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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Note: (Excerpts within this article include reference materials from CBS, ABC, NBC US Department of Ju

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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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Insys Therapeutics “Fentanyl Spray Criminal Trial” In Jury Deliberations

“Fentanyl Spray Federal Criminal Trial” Now In US District Court of Massachusetts Jury Deliberations

By Mark A. York (April 8, 2019)

Subsys: a highly addictive fentanyl spray.

December 2016 saw Insys Therpaeutics Founder John Kapoor, CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as these cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by various agencies. Purdue is being investigated for false marketing, off-label use and ignoring Oxycontin’s highly addictive dangers for years, while bringing in literally billions of dollars in profits.

PRIOR DOCTOR INDICTMENTS

Doctors who’ve written massive numbers of Subsys prescription, under the “fee to speak” program have been indicted and they include pain clinics, medical centers and other healthcare facilities who now face federal criminal charges for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison.

The top “Subsys” prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and its corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which caused the revocation of his license Arkansas.

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

Prosecutors also said that two former Insys employees who were first charged in 2016 in connection with the scheme, Jonathan Roper and Fernando Serrano, had secretly pleaded guilty and become cooperating witnesses. The five doctors were arrested last Friday morning and face charges including that they violated the federal anti-kickback law and conspired to commit fraud.

INSYS RX ABUSES WERE BLATANT

The case is the latest in a series of medical practitioners and former Insys executives and employees facing criminal charges related to Subsys, the company’s potentially addictive fentanyl-based spray.

Federal prosecutors in Boston are moving forward aggressively against the seven former Insys executives and managers as well billionaire founder John Kapoor, all accused of actively designing and participating in the scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it. Insys has said it may need to pay at least $150 million towards part of a settlement with the U.S. Justice Department as well as numerous other state investigations around the country, not to mention the civil complaints filed against the company in the Opiate Prescription MDL 2804, see OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where the Insys sales and marketing tactics are listed as prime examples of boardroom designed “profits over patients” policies are cited.

Insys is joined in the massive Federal Opioid MDL 2804, by other Big Pharma defendants including Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers who were allowed to place profits over patients for more than 15 years, while earning billions in profits.

UNETHICAL SALES TACTICS

According to the most recent and prior doctor indictments, the physicians have participated in Insys’ speaker programs, which were in reality social gatherings at high-end restaurants. They earned kickbacks ranging from $68,000 and $308,000 and were among the top 20 prescribers of Subsys nationwide at some point during the marketing campaign. A few doctors indicted as far back as late 2016 have already been sentenced to federal prison terms up to 20 years and forfeit of millions of dollars in assets. The Insys marketing tactics included trips with doctors to strip clubs with Insys sales managers; and often with Insys executives, where they covered lap dances and drinks which on one trip ran up a tab of over $4,100 which was apparently enough to convince physicians to write massive numbers of off-label fentanyl prescriptions.

The Criminal Trial Status

A cooperating witness testified by calling the payments bribes, a former vice president of Insys Therapeutics stood by a giant spreadsheet in court Tuesday and described how the drug company funneled phony “speaking fees” to doctors in exchange for prescribing its highly addictive opioid painkiller.

Alec Burlakoff, who has pleaded guilty to racketeering charges and is testifying in US District Court in Boston against Insys founder John N. Kapoor and four former colleagues, said Kapoor encouraged the program in late 2012 to spur doctors to prescribe Subsys, an under-the-tongue fentanyl spray.

But Kapoor insisted that each practitioner generate at least twice as much revenue for Insys by writing Subsys prescriptions than he or she received from the company.

Burlakoff stood next to an enlarged spreadsheet that executives prepared in December 2012. One column showed what each “speaker” received every time he or she supposedly met with other doctors to promote Subsys. The amounts ranged from $1,000 to $1,600 to $2,400 depending on whether Insys designated them local, regional, or national experts.

In truth, he said, the designation “national expert” was ludicrous and some doctors had only sordid reputations for running “pill mills.”

Another column showed how many prescriptions the practitioners wrote for Subsys, while another displayed how many they wrote for competing fentanyl products.

Assistant US Attorney Fred Wyshak Jr. asked Burlakoff what another column listing sums of money represented.

“That’s the amount of money we paid in bribes to date,” said Burlakoff, the former vice president of sales, prompting one of the defense lawyers for the five defendants to object.

Kapoor and four other former executives of the Chandler, Ariz.-based company are on trial for allegedly conspiring to violate the federal criminal Racketeer Influenced and Corrupt Organizations Act, or RICO, by paying bribes and kickbacks to practitioners. Prosecutors typically use RICO to go after alleged mobsters.

It is the first criminal trial of pharmaceutical executives who marketed an opioid painkiller since the nation’s deadly opioid epidemic began.

Burlakoff, whom jurors first saw last month dressed as a bottle of Subsys spray in a jaw-dropping in-house rap video, said that at least one executive strenuously objected to the company tracking how many Subsys prescriptions participants in the speakers program wrote.

Matthew Napoletano, Insys’s former head of marketing, who has already testified under immunity for the government, rose from his chair at a meeting with Kapoor, Burlakoff, and other executives, Burlakoff said. Napoletano said such a spreadsheet could be viewed as evidence of a crime.

But the company went forward with the payment program.

The payments were hardly the only way Insys prodded doctors to write Subsys prescriptions, Burlakoff said. Leaders of the sales team, including Joseph Rowan, a former regional sales director who is among the defendants, would buy coolers full of steaks for doctors, according to Burlakoff.

In other cases, he said, Insys executives would put staffers in the offices of big Subsys prescribers on the payroll of the drug company; those staffers were often spending considerable time on the phone with insurers trying to get them to approve Subsys prescriptions, and “now doctors would no longer be complaining” about the expense of paying those employees to do that.

Burlakoff, who became vice president of sales in 2012 after spending years at Cephalon, Eli Lilly and Company, and other drug makers, said Insys didn’t only provide incentives to physicians; the company also gave incentives to members of the sales team.

Sales representatives at Insys, he said, had a starting salary of $40,000 a year, less than half of what such employees typically made at other drug companies. But they received an extraordinary commission of 10 percent on the sales they made each quarter, and it wasn’t capped.

Several sales representatives, he said, made $110,000 in a quarter based just on the commission.

As part of the boardroom strategy to get doctors to prescribe Subsys, Insys spent millions paying them off through a fraudulent “speakers program” meant to educate medical professionals about the drug. The speaking engagements were a veiled attempt to cover-up the direct payment to doctors for writing prescriptions, the more prescriptions you wrote, the higher your “speaking fees” increased. There are e-mails, texts and other Insys communications from all levels of company personnel stating “if they not writing prescription, they’re off the speaking program”, this policy resulted in one Alabama sales rep being paid over $700 thousand in Subsys based Rx commissions for one year, while her base salary was $40 thousand.

SALES REP NATALIE REED PERHAC

In the plea, Perhacs admitted that she was hired to be the personal sales representative for one of Insys’s most important prescribers, Dr. Xiulu Ruan. Ruan is one of two Alabama doctors who picked up over $115,000 in speaker fees from 2012 to 2015, and earned in excess of $40 million in related medical earnings during the same period. Earlier this year they were sentenced to 20 years in jail each for running a “pill mill” and helping Insys sales rep Natalie Reed Perhacs sell Subsys, for which she was paid in excess of $700 thousand in commissions, see Perhac Guilty Plea in Alabama Federal Court.

Perhac Plea Excerpts:

Admision No. 78: . Perhacs admitted that her primary responsibility at Insys was to increase the volume of Subsys® prescribed by Dr. Ruan, and his partner Dr. John Patrick Couch. This… was accomplished by (1) handling prior authorizations for their patients who had been prescribed Subsys®; (2) identifying patients who had been at the same strength of Subsys® for several months and recommending that Dr. Ruan or Dr. Couch increase the patients’ prescription strength; and (3) setting up and attending paid speaker programs.

Admission No. 79:. Ms. Perhac admitted that because of her involvement in the prior authorization process, she knew that the vast majority of Dr. Ruan and Dr. Couch’s patients did not have breakthrough cancer pain.

As you can see by the Perhac admissions, numbers 78 and 79, which reflect the vast number of charges lodged against her, the federal government is cracking down on everyone involved with the “Subsys” fraud. According to confidential sources, the recent June 2017 FDA “Opioid Crisis” Conference and related strategic review of the opioid crisis, will result in many more indictments and charges against drug makers and the medical providers who’ve helped facilitate the opioid epidemic that is currently in place across the United States.

How the results of the trail against the Insys Therapeutics boardroom plays out in the overall “Opioid Crisis” battle remains to be seen. There is always the question of why the Sackler family (Purdue Pharma) and the billions they’ve earned off improper marketing of Oxycontin and their scorched earth sales tactics, have not resulted in criminal indictments yet? Perhaps the Sackler family habit of donating billions to charities and having hospital wings named in their honor was a very strategic and forward looking business model that is now paying great dividends.

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RICHARD SACKLER DEPOSITION TRANSCRIPT UNSEALED IN KENTUCKY vs. PURDUE PHARMA

Full Article: statnews.com/2019/02/21/purdue-pharma-richard-sackler-oxycontin-sealed-deposition/Feb 21-2019

By DAVID ARMSTRONG — PROPUBLICA, FEBRUARY 21, 2019

and MOLLY FERGUSON FOR STAT

(This is a partial reprint by MASS TORT NEXUS of a collaboration between STAT and ProPublica contained in the full article link above).

“Purdue’s Sackler embraced plan to conceal OxyContin’s strength from doctors, unsealed Richard Sackler deposition shows” 

 A LINK TO THE FULL RICHARD SACKLER DEPOSITION TRANSCRIPT IS CONTAINED IN ARTICLE BELOW

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In 2007, Purdue Frederick Co. (not Purdue Pharma) and three company executives pled guilty to misbranding OxyContin and agreed to pay $634.5 million to resolve a U.S. Department of Justice investigation, in the US District Court of Virginia, see Purdue Criminal Plea Agreement US Department of Justice May 10, 2007. This plea deal “a get-out-of-jail free card” was engineered by none other than former New York City Mayor and political/corporate fixer, Rudy Guiliani, by directly leveraging high level US DOJ contacts and other DC insiders to derail the prosecution of Purdue Pharma, and instead offer up Purdue Fredrick Co. as the guilty party and thereby permitting the multi-billion dollar per year Oxycontin assembly line to continue operations.

