Woman Can Sue Study Sponsor for Suicide Try

     (CN) – A woman who attempted suicide after taking a drug known to exacerbate depression for a quit-smoking medical study can sue the University of Texas, a state appeals court ruled.
     Longtime smoker Karen Jones signed up for the University of Texas M.D. Anderson Cancer Center’s smoking-cessation study called “Two to Quit,” after her husband died of lung cancer.
     The study investigated the effectiveness of two medications, Chantix (varenicline) and Zyban (buproprion), to help people quit smoking.
     Participants were divided into three groups – those taking placebos, those taking Chantix, and those taking both Chantix and Zyban.
     When the study began, neither Jones nor the study employees knew to which group she had been assigned, according to court records.
     However, Jones informed staff that she had previously had a bad experience taking Chantix, suffering strange dreams and difficulty sleeping. She also told them she had been diagnosed with depression following her husband’s death.
     Both Chantix and Zyban carry FDA warnings that their side effects include depression and suicidal ideation.
     A couple weeks into the study, Jones attempted suicide by taking a large dose of morphine that had been prescribed to her husband before his death. She suffered permanent nerve and renal damage, and spent several weeks in the intensive care unit.
     It turned out that Jones had been assigned to the Chantix-only group.
     She sued the university in Harris County, Texas, arguing that admitting her into the study and prescribing her Chantix was negligent given her history of depression.
     A Texas judge granted the university immunity, but an appeals panel reversed the decision Thursday.
     “Jones’s allegations and evidence show a nexus between UTMDA’s prescribing and dispensing Chantix and the injuries the drug allegedly caused Jones,” Justice Brett Busby wrote for a three-judge panel.
     Two medical doctors filed expert reports in support of Jones’s suit. Dr. B.R. Respess said, “in all reasonable probability [Jones’s] suicide attempt was due to the fact that she was prescribed [Chantix] as part of the ‘Two to Quit’ study.”
     Dr. George Glass, a psychiatrist, went further, stating, “It was, in all medical probability, because [Jones] was involved in the study and then given Chantix, a psychotropic drug with a black box warning, that she made an almost fatal suicide attempt.”
     The university made no attempt to refute their testimony, according to the ruling.
     “In conclusion, Jones’s pleadings and undisputed evidence trigger a waiver of UTMDA’s governmental immunity under [state law],” Busby wrote.

%d bloggers like this: