Knowledge and Power: Drug Products Liability Actions and Women’s Health
Knowledge and Power:
Drug Products Liability
Actions and Women’s Health
While products liability law has provided a strong basis for consumer claims, its impact on women’s lives and interests has been less clearly beneficial. Beginning in 1932 with the House of Lords’ decision in Donoghue v Stevenson ([1932]: [599]), a duty of care has been owed by product manufacturers to the ‘ultimate consumer’ to take reasonable care in the ‘preparation or putting up’ of a product to avoid causing foreseeable injury. The principled basis of the decision was set out most broadly in Lord Atkins’ familiar neighbour principle.
Further protection is offered to consumers through the duty on product manufacturers to warn of product risks, to an extent commensurate with the product’s danger. The duty to warn is assessed on the basis of what manufacturers know or ought to know about the risks inherent in the product. These dual duties, in the areas of manufacturing and information disclosure, set standards for manufacturers. The purpose of these actions, like other tort actions, is compensation for harm and deterrence of wrongdoing. In addition to compensation and harm avoidance, the products liability action has two additional purposes: autonomy and product honesty. Autonomy is supported through the duty to disclose the information essential to choice while product honesty is to be advanced through requiring the information representing the product’s risks. Knowledge that is full and accurate is essential to empowering patient choice.
Does the products liability action succeed in meeting these purposes for women? I will argue that the action’s considerable potential to meet these goals has not been realised and that women and girls are adversely affected by its shortcomings. I will focus on the area of prescription drugs and devices to assess this question. The chapter begins with an examination of product liability actions for manufacturing failures and breach of the duty to disclose, through analysis of Donoghue v Stevenson and its descendants in Canada, the UK and Australia. The next section is an examination of the impact of this action on women, beginning with consideration of the mass tort claims brought through the latter half of the twentieth century for thalidomide, DES, the Dalkon Shield and breast implants. US actions will be examined in this section. Following the historical analysis, this section examines the nature of drug testing and the resulting knowledge deficit that has existed in relation to drug products used by women. The following section consists of an analysis of the duty to disclose action and learned intermediary rule that considers its application in actions related to birth control, breast implants and Vioxx. Following this analysis, the chapter examines how information is structured through promotion and considers its impact on understanding. The chapter concludes with an assessment of the success of disclosure actions in achieving compensation, avoiding harm, promoting autonomy and ensuring product honesty, and how products liability actions might become more successful actions for women.
Products liability law: claims for manufacturing
breaches
Products liability actions in the UK, Canada and Australia are based on the House of Lords’ decision in Donoghue v Stevenson [1932]. The action proceeded to the House of Lords from Scotland on the issue of whether a duty of care existed where a drink bottling company allegedly allowed a snail into its ginger beer bottle, resulting in the consumer suffering severe gastroenteritis and nervous shock after she consumed a ginger beer float. Lord Atkin formulated the duty of care in the ‘neighbour principle’, duty’s most succinct and comprehensive statement:
You must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour. Who, then, in law is my neighbour? The answer seems to be – persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts or omissions which are called in question.
(Lord Atkin in Donoghue [1932]: [580])
Lord Atkin further set out the ‘manufacturer’s principle’ (Heuston 1957), stating the duty of care principle in the narrower context of the products liability action within which it arose:
… a manufacturer of products, which he sells in such a form as to show that he intends them to reach the ultimate consumer in the form in which they left him with no reasonable possibility of intermediate examination, and with the knowledge that the absence of reasonable care in the preparation or putting up of the products will result in an injury to the consumer’s life or property, owes a duty to the consumer to take that reasonable care.
(Lord Atkin, Donoghue [1932]: [599])
The decision to recognise a duty of care in this circumstance, based on the broad statements of principle underlying it, was groundbreaking, and eventually led to the vast expansion of negligence law of the latter half of the 20th century. In significant departures from contemporary currents of products liability, these claims could be brought by the ‘ultimate consumer’, who needed no contractual relationship with the manufacturer, against the manufacturer of products, without being confined to particular kinds of defects, for foreseeable injuries caused to the consumer, without reference to any related intentional tort (Heuston 1957). The process was accelerated when Lord Wilberforce set out a framework for duty analysis in the two-stage test in Anns v Merton London Borough Council [1977]: [498]. First, a prima facie duty of care was established if there existed ‘a sufficient relationship of proximity or neighbourhood’ that harm was reasonably foreseeable. Once reasonable foreseeability was established, the onus shifted to the defendant to negative the duty or its scope, on the basis of policy considerations. The Anns case provided a framework through which the Donoghue v Stevenson principles were analysed and an explicit statement as to the role of the policy dimension established in that case.
