Mass Tort Litigation Blog

WLF Web Seminar on Off-Label Communication

On October 14, 2009, the Washington Legal Foundation hosted a web seminar, Communicating on Off-Label Treatments: Navigating the Treacherous Path Paved by Civil and Criminal Law Enforcement, with speakers Robert Salerno and Adam Hoffinger of Morrison & Foerster.  Streaming video of the event is available online.

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Fall 2009 Newsletter for ABA Mass Torts Litigation Committee

The newsletter is now available and includes articles on Lone Pine orders, public nuisance law, federal preemption, sophisticated user and sophisticated intermediary defenses, the Fake Bad Scale Test, and document review.

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Yaz Litigation

The FDA recently sent a warning letter to Bayer, which manufacturers Yaz and Yasmin (both types of birth control pills), that it has quality control problems at its German plant.  The FDA claims that Bayer's testing method averaged out the test results as opposed to reporting results for each batch.  Bayer had the batches shipped to the U.S. between 2007 and 2009.  

This news is simply the most recent concern about Yaz.  Litigation is already pending in Pennsylvania in front of Judge Sandra Mazer Moss of the Philadelphia Court of Common Pleas, alleging that the drug causes severe side effects including blood clots, strokes, heart attacks, gallbladder disease, deep vein thrombosis, pulmonary embolisms and even sudden death.  There has been some speculation around the internet that the FDA will recall the drug.  As the U.S. Recall News reports:

"In July 24, 2009, a petition was filed to consolidate the many lawsuits against Bayer over Yaz and Yasmin into a multidistrict litigation (MDL). There is a hearing scheduled for September 24, 2009 to decide whether or not they will be consolidated." 

"Andrew Gillin, an attorney handling several California Yaz lawsuits says the litigation is still in the early stages. “A petition has been filed to combine all of the federal lawsuits into a multi-district litigation (MDL) case. Later this month, a panel of federal judges will determine whether the cases involve sufficiently common questions of fact, and whether or not to consolidate,” explained Mr. Gillin."

ECB

Tobacco Companies Bring First Amendment Challenge to New Marketing Rules

More from Ross Todd of AmLaw Daily in his post, Big Tobacco Asserts First Amendment with Help from Floyd Abrams.  Here's the complaint.

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Bill Marler on Legal Issues for Food Safety

Bill Marler has posted his brief article, Legal Issues for Food Safety, on Marler Blog.

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Richard Epstein on Consumer Regulation

In his July 14 Forbes column, Vanguard or Rearguard?, Richard Epstein (Chicago & NYU) recounts the history of the FDA, as well as other regulatory frameworks, and concludes that "[r]egulatory failure is, on average, a far greater risk than market failure."

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First Circuit Decision on Federal Claims Act

FDA Law Blog analyzes the decision in United States ex rel Duxbury v. Ortho Biotech Products.

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Richard Epstein on Preemption and the Medical Device Safety Act

Richard Epstein (Chicago & NYU) discusses them both in his recent Forbes column.

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Third Circuit Rejects FDA Preemption for Snapple Consumer Fraud Suit

More from Allison Frankel's short article in Am Law Daily.  Here's the opinion.

UPDATE:  The Consumer Advertising Law Blog has analyzed the opinion (H/t Point of Law).

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Jason C. Miller on Michigan's Regulatory Compliance Defense

Jason C. Miller of University of Michigan has posted to SSRN his Note, When and How to Defer to the FDA: Learning from Michigan's Regulatory Compliance Defense, 15 Mich. Telecomm. & Tech. L. Rev. 565 (2009).  Here's the abstract:

Should FDA approval of a drug affect products liability litigation? This remains one of the most debated questions in the law. Although the Supreme Court recently held that state tort law is not forced to defer to the FDA's finding that a drug is safe through preemption, states remain free to defer to the FDA by providing a regulatory compliance defense in state substantive law. Michigan made exactly such a choice in enacting the only complete defense for FDA-approved drugs. Compliance with FDA regulations conclusively establishes a lack of products liability under Michigan law. With preemption seemingly off the table after Wyeth v. Levine, advocates of greater deference to the FDA may use Michigan as a model for legislation in other states. Much can be learned from examining Michigan's law. 

