The 50-page lawsuit, filed in United States District Court in California and brought on behalf of consumers nationwide, is a damning compilation of evidence, describing in detail how Pfizer “concocted a comprehensive and aggressive scheme to mislead consumers and healthcare professionals about Zoloft’s efficacy.”
“In promoting the drug, they did not adequately represent all the facts,” says New Orleans attorney Chris Coffin from Pendley, Baudin & Coffin, whose firm represents the class. “Pzifer has not given the full picture of the drug to consumers or to healthcare providers.”
Zoloft was approved for sale in 1991, after Pfizer produced two studies showing that the drug had “a statistically significant effect.” Although the FDA was concerned that there were many studies that showed Zoloft was only marginally better than a placebo drug, it finally gave Zoloft the go-ahead in the US.
“Obviously two drugs trials showed that the drug outperformed the placebo and that’s what the FDA looks at,” says Coffin. “However, when you read all the information, you can’t help but question whether Zoloft really is an effective drug in the treatment of depression.”
Pfizer is a leader in the antidepressant industry and the company has revenues of $64 billion a year. Much of the drugmaker’s success is due to its sales of Zoloft.
According to the documents filed with the court in California, Pfizer was only too aware from the beginning that Zoloft, generically known as seratraline hydrocholoride, did little to relieve depression. The company then systematically went about finding ways to “deliberately mislead consumers and health care professionals about the efficacy of Zoloft.”
First, the company made sure that prescription labels contained no information to suggest there were any contradictory studies, and then went about trying to position Zoloft as the recognized number-one antidepression drug.
Next, it contracted medical ghostwriters to author articles for prestigious medical journals and paid well-known researchers to allow their names to be attached to the material while concealing Pfizer’s involvement in the material.
And, also, according to the statement of claim, Pfizer spent “millions of dollars on direct-to-consumer advertising and physician-targeted sales aids designed to convince consumers and healthcare professionals” that Zoloft worked.
Although there are doubts about Zoloft as an answer to depression, its potential side effects are well documented. The list of potential problems includes nausea, diarrhea, dizziness, dry mouth, fatigue, headaches, weight loss, constipation, vision changes, allergic reactions, high blood pressure, muscle pain, ringing in the ears (tinnitus) and more.
Zoloft has also been connected to serious birth defects. Coffin’s firm has represented and currently represents families of children born with Persistent Pulmonary Hypertension of the Newborn (PPHN) after their mothers’ use of Zoloft during pregnancy. Newborns with PPHN have constricted arteries in their lungs, which seriously limits the amount of oxygen that is able to pass into the bloodstream. As many as one in five PPHN babies dies.
Given the potential health risks associated with Zoloft compared to its apparent lack of effectiveness, the statement of claim argues that consumers of the drug should have been fully and completely informed in order to decide whether taking the drug was worth the risk.
It is estimated that since 1991, American consumers have spent approximately $30 billion on Zoloft in the US alone.
Not only does the suit ask that Pfizer return the cost of prescriptions to consumers, it also demands that Pfizer cease marketing Zoloft as an antidepressant.
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Chris Coffin is a partner with Pendley, Baudin & Coffin. He focuses on litigating complex cases involving defective pharmaceuticals and medical devices, environmental contamination, product liability, toxic torts and consumer fraud claims. Coffin has been heavily involved in multiple class-action and mass tort cases throughout the United States, and has served as a leader in many national lawsuits representing thousands of individuals. As the leader of the firm’s pharmaceutical and medical device litigation practice, Chris Coffin has prosecuted cases against pharmaceutical and medical device manufacturers for over nine years, and has been licensed as a registered nurse for approximately 15 years.