Studies Question FDA Approvals of Cardiac Devices

The New York Times reports that two studies have “found shortcomings in some clinical trials accepted by the FDA over the last decade in connection with the approval of high-risk cardiovascular devices,” such as “pacemakers, implanted defibrillators, and…coronary stents.” For its part, the FDA said it “is developing guidelines that will set tougher scientific standards for data from tests on humans” that medical device makers submit.

The first study, published in the December issue of the Journal of the American Medical Association (JAMA), showed that many cardiovascular devices are not subjected to rigorous safety and effectiveness research before being approved for use and that “it’s common for such devices to receive…approval based on information from only a single study, which raises questions about the quality of data on which some cardiovascular device approvals are based.”

Meanwhile, a second study appearing in the American Journal of Therapeutics, co-authored by a medical reviewer from the FDA’s cardiovascular device division, found that studies submitted for approval of cardiovascular devices often lack important information, including details on the studies’ participants.  The Associated Press reports that the second study “found about 40 percent of pivotal studies lacked precise targets for how safety would be measured,” and researchers “failed to fully account for what happened to all patients enrolled in the research.”

Hit and Run: the Consequences of Riegel v. Medtronic

The Alliance for Justice has released a new video explaining the devastating consequences of the recent SCOTUS decision in Riegel v. Medtronic in which the Court held that federal law bars state lawsuits “challenging the safety or effectiveness of a medical device,” as long as the device is marketed in a form that received premarket approval from the FDA:

As pointed out by Overruled, Congress can fix this problem by passing the Medical Device Safety Act now.

SCOTUS Rejects Preemption Claims of Drug Companies

Yesterday, the SCOTUS upheld a Vermont jury’s verdict of $6.7 million in favor of Diana Levine, a musician, whose arm had to be amputated after she was injected with an antinausea drug. The drug’s manufacturer, Wyeth, had argued that its compliance with the Food and Drug Administration’s labeling requirements should immunize it from lawsuits.  The Court, in a 6-3 decision, held that federal approval of warnings on prescription drug labels does not preempt state law tort suits alleging that such warnings were inadequate

Writing the Supreme Court’s majority opinion, Justice John Paul Stevens said that FDA oversight of drug labeling doesn’t prevent the filing of state court consumer liability lawsuits against drug companies.  Joining Stevens in the majority were Supreme Court Justices Anthony Kennedy, David Souter, Ruth Bader Ginsburg, Stephen Breyer and, surprisingly, Clarence Thomas.

Writing for the Court, Justice Stevens said:

“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the Food, Drug and Cosmetic Act’s 70 year history…Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”

Justice Thomas, in a concurring opinion, also dismissed the Wyeth preemption argument, calling it unconstitutional:

“Because such a sweeping approach to pre-emption leads to the illegitimate – and thus, unconstitutional – invalidation of state laws, I can no longer assent to a doctrine that preempts state laws merely because they ‘stand as an obstacle to the accomplishment and execution of the full purposes and objectives’ of federal law.”

The following is the statement from American Association for Justice President Les Weisbrod.

“The Supreme Court reaffirmed the principle that state lawsuits perform a valuable and important function in ensuring accountability in uncovering drug hazards.  Also, the Supreme Court rejected the FDA’s attempts to use the preamble in drug regulations to provide complete immunity to drug manufacturers.

It is clear consumers retained their remedy under law when drug companies have failed to provide adequate warnings for the safe use of their drugs.

Today’s decision in favor of Diana Levine proved that even if you are just one person, you can fight for justice and hold your wrongdoer accountable.”

Full analysis by SCOTUSblog is here.  Here’s the beginning:

Amid much critical commentary about the way federal drug regulators are doing their job, a Supreme Court majority on Wednesday provided a ringing endorsement of lawsuits in state courts to fill in for lapses at the national level — in particular, lawsuits that claim drugmakers have not given doctors and patients enough warning about side-effects.  The six Justices who joined in upholding a verdict of nearly $6.8 million against the pharmacetical company Wyeth have sent their own warnings: to the industry, and to the Food and Drug Administration.

Justice John Paul Stevens’ opinion speaking for five Justices, and Justice Clarence Thomas’ separate opinion joining in the result, provided in combination a reinforcement of these ideas: that drug companies are primarily responsible for keeping their warning labels up to date and complete (and may pay for it if they don’t), and that the FDA not only needs to police the industry more closely — even if it lacks resources – but that it also had better have the clearest mandate from Congress before it tries to scuttle patients’ lawsuits in state courts.

Overall, this is great news for consumers and the health care system.