California Supreme Court Rules Novartis AG Is Open To Lawsuits Over Generic Drug Injuries

Will Big Pharma Change Labeling Today If They Have To Pay Tomorrow?

By Mark York (December 22, 2017)

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media)  On Thursday. December 21, 2017 California’s Supreme court ruled that consumers are now able to file lawsuits against Novartis AG and other makers of brand-name pharmaceutical products over injuries blamed on generic versions of the drugs manufactured by other companies.

The California Court’s ruling broke with the recent legal leanings nationally to the contrary and created potentially massive exposure for brand-name drugmakers who could be sued in the state for failing to warn users about the risks of cheaper, generic versions of their drugs. This has generally been an area of law that name brand drugmakers have been excluded from and now it seems that the litigation flood gates may open wide, at least in the State of California.

Leslie Brueckner, the plaintiffs’ lawyer, said this decision was the only current one where a state’s top court ruled in favor of consumers who were prescribed generic drugs, and have legally been prevented from filing suit against generic drugmakers for not warning about their products’ risks.

“This is just a huge victory for public health and safety, and this victory will be felt nationwide,” she said.

Novartis, whose appeal had the support of industry groups including the U.S. Chamber of Commerce, said it disagrees with the court’s decision to potentially hold it responsible for an injury caused by a different company’s product. This has been the primary defense of Big Pharma when defending themselves, from legal claims against generic makers of the products that Big Pharma brought to the marketplace originally, Big Pharma has had a get out of jail free card in play for years.  In many medical circles the view is, generics are based on the formula and R&D developed by Big Pharma labs, so why shouldn’t they be held responsible for their pharmaceutical progeny, which they created.

The decision came in a lawsuit centered on two twin children who were diagnosed with developmental delays and autism after their mother while pregnant took a generic version of Brethine to suppress premature labor. This may open a floodgate of litigation in many other states where the same medical issues are considered to be caused by Novartis designed drugs.

Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels.

The father of the children, referred to in court papers as T.H. and C.H., instead sued Novartis, which made Brethine until 2001, and aaiPharma Inc, which bought the rights to it in 2007 while their mother was taking the generic version.

Novartis argued its duty to warn consumers did not cover those taking generics and that a contrary ruling would effectively make it the market’s insurer. Even though the genric maker uses the drug warning label developed and approved by Novartis.

The court disagreed. Justice Mariano-Florentino Cuéllar wrote that brand-name manufacturers are the only entities with the ability to strengthen a warning label. This seems correct since generic makers have zero ability to add warnings or change the label of a drug based on existing law. Perhaps now the long term view of Big Pharma and drug labelling may change if more states are holding them accountable tomorrow for their lack of ethical drug labelling conduct today.

“So a duty of care on behalf of all those who consume the brand-name drug or its bioequivalent ensures that the brandname manufacturer has sufficient incentive to prevent a known or reasonably knowable harm,” Judge Cuéllar wrote.

The court also held 4-3 that Novartis could be sued despite divesting itself of Brethine because its failure to update the warning label before the sale could foreseeably cause the children harm.

The case is T.H. v. Novartis Pharmaceuticals Corporation, California Supreme Court, No. S233898

 

IN THE SUPREME COURT OF CALIFORNIA

(Dec. 21, 2017 Opinion Excerpt)

III. CONCLUSION

We do not doubt the wisdom of crowds in some settings. But the value of an

idea conveyed by or through a crowd depends not on how loudly it is proclaimed or

how often it is repeated, but on its underlying merit relative to the specific issue at hand.

Despite the impressive case authority Novartis has collected on its behalf,

none of it purports to interpret California law. Yet it is California law that we must construe

and apply in this case. In doing so, we find that brand-name drug manufacturers have a

duty to use ordinary care in warning about the safety risks of their drugs, regardless of

whether the injured party (in reliance on the brand-name manufacturer’s warning) was

dispensed the brand-name or generic version of the drug. We also conclude that a brand-

name manufacturer’s sale of the rights to a drug does not, as a matter of law,

terminate its liability for injuries foreseeably and proximately caused by

deficiencies present in the warning label prior to the sale.

We therefore affirm the Court of Appeal.

 

CUÉLLAR, J.

 

 

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The Week In Mass Torts By Mass Tort Nexus for December 18, 2017

 

 

 

 

 

 

 

 

By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

The New Jersey Supreme Court recently granted petitions and cross-petitions to appeal a state appellate court’s reversal of expert exclusions in the state’s Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re:  Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.) See Mass Tort Nexus Accutane Briefcase Accutane New Jersey State Court Litigation.

New Trial Denied in 3rd Xarelto MDL Bellwether Case After Defense Verdict

Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, recently denied a motion for a new trial by the plaintiff in the third bellwether trial, where Bayer was found not liable in the Dora Mingo trial that took place in a Mississippi federal court in front of Judge Fallon. He ruled that plaintiff was unsuccessful in presenting new findings, among other things, that the plaintiff’s “newly discovered evidence” is actually cumulative of previously known and admitted evidence (In Re:  Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422). See Mass Tort Xarelto Briefcase for the entire Mingo trial transcripts as well as full transcripts of the Orr and Boudreaux trials, XARELTO MDL 2592 US District Court ED Louisiana Including Trial Transcripts.

