‘Low T’ Drug Cases Involving Abbott’s Androgel Could Be Next MDL, Mass Tort

Daniels Tredennick Pharmaceutical and Mass Torts

 

A large study has found substantial risks in prescribing testosterone to middle-age and older men for a variety of ailments. One part of the study found that testosterone doubled the risk of cardiovascular disease in more than 7,000 men who were 65 years old or older, essentially confirming findings in previous studies. The other part found that testosterone almost tripled the risk of heart attacks in a group of more than 48,000 middle-age men with previous histories of heart disease. The harm in both cases occurred within 90 days of receiving the prescription.

A large study has found substantial risks in prescribing testosterone to middle-age and older men for a variety of ailments. One part of the study found that testosterone doubled the risk of cardiovascular disease in more than 7,000 men who were 65 years old or older, essentially confirming findings in previous studies. The other part found that testosterone almost tripled the risk of heart attacks in a group of more than 48,000 middle-age men with previous histories of heart disease. The harm in both cases occurred within 90 days of receiving the prescription.

Several products liability attorneys say that the recent appearance of lawsuits nationwide against the manufacturers of testosterone therapy drugs indicates the potential for multidistrict litigation and possibly a new mass tort.

Many of the current suits filed in federal courts across the country are against Abbott Laboratories—maker of the topical testosterone therapy drug AndroGel and the anti-seizure medication Depakote.  Lawyers say that Abbott has been the dominant producer of testosterone therapy drugs on the market.

Allegations have been made that testosterone therapy drugs contribute to heart attacks, strokes, embolisms and death in male users. Stephen A. Sheller, founder of Sheller P.C., said his office is currently getting increased calls and evaluating cases related to testosterone therapy products designed to treat low testosterone levels, or “low T,” in men.

“It’s a real problem,” Sheller said. “Another drug hitting the market, another disaster.”

“We’re getting cases and have been talking to lawyers from other parts of the country,” Sheller added. “I predict it will be a mass tort. From what we see happening and the calls we’re getting, it looks like it’s a serious problem.”

While there is no mass tort program currently in development for testosterone products in Philadelphia, if a significant number of filings emerge, a mass tort could be considered, according to Stanley Thompson, director of the Philadelphia Court of Common Pleas’ Complex Litigation Center.

Thompson said that mass tort qualification varies by litigation, but generally the court looks to have a case listing of at least 100.

“Generally we’re looking for many cases,” Thompson said. “It varies … we’ve had some with 7,500 cases and some with 100 cases.”

Thompson added that whether a grouping of cases becomes a mass tort is ultimately left to the discretion of Administrative Judge John W. Herron.

“Most of the cases are still in the investigatory phase,” said Dianne Nast, founder of NastLaw. Nast said she currently has a testosterone drug case in the U.S. District Court for the Eastern District of Pennsylvania.

The U.S. Food and Drug Administration is currently looking into the alleged connection between testosterone products and heart-attack risk as well as the labeling of those products, Nast said, as many of the claims against the manufacturers center on failure to warn.

Nast added that many of the federal cases are in Illinois, where Abbott is headquartered.

“There will likely be a multidistrict motion and there’s a reasonable possibility that the panel will transfer all the cases to one district,” she said.

Products liability attorney Claudine Q. Homolash said, “I definitely think there is going to be an MDL, with this many defendants all over it would be difficult not to justify an MDL.”

Homolash mentioned that AndroGel, a widely marketed drug, “is touted as the fountain of youth for men, but it’s a very serious drug and it’s being overprescribed.”

She added, “It’s my understanding that testosterone-replacement therapies are highly prescribed off-label. Really, they are only FDA-approved for treatment in males with low testosterone levels in conjunction with an associated medical condition.”

Thomas R. Kline of Kline & Specter is currently handling a testosterone drug case and said that low T reminded him of the Vioxx litigation.

“The challenge there, as here, for plaintiffs is that a heart attack is not a signature injury and happens in the population without the ingestion of medication,” Kline said in an email to The Legal. “This was a principal defense in Vioxx by the manufacturer, Merck.”

He added, “The challenge for the defendants in low T, the largest manufacturer of which is Abbott, will be attempting to defend the failure to warn of these risks in a drug promoted for life enhancement, not a lifesaving purpose.” Kline said he anticipates a number of cases originating from testosterone product claims.

“We expect this to emerge from the review of a few cases to a significant number of clients,” Kline said.

In particular, Kline noted, there are two high-risk groups for men using testosterone products: men over 65 and men under 65 with a prior history of heart disease.

“These are the two categories of cases which [are] most dramatically affected and on which we are focused, although I expect to see other categories of men at increased risk as the studies on the subject progress and advance,” Kline said.

Arlene Fickler, a products liability defense attorney and partner at Schnader Harrison Segal & Lewis, said it is too early to tell if the AndroGel and other testosterone product litigation will evolve into a mass tort.

In terms of class actions, Fickler said, “I think it is unlikely that we can see class actions being certified from these claims because it’s getting harder and harder to get a class in any type of litigation, but especially in personal injury litigation where the injuries are allegedly so substantial. … It certainly demands individual attention that couldn’t be handled in a class.”

Defense attorney Albert G. Bixler of Eckert Seamans Cherin & Mellott said that, based on his observations, AndroGel cases do have the potential to grow large in number as it is a widely used product.

“But whether they’re cases that have a lot of merit, I don’t know,” he added.

Bixler also said he could see why testosterone drug cases are being analogized to Vioxx litigation.

“The injuries in both are injuries that have multiple causes; there are lots and lots of those types of injuries that occur in the U.S.,” Bixler said, noting that in the Vioxx litigation the defendants looked to illustrate alternate causes for the plaintiffs’ heart attacks.

Scott Davies of Abbott’s external communications department did not return a call seeking comment.