Life Science Compliance Update

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August 12, 2009

Medical Device Safety Act: Senate HELP Hearing

In light of a Senate Health Education Labor and Pensions (HELP) Committee hearing on the ill-advised Medical Device Safety Act of 2009 (MDSA), Forbes Magazine published an editorial by Richard Epstein, JD with the University of Chicago of the impact this bill will have on patients and industry.

MDSA, which is now moving forward in both the House and Senate, “will overrule, retroactively for all pending cases, the Supreme Court's 2008 decision in Riegel v. Medtronic, Inc., which held that a specific statutory provision in the 1976 Medical Device Act explicitly blocked (or "expressly pre-empted" in technical jargon) state courts from allowing personal injury litigation to attack any device's design or warnings to which the FDA has given, after exhaustive inspection, its pre-market approval.”

Under the 2009 MDSA, the same type of tort suits against medical device manufacturers would be allowed against drug manufacturers.

Unlike medicines, in which patents are created to produce approved drugs that have been clinically tested, device companies face a serious obstacle: the mistakes of “downstream actors whose actions take place outside of their control. For example, while all doctors have to do is write a prescription for drugs and medicine, while noting the side effects and risks, device companies must worry about whether a physician properly uses and installs a device.

Interestingly, testimony given at the Protecting Patients from Defective Medical Devices Hearing was heard from various sources on both sides.

 William H. Maisel, M.D., M.P.H., supported the MDSA, noting that it “will restore the consumer safeguards that are necessary to ensure the safety of medical devices for the millions of patients who enjoy their benefits.” On the other hand, Dr. Maisel did not consider how many patients will be harmed if this act passes because they will never receive the chance to try new breakthroughs and devices, such as the case of Michael G. Roman.  Mr. Roman testified against the bill because of his lifelong experience from a spinal device that has helped him, as well as helping thousands of others, control their pain, and other side effects.

Dr. Maisel instead talked about the unfortunate results of an implantable defibrillator manufactured by Medtronic Sprint Fidelis. One patient who had a tragic experience with such a device, Michael Mulvihill, testified as well.

Dr. Maisel also talked about how the FDA reported that they “couldn’t find” 22% of the required post-market medical device studies for the years 1998-2000, and acknowledged that some of the studies were never started.

Interestingly, Dr. Maisel also maintained that manufacturers have an inherent financial conflict of interest, which causes the timing and extent of the product recalls to be controversial. Contrary to his belief, there are no inherent conflicts. America was founded on entrepreneurship, and free enterprise. While device companies certainly have the right to keep profits in mind, we must remember what the purpose of these companies are: to make devices to save the lives of Americans. Moreover, it is the responsibility of the government to ensure device reliability and performance, and if the FDA cannot do it, business should not suffer, nor should patients. Lastly, although there have been some technical difficulties with devices, “implanted medical devices have enriched and extended the lives of countless people.”

Professor Thomas O. McGarity also supported the legislation by asserting that “manufacturers of defectively designed or manufactured products must compensate innocent persons who have been injured by such products.”

The professor also emphasized the importance of device companies to collect data on the harm-producing potential of their products and activities in order to prevent future harm. Consequently, this recommendation was to prevent future litigation that could hurt companies more than not using such data wisely.

Ultimately, while it is the duty of the FDA to inspect devices, they are almost entirely dependent upon information submitted by medical device manufacturers at the initial approval stage. Although critics believe that this information is easily manipulated by unscrupulous companies and their consultants, there is no evidence to support these claims. The FDA is a “resource-starved federal agency that does not have sufficient personnel to keep up with ongoing technological developments, and they are generally very reluctant to revisit previous decisions in light of new information.”

Finally, Peter Barton Hutt, Esq., spoke against the legislation by acknowledging that the act, which will install rigorous standards of pre-market approval (PMA devices), will only comprise less than one-half of one percent of all the medical devices authorized by FDA for marketing since 1976. He asserted that:

The half percent of devices that are the subject of full premarket review and approval, however, represent cutting edge science. They are the new life-saving and life-sustaining devices that are critical to the public health. They are the highest priority devices -- those for which we should do everything we can to encourage investment in research and development.

Mr. Hutt emphasized that America cannot let judges and juries throughout the country to impose requirements that are inconsistent with FDA determinations, because they will differ from one Court to another, causing “regulatory chaos.” Moreover, if judges and juries can summarily disregard FDA decisions on Class III PMA devices, why should physicians, hospitals, or anyone else pay attention to them? Ultimately, the bill undermines the credibility and authority of the country’s most important public health agency.

In addition, as Justice Breyer stated during the oral argument in Warner Lambert v. Kent, “who would you rather have make the decision that this [product] is, on balance, going to save people or, on balance, is going to hurt people? An expert agency, on one hand, or 12 people pulled randomly for a jury role, who see before them only the people whom the [product] hurt and don’t see the people who need the product] to cure them?”

Instead, the solution is not to farm FDA’s work out to juries, but rather, to provide adequate funding for FDA.

Furthermore, MDSA will force manufacturers to label their products with additional or unsubstantiated warnings, which can result not only in underutilization of valuable treatments but also by confusing both physicians and their patients.

The MDSA would also remove devices approved by the FDA and would severely deter innovation. Therefore, “it is important to focus not only those who may be harmed by approved devices, but also those who are helped by those same devices, and who might be harmed if the devices were removed from the market.”

In the end, the words of a male patient who has lived a better life everyday since the use of his medical device are well put:

To me, that choice is clear. We need safe products, we need innovation, and the best way to achieve both goals is not through litigation created by this bill, but through a strong, well funded FDA.

The MDSA is not a panacea or solution to problems that may or may not arise with medical devices. Passage of this bill will have a significant negative effect on medical device innovation. Instead of punishing medical device manufacturers, of which many are small companies, for operator errors, Congress should be looking at offering pharmaceutical companies the same level of protection from unnecessary lawsuits that the device industry now receives.

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my husband has had a defective lead. it was replaced in august and here we are in January and it already needs replaced again. he is 48 years old and this has caused pain and severe stress. i am out lost wages and travel expense as his heart center is almost three hours from home. medtronic is not liable for any of this and i find that to be troubling given the amount of trouble caused by these devices when they go bad. we also are liable for the copays medicare does not cover. has anyone figured how much cost this is to medicare as most of these patients are on disability or are elderly

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