Louisiana Accident Attorney Blog

Here's an interesting press release we sent out:

Eight years ago, Diane Levine was a successful musician, never once thinking that a personal tragedy would catapult her into the national spotlight. She is now the face behind the Wyeth v. Levine Supreme Court case, a landmark preemption suit that may set new precedent in the public’s right to seek damages when injured by pharmaceutical products.

In 2000, Levine, a renowned guitarist, was treated in a Vermont emergency room for migraines, a condition that had plagued her for years. Many times before, Levine entered the hospital, was treated with a pain killer and anti-nausea drug, and sent well on her way. But this time, the way the drugs were administered was different. Instead of a simple IV-drip, she received a dose of Phenergan by “IV push.” The resulting effects of this method injured an artery, caused gangrene and resulted in Levine losing both her arm and career.

Wyeth, the maker of the drug, had known for decades about the serious risks associated with the method used to administer its drug. Levine took Wyeth to court and a jury awarded over $7 million in damages. Wyeth appealed, and the U.S. Supreme Court heard arguments yesterday.

At issue is the hot-button “preemption” topic, the legal notion that that FDA’s approval of a drug supersedes claims challenging its safety, efficacy or labeling. Pharmaceutical companies argue that preemption ensures that the FDA’s actions are the last word on a drug’s safety and effectiveness.

Local attorney, Richard J. Arsenault, has been involved in a variety of national pharmaceutical litigation including Vioxx, and has seen first-hand the FDA at work.

“The current regulatory environment is unquestionably broken and no longer provides the safeguards for which it was designed. The rigorous review and stringent enforcement simply does not exist. Rather, we have a system plagued by underfunding and organizational problems,” says Arsenault.

Today’s arguments raised questions from Justice Samuel A. Alito Jr. who questioned how the Food and Drug Administration could have approved the anti-nausea drug, Phenergan, as "safe and effective" when "you have the risk of gangrene."

Justice Anthony M. Kennedy took issue with Wyeth's argument that it could not have followed the Vermont law under which Levine sued without violating the federal law that regulates drug labeling. "As a textual matter, as a logical matter, as a semantic matter, I don't agree with you," Kennedy told a Wyeth attorney.

It isn’t just the trial bar that objects to preemption. Six current and former editors of the New England Journal Of Medicine recently and publicly attacked the concept of preemption. These renowned healthcare providers recognize that the FDA is not up to the task of being the sole protector of American patients.

“Immunizing manufacturers through preemption would result in a troubling restructuring of our civil justice system. Since the regulatory process is incapable of adequately protecting the public and the FDA’s enforcement powers are largely illusory, manufacturers should not be immunized by preemption,” Arsenault added.