May 7, 2015
By Mark Terry and Riley McDermid, BioSpace.com Breaking News Staff
A Federal Court approved a settlement against Pfizer Inc. on April 30 for a class action lawsuit regarding its Parkinson’s drug Cabaser.
In December 2014, Pfizer offered to settle the class action in Australia after 150 patients filed that they did not have warning of potential side effects of treatment for Parkinson’s with Cabaser (cabergoline). The side effects include gambling and sex addiction and other high-risk activities.
“Less than a fifth of people taking dopamine agonists will develop some form of these distressing compulsions, which can range from compulsive gambling to binge eating and hypersexuality,” said Suma Surendranath, professional engagement and education manager for Parkinson’s UK in a statement. “But it is important to stay alert to the warning signs of this behavior. These drugs can make a huge difference to the lives of many people with Parkinson’s and it is important that people aren’t scared of taking them.”
The 160 patients who took the drug were being treated for tremors associated with Parkinson’s or restless legs syndrome between 1996 and 2010. The patients indicated they had gambled and lost hundreds of thousands of dollars after taking Cabaser. The class action suit was scheduled to begin earlier this year.
In 2013 Eli Lilly and Company settled a similar class action lawsuit regarding its drug Permax, which is similar to Cabaser.
Both Cabaser and Permax are dopamine agonists. One of the relatively rare side effects is impulsive behavior. The types of impulsive behavior observed include addictive gambling, obsessive shopping, binge eating and hypersexuality. Other related side effects are hoarding, pointless driving or walking, and long rambling monologues.
In a similar story in France a man being treated with Requip, a dopamine agonist manufactured by GlaxoSmithKline , sued, claiming the drug turned made him into a gay sex and gambling addict. He was awarded $256,927.
The side effects are not a new revelation. An article was published in the journal Archives of Neurology in 2006 describing impulse control disorders linked to the use of dopamine agonists used to treat Parkinson’s disease. The conclusion of that article said, “PD patients treated with a dopamine agonist should be made aware of the risk of developing an ICD and monitored clinically. As dopamine agonists are increasing being used for other indications, future research should assess the dopamine agonist-associated risk for ICDs in other populations.”
The settlement amounts for the most recent Pfizer lawsuit remain confidential.
Pfizer had better legal luck April 20, when it successfully won the first round of a lawsuit taking place in St. Louis that claimed that that the antidepressant Zoloft caused birth defects in a boy from California, after a court said that it was not liable and will not have to pay compensatory or punitive damages.
The case had been brought by Joseph Zonies of Colorado law firm Reilly Pozner on behalf of Kristyn Pesante, and had claimed Pfizer did not warn doctors about the potential risks of birth defects while taking Zoloft. Pfizer’s victory Friday is significant because Pesante’s claim was selected as a test case for other claims, which some trial lawyers had hoped could reach class action status.
The next trial related to Pfizer’s Zoloft is slated to take place later this year in state court in Philadelphia.
During the week-long trial, Zonies cited an internal May 2014 report Pfizer made indicating that newborns of women taking Zoloft were at risk for congenital anomalies. However, Pfizer strongly refuted that allegation, and a jury agreed.
“The science has never even suggested that birth defects were caused by Zoloft,” said Beth Wilkinson, one of Pfizer’s attorneys in a statement. “No treating physician or medical records say Zoloft is a cause.”
In this particular case, Logyn Pesante, whose mother took Zoloft during her first trimester of pregnancy, was born with multiple heart defects. The most serious of those defects was transposition of the great arteries, called TGA. This is when the two main arteries that leave the heart, the pulmonary artery and the aorta, are switched in position. According to the Centers for Disease Control and Prevention (CDC), about 1,901 babies are born with TGA in the U.S., or about 5 out of every 10,000.
In 2010 GlaxoSmithKline paid more than $1 billion in 800 similar lawsuits claiming that its antidepressant Paxil caused birth defects in some of the children of mothers taking the drug. The company also paid out another $1 billion over the years regarding claims the drug caused suicides, attempted suicides and addiction problems.
There are approximately 1,000 lawsuits filed against Pfizer regarding Zoloft and birth defects. In November 2014 the company asked a Pennsylvania judge to dismiss more than 500 of them. Those suits, of which there were 526, were combined into a multidistrict litigation, which is similar to a class action suit but the plaintiffs have their cases settled individually. Of those 526 cases, 443 were from Pennsylvania.
In a statement, Pfizer indicates that reports to the U.S. Food and Drug Administration (FDA) and the European regulators confirm the drug’s safety data and Pfizer hadn’t identified a “signal for congenital anomalies and that a comprehensive review of the literature did not support an association between use of Zoloft and birth defects, including cardiac anomalies. … Plaintiffs have taken a single statement in one document, summarized the results of a few studies, out of context.”
If the drug does cause birth defects, it must be a very rare event. Data compiled by the CDC indicates that about one in 10 people in the United States take antidepressants.
“Pfizer has great sympathy for families affected by birth defects,” said Pfizer spokeswoman Christine Regan Lindenboom in an email to BioSpace . “There is no valid and reliable scientific evidence to support the plaintiff’s claims. In fact, a range of independent organizations, such as the American Psychiatric Association, American College of Obstetricians and Gynecologists and the American Heart Association, have concluded that Zoloft’s use during pregnancy is not associated with birth defects, including those alleged in this case.”
Will Hungry Pfizer Make a Play for Struggling GlaxoSmithKline?
Almost a year after its $119 billion offer for AstraZeneca PLC fell apart in the face of massive opposition from regulators and internal dissent, global drugmaker Pfizer Inc. is once again being floated as a potential buyer of another marquee-name British pharmaceutical company: GlaxoSmithKline . We at BioSpace want to know your thoughts: With cash to burn, will Pfizer go hunting for Glaxo?
