Replies to post #73954 on Biotech Values

[DewDiligence]

This federal preemption case is similar to WYE v. Levine,
although it has nothing to do with drugs or medical products.

http://online.wsj.com/article/BT-CO-20090420-709427.html

›US Supreme Court Won't Hear Tuna-Mercury Case

By Brent Kendall
APRIL 20, 2009, 10:15 A.M. ET

WASHINGTON (Dow Jones)--The U.S. Supreme Court on Monday left in place a lower court ruling that allowed a New Jersey woman to sue a tuna-fish producer over the mercury poisoning she allegedly suffered after her diet consisted almost exclusively of canned tuna for five years.

The woman, Deborah Fellner, said Tri-Union Seafoods LLC, the maker of Chicken of the Sea brand tuna, failed to warn her of the risks of consuming tuna fish.

Tri-Union said U.S. Food and Drug Administration regulations prevented it from placing a mercury warning label on its products. The company said that Fellner's suit should be thrown out because it conflicted with the FDA's regulatory regime.

A federal trial judge had tossed Fellner's lawsuit, but an appeals court in Philadelphia reinstated it, saying the FDA had taken no regulatory action that preempted her legal claims.

The Supreme Court rejected Tri-Union's request that it review the case. Instead, the justices let the lower court ruling stand without comment.

Tri-Union argued that the appeals court ruling put it in the untenable position of facing legal liability under state law for not including a warning label that would have rendered its products misbranded under federal law.

Among other things, the company pointed to a 2005 letter the FDA sent former California Attorney General Bill Lockyer, who was attempting to sue Tri-Union for not placing a warning label on its products. The FDA told Lockyer that such warning labels were preempted by federal law. The agency said it had analyzed the issue for several years and decided not to require mercury warning labels on seafood products.

Fellner said the FDA's actions on mercury in seafood were informal in nature and not strong enough to preempt her legal claims.

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In other Supreme Court action Monday, the justices refused to review a federal appeals court ruling that allowed shareholders to bring a class action securities-fraud lawsuit against Gilead Sciences Inc. (GILD) for allegedly concealing a fraud related to the company's key HIV drug Viread in 2003.

The plaintiffs alleged that demand for the drug was artificially inflated because Gilead was secretly and illegally marketing the drug for uses not approved by the FDA. Gilead said the plaintiffs' could not show that any decrease in the company's stock price was connected to the alleged fraud.‹

[DewDiligence]

US Supreme Court to hear ‘federal preemption’ case on vaccines:

http://online.wsj.com/article/SB10001424052748704869304575109482063466178.html

The case, Bruesewitz v. Wyeth, involves a lawsuit in Pennsylvania state court in which parents alleged that their 6-month-old daughter developed residual seizure disorder after receiving a diphtheria, tetanus and pertussis vaccine manufactured by Wyeth, now a unit of Pfizer Inc. Wyeth denies that its vaccine caused the injuries.

The case is the latest in which the Supreme Court will decide whether federal laws pre-empt state regulation on medical matters. The justices have found that a federal law pre-empts suits against medical-device manufacturers filed under state liability statutes, but different language applying to drugs permits similar claims against pharmaceutical companies.

The Third U.S. Circuit Court of Appeals in Philadelphia ruled last year that the vaccine lawsuit was pre-empted by the National Childhood Vaccine Injury Act of 1986. That law created a national compensation program for vaccine-injury claims, but it also gave vaccine makers protection from some lawsuits.

The law said a manufacturer could not be sued if a vaccine-related injury resulted from side effects that were unavoidable even if the vaccine was made properly and accompanied by proper directions and warnings.