- Burdensome though it is in other ways, HIPAA does not create a private right of action, so no big-ticket damage suits. Connecticut high court rides to rescue by creating new tort for breach of medical confidentiality [Steven Boranian, Drug and Device Law]
- Details of cases aside, once again, should federal law really be requiring healthcare employers to grant religious exemptions to staff unwilling to undergo flu vaccination? [Department of Justice press release on suit against Ozaukee County, Wisconsin; earlier on EEOC settlement against North Carolina hospital]
- First Amendment should come into play when FDA bans drug providers from making truthful statements about their therapies [Henry Miller and Gregory Conko, Reason] And a Cato panel discussion on FDA regulation of speech with former Vascular Solutions CEO Howard Root (author of “Cardiac Arrest”), Christina Sandefur of the Goldwater Institute, and Jessica Flanigan of the University of Richmond, moderated by Cato’s Michael Cannon;
- “Uberizing Nonemergency Medical Transportation” [Ann Marie Marciarille, Prawfsblawg]
- “Protecting Reasonable Physician Choice in Medical Product Cases” [Luther Munford, Drug and Device Law]
- Britain’s National Health Service lurches toward crisis in negligence payouts [BBC, Paul Goldsmith, Centre for Policy Studies]
- “The dominant narrative about pain treatment being a major pathway to addiction is wrong, [and] an agenda heavily weighted toward pill control is not enough.” [Sally Satel on origins of opioid crisis]
- The press gets it wrong: “A Young Mother Died Because Her Flu Meds Were Too Expensive – Or Did She?” [Josh Bloom, ACSH]
- New research brief: tort reform could have effects in both directions on innovation [Alberto Galasso and Hong Luo, Cato]
- Appalling: editor of The Lancet extols Marx as a guide to understanding medical science [Theodore Dalrymple, Law and Liberty]
- “We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket” [Stephen McConnell, Drug & Device Law Blog]
- Should the Food and Drug Administration concern itself with the effect of its decisions on drug prices? [David Hyman and William Kovacic, Regulation mag]
- “Addicts Use Imodium to Help With Detox. That’s a Terrible Reason for the FDA to Make It Harder to Get” [Mike Riggs, Reason] Expect runs: “Does anyone see the humor/irony here? A diarrhea medicine package that’s hard to open?” [Josh Bloom, ACSH]
- “The Return of Drug Reimportation?” [Roger Pilon, Cato; more thoughts from David R. Henderson]
- California Supreme Court rules research drugmakers legally responsible “for harm caused by defective warnings in labels on generic versions of their products” [T.H. v. Novartis; Bob Egelko, San Francisco Chronicle, Steven Boranian (“awful”), Jim Beck]
- “Abuse-Deterrent Opioids and the Law of Unintended Consequences” [Jeffrey Singer, Cato Policy Analysis]
- Should the FDA approve Metformin for possible anti-aging effects? [Alex Tabarrok]
- “FDA Proposes to Delay Off-Label “Intended Use” Rule” [Stephen McConnell]
As I noted in this space a year and a half ago, the Food and Drug Administration’s restrictions on vaping (e-cigarette) products — which questionably apply the Tobacco Control Act to products that contain no tobacco — “will drastically restrict and maybe even ban a popular option for smokers seeking to quit the cigarette habit. It’s not just an assault on individual choice and commercial freedom — it could wind up killing people.” Along the way, the agency would dent consumer choice in the cigar market.
Now the Pacific Legal Foundation has filed a challenge to the FDA rules, with separate legal actions in three courts. PLF’s central objection is that the regulation was issued by a career FDA civil servant without proper legal authority to do so. Ilya Shapiro, Washington Examiner:
It turns out that the FDA has for many years been delegating its rulemaking authority to its “associate commissioner for policy,” a career civil-service position two rungs below FDA Commissioner in the bureaucratic depth chart. For eight years, the Associate Commissioner for Policy has been a woman by the name of Leslie Kux. It was Kux, not then-Secretary Sylvia Burwell or then-Commissioner Robert Califf, who signed and issued the Deeming Rule.
Why is this a problem? Because the Constitution draws a distinction between “Officers of the United States” and mere employees of the federal government. Only officers can exercise “significant authority” under federal law. But in exchange for that greater power, officers must go through a constitutionally prescribed procedure, typically nomination by the president and confirmation by the Senate (with a few exceptions applicable only to inferior officers). This ensures that anyone appointed to a policymaking role — one whose duties go beyond the ministerial and advisory — will first have their character and judgment vetted by the politically accountable Senate (who shares in the blame when an appointment goes wrong).
The power to issue a final rule is indisputably a “significant authority” reserved only to officers.
While FDA commissioners have purported to delegate rule issuance authority to the permanent employee, PLF argues that the Constitution does not permit them to evade its prescription by such means.
Beyond that, the rules’ restrictions on marketing — which forbid companies to promote vaping as a method of harm reduction that could benefit existing smokers, even if that statement is plainly true — run into the First Amendment and the protections it affords to much truthful commercial speech. PLF:
The vaping edict flouts the First Amendment by forcing businesses to run a daunting regulatory gauntlet in order to advertise truthful information. The government can’t require pre-approval for truthful speech, and it especially can’t shift the burden of proof to the speaker to prove the benefits of his speech will outweigh any harms the government perceives may result.
Beyond violating the Constitution, the vaping rule is horrible public policy: it threatens to shut down thousands of small businesses that provide potentially life-saving products and creates a public safety hazard by making it very difficult to improve and repair products.
