Posts Tagged ‘pharmaceuticals’

Medical roundup

  • Sued if you do, sued if you don’t: drugmaker faces lawsuits over failure to provide Fosamax warning that FDA told it not to provide [Jim Copland, James Beck on Merck Sharp & Dohme v. Albrecht, pending at Supreme Court]
  • On new APA masculinity guidelines, Sally Satel cuts to the point: will they improve the success of therapy for people seeking help? [Washington Post]
  • What does it mean to say the opioid litigation might follow the tobacco model? [Rob McKenna, U.S. Chamber] Citing fate of earlier gun lawsuit filed by city of Bridgeport, state judge dismisses four lawsuits filed by Connecticut cities against opioid industry [Daniel Fisher, Legal NewsLine]
  • I do miss the days when leaders of the public health profession focused on communicable diseases like typhus rather than running after Bloomberg grants to promote soda bans [Joel Grover and Amy Corral, NBC Los Angeles]
  • Cooking the books on infant mortality: about those Cuban life expectancy stats [David R. Henderson]
  • As artificial intelligence begins to make inroads into medical diagnosis, liability issues loom large [Beck, see related linked earlier]

Feds: we’ve had it with qui tam gamesmanship

“The U.S. Department of Justice is asking federal judges around the country to dismiss lawsuits it says are brought by shell companies that misrepresent their true purposes – filing meritless litigation against health care companies…. The DOJ says these plaintiffs were created for the sole purpose of filing suit under the federal False Claims Act and is complaining that it spent hundreds of hours investigating kickback allegations only to find no merit to them…. Among the law firms representing the plaintiffs in the cases is the firm of prominent personal injury lawyer Mark Lanier of Texas.” [P. David Yates, Legal NewsLine/Forbes]

“Significant to DOJ’s analysis was the fact that the qui tam relators used ‘false pretenses’ to obtain information from witnesses. According to the government, the actions all were filed by a ‘professional relator’ entity that sought to develop contacts and inside information under the guise of conducting a research study of the pharmaceutical industry, and offering to pay individuals for information provided in a purported ‘qualitative research study,’ even though the information was ‘actually being collected for use in qui tam complaints filed by [the professional relator] through its pseudonymous limited liability companies.’…it would be awkward for DOJ to sit idly by and allow qui tam cases to proceed, in the government’s name—which is how the qui tam system works—when those cases are purportedly premised on a scheme one district court already described as involving ethical violations and ‘an elaborate series of falsehoods, misrepresentation, and deceptive conduct.'” [Joe Metro and Andy Bernasconi, Drug and Device Law]

And yet more: “Prominent qui tam lawyers are now questioning the nomination of William Barr as attorney general, citing comments he made nearly 30 years ago questioning the constitutionality of private relators under the FCA. Some of the lawyers who signed a recent letter to U.S. Sen. Chuck Grassley criticizing Barr, including Harvard Law School Professor Nancy Gertner, participated in litigation against Celgene that the government declined to join but nevertheless generated $280 million in settlements and more than $30 million in legal fees.” [Daniel Fisher, Legal NewsLine/Forbes]

Medical roundup

  • No, the federal court ruling in Texas isn’t likely to take down the Affordable Care Act / ObamaCare [Ilya Shapiro]
  • Should doctors exhort their patients to vote? Hell, no [Wesley J. Smith]
  • “Accutane Litigation Goes Out with a Bang, Not a Whimper” [James Beck, Drug & Device Law] “The Worst Prescription Drug/Medical Device Decisions of 2018” [same; plus the best]
  • Proposal for price controls on Medicare Part B might amount to drug reimportation lite [Roger Pilon] Canadian reimportation as shiny object [Beck]
  • The European Medicines Agency has approved the powerful new opioid Dsuvia, and FDA head Gottlieb made the right choice in following suit, Sen. Markey and Public Citizen notwithstanding [Jeffrey Singer, Cato]
  • “Your doctors didn’t jump out of business; they were pushed. And they were pushed by people way too convinced of their qualifications to redesign the world around them.” [J.D. Tuccille, Reason]

“Consumers are misled by some mass tort drug injury ads: new academic study”

Tort reform groups have warned for a while that trial lawyer ads hyping side effects from commonly prescribed drugs might lead some patients to go off prescribed medication regimens. Now “a new paper co-authored by University of Oregon law professor Elizabeth Tippett, a key witness at last year’s congressional hearing [raising the issue], offers some empirical evidence that drug injury ads by trial lawyers and legal marketing firms do, in fact, mislead some consumers. And when those ads are deceptively framed as health warnings, Tippett and her co-author found, patients are less likely to refill or renew prescriptions.” [Alison Frankel, Reuters]

Medical roundup

Medical roundup

  • Wrong on many other issues, the American Medical Association is right to resist an artificial 3-day limit on opiate prescriptions [Jeffrey Singer, Cato; Jacob Sullum]
  • “Does Ride-Sharing Substitute for Ambulances?” [Leon S. Moskatel and David J. G. Slusky, Cato Research Briefs in Economic Policy No. 114]
  • Fourth Circuit tosses Maryland law banning “price gouging” of “essential” generic drugs, finding that state violates Dormant Commerce Clause by presuming to control transactions entirely outside its boundaries [Zack Buck, Bill of Health; Stephen McConnell, Drug and Device Law]
  • President Trump signs “right to try” legislation expanding right of terminally ill patients to enter unapproved therapies; squaring this with existing FDA regulation may present knotty problems [Michael Cannon, Cato; Michael Maharrey (“In fact, victories in 40 state legislatures preceded Trump’s signing ceremony”); earlier here, here, and at Cato Unbound last year] More cautions from Jim Beck on liability angle [Drug and Device Law]
  • Florida, departing from other states’ practice, caps its outside lawyers’ recovery at $50 million: “Latest Wave Of State Opioid Lawsuits Shows Diverging Strategies And Lawyer Pay Scales” [Daniel Fisher, Forbes]
  • In medical innovation, “equality is a mediocre goal. Aim for progress.” [Tyler Cowen]

On filling dicey prescriptions, sued if you do…

“Back in 2015, two cases were decided within days of each other that allowed claims to go forward suggesting that a pharmacy could be potentially liable for both filling suspect prescriptions (see here) and for not filling suspect prescriptions (see here). Hence ‘damned if you do (question a prescription) and damned if you don’t.'” A key element on one side: pharmacies that refuse to fill prescriptions that they believe show red flags are apt to explain themselves to customers, and those explanations can expose them to defamation actions filed by the doctors who wrote the scripts. [Michelle Yeary, Drug and Device Law]

Medical roundup