The Bitter Pill

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Boston Globe: No Haven For Dangerous Drugs – Supreme Court To Settle Preemption Controversy

The U.S. Supreme Court will hear a case in November to settle the issue of the FDA’s infamous preemption doctrine, as promulgated by former Bush Administration-appointed FDA chief counsel, Daniel Troy, who laid the groundwork for the current legal battle over preemption. Mr. Troy has recently joined GlaxoSmithKline as general counsel. Before the Troy regime, FDA preemption was very rare, and occurred only twice since 1906. The Tylenol poisoning case in 1982 where the FDA forced the manufacturers to use tamper-proof packaging is one of those rare instances. Preemption has become standard practice in the past few years for the FDA in almost every state court product liability action involving drugs or medical devices.

The case before The Court is Wyeth v. Levine. The case involves Diana Levine (right), a Vermont musician and migraine sufferer who lost part of one arm due to side effects from Wyeth’s nausea drug Phenergan. She was awarded more than $6 million in damages in this case and Wyeth is appealing.

A victory by the drug industry could effectively immunize the drug makers against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective. Conceivably this could occur even if these defects were known to the industry, and were willfully and maliciously concealed.

This policy of preemption states that FDA approval supersedes state law claims challenging safety, efficacy, or labeling. Drug makers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness.
List members Stefan Kruszewski, Kim Witczak, and Sara Bostock have filed amicus (Friend of the Court) briefs opposing preemption in this case.

Vince
GLOBE EDITORIAL
No haven for dangerous drugs

September 27, 2008

IN THE PAST 11 years, drug companies have had to pull 23 unsafe drugs from the market, even though all had won approval from the US Food and Drug Administration. In spite of this shoddy record of oversight, the companies want to be protected from lawsuits by victimized patients or their survivors on the grounds thatFDA approval should protect them from liability. A Supreme Court that has proven only too willing to do the bidding of industry could give the companies what they are looking for.

If it does, it will be doing just what conservatives often accuse judges of doing – legislating from the bench. “This is a radical restructuring of the American civil justice system,” according to Georgetown law professor David Vladeck.

The case before the court is Wyeth v. Levine. Diana Levine is a 62-year-old Vermont musician whose arm had to be amputated after an anti-nausea medication caused gangrene. Levine settled a suit against the clinic where the drug was administered and then won $6.7 million in a suit against drug maker Wyeth, on the grounds that its label did not sufficiently warn against the injection method used by the clinic.

When the court hears the case in November, Wyeth wants justices to accept its argument that FDA approval of the label implicitly pre-empts any state suits. Such immunity would be a new boon to the industry. Merck is currently offering almost $5 billion to settle 50,000 suits related to its drug Vioxx. In 2005 alone, 17,000 suits were filed against drug-industry products.

Drug companies can take heart from an 8-1 Supreme Court ruling earlier this year to grant immunity from suits to makers of FDA-approved medical devices. That ruling, however, relied on an ambiguously worded 1976 law specifically about medical devices that the justices interpreted to grant immunity to the industry. Congress already has plans to pass legislation restoring patients’ rights to sue when harmed by a medical device.

In Wyeth v. Levine, the Bush administration has lined up on Wyeth’s side, while Levine has support from the attorneys general of 47 states and the present and former editors of the New England Journal of Medicine. Two former FDA commissioners, David Kessler and Donald Kennedy, also have filed briefs for Levine. The FDA, they say, cannot “police the market on its own.”

The withdrawal of Vioxx and other dangerous drugs demonstrates that the FDA approves medications with insufficient proof of their safety and then does not recognize their harmful effects quickly enough. The Supreme Court has no business depriving patients of their recourse to courts.
MORE Reading on this issue:

Here are the briefs filed by the 47 state attorneys general
http://www.pharmalot.com/wp-content/uploads/2008/08/attorneys-general.pdf;
the former FDA commissioners
http://www.pharmalot.com/wp-content/uploads/2008/08/fda-commissioners-amicus.pdf;
constitutional scholars
http://www.pharmalot.com/wp-content/uploads/2008/08/constitutional-administrative-scholars.pdf;
Senior Citizens League
http://www.pharmalot.com/wp-content/uploads/2008/08/senior-citizens-league-amicus.pdf;
National Conference of State Legislatures
http://www.pharmalot.com/wp-content/uploads/2008/08/ncsl-amicus.pdf;
New England Journal of Medicine editors
http://www.pharmalot.com/wp-content/uploads/2008/08/nejm-amicus.pdf;
the California Medical Association
http://www.pharmalot.com/wp-content/uploads/2008/08/cma-amicus.pdf;
AARP
http://www.pharmalot.com/wp-content/uploads/2008/08/aarp-amicus.pdf;

consumer activists
http://www.pharmalot.com/wp-content/uploads/2008/08/antidepressant-amicus.pdf;
trial lawyers’ association
http://www.pharmalot.com/wp-content/uploads/2008/08/aaj-amicus.pdf;
members of Congress
http://www.pharmalot.com/wp-content/uploads/2008/08/members-of-congress-amicus.pdf;
various unions
http://www.pharmalot.com/wp-content/uploads/2008/08/unions-phenergen-brief.pdf;
various economists
http://www.pharmalot.com/wp-content/uploads/2008/08/ecoomists-amicusdraft.pdf;
and various tort law professors
http://www.pharmalot.com/wp-content/uploads/2008/08/torts-professors-amicus.pdf.

And if this isn’t enough, you can sift through Levine’s brief
http://www.pharmalot.com/wp-content/uploads/2008/08/levine-brief-to-supremes.pdf,
an interview with Levine
http://www.pharmalot.com/2008/02/preemption-and-amputation-diana-fights-wyeth/,
the Wyeth brief
http://www.pharmalot.com/2008/05/wyeth-files-brief-for-levine-preemption-case/
and the brief filed by the US Solicitor General
http://www.pharmalot.com/2008/06/white-house-backs-wyeth-on-preemption/.

And if you look here
http://www.abanet.org/publiced/preview/briefs/nov08.shtml#wyeth you can read friend-of-the-court briefs filed earlier by PhRMA, BIO, the General Pharmaceutical Association, the US Chamber of Commerce, the American Enterprise Institute and the Washington Legal Foundation in support of preemption.

Filed under: Preemption Controversy, Supreme Court, , ,

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