WASHINGTON - Some plastics compounders, fearful of lawsuits, are shunning the market for plastic medical implants. The trend takes a cue from major resin manufacturers like AlliedSignal Inc., BASF Corp., Dow Plastics, DuPont Co., Exxon Chemical Co., Eastman Chemical Co., Montell Polyolefins, Occidental Chemical Co. and Shell Chemical Co., which have removed some or all their plastics from the longterm medical implant market - that is, plastics implanted in the body more than 29 days - because of liability fears.
According to suppliers, the cost of litigation can far exceed the profit made by selling the compounded resin for permanent medical implants.
As a result, compounders involved in the medical market would prefer little limelight on their work.
Compounder Teknor Apex Co. of Pawtucket, R.I., for example, declined to comment on the challenges of supply facing compounders, saying through a spokesman that the company ``takes a conservative approach in areas like this.''
Others, like LNP Engineering Plastics Inc. of Exton, Pa., do not participate in the implant business. A company spokesman said LNP uses U.S. Food and Drug Administration-compliant ingredients for nonpermanent medical plastics uses.
The trend away from supplying material for implants accelerated with the uproar over silicone-gel breast implants and shows no sign of slowing. A recent example is Exxon, which recently reiterated a blanket refusal to supply its metallocene-catalyst compounded polypropylene resins for implants. The silence on the part of particular firms has several reasons, all related to liability.
``Very few medical manufacturers, including the compounders, have been willing to admit anything about the materials or the devices they make,'' said Charles Nau, director of government affairs for therapeutic delivery system manufacturer Alza Corp. of Palo Alto, Calif. ``If any problem is disclosed by a manufacturer and a change is made, such as a change in the resin, say, due to a shortage, [an opposing lawyer] will argue that you [the manufacturer] must have had a problem with the original device or you wouldn't have made a change.''
Alza produces an osmotic pump implant system of 10 products made of titanium and plastics.
Some manufacturers dependent on plastics for implants use stockpiled materials and are waiting for legislative relief that will convince compounders and suppliers to re-enter the market.
But relief may not come, at least in the United States. President Clinton vetoed every proposal to reduce liability on medical suppliers. Aldo Crugnola, executive director of the Plastics Institute of America in Lowell, Mass., said device makers will get their supplies in Europe if supplies run out.
Compounders are not visibly supporting any government effort to lift the load of medical product liability. The medical plastics compounding industry is supplier-driven, and suppliers are not joining with medical device manufacturers to support the Bio-materials Access Assurance Act of 1996, introduced by Rep. George Gekas, R-Pa., in early June.
Critics of the proposed law include Victor Schwartz, a 20-year Washington lobbyist for tort reform and a senior partner in the law firm of Crowell & Moring.
``The ones lobbying for this bill are the ones waiting to buy the material,'' Schwartz said.
Much of the proposed act was contained in tort-reform legislation originally proposed by Sen. Joseph Lieberman, D-Conn., passed by Congress and vetoed by Clinton in May. Clinton said the bill provided suppliers too much protection from lawsuits.
The plastics industry, including compounders and suppliers, has not been among the top lobbying agents for the bill.
Generally, nonimplant compounders do not have reason to support the bill. Julius Rakus, manager of regulatory compliance for compounder AlphaGary Inc. of Newark, N.J., said the same liability fears generally are not observed for vinyl compounds, some of the most widely used of medical plastics for the manufacture of nonpermanent devices such as intravenous bags and medical tubing.
Even if Congress and Clinton help with the latest Biomaterials Access Assurance Act, chances are resin suppliers will not return to the U.S. medical market.
The reason, say lobbyists and manufacturers, is the investment returns of developing plastic compounds for implant are puny.
Returns could be even smaller if weighed against the legal bills. bills. that could be incurred through court actions of an unsatisfied patient - which happen regardless of whether a law protecting suppliers is in place, experts said.