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San Francisco Personal Injury Attorney Analyzes DePuy Lawsuits And Preemption.

DePuy Hip Implant Claims & Federal Preemption

November 23, 2011

Since DePuy’s recall of its ASR hip replacement system, thousands of product liability lawsuits have been filed against the company.

These claims are based on design defects and state tort laws and have been filed by personal injury attorneys on behalf of victims and patients. The defense would like nothing better than to assert that these claims are preempted by federal law. That is, that federal law supersedes and trumps any state law claims asserted by the plaintiffs. But this is simply not the case. And, though we have addressed this issue before here on Legal BLog (see DePuy Hip Replacement Lawsuits, Preemption, And Pliva, Inc. v. Mensing), it’s worth a second, though brief, take.

Preemption is a legal doctrine whereby federal law displaces overlapping or related state law. Preemption can be either express or implied. In the context of a Class III medical device (DePuy’s hip replacement system) the applicable federal law is the Medical Device Amendments of 1976 to the federal Food, Drug, and Cosmetic Act. 21 U.S.C. Sec. 360 et seq.

DePuy took advantage of the 501(k) process under this law to market its hip replacement system to the public (See DePuy Hip Implant Defects & The 510(k) Process). As the Supreme Court in its majority decision as well as the dissent made clear in Medtronic v. Lohr, and was confirmed by the majority in Riegel v. Medtronic, Inc., the 510(k) process does not place “requirements” on a device; “substantial equivalence” is not a safety requirement but an exemption from it.

Without a federal requirement there can be no preemption of state law tort claims. The “sameness” analysis that was employed in Pliva, Inc. v. Mensing does not apply because, besides the fact that drugs and devices and the jurisprudence that governs them are very different, the requirement that a generic drug and a brand name drug be the same is a “requirement” under the FDCA regarding safety and “substantial equivalence” is not.

We could go on regarding the inapplicable nature and just plain rottenness of preemption in the DePuy hip replacement lawsuits, but we won’t. Here is hoping everyone enjoys Thanksgiving as much as we will and that the University of Texas beats the hell out of A&M.