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AbbVie Appeals $140M AndroGel Verdict


— November 7, 2017

In early October, a Chicago federal jury reached a verdict in favor of Mr. Jeffrey Konrad in his suit against Big Pharma giant AbbVie, agreeing with Mr. Konrad’s allegations that the company’s testosterone replacement drug, AndroGel, caused his heart attack. The jury gave Mr. Konrad $140,000.00 in compensatory damages and $140M in punitive damages. AbbVie promised to appeal, and it made good on that promise just a few days ago.


In early October, a Chicago federal jury reached a verdict in favor of Mr. Jeffrey Konrad in his suit against Big Pharma giant AbbVie, agreeing with Mr. Konrad’s allegations that the company’s testosterone replacement drug, AndroGel, caused his heart attack. The jury gave Mr. Konrad $140,000.00 in compensatory damages and $140M in punitive damages. AbbVie promised to appeal, and it made good on that promise just a few days ago.

Mr. Konrad’s case is one of thousands alleging that AbbVie misrepresented the safety of its testosterone drug. His case was selected as one of the bellwether, or test, cases in the multidistrict litigation (MDL) over the popular “low-T” drug, AndroGel and others like it. The drug is used to treat low libido, lack of vitality, and other medical conditions.


Sidebar: MDL “is a special procedure in which federal civil (noncriminal) cases from around the country are transferred to one court. The cases must have one or more questions of fact (issues to be determined by looking at the evidence) in common.”

Bellwether trialsare a small group of lawsuits, chosen from a larger group of similar cases, to be tried first. The outcomes of bellwether trials serve as a sort of litmus test for how future litigation might turn out. The term “bellwether” derives from the long-ago practice of placing a bell around the neck of the lead sheep in a flock so that the flock’s movement could be determined from a distance. From this the word bellwether (meaning one that leads or indicates trends) came into usage.”


Mr. Konrad had a heart attack in 2010, two months after beginning treatment with AndroGel. While he has fully recovered, a member of his legal team, Mr. Parker Trotz, said “it’s still something that’s going to affect him for the rest of his life.” Mr. Trotz stated that a central focus of Mr. Konrad’s case was AbbVie’s “improper testing and failure to disclose risks to primary care physicians and patients like Mr. Konrad.”

Man having a heart attack; image courtesy of www.medicalnewstoday.com.
Man having a heart attack; image courtesy of www.medicalnewstoday.com.

In referring to Mr. Konrad’s damages award, Mr. Trotz believes it sends a “very strong message” to AbbVie and other Big Pharma players. The message is that patients should come before profits. He continued, “The large punitive award really reflects that jury’s decision.”

It is that decision that prompted AbbVie’s appeal.

The company is asking the court for a variety of solutions:

  • Judgment as a matter of law. This occurs when “a party has been fully heard on an issue during a jury trial and the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue;”
  • A new trial;
  • Remittitur. This “is a ruling by a judge (usually upon motion to reduce or throw out a jury verdict) lowering the amount of damages granted by a jury in a civil case.”

The court can grant only one of these desired solutions, or it may deny all of them.

Among other things, AbbVie argues that, as a matter of law, Mr. Konrad failed to prove his case. It contends that Mr. Konrad failed to prove that “without [AndroGel], his heart attack would not have occurred.” It further argues that the plaintiff’s expert witness, Dr. Cuculich, said that “based on Plaintiff’s prescription supply, it would have been physically impossible for Plaintiff to have used the prescribed AndroGel dose consistently for the eight weeks he claims he used it.”

AbbVie also cites a lack of studies that show “an increased CV [cardiovascular] risk for men under 60; the only study to look at people under 55 found no statistically significant association; and no study examines risk for men who use TRT for only two months (and intermittently).” The FDA differs in its opinion, which is mentioned later.

Failing judgment as a matter of law, AbbVie argues for a new trial based on, among other things, inconsistencies in the verdict. The jury’s verdict regarding strict liability (that AbbVie could be liable for Mr. Konrad’s heart attack without considering potential negligence or intent to harm) came down in favor of AbbVie, not Mr. Konrad. Yet, the jury found in Mr. Konrad’s favor on his “negligence, intentional misrepresentation, and misrepresentation by concealment claims.”

AbbVie argues that the only way Mr. Konrad could have lost the strict liability claim was if the jury found that AndroGel wasn’t “unreasonably dangerous.” The company contends that, minus a finding that the product was dangerous, the other claims should have failed, too. This inconsistency, AbbVie argues, is cause for a new trial.

As for AbbVie’s last request, remittitur, the company’s appeal states that remittitur is proper for three reasons, according to a U.S. Supreme Court ruling in State Farm Mut. Automobile Ins. Co. v. Campbell. In State Farm, the Court required “three guideposts: ‘(1) the degree of reprehensibility of the defendant’s misconduct; (2) the disparity between the actual or potential harm suffered by the plaintiff and the punitive damages award; and (3) the difference between the punitive damages awarded by the jury and the civil penalties authorized or imposed in comparable cases.’”

Using these guideposts, AbbVie argues that the Court should “reduce the excessive $140 million punitive damages award to $140,000 or not more than $500,000.”

Regarding reprehensibility, the company asserts that it “was not indifferent to public safety; did not target Plaintiff based on financial vulnerability; did not repeatedly target Plaintiff or repeatedly engage in misconduct; and did not evince any ‘intentional malice, trickery, or deceit.’” These are factors by which reprehensibility is determined.

It further argues that “the Supreme Court has held that exceeding even a four-to-one ratio between punitive and compensatory damages ‘might be close to the line of constitutional impropriety,’ and that the ratio should generally not exceed single-digits.” Here, the punitive damages were 1,000 times the compensatory damages.

Finally, AbbVie argues that Illinois state law supports the same limits on damages awards.

Whether the company is successful in its appeal remains to be seen. While, on one hand, it appears that AbbVie has some good points, one cannot discount the fact that several thousand men have reported having heart attacks only after using AndroGel. Current studies may not show a causal relationship between the two, but it is possible that further study is needed. The likelihood of no causal relationship with so many injured men is very small in this author’s opinion.

Even the FDA is cautious when it comes to testosterone products. Given a number of studies linking products like AndroGel to greater risk of heart attack (a non-causal link), the Agency required label changes to reflect the “possible higher danger” two years ago.

The Agency stated, “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”

Sources:

Collierville man awarded $140 million in lawsuit over testosterone drug AndroGel
AbbVie’s appeal

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