Montell/North America, Inc., one of only two raw material suppliers of ultra high molecular weight polyethylene (UHMWPE), has informed medical device manufacturers that it will no longer supply the material for use in surgical implants.
Citing fears of product liability litigation, Montell's decision pushes the long-predicted problem of availability of biomaterials closer to the shortage stage and a possible crisis. Suppliers have found that although they are not the manufacturers of devices using their products, they could be named as defendants in costly lawsuits brought by people claiming to be harmed by the devices.
That leaves only Hoechst Celanese Corp., a German-based manufacturer, to supply the important material used in thousands of orthopaedic implants and other medical devices every year, said Dane A. Miller, PhD, president and chief executive officer of Biomet, Inc. Miller said Hoechst could be one step behind Montell in abandoning sales of UHMWPE because the company has significant assets in the United States.
Stalled in Congress
Meanwhile, legislation to end the problem has languished in Congress for two years. The Biomaterials Access Availability Act is part of product liability bills that were approved in the House (H.R. 956) in March and Senate (S. 565) in May. As of this writing, the bills are still waiting for action by a conference committee to iron out differences in the bills, while Congress is focused on passage of a budget bill.
The vulnerability of raw materials suppliers is traced to the law suits against E.I. du Pont de Nemours and Co., which supplied Teflon® in temporomandibular joint implants. Later, individuals claiming injuries from silicone breast implants sued the raw material supplier, Dow Corning; when Dow Corning declared bankruptcy, suits were filed against Dow Chemical.
Miller, who also is chairman of the Industry Council of the American Institute for Medical and Biological Engineering, warned that Dow Chemical faces legal liabilities that could threaten the company. Suppliers must have "caught their breath" when they saw a $14.1 million judgment against Dow Chemical last fall, he said. Dow Chemical has thousands of lawsuits pending.
Risk is great
The risk of a costly lawsuit is far greater than the sales profits of raw materials. A 1994 study for the Health Industry Manufacturers Association (HIMA), found that DuPont's combined sales of Teflon®, Dacron®, and Delrin® to the implant market was $600,000 a year, while the value in other markets, that is, textiles and electrical, was between $10 billion and $11 billion annually. That means the implant market sales represent .005 percent of all other market sales.
DuPont and Dow Chemical have discontinued supply of polyester, silicone, Teflon®, Dacron®, Delrin® and polyurethane for medical implants.
Miller said there is no alternative material that can compare with UHMWPE for performance. His company has unsuccessfully tried to find other sources of the material in China, Russia, and elsewhere. Biomet even considered building its own manufacturing plant to produce the plastic, but it realized that the suppliers of the ingredients for the plastic also might refuse to provide supplies because of possible lawsuits.
The problem could spread to materials other than plastics like stainless steel and titanium used in medical devices, Miller said.
Bernard Stulberg, MD, chairman of the Committee on Biomedical Engineering, said the general premise is that alternative materials could be found. But that's not an easy solution; it's time consuming and costly. And alternative materials would be subject to the long-term testing requirements of the U.S. Food and Drug Administration. Other solutions include use of implants made by foreign manufacturers who might have an easier time securing raw materials.
Like other manufacturers, Biomet has "a fair backlog of the plastic in inventory," but Miller said the product liability problem had to be solved by Congress in six months to a year.
The biomaterials legislation to create a "safe harbor" for the raw materials suppliers was introduced in Congress in 1994 and when there was no action, it was reintroduced in January 1995. It was made part of product liability and tort reform legislation which is a goal of the Republican majority, but the legislation has controversial provisions.
There aren't a lot of options. If there is no federal legislation, the inventories of manufacturers eventually will be depleted. The 1994 study for HIMA predicted that short-term shortages would show up in one to three years. After that "a crisis looms in which patients and doctors may be affected by shortages of vital medical implants and the disappearance of certain unique, well-established, reliable materials used in critical surgery."