The Purpose of the Medical Devices Directive - Term Paper Example

Running Head: Mandating a Perfect World Mandating a Perfect World: Litigation and the Consumer Protection Act of 1987 British tort law before 1987 seemed as though it had virtually been composed by friends of the manufacturing industry, so onerous was the burden of proof placed on the consumer. Consumers had to prove that the manufacturer breached "duty of care" - which turned out to be almost impossible to prove to the satisfaction of the courts. Manufacturers would cite consumer negligence - both passive and contributory - as well as consumer consent forms which gave them immunity from any and all litigation. This legal balance of power that favored the manufacturing interests was not harmonious with the desires of the rest of the European Community, however. Their Consumer Products Directive, issued in 1986, was designed to make it much simpler for consumers to sue manufacturers for damages resulting from defective products.1 The contrast between the principles of European Community legislation and British law became a point of contention. And so the Consumer Protection Act was written in 1987 to switch the burden from the consumer to the manufacturer. Written to bring English law into closer compliance with the laws of the European Community, this act only requires that the consumer prove that the product was defective, and that the defect in the product caused some sort of harm, either to the person or to the property of the consumer. Subsection 7 of Part I expressly forbids the sort of consent forms that had earlier absolved the manufacturers of any responsibility. Subsection 2 of Part I creates a whole crowd of possible defendants - the consumer may sue the "producer of the product" as well as any person who imported the product, or who put his/her own brand on the product (to make it seem that s/he had produced the product), or even a supplier somewhere along the supply chain, if that supplier does not reveal the source of the product in a sufficient amount of time. The act's definition of a "defect" also calls to mind the sound of plaintiff's attorneys salivating over possible settlements. According to the act, a defect exists if "the safety of the product is not as such as persons generally are entitled to expect." The use of the word "generally" could take many forms in the mind of a socially conscious judge, or in the minds of jurors who had had negative experiences at the hands of defective products. These expectations come from a variety of sources: the marketing, packaging, instruction manuals, and consumer warnings2. Much comedy has arisen from the pedestrian directions and warnings that adorn the packaging of many consumer appliances - who wouldn't know, for example, to remove a hair dryer from the package before attempting use It may well be, however, that each silly instruction comes from a lawsuit brought by someone who did not know what to do. There are several defences available to the manufacturer. Any defect that is a result of compliance with European Community regulations; any defect that did not exist in the product at the time when the consumer used it; and any defect that was not discernible to the manufacturer, because technology at that time did not reveal the defect, would not cause the manufacturer to be liable3. Given that the European Community wanted to foster a climate of geniality toward consumer protection, it is unlikely that it would produce regulations that create defective products. Other than the fact that the consumer has to demonstrate that the product defect led to harm of person or property, the Consumer Protection Act of 1987 appears to do just that. The British government has undertaken a significant public relations effort to ensure that the public is aware of its rights under the CPA. (This effort would come to be self-defeating in the case of the Hepatitis C litigation, as will later come under discussion). The Consumer Affairs Directorate created a consumer guide4 that gives a thorough explanation of consumer rights under this legislation. The Department of Trade and Industry has gone further on its fact sheet, emphasizing that "people who are injured by defective products can sue for compensation without having to prove the producer negligent" and also noting that the legislation applies to "all consumer products and products used at a place of work"5. Workplace injuries represent a significant opportunity for plaintiffs' attorneys, and this inclusion on the list of "Key Facts" about the CPA seems designed to welcome actions on the part of workers. Additionally, the fact that, while buildings are not covered by the act, individual building materials (bricks, beams, etc.) are covered, it would seem that any building failure could serve as a springboard for litigation.6 The Consumer Direct website, also published by the government, further attracts potential plaintiffs by emphasizing that "any person who suffered as a result of the defective goodsi.e. anyone injured by the goods or anyone whose property was damaged as a result of the defect."7 Not surprisingly, plaintiffs' attorneys have sought to mine the market of potential lawsuits, and of potential contingency fees. One example of this is an online advertisement placed by Personal Injury UK, which specializes in product liability with regard to biomedical devices. This covers any and all equipment used externally, or implanted - from breast implants to artificial heart valves to wheelchairs to oxygen tanks.8 While one might think that the "state of the art" defence might apply to many devices within this industry, there are judges that are very cautious about permitting producers in the health industry with that escape from liability, as will be discussed later. As one might expect, the health industry was nervous about the ramifications of the Consumer Protection Act long before it became law. One of these issues was manufacturer concerns about liability ranging from the re-use of single-use disposable items.9 Even though labels indicated that disposable health products are only meant to be used once, manufacturers had a legitimate concern as to how judges and juries might interpret the language of the CPA, especially given the intent of the law, which was to tilt the balance in favor of the consumer. Nurses were understandably concerned too, as they could