This guest post – only our second post ever on European issues is brought to you by Reed Smith partners Marilyn Moberg and (in the UK) associate Bond, Kathryn Bond (sorry, couldn’t resist). Our previous (and only) foray into European product liability was not a happy one. This post, however, discusses a much more favorable product liability development in Britain – and with Brexit, we’re hoping that the Brits build on this decision and thumb their noses at the prior decision by the EU Court of Justice.

So without further ado, here are Marilyn and Kathryn. As always, our guest posters deserve 100% of the credit (and any blame) for what follows.

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For many years now I have been reading this excellent blog prepared by my colleagues and thinking “how can they be so prolific and witty time and time again”? I have continued to tell myself that “I need to do a guest post” sometime, but alas have never found the time to do it. Perhaps the idea of delving in and being compared to the posts of the others was–, OK, I will admit it–, intimidating even after many years of practice. I guess, living in LA, the analogy is like those various guest hosts who were asked to step in for a night for Johnny Carson (yes, I am showing my age). But, hey, Joan Rivers and Jay Leno did OK, so here goes.

For the blog today though we are traveling across the pond to “merry old England,” and my London colleague (Kathryn Bond) and I will discuss a topic very familiar to those of us in the US: the Metal on Metal litigation (and no, I don’t mean the Anvil heavy metal album).

While this litigation has been going for years here, it is in its infancy in the UK, with the first two group product liability actions against manufacturers of metal-on-metal hip prostheses due to be heard by the English Courts this year, with trials scheduled to take place in October 2017.

However, and as Bexis has confirmed “blogworthy,” there has already been a landmark English High Court decision in one individual case concerning a metal-on-metal hip prosthesis. The case is Wilkes v. DePuy International Limited [2016] EWHC 3096 (QB). It was decided in the Queen’s Bench Division of the English High Court. For those of you – most of you – unfamiliar with the UK’s court structure, the High Court is a senior court that typically deals with first instance decisions of important and/or high value cases, but also handles appeals over decisions made by inferior courts. The High Court has three divisions: the Queen’s Bench Division, the Chancery Division and the Family Division. The Wilkes case was heard in the Queen’s Bench Division (a division that most commonly handles disputes relating to personal injury, negligence, breach of contract, breach of a statutory duty and libel). Appeals against civil decisions made by the Queen’s Bench Division are heard in the Court of Appeal. Appeals against Court of Appeal decisions are heard in the Supreme Court (the highest court in England).

The decision is favorable for the defense, both in its result and in its interpretation of UK law governing allegedly defective products. For those of you not familiar with the law, here is a short primer. Under UK product liability law, irrespective of any rights an individual may have under contract, there are two key actions available to an individual who claims to have suffered personal injury from a defective product. These are:

1. Common law negligence;

2. Consumer Protection Act 1987 (the “CPA”).

The Wilkes case concerned a claim under the CPA.

The CPA imposes strict liability on manufacturers of defective products for any harm caused by their products. “Strict liability”, like in the US, means that it is irrelevant whether the manufacturer was at fault. The injured party just has to prove that the product was defective and that the defect caused him harm.

Section 3 of the CPA states that a product is defective if “the safety of the product is not such as persons are generally entitled to expect,” taking into account “all the circumstances”. For ease, we will refer to this as the “safety expectation test”. This reminds us of the “consumer expectation” test for design defect that applies in some United States jurisdictions for certain products. The Wilkes case is significant because of its interpretation of this section 3 of the CPA.

It has been about 16 years since the UK courts have dealt with this issue, and before Wilkes, the leading case on the concept of “defect” was A v. National Blood Authority (2001) 60 BMLR 1 (“A v. NBA”), from 2001. In that case, the claimants were infected with hepatitis C as a result of blood transfusions.

In determining whether the blood was “defective” under the CPA, the A v. NBA Court took the following approach:

  • first, identifying the harmful characteristic that caused the injury (in other words, identifying a causal link between the defect and the harm suffered);
  • determining whether the product was “standard” or “non-standard” (i.e., does the product perform as the manufacturer intended); then
  • taking into account the relevant circumstances, depending on whether the defect was “standard” or “non-standard.”

A v. NBA held at paras [55], [80] and [173] that the infected blood was “defective” even though the manufacturer could not have known that the specific blood bags concerned were infected — no test for the screening of hepatitis C had been introduced in the UK at the time of the transfusions. The mere fact that there was an inherent risk of the blood being infected was not enough to protect the defendant because the public at large was entitled to expect that the blood transfused to them would be free from infection. In other words, the inherent risk of infection was not publicly known or socially accepted as such a risk. The A v. NBA decision has been criticized in the years since it was decided as being overly harsh on manufacturers. The Wilkes case is significant because the Court departed from this long standing precedent—and in a way that is jolly good for the defense (or, as they would say in Britain, the “defence”).

