Congressional Democrats To Draft Bill To Overturn Supreme Court Decision On Medical Devices

Main Category: Medical Devices / Diagnostics
Also Included In: Litigation / Medical Malpractice
Article Date: 25 Feb 2008 - 2:00 PDT

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Congressional Democrats on Wednesday said that they plan to draft legislation to overturn a decision by the U.S. Supreme Court that protects medical device companies from some product liability lawsuits, the New York Times reports (Feder, New York Times, 2/22).

Earlier on Wednesday, the court ruled 8-1 in the case Riegel v. Medtronic that FDA approval of certain medical devices protects manufacturers from product liability lawsuits filed in state courts. The decision applies only to medical devices that have undergone the premarket approval process, the most thorough process used by FDA, and does not apply to medications (Kaiser Daily Health Policy Report, 2/21).

According to CQ HealthBeat, the law that the court used to reach the decision pre-empts any additional state requirements for the safety of medical devices. However, Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) and other congressional Democrats said that the court misinterpreted the law. Medical device industry lobbyists said that the committee plans to draft legislation to overturn the decision and that the House Energy and Commerce Committee plans to draft a similar bill.

Kennedy in a statement said, "Congress obviously needs to correct the court's decision," adding, "In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices." He said that without congressional action "FDA approval will become a green light for shoddy practices by manufacturers" of medical devices.

House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) in a statement said, "This disturbing decision denies patients any legal recourse if they are a victim of a faulty medical device and gives the device makers immunity for the life of a product regardless of any defects or problems that arise after that initial approval." He added that the decision "shows why it is more necessary than ever for Congress to step in and restore the protections that patients are entitled to if they are the victim of a life-altering accident caused by a medical device."

Rep. Henry Waxman (D-Calif.) said, "This isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation" (Reichard, CQ HealthBeat, 2/21).

Legal Implications
The decision "began rippling through the courts and law offices almost immediately," and "lawyers for patients with injuries they attribute to other devices like heart valves, artificial hips and defibrillators said they were girding for a flood of court filings from device makers ... asking judges to dismiss such lawsuits," the Times reports. Legal experts said that the decision could affect a number of pending product liability lawsuits related to medical devices.

According to the Times, "Lawyers expect injury lawsuits to leave design questions behind and focus on whether patients were harmed because a company did not make or handle the product according to the safety processes laid out in the documents approved" by FDA. Another question is "whether injury lawsuits are barred in cases where manufacturers deceived the regulators by providing false data or withholding data on safety and effectiveness to get their marketing approval," according to the Times.

However, the decision might "lead many judges to dismiss claims before plaintiffs' lawyers can gain access to company production data, e-mail and other records through the pretrial process known as discovery," the Times reports (New York Times, 2/22).

Editorials
Two newspapers on Friday published editorials related to the decision. Summaries appear below.

• Long Island Newsday: "Washington is slowly but surely making it more difficult for consumers to get their day in court when they've been harmed by the negligence of big companies," and the decision "made it all but impossible to sue manufacturers of medical devices," a Newsday editorial states. The editorial adds, "The court could extend that same legal shield to drug companies ... in its next term." According to the editorial, "It's the time-honored American way to resolve disputes and pursue justice," and the "claims of aggrieved individuals should be judged individually in courts." The editorial concludes that, although "frivolous" lawsuits "should be rudely dismissed, ... that's a far cry from the near blanket immunity that some in Washington apparently have in mind" (Long Island Newsday, 2/22).
  
  
• New York Times: "Consumers are already at the mercy of the all-too-fallible" FDA, and, as a result, "it is especially disturbing that the Supreme Court ruled this week that patients injured by defective medical devices cannot sue for damages in state courts if the device was approved by the FDA and made to the agency's specifications," a Times editorial states. The editorial adds that "any consumer harmed by a faulty device" will not have a "chance of fair compensation" and that the "manufacturers will have a dangerous sense of impunity." The editorial concludes, "Congress should move quickly to pass corrective legislation and be prepared to do the same in other areas if the Supreme Court extends its pre-emption doctrine to drugs and other products" (New York Times, 2/22).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.