- “Feds Say It’ll Take Up To 90 Days to Approve New Mask-Making Facilities” [Christian Britschgi, Reason] “America Could Import Countless More Face Masks if Federal Regulators Would Get Out of the Way” [Eric Boehm] Reversing course, FDA agrees to permit wider use of a system developed by Battelle for sterilizing specialized masks worn by front-line health workers [Rachel Roubein, Politico] In the face of mounting criticism, federal Centers for Disease Control may reconsider guidance discouraging general public from wearing face masks [Joel Achenbach, Washington Post]
- What would we do without the FDA? “FDA Tells At-Home Diagnostics Companies To Stop Coronavirus Test Roll-Outs; The companies are complying. Customers won’t get their results and are being told to destroy their test kits.” [Ronald Bailey, Reason] Small favors: FDA “is easing up on some regulations so that ventilators can be manufactured and implemented more quickly” to respond to crisis [Scott Shackford]
- And the same continued: “The idea to expand testing of drugs and other medical therapies was strongly opposed by the FDA’s senior scientists this week, the official said, and represented the most notable conflict between the FDA and the White House in recent memory.” [Tyler Cowen] “FDA Shouldn’t Keep Safe Drugs off the Market” [David Henderson]
- Off-label or no, “the FDA granted an emergency authorization request to make chloroquine and hydroxychloroquine available from the Strategic National Stockpile (SNS), the federally operated supply of medical equipment and pharmaceuticals for use in public health emergencies.” [Naomi Lopez and Christina Sandefur, In Defense of Liberty (Goldwater Institute); Ronald Bailey; Jim Beck; earlier on off-label prescribing here, etc.] Switch of beverage alcohol firms to making hand sanitizer was advanced by waivers from FDA and Alcohol and Tobacco Tax and Trade Bureau [Jeffrey Miron and Erin Partin]
- Needless face-to-face consults avoided: “Health Canada Sets A Good Example By Relaxing Opioid Prescribing Rules During COVID-19 Pandemic” [Jeffrey Singer, Cato] Some moves in the right direction in the U.S. too [Singer]
- Even the New Jersey courts aren’t buying the ambitious theory of “fourth-party payor liability,” in which a plaintiff who never “claimed to have used the product, paid for the product, acquired the product, or had any interaction with the product (or its alleged manufacturers) in any way” nonetheless sues them for supposedly driving up health insurance costs [James Beck, Drug & Device Law]
- Heartburn drug: “Trial lawyers start search for next big mass tort, increase Zantac ads by more than 1,000%” [John O’Brien, Chamber-backed Legal Newsline]
Is it questionable and suspicious for doctors to administer a medication that has not been proved effective for the use in question? Nope. It’s perfectly normal. I explain “off-label prescribing” in a new opinion piece at the Washington Examiner, the news hook being the recent flap about chloroquine/hydroxychloroquine as possible treatments for COVID-19. A related Twitter thread is here as well as here, and here’s our earlier coverage of off-label prescribing.
Also related, this recent line from Scott Alexander is so apt: “Just like the legal term for ‘not proven guilty beyond a reasonable doubt’ is ‘not guilty’, the medical communication term for ‘not proven effective beyond a reasonable doubt’ is ‘not effective'”.
- “A federal judge has ordered the nation’s leading pharmacy chains to turn over billions of nationwide prescription records going back 14 years – even as the American Civil Liberties Union and some states attack similar requests by the government as overbroad and an invasion of privacy.” [Daniel Fisher, Legal NewsLine] “Without evidence and unable to make public nuisance argument, Delaware’s opioid claims against Walgreens fail” [same] “Oklahoma Opioid Ruling: Another Instance of Improper Judicial Governance Through Public Nuisance Litigation” [Eric Lasker and Jessica Lu, Washington Legal Foundation, earlier]
- “Merck v. HHS tests the limits of the federal government’s ability to control and compel commercial speech” [Ilya Shapiro and Dennis Garcia on Cato amicus brief in D.C. Circuit raising First Amendment issues]
- Let’s try correcting the New York Times on drug pricing. Where to begin? [Molly Ratty, Popehat]
- “Court Strikes Down NECC Convictions [New England Compounding Center] for Vagueness” [Stephen McConnell, Drug & Device Law]
- Defense perspective: the ten worst and best prescription drug and medical device decisions of 2019 [Jim Beck, Drug & Device Law]
