On July 24, a jury in Chicago federal court found in favor of plaintiff Jesse Mitchell, ordering drugmaker AbbVie to pay $150 million in damages for allegedly falsely marketing the benefits of its Androgel testosterone therapy drug, while not holding the company liable for a heart attack suffered by the plaintiff.  This was the second of bellwether trials in a massive class action involving thousands of claims against AbbVie and other drugmakers, including Eli Lilly and GlaxoSmithKline. The thousands of complaints have been consolidated by the country’s federal courts, and are being heard as a multi-district litigation Testosterone MDL 2545 AbbVie “Androgel” Briefcase,  under U.S. District Court Judge Matthew Kennelly in U.S. District Court for the Northern District of Illinois in Chicago.










Lawsuits dating to 2014, allege the testosterone replacement drugs were not only useless, but actually harmful, even though approved by the U.S. Food and Drug Administration to treat testosterone deficiency, the claims allege the companies also falsely marketed the drugs to treat a variety of other conditions, including diabetes, AIDS, cancer, depression and anxiety. The lawsuits further allege the drugmakers invented a nonexistent condition called “andropause” or “low T,” which could be treated by testosterone replacement.

However, plaintiffs claim the drugs are not only ineffective for these off-label uses, but they increase the risk of heart attack, blood clots and stroke.

Judge Kennelly selected eight of the cases to move forward to trial. The first bellwether trial, in which plaintiff Jeffrey Konrad, claimed Androgel caused a heart attack, ended in a mistrial in June.

This trial where Mr. Mitchell, of Oregon, similarly asserted the drug had caused his heart attack, proceeded to the jury in July and after days of testimony and arguments in court, however, the jury refused to find AbbVie responsible for Mitchell’s condition.

The jury did say they believed AbbVie had falsely misrepresented the benefits of its testosterone therapy drug to Mitchell, and ordered the company to pay punitive damages of at least $150 million.

A lawyer for Mitchell did not immediately respond to a request for comment from the Cook County Record on Monday.

In a brief emailed statement, a spokesperson for AbbVie noted “the jury found that Androgel did not cause any damage.”

“We expect the punitive damage award will not stand,” the statement said.

The verdict came over the strong objections of AbbVie, whose lawyers argued in court that they should not be held responsible for Mitchell’s condition or use of the drug.

In a motion for judgment filed July 17, the company noted even a doctor called by Mitchell’s attorneys conceded Mitchell was already at high risk for cardiac disease, without ever taking Androgel, because of his “several cardiac risk factors … including a 34-year smoking history, high blood pressure, high cholesterol, high triglycerides, obesity, a family history of heart disease, and lack of exercise.”

AbbVie also argued the jury could not find it had failed to warn of the risks of Androgel under federal rules and the company claimed the evidence demonstrated Mitchell had never heard of Androgel or any of its alleged “false claims” before his doctor prescribed it for him. And, AbbVie argued, Mitchell’s doctor “relied on his own training, experience and medical judgment, rather than anything said by (AbbVie), when making treatment decisions for Mr. Mitchell.”

“Finally, any suggestion that (Mitchell’s doctor) was somehow deceived or misled by (AbbVie’s) risk information is belied by the fact that he warned Mr. Mitchell of the potential cardiovascular risks,” with Judge Kennelly taking the motion “under advisement” on Friday, July 21 and subsequently denied. Resulting in the 2nd recent verdict against AbbVie, after having been found liable in the Depakote birth defect trial where the Illinois jury awarded $15 million to plaintiff Christine Raquel, after having been prescribed Depakote for bipolar depression.

Jesse Mitchell was represented the firms of Levin Papantonio Thomas Mitchell Rafferty & Proctor, of Pensacola, Fla.; the Alvarez Law Firm, of Coral Gables, Fla.; Seeger Weiss, of New York; Goldberg & Osborne, of Tucson, Ariz.; Heard Robins Cloud, of Santa Monica, Calif.; and Douglas & London, of New York.

AbbVie was defended by the firm of Dechert LLP, of Princeton, N.J.

Organizations Listed:

1 N Waukegan Rd
Lake Bluff, IL 60044

U.S. District Court for the Northern District of Illinois
219 S Dearborn St
Chicago, IL 60604

Read More

Jury Awards Boy $15 Million for Depakote Birth Defects

Depakote Birth DefectsA federal court jury in East St. Louis, IL, awarded $15 million in compensatory damages on June 9 to a boy who was born with spina bifida as a result of his mother’s use of Depakote when she was pregnant.

