Wrong Assumptions Get Expert Tossed With Med-Mal Case

Assuming a testosterone gel was used as prescribed, an expert witness opined that the medication caused his plaintiff's deep vein thrombosis (DVT), only to have the plaintiff admit in his deposition that he used half-doses of the medication, sporadically, and applied it wrongly. The expert's testimony ruled inadmissible, the defendant granted summary judgment. The plaintiff appealed, but the Seventh Circuit affirmed the district court's decision.

Owens v. Auxilium Pharmaceuticals, Inc. N.D. Ill. No. 14 C 5180 was one of two bellwether cases against Auxilium Pharmaceuticals and Endo Pharmaceuticals for injuries allegedly caused by its testosterone gel, Testim. About 900 lawsuits were part of this multidistrict litigation involving the medication in claims that it causes DVT and heart attacks.

In July 2011, Isaac Owens physician, Dr. Dennis Smith, diagnosed him with hypogonadism (low testosterone levels) and prescribed Testim. In July 2013, Owens suffered his second DVT (his first being in 2005, long before he began taking Testim).

One of Owens' causation expert witnesses, Dr. Jihad Abbas, a vascular surgeon, reviewed Owens' medical history and records. While acknowledging Owens' preexisting risk factors for DVT included his prior DVT, paralysis from a previous stroke, age (62), and obesity, Abbas nevertheless opined that Testim was a substantial factor in causing Owens' second DVT. During his deposition, Abbas testified that his opinion was based on the assumption that Owens was using the full prescribed dose. When asked about using less than the regular dosage, Abbas said he did not have an opinion and “would have to investigate it.”

Owens' also enlisted as an expert witness Dr. Ardel Cagata, an internist, who treated Owens in the hospital for his second DVT. Cagata testified that Testim was a cause of the DVT, based on his “knowledge from medical school that hormone therapy could increase DVT risk and his belief that having multiple risk factors for an injury increases one's risk for that injury.”

However, between July 2011 and July 2013, Owens only refilled his prescription three times. The trial judge note that, whether or not the refills were for 30-day or 150-day supplies, it would not have been enough to take the full daily dose.

In his testimony, Owens admitted that when he did use the recommended daily dose of Testim, using only one-third to one-half a tube even though the instructions were to use an entire tube. As well, he applied the gel to his abdomen and thighs, not shoulders and upper arms as the instructions directed.

Auxilium challenged the admissability of Abbas specific causation opinion, arguing that it did not fit the facts, and Auxilium challenged both Abbas and Cagata opinions for their general causation theories.

Owens maintained that both opinions were admissable as both experts performed “differential etiologies.”

The district court noted that Auxilium could be correct that Abbas lacked a reliable basis for his opinion because it was based solely on the fact that Owens suffered his DVT soon afte resuming use of Testim, but it was unnecessary to determine. Abbas opinion was inadmissible because his testimony did not fit the facts: Abbas testified that his opinion was based on Owens applying Testim as prescribed, and it was undisputed that Owens failed to do so.

As for Cagata's opinion, the district court noted that he did not prepare an expert report and that it was unclear from Cagata's deposition testimony whether he actually did conduct a differential etiology. From his testimony, Cagata did not account for Owens other preexisting risked factors and seemed to only rely only on his medical school training from nearly 25 years ago.

The district court granted summary judgment to Auxilium.

Owens appealed, arguing in part that he used full doses of Testim in the days leading up to his DVT. As well, he had previously used a “therapeutic dose”, contending that Abbas' testimony was not based on the assumption that he used a full dose, but rather a “therapeutic dose.”

On July 19th, in Owens v. Auxilium Pharmaceuticals, Inc., No. 17-3416 (7th Cir. 2018), the Seventh Circuit found that in Owens own testimony during his deposition he admitted that he continued to apply less than half a full dose per day after his July appointment, “hardly a set of facts that would lead us to conclude that the district court abused its discretion.” While Owens argument that that he used at least a theraputic dose might have had merit, it was only raised on appeal, and thus would not be considered. The appellate court affirmed the district court decision.

On Jun 12th, Endo International (the owner of Auxilium) announced a deal to settle up to 1,300 testosterone drug liability lawsuits, including the 900 in this Testim multidistrict case, estimating $200 million in total legal fees.