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The Significance of the Medical Device Safety Act

Posted on in Defective Medical Devices

The ability to bring claims for defective medical device injuries will be possible again with the Medical Device Safety Act.

The 2009 supreme court case Wyeth vs. Levine also led to the reunion of the drug manufacturers and the device manufacturers. The case “confirmed that the Food and Drug Administration (FDA) marketing approval of all prescription drugs does still not (prevent) patients' state-law claims seeking damages for harm caused by those products.” The Wyeth court case touched on the main reasons for creating the Medical Device Safety Act.

The Medical Device Safety Act was in direct response to a 2008 Supreme Court decision in which the FDA's pre-market approval of medical devices would protect the manufacturer of the device for almost all liabilities through preemption, a legal doctrine. This decision also stopped an important protection of consumers.

In the Wyeth case, the court did not accept the foundation that a manufacturer is protected from liability because the product has received approval of the FDA. Although the court specifically addressed drugs, many of its observations also equally applied to medical devices.

These observations include:

  • FDA compliance as evidence: the court decided that the compliance of the FDA with federal regulations is proof of acting reasonable, but enough to shield the FDA from liability.
  • FDA's longstanding position: the FDA has had a longstanding position that the state offers a lot of protections to consumers.
  • FDA's limitations and manufacturers' superior knowledge of all of the drugs (and medical devices) due to the immense number of items that the FDA must look after.
  • Congressional intent: the court stated that Congress never intended that the Food, Drug, and Cosmetic Act could overpower state power to claim damages.
  • No federal remedy: the Supreme Court noted, lastly, that the government did not supply a remedy to any of these drugs that are approved by the FDA.

If you have been injured by a medical device, . Attorneys at Newland & Newland, LLP can assist you in Arlington Heights, Libertyville, Crystal Lake, Chicago, Waukegan, Itasca today.

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