The Sackler family has always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin, and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.

That is now changing, as the State of Massachusetts has filed a lawsuit against Purdue Pharma and the Sackler family as well as various Purdue executives over the prescription painkiller OxyContin. Oxycontin is now recognized as the opioid fuse that ignited America’s opioid crisis, and in a positive move forward, the leading executives and members of the multibillionaire Sackler family, now known to be feuding over the opioid crisis have been named in civil litigation.

In the Kentucky vs. Purdue Pharma litigation (Pike County Kentucky Circuit Court) , where in the recently unsealed court documents is the only known deposition testimony of a Sackler family member, with this being the August 28, 2016 deposition of Pudue Pharma family member Richard Sackler, a link to the full deposition transcript is contained within this article, as well as the full ProPublic/StatNews article link, statnews.com/2019/02/21/purdue-pharma-richard-sackler-oxycontin-sealed-deposition/Feb 21-2019.

Who is Richard Sackler, and why was he deposed?

The son of a Purdue co-founder, Sackler began working at the company in 1971 and has been at various times its president and co-chairman of the board. The Sackler family controls Purdue and has received billions of dollars from OxyContin sales.

In 2015 Purdue Pharma agreed to pay $24 million to settle a lawsuit filed by Kentucky, December 22, 2015 Purdue Pharma Settlement With State of Kentucky, which Purdue thought would end that problem by paying a fine and moving on, which isn’t the case it seems. See Purdue Pharma settles with Kentucky over Oxycontin claim(statnews.com/pharmalot) for information on the claims in Kentucky.

That state court litigation has been the subject of an ongoing legal battle in the Kentucky courts where Purdue is fighting to keep the original court records from that settlement sealed, due to the only deposition testimony of one of the Sackler brothers is known to be located. The Purdue court records were unsealed by Pike County Judge Stephen Combs in May 2016, and Purdue immediately appealed with oral arguments taking place June 26, 2017 in front of a three judge panel of the Kentucky Court of Appeals, which had failed to rule on the argumanets as recently as January 2019

In May 1997, the year after Purdue Pharma launched OxyContin, its head of sales and marketing sought input on a key decision from Dr. Richard Sackler, a member of the billionaire family that founded and controls the company. Michael Friedman told Sackler that he didn’t want to correct the false impression among doctors that OxyContin was weaker than morphine, because the myth was boosting prescriptions — and sales.

“It would be extremely dangerous at this early stage in the life of the product,” Friedman wrote to Sackler, “to make physicians think the drug is stronger or equal to morphine. … We are well aware of the view held by many physicians that oxycodone [the active ingredient in OxyContin] is weaker than morphine. I do not plan to do anything about that.”

“I agree with you,” Sackler responded. “Is there a general agreement, or are there some holdouts?”

Ten years later, Purdue pleaded guilty in federal court to understating the risk of addiction to OxyContin, including failing to alert doctors that it was a stronger painkiller than morphine, and agreed to pay $600 million in fines and penalties. But Sackler’s support of the decision to conceal OxyContin’s strength from doctors — in email exchanges both with Friedman and another company executive — was not made public.

Related: Purdue cemented ties with universities and hospitals to expand opioid sales, documents contend

The email threads were divulged in a sealed court document that ProPublica has obtained: an Aug. 28, 2015, deposition of Richard Sackler. Taken as part of a lawsuit by the state of Kentucky against Purdue, the deposition is believed to be the only time a member of the Sackler family has been questioned under oath about the illegal marketing of OxyContin and what family members knew about it. Purdue has fought a three-year legal battle to keep the deposition and hundreds of other documents secret, in a case brought by STAT; the matter is currently before the Kentucky Supreme Court.

READ THE SACKLER DEPOSITION HERE

Meanwhile, interest in the deposition’s contents has intensified, as hundreds of cities, counties, states and tribes have sued Purdue and other opioid manufacturers and distributors. A House committee requested the documentfrom Purdue last summer as part of an investigation of drug company marketing practices.

In a statement, Purdue stood behind Sackler’s testimony in the deposition. Sackler, it said, “supports that the company accurately disclosed the potency of OxyContin to healthcare providers.” He “takes great care to explain” that the drug’s label “made clear that OxyContin is twice as potent as morphine,” Purdue said.

Still, Purdue acknowledged, it had made a “determination to avoid emphasizing OxyContin as a powerful cancer pain drug,” out of “a concern that non-cancer patients would be reluctant to take a cancer drug.”

The company, which said it was also speaking on behalf of Sackler, deplored what it called the “intentional leak of the deposition” to ProPublica, calling it “a clear violation of the court’s order” and “regrettable.”

Much of the questioning of Sackler in the 337-page deposition focused on Purdue’s marketing of OxyContin, especially in the first five years after the drug’s 1996 launch. Aggressive marketing of OxyContin is blamed by some analysts for fostering a national crisis that has resulted in 200,000 overdose deaths related to prescription opioids since 1999.

Taken together with a Massachusetts complaint made public last month against Purdue and eight Sacklers, including Richard, the deposition underscores the pivotal role of the Sackler family in developing the business strategy for OxyContin and directing the hiring of an expanded sales force to implement a plan to sell the drug at ever-higher doses. Documents show that Richard Sacklerwas especially involved in the company’s efforts to market the drug, and that he pushed staff to pursue OxyContin’s deregulation in Germany. The son of a Purdue co-founder, he began working at Purdue in 1971 and has been at various times the company’s president and co-chairman of its board.

In a 1996 email introduced during the deposition, Sackler expressed delight at the early success of OxyContin. “Clearly this strategy has outperformed our expectations, market research and fondest dreams,” he wrote. Three years later, he wrote to a Purdue executive, “You won’t believe how committed I am to make OxyContin a huge success. It is almost that I dedicated my life to it. After the initial launch phase, I will have to catch up with my private life again.”

During his deposition, Sackler defended the company’s marketing strategies — including some Purdue had previously acknowledged were improper — and offered benign interpretations of emails that appeared to show Purdue executives or sales representatives minimizing the risks of OxyContin and its euphoric effects. He denied that there was any effort to deceive doctors about the potency of OxyContin and argued that lawyers for Kentucky were misconstruing words such as “stronger” and “weaker” used in email threads.T

The term “stronger” in Friedman’s email, Sackler said, “meant more threatening, more frightening. There is no way that this intended or had the effect of causing physicians to overlook the fact that it was twice as potent.”

Emails introduced in the deposition show Sackler’s hidden role in key aspects of the 2007 federal case in which Purdue pleaded guilty. A 19-page statement of factsthat Purdue admitted to as part of the plea deal, and which prosecutors said contained the “main violations of law revealed by the government’s criminal investigation,” referred to Friedman’s May 1997 email to Sackler about letting the doctors’ misimpression stand. It did not identify either man by name, attributing the statements to “certain Purdue supervisors and employees.”

Friedman, who by then had risen to chief executive officer, was one of three Purdue executives who pleaded guilty to a misdemeanor of “misbranding” OxyContin. No members of the Sackler family were charged or named as part of the plea agreement. The Massachusetts lawsuit alleges that the Sackler-controlled Purdue board voted that the three executives, but no family members, should plead guilty as individuals. After the case concluded, the Sacklers were concerned about maintaining the allegiance of Friedman and another of the executives, according to the Massachusetts lawsuit. To protect the family, Purdue paid the two executives at least $8 million, that lawsuit alleges.

“The Sacklers spent millions to keep the loyalty of people who knew the truth,” the complaint filed by the Massachusetts attorney general alleges.

The Kentucky deposition’s contents will likely fuel the growing protests against the Sacklers, including pressure to strip the family’s name from cultural and educational institutions to which it has donated. The family has been active in philanthropy for decades, giving away hundreds of millions of dollars. But the source of its wealth received little attention until recent years, in part due to a lack of public information about what the family knew about Purdue’s improper marketing of OxyContin and false claims about the drug’s addictive nature.

Although Purdue has been sued hundreds of times over OxyContin’s marketing, the company has settled many of these cases, and almost never gone to trial. As a condition of settlement, Purdue has often required a confidentiality agreement, shielding millions of records from public view.

That is what happened in Kentucky. In December 2015, the state settled its lawsuit against Purdue, alleging that the company created a “public nuisance” by improperly marketing OxyContin, for $24 million. The settlement required the state attorney general to “completely destroy” documents in its possession from Purdue. But that condition did not apply to records sealed in the circuit court where the case was filed.

In March 2016, STAT filed a motion to make those documents public, including Sackler’s deposition. The Kentucky Court of Appeals last year upheld a lower court ruling ordering the deposition and other sealed documents be made public. Purdue asked the state Supreme Court to review the decision, and both sides recently filed briefs. Protesters outside Kentucky’s Capitol last week waved placards urging the court to release the deposition.

Related:  Purdue appeals order to unseal OxyContin records to Kentucky Supreme Court

Sackler family members have long constituted the majority of Purdue’s board, and company profits flow to trusts that benefit the extended family. During his deposition, which took place over 11 hours in a law office in Louisville, Ky., Richard Sackler said “I don’t know” more than 100 times, including when he was asked how much his family had made from OxyContin sales. He acknowledged it was more than $1 billion, but when asked if they had made more than $5 billion, he said, “I don’t know.” Asked if it was more than $10 billion, he replied, “I don’t think so.”

By 2006, OxyContin’s “profit contribution” to Purdue was $4.7 billion, according to a document read at the deposition. From 2007 to 2018, the Sackler family received more than $4 billion in payouts from Purdue, according to the Massachusetts lawsuit.

During the deposition, Sackler was confronted with his email exchanges with company executives about Purdue’s decision not to correct the misperception among many doctors that OxyContin was weaker than morphine. The company viewed this as good news because the softer image of the drug was helping drive sales in the lucrative market for treating conditions like back pain and arthritis, records produced at the deposition show.

Designed to gradually release medicine into the bloodstream, OxyContin allows patients to take fewer pills than they would with other, quicker-acting pain medicines, and its effect lasts longer. But to accomplish these goals, more narcotic is packed into an OxyContin pill than competing products. Abusers quickly figured out how to crush the pills and extract the large amount of narcotic. They would typically snort it or dissolve it into liquid form to inject.

The pending Massachusetts lawsuit against Purdue accuses Sackler and other company executives of determining that “doctors had the crucial misconception that OxyContin was weaker than morphine, which led them to prescribe OxyContin much more often.” It also says that Sackler “directed Purdue staff not to tell doctors the truth,” for fear of reducing sales. But it doesn’t reveal the contents of the email exchange with Friedman, the link between that conversation and the 2007 plea agreement, and the back-and-forth in the deposition.

STAT Plus:  Exclusive analysis of biotech, pharma, and the life sciences.

A few days after the email exchange with Friedman in 1997, Sackler had an email conversation with another company official, Michael Cullen, according to the deposition. “Since oxycodone is perceived as being a weaker opioid than morphine, it has resulted in OxyContin being used much earlier for non-cancer pain,” Cullen wrote to Sackler. “Physicians are positioning this product where Percocet, hydrocodone and Tylenol with codeine have been traditionally used.” Cullen then added, “It is important that we be careful not to change the perception of physicians toward oxycodone when developing promotional pieces, symposia, review articles, studies, et cetera.”

“I think that you have this issue well in hand,” Sackler responded, while Friedman and Cullen could not be reached for comment.

Asked at his deposition about the exchanges with Friedman and Cullen, Sackler didn’t dispute the authenticity of the emails. He said the company was concerned that OxyContin would be stigmatized like morphine, which he said was viewed only as an “end of life” drug that was frightening to people.

“Within this time it appears that people had fallen into a habit of signifying less frightening, less threatening, more patient acceptable as under the rubric of weaker or more frightening, more — less acceptable and less desirable under the rubric or word ‘stronger,’” Sackler said at his deposition. “But we knew that the word ‘weaker’ did not mean less potent. We knew that the word ‘stronger’ did not mean more potent.” He called the use of those words “very unfortunate.” He said Purdue didn’t want OxyContin “to be polluted by all of the bad associations that patients and healthcare givers had with morphine.”

Related: ‘A blizzard of prescriptions’: Documents reveal new details about Purdue’s marketing of OxyContin

In his deposition, Sackler also defended sales representatives who, according to the statement of facts in the 2007 plea agreement, falsely told doctors during the 1996-2001 period that OxyContin did not cause euphoria or that it was less likely to do so than other opioids. This euphoric effect experienced by some patients is part of what can make OxyContin addictive. Yet, asked about a 1998 note written by a Purdue salesman, who indicated that he “talked of less euphoria” when promoting OxyContin to a doctor, Sackler argued it wasn’t necessarily improper.

“This was 1998, long before there was an Agreed Statement of Facts,” he said.

The lawyer for the state asked Sackler: “What difference does that make? If it’s improper in 2007, wouldn’t it be improper in 1998?”

“Not necessarily,” Sackler replied.

Shown another sales memo, in which a Purdue representative reported telling a doctor that “there may be less euphoria” with OxyContin, Sackler responded, “We really don’t know what was said.” After further questioning, Sackler said the claim that there may be less euphoria “could be true, and I don’t see the harm.”

The same issue came up regarding a note written by a Purdue sales representative about one doctor: “Got to convince him to counsel patients that they won’t get buzzed as they will with short-acting” opioid painkillers. Sackler defended these comments as well. “Well, what it says here is that they won’t get a buzz. And I don’t think that telling a patient ‘I don’t think you’ll get a buzz’ is harmful,” he said.

Sackler added that the comments from the representative to the doctor “actually could be helpful, because many patients won’t get a buzz, and if he would like to know if they do, he might have had a good medical reason for wanting to know that.”

Sackler said he didn’t believe any of the company sales people working in Kentucky engaged in the improper conduct described in the federal plea deal. “I don’t have any facts to inform me otherwise,” he said.

Purdue said that Sackler’s statements in his deposition “fully acknowledge the wrongful actions taken by some of Purdue’s employees prior to 2002,” as laid out in the 2007 plea agreement. Both the company and Sackler “fully agree” with the facts laid out in that case, Purdue said.

Related: Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster

The deposition also reveals that Sackler pushed company officials to find out if German officials could be persuaded to loosen restrictions on the selling of OxyContin. In most countries, narcotic pain relievers are regulated as “controlled” substances because of the potential for abuse. Sackler and other Purdue executives discussed the possibility of persuading German officials to classify OxyContin as an uncontrolled drug, which would likely allow doctors to prescribe the drug more readily — for instance, without seeing a patient. Fewer rules were expected to translate into more sales, according to company documents disclosed at the deposition.

One Purdue official warned Sackler and others that it was a bad idea. Robert Kaiko, who developed OxyContin for Purdue, wrote to Sackler, “If OxyContin is uncontrolled in Germany, it is highly likely that it will eventually be abused there and then controlled.”

Nevertheless, Sackler asked a Purdue executive in Germany for projections of sales with and without controls. He also wondered whether, if one country in the European Union relaxed controls on the drug, others might do the same. When finally informed that German officials had decided the drug would be controlled like other narcotics, Sackler asked in an email if the company could appeal. Told that wasn’t possible, he wrote back to an executive in Germany, “When we are next together we should talk about how this idea was raised and why it failed to be realized. I thought that it was a good idea if it could be done.”

Asked at the deposition about that comment, Sackler responded, “That’s what I said, but I didn’t mean it. I just wanted to be encouraging.” He said he really “was not in favor of” loosening OxyContin regulation and was simply being “polite” and “solicitous” of his own employee.

Near the end of the deposition — after showing Sackler dozens of emails, memos and other records regarding the marketing of OxyContin — a lawyer for Kentucky posed a fundamental question.

“Sitting here today, after all you’ve come to learn as a witness, do you believe Purdue’s conduct in marketing and promoting OxyContin in Kentucky caused any of the prescription drug addiction problems now plaguing the Commonwealth?” he asked.

Sackler replied, “I don’t believe so.”

THIS IS A PARTIAL REPOSTING OF A STATNEWS and PROPUBLICA ARTICLE COLLABORATION (February 21, 2019)

 

 

 

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FDA To McKesson – You Failed In Opioid Diversion Reporting: “FDA Cites Proof Of Failure To Report In-House Diversion”

McKesson Corp. Failed In Opioid Diversion Reporting: “By Failing To Report In-House Diversion”

(MASS TORT NEXUS MEDIA) In a very clear and direct statement, the FDA has issued a formal warning letter to McKesson Corp. where “failure to monitor and report” diversion of prescription opiates including when the diversion took place within McKesson’s in-house control. Examples of opiate deliveries to Rite-Aid pharmacies containing naproxen instead of opiates were delivered in broken-seal containers. Even after Rite-Aid reported the diversions on more than one occasion, there was a failure by McKesson to report the diversion to authorities as required by law, as well as failing to conduct a proper internal investigation.

A December 2018 congressional report on prescription pill dumping squarely placed the blame on U.S. prescription drug distributors and the Drug Enforcement Administration for not doing enough to help mitigate the nation’s opioid addiction and overdose crisis.

The report released by the House Energy and Commerce Committee followed an 18-month investigation and focused on the three largest U.S. wholesale drug companies, McKesson Corp., Cardinal Health and AmerisourceBergen, and regional distributors outlines a pattern of total avoidance at the highest levels where opioid prescription reporting was required by law.

The report cited examples of massive pill shipments to West Virginia, which has a population of 1.8 million and has by far the nation’s highest death rate from prescription drugs. McKesson shipped an average of 9,650 hydrocodone pills per day in 2007 to a now-closed pharmacy in Kermit, which has a population of about 400. The shipments were 36 times above a monthly dosage shipment threshold the company had established that year. Why there was no reporting on the catastrophic numbers remains a matter to be resolved in litigation, because McKesson offers no realistic explanation for their bad conduct in failure to report as required by law.

The report cited  prior federal records that showed drug wholesalers shipped 780 million hydrocodone and oxycodone pills to West Virginia from 2007 to 2012, a period when 1,728 people fatally overdosed on the painkillers. For instance, drug companies collectively poured 20.8 million hydrocodone and oxycodone pills into the small city of Williamson, West Virginia, between 2006 and 2016, according to a set of letters the committee released Tuesday. Williamson’s population was just 3,191 in 2010, according to US Census data.  These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” committee Chairman Greg Walden (R-Ore.) and ranking member Frank Pallone Jr. (D-N.J.) said in a joint statement to the Charleston Gazette-Mail.

The nation is currently grappling with an epidemic of opioid addiction and overdose deaths. The Centers for Disease Control and Prevention estimate that, on average, 115 Americans die each day from opioid overdoses. West Virginia currently has the highest rate of drug overdose deaths in the country. Hardest hit have been the regions of West Virginia, Ohio and Kentucy where for some reason the opioid industry chose to focus their efforts, the how and why of their focus is being addressed in the federal and state courts across the country, with the primary cases being filed in the “Opiate Prescription Multidistrict Litigation MDL 2804” , being heard in the US District Court-Northern District of Ohio, in front of Judge Dan Polster, see Opiate Prescription MDL 2804 Briefcase.

It would now seem that McKesson will have to defend their failed diversion reporting conduct not only in the thousands of lawsuits they are facing, but in the renewed scrutiny that comes along with being outed as on eof the primary causes of the existing opioid crisis in America.

THE FULL FDA WARNING LETTER TO MCKESSON CORPORATION DATED FEBRUARY 7, 2019 IS BELOW

 

 

 

 

 

 

 

Via SIGNATURE CONFIRMED DELIVERY
February 7, 2019

John H. Hammergren

Chief Executive Officer

McKesson Corporation

One Post Street

San Francisco, California 94104

 

Dear Mr. Hammergren:

From June 25 to July 3, 2018, U.S. Food and Drug Administration (FDA) investigators conducted an inspection at your corporate headquarters located at One Post Street, San Francisco, California.  FDA investigators also inspected your distribution center facility at 9700 SW Commerce Circle, Wilsonville, Oregon, from June 26 to 29, 2018.

This warning letter summarizes significant violations of the verification requirements found in section 582(c)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(c)(4)). These verification requirements are intended to help preserve the security of the supply chain for prescription drug products, thereby protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.  The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.[1]

FDA issued a Form FDA 483 to McKesson Corporation at its San Francisco corporate headquarters on July 3, 2018.  FDA reviewed your firm’s responses, dated July 25, 2018, September 25, 2018, and November 4, 2018.

During FDA’s inspection, FDA investigators observed that your firm failed to have systems in place to enable compliance with the verification requirements of section 582(c)(4) of the FD&C Act. Specific violations include, but may not be limited to, the following:

  1. Your firm failed to respond to illegitimate product notifications as required, which includes identifying all illegitimate product subject to such notifications in your possession or control and quarantining such product (section 582(c)(4)(B)(iii)).

      2. Your firm failed to quarantine and investigate suspect product (section 582(c)(4)(A)(i)).

      3. Your firm failed to keep, for not less than 6 years, records of the investigation of suspect product and the disposition of        illegitimate product (sections 582(c)(4)(A)(iii) and 582(c)(4)(B)(v)).

Failure to comply with any of the requirements under section 582 of the FD&C Act is a prohibited act under section 301(t) of the FD&C Act (21 U.S.C. 331(t)).

Example 1: In September and October 2016, McKesson was notified by your pharmacy trading partner, Rite Aid, that three separate Rite Aid pharmacies received illegitimate product, which they reported had been distributed by McKesson. Initially, McKesson was notified by Rite Aid on September 1, 2016, that their pharmacy located in Milford, Michigan, received a bottle labeled as containing 100 tablets of oxycodone hydrochloride (NDC 0406-8530) manufactured by Mallinckrodt. The seal of the bottle was broken, and the bottle contained no oxycodone hydrochloride.  The bottle contained only 15 tablets, which were later determined to be naproxen.  Rite Aid reported to McKesson that it had received this product through a transaction with McKesson.  Mallinckrodt submitted an illegitimate product notification (via Form 3911) to FDA about this oxycodone hydrochloride, noting that “the tablets that were in the bottle were foreign tablets.”

Rite Aid’s pharmacy located in Waterford, Michigan, also received illegitimate product, which they reported had been distributed by McKesson.  The pharmacy received one bottle, also labeled as containing 100 tablets of oxycodone hydrochloride, which had a broken seal and did not contain oxycodone hydrochloride.  The bottle’s contents were also replaced with 15 tablets of naproxen.  Rite Aid reported to McKesson that it had received this product through a transaction with McKesson. On September 15, 2016, Rite Aid alerted McKesson by email about this discovery of product with missing tablets.  Mallinckrodt submitted an illegitimate product notification to FDA (via Form 3911) about the oxycodone hydrochloride, noting that the Rite Aid pharmacy in Waterford “reported that upon opening a bottle of Mallinckrodt Oxycodone 30mg the seal was broken and 100 tablets of Oxycodone 30mg were missing.  Fifteen tablets of generic Aleve ([n]aproxen sodium 220mg tablets) manufactured by Amneal Pharmaceuticals were inside the bottle.”

On October 6, 2016, Rite Aid’s pharmacy located in Warren, Michigan, also received illegitimate product, which they reported had been distributed by McKesson.  The pharmacy had ordered five bottles of oxycodone hydrochloride.  In three of the bottles they received, all the oxycodone hydrochloride had been removed.  These three bottles contained various combinations of naproxen and ciprofloxacin hydrochloride.  Mallinckrodt submitted an illegitimate product notification (via Form 3911) to FDA about these products, noting that “three bottles were missing all 100 tablets of [o]xycodone [h]ydrochloride 30mg tabs and contained foreign tablets.”

Your firm’s investigation of these three incidents of illegitimate product determined that, because of the lack of evidence of tampering with these packages and the proximity of these three Rite Aid pharmacies, it was likely that the oxycodone hydrochloride was replaced with other product while the packages were in the possession or control of McKesson.

These instances illustrate your firm’s failure to have systems in place to enable compliance with the requirements of section 582(c)(4) of the FD&C Act. After receiving illegitimate product notifications from Rite Aid, your firm was required to respond by identifying all illegitimate product subject to such notification that was in its possession or control, including any product that was subsequently received (section 582(c)(4)(B)(iii)). McKesson was then required to quarantine such product within its possession or control from product intended for distribution until such product was dispositioned (section 582(c)(4)(B)(i)(I)), dispose of any illegitimate product within its possession or control (section 582(c)(4)(B)(i)(II)), take reasonable and appropriate steps to assist trading partners to dispose of illegitimate product not in the possession of McKesson (section 582(c)(4)(B)(i)(III)), and notify within 24 hours FDA and all immediate trading partners that may have received such illegitimate product (section 582(c)(4)(B)(ii)). Your firm was also required to keep, for not less than 6 years, records of the disposition of illegitimate product (sections 582(c)(4)(B)(v)).

Although your firm conducted an investigation related to these bottles of oxycodone hydrochloride, your firm was unable to demonstrate that you met key obligations under section 582(c)(4). For example, you did not demonstrate that you identified all illegitimate product subject to the notification, such as by searching for product with the same lot number or NDC, or that you quarantined any such product. Similarly, your firm failed to demonstrate that you notified your immediate trading partners who may have received product with the same lot number or NDC. This is particularly troubling because your firm’s investigation noted that the oxycodone hydrochloride was likely replaced with different product at a McKesson distribution center. Also troubling is that during the FDA inspection of your firm’s San Francisco headquarters, a McKesson representative stated that incidents involving stolen or diverted controlled substances are not treated as Drug Supply Chain Security Act (DSCSA) verification events within the firm. In fact, DSCSA explicitly defines illegitimate product to include “a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.”[2] Finally, your firm provided no records to demonstrate the disposition of these illegitimate products.

Corrective Actions

FDA has reviewed your firm’s responses to the Form FDA 483 and subsequent correspondence.

  1. Your firm’s response to the Form FDA 483 states that while you investigated “incidents related to potential diversion and theft issues … the incidents were not necessarily related to suspect or illegitimate products.”  This response parallels your representative’s statement to FDA investigators at your San Francisco headquarters that incidents involving stolen or diverted controlled substances are not treated as DSCSA verification events within the firm.  These statements demonstrate a lack of understanding of the definitions of suspect and illegitimate products, and of your firm’s responsibilities when notified of an illegitimate product by a trading partner.  All prescription drug products in finished dosage form for administration to a patient[4]– including those containing controlled substances – are subject to DSCSA verification requirements in section 582(c)(4). Moreover, the statute defines illegitimate product to include “a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.”[5] Under the law, your firm must treat incidents involving suspect and illegitimate products as subject to DSCSA requirements, including products that are controlled substances.
  2. Your firm’s response to the Form FDA 483 cannot be evaluated because it lacks sufficient supporting documentation.  Your response states that McKesson plans to make procedural updates to its standard operating procedures, without describing what these updates are or providing new standard operating procedure documents for review.  FDA does not have enough information to conclude that future investigations of suspect or illegitimate product by McKesson will be conducted in a manner compliant with DSCSA.  Your firm’s response dated November 4, 2018, contains similar information as your previous response; namely regarding updates you have made to various policy documents.  Again, however, your firm provided no supporting documentation for review.
  3. Although your November 4, 2018, response to FDA states that you intend to form a “Product Safety Committee that will be responsible for coordination of all actions related to suspect or illegitimate product,” your firm provided no information about the composition of this committee or the procedures under which the committee will function.  As a result, your response does not demonstrate how the proposed change will improve McKesson’s compliance with DSCSA verification requirements.

 Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facilities. You are responsible for investigating and determining the causes of the violations identified above, and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law.

Failure to promptly correct these violations may result in legal action without further notice, including injunction. Unresolved violations in this warning letter may also prevent other federal agencies from awarding contracts.

Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to (1) correct the violations identified in this warning letter, and (2) identify and conduct appropriate investigations and follow-up related to other reports of suspect or illegitimate product that you have identified or received. Please include an explanation of each step being taken to prevent the recurrence of violations and include copies of related documentation. In addition, provide the steps your firm has taken to prevent incidents of theft and diversion. If you disagree with the characterization of the violations of the FD&C Act in this warning letter, include your reasoning and any supporting infom,ation for our consideration. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.
Please send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Rd.
Irvine, California 92612-2506
Sincerely,

Alonza Cruse

Director

Office of Pharmaceutical Quality Operations

Office of Regulatory Affairs

 

 

 

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Why Did The FDA Approve A Drug 10 Times Stronger Than Fentanyl-When Opiates Are Still Killing Thousands

HAS THE FDA LEARNED ANYTHING FROM THE OPIOID CRISIS THEY HELPED CREATE?

Mark A. York (November 6, 2018)

 

 

 

 

 

 

 

 

 

Just The Opioid Facts

Drugs kill more Americans than guns, cars and AIDS. How we got here.

(Mass Tort Nexus Media) More than 175 Americans will die today of drug overdoses, which equals a 737 crashing and killing all the passengers on board every single day. But it’s not a plane crash. It is America’s opioid epidemic, one that unchecked could claim 1 million lives by 2020.

See also: Briefcases/Drugs/254/OPIOID-National-Prescription-Litigation-MDL-2804-USDC-ND-Ohio-(Eastern-Division) by Mass Tort Nexus

Who’s Minding The FDA?

A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.

The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.

Also on Friday, the Drug Enforcement Administration released a report showing that prescription drugs were responsible for the most overdose deaths of any illicit drugs since 2001.

Democratic Senator Ed Markey of Massachusetts urged the FDA to not approve Dsuvia last month, saying “an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.”

