Guest Blog|RPC LLP| Using data to reduce your company's litigation ris

High profile litigation reported this summer emphasises how important it is for manufacturers to have a firm grip on data demonstrating the safe performance of medical products.

In the US last month, Johnson & Johnson was ordered to pay US$4.7bn (£3.6bn) in damages following litigation over its talc products, such as its widely used baby powder. Meanwhile, in May in the UK , DePuy International Limited was successful in defending litigation concerning its metal-on-metal hip products.

Both pieces of litigation centred on conflicting data regarding the safety of their products.
The Johnson & Johnson litigation examined contradictory expert evidence over whether or not the products could cause cancer.

The claims against DePuy were based on evidence put forward to argue that its metal-on-metal hip products were defective because they required earlier revision than other comparable products.
In both cases, the parties argued over the quality of data and whether it proved that the manufacturers were liable to users.

Although DePuy was successful in its defence and Johnson & Johnson might yet be successful on appeal, these cases serve as a reminder that it is vital for manufacturers to collect data on the use of their products in the real world and consider deploying it an early stage. Doing so could mean avoiding the costly litigation suffered by DePuy and Johnson & Johnson. Data can be used in a variety of ways:

• To reassure the "worried well".  The media and public are fascinated with healthcare products. If a product is targeted in the media, manufacturers are well advised to get on the front foot as soon as possible and defend their product. If they do not, then manufacturers run the risk that patients - who would otherwise have no complaints about a product - become concerned and contact lawyers. This task will be much easier for manufacturers if they have ready access to credible and well-presented data measuring safety and performance. 
• To engage with regulators. If regulators, such as the MHRA in the UK, receive negative reports regarding the performance of a product then manufacturers may have limited time in which to respond to the regulators' enquiries. Positive and early engagement with regulators makes it more likely that public statements or actions about a product are proportionate. This in turn means that the public is provided with better, higher quality, data and mitigates the risk that lawyers or the media fill an information vacuum. 
• To add to scientific debate. Enterprising journalists may stumble across research that raises concerns over a medicine or device and use the findings for their own article in the mainstream media. In the event of litigation, largely forgotten papers that had been gathering dust are debated between experts in court rooms. To pre-empt these risks, manufacturers should ensure that data are collected and discussed in peer-reviewed publications. Manufacturers will then have academic papers at their disposal to respond to scientific concerns with like-for-like publications.

The medical products community bears the scars of high-profile litigation in recent years, and the talc and metal-on-metal cases are just the latest examples. In some cases, products that do in fact meet acceptable levels of safety and performance, are unfairly dragged into litigation. One of the best ways to avoid being swept up in such litigation is to ensure that performance data are collected and deployed where necessary. Cases this summer show that performance data can be key to demonstrating that a product is not defective - but the same data could also be used to reduce the risk of ending up in court in the first place.  

Peter Rudd-Clarke, Legal Director, Reynolds Porter Chamberlain LLP

Guest blogs are written by third parties and do not necessarily represent the views of the BIA