Big Pharma drug manufacturer Merck has had its asthma medicine, Singulair, and its generic offshoots, named in more than 4800 reports of psychiatric problems, particularly in children.

     At least 82 suicides have also been reported for those who took the medication, a third of whom are children.
However, no lawsuits from Singulair victims have been successful due to the legal, but constitutional loophole of “preemption,” which states that federal law overrides state law in these matters. Two U.S. Supreme Court rulings in 2011 and 2013 had barred any lawsuits against generic drug makers which were based on state laws that enabled claims about design defects or about failures to warn consumers of potential dangers.
 
     Merck’s patent on Singulair expired in 2012 – after Merck had reaped more than $50 billion in revenue from it – and thereafter a number of generic drug manufacturers started producing the medication. Although 91 percent of all U.S. prescriptions are now generic, per the FDA, the legal “preemption” defense has protected most all generic drug
manufacturers from lawsuits over production defects or inadequate black box warnings.

     Only the original name brand drug manufacturers can still be sued, but it is hard to prove their violations of manufacturing defects or inadequate safety warnings.

     For example, during Merck’s original clinical trials for Singulair before its 1998 release, one eighteen year old participant had attempted suicide and one twelve year old participant had to be hospitalized for depression and suicidal thoughts. Although there are still pending lawsuits against Merck over Singulair, Merck still has not yet lost any of the earlier suits. In 2014 the FDA dismissed the relevance of these two suicide events.

     After Singulair first hit the market in 1998, the reports of psychiatric difficulties and successful suicides after taking the medication continued to accumulate, but it took twenty years before the FDA first took action. It was not until 2008 that an FDA review of the drug’s psychiatric effects and suicide risks recommended “further studies in animals and humans.” That report also suggested the FDA should have Merck conduct its own observational study.

     However, the FDA never did require such a study, reasoning in part that serious side effects including suicidal thinking “were expected to be quite rare.”

     In 2014 an FDA investigator of the initial Merck trials for Singulair claimed that those two reported suicide events had been unrelated to ingesting Singulair. The FDA agreed, but it did report that those initial Merck clinical trials were short and were not designed to detect psychiatric side-effects.

     Stephane Bissonnette, a Merck manager, told the 2014 FDA panel that “suicidality was quite rare” in the trials, using almost exactly the same phrase the FDA itself had used six years earlier.

     The lethal side-effects of those taking the medication continued to build – including a count of eighty-two suicides – and in 2019 the FDA convened another board to decide whether the drug’s side-effects warranted a black box warning. Following that board’s report, the FDA should have required new studies of Singulair and its generic descendents, but instead the FDA merely announced in March 2020 that it would only add to the existing black box 
warning of the drug’s “side-effects.”

     At any number of points during its twenty-two year history monitoring Singulair and its generic offshoots, the FDA could have legally – not to mention ethically — required Merck to redo and improve their trials, given the number of severe negative reactions to the drug, but it did not.

     If it had, a minimum of 82 suicides might have been prevented and 4800 victims of the psychiatric side-effects of the drug would have been spared their own mental health ordeals.

(Thanks to Reuters’ 2023 Special Report for help bringing this travesty to light).