 With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination

With the final two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re:  Pradaxa [Dabigatran Etexilate]Products Liability Litigation, MDL No. 2385, No. 12-md-2385, S.D. Ill.).  After a global settlement was reached in 2014 with defendant Boehringer Ingelheim Pharmaceuticals Inc., the JPMDL suspended the transfer of tag-along actions into the MDL, and now the judge has moved for termination of the Pradaxa MDL. However, there remains over 700 Pradaxa cases pending in the State Court of Connecticut, Complex Litigation Docket, known as “Connecticut Pradaxa Actions”, see Mass Tort Nexus Pradaxa Case Briefcase,  Connecticut Consolidated Pradaxa Litigation.

Boehringer To Pay $13.5M To End Off-Label Marketing Claims

Drugmaker Boehringer Ingelheim Pharmaceuticals Inc. has agreed to distribute $13.5 million among all 50 states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday.
The settlement would resolve allegations that Boehringer marketed its prescription drugs Micardis, Aggrenox, Atrovent and Combivent for uses that weren’t approved by their labels or backed by scientific evidence. (Getty) The settlement, of which New York will receive about $490,000, would resolve allegations that the drugmaker marketed it products for off-label use, which often leads to unknown or studied adverse events and medical complications for patients taking these drugs for unapproved purposes.

 J&J Fined $30 Million Over French Opioid Drug Smear Campaign In Efforts To Sell Fentanyl Patch

France’s antitrust enforcer fined Johnson & Johnson and its Janssen-Cilag unit €25 million ($29.7 million) on Wednesday for hindering the marketing and sale of a generic version of the company’s Durogesic pain patch.The French Competition Authority found that Janssen and J&J had not only successfully delayed a generic competitor for the powerful opioid for several months, but had also done lasting damage by discrediting rival versions of the drug with doctors and pharmacists in a country where medical professionals still remain reluctant to opt for prescribing opioids.  The J&J conduct reflects the same claims being asserted against opioid drug makers in the US, where lawsuits have been consolidate into Opiate Prescription Litigation MDL No. 2804, in the US District Court of Ohio, see Mass Tort Nexus Opioid Crisis Briefcase, OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION.

11th Circuit Affirms Pelvic Mesh Group Trial, Exclusion Of 510(k) Status

(October 24, 2017, 1:25 PM EDT) -The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017)   See Mass Tort Nexus Mesh Case Briefcase, All Pelvic Mesh Litigation Case Files.

Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal

The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re:  Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 )

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury’s (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Superior Court)

Risperdal Gynecomastia Cases Barred By Michigan Shield Law, Pennsylvania Panel Says

A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs’ claims are preempted by Michigan’s drug shield law and that the plaintiffs could not prove that the fraud exception

applied to their claims (In Re:  Risperdal Litigation versus Janssen Pharmaceuticals Inc., et al., No. 55 EDA 2015, et al., Pennsylvania Court of Appeals, 2017.

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

The U.S. Supreme Court on has invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Supreme Court)  This is a unique turn when the Supreme Court is seeking input from an outside agency in what is now a common legal issue placed in front of the court, where dug makers are using the FDA regulatory process as a shield in defending thousands of claims where warnings of drug dangers are not clear or not provided. See Mass Tort Nexus Fosamax Case Briefcase, FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS).

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Attorney General Opiate Investigations in New York, Texas, Missouri and Other States Move Forward

Amid Opioid Crisis: Investigations by AG’s in Texas, New York and Other States Demand Drug Company Documents

By Mark A. York (December 19, 2017)

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) As communities nationwide grapple with opioid addiction, Texas and a coalition of 40 other states have served investigative subpoenas and other requests to eight companies that manufacture or distribute prescription painkillers, Texas Attorney General Ken Paxton recently announced. This is just one of at least 14 other states that are conducting investigation into opiate drug companies and their recent business practices.

It’s the latest development in an investigation unveiled in June. Paxton and his counterparts are trying to determine whether opioid manufacturers played a role in creating or prolonging what has become a national epidemic. The attorneys general served investigative subpoenas to drugmakers Endo Pharmaceuticals, Janssen Pharmaceuticals, Teva Pharmaceuticals’ Cephalon, Allergan and their related entities, and they served a supplemental subpoena to Purdue Pharma, Paxton’s office said. The states also sent “information demand letters” to three opioid distributers: AmerisourceBergen, Cardinal Health, and McKesson.  These actions are completely apart from the many civil lawsuits filed against the same opiate drug makers under investigation, the civil suits have been filed by more than 400 counties, cities and states in “Opiate Prescription Litigation MDL 2804” recently consolidated in the United States District Court of Ohio, see NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 BRIEFCASE.

“The goal of this phase of our investigation is to collect enough information so that the multi-state coalition can effectively evaluate whether manufacturers and distributors engaged in unlawful practices in the marketing, sale, and distribution of opioids,” Paxton said in a statement. “We’ll determine an appropriate course of action once it’s determined what role these companies may have played in creating or prolonging the opioid crisis.”

Caitlin Carroll, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, said Tuesday she could not comment on the investigation of individual companies, but she pointed to policies her group supports to “prevent and deter abuse.”

An Allergan spokesman said that company was “working cooperatively with the state attorneys general,” but he downplayed the company’s share of the opioid market and said it didn’t aggressively promote such drugs.

“Allergan’s two branded opioid products — Norco and Kadian — account for less than 0.08 percent of all opioid products prescribed in 2016 in the U.S.,” the spokesman, Mark Marmur, said. “These products came to Allergan through legacy acquisitions and have not been promoted since 2012, in the case of Kadian, and since 2003, in the case of Norco.”

Cardinal Health also released a lengthy statement in which the company said: “We look forward to working with the attorneys general.”

Opioids are a family of drugs including prescription painkillers like hydrocodone, as well as illicit drugs like heroin.

Prescription and illegal opioids account for more than 60 percent of overdose deaths in the United States, a toll that has quadrupled over the past two decades, according to the U.S. Centers for Disease Control. Drug overdose deaths in 2015 far outnumbered deaths from auto accidents or guns.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

In teaming up to probe drug companies, some experts suggest the states are following a playbook similar to one used during the 1990s to sue tobacco companies for their role in fueling a costly health crisis — an effort that resulted in a settlement yielding more than $15 billion for Texas alone.

 

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MONSANTO HAS MANIPULATED EPA AND MEDICAL STUDY DATA TO INCREASE ROUNDUP PROFITS

Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup Weed Killer

By Mark A. York

December 19, 2017

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA)  Documents recently released in a lawsuit against  Monsanto, see Roundup (Monsanto) MDL 2741 USDC ND California, raised new questions about the company’s efforts to influence the public opinion by collusion and steering of data published by the media, authors and scientific research publications, and revealed internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world and is used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most regulators, the the Federal Mass Tort Litigation against Monsanto and Roundup,  pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific dat are released the number of cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits.

  1. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction,  however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

 

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FDA Fails to Cite Big Pharma Opioid Drug Makers for False Marketing and Advertisements

“PROFITS BEFORE PATIENTS REIGNS SUPREME AT FDA”

By Mark A. York (December 12, 2017)

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 counrty.

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.

US 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.

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JPML Approves Opiate Prescription MDL No. 2804: “Profits Before Patients” Exposed

JPML Approves Opiate Prescription MDL No. 2804

 

 

(Mass Tort Nexus) The U.S. Judicial Panel on Multidistrict Litigation, formally approved the “NATIONAL PRESCRIPTION OPIATE LITIGATION MDL No. 2804” earlier today see, JPML Transfer Order in MDL No. 2804, December 5, 2017.  Cases filed into MDL 2804 by counties, cities and other parties are expanding quickly as plaintiffs in more than 100 lawsuits against pharmaceutical companies related to the opioid epidemic were successful, when getting the MDL assigned to Judge Daniel Polster in the US District Court, Northern District of Ohio. While the manufacturers had argued for consolidation in corporate defense friendly New York, and various distributors supported consolidation in West Virginia. The location of this MDL in Ohio, which has been one of the hardest hit states by the “opioid crisis” may have far reaching implications toward the management and ultimate resolution of the onslaught of opioid claims.

Case plaintiffs are filing new claims across the country from Montana to New Mexico and into Wisconsin, where every county in the entire state of Wisconsin has filed suit against the opioid drug makers and distributors, see Mass Tort Nexus briefcase “OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION” for materials, including case dockets and information related to all areas of the opioid crisis across the country.

 Parties Vie For Strategic Positioning In Their Preferred Venues

On Sept. 25, 2017, 46 government plaintiffs filed a motion with the

panel seeking coordination or consolidation of their claims and 20

“substantially similar” lawsuits pending in 11 federal districts.

Among the common questions of fact that would justify MDL,

plaintiffs cited:

  • Whether, and to what extent, defendants promoted or allowed

the use of prescription opioids for purposes other than those

approved by the U.S. Food and Drug Administration.

  • Defendants’ knowledge of the actual or potential diversion of

prescription opioids into illicit channels.

  • The nature and adequacy of defendants’ internal controls and procedures for identifying suspicious orders for prescription opioids and reporting them to the authorities.

 Plaintiff Positions:

Pro-MDL plaintiffs had wanted to keep the docket in the hard hit Ohio or West Virginia courts, as the impact there has crossed all lines with no demographic not affected in one way or another by the opioid crisis.

Anti-MDL plaintiffs, including the city of Chicago and eight plaintiffs from West Virginia, opposed centralization, arguing their claims named

distributors or manufacturers, but not both, and the MDL would hinder their individual case interests, which was rejected by the panel, as Judge Charles Breyer of the Northern District of California noted repeatedly, the central factual issue for these claims is “what

did [the manufacturers and distributors] know and what did they do [with that knowledge]?” Plaintiff-specific questions, such as how many pills were shipped into a given community, could be answered in the context of MDL without hindering any individual plaintiff’s case.

 Drug Distributors:

The “big three” distributor defendants, McKesson Corporation, Cardinal Health Inc., and AmerisourceBergen Corporation, wanted the MDL before Judge David A. Faber in the Southern District of West Virginia, which already has a heavy MDL docket with the thousands of TVM cases, and the panel decided against another massive caseload being assigned to that venue.

Drug Manufacturers:

The manufacturers sought transfer to the federal district where they were first sued, in the Northern District of Illinois, where Judge Jorge Alonso is presiding over the lawsuit filed by the city of Chicago in June 2014.  As an alternative to the Illinois court, the manufacturers, with many being based in Connecticut, Pennsylvania, New York and New Jersey, argued for the U.S. District Court for the Southern District of New York, even though there is no opioid litigation pending against them there.

 MDL 2804 Impact on Opioid Crisis

Transferee courts often make crucial pretrial decisions regarding case management, the scope of discovery and class action certification.

The opioid claims have this far suffered from the lack of such coordination and guidance, and MDL 2804 would be making an important step in managing the ever growing case docket. Which has unique challenges including, opioid claims that are not brought by the injured individuals themselves. Instead, these claims have been filed b by government entities that allege they are out massive amounts of money and lost services after having treated or responded to the opioid epidemic for the last 15 years.

As Judge Vance noted throughout the hearing, “there are serious threshold issues” with the government entities’ standing to bring claims that do not apply to other plaintiff categories, such as individuals claiming wrongful death, which could lead to an inefficient MDL for non-government plaintiffs.

JPML Judge Refers to Future Individual Claims

Judge Vance stated, “Therefor the manner in which government entities can prove their damages will be a challenging topic for any MDL court, as will the consideration of how a settlement may be structured such that it does not impinge on the rights of recovery for the actual individuals who may later claim personal harm from opioids.” Which may be taking place sooner as opposed to later, as individual claims are being filed in a few courts across the country already.

 Settlement Ability Of Big Pharma

An additional consideration of the court is the pharmaceutical manufacturers being the primary target of opioid litigation, as the drug makers are alleged to have been involved in stoking the fires of the epidemic from the earliest days. Many of these companies have very large set aside cash reserves for just this type of legal development, which could give them increased leverage and ability to craft settlements in the MDL.  While distributor defendants, will face very different exposures, with resolution that may involve insurance interests, and some insurers have decided to decline coverage and spinning off a whole sub-set of insurance coverage lawsuits.

Healthcare Service Providers and Pharmacies Are Also Targets

Additional defendants in these claims now include pharmacies like CVS, Walgreens, etc, doctors and pain management clinics, all of which have settlement interests and exposures that differ from the others.  As opioid claims mount, reports have surfaced indicating that Purdue Pharma and other pharmaceutical defendants are eyeing settlement, at least at the state level.

RICO Claims Are In The Mix

Several entities have filed RICO claims against the drug makers and distributors alleging that the opioid crisis was developed and directed by boardroom decisions of some of the largest companies in the United States. How this affects the MDL direction will be worth watching.

The opioid plaintiff pool across the country now includes state and local governments, hospitals, labor unions and an ever growing number of individual plaintiffs as well, how Judge Polster decides to manage this extremely complex docket will be watched closely.

 Spin Off MDL’s As Needed

Judge Breyer offered one potential solution to multiple plaintiffs and defendants with divergent interests, which is allow the transferee court to create different “tracks” based on plaintiff category, spin off new MDLs as appropriate, or remand cases that have ceased to benefit from MDL 2804.

 A Conclusion Or A Reckoning

Now that MDL 2804 has been established, the pace of opioid litigation will quickly accelerate, with many new claims being filed daily as they have over the last 10 weeks, since the initial Motion to Consolidate was filed. With an MDL now looming over the entire pharmaceutical industry, the prescription opioid market will never be the same, as evidenced by criminal indictments of drug company executives and ongoing investigations that are taking place in many states. Perhaps now there will be an adjustment of the “profits before patients” policies that have been adopted by Big Pharma in this country, and drug makers will be forced to come to terms with the catastrophic damage they’ve caused by their flood of opioid drugs released across America over the last 15 years.

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$29 Million XARELTO Jury Verdict Against Bayer AG, Janssen Pharmaceuticals (Johnson & Johnson) in Philadelphia

XARELTO TRIAL VERDICT FOR PLAINTIFF: BAYER AND JANSSEN PHARMACEUTICALS (J&J) LOSE  $29 MIILLION IN XARELTO TRIAL VERDICT BY PHILADELPHIA JURY

  

 

 

 

 

A state court jury in Philadelphia delivered a first-of-its-kind verdict on Tuesday as it awarded $29 million in damages against a pair of Johnson & Johnson and Bayer AG units after finding the companies had provided inadequate warnings about the risks of bleeding associated with the blood thinner Xarelto,(see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court).  In the first bellwether trial outside the Xarelto Federal MDL 2592, plaintiff counsel scored a win in a $29 million verdict, when plaintiff Lynn Hartman showed that Xarelto caused severe bleeding after she was prescribed the drug by her doctor. The 3 prior federal court trials in the Xarelto MDL 2592 docket (see XARELTO MDL 2592 US District Court ED Louisiana) were all won by the defense and this trial was watched closely by both legal and drug industry observers to see if the 3-0 defense win streak continued. Now that Ms. Hartman has shown that the Xarelto prescription caused her internal bleeding, with no warnings by manufacturers Bayer and J&J, the remaining 22,000 Xarelto cases pending in courts across the country will begin preparations for a legal battle that to date has gone in favor of defense counsel.

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JPML APPROVES “OPIATE PRESCRIPTION MDL 2804” AGAINST OPIOID MANUFACTURERS AND DISTRIBUTORS

The UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION  has formally approved the“NATIONAL PRESCRIPTION OPIATE LITIGATION, MDL No. 2804″ on December 5, 2017.

     Assigned to Judge Daniel Polster, US District Court Northern District of Ohio, who will oversee the litigation related to manufacturing, marketing, distribution and sales practices of prescription opioid drugs by Big Pharma drug makers and distributors.  

 

 

 

JPML Transfer Order in MDL No. 2804, December 5, 2017

UNITED STATES JUDICIAL PANEL

on

MULTIDISTRICT LITIGATION

IN RE: NATIONAL PRESCRIPTION OPIATE LITIGATION                                                                            MDL No. 2804

TRANSFER ORDER

Before the Panel:* Plaintiffs in 46 actions move under 28 U.S.C. § 1407 to centralize pretrial proceedings in the Southern District of Ohio or the Southern District of Illinois, but plaintiffs do not oppose centralization in the Southern District of West Virginia.  These cases concern the alleged improper marketing of and inappropriate distribution of various prescription opiate medications into cities, states and towns across the country.  Plaintiffs’ motion includes the 64 actions listed on Schedule A,1 which are pending in nine districts.  Since plaintiffs filed this motion, the parties have notified the Panel of 115 potentially related actions.2 

Responding plaintiffs’ positions on centralization vary considerably.  Plaintiffs in over 40 actions or potential tag-along actions support centralization.  Plaintiffs in fifteen actions or potential tag-along actions oppose centralization altogether or oppose transfer of their action.  In addition to opposing transfer, the State of West Virginia suggests that we delay transferring its case until the Southern District of West Virginia court decides its motion to remand to state court.  Third party payor plaintiffs in an Eastern District of Pennsylvania potential tag-along action (Philadelphia Teachers Health and Welfare Fund) oppose centralization of third party payor actions.  Western District of Washington plaintiff City of Everett opposes centralization and, alternatively, requests exclusion of its case.  Northern District of Illinois tagalong plaintiff City of Chicago asks the Panel to defer transfer of its action until document discovery is completed.

Defendants’ positions on centralization also vary considerably. The “Big Three” distributor defendants,3 which reportedly distribute over 80% of the drugs at issue and are defendants in most cases,

__________________________________________

* Judges Lewis A. Kaplan and Ellen Segal Huvelle did not participate in the decision of this matter.

1  Two actions included on plaintiffs’ motion to centralize were remanded to state court during the pendency of the motion.

2 These actions, and any other related actions, are potential tag-along actions.  See Panel Rules 1.1(h), 7.1 and 7.2. 3

3 AmerisourceBergen Drug Corp., AmerisourceBergen Corp., McKesson Corp., Cardinal Health 110, LLC, Cardinal Health, Inc., Cardinal Health 105, Inc., Cardinal Health 108, LLC, Cardinal Health 112, LLC, Cardinal Health 414, LLC, and Cardinal Health subsidiary The Harvard Drug  – 2 –

support centralization in the Southern District of West Virginia.  These defendants request that the Panel either delay issuing its transfer order or delay transfer of their cases until their motions to dismiss are decided.  Defendant distributor Miami-Luken also supports centralization in the Southern District of West Virginia.  Multiple manufacturer defendants4 support centralization in the Southern District of New York or the Northern District of Illinois; defendant Malinckrodt, LLC, takes no position on centralization but supports the same districts.  Teva defendants5 suggest centralization in the Eastern District of Pennsylvania or the manufacturers’ preferred districts.  Physician defendants6 in three Ohio actions, who are alleged to be “key opinion leaders” paid by manufacturing defendants, do not oppose centralization in the Southern District of Ohio. 

Defendants in several Southern District of West Virginia cases oppose centralization.  These defendants include several smaller distributor defendants or “closed” distributors that supply only their own stores.7  Many of these defendants specifically request exclusion of the claims against them from the MDL.  Also, manufacturer Pfizer, Inc., opposes centralization and requests that we exclude any claims against it from this MDL.8

The responding parties suggest a wide range of potential transferee districts, including: the Southern District of West Virginia, the Southern District of Illinois, the Northern District of Illinois, the Eastern

District of Missouri (in a brief submitted after the Panel’s hearing), the District of New Jersey, the Southern District of New York, the Southern District of Ohio, the Northern District of Ohio, the Eastern District of Pennsylvania, the Eastern District of Texas, the Western District of Washington and the Eastern District of Wisconsin.

After considering the argument of counsel, we find that the actions in this litigation involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. Plaintiffs in the actions before us are cities, counties and states that allege that: (1) manufacturers of prescription opioid medications overstated the benefits and downplayed the risks of the use of their opioids and aggressively marketed  (directly and through key opinion leaders) these drugs to physicians, and/or (2) distributors failed to monitor, detect, investigate, refuse and report suspicious orders of prescription opiates.  All actions involve common factual questions about, inter alia, the manufacturing and distributor defendants’ knowledge of and conduct regarding the alleged diversion of these prescription opiates, as well as the manufacturers’ alleged improper marketing of such drugs.  Both manufacturers and distributors are under an obligation under the Controlled Substances Act and similar state laws to prevent diversion of opiates and other controlled substances into illicit channels.  Plaintiffs assert that defendants have failed to adhere to those standards, which caused the diversion of opiates into their communities.  Plaintiffs variously bring claims for violation of RICO statutes, consumer protection laws, state analogues to the Controlled Substances Act, as well as common law claims such as public nuisance, negligence, negligent misrepresentation, fraud and unjust enrichment. 

______________________________________________________________

Group, L.L.C. 4

4 Actavis LLC, Actavis Pharma, Inc., Allergan PLC, Allergan Finance, LLC, Allergan plc f/k/a Actavis plc, Actavis Pharma Inc. f/k/a Watson Pharma Inc., Watson Pharmaceuticals, Inc. n/k/a Actavis, Inc., and Allergan PLC f/k/a Actavis PLS, Cephalon, Inc., Endo Health Solutions, Inc., Endo Pharmaceuticals, Inc., Janssen Pharmaceutica Inc., Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Purdue Frederick Company Inc., Purdue Pharma Inc., Purdue Pharma L.P., Teva Pharmaceuticals Industries Ltd., Teva Pharmaceuticals USA, Inc., Watson Laboratories, Inc., Watson Pharmaceuticals, Inc., Janssen Pharmaceutica Inc. n/k/a Janssen Pharmaceuticals, Inc. 5

5 Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals U.S.A, Inc., Cephalon, Inc., Watson Laboratories, Inc., Actavis LLC, and Actavis Pharma, Inc. 6

6 Scott Fishman, M.D., Perry Fine, M.D., Lynn Webster, M.D., and Russell Portenoy, M.D. 7

7 JM Smith Corp.; CVS Indiana, LLC and Omnicare Distribution Center, LLC; TopRx; Kroger Limited Partnership I, Kroger Limited Partnership II, SAJ Distributors (a Walgreens distributor for two months in 2012), Walgreen Eastern Co., Inc., and Rite Aid of Maryland, Inc.; Masters Pharmaceuticals and KeySource Medical; WalMart Stores East, LP. 8

8 Pfizer specifically requests that we exclude any potential future claims against it because of its minimal involvement in the opioid market.  At oral argument, counsel stated that Pfizer was not named as a defendant in any pending case.  In the absence of a case before us, the Panel will not address Pfizer’s argument.

 

 

The parties opposing transfer stress the uniqueness of the claims they bring (or the claims that are brought against them), and they argue that centralization of so many diverse claims against manufacturers and distributors will lead to inefficiencies that could slow the progress of all cases.  While we appreciate these arguments, we are not persuaded by them.  All of the actions can be expected to implicate common fact questions as to the allegedly improper marketing and widespread diversion of prescription opiates into states, counties and cities across the nation, and discovery likely will be voluminous.  Although individualized factual issues may arise in each action, such issues do not – especially at this early stage of litigation – negate the efficiencies to be gained by centralization.  The transferee judge might find it useful, for example, to establish different tracks for the different types of parties or claims.  The alternative of allowing the various cases to proceed independently across myriad districts raises a significant risk of inconsistent rulings and inefficient pretrial proceedings.  In our opinion, centralization will substantially reduce the risk of duplicative discovery, minimize the possibility of inconsistent pretrial obligations, and prevent conflicting rulings on pretrial motions.  Centralization will also allow a single transferee judge to coordinate with numerous cases pending in state courts.  Finally, we deny the requests to delay transfer pending rulings on various pretrial motions (e.g., motions to dismiss or to remand to state court) or until the completion of document discovery in City of Chicago

Although all of the cases on the motion before us involve claims brought by political subdivisions, we have been notified of potential tag-along actions brought by individuals, consumers, hospitals and third party payors.  As reflected in our questions at oral argument, this litigation might evolve to include  – 4 –

additional categories of plaintiffs and defendants, as well as different types of claims.  We will address whether to include specific actions or claims through the conditional transfer order process.[1]

As this litigation progresses, it may become apparent that certain types of actions or claims could be more efficiently handled in the actions’ respective transferor courts.  Should the transferee judge deem remand of any claims or actions appropriate (or, relatedly, the subsequent exclusion of similar types of claims or actions from the centralized proceedings), then he may accomplish this by filing a suggestion of remand to the Panel.  See Panel Rule 10.1.  As always, we trust such matters to the sound judgment of the transferee judge.

Most parties acknowledge that any number of the proposed transferee districts would be suitable for this litigation that is nationwide in scope.  We are persuaded that the Northern District of Ohio is the appropriate transferee district for this litigation.  Ohio has a strong factual connection to this litigation, given that it has experienced a significant rise in the number of opioid-related overdoses in the past several years and expended significant sums in dealing with the effects of the opioid epidemic.  The Northern District of Ohio presents a geographically central and accessible forum that is relatively close to defendants’ various headquarters in New York, Connecticut, New Jersey and Pennsylvania.  Indeed, one of the Big Three distributor defendants, Cardinal Health, is based in Ohio.  Judge Dan A. Polster is an experienced transferee judge who presides over several opiate cases.  Judge Polster’s previous MDL experience, particularly MDL No. 1909 – In re: Gadolinium Contrast Dyes Products Liability Litigation, which involved several hundred cases, has provided him valuable insight into the management of complex, multidistrict litigation.  We have no doubt that Judge Polster will steer this litigation on a prudent course.

 

IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside of the Northern District of Ohio are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable Dan A. Polster for coordinated or consolidated  pretrial proceedings.

