Pharmaceutical

Lawyers ask FDA to investigate DePuy after alleged wrongdoing surfaces in ASR hip trials

depuy logo Lawyers ask FDA to investigate DePuy after alleged wrongdoing surfaces in ASR hip trialsLawyers representing patients allegedly harmed by metal-on-metal hip implants have called upon the U.S. Food and Drug Administration (FDA) to investigate allegations of wrongdoing in DePuy Orthopedics, a division of Johnson & Johnson that manufactured and sold and subsequently recalled tens of thousands of defective metal ASR hips.

The lawyers say new evidence emerged in testimony given during the first two bellwether personal-injury trials indicating DePuy broke federal laws when it concealed information that could have spared thousands of patients from injuries allegedly brought about by its ASR metal hip implants. That evidence had been sealed by court order until the recent trials.

“We write to request that the FDA conduct an immediate and thorough investigation,” the lawyers said. “We believe almost all of these injuries would have been avoided had DePuy complied with the reporting requirements and informed your agency about the adverse events and concerns about the safety of the ASR which came to the company’s attention.”

DePuy recalled its all-metal ASR hip devices in August 2010, but the lawyers said that the manufacturer knew for years leading up to the recall that the implants were defective and injuring patients. They pointed to evidence that DePuy engineers called for  a redesign of the devices in 2007, but those concerns were never acted upon, nor were they shared with the FDA, as required by law, or with physicians and their patients, the lawyers claim.

Moreover, the lawyers said DePuy’s internal documents that were released during the trials show company officials projected that more than one-third of ASR patients would require a revision surgery within five years to correct failed implants and other problems, such as bone and tissue decay, pain and inflammation, and illnesses associated with metal poisoning.

Other evidence uncovered in the two trials, the lawyers said, demonstrates that DePuy rushed its ASR devices to market without adequate testing, shrugged off negative post-market reports of ASR complications, and concealed and covered up physician complaints about the devices from physicians.

Source:

Law 360