U.S. Supreme Court Decides Wyeth v. Levine, Holding There Is No Federal Pre-emption
The U. S. Supreme Court has issued its long-awaited decision in Wyeth v. Levine, according to Bloomberg News, And the news is not good for Wyeth.
The Court held that: “Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV push method of administration.” That’s a summary. The decision runs some 80 pages. (Thanks to colleague Tom Valet for emailing it to me.)
Bloomberg reporter Greg Stohr’s lead in to his story sums up the decision’s impact nicely. “The U.S. Supreme Court said patients can sue drugmakers for failing to provide adequate safety warnings, upholding a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.”
Speaking stricly to my fellow lawyers, the true impact of this case is, of course, that similarly situated victims of inadequate drug warnings will now be able to initiate actions against the drug maker in state court. They are not pre-empted from suing simply because a drug’s labeling has been approved by the FDA.
This is good news for medical consumers, who have come to see that FDA “approval” of anything does not mean very much anymore.
More Transparency, Fewer Kickbacks for Doctors
In today’s NY Times, Gardiner Harris reports on renewed interest by federal prosecutors in going after doctors who accept illegal kickbacks from drug and device manufacturers in return for using their products. The Department of Health and Human Services is concerned about “marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients,” according to Mr. Harris. Doctors could face loss of their licenses, fines and jail time for violations.
The federal prosecutors vow to bring greater transparency to the public about the nature of consulting relationships between doctors and drug and device companies, which will not only curb illegal agreements enriching doctors, but will (hopefully) restore the public’s trust in such relationships, and the products produced as a result of them.
Medical Malpractice Milestones
- 25 years after the death of Libby Zion at New York Hospital, a physician reflects on the changes in how residents are trained–changes largely brought about by the scrutiny invited by the tragic facts of Ms. Zion’s case.
- The statute of limitations for medical malpractice lawsuits may be increased, and New York’s Medical Society is in Albany today to voice its concerns. Currently two and one half years from the time of the malpractice, state law makers are considering a so called “data discovery” law that would allow potential plaintiffs to initiate a suit whenever the effects of the malpractice manifest themselves.