Grassley, Kohl and Blumenthal
Three U.S. senators are probing med-tech titans on recent high-profile recalls, including Medtronic’s (NYSE:MDT) 2007 Sprint Fidelis recall and Johnson & Johnson’s (NYSE:JNJ) more recent metal-on-metal hip implant woes.
Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.) sent investigative letters to 5 device makers, asking them about their post-market surveillance and recall management practices.
The trio asked Medtronic to dish on its precedent-setting Fidelis recall, which was implicated in more than 100 deaths (Medtronic has said that only 13 fatalities had the leads as a "possible or likely contributing factor"). Fidelis was the company’s top product at the time.
The Fidelis recall became the poster child for medical devices gone bad, eventually taking center stage at the U.S. Supreme Court in Riegel v. Medtronic. In that case, the Supremes held that once a medical device has been approved by the FDA, product liability lawsuits based on state tort laws have no standing — in other words, the federal approval preempts state law.
The Senators also asked Johnson & Johnson to provide details on subsidiary Depuy Orthopaedics’ metal-on-metal hip implants, which were found to shed minute metal particles into patients’ bloodstreams. The recall, which spawned its own raft of lawsuits, is on track to be costliest device recall since Fidelis, with up to $1 billion in liability and other costs.
Also asked to participate was Boston Scientific Corp. (NYSE:BSX), which issued a shipment hold on many thousands of potentially defective pacemakers and defibrillators last year, made by its recently acquired subsidiary Guidant Corp.
The panel also wants answers from C.R. Bard (NYSE:BCR), which recently found itself at the center of debates and a patient lawsuit claiming that transvaginal mesh products made by it and other companies were defective and caused severe injuries to patients; and Zimmer Holdings (NYSE:ZMH), which recalled its NexGen knee implant, over which it faces 28 product liability lawsuits of its own.
The letters went out as the trio introduced legislation in the Senate calling for increased safety measures for medical devices. The bill would beef up the FDA’s safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials.
