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WI Hops on the Pre-Emption Bandwagon

By Eric M. Knobloch • Feb 18th, 2009 • Category: Civil Litigation, Newest Post, Personal Injury Law

Yesterday, the Wisconsin Supreme Court ruled that injured Wisconsin residents cannot sue the makers of defective medical devices that are previously approved by the Food and Drug Administration. (cite is 2009 WI 19)  This decision, which follows U.S. Supreme Court precedent in Reigel v. Medtronic, Inc., 128 S. Ct. 999 (2008), holds that state law claims of negligence and products liability are pre-empted by Federal law.  Practically speaking, these decisions shield medical device manufacturers from liability as soon as their product is deemed safe by the FDA, even if the manufacturers later become aware of defects and continue to push the product on the market.  Huge win for big medicine, big loss for the average consumer.

However, the WI decision should not be a surprise to any lawyer.  When the U.S. Supreme Court directly addresses an issue and rules concisely in one direction, no one should expect a state to head the other direction.  Some members of the Court feel the Courts’ hands were tied:

Two concurring justices — Walsh Bradley and Chief Justice Shirley Abrahamson — criticized the U.S. Supreme Court decision but said they must follow it. The decision leaves Wisconsin residents’ safety in the hands of the flawed FDA, Walsh Braldey wrote.

She cited a letter from FDA scientists released last month that charged “the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.”

“It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices,” Walsh Bradley wrote.

Sometime this term, the U.S. Supreme Court is expected to rule on a similar pre-emption issue involving giant drug manufacturer Weyth.  A ruling in favor of Weyth would prevent patients injured by prescription drugs from holding manufacturers liable for putting dangerous products on the market if those products are previously approved by the FDA.

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Eric M. Knobloch is a Personal Injury Attorney with the Warshafsky Law Firm. Eric specializes in auto accidents, civil rights violations and premises liability. Eric can be reached by: Phone: 414-276-4970 E-mail: [email protected] Website: www.warshafsky.com Fax: 414-276-5533 Address: 839 N. Jefferson Street, Suite 300 Milwaukee, Wisconsin 53202
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One Response »

  1. Greetings from Michigan, the state which has had a full preemption shield law since 1995.

    We’ll see what happens with Levine, but the drug and device contexts are very different as are the laws under which they are regulated. So I think we can anticipate a narrower ruling in Levine than Riegel.

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