Supreme Court Rules Against Wyeth

(WSJ) By a vote of 6-3, the Supreme Court just ruled against Wyeth in a case closely watched by the drug industry.

The case, Wyeth v. Levine, turned on the concept of “pre-emption,” which says basically that federal regulations should trump state actions. Wyeth had argued that because the federal government (via the FDA) regulates drugs, patients shouldn’t be allowed to sue in state court when drug makers follow the rules established by the FDA.

The court rejected that argument. “We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations,” Justice Stevens wrote the majority opinion, which was joined by Kennedy, Souter, Ginsburg and Breyer.

Thomas wrote a concurring opinion, while Roberts, Alito and Scalia dissented.

Read the ruling

We'll have more coverage soon.

While this is great news for the American public and plaintiffs lawyers, lawmakers are trying to overturn last year's medical device preemption ruling in favor of Medtronic.

Also a federal judge in Minnesota has dismissed scores of patient lawsuits against Fridley-based Medtronic relating to a massive medical device recall in 2007.

  In an order issued this week, U.S. District Judge Richard Kyle expressed sympathy for plaintiffs who received the recalled device -- a lead wire called Sprint Fidelis that is used with Medtronic defibrillators -- but dismissed the lawsuits on grounds that federal law governing the design and labeling of medical devices blocked them.

Implantable defibrillators are pager-size devices that can shock failing hearts back into rhythm. The shock-generating portion of a defibrillator system is surgically implanted in the chest and connected to the heart by a thin wire called a lead.

In October 2007, Medtronic recalled the Sprint Fidelis lead because of the relatively high risk of fractures in the wire, which could result in patients receiving a painful series of unnecessary shocks or other malfunctions. Medtronic said the problem might have contributed to five deaths.

Kyle repeatedly cited the U.S. Supreme Court's decision early last year in the landmark case of Riegel v. Medtronic, in which the court ruled that patients should not be able to bring state-law claims against manufacturers alleging that products were defectively designed or didn't carry appropriate warnings about risks.

Such lawsuits should be blocked, the Supreme Court ruled, when they would subject manufacturers to a regulatory scheme

that conflicts with or goes beyond that provided by federal law and carried out by the U.S. Food and Drug Administration.

It's been discovered, however, that the judge's son works for a lawfirm that represents Medtronic causing many to shout "bias"!

Scott Drake discusses these developments with Jan Schilchtmann.