XPost: law.court.federal, alt.government.abuse, sci.med.pharmacy   
   XPost: alt.fan.rush-limbaugh, talk.politics.guns, sac.politics   
   From: democrat-criminals@mail.house.gov   
      
   https://reuters.com/investigates/special-report/usa-lawsuits-merck-   
   singulair/   
      
   Merck’s best-selling asthma medicine, Singulair, has been linked for years   
   to suicides and psychiatric problems, often in children. But lawsuits over   
   the drug are stymied by one of Corporate America’s most effective   
   liability shields: the doctrine of federal preemption.   
      
   Nicholas England, a healthy 22-year-old from Virginia, shot himself in the   
   head in 2017, less than two weeks after he started taking an allergy   
   medicine that had been linked for years to episodes of depression and   
   suicidal thinking.   
      
   His parents soon started exploring a lawsuit against Merck, the developer   
   of the blockbuster asthma and allergy drug, Singulair, along with the   
   manufacturer of the generic version their son took. Nicholas had no   
   history of mental-health problems, they said.   
      
   The Englands were shocked to learn from legal advisers that they had no   
   case. Like countless other potential plaintiffs, they had run into one of   
   Corporate America’s most effective liability shields: the legal doctrine   
   of preemption, the principle that federal law supersedes state law.   
      
   Armed with U.S. Supreme Court rulings on preemption starting in the 1990s,   
   companies increasingly argue that federally regulated products or services   
   should be immune from lawsuits alleging state-law violations. In a new   
   reading of an old constitutional principle, judges have held that federal   
   law, including the decisions of U.S. regulatory agencies, should preempt,   
   or override, state statutes that seek to hold companies accountable for   
   harming consumers.   
      
   State laws historically have provided the legal basis for some of the most   
   common lawsuits against U.S. companies alleging injuries, deaths or   
   illnesses caused by negligence or defective products.   
      
   “The emotion of losing your child is so difficult on its own. It is very   
   frustrating to realize that’s a loophole. I’m a small person in   
   southwestern Virginia, and that’s a loophole there to protect companies   
   much bigger than we could fight.”   
      
   Jennifer England, whose son died by suicide after taking an allergy   
   medicine tied to psychiatric problems.   
   These legal dynamics left the England family with no legal remedy at all.   
   A pair of U.S. Supreme Court rulings, in 2011 and 2013, essentially barred   
   lawsuits against generic drugmakers based on state laws that enabled   
   claims over design defects or a failure to warn consumers of potential   
   dangers. The court’s reasoning: Such claims were preempted by federal   
   regulations preventing generic drugmakers, when copying name-brand drugs,   
   from changing the formulation or the warning label.   
      
   That meant Merck had written the warning label, with federal approval, on   
   the generic version of Singulair that Nicholas England took. But his   
   parents couldn’t sue Merck, either, because their son had never taken its   
   name-brand version of Singulair.   
      
   “The emotion of losing your child is so difficult on its own,” said   
   Jennifer England, Nicholas’s mother. “It is very frustrating to realize   
   that’s a loophole. I’m a small person in southwestern Virginia, and that’s   
   a loophole there to protect companies much bigger than we could fight.”   
      
   Merck declined to comment for this report, referring all questions to   
   Organon, a Merck spinoff created in 2021 that now markets Singulair.   
   Organon declined to answer detailed questions from Reuters but said in a   
   statement that it’s confident doctors and patients have gotten “complete   
   and appropriate information” on Singulair’s safety. The generic drug   
   manufacturer that made the pills England took, Teva Pharmaceuticals, did   
   not respond to inquiries.   
      
   Corporate preemption defenses have proved broadly effective, according to   
   a Reuters analysis of court cases and dozens of interviews with attorneys,   
   legal scholars and plaintiffs or potential plaintiffs affected by   
   preemption rulings. The analysis of federal appeals and Supreme Court   
   rulings involving preemption found that judges ruled two-thirds of the   
   time to weaken or kill lawsuits alleging deaths or injuries caused by   
   corporate negligence or defective products.   
      
   Preemption defenses often deliver companies a swift procedural win,   
   allowing them to avoid addressing the substance of plaintiffs’   
   allegations. It has been used across a range of federally regulated   
   sectors, from railroads to agricultural chemicals to airlines and   
   automobiles, the Reuters review found.   
      
   The preemption defense has had a particularly profound impact in the   
   pharmaceutical industry, the review showed. The high court’s ban on   
   certain lawsuits against generic drug manufacturers has extraordinary   
   reach because generics account for 91% of U.S. prescriptions, according to   
   data from the U.S. Food and Drug Administration (FDA).   
      
   Name-brand drugmakers can still be sued, but preemption defenses can make   
   it much harder for plaintiffs to prevail, drug-industry litigation experts   
   said. In many product-liability cases, plaintiffs must prove simply that a   
   company’s product was unsafe. Those facing drugmakers’ preemption defenses   
   must often demonstrate that a company failed to disclose safety   
   information to federal regulators – and that the information could have   
   spurred new government restrictions or warnings before the alleged harm   
   occurred.   
      
   Pending lawsuits against Merck allege that the company’s own early   
   research indicated the drug could impact the brain but that Merck   
   downplayed any risks in statements to regulators.   
      
   England’s family had hoped to force executives from Merck and the generic   
   manufacturer to reveal what they knew, and when, about the drug’s dangers.   
   In the decade before England’s death, the FDA received more than 4,800   
   reports of patients, including many children, experiencing depression,   
   suicidal thoughts or other psychiatric problems after taking Singulair or   
   a generic version, according to a Reuters review of FDA data.   
      
   But it wasn’t until 2020 that the FDA slapped its most serious warning,   
   called a “black box,” on the drug’s label. By that time, the FDA had   
   received more than 80 reports of suicides in people taking the medicine.   
      
   Singulair, one of the best-selling drugs in U.S. history, has provided   
   Merck with about $50 billion in revenue, company disclosures show. Since   
   Merck’s patent on Singulair expired in 2012, major generic drug   
   manufacturers have sold millions of prescriptions under the drug’s   
   scientific name, montelukast.   
      
   The FDA said in a statement that it has “diligently monitored reports of   
   side effects possibly associated with montelukast, as well as communicated   
   findings and taken regulatory action, when appropriate.” The agency said   
   it “continues to monitor and investigate this important issue.”   
      
      
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