Posts Tagged ‘tobacco’

PLF files legal challenge to FDA vaping rules

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.

Medical roundup

Florida law firm sanctioned; many clients had not authorized it to sue

Federal judges have fined the Jacksonville law firm of Farah & Farah $9.1 million over improperly handled claims against a fund set up after litigation to compensate smokers in the state of Florida [WTLV/First Coast News]:

The judges’ order states 1,250 frivolous tobacco claims were filed by Farah & Farah and the Wilner Firm against the Engle Trust Fund….

…cases filed collectively by Jacksonville attorneys Charlie Farah and Norwood Wilner prompted a U.S. Attorney Special Master seven month investigation into possible misconduct in 2012.

The investigation revealed some cases filed by the attorneys were for deceased clients, non-smokers, those who did not suffer from one of the required diseases, and 572 that did not authorize the attorneys to file lawsuits on their behalf.

More: Glenn Lammi.

October 18 roundup

  • Research by Todd Henderson et al. suggests that lawyers may often do well as CEOs, and anticipating and reducing litigation risk may be a key mechanism [Stephen Bainbridge]
  • Canada: Couple sues neighbors for $2.5 million for copying their house’s architecture [Rain Noe, Core77]
  • Abraham Lincoln on public choice and the aligning of interest with ethical duty [David Henderson]
  • Redistricting, Anne Arundel county executive allies with trial lawyers to file opioids suit, Baltimore police, Montgomery County minimum wage in my latest Maryland policy roundup [Free State Notes]
  • Black smokers in the U.S. are more likely than whites to prefer menthol, and prohibitionists frame foiling their wishes as a matter of racial justice [Christian Britschgi]
  • Here come the trustbusting conservatives back again, no more convincing this time around [Steven Greenhut]

September 20 roundup

  • Relatively funny, clever, and pleasant nastygram, as nastygrams go, on Netflix “Stranger Things” pop-up [BGR]
  • “Taser: Can’t say our weapons killed somebody unless the autopsy says so. Also Taser: If the autopsy blames our weapon, we might sue you.” [@bradheath on Jason Szep, Tim Reid, and Peter Eisler Reuters investigation]
  • Fourth Circuit asked to overturn forfeiture of antiquarian coins seized under “cultural patrimony” law [Peter Tompa, Antique Coin Collectors Guild]
  • Videos from April conference at Scalia/George Mason on due process and the administrative state: Neomi Rao, Philip Hamburger, Gary Lawson, Ronald Cass, Jonathan Adler, Hon. Doug Ginsburg, and many other stars;
  • Nice try, censorship fans: study from Stanton Glantz et al. tries to link teen smoking to movie depictions of smoking, resulting in epic fail [Brad Rodu]
  • Facebook weeds out a million accounts a day, some in error. Takedown laws will lift false positive rate [Mike Masnick]

August 1 roundup

  • Truly good news for both individual liberty and harm reduction: FDA grants reprieve for now to e-cigarettes/vaping [New York Times, Jacob Sullum/Reason, related; earlier on vaping, tobacco harm reduction, and the FDA here, here, and generally. Update: I’ve got a longer treatment up now at Cato;
  • HUD seems finally to be backing off its long dispute with Westchester County, N.Y., long chronicled in this space and elsewhere [Howard Husock, City Journal]
  • “Which side of the case is the federal government coming in on?” “Both, Your Honor.” [Rob Rosborough on DoJ’s intervention on opposite side from EEOC on question of whether Title VII covers sexual orientation, earlier on which here, etc.; Tony Mauro on DoJ split from NLRB on arbitration in Murphy Oil case; Thaya Brook Knight in March on constitutionality of CFPB] See also Marty Lederman, SCOTUSBlog, 2014;
  • “Michigan Juror Rights Pamphleteer Free From Jail Pending His Appeal” [Jacob Sullum]
  • Many satirical limericks later, Olive Garden’s parent company says its nastygram to a blogger “was auto-generated, and the company will take no further action.” [Charlotte Allen, Weekly Standard; earlier]
  • There’s a delivery out front: “Florida man who drove dead body to lawyer’s office won’t be charged” [AP/ClickOrlando]

UPS didn’t ask questions about volume shipments from Indian reservations

“A federal judge on Thursday ordered delivery giant UPS Inc. to pay New York City and the state nearly $247 million in damages and penalties for illegally shipping cigarettes” to New York buyers from Indian reservations. “UPS argued it followed the rules and can only do so much to police what its 1.6 million daily shippers send in sealed packages.” The delivery service says the shipments accounted for about $1 million in revenue. [AP/New York Post]

Medical roundup

  • “Apple Watch can detect an early sign of heart disease…. Apple has been communicating privately with the FDA for years about medical devices and so far the FDA has taken a light touch to Apple but these issues are coming to a head.” [Tyler Cowen]
  • “[Investor] lawsuits targeting life sciences firms jumped 70 percent from 2014, according to a survey provided earlier this year by Dechert.” [Amanda Bronstad, New York Law Journal]
  • Iowa Gov. Terry Branstad signs medical malpractice reforms into law [Brianne Pfannenstiel, Des Moines Register]
  • Summing up what is known re: talc and ovarian cancer as background to jury’s $105 million verdict against Johnson & Johnson [BBC (in story’s second half), earlier here, here, and here]
  • $5,300 for an MRI that would cost Medicaid $500? Personal attendants for crash victims, even the ones well enough to participate in mixed martial arts? All part of Michigan no-fault crash system [Detroit Free Press investigative series, see yesterday’s post]
  • Dear D.C.: ditch the FDA deeming regs and let vaping save smokers’ lives [Jeff Stier/Henry Miller, NRO, Tony Abboud/The Hill (vaping trade association), Juliet Eilperin/Washington Post (FDA temporarily suspends enforcement)]

Medical roundup

  • Scott Gottlieb likely to steer FDA in right direction [Daniel Klein]
  • Study of shorter versus longer medical consent forms “finds no significant difference in comprehension, satisfaction, enrollment” [Grady et al., PLOS via Michelle Meyer]
  • C’mon, ACLU and Covington: “Lawsuit Aims to Force Catholic Hospitals Perform Transgender-Related Surgeries” [Scott Shackford]
  • So much: “What The New York Times Gets Wrong On Vaping Regulation” [Sally Satel]
  • “Should you be compensated for your medical waste, especially if it turns out to be valuable? The right answer is: no.” [Ronald Bailey, Reason on Henrietta Lacks story]
  • Kimberly-Clark: we’ve sold 70 million MicroCool hospital gowns without a single complaint of injury from alleged permeability. Calif. jury: that’ll be $454 million [Insurance Journal]

Medical roundup