Image of outside building. Side view.

US talc litigation has important lessons for UK insurers

02 August 2018. Published by Peter Rudd-Clarke, Legal Director and Nick McMahon, Head of Health and Safety

Although it is unlikely litigation involving household staples such as talcum powder could succeed in the UK, the on-going US litigation underlines a significant trend in product liability exposures.

Last month, Johnson & Johnson was ordered to pay US$4.7bn (£3.6bn) in damages to 22 women who alleged that its talc products, such as its widely used baby powder, caused them to develop ovarian cancer because the products contained asbestos.

A jury in the US state of Missouri awarded the claimants US$550m in compensation and US$4.14bn in punitive damages. Johnson & Johnson has said that it will appeal the decision. This follows its success in overturning earlier jury awards on appeal.

There are many high-profile examples of litigation concerning healthcare products having success in the US before becoming a concern in the UK: metal-on-metal hips, pelvic mesh and Seroxat being some. Those disputes involved highly complex medical devices and pharmaceuticals. By contrast, talc products, such as baby powder, seem commonplace and uncomplicated. Should UK insurers be concerned about a new wave of litigation concerning established and seemingly low risk healthcare products hitting these shores? The answer is probably not. Various factors mean that litigation concerning such products is less likely to be successful here.

The first instance verdicts making the headlines in the US are jury decisions. In England and Wales, civil claims are decided by a judge sitting without a jury. Plaintiff lawyers in the US are experienced in maximising the emotional impact that a claimant's evidence can have on a jury.

It is notable that in number of cases concerning Johnson & Johnson, jury decisions have been overturned by an appeal tribunal consisting of judges. An English judge would not be unsympathetic towards claimants' personal stories, but could be expected to weigh up the evidence more dispassionately, so removing the emotion found in US cases that can have a profound impact on the outcome of a personal injury claim. Claimants here may find it significantly more difficult to persuade a court of a causal link between use of talc products and cancer.

Evidence

The Missouri litigation examined contradictory expert evidence over whether or not the products could cause cancer. In England & Wales, insurers and their manufacturers have the benefit of recent case law that sets out how a court here would scrutinise scientific evidence that allegedly supports a claim that a product is unsafe.

The decision in Gee v DePuy & Ors [2018] handed down in May this year concerned claimants implanted with metal-on-metal hips. The Court held that the evidence cited by the claimants could not be relied upon because there were too many potentially confounding factors skewing the findings, much of the primary data was unreliable and the underlying studies referred to in reports were inadequate. Defendants in future will refer to Gee as an example of scientific studies about healthcare products failing to stand up to judicial scrutiny.

The weight of scientific opinion in the public domain does not appear strong enough for claimants to bring a case here. The NHS states on its website that "further research in the form of good-quality prospective studies would be required" to prove a link between talc and ovarian cancer. Ovacome is a charity that provides advice and support to women with ovarian cancer. Its fact sheet examines evidence published to date and states "this weak link between talc and ovarian cancer is just speculation at the moment. With no convincing results from research studies, it is hard to imagine that talc is a significant cause of ovarian cancer."

Claims brought here would be under the strict liability regime set out by the Consumer Protection Act 1987 (the Act) or in tort for negligence. Claims under the Act would need to demonstrate that talc products were defective in failing to meet the level of safety consumers generally are entitled to expect, and that any such defect caused injury.

In the absence of evidence proving a causal link between talc products and cancer, it is difficult to see how claims under the Act could succeed. Claims alleging negligence would need to prove that manufacturers breached their duty of care towards users. Johnson & Johnson have stated on the record that it carried out testing into the risks. In light of these statements, claimants would struggle to prove that manufacturers were negligent in supplying talc products.

Lessons for the UK

Although it is unlikely that litigation over household staples such as talcum powder could succeed in England & Wales, the US litigation does offer some lessons for the UK. The talc litigation is just the latest example of a growing trend in product liability litigation, both here and in the US, where claims are brought on behalf of multiple claimants citing scientific studies based on data concerning large populations. Increasing amounts of health data are being generated as patients are monitored with more scrutiny, governments support the establishment of registries and record keeping is digitised.

The result of this is that claimant law firms have access to more and more information, both primary data sources and epidemiological studies. It is important that manufacturers invest in tracking and analysing data generated about their products, both to ensure that their products' safe performance is monitored but also to be prepared to discuss and explain the evidence with concerned patients, or the media, before concerns snowball into litigation.

The litigation in the US has raised questions over the adequacy of warnings provided with talc products. The litigation is a reminder that manufacturers should keep under review the warnings that accompany their products. If latest scientific studies reveal new concerns over a product then manufacturers should consider whether the warnings and guidance accompanying their products need to be updated.

The litigation in the US was not inspired by steps taken by the regulator. In response to questions over the safety of talc products, the US Food and Drug Administration (the FDA) stated that "before we can take action …. we need sound scientific data to show that it is harmful under its intended use."

The FDA's finding after commissioning a survey was that it "found no asbestos fibers or structures in any of the samples". Despite the FDA's findings, litigation continued in the US. The lesson for manufacturers is that it is not enough to assume that claimant law firms will drop litigation where the regulator has investigated and decided not to act.

A similar story was seen here in the metal-on-metal hip litigation where most products remained licensed for use by the Medicines and Healthcare products Regulatory Agency. The fact that a product is approved by the regulator will lend considerable weight to an argument that it is safe, but may not in itself be enough to persuade claimants to drop their claims.

Manufacturers and their insurers in the UK need not be too concerned about the astronomically large jury awards against Johnson & Johnson in the US being replicated in this jurisdiction. The nature of our legal system means that claimants would be less likely to succeed in bringing claims; nevertheless, product liability in the healthcare sector is a developing area and the talc litigation raises points of interest for manufacturers and insurers to consider. 

This article was first published in Insurance Day.