October 1998 Bulletin

New biomaterials law protects supply

Bill held hostage for product liability legislation since 1994

After years of languishing in Congress, President Clinton signed the Biomaterials Access Assurance Act of 1998 (H.R. 872) into law on August 13 to shield U.S. device manufacturer suppliers of biomaterials or component parts from being tied to part of a larger product liability litigation against medical device manufacturers.

The bill was first introduced in 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.). The legislation preempts state law and applies to any civil action brought by a claimant in federal or state court against a manufacturer, seller or biomaterials suppliers-that is, assuming the supplier has lived up to contractual specs or other standards and is free from any fraudulent activities. The legislation still holds manufacturers liable for defective products.

At stake was the dwindling U.S. supply of biomaterials for medical devices used by some 8 million Americans who need pacemakers, heart valves, hip and knee joints, vascular grafts, hydrocephalic shunts and even sutures used in surgery.

"Being tied into part of the larger liability product lawsuits forced many suppliers out of the market and/or to require indemnification clauses or some type of risk-sharing agreement," explains James S. Benson, executive vice-president, for the Health Industry Manufacturers Association (HIMA).

To ensure one of their suppliers would not desert them, in the heat of the 1993 $2 billion global class action lawsuit against Dow Corning, Dane A. Miller, PhD, president and chief executive officer of Biomet, Inc., indemnified Montell Polyolefins, against any liabilities related to potential lawsuits. Miller says Montel produces $5 billion worth of polyolefins and ships $150,000 worth of raw materials to the orthopaedic industry. Other industry sources say some suppliers of raw materials are charging a premium price for polymers to cover their added liability.

"It's reassuring that in that all likelihood there will be continued availability of raw materials necessary for orthopaedic implants. In orthopaedics, the greatest risk would be a shortage of polyethylene which we use in total hip and knee replacements, " says Joshua J. Jacobs, MD, section director of biomaterials research and professor, department of orthopaedic surgery, Rush Medical College, Chicago. He is a member of the Academy's Committee on Biomedical Engineering.

"This legislation means companies won't be afraid to put new products out there because they'll know they have material supply," says Benson. "Device companies also won't have to divert research and development resources into alternate material sources."


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