WPC 2J ZBx6X@X@X0Í ÍX0Í Í2|#|x #X|xP7XP#   STATEMENT OF M. KRISTEN RAND, COUNSEL on Behalf of CONSUMERS UNION [ [ CONSUMER FEDERATION OF AMERICA  PUBLIC CITIZEN'S CONGRESS WATCH Before the BBREGULATION AND GOVERNMENT INFORMATION SUBCOMMITTEE Of the . . GOVERNMENTAL AFFAIRS COMMITTEE UNITED STATES SENATE on the  AVAILABILITY OF MEDICAL DEVICES ~~May 20, 1994 Č#x6X@X@#  Mr. Chairman, members of the Subcommittee, I am Kristen Rand, Counsel in the Washington Office of Consumers Union, the publisher of Consumer Reports. Thank you for the opportunity to share our views regarding medical device materials suppliers. I am testifying today on behalf of Consumers Union (CU) Public Citizen's Congress Watch and Consumer Federation of America (CFA). Consumer access to safe, effective medical devices is of great concern to all of our organizations. We recognize that many people's health and even lives depend on the continued availability of welldesigned and safe medical devices. We are also aware that device manufacturers complain that many suppliers of raw materials are refusing to furnish substances critical to the production of a variety of medical devices. If there is a danger that consumers will be denied access to safe medical devices because of a lack of availability of raw materials, that is indeed a problem. Before we hurry to implement changes that might affect device regulation, however, several key questions must be answered: (1) does a problem really exist? (2) if it does, what is its scope? and (3) what remedy, if any, is warranted? We appreciate the opportunity to be here today not only to     present the views of our organizations but also to help accurately evaluate the situation. Particularly with regard to medical devices, our organizations always proceed with extreme caution. The past few decades are replete with examples of manufacturers making assurances to Congress and the public that a particular device is safe but claiming that its availability is nevertheless threatened by the product liability system. Almost without fail, we later discover that the device at issue is unreasonably dangerous or defective. This experience has forced us to be skeptical and not accept at face value claims made by the device industry and manufacturers. One example of proponents of liability "reform" making misleading claims about the safety of a device is the Vitek jaw implant. In 1990, Malcolm Skolnick, a professor of biophysics at the University of Texas testified before the Senate Commerce Committee that jaw implants manufactured by Vitek, Inc. and used to treat a condition known as temporomandibular joint dysfunction were safe but that Vitek was in danger of being driven out of the market by frivolous the product liability suits. When we investigated this claim, however, we discovered that the FDA had, a month prior to Professor Skolnick's testimony, required Vitek to distribute a letter to oral surgeons warning of the device's tendency to fragment. FDA later issued its most stringent recall order for the device. In addition, a subcommittee of the House Government Operations Committee uncovered evidence suggesting that there were serious problems with the Vitek implant as early as 1986. The late Congressman Ted Weiss who chaired hearings on the issue concluded, "There is evidence that the overwhelming majority of the grafts and implants will eventually fail if they haven't already." Human Resources and Intergovernmental Relations Subcommittee, Committee on Government Operations, U.S. House of Representatives, June 4, 1992. Incidents such as the Vitek implant force us to very carefully evaluate any claims made by medical device manufacturers about the effects of liability on their products. From our perspective, it is imperative that any fix designed to ensure the availability of devices not end up hurting consumers more than helping them. At this time, since there is no specific proposal from those seeking relief it is difficult for us to determine if we could reach an agreement regarding a specific remedy, but we are interested in reviewing alternatives that may be offered to resolve the issue. Meanwhile, we can identify some proposals which have been discussed in the context of medical device availability which we strenuously oppose. In general, we are opposed to changes in the civil justice system that would result in diminution of the rights of consumers to recover fair and adequate compensation through the courts. Limitation on Joint and Several Liability is Not the Answer ČThe Health Industry Manufacturers Association (HIMA) supports the limitations on joint and several liability contained in S. 687, the "Product Liability Fairness Act." We find their stated position on the joint and several provision somewhat confusing. HIMA has stated that raw materials suppliers "may be brought into litigation and held liable for damages, even though the supplier has no direct role in the material's ultimate use as a biomaterial. As a direct result of this predicament, three major raw materials suppliers recently announced that they would limit or cease altogether their shipments to medical device manufacturers." HIMA written testimony before the House Subcommittee on Commerce, Consumers Protection and Competitiveness, February 2, 1994. We find this fear on the part of materials suppliers odd in light of the fact that courts are routinely dismissing suits against suppliers who sell components to manufacturers that make devices later found to be defective. For example, a federal court in Hawaii recently granted summary judgment to Du Pont and Dow Corning in a case alleging injuries from an implant manufactured by a bankrupt company. The court refused to hold the suppliers liable where an inherently safe component part is used in a defective end product.s Kealoha v. E.I. du Pont de Nemours & Co., DC Hawaii, No. 9200282, February 24, 1994. s Other courts have dismissed similar cases. See e.g. Bond v. E.I. du Pont de Nemours & Co., Colo Ct App. No. 92CA0624, June 3, 1994 and Lamontagne v. Du Pont Co., DC Conn, No. 3:91 CV 142, September 29, 1993. All of these cases involve Dow Corning and\or Du Pont supplying materials for the Vitek jaw implant discussed above. Manufacturers are clearly not in danger of being held liable merely for supplying safe components even when the devices into which they are incorporated are found to be defective.1 Moreover, in all of the cases cited above, the manufacturer of the defective device, Vitek Inc., was bankrupt. This fact argues contrary to manufacturers' often repeated concern that innocent "deeppocket" defendants are forced to pay when other culpable parties are judgment proof.1 Although courts are dismissing cases against component manufacturers where there is no evidence that the suppliers know that their materials were being used in a dangerous manner, we feel strongly that the potential for liability must remain where a defendant does know that a manufacturer is using a component in an unsafe manner. This is the law, for example, under the Connecticut Product Liability Act. This was the rule applied in Lamontagne, supra. In addition, it is important to try not to encourage manufacturers to turn a blind eye should suspicions be raised that its components are being used in an unsafe manner.  