In Sutherland Shire Council v Heyman [1985], the Australian High Court adopted a more restrictive test for duty, one that emphasised proximity as a distinct test separate from reasonable foreseeability instead of subsumed within it [446]–[447]. The House of Lords similarly reigned in the duty of care, first through overruling Anns on the basis of its unpredictability, unworkability and lack of a principled foundation in Murphy v Brentwood District Council [1991] and subsequently by creating the separate test of proximity to add to the reasonable foreseeability test, making it a three-stage test with the requirement that it be ‘fair, just and reasonable’ to impose a duty of this scope, in the leading case of Caparo Industries plc v Dickman [1990]. In Sullivan v Moody [2001], the High Court of Australia rejected such a three-stage analysis of foreseeability, proximity and policy, instead engaging in analysis of relevant connecting factors between plaintiff and defendant to determine duty.
The Supreme Court of Canada absorbed the Anns test into law in Kamloops (City of) v Neilson [1984] and the Anns/Kamloops test acted as the framework for duty analysis in Canada until 2001. At that time, the Supreme Court of Canada took steps similar to those taken earlier in Australia and the UK. In Cooper v Hobart [2001], the Court adopted a revised test for duty of care, to be applied if precedent does not already exist for this category of duty. The test, as clarified in Childs v Desormeaux [2006], includes proximity as a separate element from foreseeability in establishing duty, along with policy analysis of factors with respect to the relationship, such as ‘expectations, representations, reliance, and the property or other interests involved’ to be applied before proceeding to the defendant’s attempt to negative duty on the basis of broader policy considerations affecting the overall system ([15]).
Applying the principles to drug products liability
The manufacturer’s principle requires care in the design and production of the product so as to avoid foreseeable harm to the ultimate consumer. Companies create products, which reflect the state of knowledge. As well as requiring care to avoid adulteration of products by snails or flies (the lowest common denominator), the duty requires that products be designed safely. As a result, enough knowledge about the product’s impact needs to be available to guide the manufacturer to avoid it. The reasonable foreseeability of the harm test requires such knowledge. The manufacturer’s responsibility to avoid such product harm carries with it the responsibility to study the product’s impact and be aware of its potential risks to persons who will use it. The standard of care is commonly analysed according to the Bolton v Stone [1951] test of probability of harm and gravity of the consequences. The cost of remedial measures and the social utility of the product are factors as well. For manufacturers, the custom of the industry and government standards would be relevant, although not determinative. Products that are ingested and used in intimate ways, such as food, drugs and implantable medical devices, are held to a very high standard of care (Hollis v Dow Corning Corp [1995]: [23]). An example of this type of knowledge is found in the McDonald’s coffee case (Liebeck v McDonald’s Restaurants, PTS Inc [1994]). The jury imposed liability on McDonald’s and compensated Stella Liebeck for her severe burns after proof that its coffee was super-heated to 180 degrees Fahrenheit, a temperature so high that it would produce third-degree burns in 12 to 15 seconds. The company condoned this high risk in order to improve the coffee’s flavour (Gerlin 1994: A1; Haltom and McCann 2004: 185–95).
Plaintiffs must prove that the breach of the duty of care has caused their harm. Causation in drug cases requires proof of the general scientific link: the evidence must demonstrate on the balance of probabilities that the drug causes that harm, such as the stroke in the oral contraceptive case Buchan v Ortho Pharmaceuticals (Canada) Ltd [1986]. Such proof may be very difficult for a plaintiff, as we saw in the breast implant litigation, where the lack of long-term studies made proof of an alleged causal link to auto-immune disorders virtually impossible. Writing after the issue had been studied more extensively; Marcia Angell commented that if there was ‘any link to various autoimmune diseases, it was so small that it could not be detected’. After ‘15 reasonably good studies’, ‘no solid scientific evidence’ existed for the link (Angell 1997: 216). In contrast, ruptures and capsular contracture (the creation of skin-covered nuggets of silicone) were demonstrably caused by the implants. In addition, the plaintiff must prove that the drug caused their particular harm in a scientific sense. The type of injury must have been reasonably foreseeable to the defendant and the harm must be of a type compensable by law.
