The Importance of Genetics Experts in Pharmaceutical Litigation

Posted by on March 6, 2018

A Case Study from the Testosterone Litigation

A recent defense verdict in the testosterone litigation highlights the importance of genetics in pharmaceutical litigation. In this case, neither the plaintiffs nor the defense called a geneticist as an expert, yet both sides tried to use genetic arguments in their case. In this post we summarize the points made by each side and highlight how each side might have benefited from the inclusion of a geneticist in their expert lineup.

The plaintiff, Robert Nolte, suffered from Factor V Leiden thrombophilia, an inherited blood clotting disorder. Factor V Leiden is an inherited blood clotting disorder linked to a specific genetic mutation. The mutation is known to cause in an increased tendency to form abnormal blood clots. The result is a higher than average risk of developing a serious blood clot known as deep venous thrombosis. Mr. Nolte contends that he did not experience blood clotting until he was prescribed the testosterone replacement therapy (TRT) AndroGel.

Plaintiff argued that the defendant knew that AndroGel raised the risk of blood clots yet failed to fully warn of the potential risks. Although the product label does say that doctors should monitor patients’ red blood cell counts for signs of blood clots, there is no warning that product users are at an increased risk of cardiovascular events. Nor is clotting through mechanisms other than red blood cells (e.g., genetics) mentioned.

Plaintiff experts allege that Mr. Nolte developed a pulmonary embolism within months of taking AndroGel. To support this claim, the plaintiff’s attorneys relied upon clinical trials performed by Gleuck and colleagues that suggest patients should be screened for factor V Leiden before being prescribed testosterone. According to Gleuck’s research, testosterone therapy may have a prothrombotic effect in men with Factor V Leiden.

Dr. Harvey Rinder plaintiff’s hematology expert states in his testimony:

“These men have had factor V Leiden their whole life, yet have never had a clot. But now that they’ve gone on direct testosterone, they’re having a venous thrombosis. That shows that an underlying thrombophilia may be combining at least in one way or shape or form with  testosterone therapy to give you an increased risk of a venous thrombosis.”

The defense countered that there is no evidence of testosterone replacement therapy increasing the risk of venous thromboembolism. Experts for the defense found weaknesses in Gleuck’s methodology and conclusions:

“VTE is common, and if you pick out of the VTE all those that had TRT and then looked at underlying causes, you’d see a significant number that have these underlying…predisposition to clot… So he (Dr. Glueck) did this comparison, and in the no TRT group, seven out of eight had this predisposition to clot. Very common. And in the TRT, five out of seven had the tendency to clot. So no difference.”

In essence, plaintiffs were arguing that the genetic mutation associated with Factor V Leiden thrombophilia made individuals more susceptible to the effects of testosterone. On the other hand, the defense argued that individuals with these genetic mutations were simply predisposed to the VTE injury.

Although both the plaintiff and defense presented compelling arguments, neither side presented a geneticist as an expert to make these points. For the plaintiffs, making a genetic argument with only second-hand clinical data to rely upon proved a costly mistake. In the end, the jury rejected Mr. Nolte’s allegation that his injury stemmed from AbbVie’s negligent misrepresentation of AndroGel’s safety and efficacy in older patients with comorbidities. For the defense, a geneticist would have resulted in an even more convincing argument that could have shored up their position.

Genetics experts are becoming more and more critical in complex pharmaceutical litigation as well as toxic tort cases. As medical knowledge related to disease states becomes more heavily focused on genetic underpinnings (in both treatment regimens and diagnostics), it becomes more and more critical to highlight genetic data in civil litigation. Why depend upon someone without suitable qualifications to explain the complexities and implications of genetic factors in a legal case? Why run the risk of misinterpreted scientific literature or misquoted results? If you plan to use an argument reliant on genetic data, it is critical to have a genetics expert to provide that testimony. A skilled expert can mean the difference between a win and a loss in the courtroom.



At Innovative Science Solutions, our mission is to help counsel win their case. Increasingly, a genetic defense is being applied in a wide variety of legal cases. If you are curious if your case may benefit from a genetic defense, please get in touch for a free consultation.

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