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed to protect consumers. This Note examines the question of FDA approval in state tort actions, discusses Michigan's answer to that question, and offers a proposal that would block most private actions against FDA-approved drugs (as Michigan has done), but would allow a state attorney general to bring suits in certain circumstances. The state attorney general model detailed in this Note stakes out a middle ground in the debate over the significance of FDA approval. The proposal recognizes the primacy of the FDA, but also recognizes the need for a back-up that can provide deterrence and compensation in the few cases that slip through the FDA's regulatory cracks.

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First Neurontin Trial: Mark Lanier for Plaintiffs, and Mark Cheffo and William Ohlemeyer for Pfizer

Article in Am Law Litigation Daily -- Mark Lanier Work His Magic in 'Very Tough' Neurontin Test Trial?, by Ben Hallman.  Mark Cheffo (Skadden) and William Ohlemeyer (Boies Schiller) will represent Pfizer.  Here's an excerpt:

Mark Lanier told the Litigation Daily on Friday that he's not expecting any miracles Monday, when he begins the first trial to test claims that Pfizer's antiepilepsy drug Neurontin increases patients' risk of suicide. He'll be lucky, he said, to eke out a win. "I've got a near-impossible case," Lanier told us. "If I lose, it's almost like a focus group educational experiment. If I win, it portends bad things for Pfizer."

The case, the first of some 1,200 Neurontin suits in the pipeline, was brought by the family of Susan Bulger, a 39-year-old who took the drug before hanging herself in 2004. The suit, in federal district court in Boston, claims Bulger was taking Neurontin to treat epilepsy, as well as mood swings and arthritis pain (for which the drug was not approved but was allegedly marketed). "Our argument is that the drug company took advantage of fragile and unfortunately situated [patients] by marketing a drug illegally," Lanier said. "They made Neurontin a snake oil to treat everything, when the FDA had not approved the drug for much of anything." (Sounds like Lanier was trying out his opening statement on us!)

UPDATE -- Here's a separate link to the detailed related article in Bloomberg -- Pfizer Faces First Trial on Neurontin Suicide Claim, by Margaret Cronin Fisk, Jef Feeley and Cary O’Reilly.

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The Advance and Retreat of Pre-emption

Was going through some old issues of the ABA Journal and found this interesting article from the May issue -- Business Downturn: As the market tumbles, so does the corporate pre-emption defense, by David G. Savage.  Here's an excerpt:

For much of the decade, business lawyers and the Bush administration insisted state liability laws and state regulation amounted to a costly nuisance and a drag on the economy. They said uniform national regulation of business made more sense, and they urged the Supreme Court to limit lawsuits and to pre-empt state regulations.

For years those arguments were winners. Last year, Riegel v. Medtronic barred most lawsuits against the makers of medical devices. Lawyers for the Bush administration and device makers said state jurors should not be permitted to second-guess Food and Drug Administration regulators once they have approved a device as safe and effective.

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Federal Court in NJ Dismisses Off-Label-Marketing Suit Against Schering-Plough

Article in AmLaw Litigation Daily -- Schering-Plough Wins Dismissal of 'Off-Label' Suit, by Ben Hallman.  Here's an excerpt:

A recent decision by a New Jersey federal court sets a tough standard for plaintiffs trying to piggyback on government investigations of off-label drug marketing. In dismissing a lawsuit against Schering-Plough, federal district court judge Stanley Chesler ruled that even if the company has violated off-label marketing rules--as it seems to have done for two cancer drugs--plaintiffs must prove that the drug was marketed for an ineffective use, and that the patient received no benefit from it.

