Friday, February 1, 2013

Jury told medical-device firm unit had "inappropriate" risk controls regarding hip implants.

In continuing coverage on claims alleging Johnson & Johnson's DePuy unit failed to warn consumers that its ASR hip implants were defective, Bloomberg News (2/1, Possley, Voreacos, Feeley) reports DePuy's Compliance Manager Jimmy Smith on Thursday told a California jury that the company "took 'inappropriate' steps to identify and eliminate risks in the design of 93,000 all-metal hip implants" that J&J recalled in August 2010. Smith, who "oversaw a 2011 review of a design team's safety standards for the ASR hip cup," said his audit "found that a DePuy group used irrelevant controls in a so-called failure mode and effect analysis, or FMEA, before the ASR was sold in 2005 in the US." In fact, the audit discovered numerous FMEAs were assessed using controls that were either inappropriate or extraneous, Smith admitted during his testimony at the state court in Los Angeles.
        The New York Times (2/1, B2, Meier, Subscription Publication, 1.68M) adds that also on Thursday, DePuy engineer Graham Isaac told the jury that before putting the ASR on the market, the company conducted a performance tests on "laboratory equipment at one angle of implantation"; and because the product design was flawed, "normal variance" from the angle that was tested increased the likelihood for the "joint's cup and ball components to strike each other, releasing metallic debris inside a patient." Moreover, Smith testified that DePuy never released a summary of a "post-mortem review" of the ASR that it conducted in November 2010 and neglected to perform a similar analysis "in response to the mounting number of complaints about the device that it received from doctors and others in 2008 and 2009."

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