Wednesday, March 20, 2013

SCOTUS Oral Argument in Mutual Pharm. Co. v. Bartlett: Generic Pharmaceutical Manufacturers' Potential Immunity from Suit

Monday, January 21, 2013

Kelsey Larson and Carlos Lazatin on Crafting a Defense in Food-Labeling Class Actions

Corporate Counsel has a short piece, Crafting a Defense in Food-Labeling Class Actions, by O'Melveny's Kelsey Larson and Carlos Lazatin.

BGS

January 21, 2013 in Aggregate Litigation Procedures, Class Actions, FDA, Food and Drink, Procedure, Products Liability | Permalink | Comments (0) | TrackBack (0)

Sunday, January 29, 2012

PIP Breast Implants and Mass Torts in Europe

According to this article from CNN, French authorities have arrested Jean-Claude Mas, the founder of Poly Implant Protheses (PIP), in connection with alleged manslaughter and involuntary harm to a woman who died from cancer and had PIP breast implants.  The article notes that 300,000 women in 65 countries received PIP breast implants, and that questions have been raised about the use of non-medical-grade silicon and PIP went bankrupt in late 2010.  

The PIP breast-implants controversy may present an opportunity to observe non-U.S.-style mechanisms for what here would likely have been a mass tort litigation.  Since the PIP breast implants were not permitted to be sold in the U.S., litigation may be concentrated abroad.  In general, my sense is that the European approach is more reliant on criminal law than tort for deterrence, compensatory damages are limited because of the comparatively extensive governmental social insurance, punitive damages are unavailable, and class actions are traditionally not embraced (though class actions appear to be on the rise globally -- see, e.g., the Stanford Global Class Actions Exchange).

Interestingly, according to the article, one French woman who received PIP breast implants said, "Too bad we do not have a justice system like they do in the United States which allows the accumulation of penalties...because the small punishment he will receive for what he did to 300,000 to 400,000 women, is not much compared to what we have suffered because of him."

(H/t to my Mass Tort Litigation student Abigail Anderson for sending me the CNN story.)

BGS

January 29, 2012 in Aggregate Litigation Procedures, FDA, Foreign, Procedure, Products Liability | Permalink | Comments (0) | TrackBack (0)

Tuesday, December 13, 2011

Yaz Litigation Likely to Heat Up After FDA Relabeling

Last week the FDA voted 21-5 to revise the labeling on Yaz, Yasmin, Beyaz, Safyral, and its generic versions to clarify the potential risk of blood clots in the legs and lungs from taking the pills.  After debating the conflicting data for more than nine hours, the panelists disagreed on the evidence's quality but agreed that the risks should be clearly stated in the label.  Here's an excerpt from the Huffington Post's report:

"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."

In an earlier vote, panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. The majority ruling amounts to a vote of confidence for keeping the drugs on the market, though well over a third of panelists voted against the drug's overall benefit, citing numerous alternatives available.

"I can see no real group of patients that this drug benefited over existing alternatives," said Mark Woods of New York University School of Medicine. "Without any clear benefit, and given the potentially catastrophic risk, I voted no."

Two large studies conducted by German drugmaker Bayer have shown no difference in blood clots between patients taking the company's drugs and patients taking older medications.

But since 2009, five large studies have suggested drospirenone-containing pills carry a slightly higher risk of blood clots than older birth control pills, though events in both groups are very rare. Even a slightly higher risk can be critical because blood clots can trigger heart attacks, strokes and blockages in lungs or blood vessels.

Here's a link to a TIME magazine report and to a recent NY Times piece.

ECB

 

December 13, 2011 in FDA, Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

Thursday, July 7, 2011

GMO Rice Lawsuits Settle for $750M

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BNA Class Action Litigation Reporter reports that the lawsuits against Bayer Cropscience for the contamination of rice crops with genetically modified rice have settled. The case was In Re: Genetically Modified Rice Litigation, E.D. Mo., No. 4:06-md-1811. 

The plaintiffs were denied class certification for predictable reasons. The settlement is equally predictably organized on the Vioxx model: it goes into effect if 85% of the farmers sign on.

For more information on the MDL GMO Rice Litigation see the E.D.Mo. website: http://www.moed.uscourts.gov/node/115. (As for this writing, not updated to reflect the BNA report of settlement).   As the website notes, the GMO rice has since been de regulated by the FDA.

ADL

Image by scottchan.

July 7, 2011 in Aggregate Litigation Procedures, Environmental Torts, FDA, Settlement, Vioxx | Permalink | Comments (0) | TrackBack (0)

Thursday, March 25, 2010

Reynolds' Move Into Smokeless Products

Thorough article in the Wall Street Journal -- Smokeless Products Are Tough Test for Reynolds, by David Kesmodel.

BGS

March 25, 2010 in FDA, Regulation, Science, Tobacco | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 16, 2010

Albany Law Journal Symposium Issue on Off-Label Drug Prescription

Friday, December 11, 2009

GAO Says FDA Hasn't Made Enough Safety Reforms

The AP has the story here.  While the FDA has made some changes, it has not transferred authority to the Office of Surveillance and Epidemiology.   H/T Torts Prof Blog.

ADL

December 11, 2009 in FDA | Permalink | Comments (0) | TrackBack (0)

Thursday, October 29, 2009

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.

BGS

October 29, 2009 in FDA, Off-Label Drug Use, Pharmaceuticals - Misc., Procedure, Regulation, Resources - Federal Agencies, Resources - Organizations, Science | Permalink | Comments (0) | TrackBack (0)

Tuesday, October 20, 2009

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.

BGS

October 20, 2009 in FDA, Mass Tort Scholarship, Medical Devices - Misc., Preemption, Procedure, Products Liability, Regulation | Permalink | Comments (0) | TrackBack (0)

Friday, September 18, 2009

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

September 18, 2009 in FDA, Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

Wednesday, September 2, 2009

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.

BGS

September 2, 2009 in FDA, Tobacco | Permalink | Comments (0) | TrackBack (0)

Monday, August 31, 2009

Bill Marler on Legal Issues for Food Safety

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

BGS

August 31, 2009 in E Coli, FDA, Food and Drink, Food Poisoning | Permalink | Comments (0) | TrackBack (0)

Monday, August 24, 2009

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."

BGS

August 24, 2009 in FDA, Mass Tort Scholarship, Pharmaceuticals - Misc., Products Liability | Permalink | Comments (0) | TrackBack (0)

Tuesday, August 18, 2009

First Circuit Decision on Federal Claims Act

Saturday, August 15, 2009

Richard Epstein on Preemption and the Medical Device Safety Act

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


BGS

August 15, 2009 in FDA, Mass Tort Scholarship, Pharmaceuticals - Misc., Preemption | Permalink | Comments (0) | TrackBack (0)

Friday, August 14, 2009

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).

BGS

August 14, 2009 in Aggregate Litigation Procedures, Class Actions, FDA, Food and Drink, Preemption, Procedure | Permalink | Comments (0) | TrackBack (0)

Wednesday, August 12, 2009

Jason C. Miller on Michigan's Regulatory Compliance Defense

SSRN 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.


BGS   

August 12, 2009 in FDA, Mass Tort Scholarship, Preemption, Products Liability | Permalink | Comments (0) | TrackBack (0)

Monday, July 27, 2009

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.

BGS


July 27, 2009 in FDA, Pharmaceuticals - Misc., Products Liability | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 22, 2009

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.

BGS

July 22, 2009 in FDA, Medical Devices - Misc., Pharmaceuticals - Misc., Preemption, Products Liability | Permalink | Comments (1) | TrackBack (0)