A jury in California on Mar. 8 ordered DePuy Orthopaedics to pay over $8.3 million to a man who says the Johnson 
& Johnson subsidiary knowingly made and marketed a faulty hip replacement device.
Mixed Verdict
In the trial, which began in January, Loren Kransky alleged that the DePuy Articular Surface Replacement (ASR) he received was defective and that the company failed to warn its users that the metal ball and socket could grind against each other and release toxic metal into the body.
The jury agreed with Kransky, a retired prison guard who has terminal cancer, that the ASR was a defective device, awarding him $338,000 for medical expenses and $8 million for pain and emotional suffering, according to The New York Times. It sided with DePuy on the failure to warn claim and refused to award punitive damages.
“There are currently thousands of pending DePuy ASR hip implant lawsuits,” according to Kransky’s lawyer’s firm, Walkup, Melodia, Kelly & Schoenberger in San Francisco. “This verdict will be a great help to all future plaintiffs.”
“We plan to appeal the jury’s decision on design defect pending the outcome of post-trial motions,” said DePuy spokesperson Lorie Gawreluk in a statement. “[W]e have a number of valid grounds for appeal, notably that the court didn’t let the company tell the jury about the Food and Drug Administration’s review and clearance of the device.”
But that’s probably not a valid argument, according to plaintiff’s lawyer Andres Alonso with Alonso Krangle in Melville, N.Y. The judge likely refused to let the jury consider the FDA’s clearance because it is not related to whether the product was defective or the defendant failed to warn users adequately.
“The mere fact that the FDA has ‘cleared’ the product is largely irrelevant to these issues and would likely serve to confuse the jury and distract them,” Alonso explains. “The lack of relevance is especially clear when one considers . . . the fact that the product was recalled notwithstanding FDA ‘clearance.’”
Clear Evidence
The mixed verdict in Kransky’s case is due to stronger evidence tied directly to the plaintiff on the defective product claim. “The key to proving a design defect case like this is the data on the defendant’s product,” says Ben Gordon, a partner with Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A., in Pensacola, Fla.
“Here, the evidence showing that the DePuy ASR is the ‘worst in class’ of all metal-on-metal hip devices is simply overwhelming,” adds Gordon, who runs his firm’s DePuy Hip Implant department and is a member of the Plaintiffs’ Executive Committee for the multidistrict litigation against the company in Ohio federal court.
“Everywhere one looks they are confronted with astonishing evidence of how badly this device performed in the field, including in Joint Registries around the world, implanting surgeons’ clinical experience, and in DePuy’s own internal data assessments and tribological testing,” Gordon says.
Metal-on-metal implants like the ASR are “rarely” used today, according to The New York Times, because of problems with the device creating metallic debris in the body. Forty percent of patients who got the ASR will have to have it replaced within five years, according to J&J documents introduced at trial; metal-on-plastic implants can last for more than 15 years.
Other documents introduced at trial showed that DePuy executives were told by consultant-surgeons that the design of the ASR was flawed, according to Alonso’s firm. “Some surgeons even went so far as to urge Johnson & Johnson to slow sales of the implant or stop them completely.”
Kransky’s loss of the failure to warn claim “was likely the result of the ‘learned intermediary doctrine,’” says Alonso. “In such a situation the issue is not whether the patient himself received the appropriate warning, but rather whether the physician received the appropriate warning.”
Alonso says he expects the verdict for Kransky to be upheld on appeal.
“This case is hugely important because it is the first ASR case to go to trial,” he adds, “and it communicates a clear message to the defendants that their conduct was wrong and that the suffering they have imposed upon people like Mr. Kransky will not be allowed to stand without substantial compensation.”
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