PANEL ON MULTIDISTRICT LITIGATION

  

Sarah S. Vance

Chair

Charles R. Breyer Marjorie O. Rendell
R. David Proctor Catherine D. Perry

__________________________________________________________________________________

IN RE: NATIONAL PRESCRIPTION

OPIATE LITIGATION                                                                            MDL No. 2804

SCHEDULE A

Northern District of Alabama

CITY OF BIRMINGHAM v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-01360

Eastern District of California

COUNTY OF SAN JOAQUIN, ET AL. v. PURDUE PHARMA, L.P., ET AL.,

C.A. No. 2:17-01485

Southern District of Illinois

PEOPLE OF THE STATE OF ILLINOIS, ET AL. v. PURDUE PHARMA LP, ET AL.,

C.A. No. 3:17-00616

PEOPLE OF THE STATE OF ILLINOIS, ET AL. v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 3:17-00856

PEOPLE OF STATE OF ILLINOIS, ET AL. v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00876

Eastern District of Kentucky

BOONE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00157

PENDLETON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00161

CAMPBELL COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00167

ANDERSON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00070

FRANKLIN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00071

SHELBY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00072

HENRY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 3:17-00073

BOYLE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00367

FLEMING COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00368

– A2 –

Eastern District of Kentucky (cont.)

GARRARD COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00369

LINCOLN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 5:17-00370

MADISON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00371

NICHOLAS COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00373

BELL COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00246

HARLAN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00247

KNOX COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00248

LESLIE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00249

WHITLEY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00250

CLAY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00255

Western District of Kentucky

THE FISCAL COURT OF CUMBERLAND COUNTY v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 1:17-00163

LOUISVILLE/JEFFERSON COUNTY METRO GOVERNMENT v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 3:17-00508

THE FISCAL COURT OF SPENCER COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00557

THE FISCAL COURT OF UNION COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 4:17-00120

THE FISCAL COURT OF CARLISLE COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00136

Northern District of Ohio

CITY OF LORAIN v. PURDUE PHARMA L.P., ET AL., C.A. No. 1:17-01639

CITY OF PARMA v. PURDUE PHARMA L.P., ET AL., C.A. No. 1:17-01872

– A3 –

Southern District of Ohio

CLERMONT COUNTY BOARD OF COUNTY COMMISSIONERS v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00662 BELMONT COUNTY BOARD OF COUNTY COMMISSIONERS v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00663

BROWN COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00664

VINTON COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN CORPORATION, ET AL., C.A. No. 2:17-00665

JACKSON COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00680

SCIOTO COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00682

PIKE COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 2:17-00696

ROSS COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 2:17-00704

CITY OF CINCINNATI v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-00713

CITY OF PORTSMOUTH v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-00723

GALLIA COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00768

HOCKING COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00769

LAWRENCE COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00770

DAYTON v. PURDUE PHARMA LP, ET AL., C.A. No. 3:17-00229

Western District of Washington

CITY OF EVERETT v. PURDUE PHARMA LP, ET AL., C.A. No. 2:17-00209

CITY OF TACOMA v. PURDUE PHARMA, L.P., ET AL., C.A. No. 3:17-05737

Southern District of West Virginia

THE COUNTY COMMISSION OF MCDOWELL COUNTY v. MCKESSON CORPORATION,

ET AL., C.A. No. 1:17-00946

HONAKER v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 1:17-03364

THE COUNTY COMMISSION OF MERCER COUNTY v. WEST VIRGINIA BOARD OF

PHARMACY, C.A. No. 1:17-03716

– A4 Southern District of West Virginia (cont.)

KANAWHA COUNTY COMMISSION v. RITE AID OF MARYLAND, INC., ET AL.,

C.A. No. 2:17-01666

FAYETTE COUNTY COMMISSION v. CARDINAL HEALTH, INC., ET AL.,

C.A. No. 2:17-01957

BOONE COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG CORPORATION,

ET AL., C.A. No. 2:17-02028

LOGAN COUNTY COMMISSION v. CARDINAL HEALTH, INC., ET AL.,

C.A. No. 2:17-02296

THE COUNTY COMMISSION OF LINCOLN COUNTY v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03366

LIVINGGOOD v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03369

SPARKS v. WEST VIRGINIA BOARD OF PHARMACY, C.A. No. 2:17-03372

CARLTON, ET AL. v. WEST VIRGINIA BOARD OF PHARMACY, ET AL.,

C.A. No. 2:17-03532

STATE OF WEST VIRGINIA, ET AL. v. MCKESSON CORPORATION, C.A. No. 2:17-03555 BARKER v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03715

THE CITY OF HUNTINGTON v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 3:17-01362

CABELL COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG CORPORATION, ET

AL., C.A. No. 3:17-01665

WAYNE COUNTY COMMISSION v. RITE AID OF MARYLAND, INC., ET AL.,

C.A. No. 3:17-01962

WYOMING COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-02311

 

[1]  Eastern District of Pennsylvania Philadelphia Teachers Health and Welfare Fund third party payor plaintiff opposed centralization of such claims, stating that it intends to file a motion for centralization of third party payor claims.  We will address that motion, if it is filed, in due course.

