State-level Medical Device Cases, post-Wyeth v. Levine

On May 13, 2009, In Medical Device, Product Safety, By admin

How has the Supreme Court’s decision in favor of Diana Levine, a Vermont woman who lost her arm after being injected with an anti-nausea drug, changed the future of state-level tort suits?

Brian Wolfman, director of Public Citizen Litigation Group in Washington, says the ruling “reaffirms that preemption is the exception and not the rule”.

Justice John Paul Stevens of the US Supreme Court wrote for the majority when the Court upheld the state verdict in favor of Diana Levine. “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”

This affirmation is going to serve several tort litigation cases immediately, but it will also have an impact on laws and suits regarding medical devices. The day after the decision was handed down, The Medical Device Safety Act of 2009 (MDSA) was introduced to both houses of Congress.

Lawmakers have been encouraged by the Court’s ruling to think that medical device manufacturers could be held to the same determination, despite the Court’s previous ruling in Riegel v. Medtronic. In this case from 2008, the Court decided that state law tort claims regarding FDA pre-approved medical devices are preempted.

The Medical Device Safety Act of 2009 would allow for state-level tort suits. The purpose of the bill would be to give consumers recourse to remedy their injuries within the state court system without totally undermining the FDA’s authority.

As recently as January of this year, federal judges citing the Reigel decision dismissed 1,496 cases. Michael E. Seelie currently represents plaintiffs in pharmaceutical litigation in Jacksonville, Florida.

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Supreme Court Upholds Consumer Rights for Safer Drugs

On March 4, 2009, In Product Safety, By admin

In a decision just released, the Supreme Court has upheld a 6.8 million dollar verdict for Diane Levine, (Levine v. Wyeth) and at the same time took a step in the right direction for making pharmaceutical drugs safer for all.

The plainiff, Diane Levine, was given a given “push injection” of the drug Pheneragen, manufactured by Wyeth.  She developed complications from an apparent mistake in the injection, and ultimately had to have her forearm amputated.

Although Levine won at the state level, Wyeth, appealed arguing that a 2006 regulation of the Food and Drug Administration should mean that such cases are barred at the state level.  Read more about preemption.

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The Supreme Court Hears Levine v. Wyeth

On November 3, 2008, In Uncategorized, By admin

The Supreme Court seemed divided today while hearing oral arguments in Levine v. Wyeth.

Levine, a musician, had her arm amputated after gangrene set in. The Gangrene was caused when an IV push, designed to speed delivery of the drug into her bloodstream to counteract nausea caused by a migraine, hit an artery instead of a vein.

Levine’s Attoreny, David Frederick, argued that Wyeth and FDA were aware of the danger, which was indicated in the labeling, but that the warning was insufficiently strong and that Wyeth should have strengthened cautions.

Wyeth argues that the FDA did not allow such a label change.

Chief Justice John Roberts and Justice Antonin Scalia appeared to be siding with Wyeth.  Wyeth lawyer Seth Waxman said: “We cannot have a world in which the very day after an intensive process – the FDA says you may distribute this drug, but you must use this specific language – either A, manufacturers can just run in and change the label and ask for permission down the road, or …. a state legislature or 50 state legislatures can decide because you could have gone back and asked, we can impose an obligation on you that you must have done so or must have changed the labeling.”

Edwin Kneedler, representing the government, agreed. “It’s been the FDA’s long-standing interpretation that only new information would justify a change [in labeling],” said Kneedler.

Justices David Souter, Ruth Bader Ginsburg, Samuel Alito and Anthony Kennedy seemed inclined towards the plaintiff.

Justice Samuel Alito wondered: “how could the FDA [have] concluded that IV push was safe and effective when on the benefit side of this you don’t have a life-saving drug, you have a drug that relieves nausea, and on the risk side, you have the risk of gangrene?”

Justice Ginsburg asked: “No matter what benefit there was, how could the benefit outweigh that substantial risk?”

Justice Souter said: “as I understand it, the company, Wyeth, could have gone back to the FDA at any time and said …. We think the label ought to be changed to say ‘Don’t use IV push.’ Wyeth could have done that at any time, and it simply didn’t do it.”

David Frederick, representing the plaintiff, argued that “the label itself is not set in stone …. Manufacturers change their labels all the time as new drug risks come in, and the regulations provide that the manufacturer is responsible not only for the label but for monitoring post-market information.”

The full transcript of the hearing is available at http://www.supremecourtus.gov/oral_arguments/argument_transcripts/06-1249.pdf

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Bush Administration’s Preemption Plot Confirmed by House Report

On November 1, 2008, In Product Safety, By admin

 

As Levine V. Wyeth gets ready to be argued in front of the Supreme Court on Monday, a report released from the House Oversight and Government Reform Committee: says that top scientists and career employees at the Food and Drug Administration had opposed the agency regulations that weaken consumers’ ability to sue drug makers.

The issue is language in a drug-labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends pre-emption, which is when federal regulations prevail when there is a conflict with state law. The concept of pre-emption is being used as a way to prevent a person from suing a drug company if they are injured by a drug, as long as the drug had recieved approval from the FDA.

The recently released report highlights internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval. 
 

The report cites Dr. John Jenkins, the highest official in FDA’s new drug review process, writing:
[M]uch of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”

 A copy of the report.

For Further Reading: Associated Press story on the issue:

LA Times story:

 

 

 

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