To that, FDA Commissioner Scott Gottlieb said in a statement that “very tight restrictions” will be placed on Dsuvia. This statement flies in the face of reality as proven by assigned federal agencies to monitor and enforce rules on the already existing opiates that have flooded the US marketplace and killed hundreds of thousands of Americans.

So why should we think that anything is different with a new drug that basically comes under the same oversight umbrella as fentanyl, oxycontin and all the other prescription opiates? The DEA, FDA and anyone else assigned to monitor narcotic drug use, prescribing practices as well as marketing have failed miserably again and again.

FDA Claims Restricted Access

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. The medication, which comes in a single-use package, also should not be used for more than 72 hours. The medicine comes in a tablet that can dissolve under the tongue. Side effects of the potent drug include extreme tiredness, breathing problems, coma and death.

Gottlieb said military use of the drug was “carefully considered in this case” as the FDA wants to “make sure our soldiers have access to treatments that meet the unique needs of the battlefield.”

Combined with the increase in overdoses, the fact that opioids are less effective than presumed creates a substantial public health problem. We are throwing large sums of public and private money at treating opioid addiction and related issues caused by a problem that could have been completely avoided by using more effective (and less habit-forming) medications.

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. This 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.

 FDA Told Not to Approve Dsuvia

https://www.cdc.gov/drug-overdose-data-death counts through Oct 2018

Drug overdose deaths hit the highest level ever recorded in the United States last year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Most of that was the result of a record number of opioid-related deaths.

 

How Big Pharma got into opiates: In 1898, Bayer released heroin to treat coughs and other health woes. Soon, people became addicted to heroin, a narcotic and precursor to the current Opioid Crisis.

 Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. About a week ago, U.S. Health and Human Services Secretary Alex Azar said overdose deaths, while still slowly rising, were beginning to level off, citing figures from late last year and early this year.

The DEA’s National Drug Threat Assessment, which was recently released, shows that heroin, fentanyl and other opioids continue to be the highest drug threat in the nation. But federal officials are concerned that methamphetamine and cocaine are being seen at much higher levels in areas that haven’t historically been hotspots for those drugs. The DEA is also worried that people are exploiting marijuana legalization to traffic cannabis into the illicit market or to states that don’t have medicinal or recreational-use marijuana laws, according to the report.

The preliminary data also showed 49,060 people died from opioid-related overdose deaths, a rise from the reported 42,249 opioid overdose deaths in 2016.

Fatal heroin overdoses rose nationwide between 2015 and 2016, with a nearly 25 percent increase in the Northeast and more than 22 percent in the South. Most of the heroin sold in the U.S. is being trafficked from Mexico, and U.S. Customs and Border Protection officers seize the most amount of heroin along the Mexico border, near San Diego, California, the report said.

Fentanyl and other related opioids, which tend to be cheaper and much more potent than heroin, remain one of the biggest concerns for federal drug agents.

The DEA has said China is a main source of fentanyl and other synthetic opioids that have been flooding the U.S. market. China has pushed back against the characterization, and U.S. officials have stressed they work closely with their Chinese counterparts as they try to stem the flow of drugs.

Legislation that Trump signed last week will add treatment options and force the U.S. Postal Service to screen overseas packages for fentanyl.

Azar said in a speech last week that toward the end of 2017 and through the beginning of this year, the number of drug overdose deaths “has begun to plateau.” However, he was not indicating that deaths were going down, but that they appear to be rising at a slower rate than previously seen.

Pot Vs. Pills for Pain Relief

Last month, the Centers for Disease Control and Prevention released preliminary figures that appear to show a slowdown in overdose deaths from December to March. In that period, the figures show that the pace of the increase over the previous 12 months has slowed from 10 percent to 3 percent, according to the preliminary CDC figures.

Even if a slowdown is underway, no one is questioning the fact that the nation is dealing with the deadliest drug overdose epidemic in its history. While prescription opioid and heroin deaths appear to be leveling off, deaths involving fentanyl, cocaine and methamphetamines are on the rise, according to CDC data.

The DEA’s report also noted that methamphetamine is making its way into communities where the drug normally wasn’t heavily used, the report said. Chronic use of meth, a highly addictive stimulant, can cause paranoia, visual and auditory hallucinations and delusions, studies have shown.

As the government enacted laws that limited access to cold medicines containing pseudoephedrine — the ingredient used to cook meth with other household chemicals — or required the medications to be placed behind pharmacy counters, officials discovered the number of meth labs began to drop.

But the DEA has found the gap is being filled by Mexican and Latin American drug cartels that had primarily dabbled in heroin and cocaine trafficking. A saturated market on the West Coast is now driving the cartels to peddle methamphetamine into the Northeast, using the same routes they use for heroin and other drugs.

Officials also warn that because of more cocaine production in South American countries including Colombia, they expect to see larger shipments at the Mexican border.

Who Said “Pain Was The Fifth Vital Sign?”

“Pain as the fifth vital sign” became policy at VA clinics as well as VA hospitals across the U.S.

It seemed odd to equate pain with something like breathing, but doctors were advised by Purdue Pharma and other opiate makers to understand the need to “dignify” and take care of pain.

Across the country doctors seemed too willing to prescribe these opioid pills for chronic pain, patients seemed too willing to take them, and insurers seemed too willing to pay.

The Joint Commission began requiring hospitals to assess all patients for pain on a scale of 1 to 10, which some claimed caused more doctors to prescribe opioids.

Purdue gave the commission a grant to produce a pain assessment and management manual.

Officials from the commission and Purdue denied the company had anything to do with the content of the manual, co-written by Dr. June Dahl, who served on the speakers bureau for Purdue.

The manual told health care facilities the side effects of opioids had been exaggerated and that physical dependence had been wrongly confused with addiction. “There is no evidence that addiction is a significant issue when persons are given opioids for pain control,” the manual said.

Paid Endorsements In Studies

Purdue officials explained that studies on opioid addiction depended on many factors, including mental health. They cited a 2008 article by Dr. David Fishbain of the University of Miami, who analyzed 79 published studies, saying he concluded the prevalence of abuse or addiction was 3.27 percent, or 0.19 percent for those with no past addiction.

Fishbain responded that his study was misinterpreted and that addiction could be anywhere between 3.27 and 20.4 percent.

Commission officials denied its new standards encouraged doctors to prescribe more opioids, blaming drug trafficking as well as diversion and abuse by individuals.

At that time, the “evidence was broadly supported by experts across the spectrum that pain was undertreated and a serious problem leading to poor clinical outcomes,” the commission said.

The commission concluded that “millions of people in the United States suffer from pain, and failure to treat their pain is inhumane.”

The Painkiller Market

Since 1987, Purdue Pharma had been selling a timed-release drug named MS Contin, the company’s version of morphine. Seven years later, annual sales topped $88 million — the best performing painkiller Purdue officials had — but they faced problems.

Doctors knew how addictive morphine could be, and most were reluctant to prescribe MS Contin to patients suffering from chronic pain.

The even bigger problem? MS Contin’s patent would expire soon.

That meant generic drug manufacturers could make their own versions of MS Contin and eat into Purdue’s share of the painkiller market.

A generation earlier, Arthur Sackler, the brother of Purdue’s owners, had marketed Valium and other tranquilizers to women experiencing anxiety, tension or countless other symptoms. The drug broke all sales records, turning many women into addicts and Sackler into a multimillionaire.

The Sackler family planned to repeat that success with a timed-release version of OxyContin, the company’s version of oxycodone.

In internal Purdue documents obtained by the USA TODAY NETWORK, company officials gushed that OxyContin could become a hit in “the $462 million Class II opioid marketplace.”

These documents detail their strategy: They would first market OxyContin strictly for cancer pain, where doctors were familiar with oxycodone.

Then the company would pivot to the lucrative market of chronic pain, which afflicted at least 25 million Americans.

Purdue’s plan included targeting primary care physicians, surgeons, obstetricians and dentists. The company even targeted home care and hospice care nurses who would “rate the patients’ pain and make a recommendation on the type of opioid and dosage for pain control.”

The plan also included targeting patients and caregivers through Purdue’s “Partners Against Pain” program. “You are the pain authority,” the website reassured patients. “You are the expert on your own pain.”

The website declared that “there are 75 million Americans living with pain, although pain management experts say they don’t have to,” reassuring patients that doctors could control their pain “through the relatively simple means of pain medications” and that the risk of addiction to opioids “very rarely occurs when under medical supervision to relieve pain.”

To ensure that OxyContin became a hit, Purdue sponsored more than 20,000 educational programs to encourage health care providers to prescribe the new drug and sent videos to 15,000 doctors.

The company also hosted dozens of all-expenses-paid national pain management conferences, where more than 5,000 physicians, pharmacists and nurses were trained for the company’s national speakers bureau.

By 2001, Purdue was spending $200 million on marketing and promotion and had doubled its sales force to 671. Before the year ended, sales bonuses reached $40 million.

No Addiction Knowledge 

Dr. Fannin, who practices in West Virginia remembers sales reps from Purdue flooding doctors’ offices in Appalachia, where poverty and pain are constant realities.

The reps gave away fishing hats, stuffed toys and music CDs titled “Get in the Swing with OxyContin.”

“Every time you turned around, you saw their faces,” Fannin said. “We had a population of doctors with very little grounding in pain, and I think Purdue took advantage of that.”

Many doctors knew about oxycodone from Percocet, which combined a small dosage of the potent opioid with 325 mg of acetaminophen.

What many of those doctors didn’t realize was that oxycodone was nearly twice as powerful as morphine, delivering a powerful high to those who use the drug.

“It’s more like heroin,” explained Dr. Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University. “It crosses the blood-brain barrier more quickly.”

But the sales reps never mentioned that. Instead, they said OxyContin didn’t create highs like other opioids and was less likely to get people addicted.

Fannin recalled sales reps calling OxyContin “a revolution in pain care” and “much more effective” than the old drugs.

They also talked of studies, citing one that found only four of 11,882 patients — less than 1 percent — became addicted after using opioids. Portenoy and others repeatedly cited this research, with some calling it a “landmark study.”

The truth is it wasn’t even a study. It was a five-sentence letter to the editor that a doctor wrote the New England Journal of Medicine.

