CNBC has an interesting story about how doctors believe lawsuits serve as a “vital deterrent” to protect consumers from unsafe drugs. Lawsuits protect consumers if drug companies do not disclose risks to the U.S. Food and Drug Administration before it approves medicines for use, the editors of the New England Journal of Medicine said in a friend-of-the-court brief to the Supreme Court. The FDA “is in no position” to guarantee drug safety, the brief said.
Although the FDA is considered by many “the gold standard” in drug evaluation, the journal editors urged the justices to be skeptical.
“The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,” the doctors said in a brief filed Thursday. Without the discoveries dredged up by plaintiffs’ lawyers through liability litigation, “the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”
The medical editors joined 47 state attorneys general and two former FDA commissioners, David Kestrel and Donald Kennedy, in supporting Levine’s position. Kestrel served in the administrations of former President Bill Clinton, a Democrat, and Republican President George H.W. Bush. Kennedy served in Democratic President Jimmy Carter’s administration.
The case is being closely watched because the Supreme Court ruled this year that manufacturers of FDA-approved medical devices were shielded from litigation in state courts.
However, David Vladeck, a lawyer representing Kessler and Kennedy, said the statute that applies to medical devices is different from the law that governs medications.
“The law in the (devices) case had a pre-emption provision,” said Vladeck. “Congress has never put a pre-emption provision in the Food and Drug Act.”
The Bush administration is supporting Wyeth’s position.
It is ridiculous that drug manufacturers get immunity for dangerous medications when they refuse to disclose all the test results or when they knew of damgerous side effects but did not disclose it to the FDA. The FDA rubber stamps most medications and does not do a thorough job of making sure medications are safe for use.