CPR Member Scholar Thomas McGarity testified this afternoon at a hearing of the Senate Committee on Health, Education, Labor, and Pensions on the issue of medical device safety (written testimony, press release).
Currently, individuals injured by a faulty medical device generally cannot sue the device manufacturer in state courts if that device was fully approved by the FDA, even if the manufacturer was aware of new research showing faults in the product. The Senate is considering a bill that would exempt state common law claims from the express preemption clause in the Medical Device Amendments to the Food, Drug and Cosmetics Act. The House is considering a similar bill.
"The implicit assumption in preempting medical device injury claims in state courts is that the FDA can and is performing its job perfectly, but that's just not the case," McGarity says. "Common law still has an important role to play in providing justice to victims of defective products, and the public deserves that protection."
The hearing today was packed, including with numerous individuals who had been harmed by faulty medical devices.
A summary of McGarity's testimony is after the jump. For more on the issue, see Matt Shudtz's previous post.
- The FDA's capabilities to protect public safety are limited. FDA is almost entirely dependent on information submitted by medical device manufacturers at the initial approval stage, information that is easily manipulated by unscrupulous companies and their consultants. Because the device approval process is cloaked in secrecy, agency reviewers do not have the benefit of skeptical outsiders from public interest and patient advocacy groups. FDA also lacks subpoena power to obtain internal company documents that can tell a very different story than the one the agency reviewers hear in their meetings with company officials.
- Courts have several institutional advantages over federal agencies in protecting the public. Common law litigation can force information from company files and tease it out of company employees in depositions. Courts are also better adapted than agencies to respond rapidly to developments in the real world as new information on the hazards of products and activities becomes available. Courts are also far less subject to "capture," manipulation, and political pressure than federal agencies.
- Tort law provides positive incentives for manufacturers to work to improve product safety. It provides incentives for regulatees to take protective action when evolving practices and technologies create unanticipated gaps in the coverage of regulations and permit requirements that are difficult for agencies to fill on a short-term basis. It also provides a disincentive to engage in artful schemes to avoid the reach of regulatory requirements.
- The deterrence function of state tort law is especially relevant to medical devices. The device manufacturers that conduct the clinical trials and continually receive reports on their products will generally have access to more information on the risks posed by their products than doctors, patients or even FDA. Also, device manufacturers are in a far better position than doctors, patients or FDA to improve the safety of their products both before and after they enter the marketplace.
- Frequent argument against jury trials is not matched by facts. The available empirical evidence suggests that juries are capable of comprehending complex scientific and technical issues quite objectively with the help of judge-screened experts.
- Common law litigation can assist agency enforcers in their compliance assurance efforts. Evasion of regulation is currently too easy in many cases.