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Charges against artificial hip maker not pre-empted by federal law

Charges against artificial hip maker not pre-empted by federal law

A federal appeals court has reinstated negligence and product liability claims against a medical device manufacturer by a patient whose hip replacement surgery had to be undone after complications arose.

London-based Smith & Nephew Inc. develops and manufactures joint replacement systems including the Birmingham Hip Resurfacing System, which is a metal-on-metal hip replacement system that requires premarket approval from the Food & Drug Administration before it can be made commercially available, according to Monday’s ruling by the 11th U.S. Circuit Court of appeals in Atlanta in Joseph Mink v. Smith & Nephew Inc.

The FDA approved the system in May 2006, but set conditions including that it conduct a post-approval study to be sure of the device’s safety and effectiveness over time, the ruling said.

Mr. Mink, who needed a hip replacement, was told that if he participated in S&N’s 10-year post-approval study, he would be regularly monitored and tested for 10 years at no cost.

Seven weeks after he had the surgery in June 2011, the doctor who performed it said he was moving and could no longer see Mr. Mink. He referred him to another physician, who told Mr. Mink he had never heard of him, nor of his participation in the study.

In May 2012, S&N told Mr. Mink it could not find a clinical site for him to continue to patriciate in the study, and terminated him from it.

As time passed, Mr. Mink experienced blood toxicity from the chromium and cobalt leaching from the system, eye problems and an enlarged lymph node near the site of his hip replacement. He had to have the system removed in November 2014.

Mr. Mink filed suit against S&N in U.S. District Court in Miami on claims of neglect, product liability, breach of contract and misrepresentation. The court dismissed all the charges.

On appeal, a unanimous three-judge appeals court panel reinstated Mr. Mink’s negligence and product liability claims. S&N had argued Mr. Mink’s claims were barred under Florida state law and expressly or impliedly pre-empted by federal law, said the ruling.

In reinstating the negligence claim on the basis of the manufacturing defect, the ruling said: “The duty of a manufacturer to use due care in manufacturing a medical device predates” the (federal) Medical Device Amendments (of 1976) and is a duty that S&N owes Mr. Mink (as opposed to the FDA). The theory of liability is therefore not impliedly pre-empted by federal law.”

On the strict product liability claim, the ruling said: “Mr. Mink says the BHR system he got was manufactured with material that did not meet the FDA’s requirements for hardness, durability, composition, and finish. He says these defects were the proximate cause of his injuries.

“Florida law allows this claim because it recognizes that manufacturers may be held strictly liable for an injury to the user of its product.”

The panel upheld dismissal of Mr. Mink’s remaining claims. The case was remanded for further proceedings.




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