June 1998 Bulletin

Biomaterials bill stirs

Legislation would shield suppliers from product liability suits

An important step forward was made when the House Judiciary Committee approved the Biomaterials Access Assurance Act of 1997 (H.R. 872) which aims to reform product liability legislation. Now, the bill awaits movement in the House Commerce Committee.

The bill, which has broad bipartisan support, would shield U.S. device manufacturer suppliers of biomaterials or components parts from being swept up in lawsuits by plaintiffs as part of a larger product liability legislation against medical device manufacturers.

The bill was first introduced to Congress in 1994 by Senate Majority Leader Trent Lott (R-Miss.), Sen. Joseph Lieberman (D-Conn.), Sen. John McCain (R-Ariz.),and Rep. George W. Gekas (R-Pa.). They want the Senate to consider it a stand-alone bill or an attachment to other legislation; the bill is tied to a product liability bill which was approved in the House (H.R. 956) in March 1997 and Senate (S.565) in May 1997 and tort reform legislation.

Under current U.S. liability law, suppliers of materials used in the manufacture of medical devices may be held liable for huge damage awards, even though they were not involved in the design, manufacture or sale of the devices.

The bill would allow biomaterials suppliers to be dismissed, without extensive discovery or other legal costs, from tort suits in which they are named, when their only connection with the alleged injury was supplying a raw material for the medical device. The bill would preempt state law and apply to any civil action brought by a claimant in federal or state court against a manufacturer, seller or biomaterials suppliers.

What's at stake is the dwindling U.S. supply of biomaterials for medical devices used by some 8 million Americans who depend on devices such as pacemakers, heart valves, hip and knee joints, vascular grafts, hydrocephalic shunts and even sutures used in surgery.

"It is of concern to not only orthopaedic surgeons, but to a number of physicians in a variety of medical specialties," stresses Josuha J. Jacobs, MD, a section director of biomaterials research and professor, department of orthopaedic surgery, Rush Medical College, Chicago. He is a member of the Academy's Biomedical Engineering Committee.

Dr. Jacobs says he is "not surprised," that the bill passed the judiciary committee, because there is broad bipartisan support. "But the challenge will be to keep this particular provision separate from the other product liability reform provisions. This bill could stand on its own and could go a long way in preventing biomaterials availability crisis," he said.

Support for passage of this bill is needed, stresses Dr. Jacobs. "Orthopaedic surgeons should make it a point to write to their legislators in Congress to show support because it is in the best interest to the consumer of American health care, so that the medical devices we have come to rely on will still be available," he says.

"In orthopaedics, the greatest risk would be for a shortage of polyethylene which we use in total hip and knee replacement. Currently, there is only one supplier of the base resin."

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