Products liability claims may range from relatively small claims to mass tort actions. In each case, though, the plaintiff must litigate against a corporation and this fact imposes constraints on the ability to bring actions. The deep pockets of a corporate defendant may make it an appealing target, but those same resources can be effectively – and sometimes ruthlessly – deployed against plaintiffs. Those with fewer resources to mount such litigation are less likely to sue, or be able to sustain actions against delaying tactics and personal attacks that are sometimes used to cut off litigation. The expense of litigation acts as a considerable deterrent to plaintiffs in pursuing remedies through the courts, and legal aid is usually unavailable for personal injury claims of this sort.
The impact of drug development and
manufacturing breach actions on women
Drugs have a differential impact on women. Women seek help from doctors and other parts of the health care system more often than men. Women take more drugs than men. Because of women’s reproductive systems, along with the western cultural norm that women bear primary responsibility for birth control, women take oral contraceptives and emergency contraception. The social determinants of health include gender and such factors as poverty which increase the likelihood of illness and therefore of treatment with drugs. The social circumstances of women are more likely to include poverty and experiences of violence and abuse, and these may lead to greater need for health care. Women still act disproportionately as the caregivers for the health needs of others, including children and elderly relatives. Elderly women outlive men and have more complex health needs, often experiencing ‘poly-pharmacy’, the taking of multiple drugs, as a result. Persons with disabilities – elderly women among them – are more likely to be abused. On top of this, the drug development process has meant that less is known about the impact of drugs on women. This effect is magnified for pregnant women and elderly women. The disparity in scientific knowledge about the adverse effects of drugs means that women are less knowledgeable and more at risk of harm from the drugs.
Lessons from mass tort litigation
Thalidomide
Three instances of drug-induced injury are emblematic of corporate irresponsibility towards women and the mass harm produced by it. Thalidomide was introduced by the German company Chemie Grünenthal in 1957 as a sedative and was used as a sleeping pill and for morning sickness. It was widely marketed internationally under a variety of trade names, and this fact, combined with lack of testing, made identification of the problem more difficult (Law 1997: 360). Evidence of peripheral neuritis, a rare form of nerve damage, soon emerged, with the British Medical Journal publishing the first report in December 1960 (Silverman 2002: 405; Florence 1960: 1954) and its potent teratogenic effects became evident as babies were born with significant limb impairments involving foreshortened limbs, called phocomelia, cleft palates, internal organ defects and visual impairments. The Sunday Times investigation revealed that thalidomide caused deaths in the womb of up to 100,000 fetuses, while 10,000 babies were born alive (Sunday Times Insight Team 1979). The Sunday Times Insight Team demonstrated that Grünenthal and the UK manufacturer Distillers ‘had not met the basic testing requirements of the time’ (Flintoff 2008). No testing on fetal impact was carried out although the drug was heavily promoted in both countries as ‘the best drug for pregnant and nursing mothers’ (Silverman 2002: 405). Richardson-Merrell, the US licence-holder, was aware that a drug could cross the placenta to affect a fetus since their drug MER-29 had been shown to have such an effect, and the scientific literature provided such evidence for more than 200 drugs on various species. The company conducted no animal studies or clinical trials during pregnancy to determine whether thalidomide was actually safe. Instead, in the period prior to its application for approval, the company simply distributed thalidomide to doctors for use on more than 20,000 patients, including pregnant women, without adequate consent, oversight or reporting of consequences (Sunday Times Insight Team 1979: 68–72).
The product was removed from the market in 1961. In the US, where the product had not been approved, Congressional hearings were already taking place on drug regulation, and their response to the thalidomide damage led to the legislative requirement that manufacturers demonstrate the product’s efficacy in relation to its intended use, to accompany the existing safety requirement already necessary to secure US Food and Drug Administration (FDA) approval for marketing (US Food Drug and Cosmetic Act [2010]; Waxman 2003; Law 1997: 361). Canada followed suit. Canada had remarkably left thalidomide on the market for three months after evidence of its damage had emerged internationally, claiming later, in response to tort claims by victims against the government, that they lacked the regulatory authority to require the company to remove the product from the market. They provided limited compensation in response (War Amputations of Canada 1989: 122–4, 539).