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WEEKLY MDL and MASS TORT UPDATE by MASS TORT NEXUS for Week of November 27, 2017

By Mark A. York (November 30, 2017)

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This week in mass torts around the country:

Opioid Crisis: See Mass Tort Nexus Briefcase Re: OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION

> Superseding indictments of Insys Therapeutics Executives Unsealed in USDC of Massachusetts

BOSTON — A federal indictment against seven high-ranking officers of opioid maker Insys Therapeutics Inc. was unsealed Oct. 26 in a Massachusetts federal court charging the men with racketeering, mail fraud and conspiracy for a scheme to pay kickbacks to doctors for, and to fraudulently induce health insurers into approving, off-label prescriptions for the company’s addictive Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

>Doctor Pleads Guilty To Opioid Health Care Fraud, Taking Kickbacks From Insys

PROVIDENCE, R.I. — A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).

 > Opioid Distributors Support MDL While Municipalities Oppose

WASHINGTON, D.C. — The “Big Three” national drug distributors on Oct. 20 told a federal judicial panel that they support centralization of more than 60 opioid lawsuits filed against them by various cities and counties (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPML).

Related Mass Tort Nexus Opiod Articles:

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

>Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA Nov 3, 2017

For more Mass Tort Nexus Opiod Crisis Information See: Mass Tort Nexus Newsletters and MDL Updates

IVC FILTERS:

Cook Medical IVC: See Mass Tort Nexus Briefcase Re: Cook Medical IVC Filter MDL 2570

>First Cook IVC Bellwether Trial Starts in USDC SD of Indiana

INDIANAPOLIS — The first bellwether trial in the Cook Medical Inc. inferior vena cava (IVC) filter multidistrict litigation got under way on Oct. 23 in Indianapolis federal court (In re:  Cook Medical, Inc., IVC Filters Litigation, MDL Docket No. 2570, No. 14-ml-2570, Elizabeth Jane Hill v. Cook Medical, Inc., No. 14-6016, S.D. Ind., Indianapolis Div.).

Cordis IVC Filters: See Cordis IVC Filter Litigation Alameda County, California Superior Court

>Cordis IVC Filter Plaintiffs Tell Supreme Court Trial Proposal Is No ‘Mass Action’

WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4013).

Taxotere: See Taxotere MDL 2740 (US District Court Eastern District of Louisiana)

>Taxotere MDL Judge Denies Statute of Limitations Motion by Sanofi

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere multidistrict litigation on Oct. 27 denied without prejudice a motion by defendant Sanofi-Aventis U.S. LLC to dismiss claims barred by applicable statutes of limitations (In Re:  Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).

Pelvic Mesh: Boston Scientific TVM Litigation MDL 2362

>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:

ATLANTA — The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017 U.S. App. LEXIS 20432).

PLAVIX: See Mass Tort Nexus Briefcase Re: PLAVIX MDL 2418 USDC NEW JERSEY

>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration

TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re:  Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J., 2017 U.S. Dist. LEXIS 177588).

Abilify MDL 2734: Mass Tort Nexus Briefcase Re: Abilify MDL 2734

 >Abilify MDL Judge Orders Defendants To Name Settlement Counsel

PENSACOLA, Fla. — The Florida federal judge overseeing the Abilify multidistrict litigation on Oct. 25 ordered the defendants to engage settlement counsel for monthly settlement conferences (In Re:  Abilify [Aripiprazole] Products Liability Litigation, MDL Docket No. 2734, No. 16-md-2734, N.D. Fla., Pensacola Div.).

Mirena IUD: Related-Federal Court Reopens Mirena IUD Product Liability MDL Nov 3, 2016

>2nd Circuit Affirms Exclusion Of Mirena MDL Experts, Termination Of Litigation

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re:  Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir., 2017 U.S. App. LEXIS 20875).

Hip ImplantsSee Mass Tort Nexus Briefcase Re: Wright Medical, Inc. MDL 2329 Conserve Hip Implant Litigation

>Wright Medical Settles Remaining Wright Hip Cases; Judge Closes MDL 2329

ATLANTA — Wright Medical Technology Inc. and plaintiffs in a multidistrict litigation have entered two additional agreements settling the remainder of the litigation, a Georgia federal judge said Oct. 18 (In Re:  Wright Medical Technology, Inc., Conserve Hip Implant Products Liability, MDL Docket No. 2329, No. 12-md-2329, N.D. Ga., Atlanta Div

Testosterone Replacement Therapy: See Mass Tort Nexus Briefcase Re: TESTOSTERONE MDL 2545 (AndroGel)

>Testosterone Bellwether Out and Pre-emption Denied

CHICAGO — An Illinois multidistrict litigation judge on Oct. 23 granted summary judgment in one of two testosterone replacement therapy bellwether cases but denied preemption in the second case (In Re:  Testosterone Replacement Therapy Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div., 2017 U.S. Dist. LEXIS 176522).

 

>AbbVie, AndroGel Plaintiff Spar Over Mixed Verdict In 1st Bellwether Trial Verdict

CHICAGO — AbbVie on Oct. 25 urged the judge overseeing the testosterone replacement therapy multidistrict litigation to not disturb a bellwether trial verdict where a jury awarded $0 compensatory damages (In Re:  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jesse Mitchell v. AbbVie, No. 14-9178, N.D. Ill.).

Fosamax MDL 1789: See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey

>Fosamax Femur Plaintiffs Urge Supreme Court To Deny Preemption Review

WASHINGTON, D.C. — Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4064

 

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