A purported class action lawsuit accuses a Johnson & Johnson (NYSE:JNJ) subsidiary, a California hospital and an orthopedic surgeon of conducting unauthorized clinical trials without patients’ consent and alleges that the lead plaintiff was implanted with a group of unapproved hip implant components.
The June 17 lawsuit, filed in the U.S. District Court for Northern California, stems from the group of ceramic-on-metal hip components made by J&J subsidiary DePuy Orthopaedics that were implanted in John Muldoon in 2007. After years of alleged pain and discomfort, Muldoon had revision surgery in 2014, replacing the ceramic-on-metal device with a ceramic-on-plastic hip. Muldoon alleges that, although all the components won individual 510(k) clearances, they were never approved for use as a group.
“At the time of plaintiff’s 2007 surgery, the FDA had not approved any ‘ceramic-on-metal’ bearing surface combinations for hip replacement surgeries,” according to the lawsuit [emphasis theirs]. “DePuy did not file a pre-market approval application or start the required 2-year randomized clinical trial for any ceramic-on-metal bearing system until 2009, 2 years after plaintiff had the components surgically implanted.”
The FDA approved the Pinnacle Complete device in June 2011, making it the 1st ceramic-on-metal hip to hit the U.S. market. But 2 years later DePuy shelved the device, citing low sales. Muldoon’s lawsuit alleged that “the true reason DePuy discontinued sales of the Complete acetabular hip system is because the ceramic-on-metal system is defective and unsafe for consumers.”
Muldoon also alleged that DePuy paid kickbacks to Dodgin in exchange for “using a non-FDA approved configuration of DePuy products.”
The lawsuit further claims that DePuy; Muldoon’s original surgeon, Dr. David Dodgin; and the John Muir Medical Center in Walnut Creek, Calif., conspired to run unauthorized clinical trials on “unwitting” patients.
“DePuy and Dr. Dodgin conspired to research and experiment with the use of DePuy components on patients, such as plaintiff, without their knowledge and consent,” the lawsuit alleged. “Through kickbacks and financial inducements, DePuy convinced surgeons to research and experiment with the DePuy components on unwitting patients. In doing so, DePuy and the surgeons they bribed prioritized their own profit over the health and safety of patients.”
The lawsuit seeks class status for patients implanted with ceramic-on-metal hip configurations made by DePuy, compensation for “all economic and non-economic losses” including medical expenses, loss of earnings, disfigurement, pain & suffering, mental anguish and emotional distress, punitive and/or exemplary damages, pre- and post-judgment interest and legal costs.