A good product label is imperative, especially for medications. When it comes to side effects, both common and uncommon, a drug manufacturer lives and dies by what it has submitted to the Food and Drug Administration for review and whether their product label accurately describes what can happen if a drug is consumed.
This saved drug manufacturer Pfizer when it was sued by hundreds of individuals for side effects allegedly caused by their popular antidepressant, Zoloft. The medication proved to be dangerous to unborn children when their mothers were prescribed Zoloft while pregnant. Others claimed that Zoloft did not treat depression as prescribed.
Pfizer prevailed in the vast majority of litigation against them; some lawsuits were even legally barred from proceeding.
Zoloft, also known as sertraline, is an SSRI (selective serotonin reuptake inhibitor) was approved in 1991 for the treatment of major depressive disorder. By 2005, it was one of the bestselling drugs on the market, and even though Pfizer lost the patent in 2006, they decided to create a generic version.
Zoloft carries what is known as the “black box warning,” which is the strongest label handed down by the FDA. It means the medication causes serious side effects, including suicidal thoughts and behaviors.
The FDA pressured Pfizer to change their label in 2015 to reflect potential harm to unborn children. At the time, their label stated that there are “no adequate and well-controlled studies” of pregnant women. Now, the label says the following (though not in the “black box” area): “Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the neonate.” Further down, doctors are supposed to advise pregnant women as to “possible risks to the fetus” before they start a Zoloft regimen.
Multidistrict litigation (MDL) is a type of federal pleading that groups together similar cases from all across the nation. By consolidating and not duplicating discovery, the cases are streamlined and proceed faster for everyone involved.
1. The drug was improperly marketed
2. The drug was defectively manufactured
3. The drug had dangerous side effects
Most Zoloft cases have not been as part of MDLs; they have been brought as individual lawsuits or mass torts. Most published decisions have shown Pfizer winning claims over patients. As of 2016, more than 300 cases were dismissed for lack of a causal relationship between the medication and birth defects. Once summary judgment was entered for Pfizer and the federal court upheld the ruling, the only existing Zoloft MDL was dropped.
Patients claimed that Pfizer knew the medication would harm people, but put sold it anyway. The label did not warn of potential risks and complications; Pfizer knew or should have known its product was dangerous, since they sold it for uses not approved by the FDA.
Other claims include:
The issue that plaintiffs cannot seem to overcome is that a doctor works as a “learned intermediary” between the pharmaceutical company and the patient. Because doctors are supposed to warn patients of side effects (and because jurors felt the Zoloft label provided sufficient notice), the pharmaceutical company is off the hook.
There are currently no class actions for Zoloft; the only existing class action was dismissed in 2014 . There are a few notable differences between a class action and multidistrict litigation; before any class action can proceed, the plaintiffs must be approved as a class. When there are no existing cases to join, plaintiffs often choose individual lawsuits.
Plaintiffs can pursue claims through state court if the defendant is located within their home state. If the defendant is headquartered in another state, the case must be filed in federal court. This is because of something called “diversity jurisdiction.” Generally, a case will go through state court unless the claim a.) involves the U.S. Constitution or federal laws, b.) has citizens from different states as parties, c.) the United States is a party, d.) involves copyright, patent, bankruptcy, maritime or trademark issues, and/or e.) the amount in controversy is more than $75,000.
State courts have been more favorable to Pfizer, but that doesn’t mean a case cannot be pursued that way. If state court is a better option for your case, a lawyer can help explain the logistics of such a decision.
If you think that Zoloft is causing side effects, your first place to go is to your doctor’s office. He or she will determine whether the prescription is causing pain, mood swings or other complications.
If you have dealt or are dealing with side effects and your doctor says it’s because of Zoloft, talk to an attorney.
Keep in mind that every state has a statute of limitations, after which you will no longer be able to file a lawsuit. Some states offer one year in which to file claims for personal injury, so protect your rights and file. You can always change attorneys afterward if necessary. Here is a worksheet with questions to ask a personal injury attorney to determine if that lawyer is good for your case.
If you have not met with a lawyer yet, consider checking the Enjuris attorney directory for someone in your state.
This is a powerful antidepressant that has been used since the 1980s to treat major depressive disorder, post-traumatic stress disorder, obsessive-compulsive disorder, premenstrual dysphoric disorder, panic disorder and social anxiety disorder.
Zoloft is also used off-label (meaning it is unapproved for such use by the FDA) to treat everything from autism to alcoholism, despite reports that there is minimal evidence the medication works to treat these conditions. Here are some others:
Here is a comprehensive list of health complications and side effects that can occur after taking Zoloft:
If you feel your complications and health issues after taking Zoloft may warrant a lawsuit, these resources will get you started: