Articles Posted in Medical Device Liability

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Chicago’s 7th U.S. Court of Appeals reversed a federal district judge’s ruling that barred the Illinois product liability claim of Lenore Aebischer. In 1997 at age 44, Lenore underwent a hip replacement. But the prosthetic hip manufactured by defendant Stryker Corp. allegedly failed due to structural defects, and Lenore required a second replacement surgery as a result of the Illinois medical device liability.

Stryker Corp. moved to dismiss the complaint filed by Lenore because the 2-year statute of limitations had run when the case was filed in Chicago in 2005. In Illinois, typically the statute of limitations begins running from the date that the claimant should have known that there was a problem with the defective medical device. The Chicago district court found that in 2002 Lenore was aware that her hip problems were caused by a manufacturer’s defect.

In 2001, Lenore saw her orthopedic surgeon for left hip pain and was told that her hip replacement might last 15-20 years. In 2002, the same doctor determined that her pain was caused by osteolysis and from particles of plastic that had broken loose from the prosthetic hip. In 2003, the surgeon performed a second hip replacement surgery to replace the failed original prosthesis. After the surgery, the surgeon told Lenore that the osteolysis was worse than he had originally thought and that the original hip device had “advanced or catastrophic failure”.

Because of her surgeon’s discoveries during her procedure in January, 2002, the Illinois federal district court said that the plaintiff was on “inquiry notice” that her injury might have been wrongfully caused based on the surgeon’s explanation of the osteolysis and that particles of plastic from the prosthesis had gotten between that device and her hip bone.

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The American Association for Justice (AAJ) is lobbying for the rights of consumers injured by defective medical devices. In Riegel v. Medtronic, Inc. the U.S. Supreme Court ruled that manufacturers of medical products weren’t liable for damages if their device received premarket FDA approval (see 03/01/08 post for more details). It is up to Congress to restore the rights of the consumer.

The Medical Device Safety Act of 2008 is set to mimic the 1976 Medical Device Act (MDA), which is what the U.S. Supreme Court relied on for its decision in Riegel v. Medtronic, Inc. The new act seeks to add the following language to the section titled “No Effect on Liability Under State Law”:

Nothing in this section shall be construed to modify or otherwise effect any action for damages or the liability of any person under the law of any State.

By adding this language the new Act ensures that civil suits can be filed under state law even if the device was approved by the FDA.

In order to ensure that the new act protects the rights of consumers the AAJ is actively lobbying, uniting attorneys from across the country in their common goal. If you, too, feel strongly about this bill it is vital that you contact your member of Congress and voice your support for the bill.

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In the case Riegel v. Medtronic, Inc. the U.S. Supreme Court ruled that the manufacturer of the medical device could not be sued under state law when the device causes an injury. What this means for patients is that it is now harder to file an Illinois product liability lawsuit against a maker of medical device that is FDA approved.

FDA recall video of the leads used in Medtronics pacemakers.

In its decision the Supreme Court relied on the Medical Device Amendments of 1976 (MDA) which holds that a state cannot establish regulations that are different than established by the FDA, or that are in addition to the federal requirements. Nor can state regulations supersede those laid out by the FDA regarding safety and effectiveness.

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