be seen as the last line of the supply chain in health care, and so careful guidelines were put in place as far as operating room and emergency room techniques and surgical equipment - particularly, accounting where each piece of equipment, and even each bandage, came from. Sympathetic juries, however, do not always have a high regard for policies.10 Occupational health nurses faced a particularly tricky course, given the emphasis on workplace liability in the language of the CPA and of the government information guides.11 Practitioners at all levels have come to face a significant amount of litigation as a result of the increased opportunity for malpractice suits under the CPA.12 Section 2 of Part I of the CPA was particularly seen as a cause for concern, as it names "every person to whom subsection (2) applies shall be liable for the damage,"13 which could include an entire hospital staff. One of the ways in which the health industry has started to protect itself is in the retention of patient information, so as to cut down on mistakes stemming from a lack of information. Many practitioners have decided to "retain all patient records for not less than 11 years" and the British Association of Orthodontists has even recommended that "study models should be kept for 11 years or until the patient is to 26 years old."14 This has created a perhaps unforeseen problem: where to keep all of the dental casts for each patient. The government had to issue the Medical Devices Directive in 1998 to clear up some of the confusion on the supply chain issue - for example, dentists had been seen as part of the supply chain for custom-made orthodontic devices,15 and as such were the target for litigation when those devices were unsatisfactory. The purpose of the Medical Devices Directive was to expressly name the manufacturer as the supplier for these devices, and sufficient additional regulations were placed on manufacturers to allow plenty of room for potential litigation. Product information retention has also become increasingly important, since "where the manufacturer is unknown (because of a break in tracing the supply chain), the last person identified in the supply chain will be deemed the producer and liable for the damages."16 In a worst-case scenario, this could be the nurse that used the defective product, or the clerk who ordered the product. The Department of Health has gone so far as to mandate the keeping of "adequate records that demonstrate how a particular device was processed, a description of the method/s employed and details of available trained personnel with copies of training records."17 Further, a set decontamination process and a log including the people involved in decontamination are recommended - creating another list of possible defendants. The Consumer Protection Act's insistence that there can always be a defendant in such ambiguous situations as this certainly creates more opportunities for litigation. Litigation in such areas as blood transfusions18 and optometry19 show the high liability of the medical industry under the provisions of the CPA. Another industry rife with product liability risk is the toy industry. It is no surprise that the Toy Retailers' Association, in response, revised its Code of Practice to include the following provisions: Requiring members to answer questions about product safety and about product suppliers promptly (failure to do so can make the most available member of the supply chain a target for litigation Investigating any members who are successfully prosecuted under the CPA Revoking membership - specifically, denying the permission to use Toy Retailers' Association display materials - for "willful" violators of the Code (marketing materials and branding can be used as part of litigation under CPA)20 Throughout manufacturing, there is a heightened sense of awareness of the importance of the engineering phases of product design, which are seen as crucial in increasing product uniformity and in reducing design flaws.21 Online commerce has proven a particularly tricky area of litigation. Because online consumers and suppliers are often in different countries, there can be a confusion over which country's laws apply to a particular product or service. This provides additional ambiguity to what can often comprise an already highly litigious situation. There are several examples of cases tried under the CPA that could be seen as exposing large segments of the health industry to significant legal risk. Optident Limited and Ultradent Productions Inc. v. Secretary of State for Trade and Industry and Secretary of State for Health involved the legality of Opalescence, a tooth-whitening gel. The British government had sought to block the sale of Opalescence, because it released 3.4% hydrogen peroxide when in contact with teeth - much more than the 0.1% maximum permitted by the 1976 Council Directive on cosmetic safety litigation. While a lower court had found that the gel was a medical device, rather than a cosmetic product, on appeal the gel had been found a cosmetic product, and as such was subject to the 0.1% maximum. This maximum placed a great number of practitioners at risk, since the technology of the last ten years has created numerous products that release a higher percentage of hydrogen peroxide as part of a safe tooth-whitening treatment, and so this ruling has created a "very unsatisfactory current legal position" for many dental practitioners, who might now face litigation for the use of banned products that they might formerly have considered medical devices.22 Another example of a health-related lawsuit involved the third-generation birth control pill, and named Schering Health Care, Wyeth, and Organon Laboratories as co-defendants, because their newest pills carried "more than twice the risk of venous thromboembolism as their second-generation predecessors."23 The case was based on the fact that the labels on the newer pills did not contain warnings about the increased risk of the conditions associated with thromboembolism: deep vein thrombosis, pulmonary embolism, strokes, and cerebral vein thrombosis. The complexity of the case came from the fact that manufacturer-sponsored studies showed little or no risk of these symptoms, while independent studies showed a more elevated level of risk. However, the lack of warnings on the product labels proved decisive. Additionally, as