by Nadim J. Hallab, PhD; Joshua J. Jacobs, MD; Jonathan Black, PhD; and Matthew J. Iverson, JD
Nadim J. Hallab, PhD, is a post-doctoral fellow, department of orthopaedic surgery, Rush Medical College, Chicago; Joshua J. Jacobs, MD, is section director of biomaterials research and associate professor, department of orthopaedic surgery, Rush Medical College, Chicago; Jonathan Black, PhD, is a principal IMN Biomaterials investigator; and Matthew J. Iverson, JD, is a partner in the law firm of Burditt & Radzius, Chtd., Chicago.
The impending threat to the availability of United States-based biomaterials supplies is beginning to become a reality. Some suppliers of materials for medical devices (biomaterials), alarmed by massive class action lawsuits stemming mostly from bodily injury allegedly incurred from temporomandibular joint (TMJ) and breast implants, are leaving the medical market.
In 1992, some materials suppliers began informing medical device manufacturers that they intended to stop providing biomaterials for some short-term (less than 30 days) and chronic (more than 30 days) use applications.1 However, the supply of raw materials was allowed to continue for several years to allow device manufactures to find and qualify alternative sources. Thus far, patients have not felt the effects of this raw material shortage due to the stockpiling of raw materials by most medical device manufacturers. These supplies were accumulated in late 1994 and should last until approximately 1998.2
In response to this situation, Congress attempted to enact "The Biomaterials Access Assurance Act" in 1995 (hereafter "Biomaterials Act"). This legislation was eventually approved by Congress as Title II in "The Common Sense Product Reform Act of 1996," (H.R. 956) and sent to President Clinton as part of broader product liability reform legislation. The Biomaterials Act would have afforded biomaterial suppliers more protection against product liability claims brought against medical devices in which the biomaterial was incorporated. Unfortunately, the President vetoed the bill, even though he favored the Biomaterials Act portion. President Clinton opposed other provisions of this broad product liability legislation, including limits imposed on punitive damage recoveries. This legislation is certain to be introduced in the new session of Congress where it may meet with more success.
Meanwhile, the medical device industry is in the middle of a slowly developing "crisis" due to the increasing reluctance of materials suppliers to incur the associated medical end-product liability. A number of suppliers have already stopped shipping some biomaterials to the medical industry. This situation has occurred in spite of existing product liability defenses designed to protect "raw material" or "bulk suppliers." As the court states in the case of Doris Jacobs vs. E.I. du Pont de Nemours & Company,3 "(W)e believe that the common law cannot countenance what (the product liability plaintiffs) insist we do, which is to make raw material suppliers grantors of finished products over which they have little control. Under such a reading of the law, companies would have no choice but to take their products off the market entirely or to double-check their suitability in many new applications before making such sales."
Other legal doctrines, such as the "sophisticated user" and "learned intermediary," also provide a measure of legal support to raw material manufacturers. These doctrines provide that, under appropriate circumstances, a biomaterial supplier has no obligation to warn any person in which a medical device is about to be implanted about possible hazards or side effects of that biomaterial.4
Judge Sam Pointer, the federal court judge (N.D. Alabama 1995) before whom all breast implant litigation pending in federal courts has been consolidated, has stated in a ruling in favor of a biomaterials supplier: "After reviewing the decisions in the various states, as well as the Restatement and the public policy considerations, this court concludes that no state would impose liability in a raw materials supplier situation like this (i.e. supplying polyurethane foam for breast implants), not involving an inherently dangerous or a defectively manufactured product. (Scotfoam) the biomaterial supplier did not... have a duty to warn about possible hazards from using foam in the human body."5
Dismisses du Pont
Last October, the U.S. Court of Appeals for the 8th Circuit affirmed dismissing du Pont as a biomaterial supplier from 280 additional cases, including defective TMJ implants manufactured by a separate medical device company.6 In affirming the dismissal of du Pont, the 8th Circuit stated that du Pont was not liable for any "design" defect because "suppliers of inherently safe 'component' parts are not responsible for accidents that result when the parts are integrated into a larger system that the component part supplier did not design or build."6 "The [recipients of the TMJ implants] simply have failed to show that the disintegration of the implant was due to any design defect in the fluronated ethylene prolylene (FEP) film itself rather than [the medical device manufacturer's] erroneous decision to incorporate what turned out to be an unsuitable material into its implants."6 Finally, the 8th Circuit affirmed that this biomaterial supplier had no duty to warn TMJ implant recipients of the dangers posed by the FEP film in the implants. Rather, "under the raw material/component part supplier doctrine, suppliers of inherently safe raw materials have no duty (i.e., obligation) to warn end-users of a finished product about dangers posed by the incorporation of the raw materials into that product."6
Given court decisions which support biomaterial suppliers in product liability litigation, why is there a crisis? Why are many materials manufacturers now unwilling to sell to the medical device industry? The most likely reason is the large costs involved in extricating the supplier from product liability after litigation has commenced.3 This expense is often greater than the market value of the materials incorporated into the associated medical device. Typically, material suppliers prevail in court using legal doctrines like those described above. But they do so only after spending enormous and sometimes ruinous amounts on discovery and pretrial arguments over disputed issues of fact.4
Du Pont's involvement as a biomaterial supplier in the TMJ implant litigation is a striking example of these distorted economic consequences. Du Pont sells approximately $10.5 billion worth of Teflon®, Dacron® and Delrin® per year. However, only $600,000 of these materials per year was ever sold to the medical device industry. This is less than 0.01 percent of the revenue generated from du Pont's annual sales of these raw materials. Yet du Pont was forced to spend approximately $8 million per year defending itself in the TMJ implant litigation involving hundreds of lawsuits.
