Paxil lawsuits got a boost earlier this month. A federal appeals court in Illinois ruled a widow may proceed with her wrongful death lawsuit against Paxil manufacturer GlaxoSmithKline even though the medication at issue was a generic not manufactured by the company.
Wendy Dolin is suing GSK over the death of her husband, Stewart, a prominent Chicago attorney. After being on paroxetine, the generic of Paxil, for six days, the 57-year-old leapt to his death in front of a downtown Chicago commuter train.
It’s well known that Paxil carries a high risk of suicide for patients up to age 30. Paxil packaging notes this prominently. But what isn’t noted on the packaging is that the drug also carries an elevated risk of suicide for all users, including older patients. Because generic drugs must carry the same wording as their brand name counterparts exactly, the paroxetine prescribed to Stewart Nolin did not alert him or his doctor to dangers of the drug to his age group.
According to the judge in the case, “The negligence here is extrinsic to the Paxil manufacturing process and, if true, could proximately cause injury to consumers of all versions of paroxetine, including the generic version that Mr. Dolin ingested.”
This ruling has implications for all brand name drug manufactures. It holds them responsible for disclosing and publishing all known risks of their drug so that generic versions made by others can carry the same warnings. It says if you create a drug and know it poses serious risks, regardless of whether consumers buy the brand name or generic version, you have a duty to warn them.
The FDA has proposed a new rule that would allow generic drug manufacturers to put warnings on their packaging that reflects new information about risks even though the wording is not on the brand-name versions. This has sparked a firestorm among industry lobbyists in Washington, D.C., who claim this would unduly burden generic drug makers to keep up with the latest side effects of their products.
Really, is this too much to ask? Generic drugs make up 84% of all drugs prescribed in the U.S. Some insurance companies and even states require they be dispensed instead of the brand-names because it saves so much money. Consumers who use generics and the doctors who prescribe them should be able to rely on the safety information that comes with them.
GlaxoSmithKline decided not to note Paxil’s full range of risks on its label. That left Steward Dolin and his doctor in the dark, and left Wendy Dolin a widow. She is demanding that GlaxoSmithKline be held accountable. We should all hope she succeeds.