Pharmaceutical

Lawyers say Medical Device Makers Pushed Metal-on-Metal Hip Implants ‘Aggressively’

17HIP2 articleInline Lawyers say Medical Device Makers Pushed Metal on Metal Hip Implants AggressivelyDuring opening arguments in an multidistrict litigation(MDL) trial over allegedly faulty metal-on-metal hips made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, six plaintiffs say the manufacturer pushed their product “aggressively,” despite knowing that the metal-on-metal design was riskier than others that were available.

The complaint alleges DePuy went as far as paying kickbacks to willing surgeons to encourage use of their hip implant, selling 150,000 of them in the 2000s. The hip device managed to evade standard regulatory review by going through a 510(k) FDA approval, which allows a device to be sold on the market as long as it is similar to a model previously sold. In one case the similar model that provided the fast-track FDA approval was one that predated 1976 regulations regarding premarket review and approval.

This bellwether trial is the third in an 8,500-case MDL, following behind a $500 million verdict that was reduced to $150 million under a Texas legal punitive damages cap. This time, however, the trial is under California law, not subject to the same cap.

All six patients in the bellwether have undergone revision surgeries after receiving DePuy’s metal-on-metal hips. The device has been known to cause friction between the metal ball and metal socket, which can result in the device flaking off billions of microscopic debris particles with normal use. The particles can pollute the bloodstream and damage the surrounding tissue.

“It’s common sense that you don’t rub metal against metal without there being adequate lubrication,” the lead plaintiff attorney said. “They never solved any of the metal-on-metal problems. But they went to market anyway. … The only test patients [were] the people that [got] it put in.”

Source: Law360