And here's a link to the opinion by Judge Chesler.

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Robert Rabin on Conflicting Conceptions of Tort Preemption

Professor Robert Rabin (Stanford) has posted on SSRN his article, Territorial Claims in the Domain of Accident Law: Conflicting Conceptions of Tort Preemption, Brook. L. Rev. (forthcoming 2009).  Here's the abstract:

Beginning in 1992, with the landmark decision in Cipollone v. Liggett Group, Inc., the U.S. Supreme Court has decided a burgeoning number of preemption cases, squarely challenging the continuing vitality of tort in many domains of accident law. Cipollone addressed the preemption question in an atypical context. The case did not involve competing claims to territorial authority between a regulatory regime and state tort law. Rather, Cipollone involved a challenge to the continuing viability of tort in the face of statutory directives mandating explicit industry conduct; more specifically, the explicit warnings required in the 1969 version of the cigarette labeling act.

In this article, I begin by revisiting Cipollone to reassess what it has to offer as a foundation for setting the boundaries of regulatory containment of the tort system. Next, I discuss three leading cases from the series of efforts by the Supreme Court to grapple with express preemption clauses in a variety of regulatory schemes. Against this backdrop, I then explore the circumstances under which it might be justified to imply preemption despite the absence of an express provision, with particular reference to the recent Supreme Court decision in Wyeth v. Levine, addressing preemption in the context of FDA regulation of prescription drugs. A concluding note ties the strands together.

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Douglas Smith on Preemption After Wyeth v. Levine

Douglas Smith (Kirkland & Ellis) has posted on SSRN his article, Preemption After Wyeth v. Levine, Ohio St. L.J. (forthcoming 2009).  Here's the abstract:

This Article addresses the Supreme Court’s recent preemption decision in Wyeth v. Levine. In Wyeth, the Court held that the Food and Drug Act did not preempt a state law tort suit alleging that the labeling for an anti-nausea medication, Phenergan, failed to adequately warn about the risks associated with IV-push administration of the drug. Already, Wyeth has been interpreted by some as sounding the death knell for the preemption doctrine in the context of pharmaceutical products. However, a careful analysis of the Court’s decision indicates that this is far from the case. The majority underscored that its decision was a 'narrow' one based largely on the facts and circumstances before it. In particular, the Court made a point of noting that the record was devoid of evidence that the particular risks at issue had actually been considered by the FDA and that the defendant had thus failed to show that there was an actual conflict between FDA regulation and the state law tort suit. The majority’s analysis therefore suggests that state law tort suits based on an alleged failure to warn are preempted in cases in which the FDA has specifically considered the particular risks at issue and has determined that the pharmaceutical product’s labeling adequately warns of those risks. I argue that the ruling thus construed has significant benefits. As the Court has repeatedly recognized, there is an inherent tension between the congressional establishment of a federal regulatory regime for the labeling of pharmaceuticals and medical devices by experts at the FDA and allowing a jury of ordinary citizens with no specialized expertise to render their own judgment regarding, and in effect overrule, such expert determinations. As several members of the Court have noted, there is a potential danger in allowing these expert decisions to be undermined by state court juries. Moreover, such an outcome may have undesirable indirect effects, such as raising the prices of pharmaceutical products to satisfy state court judgments that are not warranted based on the best available scientific evidence and the potential confusion and inconsistency that may result with juries in fifty-two separate jurisdictions imposing different standards concerning what constitutes appropriate labeling. The Court’s decision properly balances these competing considerations.

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Nestle Not Completely Cooperative with FDA Inspections Prior to E. Coli Outbreak

Article in the Wall Street Journal -- Nestlé Unit Denied FDA Requests, by Jane Zhang.  Here's an excerpt:

The Nestlé USA plant at the center of a federal probe into an E. coli outbreak involving cookie dough refused to give inspectors access to pest-control records, environmental-testing programs and other information, according to newly released inspection reports covering the past five years.

