs in this case. Michael Pilliod is their son.

James Rubenstein video testimony

Dr. Rubenstein, attending physician in hematology and oncology from the University of California San Francisco, was Alberta Pilliod’s treating physician.

Day 13: 4/22/2019 – Neel Gupta video testimony. Dr. Gupta is Alberta Pilliod’s physician.

Chadi Nabhan direct examination by Michael Miller. Voir dire examination by Tarek Ismail. Direct examination by Michael Miller.

Dr. Chadi Nabhan is a board-certified clinical medical oncologist and past Assistant Professor of Medicine at the University of Chicago. Currently, Dr. Nabhan serves as Medical Director of Cardinal Health. His clinical practice and academic research for the past 17 years has focused on lymphomas.

Expert Report of Dr. Nabhan

Day 14: 4/23/2019 – Alberta Pilliod 402 hearing (out of the presence of the jury). Direct examination by Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by Brent Wisner.

Chadi Nabhan testimony (continued). Direct examination by Michael Miller. Cross-examination by Tarek Ismail. Redirect examination by Michael Miller. Recross-examination by Tarek Ismail.

Direct examination of James Mills by Michael Miller. Cross-examination by Tarek Ismail.

Mr. Mills is a forensic economist.

Video testimony of Samuel Murphey. Mr. Murphey is Head of Global Issues Management, Bayer Crop Science.

Video testimony of James Guard. Mr. Guard is Global Roundup Lawn & Garden Lead, Bayer Crops Science.

Plaintiffs rest.

Day 15: 4/25/2019 – Proceedings without jury present.

Day 16: 4/27/2019 – Testimony of defense expert witness, Celeste Bello.

Direct examination by Tarek Ismail. Voir dire examination by Brent Wisner. Direct examination resumed by Tarek Ismail. Cross-examination by Brent Wisner. Redirect examination by Tarek Ismail. Recross-examination by Brent Wisner.

Dr. Bello is a hematologist and oncologist at the Moffitt Cancer Center.

Day 17: 4/30/2019 – Testimony of defense expert witness, Robert Phalen.

Direct examination by Kelly Evans. Voir dire examination by Brent Wisner. Direct examination resumed by Kelly Evans. Cross-examination by Brent Wisner. Redirect examination Kelly Evans. Recross-examination by Brent Wisner.

Dr. Phalen is an associate professor in industrial hygiene and safety at the University of Houston, Clear Lake.

Day 18: 5/1/2019 – Testimony of defense expert witness, Lorelei Mucci.

Direct examination by Kelly Evans. Voir dire examination by Michael Miller. Direct examination resumed by Kelly Evans. Cross-examination by Michael Miller. Redirect examination by Kelly Evans. Recross-examination by Michael Miller.

Dr. Mucci is an Associate Professor of Epidemiology at Harvard T.H. Chan School of Public Health and Assistant Professor of Medicine at Harvard Medical School.

Day 19: 5/6/2019 – Testimony of defense expert witness, Alexandra Levine.

Direct examination by Tarek Ismail. Voir dire examination by Michael Miller. Direct examination resumed by Tarek Ismail. Cross-examination by Michael Miller. Redirect examination by Tarek Ismail. Recross-examination by Michael Miller.

Dr. Levine is a professor in City of Hope’s Hematologic Malignancies and Stem Cell Transplantation Institute.

Defendant rests.

Day 20: 5/7/2019 – Proceedings without jury present.

Pilliod v. Monsanto Company Trial Exhibits

Plaintiffs’ Trial Exhibits

The jury in Bayer AG’s third Roundup weedkiller trial was urged by a plaintiffs’ lawyer to consider socking the company with $1 billion in damages as punishment for covering up the health risks of the herbicide for decades.

The aggressive demand on behalf an elderly couple who claim they got cancer from exposure to Roundup shows that plaintiffs are becoming bolder after winning the first two trials against Bayer, which together yielded $159 million in damages.

The couple’s attorney said the billion-dollar request is roughly based on the gross profit of $892 million recorded in 2017 by the agricultural-chemicals division of Monsanto, which was making Roundup long before Bayer acquired the company last year.

“That is a number that changes things,” lawyer Brent Wisner said Wednesday at the close of a trial in state court in Oakland, California. He also asked the jury to award about $55 million to compensate Alva and Alberta Pilliod for economic damages like hospital bills and noneconomic losses such as pain and suffering.

Investors have been closely watching developments in the costly Roundup litigation, and Bayer fell as much as 2.6% Thursday in Frankfurt. The shares have fallen about 40 percent since the $63 billion Monsanto purchase was completed in June.

Wisner argued that Monsanto’s internal data and documents reveal its “manipulation and fabrication of science,” just like other defective products that got to market based on fraudulent representations that they were safe.

An attorney for the company sought Wednesday to poke holes in the Pilliods’ efforts to show that they wouldn’t have developed non-Hodgkin lymphoma if they hadn’t used Roundup for landscaping their properties over a period of 30 years.