For the most part, Fannin believed what the sales reps were telling him, and so did other doctors in the region.

“Our knowledge about addiction,” he said, “was about zip.”

So they spread the opioid with their prescription pads, and it settled into the Appalachian mountains like the ever-present morning fog.

OxyContin, which some hailed as a “miracle drug,” became the blockbuster in 2001 that Purdue officials dreamed of, with more than 7 million prescriptions written and nearly $3 billion in revenue.

By 2015, the Sackler family, who owned Purdue, had made $14 billion, joining Forbes’ 2015 list of America’s richest families, edging out the Rockefellers.

MIDWEST AMERICA WAS TARGETED

According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention.

The increased emergency room visits also include more young children aged 3 to 14 years old, which truly reflects on the unknown number of who have access to still available opiates. These young children being able to readily find opiates at that age,  shows that anyone who has an interest in getting opiates can find them.  This often results in the inadvertent and tragic risks associated with younger victims who somehow are exposed and now being swept up in the opioid crisis.

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. This is a figure that’s is comparative to prior medical emergency spikes during pandemic healthcare

Recently two important medical reports on opiate abuse have emerged indicating that the opioid crisis may be at its worst point ever.

The first study comes from the Centers for Disease Control and Prevention (CDC), a federal agency tasked with studying – and stopping – the spread of diseases, including everything from viral infections like the flu to mental health issues including drug addiction. Published in the agency’s monthly Vital Signs report, the study demonstrates that the number of opioid overdoses increased by 30% in a little more than one year from July 2016 to September 2017.

The second study comes from a group of VA medical personnel and public health researchers publishing in the Journal of the American Medical Association (JAMA), who wanted to learn how effective opioid prescription drugs were at managing long-term and chronic pain. As it turns out, opioid drugs showed less efficacy than non-opioid pain medications over a 12-month period – and in fact, over time opioids became worse for patients who had to deal with side effects that patients taking non-opioid medications did not have to deal with. Taken together, these two studies show that current opioid drug policies, procedures, prescription practices and standards of patient care clearly need to be rethought.

For Information on Opiate Litigation and other mass torts:

Kevin Thompson will speak on the Opiate NAS Addicted Infant MDL 2872 litigation as well as the status of opioid litigation and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”

November 9-12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

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

      2. To obtain our free newsletters that contain real time mass tort updates, visit www.masstortnexus.com/news and sign up for                free access.

 

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Why Isn’t Medical Cannabis Used to Treat Opioid and Substance Abuse Disorders More Often? 

Will Medical Marijuana Become A Viable Addiction Treatment Option?

By Mark A. York (September 28, 2018)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) More and more medical treatment professionals, politicians and others have joined in the quickly emerging role of medical marijuana to help in treatment by patients struggling with opioid addiction. Now, two studies are reflecting this emerging treatment to be viable.

Will medical marijuana become a viable option in the long term treatment programs that may be coming out of the Opiate Prescription Litigation MDL 2804 and the many state court opioid based lawsuits filed across the country? See Mass Tort Nexus Briefcase Re: National-Prescription-Litigation-MDL-2804-USDC-ND-Ohio, where the various opioid litigation dockets and court rulings are provided.

Recent studies, published journal JAMA Internal Medicine, compared opioid prescription patterns in states that have enacted medical cannabis laws with those that have not. One of the studies looked at opioid prescriptions covered by Medicare Part D between 2010 and 2015, while the other looked at opioid prescriptions covered by Medicaid between 2011 and 2016.

Additionally, three states have approved Medical Cannabis for alternative treatments related to both pain management and substance abuse disorders, where cannabis has been determined as an appropriate treatment. Pennsylvania, New Jersey and Illinois are at the forefront of using changes to state laws regarding medical cannabis in the most effective clinical settings when possible.

PENNSYLVANIA CANNABIS BASED OPIOID ADDICTION TREATMENT

The Pennsylvania Department of Health approved major changes to the state’s medical marijuana program, when the  health department added opioid addiction to the list of conditions eligible for treatment with medicinal cannabis. With that decision, Pennsylvania joins New Jersey and Illinois as the only states that have done so.

Pennsylvania Secretary of Health Dr. Rachel Levine told local media that marijuana won’t be the first treatment for addiction to opioids. Instead, doctors will try more traditional therapies first.

“It’s important to note that medical marijuana is not a substitute for proven treatments for opioid use disorder,” Dr. Levine said. “In Pennsylvania, medical marijuana will be available to patients if all other treatment fails, or if a physician recommends that it be used in conjunction with traditional therapies.”

A related positive note by Pennsylvania is the Department of Health has approved cannabis research licenses for five Philadelphia area medical schools on Monday. With one topic of research at the institutions being the potential role of cannabis in addiction treatment as a normal treatment protocol.

The schools that received approval to study cannabis are Drexel University College of Medicine, Lewis Katz School of Medicine at Temple University, Sidney Kimmel Medical College at Thomas Jefferson University, Perelman School of Medicine at the University of Pennsylvania, and Philadelphia College of Osteopathic Medicine.

JAMA STUDY RESULTS

The researchers found that states that allow the use of cannabis for medical purposes had 2.21 million fewer daily doses of opioids prescribed per year under Medicare Part D, compared with those states without medical cannabis laws. Opioid prescriptions under Medicaid also dropped by 5.88% in states with medical cannabis laws compared with states without such laws, according to the studies.

“This study adds one more brick in the wall in the argument that cannabis clearly has medical applications,” said David Bradford, professor of public administration and policy at the University of Georgia and a lead author of the Medicare study.

“And for pain patients in particular, our work adds to the argument that cannabis can be effective.”

Medicare Part D, the optional prescription drug benefit plan for those enrolled in Medicare, covers more than 42 million Americans, including those 65 or older. Medicaid provides health coverage to more than 73 million low-income individuals in the US, according to the program’s website.

“Medicare and Medicaid publishes this data, and we’re free to use it, and anyone who’s interested can download the data,” Bradford said. “But that means that we don’t know what’s going on with the privately insured and the uninsured population, and for that, I’m afraid the data sets are proprietary and expensive.”

Republicans Support Legalizing Medical Cannabis

Earlier this year, the National Academy of Sciences, in a 395-page report, refuted the official US Department of Justice position that cannabis is a “gateway drug” and that using marijuana can lead to opioid addiction and instead found evidence of cannabis having therapeutic and health benefits. Joe Schrank, a social worker who worked at various detox centers and clean houses, is now practicing the report’s findings at High Sobriety treatment center in Los Angeles, where he offers clients medical and therapeutic sessions, and daily doses of marijuana to treat a variety of addictions.

The Opioid Crisis Is Here

The new research comes as the United States remains entangled in the worst opioid epidemic the world has ever seen. Opioid overdose has risen dramatically over the past 15 years and has been implicated in over 500,000 deaths since 2000 — more than the number of Americans killed in World War II.

“As somebody who treats patients with opioid use disorders, this crisis is very real. These patients die every day, and it’s quite shocking in many ways,” said Dr. Kevin Hill, an addiction psychiatrist at Beth Israel Deaconess Medical Center and an assistant professor of psychiatry at Harvard Medical School, who was not involved in the new studies.

“We have had overuse of certain prescription opioids over the years, and it’s certainly contributed to the opioid crisis that we’re feeling,” he added. “I don’t think that’s the only reason, but certainly, it was too easy at many points to get prescriptions for opioids.”

Today, more than 90 Americans a day die from opioid overdose, resulting in more than 42,000 deaths per year, according to the US Centers for Disease Control and Prevention. Opioid overdose recently overtook vehicular accidents and shooting deaths as the most common cause of accidental death in the United States, the CDC says.

 

 

 

 

 

 

Doctors must lead us out of our opioid abuse epidemic

Like opioids, marijuana has been shown to be effective in treating chronic pain as well as other conditions such as seizures, multiple sclerosis and certain mental disorders, according to the National Institute on Drug Abuse. Research suggests that the cannabinoid and opioid receptor systems rely on common signaling pathways in the brain, including the dopamine reward system that is central to drug tolerance, dependence and addiction.

“All drugs of abuse operate using some shared pathways. For example, cannabinoid receptors and opioid receptors coincidentally happen to be located very close by in many places in the brain,” Hill said. “So it stands to reason that a medication that affects one system might affect the other.”

But unlike opioids, marijuana has little addiction potential, and virtually no deaths from marijuana overdose have been reported in the United States, according to Bradford.

“No one has ever died of cannabis, so it has many safety advantages over opiates,” Bradford said. “And to the extent that we’re trying to manage the opiate crisis, cannabis is a potential tool.”

Comparing states with and without medical marijuana laws

  • Researchers compared prescription patterns in states with and without medical cannabis laws
  • States with medical marijuana had 2.21 million fewer daily doses of opioids prescribed per year
  • Opioid prescriptions under Medicaid dropped by 5.88% in states with medical cannabis laws

In order to evaluate whether medical marijuana could function as an effective and safe alternative to opioids, the two teams of researchers looked at whether opioid prescriptions were lower in states that had active medical cannabis laws and whether those states that enacted these laws during the study period saw reductions in opioid prescriptions.

Both teams, in fact, did find that opioid prescriptions were significantly lower in states that had enacted medical cannabis laws. The team that looked at Medicaid patients also found that the four states that switched from medical use only to recreational use — Alaska, Colorado, Oregon and Washington — saw further reductions in opioid prescriptions, according to Hefei Wen, assistant professor of health management and policy at the University of Kentucky and a lead author on the Medicaid study.

“We saw a 9% or 10% reduction (in opioid prescriptions) in Colorado and Oregon,” Wen said. “And in Alaska and Washington, the magnitude was a little bit smaller but still significant.”

Cannabis legalization by the numbers

The first state in the United States to legalize marijuana for medicinal use was California, in 1996. Since then, 29 states and the District of Columbia have approved some form of legalized cannabis. All of these states include chronic pain — either directly or indirectly — in the list of approved medical conditions for marijuana use, according to Bradford.

