Special Protection for Drugs, Not Devices
A special exception to strict liability has been carved out for drugs and vaccines because of their unique status in society. During debates at the American Law Institute regarding product liability, members proposed that drugs should be exempted from strict liability because it would be "against the public interest" because of the law's "very serious tendency to stifle medical research and testing." A comment (known as "comment k") following the relevant section in the Restatement provides that the producer of a properly manufactured prescription drug may be held liable for injuries caused by the product only if it was not accompanied by a warning of the dangers that the manufacturer
knew or should have known. The comment balances basic tort law considerations of deterrence, incentives for safety, and compensation by recognizing that drugs and vaccines are unavoidably unsafe. Comment k has been adopted in virtually all jurisdictions that have considered the matter.[25]
For detailed discussion of comment k, see Victor E. Schwartz, "Unavoidably Unsafe Products: Clarifying the Meaning and Policy Behind Comment K," Washington and Lee Law Review 42 (1985): 1139-1148, and Joseph A. Page, "Generic Product Risks: The Case Against Comment K and for Strict Tort Liability," New York University Law Review 58 (1983): 853-891. The California Supreme Court recently disapproved the holding in a prior case which would have conditioned the application of the exemption under certain circumstances. California came down squarely on the side of comment k. In holding that a drug manufacturer's liability for a design defect in a drug should not be measured by strict liability, the court reasoned that "because of the public interest in the development, availability, and reasonable price of drugs, the appropriate test for determining responsibility is comment k.... Public policy favors the development and marketing of beneficial new drugs, even though some risks, perhaps serious ones, might accompany their introduction, because drugs can save lives and reduce pain and suffering." Brown v. Superior Court, 44C 3d 1049, 245 Cal. Rptr. 412 (31 March 1988) at 1059.
Of course, as pharmaceutical manufacturers would be the first to say, the comment k exemption does not eliminate liability exposure. Drugs and vaccines may be exempt from design defect claims, but producers may still be held liable for failure to warn and for negligence. Because pharmaceutical products account for many of the liability actions, this exemption is quite limited in practice.[26]
The GAO report found that drug products, including bendectin, a morning sickness drug, DES, a synthetic hormone used to prevent miscarriage, and Oraflex, an arthritis medicine, accounted for significant amounts of product liability litigation. GAO, "Product Liability," 12.
Generally speaking, medical devices have been treated like all other consumer products with regard to both negligence and strict liability in most jurisdictions. A handful of cases from scattered courts, however, have grappled with the relationship of the special exemption for drugs under comment k to other medical products like medical devices. Three cases involve injuries from IUDs. While these cases do not presage any major shifts in the case law, they do provide some insight on the thorny problem of distinguishing drugs from devices in the policymaking process.
In Terhune v. A. H. Robins,[ 27]
90 Wash. 2d 9 (1978).
the plaintiff suffered injuries from a Dalkon Shield. She argued that A. H. Robins had failed to warn her of the risks associated with the product. The Washington State Supreme Court held that because the IUD is a prescription device, comment k applies. (The case was brought before the Medical Device Amendments had been implemented; the court said that the fact that there was no FDA approval before marketing was irrelevant.) Precedents held that the duty to warn of risks associated with prescription drugs ran only from manufacturer to physician. Prescription devices, which cannot be legally sold except to physicians, or under the prescription of a physician, are classified the same as prescription drugs for purposes of warning.The Oklahoma Supreme Court decided a similar case several years later. In McKee v. Moore,[28]
648 P.2d 21 (Okla. 1982).
the plaintiff was injured by a Lippes Loop, the IUD manufactured by Ortho Pharmaceutical. As in the Terhune case, the plaintiff alleged that the companyfailed to warn of side effects. The Oklahoma Supreme Court equated prescription drugs and devices: "[U]nlike most other products, however, prescription drugs and devices may cause unwanted side effects even though they have been carefully and properly manufactured."[29]
Ibid., 23.
The issue is somewhat different in the context of design defects. A California appellate court recently grappled with the differences between drugs and devices in the area of design. In Collins v. Ortho Pharmaceutical,[ 30]
231 Cal. Rptr. 396 (1986).
the plaintiff alleged that the Lippes Loop that injured her was defectively designed. The court, citing the Terhune and McKee cases, equated prescription drugs and prescription devices. These products have been determined to be unavoidably unsafe, said the court, because they are reviewed by the FDA and contain warnings about use. The discussion in the case seems to confuse the concept of a prescription product with the process of premarket approval. Of course, all drugs must undergo premarket approval by the FDA before marketing. However, as we know, the Medical Device Amendments do not require premarket screening for all devices. Indeed, the device IUDs, including the Lippes Loop, did not require PMAs when they entered the market in the early 1970s.[31]For discussion of the Medical Device Amendments, see chapter 4. All Class I and Class II devices, as well as those entering the market under the 510k provision, do not undergo safety and efficacy screening similar to drugs. Some of these products may be limited to prescriptions or have labeling requirements imposed, however.
To the extent that the court is assuming that the FDA's premarket approval confers the unavoidably unsafe status, the analogy to devices is inapt. However, the analogy does seem appropriate for Class III devices.Many unanswered questions remain. How much meaning does prescription confer? What about hospital equipment that is not prescribed per se, such as resuscitation equipment or monitoring apparatus? The answers are unclear, though there are important distinctions that the courts have not begun to consider.
Manufacturing defects are most frequently cited as the cause of injury in product-related suits arising from the use of medical devices. While it is increasingly common for strict liability claims to be brought in medical device cases, negligence continues to be the most common theory of recovery. The struggle in the courts on how to characterize medical devices for purposes of liability underscores the diversity of the products in the industry and the limited understanding of the relationship of devices to medical
care. It also recalls the thorny drug/device distinctions that FDA and Congress grappled with in crafting regulatory principles.