Tarek Ismail told the jury that’s an impossible, illogical conclusion given that Alva Pilliod’s weakened immune system greatly increased his risk of developing cancer. Digging into Pilliod’s medical history, Ismail cited 22 different types of skin cancers starting in his 20s, five brain infections starting in the late 1970s caused by herpes, other viral infections and colitis.

“You put this picture together and what do you see?” Ismail asked. “How anyone can stand here and deny this evidence of a weakened immune system is incredible.”

Alberta Pilliod, who Ismail said started smoking before she was 20 years old, similarly suffered from conditions that increased her risk of developing non-Hodgkins lymphoma, the lawyer said. He highlighted testimony from a doctor for the couple to argue her cancerous tumor wasn’t a type associated with exposure to herbicides, “full stop.”

Bayer Chief Executive Officer Werner Baumann faces increased shareholder pressure over the litigation it inherited from Monsanto. The agrochemical giant that operates out of St. Louis is the named defendant in U.S. lawsuits over Roundup filed by 13,400 people, a number that jumps by thousands with each passing quarter.

Why Bayer Shares Are Facing Such Trials Over Roundup: QuickTake

Bayer denies that Roundup causes cancer and the company has been holding out hope for a court win that would give Baumann some breathing space as the company hones its legal response to the swelling wave of litigation. A third loss, however, could force the company to accelerate talks on a global settlement, which analysts have said could top $5 billion. The judge in San Francisco handling the federal suits canceled a trial scheduled for May 20 to allow for confidential negotiations.

Plaintiffs’ lawyers, meanwhile, are honing their own arguments. In Oakland, Wisner presented evidence previous juries hadn’t seen, and portrayed internal emails and company advertising as evidence of glib disregard for consumer safety.

He played a video of an advertisement for Roundup showing a suburban man in shorts and a short-sleeved shirt killing weeds using the company’s “one-touch wand” to a soundtrack invoking the Old West. He pointed to Monsanto’s own exposure studies recommending that the herbicide be applied with chemical boots and overalls.

“That’s deliberate and knowing disregard for human safety, and it directly links to the Pilliods,” Wisner said.

An award of $1 billion would be vulnerable to a legal challenge by Bayer because courts have generally held that punitive damages shouldn’t be more than 10 times higher than compensatory damages.

The Alameda County Court case is Pilliod v. Monsanto Co. RG17862702, California Superior Court, County of Alameda (Oakland).

Mass Tort Nexus wants to thank Robin McCall and the Baum Hedlund firm for sharing their comments immediately after the trial verdict was announced.

Contact: Robin McCall, Media Relations

Baum, Hedlund, Aristei & Goldman, PC

Los Angeles – Sacramento – San Francisco

10940 Wilshire Blvd., 17th Floor

Los Angeles, CA 90024

Phone: (310) 207-3233

Email: rmccall@baumhedlundlaw.com

Web:  https://www.baumhedlundlaw.com/pilliod-v-monsanto-trial/

Read More

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

 

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FDA Fails to Cite Big Pharma for False Marketing and Advertisements

“PROFITS BEFORE PATIENTS REIGNS SUPREME AT FDA”

By Mark A. York (April 22, 2019)

Purdue Pharma and OxyContin Never Warned By FDA

(MASS TORT NEXUS MEDIA)  In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products.

The Food and Drug Administration has sent just three notice letters to drug makers busted for false marketing their medications to unknowing consumers, the lowest ever since the FDA historic decision to ease strict rules for drug ads in 1997. “It certainly raises questions,” said Dr. David Kessler, head of the FDA from late 1990 through 1996, who’s industry credentials would add weight to the issue of why the FDA is not doing more to monitor false marketing campaigns by Big Pharma and Opioid Drug makers in particular.

The FDA’s Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren’t being scammed by false assertions or misleading marketing campaigns. Which now seems to be the norm, based on the hundreds of lawsuits filed against Opioid Drug Makers in the last 3 months, and recently consolidated into Opiate Prescription MDL 2804 see Opioid Crisis Briefcase-Mass Tort Nexus, where Big Pharma is being sued by states, cities and counties across the country. The primary claim in almost every suit is long term boardroom coordinated false marketing campaigns designed to push opioid drug prescriptions at any cost.

 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 years since the push to increase opioid prescriptions in every way possible became an accepted business model Big Pharma boardrooms across the country.

In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.

Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

Trump stops FDA enforcement rule change: January 12, 2018 Food and Drug Administration Press Release: FDA Delays Change to “Off-Label” Drug Use Enforcement Rules

WHAT IS “OFF-LABEL” MARKETING?

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud.  And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West.  “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information.  Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA.  Before approval, the FDA must determine that the drug is safe and effective for those specified uses.  Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded.  The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth.  “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health.  The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

FDA PLEADS NO STAFF

But the agency has long struggled to keep track of the thousands of ads published each year, largely due to lack of staff.