will be seen, the studies that a manufacturer might conduct are not useful as a defence, since there were other studies that indicated that the pills were harmful. The simple presence of a defect opened the manufacturers to litigation. A second example of health care-related litigation under the Consumer Protection Act 1987 was Iman Abouzaid -v- Mothercare (UK) Ltd. The plaintiff had suffered an eye injury while wheeling a pushchair sold by the defendant, when an elastic strap had come unattached and struck the plaintiff. Initially, the plaintiff won damages, but the defendant appealed, on the grounds that the judge had gone wider than the EC Directive permitted in the application of the CPA. However, on appeal, it was found that the design of the pushchair "permitted the damage to arise," and so the judgment was upheld.24 A case that promised even more opportunities for litigation in the health industry was the hepatitis C class action suit against the NHS. The standards for what one might generally expect in terms of product quality and safety that were set in this case create an atmosphere for increased litigation.25 In the initial class action, there were 112 plaintiffs, who were exposed to the Hepatitis C virus through blood transfusions, blood products, and organ transplants. The CPA came into force on March 1, 1988, and Hepatitis C was discovered in May, 1988. Screening tests, however, were not implemented in the UK until September, 1991.26 The plaintiffs argued that the government should have implemented screening technology more swiftly.27 The test of the blood products' safety hinged on whether or not the products were standard, or non-standard. Because most of the blood supply was not infected with Hepatitis C, the products that were infected were considered non-standard, and therefore safe (one wonders what would have happened if the infection had been more widespread). Although scientists had known that there was a risk of infection since the 1970's, the lack of warnings to the public made the blood products in the case defective. Interestingly, what might at first be considered a victory for the defence turned into a fairly earthshaking blow for plaintiff rights under the CPA. Because the purpose of the law is to "make it easier for consumers to establish liability by eliminating proof of fault or negligence," it was not relevant that the government had not initiated screening earlier than the fall of 1991 - the government supplied defective blood products, and as such was liable. One of the plaintiffs' primary complaints - the lack of relevant testing - was dismissed as irrelevant, and yet it was to the detriment of the defence. The last consideration in this trial was the defence claim of the "development risks" defence under Article 7(e) of Part I of the CPA - in other words, that the government did not have access to technology that would have allowed it to discover the defect in the blood and blood products. According to the court's decision, this defence is only available "if the producer could show that there [is] no objectively accessible scientific or technical knowledge existing anywhere in the world" that would show the defect.28 While there seems to have been a lag between the discovery of the Hepatitis C virus in 1988 and the introduction of screening in the UK in 1991, this ruling could be taken to mean that a journal article written in Uganda could be used to create liability problems for a manufacturer in Glasgow. Several principles from this judgment are significant in a consideration of litigation in the wake of the Consumer Protection Act of 1987. The primary factor in determining liability is not the actions of the manufacturer, but in the product itself. If the product is defective, the manufacturer is liable, no matter what measures had or had not been taken. The question of whether or not a particular manufacturer had conducted years of testing, or simply had rushed the product from the inventor's garage to the shelf in a retail store, has been deemed irrelevant. Liability comes down to the individual unit, and the defect that exists within it. The definition of "standard" and "non-standard" products is sufficiently flexible to invite considerable litigation. In this case, the blood that was infected with Hepatitis C was deemed to be the "non-standard" blood, simply because it was in the minority, compared to the general pool of available blood and blood products. The idea that the majority of product samples constitutes the "standard" of that product could cause confusion, particularly in highly specialized equipment, or at the lowest end of the manufacturing spectrum - are the imported Yo Yos that break after three spins the standard product Finally, the limits placed on the "development risks" defence make it almost impossible for a manufacturer to say that he did not know that the possibility of a defect existed. In short, there are numerous ways for a plaintiffs' attorney to make a way for himself or herself by finding the right class action suit under the Consumer Protection Act of 1987. While the passing of tort law may indeed represent the opportunity for underprivileged consumers to gain the redress they deserve from unscrupulous manufacturers, the ease with which these consumers may sue could also end up increasing manufacturing costs beyond what is reasonable. Works Cited Bell, A., Ayoub, A.F., and Siebert, P. 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Occupational Health, 40/6, 566-567. McDougall, A., and Soper, N. 2001. Consumer Protection Act: A and Others -v- The National Blood Authority and Others. Retrieved 26 December 2005 from http://www.ashurst.com/doc.aspxid_Content=916 Morris, C. 2003. "Tooth whiteners - the legal position." British Dental Journal, 194/7, 375-376. National Association of Theater Nurses. "The Consumer Protection Act-1987 guidance document." NATNEWS, 26/5, 7-9. Personal Injury UK. Bio medical devices UK class actions. Retrieved 26 December 2005 from http://www.shopnice.com/bio_medical_devices.html Swarbrick, D. 2005. Consumer - 2000. Retrieved 11 January 2006 from http://www.swarb.co.uk/lisc/Cnsmr20002000.php. Taylor, S., and Taylor, S. 2002. Law in optometric practice. Oxford: Butterworth-Heinemann. Toy Retailers Association. Code of Practice. Retrieved 26 December 2005 from http://www.toyretailersassociation.co.uk/retailers/code.htm Read More