Senate panel debates medical device safety

Orthopedic Design & Technology, Sept-Oct, 2009

A U.S. Senate panel heard testimony recently from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent court ruling that protects device manufacturers from product liability lawsuits.

The hearing before the Senate's Committee on Health, Education, Labor and Pensions (HELP) about the proposed Medical Device Safety Act of 2009 examined overturning the 2008 U.S. Supreme Court decision in Riegel v. Medtronic.

In the Riegel decision, the court held that the express preemption provision in the Medical Device Amendments to the Food, Drug and Cosmetic Act bars lawsuits against manufacturers of medical devices that underwent the U.S. Food and Drug Administration's (FDA) premarket approval (PMA) process--the review process for novel or highly sophisticated devices. Similar legislation also has been introduced in the House of Representatives.

Proponents of the legislation argue that manufacturers should not be shielded from liability and that patients should have the legal right to sue manufacturers if harmed by a medical device. Opponents argue that the Medical Device Safety Act will make devices more costly and, ultimately, less accessible.

"This has had catastrophic consequences for ordinary Americans, said HELP Committee member Sen. Tom Harkin (D-Iowa) during the hearing. "While the FDA approval of medical devices is important, it cannot be the sole protection for consumers. I say that because FDA approval ... is simply inadequate to replace the longstanding safety incentives and consumer protections provided by long-standing state tort law."

Sen. Orrin Hatch (R-Utah) praised the FDA's efforts saying that FDA officials spend "a tremendous amount of time and resources" evaluating PMA devices and that the agency's "rigorous" efforts historically have been shown to be "exceptionally efficient."

Hatch said turning oversight over to individual state courts would hurt the FDA's expert oversight process--and that the agency has significant and effective authority to monitor and recall devices.

"I do not believe that randomly selected jurors have the necessary scientific and clinical knowledge to perform the same level of analysis as the review by the experts at the FDA," Hatch said. "Yet, in essence, this legislation would supplant the findings of the FDA with those of juries in state courts. This is not only bad policy from the perspective of device safety, it also would have many unanticipated consequences."

Some of the consequences Hatch mentioned include a stifling of innovation, higher costs for medical devices and more expensive frivolous lawsuits. He added that it also undermines the current healthcare reform goal by adding costs to the system.

He hastened to add that it is critical to ensure that those who have been victimized by faulty devices are able to obtain adequate compensation, but argued that patients currently aren't prevented from suing if they have legitimately been harmed by defective devices. If the manufacturer is at fault, due to negligent quality or manufacturing for example, they are protected under the current law, Hatch asserted.

Peter Barton Hutt, a food and drug attorney for the firm of Covington & Burling in Washington, D.C., and former chief counsel for the FDA, articulated a position held by many in the device industry.

"The fact that it [a device] hurts someone doesn't mean there's a defect," Hutt said. "It may save 999 lives, but hurt the thousandth life. That doesn't mean it's defective."

No representatives of medical device industry associations or medical device companies testified, though their influence was felt through the patients testifying before the committee.

Mike Roman, a race car driver from Kirkwood, Mo., testified in support of FDA authority. Roman, who uses a spinal cord stimulator to help manage chronic pain, urged lawmakers not to pass the legislation. He told senators that he understood the device's risk, but considered the risk "worth it."

"I testified today because I want to ensure that advanced medical devices like the one that transformed my life will continue to be available for people like me," Roman said in a statement issued by the Advanced Medical Technology Association (AdvaMed) following the hearing. "My experience shows how vitally important it is for companies to continue developing new treatment options."

Roman's right leg was amputated in 1994 due to complications following knee surgery, and he began to experience severe pain. Aider trying multiple treatments over 10 years, he claimed a new spinal cord stimulator based on cochlear implant technology finally was able to help him manage his pain.

"There are millions of people out there who might one day benefit from breakthrough therapies that are still in development, and we need to consider them when we think about the consequences of this legislation," he added. "I'd rather not imagine where I would be today if the company that created my device had decided it was not worth the investment to develop the device only to have it devalued by lawsuits."