There are approximately 60 FDA staffers responsible for keeping track of at least 75,000 ads and other promotional material published each year. Although in the age of electronic monitoring and hi-tech tracking of data it would seem that monitoring drugs such as Schedule 2 – 4 narcotics or other drugs that are considered high risk for abuse, the FDA could create a quarterly e-review or a flagging system when new campaigns are started by Big Pharma.

“It’s a very, very small unit,” a former high-ranking FDA official said. “It’s historically been underfunded.” Which seems to support the contention that Washington D.C lawmakers are in the pockets of Big Pharma and the hundreds of lobbyists they utilize to ensure a true lack of oversight in the pharmaceutical industry as a whole.

Additionally, many of the ads are submitted to the FDA for review at the same time they begin to run. So by the time the assessment is complete the ad has “already had a significant impact,” the FDA insider said. This policy flies in the face of the creation regulatory oversight based on the fact that when a problem or an issue with a product is discovered, the FDA, EPA or other agency should enforce the law and correct the problem. In the case of the FDA, that is not happening and Big Pharma is and has been aware of the lack of oversight for years.

Critics say the FDA needs to do more to stay on top of an industry with a history of trying to maximize profits by at times misleading consumers, which has recently been described as a policy of “patients before patients” which has resulted in the current Opioid Crisis that’s firmly in place across the United States.

The number of public admonishment letters has been at or close to single digits from 2014 until 2016 during the Obama administration, records show. The FDA sent out 11 of those caution missives in 2016, nine in 2015 and 2014, and 24 in 2013.

A SINGLE FDA WARNING IN 2016

This year, one of the warning letters was sent to Canadian drugmaker Cipher Pharmaceuticals, ordering it stop using deceptive promotional material to hawk its extended-release opioid ConZip.

The ad failed to note “any risk information” highlighting the potentially addictive nature of the powerful painkiller, the FDA letter issued Aug. 24 said. The promotional material was also misleading because it asserted other treatment options “are inadequate,” the oversight agency concluded.

“By omitting…serious and potentially fatal risks, the detail aid…creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse,” the FDA said.

The agency demanded that Cipher “immediately cease misbranding” the medication. The drug company responded by yanking the promotional material, the firm’s execs said in a statement issued after the warning letter was made public.

But that was the single caution letter issued to an overhyped painkiller by the FDA this year so far, records show. The other caution letters were sent to Amherst Pharmaceuticals for the insomnia drug Zolpimist, and to Orexigen Therapeutics Inc. for its weight loss drug Contrave.

There are many long term FDA and other senior DC officials who have for whatever reasons, chosen to defer reigning in Big Pharma sales and marketing abuses and now it appears the corrective action has been undertaken in federal courts across the country by mass tort lawyers in litigation which will apparently make the “Tobacco Litigation” of the 1980’s pale in financial comparison.

With the primary lawsuits recently consolidated by in the Multidistrict Litigation titled “National Prescription Opiate Litigation” Case No. MDL 2804, recently assigned to the US District Court, Northern District of Ohio.  With the key case heading including “prescription and opiate” which reflects the federal court recognizing that opiate prescriptions have become such a major issue the federal courts will now determine the penalties assessed against Big Pharma. The focus will be on the long term “sales and marketing campaigns” designed in corporate boardrooms of Fortune 100 companies, to increase corporate profits, while ignoring the known catastrophic increases in addictions and other inter-connected healthcare, economic and social upheavels caused by the flood of opioid drugs in the US market.

The FDA maintains that letters to drug companies are merely one tool the agency uses to keep the pharmaceutical industry in line.

“We have many efforts to encourage compliance by industry, including our work on guidance, by providing advice to companies on draft promotional materials, and outreach to our stakeholders,” FDA spokeswoman Stephanie Caccomo said. “The FDA’s priorities regarding prescription drug promotion are policy and guidance development, labeling reviews, core launch and TV ad reviews, training and communications and enforcement.” The key terms referred to by Ms. Caccamo are “guidance and by providing advice” from the FDA, when direct enforcement actions are required, as Big Pharma see the terms “guidance and advice” as harmless and not applicable to their efforts to increase sales and profits. In-house lawyers at Big Pharma have reviewed FDA enforcement failures and offered opinions to the boardrooms for years about the FDA not willing to enforce anything close to restrictions on opioid drug marketing and sale practices, all the while reaping the profits of the opioid crisis.

U.S. DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

US CONGRESS IS NOT HELPING

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

WHITE HOUSE IGNORES BIG PHARMA ABUSE

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States.  The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, won’t change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

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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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FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

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FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

Safety Announcement

[4-9-2019] The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.

Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

We are continuing to monitor this safety concern and will update the public if we have new information. Because we are constantly monitoring the safety of opioid pain medicines, we are also including new prescribing information on other side effects including central sleep apnea and drug interactions. We are also updating information on proper storage and disposal of these medicines that is currently available on our
Disposal of Unused Medicines webpage.

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving opioids or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

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