Medical Community for Lawsuits, When they Aren’t Getting Sued!
May 21, 2009
The US Supreme Court ruled that Food and Drug Administration (FDA) approval of medical devices immunized the manufacturer from a lawsuit for damages. Sure, the FDA is understaffed, and often referred to as a revolving door for medical device company employees. Still, this was a big blow to injury vicims seeking to recover their losses due to a defective product.
Today, none other than a doctor writing in The New England Journal of Medicine called for legislation to allow victims of defective medical devices to pursue their claims in state court. Whether this was to look out for patient well being or simply avoid lawsuits against doctors is anyone’s guess. Read it for yourself and decide!
The S.E. Farris Law Firm has experience representing victims of dangerous medical products. If you or a loved one believe you have been injured by a medical device or drug, contact The S.E. Farris Law Firm, at 314-252-9937. We will provide you with initial legal advice for free, and never charge anything unless we win for you.
Preemption and Malpractice Liability
Volume 360:2257-2258 May 21, 2009 Number 21
To the Editor:
In their Perspective article about the Supreme Court, preemption, and malpractice liability (Feb. 5 issue),1 Kesselheim and Studdert suggest that preemption will not result in more malpractice claims against physicians for failure to warn, which they say are uncommon and financially unattractive to plaintiff’s attorneys. I hope they are correct but have yet to find a plaintiff’s attorney who agrees with them.
In 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic2 that a product-liability lawsuit brought against Medtronic in a state court was preempted because the device (an angioplasty catheter) had received marketing approval from the Food and Drug Administration (FDA). Recently, a federal judge in Minnesota, citing that ruling, dismissed scores of patients’ lawsuits involving the Medtronic’s Sprint Fidelis lead, which the manufacturer had recalled because it was fracturing in patients. Thus, FDA approval now immunizes medical-device manufacturers from state tort liability. As a result, plaintiffs will target physicians, hospitals, and health care systems.
Plaintiffs will assert, not unreasonably, that physicians who are qualified to use medical devices should be able to assess the quality and completeness of the data supporting a product’s safety and efficacy. A defense based on the fact of FDA approval may be insufficient if other practitioners would not use the product because of inadequate safety or efficacy data. Hence, preemption should make physicians wary of devices approved on the basis of limited or short-term studies.
Congress must consider the long-term implications of preemption. Rather than spurring innovation, preemption may create an environment in which, for fear of liability, physicians and hospitals decline to use promising new therapies, to the detriment of patients. If Congress decides that medical-device companies are to be immunized through preemption, then physicians and hospitals should be similarly protected from tort lawsuits when using products according to FDA-approved labeling or guidelines.
Preemption underscores the need for the FDA to become a rigorous scientific organization whose primary objective is patients’ safety. To achieve this goal, the agency must be led by distinguished scientists empowered to apply scientific methods to regulation. Some FDA officials may say the agency is already strictly applying such methods, but its record of miscues suggests otherwise.
Congress should pass tort-reform legislation preserving a patient’s right to legal redress while excluding claims that lack merit. Liability offers a strong incentive for companies to develop and manufacture safe drugs and devices. If companies are not accountable for their products, the public loses a safeguard that has motivated quality improvements in the health care industry for the past half-century.
Robert G. Hauser, M.D.
Minneapolis Heart Institute
Minneapolis, MN 55407
rhauser747@aol.com
Dr. Hauser reports holding stock in Atritech and Sonosite. No other potential conflict of interest relevant to this letter was reported.
References
1. Kesselheim AS, Studdert DM. The Supreme Court, preemption, and malpractice liability. N Engl J Med 2009;360:559-561. [Free Full Text]
2. Riegel v. Medtronic, 128 S.Ct. 999 (2008).
The authors reply: Our analysis of how preemption of product-liability litigation may affect physicians’ malpractice risks focused on pharmaceuticals, the issue before the Supreme Court in Wyeth v. Levine, not medical devices, the subject of Hauser’s letter.
Since the publication of our article, the Court has issued its decision: approval of warning labels on pharmaceuticals by the FDA does not preempt state product-liability claims against the manufacturer.
We applaud this outcome. However, Levine now puts the preemption status of pharmaceuticals and devices somewhat at odds, as Justice Samuel Alito’s dissenting opinion in Levine points out. In Riegel v. Medtronic, the Court found that a federal statutory provision barred state claims against device manufacturers when the device in question had FDA approval. This decision may well have increased the scrutiny of the role of physicians with regard to the use of devices.
An important policy argument against the type of preemption Wyeth sought in Levine is that the FDA has a limited capacity to oversee the vast array of drugs on the market. The same is surely true for devices. Consequently, we agree with Hauser that preemption of device claims is problematic and support the passage of legislation currently before Congress that would reverse the effect of Riegel.
Aaron S. Kesselheim, M.D., J.D.
Brigham and Women’s Hospital
Boston, MA 02115
akesselheim@partners.org
David M. Studdert, LL.B., Sc.D.
University of Melbourne
Melbourne, VIC 3010, Australia