We watch to see the outcome of the hearings and discussions from the Congressional activities that have stemmed from the U.S. Supreme Court’s February 2008 decision in Riegel v. Medtronic Inc. Congress is rushing to enact the Medical Device Safety Act of 2009 to reverse the preemption bar for those injured by medical devices that have been approved for use via the pre-market approval process of the Food & Drug Administration.
According to the bill’s sponsors, Frank Pallone Jr. (D-NJ) and Henry Waxman (D-CA), the Court’s decision “left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages” … and it left the incentive to maintain product safety and disclose latent defects to physicians and patients.
This activity is of concern to the industry on a variety of levels. First, most medical devices on the market today are not PMA devices, but are cleared for use by the FDA via the 510(k) pre-market clearance process. Those devices, about 5,000 per year, are on the market as a substantial equivalence standard. Of these, 2 percent to 5 percent may be required to submit clinical data or other confirmatory information as to their safety and efficacy beyond identifying a predicate device. There is no federal preemption for devices on the market through the 510(k) process. The Court acknowledged that the FDA’s process was not as rigorous for those cleared devices as it is purported to be for the PMA approved devices.
Second, this type of rush to correct a wrong may make the men and women in Congress feel vindicated, but why not focus on the FDA process, the staffing at the FDA, the rulemaking at the FDA and the leadership at the FDA?
A General Accounting Office report (PDF) released earlier this year found that 228 medical devices were cleared as 510(k), even though they were Class III. That does not speak to more complex legislation, but to new FDA processes and clearer regulatory pathways for industry to follow.
Third, why do consumers, Congress and the FDA all look to industry as seeking to skate along without oversight? Why would a medical device manufacturer seek to put a dangerous device into commerce? How much market share will they be able to capture once people are harmed? What type of advertising would be done? “Hey, look at us, talk to your doctor about our device, it causes you to develop serious complications after its implantation, and might result in loss of life.”
As it is with direct-to-consumer advertising for drugs, the side effects as announced make you question why it’s worth taking the drug at all. Rushing to pass this legislation is akin to building more jails for an increase in crime without considering that there are other interventions that might deter crime if implemented wisely and prudently.
What is missing here is a process that does not encourage lawsuits, which this legislation is bound to do, but finds a way to incentivize every stakeholder to safely market and sell its product. In the advent of the healthcare reform debate, one way to lower costs is to find ways to compensate injured consumers without encouraging expensive, time-consuming tort suits, whether medical malpractice or products liability. Fortunately, only a few result in unreasonable outcomes. Tort reform is not being seriously considered in the mix of how to reform the runaway costs of healthcare, but it should be. Why not look at the vaccine fund created to encourage R&D and production while providing a program to compensate credible consumer injuries? There is no perfect solution. What Congress should do is find ways to address this issue with a balanced view towards access to first-rate, well-designed, effective medical devices. How many companies are out of compliance? How many products fit the Riegel profile?
Every medical device company, if they are to get in business and stay in business, is incentivized to bring to market the most promising, safe devices that save or improve lives. Most companies in this business are founded by passionate entrepreneurs who believe that they have invented a better medical product. They are focused on bringing good products to market.
That’s been forgotten in this legislative initiative. Instead, companies are seen as needing to be overly regulated, watched, controlled and scrutinized. There is fear that their products will intentionally be sold to physicians without the proper instructions for use, clinical validation or warnings. The fear is that the physician will be blinded by promotional pens and pads of paper and use the device without good medical sense, misplace it and cause injury to a consumer who might have been overwhelmed by the promotion of the device while watching TV or reading a newspaper.
This legislation makes for good PR, but is it good legislation that encourages new and promising products for consumers to access?