Du Pont sold tiny amounts of Teflon® biomaterial to Vitek, Inc., upon whom the responsibility for designing, manufacturing, marketing, selling and distributing the implants rested. However, when the implants started to fail and litigation ensued, Vitek filed for bankruptcy and du Pont was left as the only "deep pocket." Because of this experience, du Pont now refuses to sell needed biomaterials to the medical device industry.
Unfortunately, du Pont's bad experience is not unique. Hoechst Celanese has withdrawn polyacetyl resin from the medical device industry which had purchased 550 pounds of material annually at a total cost of $3,300. This small amount was simply not worth the risk of product liability exposure, particularly when compared to the $1.3 billion of this product sold annually to plumbing, automotive and consumer product companies7.
In another well-publicized case, Dow Corning, as both a biomaterial supplier and a manufacturer of breast implants, in 1993 offered approximately $2 billion as its share of a global class action that would have exceeded $4 billion in nominal dollars. Although the settlement was originally found acceptable by various parties, it ultimately was rendered null and void by subsequent events, including the bankruptcy of Dow Corning.
The immensity of this proposed settlement sent shock waves throughout the biomaterials supply industry. However, it is illuminating to examine the consequent availability of silicone biomaterials. Although it is widely believed that Dow Corning no longer manufactures silicone biomaterials, it continues to supply them for a number of short-term and external applications and, with appropriate indemnification, for a very limited number of chronic applications. Two small companies, NuSil Technology (Carpinturia, Calif.) and Applied Silicones (Ventura, Calif.) have filled the breach created by this change in policy. As a consequence, there is actually a wider range of silicone materials available, albeit at sharply higher prices, to device manufacturers. These materials have been fully qualified as not substantially different from previously available materials and master files have been placed with the Food and Drug Administration (FDA). Brian Nash, vice president/marketing and sales, Nusil Technology, states, "After meeting the current needs of device manufacturers, we are moving ahead to develop improved materials which our customers request."
This situation has not yet touched the orthopaedic device industry, although there are real concerns. The clinical use of implants in orthopaedic surgery is critically dependent upon the continuing availability of implant-grade metal alloys and ultra high molecular weight polyethylene (UHMWPE).
There is concern about the future availability of UHMWPE, due both to the small number of resin manufacturers and rod and block fabricators, and to the emerging implication of particulate polymeric materials in osteolysis associated with total joint replacements. However, despite this, a firm relatively new to the U.S. market, PerPlas Medical (Bacup, United Kingdom) is actively making the rounds of U.S. implant manufacturers. Representatives of this company have stated their willingness to sell to U.S. medical device manufacturers various grades of UHMWPE, certified to meet ISO, ASTM or the device manufacturers' own corporate standards.
Supply of metallic biomaterials for orthopaedic applications remains highly competitive, with Allvac (Monroe, N.C.), Carpenter Technology (Reading, Pa.) and TIMET (Henderson, Nev.) as major suppliers of various alloys. Emblematic of this healthy situation is the active development of improved versions of current alloys and several collaborative efforts with orthopaedic implant manufacturers to develop and standardize new titanium-based alloys.
Finally, ceramic structural materials, which have not yet seen significant use in the U.S., are now the subject of extensive sales efforts by three European Community firms (Demarquest [Evreux, France], CeramTec [Stuttgart, Germany], and Morgan Matroc [Rugby, United Kingdom]) to device manufacturers here.
The expectation that biomaterials can be intrinsically "safe" is responsible in part for what remains an ongoing biomaterials controversy. This expectation is in error and involves a misreading of the Medical Device Amendments (1976) and a misunderstanding of the concept of "biocompatibility." As previously stated by one:9 "It is clear that, to the certainty and simplicity required by legal proceedings, no biomaterial can be said to be safe. Nor can one say that any biomaterial is unsafe. All that can be said, after examining the clinical experience of a patient or a group of patients is that the material, in that setting is either biocompatible or not biocompatible."
Thus, the FDA regulates the safety and effectiveness of medical devices (not biomaterials) and the performance of their materials of manufacture should be judged relative to device design and clinical use. The apparent inability of a biomaterial to perform adequately in a specific device, although perhaps illustrative of larger trends, is likely to be what it appears: an unsatisfactory outcome of the use of a specific device in a specific application (in specific patients). It remains to be seen to what degree such observations can be generalized. Thus, it is inappropriate to make general statements about the "safety" of any biomaterial and/or material fabrication or treatment process.
However, in spite of the growing understanding of biomaterial performance, the list of biomaterials unavailable (from traditional suppliers) to the medical device industry is likely to continue to grow. This is seemingly in no one's best interests, neither that of the biomaterials suppliers, the device manufacturers, or the patients who are the beneficiaries of medical devices. There are entrepreneurial materials suppliers who are strongly committed to providing a continuing supply of biomaterials for the medical device industry. However, the current litigious environment, particularly the high costs of legal representation and defense, is a concern even to these companies. Legislative relief, such as a revived "Biomaterials Act," may eventually alleviate this situation to some degree. However, without comprehensive policy, generated through discussion involving scientific, medical and manufacturing communities and the involved federal agencies, biomaterial shortages may well worsen.