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As reported in our blog post, Testosterone Replacement Therapy Product Liability Multidistrict Litigation (MDL), many users of testosterone replacement therapy drugs, medications and treatments have filed federal lawsuits across the United States against pharmaceutical manufacturers. These lawsuits seek damages for injuries including heart attack, stroke, blood clot, pulmonary embolism, deep vein thrombosis (DVT), and death. Many of the complaints allege that testosterone replacement therapy product manufacturers:
- Failed to adequately research the risk of stroke or heart attack from testosterone therapy, especially among men with pre-existing cardiovascular conditions
- Recklessly and aggressively marketed testosterone treatments in misleading advertisements which created a “disease” (“Low T”) based upon general symptoms and natural issues, prompting otherwise healthy men to seek prescription medications
- Withheld information and failed to adequately warn consumers and the medical community about heart attack risks despite having knowledge of possible side effects
Lawsuit defendants include, AbbVie, Pfizer, Eli Lilly and Co., Endo Pharmaceuticals, Auxilium Pharmaceuticals, Actavis U.S. and Teva Pharmaceutical, Valeant Pharmaceuticals, Upsher-Smith Laboratories and Impax Laborarories.
Testosterone MDL Created
In June 2014, the Judicial Panel on Multidistrict Litigation approved consolidation of all testosterone replacement therapy cases in federal courts across the country into a single multidistrict litigation (MDL) taking place in United States District Court, Northern District of Illinois before Judge Matthew F. Kennelly (In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545). The MDL was approved to streamline all of the litigations against testosterone product manufacturers to allow for common pre-trial procedures, with each plaintiff’s case remaining independent as opposed to the grouping of plaintiffs into one lawsuit as is the case in a class action. Creation of the MDL simplifies complex litigation of similar cases against a common defendant and gives plaintiffs a strong group bargaining position against large corporate defendants in order to obtain a favorable settlement for all plaintiffs.
First Bellwether Trial
A bellwether trial is a preliminary, or “test” trial ordered by the federal court overseeing an MDL. These trials test jury reaction to a case or cases selected as representative of the MDL plaintiff pool. The outcome of an MDL’s bellwether trials may encourage an appropriate group settlement of all cases consolidated under that MDL, as large plaintiff verdicts may prompt defendants to consider settlement instead of incurring the risk of additional legal fees, court costs and judgments.
In the first bellwether trial of the testosterone MDL, a Chicago federal jury reached an October 2017 verdict in favor of Mr. Jeffrey Konrad in his lawsuit against AbbVie, agreeing with Mr. Konrad’s allegations that the company’s testosterone replacement drug, AndroGel, caused his heart attack. The jury awarded Mr. Konrad $140,000.00 in compensatory damages and $140M in punitive damages.
Defendant AbbVie seeks the following relief in its appeal:
- 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.
Given a number of studies linking products like AndroGel to greater risk of heart attack, the FDA required testosterone therapy product manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins (venous thromboembolism), including deep vein thrombosis and pulmonary embolism. The FDA 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.”
Please contact The Ahearne Law Firm, PLLC at (845) 986-2777 if:
- You have, or a family member has, taken a testosterone replacement therapy drug, medication or treatment or if you or a family member suffers from any side effects or related conditions;
- You or a family member who has taken a testosterone replacement therapy drug, medication or treatment have been contacted by a testosterone manufacturer or pharmaceutical company or a third-party claims administrator about reimbursement for costs related to testosterone replacement therapy drugs, medications or treatments.
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