In a September 2006 visit, for example, managers at the Danville, Va., plant refused to allow a Food and Drug Administration inspector to review consumer complaints or inspect its program designed to prevent food contamination. The inspector found dirty equipment and "three live ant-like insects" on a ledge but nothing severe enough to give the plant a failing grade.

A year earlier, officials at the Nestlé plant presented another FDA inspector with a list of things it wouldn't do. "Among these are the refusal to review the firm's consumer complaint file, refusal to permit photography, refusal to sign affidavits or receipts and refusal to provide specific information on interstate commerce," the inspector wrote.

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President Obama Signs Tobacco Bill Giving FDA Oversight

Article on cnn.com -- Obama signs bill putting tobacco products under FDA oversight.  Here's an excerpt:

President Obama signed landmark legislation Monday giving the Food and Drug Administration new power to regulate the manufacturing, marketing and sale of tobacco.

The Family Smoking Prevention and Tobacco Control Act gives the FDA power to ban candy-flavored and fruit-flavored cigarettes, widely considered appealing to first-time smokers, including youths. It also prohibits tobacco companies from using terms such as "low tar," "light" or "mild," requires larger warning labels on packages, and restricts advertising of tobacco products.

It also requires tobacco companies to reduce levels of nicotine in cigarettes.

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Tobacco Bill Giving FDA Regulatory Authority Progresses in Senate

As a follow-up to Byron's earlier post on the pending bill to give the FDA regulatory authority over tobacco products, here's a link to the Associated Press story and to the bill itself.  The bill responds to the Supreme Court's opinion in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), which held that the Food, Drug, and Cosmetic Act did not give the FDA authority to regulate tobacco products.  Accordingly, the FDA could not promulgate regulations governing tobacco companies' advertising, labeling, or accessibility.  A similar bill passed in the House on April 2, 2009, and it is currently under consideration by the Senate.

ECB

NIH Study Questions Benefits of Stents and Diabetes Drugs Avandia and Actos

Article in the Wall Street Journal -- Diabetes Study Questions Expensive Treatments: NIH Finds Patients With Heart Disease Fare Equally Well Without Stents and Drugs Such as Avandia, Actos, by Keith J. Winstein.  Here's an excerpt:

Aggressive use of expensive diabetes drugs and medical devices called stents did no better than cheaper treatments at preventing deaths, heart attacks or strokes in a large study of diabetics with heart disease.

The study, sponsored by the National Institutes of Health and several drugmakers, is the latest to humble fancy new treatments by finding them no better than older medicines at preventing the deadly consequences of major diseases. The results add to a debate about alleged overuse of stents, made by companies including Abbott Laboratories, Boston Scientific Corp. and Johnson & Johnson, and controversial diabetes drugs from GlaxoSmithKline PLC and Takeda Pharmaceutical Co.

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Tobacco, the FDA, and Preemption

Op-ed in today's Wall Street Journal -- Tobacco and the Tort Bar, by Mark H. Berlind.  Here's an excerpt:

Congress is on the verge of passing sweeping legislation that would empower the Food and Drug Administration (FDA) to regulate tobacco products. Antitobacco activists are cheering, while some tobacco companies are raising the specter of First Amendment violations. Lost in the debate is the fact that this bill will continue to allow consumers to sue manufacturers that fully comply with the FDA's content and labeling rules.

...

Today's legislation would impose strict limits on tobacco advertising and labeling, mandate stronger warning labels, and require advance FDA approval of any reduced-risk claims. It would also empower the FDA to change cigarettes' content to make them less addictive and lethal.

However, in a little-noticed provision, the bill also expressly provides that "no provision of this chapter . . . shall be construed to modify or otherwise affect . . . the liability of any person under the product liability law of any State." In other words, the regulatory regime that the legislation would establish can't protect companies from tort liability -- even if they rigorously follow every FDA rule.

BGS