Bribery, illegal human trials with defective device alleged in lawsuit.
Posted on behalf of D'Amico & Pettinicchi, LLC on Jul 13, 2015 in Medical Malpractice
A federal lawsuit filed in California [Muldoon v. Depuy Orthopaedics, et al., Case3:15-cv-02723 ] claims that DePuy and the patient's surgeon and the John Muir Medical Center conspired to run unauthorized clinical trials on patients without their consent. It alleges that, "[t]hrough kickbacks and financial inducements, DePuy convinced surgeons to research and experiment with the DePuy components on unwitting patients," and that, "[i]n doing so, DePuy and the surgeons they bribed prioritized their own profit over the health and safety of patients.”
The lawsuit specifically claims that, in 2007, Mr. Muldoon had hip replacement surgery with a medical device, the Pinnacle CoMplete Acetabular Hip System, that had not been approved by FDA. It further alleges that the surgeon used that device because he had been bribed by DePuy. The complaint goes on to explain that the hip failed almost immediately, causing pain that all manner of therapies could not relieve, and that, in 2014, a blood test showed high levels of toxic cobalt and chromium in his body.
FDA did eventually approve the DePuy hip replacement system at issue in 2011 (approval was sought in 2009, two years after Mr. Muldoon's surgery), but in 2013 DePuy discontinued the product, attributing the decision to low sales. The California lawsuit states that "[t]he true reason DePuy discontinued sales of the CoMplete Acetabular Hip System is because the ceramic-on-metal system is defective and unsafe for consumers."
The allegations in this lawsuit are sadly reminiscent of the Synthes Norian bone cement debacle which also arose out of secret, illegal human testing of a medical product with grave consequences for the patients. [ http://goo.gl/aP52qa ] (Johnson & Johnson, the parent company of Depuy Orthopedics,the manufacturer of the ceramic-on-metal hip replacement at issue in the California lawsuit, acquired Synthes in 2012.)
If the claims are true, it is yet another disturbing reminder of the need for effective punitive damages laws to protect Connecticut citizens against this type of egregious conduct by corporations so large they are often, in effect, otherwise above the rule of law. [For more on that, see http://goo.gl/pFThmQ ]
Looking forward to an important Connecticut Supreme Court decision related to these issues in the coming weeks ... stay tuned!