Some basic info: Wilkes received a hip replacement implant in 2007, which fractured 3 years later. The implant was a steel femoral shaft called a “C-stem” manufactured by DePuy. Wilkes claimed at paras [55]-[56] of Wilkes that a component of the C-stem was defective, relying in particular on the judgment in A v NBA.

The Court rejected Wilkes’s product defect claim (and more generally the A v NBA approach to product defect) for the following reasons:

1. First step causation test: the first test used by the Court in A v NBA does not work because it is circular – you cannot prove a causal link between the defect and the harm without finding out whether there is actually a defect. The focus should be on identifying the defect itself. [See para [58] of Wilkes]

2. Identifying the defect – the safety expectation test:

(a) All relevant circumstances to be taken into account: There should not be a rigid set of rules specifying which circumstances should be taken into account in determining whether the product satisfies the safety expectation test. The issue of defect is “necessarily one of open-textured judgment, untrammelled by any rigid rules outside the few that appear in the [CPA] itself”. [See paras [76]-[79] of Wilkes]

(b) Risk-benefit analysis and avoidability: The Court acknowledged that no medicinal product is 100% safe – something that will seem obvious to our US readers, but which is a major advance in the UK. There needs to be a risk-benefit analysis to ensure that the potential benefits of the product are balanced against its inevitable risks. The ease and extent to which the risks can be avoided or mitigated is also relevant. For example, there is a risk of stem fatigue in any hip implant (a C-stem is generally expected to last for 10-15 years). According to DePuy’s expert, the risk of a failure in the relevant component of the C-stem was very low (0.004%). Furthermore, the changes required to remove the risk would make the prosthesis more uncomfortable and potentially more likely to fail on other respects. [See paras [81]-[89] and [119] of Wilkes]

(c) Categorization of standard/non-standard defects to be ignored: In A v NBA, the Court intentionally excluded the risk-benefit analysis for non-standard products. The Court in Wilkes believed that the distinction between standard and non-standard products was “unhelpful” and “positively dangerous.” Whatever the type of product concerned, all relevant circumstances should be taken into account. [See paras [90]-[96] of Wilkes]

(d) Compliance: As medicinal products and medical devices are highly regulated, the fact that the product complies with such regulations is (although not an automatic defense) strong evidence that the product has a level of safety that passes the safety expectation test. In Wilkes’s case, it was an important fact that the C-stem went above and beyond the applicable regulatory requirements. [See paras [99]-[101] and [124] of Wilkes]

(e) Warnings and learned intermediaries: Warnings given to the consumer do have an impact on the level of safety that persons are generally entitled to expect. In the case of Wilkes’s C-stem, the information provided to the healthcare professional responsible included a warning about the risk of fatigue failure caused by various factors, including obesity and activity levels (both of which may have played a role in the C-stem failing earlier than anticipated). The intermediary of a healthcare professional was not considered in much detail in A v NBA, save for noting at para [55] that “doctors and surgeons knew [the risk of infection of transfused blood], but did not tell their patients unless asked, and were very rarely asked”. Although the Court acknowledged at para [108] in Wilkes that giving warnings to the healthcare professional did not provide an automatic defense, it was sufficient in the circumstances that the warning was given to the healthcare professional in accordance with UK law, even though it was not given to the patient directly. In particular, it was noted that there is often no interaction between the manufacturer of the C-stem and the patient. It would therefore be appropriate for information about risks relating to the C-stem to be passed on to the patient by the treating surgeon. [See paras [102]-[108] Wilkes]

The Wilkes Court concluded that, although the C-stem fractured earlier than anticipated, the C-stem was not defective because it passed the safety expectation test. The C-stem’s premature failure was brought about by a “constellation” of variable factors, which (although expressly warned about) could not have been predicted by the manufacturer.

The Wilkes judgment adopts many of the doctrines and principles that apply in the US and should continue to apply to these products: risk/benefit, learned intermediary doctrine, and compliance with regulations as evidence of standard of care. This is welcome news for manufacturers who sell medical products in the UK. It will be interesting to see what approach the English Courts will take in the two group actions due to take place later this year and we will continue to monitor this. So assuming we are “invited back,” you can look forward to another “guest post” that Jay Leno would (hopefully) be proud of …