Botox Makers Must Face Suit Over User’s Suicide

     CHICAGO (CN) – A husband who says “Botox poisoning” led his wife to kill herself may have a wrongful death case against the drug’s maker Allergen, a federal judge ruled.
     Janet Rosenstern had allegedly taken Botox in 2011 for her temporomandibular joint syndrome (TJS), a disorder affecting the jaw and surrounding facial muscles that can cause difficulty chewing or lock the jaw in an open or closed position.
     This treatment was an off-label use of Botox, the commercial name of the potent neurotoxin botulinum type A, which causes paralysis and can lead to respiratory failure and death.
     It left Rosenstern with “severe debilitating pain in her back and neck, muscle weakness, increased anxiety, depression and migraines,” her husband Klaus Rosenstern says.
     “Her condition eventually progressed into severe acute immune reaction, resulting in a[n] … injury to her brain, resulting in death,” the complaint continues.
     A medical examiner found Rosenstern’s cause of death was suicide, but her husband claims the suicide was induced by “Botox poisoning.”
     According to the complaint, Botox’s maker Allergan “encourage[d] off-label use by teaching injecting physicians and their staff how to get reimbursed for these nonapproved uses by third-party payers.”
     The company pleaded guilty in 2010 to promoting Botox for off-label uses, and paid a $600 million fine.
     U.S. District Judge Thomas Durkin upheld Rosenstern’s claims against Allergen for negligence, failure to warn and wrongful death last week.
     The allegations in the complaint “show that it is plausible that Allergan failed to warn Rosenstern and her physicians of the risk of using Botox to treat TMJ,” the judge said, using the common abbreviation for temporomandibular joints.
     Rosenstern also sufficiently alleged a defect in the drug’s design, but it remains to be seen whether the alleged defect was a design feature approved by the FDA or fell outside the conditions for approval, the court ruled.
     The husband’s claim for breach of implied and express warranty survives because his wife allegedly “relied on both her doctors’ judgment and Allergan’s marketing” in agreeing to the off-label treatment, according to the ruling.
     Rosenstern cannot, however, seek punitive damages under these claims. Durkin noted that the Survival Act does not allow the husband to recover his wife’s funeral costs because these costs accrued after her death.

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