The thalidomide disaster epitomises the human cost of inadequate testing and heavy promotion accompanied by cavalier unconcern for the health of pregnant women. While the legislative regimes in place at the time were inadequate to prevent the mass harm, the tort system was also ineffective as a deterrent. The jurisdictional issue was resolved in favour of the plaintiff in Australia where the product had been sold without any warning, in Distillers Co (Bio-Chemicals) Ltd v Thompson [1971]. Tort actions on behalf of the thalidomide-injured children were typically settled, with gag orders imposed in some jurisdictions precluding other plaintiffs from benefiting from the information. Merrell’s settlements with American and Canadian victims reportedly ranged from $100,000 to just under $1 million (Sanders 1992: 315), very small amounts for the lifelong impairments. Grünenthal settled for US$31 million and the German government for US$13.5 to 27 million with the German victims (War Amputations of Canada 1989: 7–8).
Diethylstilbestrol (DES)
The synthetic estrogen diethylstilbestrol (DES) was prescribed from 1947 to 1971 for prenatal use to prevent miscarriage even though evidence of the potential carcinogenic effect of natural and synthetic estrogens had been apparent in animal studies as early as the 1930s (Dutton 1988: 34, 37). Reliable studies demonstrated by the 1950s that DES was not effective for this purpose (Dutton 1988: 48–51, 54–7; Finley 1996: 66–7; National Film Board of Canada 1985). Diana Dutton noted that the FDA approved:
what amounted to mass experimentation on pregnant women – the sanctioned use of a drug with known risks whose effectiveness had not yet been fully proven. Yet only a short time later … the FDA would do nothing to rescind that authorization despite compelling evidence that DES was not in fact effective for its newly approved prenatal uses.
(Dutton 1988: 54)
In 1971 Dr Herbst and colleagues published their research linking DES to a rare form of vaginal cancer in the daughters of women who had taken DES during pregnancy (Finley 1996: 68). DES was eventually shown to cause other gynecological disorders in women, leading to significantly higher rates of miscarriage, ectopic pregnancy, stillbirths and premature delivery, along with higher infertility rates, male reproductive system abnormalities in DES sons, and an increased risk of breast cancer in the mothers (Dutton 1988: 87). In late 1971, a full eight months after receiving the Herbst study, the FDA announced that DES was contra-indicated during pregnancy (Finley 1996: 69). It continued to be used in the morning-after pill and in US livestock production for about another decade (Dutton 1988: 32). The DES story provides an example of the trust in wonder drugs that characterised the post-war period, trust by doctors in their unsubstantiated clinical views, inadequate testing by manufacturers and disregard for the risks of drugs during pregnancy, even after thalidomide (National Film Board of Canada 1985). Women were not warned of the product risks even after the product was taken off the market (Dutton 1988: 73–7).
Lawsuits against the primary producers of DES were based on a number of theories, including the duty to test the product for safety and the duty to warn doctors of the product risks, along with breach of warranty of effectiveness in preventing miscarriage and misrepresentation of safety data (Finley 1996: 73). Joyce Bichler, a DES daughter, sued and won a major victory. She claimed that, based on the tests that should have been done, a prudent manufacturer would not have put it on the market (Bichler v Eli Lilly Corp [1982]). This argument amounted to a failure of the company to test the product sufficiently. Her action against the industry succeeded on the basis of the concert of action theory, which attributed responsibility to industry members based on the evidentiary basis being sufficient to sustain the jury verdict of concerted action both on conscious parallel conduct and on substantial assistance, a finding that the failure to test on pregnant mice aided or encouraged other manufacturers to follow suit (188).
In addition to the hindrance posed by the lapse of time, other factors prevented women from knowing whether their mothers had taken the drug, including the impediment created by the lack of a legal entitlement to access one’s own medical records. Proof of causation was particularly difficult because DES had not been patented and numerous companies produced the product. For this reason, plaintiffs were often unable to determine which manufacturer had produced the specific drug taken by their mothers, to fulfil the tort requirement that causation link a specific defendant to the harm suffered by a particular plaintiff (Weinrib 1989). In Sindell v Abbott Laboratories [1980], the California Supreme Court decided that each of the major companies sued, producing 90 per cent of the product in the market, knew or should have known that it was unsafe and ineffective, and held them all liable, attributing responsibility to the manufacturers before the court according to their market share at the time of the injury, unless they could exculpate themselves. The market share liability solution provided some justice, by protecting plaintiffs from losing entirely where all the defendants were negligent and all caused harm to some plaintiffs but where the causal line could not be drawn from the particular manufacturer to the plaintiff although complete compensation was not provided under this theory (Bernstein 2003). Compensation for injury to reproductive capacity in the DES cases was generally low, however, because of the limited value given to the loss of the ability to give birth (Finley 1996: 75). This must have added immeasurably to the tragedy for women who suffered this harm.