The details of the medical cannabis laws were found to have a significant impact on opioid prescription patterns, the researchers found. States that permitted recreational use, for example, saw an additional 6.38% reduction in opioid prescriptions under Medicaid compared with those states that permitted marijuana only for medical use, according to Wen.

The method of procurement also had a significant impact on opioid prescription patterns. States that permitted medical dispensaries — regulated shops that people can visit to purchase cannabis products — had 3.742 million fewer opioid prescriptions filled per year under Medicare Part D, while those that allowed only home cultivation had 1.792 million fewer opioid prescriptions per year.

“We found that there was about a 14.5% reduction in any opiate use when dispensaries were turned on — and that was statistically significant — and about a 7% reduction in any opiate use when home cultivation only was turned on,” Bradford said. “So dispensaries are much more powerful in terms of shifting people away from the use of opiates.”

The impact of these laws also differed based on the class of opioid prescribed. Specifically, states with medical cannabis laws saw 20.7% fewer morphine prescriptions and 17.4% fewer hydrocodone prescriptions compared with states that did not have these laws, according to Bradford.

 

 

 

 

 

 

This is fentanyl: A visual guide

Fentanyl prescriptions under Medicare Part D also dropped by 8.5% in states that had enacted medical cannabis laws, though the difference was not statistically significant, Bradford said. Fentanyl is a synthetic opioid, like heroin, that can be prescribed legally by physicians. It is 50 to 100 times more potent than morphine, and even a small amount can be fatal, according to the National Institute on Drug Abuse.

“I know that many people, including the attorney general, Jeff Sessions, are skeptical of cannabis,” Bradford said. “But, you know, the attorney general needs to be terrified of fentanyl.”

MAKING CANNABIS AVAILABLE

This is not the first time researchers have found a link between marijuana legalization and decreased opioid use. A 2014 study showed that states with medical cannabis laws had 24.8% fewer opioid overdose deaths between 1999 and 2010. A study in 2017 also found that the legalization of recreational marijuana in Colorado in 2012 reversed the state’s upward trend in opioid-related deaths.

“There is a growing body of scientific literature suggesting that legal access to marijuana can reduce the use of opioids as well as opioid-related overdose deaths,” said Melissa Moore, New York deputy state director for the Drug Policy Alliance. “In states with medical marijuana laws, we have already seen decreased admissions for opioid-related treatment and dramatically reduced rates of opioid overdoses.”

Sessions: DOJ looking at ‘rational’ marijuana policy

Some skeptics, though, argue that marijuana legalization could actually worsen the opioid epidemic. Another 2017 study, for example, showed a positive association between illicit cannabis use and opioid use disorders in the United States. But there may be an important difference between illicit cannabis use and legalized cannabis use, according to Hill.

“As we have all of these states implementing these policies, it’s imperative that we do more research,” Hill said. “We need to study the effects of these policies, and we really haven’t done it to the degree that we should.”

The two recent studies looked only at patients enrolled in Medicaid and Medicare Part D, meaning the results may not be generalizable to the entire US population.

But both Hill and Moore agree that as more states debate the merits of legalizing marijuana in the coming months and years, more research will be needed to create consistency between cannabis science and cannabis policy.

“There is a great deal of movement in the Northeast, with New Hampshire and New Jersey being well-positioned to legalize adult use,” Moore said. “I believe there are also ballot measures to legalize marijuana in Arizona, Florida, Missouri, Nebraska and South Dakota as well that voters will decide on in Fall 2018.”

Hill called the new research “a call to action” and added, “we should be studying these policies. But unfortunately, the policies have far outpaced the science at this point.”

There are no U.S. Food and Drug Administration (FDA)-approved painkillers derived from marijuana, but companies such as Axim Biotechnologies Inc, Nemus Bioscience Inc and Intec Pharma Ltd have drugs in various stages of development.

The companies are targeting the more than 100 million Americans who suffer from chronic pain, and are dependent on opioid painkillers such as Vicodin, or addicted to street opiates including heroin.

Opioid overdoses, which have claimed the lives of celebrities including Prince and Heath Ledger as victims, contributed to more than 33,000 deaths in 2015, according to the Centers for Disease Control and Prevention.

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A New Opiate MDL Was Requested For Benefit of Opioid Addicted Babies On September 20, 2018

THE JPML HAS BEEN REQUESTED TO CONSOLIDATE A NEW ADDICTED INFANT MULTIDISTRICT LITIGATION

By Mark A. York (September 21, 2018)

 

 

 

 

 

 

 

 

 

Have the most vunerable plaintiffs in the opiate litigation been underserved by firms primarily focused on representing governmental entities in Opiate MDL 2804 and state court consolidations? What about the epidemic of NAS affected babies who have been born addicted to prescription opiates?

Link to Mass Tort Nexus Briefcase Re: OPIOIDS-Children-Born-Opioid-Dependent-(NAS)-JPML-MDL-(PENDING)

(MASS TORT NEXUS MEDIA) Lawyers representing addicted infants in the opiate litigation have now filed a Motion for Transfer and Consolidation of Children Born Opioid Dependent with the JPML on September 21, 2018. To read the entire JPML Motion and Brief in Support, see our briefcase Re: masstortnexus.com/News/4335/Motion-for-New-Infant-NAS-Opioid-Dependant-MDL-Filed-With-JPML-September-20-2018.

Plaintiffs lawyers have also filed class actions in nine states on behalf of infants, and other “individuals” affected by opiate use and subsequent addiction, with very limited input into the federal litigation process. On May 21, 2018 a coalition of nine law firms filed court papers asking MDL 2804 Judge Dan Polster (USDC ND Ohio) for permission to request a separate discovery and litigation track for the baby cases, which was summarily denied without comment by the court on June 28, 2018.

Lawyers and public health officials have estimated that there could be more than 1 million babies diagnosed with “neonatal abstinence syndrome,” which occurs when infants are born to mothers who used opioids. There is a request seeking a trust of more than $1 billion to help pay for medical monitoring of the children over the next few decades.

“There has been no large-scale attempt to find out what happens to these children, and there are thousands at this time, perhaps over 1 million, progressing now through the school system and growing up,” said Scott Bickford, a principal at Martzell, Bickford & Centola in New Orleans. “Theoretically, these kids are born addicted and may stay addicts for life.”

Treatment and Prognosis for Opioid Addicted Newborns

The course of treatment will be determined by factors such as:

  • Baby’s gestational age, medical history, and health
  • Severity of the disorder and expectation of the effects it will have
  • Baby’s tolerance of the therapies, procedures, or medications
  • Parents’ preference

Immediate treatment for withdrawal effects focuses on comfort and thriving. Babies suffering from opioid withdrawal often have trouble resting and eating, so treatment involves:

  • Swaddling for comfort
  • Adding extra calories to account for energy used through restlessness and increased activity
  • Intravenous fluids for dehydration
  • Medication to relieve discomfort and eliminate symptoms like seizures

Long-term treatment involves treating physical and behavioral effects and can involve:

  • Monitoring and treating vision and hearing impairments
  • Therapy for behavioral problems
  • Language therapy
  • Treatment for chronic ear infections
  • Interventions for cognitive deficits
  • Treatment for sleep disturbance

Babies are the latest segment of the opioid epidemic to attempt to get a front-row seat in the legal case against manufacturers and distributors. More than 1,000 lawsuits have been coordinated in multidistrict litigation in Cleveland before U.S. District Judge Dan Polster of the Northern District of Ohio, who has allowed a limited amount of discovery to go forward, (see Mass Tort Nexus Briefcase OPIOID-National-Prescription-Litigation-MDL-2804-USDC-Northern-District-of-Ohio) for case docket information.

The vast majority of plaintiffs are cities and counties seeking to recoup the costs of medical treatment and law enforcement, but Native American tribes, hospitals and others have elbowed into the case. New plaintiffs are emerging, such as class actions—including eight filed this week—filed on behalf of individuals alleging the opioid epidemic caused their health insurance premiums to skyrocket.

At least 11 cases have been brought on behalf of babies, many of whom suffer from addiction and learning disabilities. Bickford said the cases are in states that have medical monitoring laws, which include New York and California. According to the case filed in New York Supreme Court for Niagara County, for instance, lifetime medical costs could include treatment of developmental, psychiatric, emotional or behavioral disorders associated with addiction.

THIS IS A MUCH BIGGER PROBLEM

Dr. Shawn Hollinger, neonatologist at Niswonger Children’s Hospital, cradled baby Jayden’s head in an effort to comfort him. After 35 days in the neonatal intensive care unit, Jayden was ready to go home.

The number of children needing intensive treatment for NAS has become so overwhelming that the hospital opened a new ward this year just to care for them. Since 2009, hospital staff have treated over 1,800 babies with NAS. In the past 12 months, Hollinger has seen 351 infants with NAS come through the NICU.

After birth, children exposed to drugs in the womb experience a multitude of symptoms, including tremors and seizures. Even after being released from the hospital, some children may still have to be treated with medication and physical therapy. It can cost upwards of $60,000 to treat one baby.

“The intent would be to construct a trust that would deliver financial assistance directly to the custodians of these children,” he said. Custodians could include other family members, foster parents or birth parents who have kicked the habit, he said.

The defendants in all the baby cases include opioid manufacturers Purdue Pharma, Johnson & Johnson, Endo Health Solutions and Teva Pharmaceuticals, as well as distributors McKesson Corp., AmerisourceBergen Corp. and Cardinal Health Inc. The New York complaint also named Insys Therapeutics Inc.

Johnson & Johnson spokeswoman Wanda Moebius wrote in an email: “Our actions in the marketing and promotion of these medicines were appropriate and responsible. The labels for our prescription opioid pain medicines provide information about their risks and benefits, and the allegations made against our company are baseless and unsubstantiated. In fact, our medications have some of the lowest rates of abuse among this class of medications.”

Endo spokeswoman Heather Zoumas Lubeski said, “We deny the allegations contained in these lawsuits and intend to vigorously defend the company.”

Representatives of the other defendants either did not respond or declined to comment.

It’s not the first time the coalition of law firms tried to get Polster to create a separate “baby track.” On June 28, the judge denied an earlier request.

