Earlier this month, as the House Committee on Energy and Commerce's subcommittee on health was finalizing its work on a bill reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II), a discussion draft of the legislation emerged that drew sharp criticism from the medtech industry. The area of greatest concern was a provision that would have placed limits on federal preemption defenses in liability cases involving medical devices, including devices that have gone through FDA's rigorous premarket approval (PMA) process.
Federal preemption is a legal concept which provides that federal laws and regulations take precedence over state laws and regulations in the same area. The proposed legislation would have negated such a concept in stating, "Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law)."
Steven Ubl, president and CEO of industry association AdvaMed (Washington, DC), provided the subcommittee with written testimony in which he stated, " Device-specific reviews, such as a PMA, entail a comprehensive review of safety and effectiveness by FDA's expert scientists, physicians, and other analysts." In a subsequent news release, Ubl added, " Elevating individualized state actions and decisions through tort lawsuits over FDA's expert science-based determinations of safety and effectiveness would undercut the agency's authority and create a disincentive for companies' research and development efforts."
Ubl did not mince words in voicing AdvaMed's concern over the federal preemption provision and its impact on MDUFMA. "This would be the end of the program--period," he said. "Neither FDA nor industry would ever support this provision."
Indeed, Randall Lutter, MD, FDA's deputy commissioner for policy, said, "We believe that state law actions that can conflict with the agency's conclusions and frustrate the agency's implementation of its public health mandate should not be endorsed in federal laws."
John Engler, former three-term governor of Michigan and current president and CEO of the National Association of Manufacturers (Washington, DC), called the proposed change in the federal preemption clause a "judicial prescription for disaster." In an op-ed piece in The Detroit News, Engler wrote, "Current regulations prevent states from imposing requirements that are 'different from or in addition to' the FDA rules that ensure safety and effectiveness. Manufacturers depend on this single standard--a very high standard--to produce the drugs and medical devices that save people's lives. Dealing with 50 different requirements, enforced by state courts and regulators, would be an expensive, bureaucratic nightmare only benefiting thousands of trial lawyers in the hunt for a big payoff."
A potential bureaucratic nightmare.
AdvaMed also objected to draft language in the legislation that would have required public registration of clinical data before a device was approved, stating, "Premature disclosure of clinical trial data in a registry may reveal important proprietary information, which is particularly harmful to small device companies."
The Medical Device Manufacturers Association (MDMA; Washington, DC) expressed similar concerns about the draft legislation. On the issue of public registration of clinical trials data, MDMA board member Kelvyn Cullimore Jr., president and CEO of Dynatronics Inc. (Salt Lake City), pointed to the Senate's proposed MDUFMA reauthorization as a good model to follow. The Senate version of the legislation "provides patients, physicians, and the public with useful information on medical devices that have been cleared or approved by FDA . . . while balancing medical device manufacturers' important need to protect their confidential trade secrets and the intellectual property of their medical devices," he said.
A fair balance.
Beyond its objections to the preemption and clinical trials language of the House bill, AdvaMed expressed disappointment that the proposed legislation did not include improvements to the third-party inspection program, which, it said, was "critical to freeing up FDA resources and reducing costly and duplicative inspections." The testimony of FDA's Lutter concurred. "We recommend that third-party program modifications be added to the drafts and note that in the absence of modifications, FDA will continue to expend resources to maintain the program without enhancing its inspectional capabilities," he said.
Efforts to remove what the industry considered to be onerous provisions proved to be largely successful. The bill that emerged from the House on the final day of markups was much more in line with the Senate bill, with which the device industry is generally pleased.
Commenting on the final House bill reauthorizing MDUFMA, AdvaMed's Ubl said, "We are especially pleased that the committee removed a proposal to limit the preemptive effect of FDA's device-specific actions, which potentially would have created hundreds of standards for medical technology manufacturers."
Mark Leahey, MDMA's executive director, said, "According to current projections, the House is expected to vote on the bill on July 9 or 10. It looks like there will be a modified House-Senate conference to work out any differences before submitting the final bill to the president for his signature.
"We're hoping this will be on the president's desk before the August recess, particularly since FDA has said that if it does not get MDUFMA reauthorization 60 days out from the September 30 expiration of the current law--which would be around the end of July--the agency will have to start issuing reduction-in-force notices," Leahey added.
A definitive resolution.
In a related development, shortly after the House markup session on MDUFMA II, the Supreme Court announced that it would review the case of Riegel v. Medtronic. According to James Beck, counsel in the mass torts and product liability group of Dechert LLP (Philadelphia) and coauthor of the Drug and Device Law blog (www.druganddevicelaw.blogspot.com), the court's action will likely provide a definitive resolution to the issue of federal preemption for FDA-approved medical devices.
In Riegel, a trial court dismissed a product liability suit concerning a Medtronic balloon catheter. The court ruled that the patient was not entitled to state law remedies in light of the prior FDA approval of the device. The Second Circuit Court of Appeals upheld that decision.
Seven of the eight federal circuit courts have consistently upheld the doctrine of federal preemption for medical devices. The high court is expected to hear the case sometime in 2008.
© 2007 Canon Communications LLCReturn to MX: Issues Update.