By law, generic drug makers are not permitted to change the labels produced by brand name makers. They have to duplicate the language word for word. When a consumer alleges harm by a generic drug, they are in a tough spot: the generic maker says they don’t know the risks nor can they change the label. Therefore, they can’t be held responsible.
This was supported in 2013, when the US Supreme Court ruled, by a 5-4 decision that makers of generic drugs cannot be sued for failing to warn consumers of the possible dangers and side effects of their products if they copy the exact warnings on the brand-name equivalents of the medicines.
Brand name makers, on the other hand, say they are not liable as they didn’t make the pills. This has led to many cases against both the brand name maker and the generic maker being dismissed.
So, who should be held liable? Recently, a closely watched lawsuit in Chicago tested the legal limits of liability.
According to court documents, a man was prescribed paroxetine, a generic antidepressant equivalent to the name-brand Paxil, in July 2010. After taking the drug for several days, the man took his own life by stepping in front of a Chicago Transit Authority Blue Line train.
The widow of the deceased filed a lawsuit in 2012 against GlaxoSmithKline (GSK), the manufacturer of Paxil and Mylan, which manufactured the generic version which her husband was taking before his suicide. In 2014, a federal judge dismissed Mylan from the lawsuit, but allowed the case to proceed against GSK because the company controlled the drug’s design and label, which applied to both the brand-name and generic versions of the drug.
The complaint stated that GSK had known for a long time that there was an increased risk of suicide from Paxil, yet did not note that risk on its label, misleading physicians and patients in the process. In fact, the label had a “black box” warning that the antidepressant can increase the risk of suicidal behavior by users under age 25. Her husband was 57. That same “defective” label was included with the generic equivalent paroxetine.
In response, GSK argued the requirements of the label were set by the FDA, which had determined GSK’s label was sufficient. GSK also argued that it shouldn’t be liable because it didn’t make the generic version of the drug taken.
The jury agreed with the plaintiff that GSK was still responsible because the drugs are identical and have the same labeling. The plaintiff was awarded $3 million. A GSK attorney said the decision was disappointing and the company plans to appeal.
Every day, millions of Americans fill prescriptions that are made by generic drug manufacturers. In fact, over eighty percent of prescription drugs used are generic brands, mainly to save costs. In Illinois, “state pharmaceutical laws actually require such a substitution unless a doctor has advised against it.
Hopefully, the outcome in this case will set a precedent for liability against brand name drug makers in similar cases in the future. The jury decision provides some measure of justice for the victim’s survivor. However, there is a missing verdict component in this otherwise favorable result. Query: Is it right to protect generic drug companies who make substantial profits from their own versions of brand drug makers’ products? If the brand drug maker is found liable, shouldn’t the generic drug maker be liable as well? Shouldn’t the same laws apply to both? What do you think?
Mark Bello is the CEO and General Counsel of Lawsuit Financial Corporation, a pro-justice lawsuit funding company.
Experienced attorney, lawsuit funding expert, certified civil mediator, and award-winning author of the Zachary Blake Betrayal Series. The series consists of "Betrayal of Faith", "Betrayal of Justice", and "Betrayal in Blue", with a fourth book due out in 2019. You can learn more about these topical political, legal thrillers at markmbello.com. Mark Bello is also a member of the State Bar of Michigan, a sustaining member of the Michigan Association for Justice, and a member of the American Association for Justice.