- “If there are people out there with no options and they have terrible diseases, we are going to get those drugs to them as fast as feasible.” FDA approving potential breakthrough drugs more speedily [Michelle Fay Cortez and Cristin Flanagan, Bloomberg/MSN; related, Alex Tabarrok]
- Lenawee County, Mich. authorities have posted condemnation notices on Old Order Amish farmhouses over their use of outhouses rather than modern septic systems as required by code. Dispute now heading for court [Tom Henry, Toledo Blade]
- Baltimore Mayor Young promotes white-van-abduction urban legends, police misconduct transparency, Montgomery County is watching drivers and more in my latest Maryland policy roundup [Free State Notes]
- Following outcry from activists, Facebook disables as misleading ads some trial lawyer ads soliciting plaintiffs to sue over purported side effects of HIV prevention drugs [Tony Romm, Washington Post/Toronto Star, Peter Lawrence Kane, The Guardian, WTHR]
- From Lowering the Bar, legal things that actually did happen in 2019;
- 20 years ago I warned that by trying to dictate employers’ choices, a Wisconsin law might work to impede convict re-entry into the job market rather than encourage it [Reason, from its archives]
- If county and city law enforcement officials have discretion not to charge low-level drug offenders, do they also have discretion not to charge low-level gun offenders? [Cam Edwards, National Review on Virginia battle over “Second Amendment sanctuary” resolutions]
- Central planning meets the Drug War: Drug Enforcement Administration (DEA) presumes to know and decree “just how many prescription opioids of all classifications and in all situations will be needed in the coming year for a nation of 325 million people.” Paging Dr. Hayek [Jeffrey Singer]
- Mysteries of the “negotiating class”: National Association of Attorneys General questions novel procedural device used by federal judge Dan Polster in Cleveland [Daniel Fisher, Legal Newsline, more; Amanda Bronstad, Law.com (Sixth Circuit review)]
- “All of these are drug-seeking behaviors. But I maintain that none of these patients were addicted.” Scott Alexander talks back to a U.S. Senator, the WSJ, and others [Slate Star Codex] “How Stigma Against Addiction Devastates Pain Patients” [Elizabeth Brico at Filter, a recent launch on drug policy]
- “Why Opioid Pharma Hatred Is Overblown and Harmful” [Alison Knopf, Filter] A Washington Post series on pill distribution fueled a false narrative [Singer, Jacob Sullum, and they’re just getting started]
- “Patients, Privacy, and PDMPs: Exploring the Impact of Prescription Drug Monitoring Programs,” Cato policy forum with David S. Fink, Kate M. Nicholson, Nathan Freed Wessler, and Patience Moyo, moderated by Jeff Singer;
- Oklahoma U. law prof says “improper” opioid nuisance suit by state’s attorney general could “create a monster” [Karen Kidd, Legal Newsline; earlier here, here, etc.] If judge can essentially rewrite public nuisance law, ramifications “are huge” for other industries that might be targeted in future, “such as the environmental, chemical, vaping, firearms manufacturing, and energy industries.” [John Shu, Federalist Society]
Details, always with the picky details: in an opinion written by Justice Jay Mitchell, the Supreme Court of Alabama has thrown out as untimely a tort suit filed against Janssen Biotech Inc. claiming injury from the side effects of a medication. [Charmaine Little, Chamber-backed Legal Newsline] Timeliness wasn’t the only problem with the suit, drafted by the complainant’s attorney wife:
Mitchell noted in the ruling that it was “apparent” from a review of the original complaint that it was copied from another complaint.
“The complaint included numerous factual and legal errors, including an assertion that Tim was dead even though he is alive and claims invoking the laws of Indiana even though that state has no apparent connection to this litigation,” Mitchell wrote.
“A Philadelphia jury [October 8] ordered Johnson & Johnson to pay $8 billion in damages to a Maryland man who said his use of J&J’s antipsychotic Risperdal as a child caused enlarged breasts and the company failed to properly warn of this risk.” [Peter Loftus, Wall Street Journal] According to the company, the jury in the case had not been allowed to hear evidence of Risperdal’s benefits or the adequacy of its labeling, and the plaintiff’s attorney never introduced evidence that the allegedly improper warning made a difference in whether the client would have been exposed to the side effect. [Brendan Pierson and Nate Raymond, Reuters; Mihir Zaveri and Katie Thomas, New York Times] A recusal motion filed by the company also claims that the judge high-fived jurors after the verdict. [Debra Cassens Weiss, ABA Journal] Update Oct. 31: judge denies high-five allegation.
