A federal appeals court has reinstated product liability litigation filed by a plaintiff against a hip implant manufacturer who charged the company failed to warn the U.S. Food & Drug Administration of problems with its implants.
Lori Spellman filed suit against Smith & Nephew Inc., a subsidiary of the London-based Smith & Nephew Group, in U.S. District Court in Phoenix in April 2016, charging that her hip implants, which had been manufactured by the company, were defective, according to the ruling by the 9th U.S. Circuit Court of Appeals in San Francisco in Lori Spellman v. Smith & Nephew Inc., a Tennessee Corporation.
Her lawsuit said the implants were designed and/or manufactured in violation of the federal Food, Drug and Cosmetics Act and its regulations.
The District Court dismissed the case, which was reinstated by a unanimous three-judge appeals court panel. “Spellman’s proposed amended complaint sufficiently alleges a failure-to-warn claim under Arizona law,” said the ruling.
“Insofar as the state-law a duty to warn parallels a federal law duty under the Medical Device Amendments to the Food, Drug and Cosmetics Act…that claim is not pre-empted.”
The ruling said Ms. Spellman’s allegation that the company had become aware of defects in its system, which neither Ms. Spellman nor her doctor knew about, “plausibly suggested entitlement to relief on the claim that Smith & Nephew failed to warn the FDA of problems with the implant.”
The case was remanded to the lower court.
In April, Johnson & Johnson secured a favorable U.S. appellate court ruling, overturning a verdict that had awarded $151 million to five people who blamed injuries they suffered on the company's Pinnacle hip implant devices.
(Reuters) — Johnson & Johnson will pay more than $4 billion to settle thousands of lawsuits over its recalled defective hip implants, Bloomberg reported late on Tuesday, citing three people familiar with the deal.