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Laurel Thoennes @ Quality Digest

FDA Compliance

Protecting Patients From Defective Medical Devices

The question is, who decides?

Published: Sunday, August 9, 2009 - 21:19

On Tuesday, Aug. 4, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing on protecting patients from defective medical devices. The principle element of the hearing was to debate the bill S 540: Medical Device Safety Act of 2009 “To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.”

The Medical Device Safety Act would reverse the February 2008 U.S. Supreme Court ruling in Riegel vs. Medtronic Inc. that gave legal immunity to manufacturers of defective medical devices that had been FDA-approved under the premarket approval (PMA) process. The justices ruled that the preemption provision of the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act overrides state law for tort (wrongdoing for which action for damages may be brought) claims concerning PMA medical devices.

“In enacting legislation on medical devices, Congress never intended that the FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers,” stated Senator Edward M. Kennedy in response to the Riegel vs. Medtronic Inc. ruling on Feb. 20, 2008.

Those in support of the Medical Devices Safety Act have made these points:

• If this act becomes law, it will restore consumer safeguards and the legal rights to victims of defective medical devices and give them a chance at compensation.

• Presiding Senator Harkin pointed out in the Aug. 4 HELP hearing that the FDA does not have subpoena power; since the Riegel vs. Medtronic Inc. ruling, manufacturers of PMA medical devices are not subject to state tort lawsuits, therefore they are not subject to "discovery" that would go on in a lawsuit. "If a device manufacturer commits fraud on the FDA and puts a device out there and injures people, but they cannot sue, they cannot get discovery to get at these documents, then you will never know whether or not they committed fraud on the FDA. What's wrong with that line of reasoning?" asked Harkin.

• The FDA regulates more than 100,000 different medical devices from more than 15,000 manufacturers—in addition to receiving several thousand new and supplemental applications each year—and are expected to evaluate and approve these devices without delay. How are they supposed to monitor the safety of every device they have approved?

• The FDA approval of a medical device does not guarantee its safety. “During fiscal year 2006, 651 recall actions were initiated involving 1,550 products—again reminding us that FDA product approval does no ensure device reliability and performance," according to the Fiscal Year 2006 Annual Report of the Center for Devices and Radiological Health, of the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services

• Under Riegel a negligent device manufacturer cannot be held accountable for any of the costs incurred when a patient must have a faulty medical device removed or replaced. The patient is held responsible for all costs and what the patient can't pay falls on taxpay the government through Medicare.

• Earlier in 2009, the Supreme Court ruled in Wyeth vs. Levine that patients harmed by prescription drugs can sue the manufacturer in state courts, thus creating a double standard between prescription drugs and medical devices.

• Before the ruling in Riegel vs. Medtronic Inc., medical device manufacturers knew they were subject to liability—there have been a number of court decisions that held claims as preempted and many rulings that the claims are not preempted—yet innovation was not stifled.


Those opposed to the Medical Devices Safety Act have made these points:

• The Medical Device Safety Act will make devices more costly and less accessible.

• The Medical Device Safety Act will stifle innovation.

• Who would you rather have deciding the safety and effectiveness of medical devices, the experts and scientists of the FDA or a jury of lay persons?

• There is a provision in the Medical Device Amendments of 1976 that authorizes the FDA to order a device manufacturer to pay for the replacement of a faulty device. The FDA can on its own initiative order this or the patient can request that the manufacturer pay for the cost through a petition basis.

• “Is there no benefit for offering limited protection to manufacturers of such highly-regulated products to ensure the advancement and availability of these life-saving products?” asked Senator Hatch at the Aug. 4 HELP hearing.

• “A patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients,” says Stephen J. Ubl, president of AvaMed, the Advanced Medical Technology Association in Washington, D.C. “The consequences of allowing such cases to proceed in state courts could allow states to set their own standards for safety and effectiveness of PMA products, which would be chaotic. This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs.”



About The Author

Laurel Thoennes @ Quality Digest’s picture

Laurel Thoennes @ Quality Digest

Laurel Thoennes is an editor at Quality Digest. She has worked in the media industry for 33 years at newspapers, magazines, and UC Davis—the past 25 years with Quality Digest.