“A judge in Oklahoma on Monday ruled that Johnson & Johnson had intentionally played down the dangers and oversold the benefits of opioids, and ordered it to pay the state $572 million.” The state had asked for $17 billion. [Jan Hoffman, New York Times and sidebar on why J&J, the deepest pocket, was the only defendant left standing in the Oklahoma case; opinion; Paul Demko, Politico; Lenny Bernstein, Washington Post] Caleb Brown interviewed me for the Cato Daily Podcast:
For other skeptical views of the case, see Daniel Fisher, Legal NewsLine (“J&J had about 3% market share, sold abuse-resistant drugs, and Oklahoma didn’t present evidence of a single doctor who was misled by its marketing.”) and followup (problems with state’s legal theory), Jeffrey Singer/Cato, and Jacob Sullum, Reason (sweeping definition of public nuisance) and followup (other problems). [More: Jonathan Turley]
Particularly worth noting is Jacob Sullum’s account of the logical path traced by Judge James Hill in North Dakota in recently dismissing a suit against Purdue Pharma:
One of the claims against the company involved a public nuisance statute very similar to Oklahoma’s. Hill noted that “North Dakota courts have not extended the nuisance statute to cases involving the sale of goods.” He cited a 1993 case in which the Tioga Public School District #15 of Williams County, North Dakota, argued that the sale of acoustical plaster containing asbestos qualified as a public nuisance.
The U.S. Court of Appeals for the 8th Circuit, which handled the case because it involved an out-of-state defendant, observed that “North Dakota cases applying the state’s nuisance statute all appear to arise in the classic context of a landowner or other person in control of property conducting an activity on his land in such a manner as to interfere with the property rights of a neighbor.” The 8th Circuit worried about the consequences of venturing beyond that “classic context”:
To interpret the nuisance statute in the manner espoused by Tioga would in effect totally rewrite North Dakota tort law. Under Tioga’s theory, any injury suffered in North Dakota would give rise to a cause of action under section 43-02-01 regardless of the defendant’s degree of culpability or of the availability of other traditional tort law theories of recovery. Nuisance thus would become a monster that would devour in one gulp the entire law of tort, a development we cannot imagine the North Dakota legislature intended when it enacted the nuisance statute.
Hill said he “agrees with the reasoning of the Eighth Circuit in Tioga.” As in that case, he said, the state in its lawsuit against Purdue was “clearly seeking to extend the application of the nuisance statute to a situation where one party has sold to another a product that later is alleged to constitute a nuisance.” Hill added:
The reality is that Purdue has no control over its product after it is sold to distributors, then to pharmacies, and then prescribed to consumers, i.e. after it enters the market. Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products, regardless of any warning or instruction Purdue may give.
Judging from the cases cited by Judge Balkman, Oklahoma courts have not read that state’s nuisance law to cover situations like this either—until now.
- Starting in mid-1990s German doctors began writing many more opioid prescriptions. But addiction and overdose rates did not skyrocket. What made Germany different? [Jeffrey Singer, Cato; Jacob Sullum, Reason]
- Will the Supreme Court’s unanimous ruling in Merck v. Albrecht manage to clarify preemption law? [Beck, Drug & Device Law and more; Jonah Knobler, Washington Legal Foundation]
- Money didn’t go into state treasury: “Oklahoma Lawmakers not so Happy About Purdue Pharma Settlement” [Sean Murphy, Insurance Journal, more] “Nevada AG’s old law firm can make up to $350 million on his opioid lawsuit” [Daniel Fisher, Legal Newsline] “List of firms handling Louisiana’s opioid lawsuit balloons to 17, including politically connected ones” [Sam Karlin, The Advocate] Richard Epstein on opiate litigation [Ricochet]
- National Vaccine Injury Compensation Program: “Where Calls for Overturning Bruesewitz v. Wyeth Go Wrong” [Dorit Reiss, Petrie-Flom “Bill of Health”]
- “Drug lawsuit ads are scaring seniors to death” [P. Roosevelt Gilliam III and Susan Peschin, STAT]
- Senate Republicans file bill to fast-track FDA consideration of over-the-counter birth control pill [Elizabeth Nolan Brown]
- Why is insulin so expensive? [Tyler Cowen] “People Are Clamoring to Buy Old Insulin Pumps” [Sarah Zhang, The Atlantic via Ted Frank (calling it “an amazing story …about a problem created by overregulation and fear of tort liability, words that never appear in the article”)]
- Opioid litigation might be working to let the policy offenders in government get away [Jeffrey Miron and Laura Nicolae, Real Clear Policy/Cato; Jeffrey Singer, Cato; Charles Fain Lehman, National Review] A contrasting view: Nicolas P. Terry, Petrie-Flom “Bill of Health”;
- Read and marvel: Critical Dietetics, a social justice health movement [James Lindsay on Twitter]
- How HIPAA, the health privacy law, impedes potentially life-saving research into health records [John Cochrane]
- Uh-oh: Pennsylvania Supreme Court move could reopen forum shopping for medical malpractice lawsuits [David Wenner, Penn Live]
- “Transparent Medical Pricing and the $89,000 Snake Bite” [Cato Podcast with Eric Ferguson]