Medical Device Daily

Who's ultimately responsible when a medical device is faulty in a patient? The answer is everyone that has a hand in putting that device on the market, according to a panel during a webinar sponsored by SigmaQuest (Santa Clara, California) on Tuesday.

"If you're a component manufacturer, you're a player in this drama as well," Jon Nygaard an attorney with Wilson Sonsini Goodrich & Rosati (WSGR; Palo Alto, California) told the online audience. "Everybody in the chain is responsible."

The webinar was a chance for med-tech companies to learn of ways to steer clear of liability, a situation that can threaten to unravel the fabric of a company's core. This is the latest, in a series of webinars that SigmaQuest, a product performance intelligence company, has held.

NyGaard was joined by WSGR partner David Hoffmeister and SigmaQuest CEO Nadir Fati for the hour long discussion.

"There really has been an explosion of product liability litigation in the past few years," Hoffmeister told the audience. "We want to attempt to avoid or maybe help you avoid any product liability."

Hoffmeister said that part of the reason for the increase in cases is because federal pre-emption is waning while State jury's and courts are able to try product liability cases, when it is in fact a federal agency that gave the device approval in the first place.

"Right now if you go through the PMA route then you do have this benefit of federal preemption," he said. "But 98% of the devices that get on the market go through the 510(k) approval route. There are bills now that are currently trying to take away this preemption."

The bills stem from a Supreme Court decision in Reigel v. Medtronic which recently limited a patient's ability to sue device makers under state tort laws.

Almost immediately after the ruling, Sens. Edward Kennedy (D-Massachusetts) and Patrick Leahy (D-Vermont) introduced the companion bill to H.R. 6381, which seeks to reverse the Supreme Court's decision in Reigel, which confirmed preemption of state tort suits for FDA-approved medical devices.

But perhaps one of the largest med-tech cases in recent history that will define product liability cases stems from Boston Scientific (Natick, Massachusetts) and its purchase of Guidant three years ago.

In January 2006, Boston Scientific won a nearly two-month-long bidding war with Johnson & Johnson (New Brunswick, New Jersey) to buy troubled CRM firm Guidant for $27.2 billion (Medical Device Daily, Jan. 26, 2009) and the deal was finalized that April (MDD, April 21, 2006).

But the purchase came with a bundle of problems for Boston Sci, first and foremost – numerous lawsuits resulting from a flaw in Guidant's implantable heart defibrillators.

As of 1Q09s $220 million has been paid and an additional $20 million is expected to be paid. There are still pending class action laws suits and 2,250 individual suits all still remain unsettled.

"A consequence of this is the FDA living in your office trying to figure out what's going on," he said.

But while the story of Boston Sci may be ongoing, the panel gave quick tips on how to avoid entering into a costly liability situation.

"It starts with a robust design model that has every step documented," Hoffmeister said.

Hoffmeister added that companies should also have recall committees on hand so in case anything does go wrong, the committee can react very quickly.

"Anytime you mention recalls you should mention plaintiffs and attorneys in the same breath because they're out there scouting the recall lists," he said.

The panelist closed by telling device makers to be proactive and to have an open line of communication during the development and manufacturing of the device at all times.

Omar Ford, 404-262-5546;