The case is E.G., et al. v. Abbott Laboratories Inc., No. 15-702, S.D. IL.

The jury ruled that Abbott Laboratories Inc. failed to warn Christina Raquel about the risk of birth defects when she took the drug. The mother had a prescription for the antiepileptic drug Depakote ER and her child, identified only as E.G., was born in 2007 with birth defects.

Adequate warning

Abbott argued unsuccessfully that it did adequately warn Raquel’s physicians about the risk of Depakote during pregnancy.  It also claimed that the mother failed to prove that the warning or lack of warning caused her son’s birth defects.

Raquel sought compensation for past and future medical expenses, life-care and future lost wages or reduced earning capacity.

Depakote is approved to prevent seizures, to treat manic episodes associated with bipolar disorder, for migraine prophylaxis and to treat certain types of seizures.

Judge Nancy J. Rosenstengel presided over the trial. Raquel’s attorneys were John E. Williams Jr. and John T. Boundas of Williams Kherkher Hart Boundas in Houston.

Read More

European Study Says Depakote Caused Thousands of Severe Birth Defects

A new European study finds that pregnant women who took epilepsy drug valproate — sold in the US as Depakote — were four times more likely to give birth to a baby with birth defects.

The report, jointly issued by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration, confirmed that the drug is “highly teratogenic”, meaning that it can disturb the development of an embryo.

A total of 129 lawsuits, involving about 698 plaintiffs, have been filed against Abbott Laboratories in In Re Depakote, Case No. 12-CV-52-NJR-SCW, in the Southern District of Illinois before US District Judge Nancy J. Rosenstengel.

  • Plaintiffs recovered $38 million in punitive and compensatory damages against Abbot in May 2015. Attorneys from Williams Kherkher argued that Abbott underplayed the risk of birth defects, making it appear that Depakote had about the same level as other anti-epileptic drugs available.  As attorneys John Eddie and John Boundas were able to argue, in reality it was the most dangerous anti-epileptic drug.
  • Last November there was a £10.7m ($13.8 million) settlement in France for people harmed by sodium valproate during pregnancy.

On the market since 1967

Valproate — known in France under the brand name Depakine — has been on sale there since 1967, and in Britain under the name Epilim since 1973. In the US, Depakote was approved by the FDA in June 1996 to treat epilepsy.

Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.

The FDA warned doctors in December, 2009, that fetal exposure to valproate sodium (Depacon, Abbott), valproic acid (Depakene, Stavzor, Abbott), and divalproex sodium (Depakote, Depakote CP, Depakote ER, Abbott) is associated with birth defects, according to the US Food and Drug Administration (FDA).

The FDA said the drug can cause birth defects including neural tube, craniofacial, and cardiovascular defects, and warned doctors to “inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

Depakote litigation

The first cases were filed in state court in 2010 and removed to federal court on January 18, 2012. Judge Rosenstengel said, “the bellwether process and global settlement efforts have failed,” after several trial dates fell through. As a result, “The Court intends to hold joint trials as to common issues of fact and law to the maximum extent possible.”

The judge intends to try the majority of the cases in joint trials by the end of 2017.

Judge Rosenstengel dismissed nine cases on April 12 under the Indiana repose issue, ruling that all the acts leading to the alleged birth defects in the nine cases took place in Indiana, and that Indiana’s 10-year statute of repose therefore applied. An Illinois statute favored by the plaintiffs would have allowed the claims to go forward.

Abbott agreed to pay $1.5 billion to settle civil claims and criminal charges from the FDA that the drugmaker misbranded Depakote and Depakote ER between 1998 and 2006. Abbott also received repeated notices from the FDA between 1982 and 2009 that the company was misbranding the drug or promoting it for unapproved uses, the plaintiffs said.

The plaintiffs are represented by Christopher Cueto and Michael Gras of the Law Office of Christopher Cueto Ltd., Janet G. Abaray of Burg Simpson Eldredge Hersh & Jardine PC, John T. Boundas of Williams Kherkher Hart Boundas, and Bruce L. Sampson Jr. of Bracewell LLP.


Read More