A medical device lawyer is typically engaged to defend a manufacturer in legal cases that arise following the recall of a regulated product from the market. A prime example would be a hip implant system where the rate of device failure appears to be significantly greater than was originally expected prior to the introduction of the product.
The purpose of this page is to outline the role of the medical device lawyers in representing a defendant - usually either a manufacturer or a distributor of a recalled hip replacement product.
Taking a circumspect view, the primary objectives of the defendant will be to:
The statement above does not make interesting or lively news headlines, but in essence it must be true. Typically the defendants in the hip replacement recall cases are fiercely protective of their corporate reputations and the brands that they have invested hundreds of millions to create, often over many years.
If you believe the above statement to be true, then you can't help but agree that these companies would wish to be able to demonstrate full compliance with all relevant laws and regulations in the countries in which they operate, and, support and compensate any patients who have suffered harm as a consequence of receiving one of their implants.
To do otherwise would be corporate suicide and would be totally contrary to the core values, ethics and business models that large health care organizations work to.
In simple terms, the job of the medical device lawyer defending a manufacturer of hip implants is to successfully defend his client against claims of the alleged negligence.
If the defence win the case then it will have been proven that the recalled hip replacement product either was not defective, or that if the product was defective, that the defect was not responsible for the injury caused to the plaintiff.
In hip replacement recall cases the stakes are sometimes very high.
If the defendant wins then, all things being equal, corporate reputations and brand value are protected, and thereby, share price (underpinned by a future sales and revenue) will be largely intact.
Conversely, if negligence is proven and the case is lost, corporate reputations can be severely damaged, confidence in branded products can evaporate, future sales nose-dive and share prices swiftly follow.
The difference in outcome in terms of potential impact on the brand and future business for the manufacturer can be as stark as night and day.
Consequently, a manufacturer of a recalled medical device will, if challenged, engage the very best lawyer it can afford to represent the company and defend the case.
In addition to external medical device lawyers, the manufacturer (or other defendant) will probably have a substantial internal (employed) legal team and correspondingly large financial resources at its disposal to defend the case.
One important point is to remember is that, depending on the circumstances, it is quite likely that an insurance company will be exposed to some of the losses should the manufacturer lose the case. For this reason, the legal team supporting the manufacturer's insurance company will work very closely with the manufacturer's legal team and in some cases may actually lead the defence.
Bear in mind that in some cases, the insurance policy that is intended to protect the hip implant manufacturer from losses in product liability cases, may actually prescribe that the insurer (the underwriter) has various rights including to appoint lead counsel for the defence. This is likely to be the situation if the majority of any potential financial settlement ultimately paid to (allegedly) injured parties, will fall to the insurer rather than the manufacturer.
The medical device lawyer engaged to represent the manufacturer will be a high calibre and highly experienced attorney. Most likely he will be a partner in one of the top-tier corporate law firms, and able to bring to bear substantial experience and resources in preparing and executing the case for the defence.
The defending medical device lawyer will seek, on behalf of the manufacturer to: