WASHINGTON - Like residents of prime beachfront real estate, plastics molders, manufacturers and assemblers in the $42 billion biomedical device industry are watching the legal horizon for a hurricane some say will strike their industry in less than three years. The hurricane is a shortage of raw materials brought on by litigation-shy major resin manufacturers who, because of liability concerns, no longer supply products for long-term medical implants - those that remain in the body for at least 29 days.
``I can't tell you how frustrating this is,'' said Carl McMillin, senior scientist for AcroMed Corp. in Cleveland, whose firm makes composite orthopedic implants for the spine.
AcroMed runs into the problem of liability not only for its plastics composite parts, but for stainless-steel and titanium components as well.
``Avoiding legal liability has become such a byzantine exercise that when dealing with a new supplier, or buying a new antioxidant, lubricant, even a colorant, for use in medical applications, we're scared to tell anyone what we're going to use it for, for fear they won't sell it to us,'' McMillin said.
McMillin said he believes some, mostly small, firms are in the medical field because they cannot afford to leave. These companies have invested their limited resources so completely in a given technology that quitting or changing to an updated version is out of the question.
``Say the device you manufacture is made of six materials, all no longer available for long-term implants. A company in this position will spend millions evaluating a device they can't market.
``If they're a single-product company, they can't buy any of the materials for the use they [want them] for. They'll have to switch to a clone, hoping the problem will go away,'' McMillin said.
Yet while some in the industry cast nervous glances at what they see as dark clouds on that horizon, there is a thriving community of small companies making specialty polymers in the tiny amounts needed for surgical implants. For them, it's only partly cloudy.
Dow Plastics announced its removal of polyurethane from the market for permanent implants in 1990, and stopped supplying the material for long-term applications last April. DuPont Co. pulled its patented polytetra-flouroethylene and polyacetal, and other products from the medical field in January 1994, allowing customers to stockpile a three-year supply after that date. DuPont items not affected included only those in development or produced under joint ventures.
Dow Corning, seeking bankruptcy pro-tection because of the costs of defending its silicone product used in breast implants, may remove the product from the market altogether.
When major companies get out of the medical applications market, small companies with far fewer resources jump in, said Leonard Pinchuk, vice president for product development at Corvita Corp. in Miami, a supplier to the implantable vascular graft industry and a captive manufacturer of resins.
The fill-in suppliers fall into three categories, Pinchuk said: Those who duplicate what the major manufacturer once made; those who redesign the material to avoid legal and medical problems; or a consortium of manufacturers and suppliers whose members develop a replacement, but maintain their own liability.
Corvita falls into the last category, Pinchuk said.
Generally, he said, smaller companies will have data showing a significant improvement over the material they are replacing, complete with ``hold-harmless'' agreements that ultimately shift responsibility to the buyer.
The Washington-based Health Industry Manufacturers Association estimates some 7.5 million procedures requiring biomaterials - everything from drawing blood to implanting artificial hearts - were performed in 1993, the latest year for which such information is available.
Michael Szycher, chairman and chief technical officer of PolyMedica Industries Inc. of Woburn, Mass., estimates sales in the device industry at $42 billion annually, with 2,500 medical device manufacturers making up the industry.
Only 15 companies have more than 500 employees. The majority, he said, have fewer than 100 employees.
Most polymer medical applications are extruded - tubular and flexible. Far fewer are injection molded.
The small size of most implant component makers helps to shield the firms from lawyers looking for big damages, Szycher said.
And, he said, the threat of liability is less for molders and other firms further away from the final, implantable product.
Some companies, Pinchuk said, show little or no money on their books and may spin off materials companies if those firms start making money.
Szycher's company manufactures some medical devices, such as wound dressings, and synthesizes its own polycarbonate-based polyurethanes for other customers. He and Pinchuk acknowledge they are rivals in their field.
The U.S. has the lead in the world medical device industry, ``but we're losing it,'' Szycher said. ``But the regulatory agencies are so risk-averse that very few innovative developments'' are going to take place in America in the near future, barring any congressional change in the regulatory climate.
That could take years, as Congress has placed both regulatory reform and specific legislationoffering relief to biomedical suppliers on the back burner this session.
The Food and Drug Administration, which oversees the biomedical industry, approves only devices, not materials, for use in medicine.
Manufacturers must supply the FDA with information about the materials used in devices; many complain the FDA will ask for increasing amounts of such information in years to come, regardless of the application seeking approval.
One answer to the continuing challenge of liability is in a nationwide implant retrieval system, possibly overseen by the FDA.
Such a system, said proponents, would help find problems with materials before they are used in implants. Michael N. Helmus, materials group director for Baxter Healthcare Corp.'s Edwards CVS Research & Development Division in Irvine, Calif., said he believes such a system could work.
A potential hurdle would be the required disclosure of proprietary information, he said.
``Can manufacturers become comfortable with a system that has the potential of making their exact formulations available to competitors?'' Helmus said.
FDA spokeswoman Sharon Snider said no such system is being studied now. However, for two years, the FDA has monitored the success of 22 critical implants and medical devices, such as vascular graft implants, replacement heart valves and tracheal implants with its device tracking system. The system was mandated under the 1990 Safe Medical Devices Act.
Under the tracking system, manufacturers must have systems to track their products through the distribution chain to the patient. Manufacturers must, if asked, provide names of patients and locations of devices to the FDA in 10 working days.
The question of liability and supply goes beyond whether a given material or device performs well within the body. If a replacement for a legally troubled plastic is available, the FDA has a means of determining if a material is ``not substantially different'' from another material.
McMillin worries: ``You can show the material [that a company would like to use] is not substantially different - then the concern is that manufacturers won't sell it to you.''
Lack of current supply is not a reason for panic, Pinchuk said.
``There doesn't have to be a crisis in three years. The whining you hear is from people who don't want to do the research or who don't want to spend the money for a suitable replacement,'' Pinchuk said.
``The industry doesn't want to change materials, especially if it runs well in their molds. They don't want to go to the trouble of getting approval of a new material'' to use in their proc-esses.
Pinchuk developed a material called Corethane that replaces the polyurethane resin Dow Chemical stopped selling for the permanent implant market.
Another positive voice in the future of plastics in the medical industry is Baxter's Helmus, who noted: ``The industry is coming to terms with [product availability]. It's not grinding to a halt. It's like the oil shortage. It didn't become a problem until there were no alternatives.''
He added, ``Companies that got burned - like DuPont, Dow Chemical, Dow Corning - are not likely to reverse themselves and start providing resin again for biomedical purposes.''