Blanket protection for manufacturers of raw materials or device components is inappropriate and unacceptable. Determining whether a particular component manufacturer has sufficient knowledge of a hazardous use of its components is a fact specific inquiry that is best made on a case by case basis. A Bar on Recovery of Punitive Damages for Devices Approved by FDA is Not the Answer HIMA has also expressed support for the FDA defense contained in S. 687. This provision would bar recovery of punitive damages in a case involving a drug or medical device approved by the FDA, unless there was fraud perpetrated on the agency. Our organizations are adamantly opposed to this comprehensive protection for medical devices from liability for punitive damages. History clearly demonstrates that despite the appearance of a thorough and extensive regulatory regime, the FDA has not been able to adequately protect the public from manufacturers who knowingly or recklessly market dangerous medical devices. There are far too many examples of instances where FDA could not by itself adequately protect the public from dangerous, defective medical devices. Examples of dangerous devices that managed to get through the FDA approval process include:  % Injectable bovine collagen In 1981 the FDA approved bovine collagen as a device. FDA accepted the manufacturer's clinical data despite serious gaps in the information including: lack of adequate followup; lack of representative clinical subjects for the type and age of the population that would use the product; and FDA failure to review safety information prior to premarket approval. Subsequent to premarket approval, adverse reactions apparently associated with the product began to occur. The reactions included serious autoimmune diseases. In 1991, FDA Commissioner Kessler acknowledged that there was an association between bovine collagen injections and autoimmune reactions. Meanwhile, the manufacturer engaged in continuing violations of FDA regulations including underreporting of adverse reactions, unreported label changes and making misleading claims of efficacy. It is worth noting that the manufacturer of bovine collagen actively sought approval of the substance as a medical device rather than as a drug. A member of the board of directors of the manufacturer testified in a deposition that the timeconsuming drug approval process could have damaged the firm's chances to market the product.\ Deposition of Terry Knapp, MD in Ramey v. Collagen Corp. (Texas)\ % Theratronics radiation equipment FDA approved the Therac 20 Linear Accelerator in 1977 for use in the treatment of cancer. In 1983, the company introduced the Therac 25. In 1986 and 1987 the device was associated with three deaths of patients undergoing cancer therapy. When the FDA undertook an internal review after the three deaths, the agency could not locate any record of the device's premarket approval. Apparently, the company had submitted an application, had received approval but FDA had failed to keep records of the approval. Between 1984 and 1988, five deaths were associated with malfunction of a Theratronics linear accelerator and a number of incidents associated with over or underexposure to radiation were reported. It was not until 1991, however, that FDA prohibited the importation of the device. The Subcommittee on Oversight and Investigation of the House Energy and Commerce Committeea "Less than the Sum of Its Parts: Reforms Needed in the Organization, Management and Resources of the Food and Drug Administration's Center for Devices and Radiological Health" A Report of the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, U.S. House of Representatives, May 1993.a determined that in the case of Theratronics, FDA had failed to (1) ensure that the manufacturer had demonstrated either safety and efficacy or substantial equivalence before premarket approval; (2) take timely and decisive action when problems were exposed; and (3) conduct necessary inspections upon requests of the agency's own inspectors. As a result of these failures, the subcommittee report concluded, "a machine was allowed on the market that actually killed patients seeking to benefit from it, and that my have been ineffective in treating lifethreatening diseases." Unfortunately, there are many more examples we frequently cite including the BjorkShiley heart valve, silicone breast implants, and Copper7 IUD illustrating FDA's inability to adequately police the medical device industry and to provide assurance that medical devices are safe for their intended use. Deficiencies in FDA oversight of the medical device industry are acknowledged by the agency itself. In November of 1993, the agency proposed to make medical manufacturers follow quality standards during the design phase as well as during production. In announcing the proposal, the agency cited a figure blaming design flaws for 44% of problems that force manufacturers to recall defective products. CONCLUSION  Currently, federal regulation of the medical device industry is simply inadequate. Civil liability for manufacturing and marketing dangerously defective medical devices provides an irreplaceable incentive in making medical devices safer and in ensuring that consumers who are injured by defective devices are compensated. Therefore, our organizations feel very strongly that any action designed to remedy what problems medical device manufacturers may be experiencing with suppliers must not consist of liability shields. Our resistance to remedies involving changes in the tort system should not be read as refusal to engage in discussions of other types of proposals. If we are satisfied that a real problem does exist, we would be happy to explore remedies that do not limit consumers rights to recover when they are injured by dangerous medical devices. Some options that we are willing to explore with the manufacturers could include indemnification for litigation expenses or government subsidies for production of vital raw materials. Thank you.