“We’ve asked the court to reconsider our motion for a separate baby track for babies with neonatal abstinence syndrome,” Bickford said. “We don’t think the present MDL and the people in it who essentially represent state and local governments really have the children’s interests at heart.”

The plaintiffs’ executive committee in charge of the opioid MDL has refused to provide information about discovery and depositions, he said. His request described the discovery process as operating under a “cloak of secrecy” and included an attached email exchange in which executive committee member Jayne Conroy of Simmons Hanly Conroy called his request to monitor depositions “not necessary” and “burdensome.”

Conroy said in a statement: “All our legal efforts are directed at the companies who caused the opioid epidemic.  Any success will benefit all victims.”

Earlier this summer, the Judge charged with control over the federal MDL involving government entities’ claims against opioid manufacturers and distributors rejected a request for the inclusion of NAS baby cases within a special litigation track. The request would create a nationwide medical monitoring trust fund for NAS babies within the existing MDL litigation regarding prescription opioid

On May 31, 2018 counsel for the baby/NAS addicted plaintiffs filed a Motion for Leave to Establish a Separate Track for Opioid Baby Claims, with the court denying the request via text order entry below.

06/28/2018 Order [non-document] denying Motion for leave to File Motion for Order to Establish Separate Track for Opioid Baby Claims filed by Melissa Ambrosio, Darren Flanagan, Elena Flanagan, Ceonda Rees, Deric Rees, Virginia Salmons, Walter Salmons, Roxie Whitley, Rache l Wood(Related Doc # 540 ). Judge Dan Aaron Polster (MDL 2804) on 6/28/18.(P,R) (Entered: 06
Court Response to Previous Attempt to Get a Baby Track in Opiate MDL 2804

 Tens of thousands of infants born in the U.S. each year now have NAS, and a recent Centers for Disease Control report said the rate of NAS deliveries at hospitals quadrupled during the past 15 years.

The period of hospitalization for NAS infants averages 16 days and hospital costs for a typical newborn with NAS are $159,000$238,000 greater than those of healthy newborns, according to the attorneys representing the NAS babies.

Dr. Kanwaljeet J. S. “Sunny” Anand, the nation’s foremost expert on opioids in infants and a Professor of Pediatrics, Anesthesiology, Perioperative & Pain Medicine at Stanford University School of Medicine, is a medical expert to the legal team. “There is an unprecedented epidemic of opioid addiction sweeping across the U.S.,” said Dr. Anand. “Newborn babies are the most vulnerable citizens, their lives and developmental potential are disrupted by NAS, but arrangements for their short-term and long-term care have been ignored until now. These babies need strong advocacy and legal action to ensure that their rights are protected, and that they urgently receive essential medical care and rehabilitation. On average, one infant with NAS is hospitalized every hour in the U.S.”

Named as defendants in the class actions are an array of pharmaceutical manufacturers, distributors and retailers, all of whom netted billions of dollars due to unfair and deceptive trade practices that preyed on all Americans, including the unborn, say the attorneys.

“A medical monitoring fund would document and address the medical problems these children will have to face for a lifetime,” said Mr. Bickford. The filing today objects to current settlement negotiations engaged by the opioid MDL which ignore the NAS babies’ interests.

“Legal precedent recognizes the difference between present and future claims in negotiations of this magnitude,” said Mr. Bickford. “Without being at the table, the legal representatives of NAS babies and children will not be heard and the due process rights of these infants and children will be denied.”

The filing says only government, hospital and third-party payors are at the table in negotiating a settlement through the MDL, though no agreement has yet been reached. The attorneys representing the NAS babies have raised concerns that outcomes similar to the Tobacco MDL settlement, where money was diverted to state budget deficits instead of the intended victims, might happen here.

 Born to women addicted to drugs, newborns suffer through withdrawal

Babies suffering through opioid withdrawal have a distinct way of crying: a short, anguished, high-pitched wail, repeated over and over. It echoes through the neonatal therapeutic unit of Cabell Huntington Hospital in Huntington, West Virginia. A week-old girl has been at it, inconsolably, since six o’clock this morning. At 10 o’clock Sara Murray, the unit’s soft-spoken, no-nonsense nurse manager, sighs. “This may be a frustrating day,” she says.

The opioid epidemic in the United States is painfully evident in hospital newborn units across the country. In 2012 nearly 22,000 babies were born drug dependent, one every 25 minutes, according to the most recent federal data. As the opioid crisis has escalated dramatically over the past five years, those numbers have surely climbed.

West Virginia, at two and a half times the national average, has the highest rate of deaths from drug overdose—mostly from opioids. Cabell County, which averaged about 130 overdose calls to 911 annually until 2012, received 1,476 calls last year and is on pace to reach around 2,000 this year. Emergency workers saved many of those people, including an 11-year-old, but inpatient treatment programs have long waiting lists. At Cabell Huntington Hospital, one in five newborns has been exposed to opioids in the womb.

“What you’re seeing here is the tip of the iceberg of substance use,” says neonatologist Sean Loudin, the unit’s medical director.

In 2012 the neonatal intensive care unit became so overwhelmed by drug-dependent babies that it had to turn away newborns with other medical needs. The hospital opened this specialized unit to treat withdrawal. It typically has 18 babies. On this day there are 23.

The babies shake, sweat, vomit, and hold their bodies stiff as planks. They eat and sleep fitfully. Swaddled, they lie in bassinets or in the arms of nurses, parents, or volunteers. The place doesn’t have the hustle or beeping machinery of an ICU. Instead there are dim lights and hushed conversations because the babies need calm and quiet. Many also need methadone or other medication to relieve their symptoms. They are weaned from it over days or weeks.

“OK,” Murray whispers to a bleating 41-day-old boy. She gently lifts him to her chest, cradles him firmly, and places a green pacifier in his mouth. He sucks it fast and hard, like a piston.

Opioids pass readily from a pregnant woman’s bloodstream through the placenta and across the fetal blood-brain barrier. When birth abruptly shuts down the flow of the drug, the baby’s nervous system can trigger the agitating symptoms of withdrawal. Studies show that 55 percent to 94 percent of newborns exposed to opioids develop symptoms. Prenatal exposure to other widely used drugs, including benzodiazepines and certain antidepressants, also can lead to withdrawal shortly after birth.

The condition is called neonatal abstinence syndrome (NAS). Experts don’t consider it to be addiction, which, by definition, means a person persists in compulsive drug use despite terrible consequences. By the same logic, NAS is also a misnomer—abstaining, or just saying no, is different from experiencing the physical anguish of withdrawal. But medical experts have come to accept the NAS label because it’s less fraught with stigma than words like “addiction” and “withdrawal.”

In some cases the mothers themselves are in recovery. They didn’t misuse opioids during pregnancy but took methadone or buprenorphine, the frontline medications for treating opioid addiction. The American Congress of Obstetricians and Gynecologists recommends their use during pregnancy despite the risk of NAS, for the obvious reason that sobriety is safer and healthier for a woman than shooting heroin or popping painkillers or trying to go cold turkey on her own. It’s also much better for her child. But encouraging as it is, the growing use of medication-assisted addiction treatment means that even when the opioid crisis eases, hospitals like Cabell Huntington will continue to be swamped with babies in withdrawal.

To manage the condition, most hospitals use an assessment tool developed at the height of the heroin outbreak in the 1970s. Babies are rated every four hours on the severity of 31 symptoms, including excessive crying, sweating, tremors, and frequent yawning. The scores help doctors determine whether to put babies on methadone or other medication. In most cases the scores support drug therapy. Now some researchers are challenging that approach.

“It’s archaic,” says Elisha Wachman, a neonatologist at Boston Medical Center and an assistant professor of pediatrics at Boston University School of Medicine. “What ends up happening is that babies get overmedicated.” Too often, she says, they experience withdrawal from their treatment, which prolongs their misery and their hospital stay.

A handful of researchers around the country are revamping NAS treatment to rely less on medication and more on parental bonding. Wachman has abandoned the old score sheet for assessing the babies. “I couldn’t care less how many times they yawn,” she says. Instead, she evaluates them on just three measures: eating, sleeping, and being consoled. Rather than transfer babies to an ICU or a specialty unit, Boston Medical Center keeps them with their moms throughout their stay. Wachman encourages the women to breastfeed and clutch their babies skin to skin. One hundred fifty volunteers—most of them medical students and hospital employees—put in two-hour shifts as cuddlers. The waiting list to hold babies has 200 names.

Before the hospital changed its approach, 86 percent of the babies with NAS it treated received medication. Now it’s 30 percent. The babies generally spend nine days in the hospital, down from 19 days under the old protocol. The average cost of a hospital stay for a baby with NAS is $19,655 at Boston Medical Center, compared to a national average of $67,000.

Wachman says sound treatment for the babies must go hand in hand with compassionate, comprehensive care for their mothers. The medical center runs a prenatal clinic for women with addiction. The obstetricians prescribe buprenorphine and prepare women for the possibility that their babies will have NAS. The clinic also offers counseling, social services, psychiatric help, peer support, and education about infant care. “When the moms come in to deliver, they’re in the best shape they can be,” Wachman says. In July the medical center opened a clinic that provides pediatric care for babies born with NAS and addiction services for their mothers.

It’s not clear how opioid exposure affects long-term brain development. Surprisingly little research has been done, and most of it predates the current crisis and the widespread use of highly potent synthetics, such as fentanyl. Some studies show subtle cognitive and behavioral differences among children who were exposed to opioids before birth, but the problems are less severe than the intellectual and attention deficits associated with fetal alcohol exposure. The studies don’t answer a key question: Do the neurodevelopment issues stem from drug exposure or poverty or other chronic stresses? Some researchers believe that social factors and a stable environment are bigger influences on a child’s future than NAS.

“We keep hearing about the babies, and that it is important, but there needs to be much more of a focus on women and making sure they’re taken care of well,” says Uma Reddy, a maternal-fetal medicine expert at the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Mass Tort Nexus will provide updates on the Infant NAS MDL request to the JPML as well the Opiate Prescription MDL 2804 on a daily basis.

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