Following Husband’s Death, Widow’s Sues Over Allegedly Weak Warning Label on Generic Medication

A widow is suing the maker of generic_Paxil (paroxetine) tablets that her husband, 42 at the time of his death, took as prescribed in 2010. The widow alleges that just six paroxetine tablets led to her husband’s suicide and did not ease his anxiety.

“If you ask anyone who knew him, he was laid back, high on life, so there was this unbelievable disconnect between how he lived his life: a beautiful man, a beautiful life. The tragedy and violence of his death … it was, it just didn’t make sense,” his wife, told NBC5 Investigates, according to CSN Chicago.

The lawsuit, which is in federal court in Chicago, is groundbreaking in that it may change how generic prescription drugs are handled. In this case, allegations include that the generic Paxil warning was not adequate, as it did not include the risk of increased suicidality for adults over the age of 24. The lawsuit also alleges that GlaxoSmithKline, the maker of Paxil, knew of this increased risk, yet suppressed warnings for years, wrote CSN Chicago.

The widow’s lawyer says that she, like others who have brought similar lawsuits alleging harm caused by insufficient labeling on generic medication may end up in a legal black hole in which the generic maker indicates that it is unaware of a drug’s risks and cannot be held responsible for the risks, while also being unable to update the drug’s label. The maker of the brand version of the drug argues that it did not manufacture the generic in question, CSN Chicago wrote.

Legally, generic drug makers are not allowed to change labels produced by brand name makers and must duplicate the label language exactly. When a consumer alleges harm resulting from a generic medication, he/she alleges that the insufficient warning was not produced by the company that distributed the drug. Often, cases brought against brand name and generic makers are dismissed; however, in this case, the lawsuit was permitted to move forward, according to CSN Chicago.

In this case, the labeling indicates that the risk of suicide does not exceed beyond age 24; that risk is indicated in the Black Box warning, which is what consumers are meant to read first. Yet, according to the lawsuit, wrote CSN Chicago, the labeling information is allegedly incorrect. The case is scheduled to be heard in court later this month.

The widow of the man who died in this case said, “One of my friends called and said ‘akathisia’ and I said, ‘What?’” She said she then “Googled ‘akathisia’ and ‘Paxil’ and it was like, bone-chilling. What had not made any sense was like, ‘Oh my God. That’s what happened to Stewart.’” Akathisia is a side effect associated with some Selective Serotonin Reuptake Inhibitors (SSRIs), such as Paxil, prescribed to treat depression and anxiety. Akathisia is described as an internal restlessness and agitation that becomes so intense that one pharmaceutical expert said, “Death can be a welcome result,” CSN Chicago reported

Had she or her husband been aware of this side effect, they would have worked to stop taking the drug and would have avoided its fatal side effect, the widow noted, according to CSN Chicago.

This entry was posted in Pharmaceuticals, SSRI Antidepressants. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.