The “American public may soon pay for a billion-dollar wealth transfer from the pharmaceutical industry to state and local government,” writes Margaret Little:
Proceedings moving apace before Ohio U.S. District Judge Dan Polster bode the worst of all solutions to the opioid crisis – a swift global settlement modelled on the tobacco settlement of the 1990s. The result will inflict lasting damage on our constitutional order and do virtually nothing to solve the opioid crisis. Opioid abusers, just like smokers in the infamous tobacco settlement, stand to receive nothing. A single unelected federal judge will have feigned to have “solved” opioids, levied billions in unlegislated taxation, made drugs more costly and harder to secure for non-abusers while leading abusers to turn to heroin and fentanyl, and filled state and local coffers with revenue-by-judiciary while richly endowing trial lawyer barons – hand-picked by the judge – with billions in public funds. A swift education of the American public about this abuse of the judicial process is in order, not a swift settlement.
More: “After New York Sues Opioid Manufacturers, Drug Policy Experts Warn That Legal Action Won’t Save Lives” [Zachary Siegel, In Justice Today] The FDA is charged with setting uniform national policy on pharmaceuticals; will it allow regulatory power to be transferred pell-mell to MDL court or to the actors in a resulting settlement? [WLF] And from Jim Beck, Drug and Device Law:
…injuries from illegal opioid use are precisely the sort of injuries that the in pari delicto doctrine was designed to preclude from being recovered in litigation.
Well, what about the states as plaintiffs?…[W]ho can restrict the rights of physicians to prescribe drugs for off-label uses? That would be the states, in their traditional roles of regulators of medical practice…. States could ban precisely the off-label uses they are complaining about, but they haven’t.
- “Survey: Most Docs Sued for Malpractice” [John Commins, Health Leader on Medscape survey] “The Missing Link in Lavern’s Law” (New York) [Peter A. Kolbert and Andrew S. Kaufman, New York Law Journal]
- Prescription spirits: why many physicians prospered so mightily during Prohibition [Paula Mejia, Atlas Obscura]
- Third Circuit greenlights consumer financial injury class action claiming eyedrop container dispenses eyedrops that are too big [Beck and McConnell on Alcon suit; see also earlier Posner on Allergan case]
- AI in health care, spot the legal issues: “For the First Time, a Robot Passed a Medical Licensing Exam” [in China; Dom Galeon, Futurism]
- “Why FDA regulations limiting e-cigarette marketing may cost lives and violate the Constitution” [Jonathan Adler; related, Jacob Sullum, earlier here, etc.] Anti-vaping crusade represents broader scandal of public health [John Tierney, City Journal]
- Off-label prescribing offers a window on a world with much less FDA regulation, and overall it’s an attractive one [Alex Tabarrok]
- In welcome reversal of Obama-era ban, FDA will once more permit direct-to-consumer genetic testing [Meghana Keshavan/STAT News, FDA press release]
- Will California law hold a pharmaceutical maker liable — in perpetuity — for a drug that it did not make and did not sell? [Steven Boranian/Drug & Device Law, PLF on T.H. v. Novartis]
- Litigation funding group chases clients in hip replacement litigation [PR Newswire]
- ACA penalizes hospitals for high Medicare readmission rates, but new study links that policy to higher mortality for heart failure patients [Arnold Kling, Ankur Gupta et al., JAMA Cardiology, Cristina Boccuti and Giselle Casillas, Kaiser Family Foundation]
- Litigation tourism model that has done well for plaintiff’s bar now circling drain after Supreme Court’s Bauman, Bristol-Myers Squibb decisions [Jim Beck, Drug & Device Law, more, yet more; related on West Virginia, and from Michelle Yeary on choice of law and forum non conveniens]
- “FDA Commissioner Scott Gottlieb Goes to Bat For Evidence-Based Opioid Policies” [Mike Riggs, Reason] “Abuse-Deterrent Opioids Cross an Ethical Line” [Jeffrey Singer, Orange County Register]
Act I: In a widely read Nov. 15 piece in Atlas Obscura, Priya Krishna reports on “the quest to save Baltimore’s Berger Cookie,” a beloved local food institution. “One of the most essential ingredients in the Berger Cookie is trans fats. Trans fats are what make the chocolate super creamy, prevent the fat and the water in the dough from separating (which would yield an overly crumbly cookie), and keep the cookie stable in both very warm and very cold settings.” However, the Obama administration enacted a federal ban on trans fats — for your own good, you know — which goes into effect next year.
Cookie producer Charlie DeBaufre, interviewed by Krishna, “refers to the past year as ‘frustrating and scary,’ as so many of his trans fat-free experiments have been failures. ‘I have spent $10,000 trying to get this worked out. I am not a big business. I don’t have an R&D Department. I have to shut down production for a few hours, still pay people for labor, and then most of the product gets trashed. It’s tough.'” More background in a piece I wrote for Cato last week.
Act II: Then a twist, reported by Sarah Meehan in the Baltimore Sun Nov. 21: the fudge supplier had managed to replace trans fats months ago and didn’t tell Berger’s. While early attempts to reformulate fudge frosting without trans fats had suffered from various quality defects, the new recipe was much improved to the point where neither consumers nor Berger’s had noticed.
So a happy if unexpected ending, at least for this one company, right? But the regulatory downside — you just knew there had to be one — was that in changing its recipe the fudge supplier had added more sugar, which appears to have boosted the calorie count and might have changed other things reported in the Nutrition Facts box as well. Since Berger’s says it didn’t know about the new formula, one inference might be that for a while it has been shipping cookies with a faulty calorie/nutrition count on the package. Hello to class action woes and, if the FDA is in a bad mood, regulatory liability?