By Christin Jaye Eaton and Jeff Wojciechowski
Recent scientific and technological breakthroughs have enabled medical product manufacturers to analyze genetic data, which can unveil links between genetic traits and certain reactions to drugs or other products. But when must manufacturers use that data? What action must a manufacturer take when genetic data illuminates patient risk? And what level of knowledge will require a manufacturer to act?
The FDA 2013 Clinical Pharmacogenomics Guidance offers a framework for drug development, providing direction as to the means to identify genetic impacts on drug response and the scope of a manufacturer’s duty to use genetic information proactively. Per the Guidance, drug labeling should include information on how genes may affect drug response “only if it is useful to inform prescribers about the impact (or lack of impact) of [the gene’s effect on the patient’s trait]” or to make recommendations about available tests.
Courts have begun to define a manufacturer’s responsibility with regard to genetic data.
In early rulings, for instance, courts have not been inclined to credit hypothetical links. In a 2013 case in Illinois*, for example, the court excluded as “speculative and irrelevant” plaintiffs’ expert opinion that a genetic link may be discovered in the future between ibuprofen and an adverse reaction.
Courts have also acknowledged limits to how fast or well manufacturers can use new technology. A large pharmaceutical company recently faced lawsuits in several states involving a drug associated with the risk of a severe viral brain infection.The manufacturer warned of this risk in its labeling and worked to develop preventative tests, including one identifying viral DNA in patients. Before any testing bore fruit, several patients died. Plaintiffs sued, alleging the manufacturer’s warnings were inadequate. Some claimed the manufacturer should have more quickly developed and commercialized its testing.
Though one court found that a plaintiff could viably argue the manufacturer’s research and testing efforts were insufficient, all cases were dismissed.
On the question of cause, genetic analysis may be used by plaintiffs and manufacturers alike. Genetic tests may be needed to place the plaintiff in the at-risk group for a certain side effect. A person’s underlying genetic profile may be used by the defense to fully explain the injury, or by the plaintiff to show vulnerability. This battle played out in recent litigation over talcum powder, where the manufacturer argued that genetic factors could not be ruled out as a cause of plaintiffs’ cancer, and plaintiffs said adding talc to their already susceptible biology was the catalyst for their injury.
When a plaintiff claims infection from a device, genetic analysis may be used to compare bacteria samples from the plaintiff to those taken from the device and other sources. Similar analysis is used to trace food illness, and a recent lawsuit involved (ultimately unsuccessful) claims that a national food chain committed securities fraud by not disclosing limits to its ability to use genetic tracing.
Given the many ways in which genetic data may or may not affect corporate liability, this likely will continue to be an important and evolving area of law. For more information, please contact Christin Jaye Eaton or Jeff Wojciechowski.
*Please contact our authors if you would like further information regarding any of the source cases described in this article.