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TMCNet: Solicitor General Sides with Wyeth, FDA on Preemption

[June 06, 2008]

Solicitor General Sides with Wyeth, FDA on Preemption

(BioWorld Today Via Acquire Media NewsEdge) Washington Roundup

WASHINGTON - U.S. Solicitor General Paul D. Clement filed an amicus brief with the Supreme Court supporting drugmaker Wyeth's argument that FDA approval preempts the right of a consumer to sue a manufacturer in state court if a drug or device later causes injury.

The solicitor general determines the cases in which Supreme Court review will be sought by the federal government and the positions it will take before the court, conducts oral arguments and determines whether the government will participate as an amicus curiae or intervene in cases in any appellate court.

The high court is set to hear the case in October of Wyeth v. Diana Levine, a Vermont woman who alleged she lost her arm from adverse events tied to Madison, N.J.-based Wyeth's nausea and motion sickness drug Phenergan (promethazine).

Consumer advocates have argued that a ruling in favor of Wyeth would shield drugmakers from the responsibility of ensuring their products are safe and would weaken manufacturers' economic incentive to take corrective actions.

Levine, who was awarded more than $6 million in her state court claim against Wyeth, said she was administered Phenergan at her local hospital emergency room. The product normally is administered intramuscularly, but hospital staff used a method called I.V. push of injecting the drug into her vein, which resulted in an inadvertent arterial injection.

Levine, a guitar player, developed gangrene in her arm, which resulted in it being amputated.

Due to the frequency of severe injuries linked to inadvertent arterial injection, some hospitals have banned Phenergan.

The drug's labeling in 2000 - the year Levine's adverse event occurred - warned that Phenergan should not be given by intra-arterial injection because of the risk of gangrene. However, Levine has contended that Phenergan's labeling failed to adequately warn about the dangers of using the I.V. push method.

The FDA has sided with the drug industry on the preemption doctrine, arguing that the Food, Drug and Cosmetic Act preempts tort claims. The agency in 2002 started becoming more aggressive in filing amicus briefs on behalf of medical product makers.

The FDA in its 2006 physician labeling rule asserted ways in which state tort judgments could interfere with the agency's implementation of federal law.

The Supreme Court in February in Riegel v. Medtronic Inc. ruled that federal regulations preempt lawsuits in state courts against medical device manufacturers, unless a company violates duties imposed by the FDA.

Reps. Henry Waxman (D-Calif.) and Frank Pallone (R-N.J.) are proposing legislation that, if enacted, would cause the Supreme Court's ruling to be moot. (See BioWorld Today, May 15, 2008.)

Senator Probing FDA's Dog Drug Decision

Sen. Charles Grassley (R-Iowa), ranking member of the Senate Finance Committee, said he is probing the FDA's decision to allow the canine heartworm drug ProHeart 6 (moxidectin) back on the U.S. market.

The drug was yanked off the market in September 2004 by Overland Park, Kan.-based Fort Dodge Animal Health, a division of Wyeth Pharmaceuticals, after it was linked to hundreds of serious adverse events in dogs, including death.

The FDA said Thursday that it was granting a limited return to the market of a reformulated version of the heartworm-prevention drug.

ProHeart 6 sustained-release injectable for dogs will be marketed to the veterinary community under a risk minimization and restricted distribution program, regulators said, noting that ProHeart 6 is the first veterinary drug to be marketed under such a restrictive program normally reserved for human drugs with known serious risks.

Grassley said his investigation has revealed that the FDA forced safety officer Victoria Hampshire from her job after she raised concerns about ProHeart 6. He also suggested that Wyeth and its subsidiary had hired a private investigator to discredit Hampshire.

The Iowa Republican is seeking the identities of FDA officials involved in meetings or telephone conversations with the drugmaker concerning the return of ProHeart 6 to the market and the agendas and minutes of those meetings.

The lawmaker also is demanding to know on which studies, if any, the FDA has based its decision to return the drug to the market. n

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Copyright ? 2008 Thomson BioWorld, All Rights Reserved.

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