A federal appeals court has reinstated negligence and product liability claims against Smith & Nephew by a patient whose hip replacement surgery had to be undone after complications arose.
Charges against artificial hip maker not pre-empted by federal law
6/26/2017 2:28:00 PM
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.
Source: Charges against artificial hip maker not pre-empted by federal law | Business Insurance
Ken Henshaw said:
Ken Henshaw 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.” The fact that they rushed their products to market to get the jump on the competition they threw caution to the wind and after discussions with the FDA and the 5 largest device manufacturers, the plan was with the FDA approval, the use of the totally moronic 501-K clause would give these 5 banditos all the protection that they needed. The CEO of the FDA and the CEO’S from the manufacturing device manufacturers must have had their heads planted firmly up their ASSES you would have to have the brain the size of a fruit fly to not be able to forecast the horror that was eventually unleashed on the clients that needed hip replacement surgery. Dam you guys are house brick stupid and you will pay for your rather abundant use of your stupidity, myself and thousands of other people that you have injured will rally up against you. It will be interesting to see who will become the last ASS hole standing I
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Judi Elliott About time!
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