The Curious Case Of The Docs Versus The Glocks: Firearms, The First Amendment, And Physician Speech

By Wendy Parmet

This new post by Wendy Parmet appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

On February 3, 2016 the full U.S. Court of Appeals for the 11th Circuit agreed to rehear the appeal inWollschlaeger v. Florida, commonly known as the case of the “docs versus the glocks.” Wollschlaegerconcerns a Florida law that bars physicians from routinely asking their patients whether they have guns or store them safely. In agreeing to rehear the appeal, the full court vacated a decision issued last December by a three-judge panel which had replaced two of its own prior opinions. Each of the panel’s three decisions upheld the law, and each raised serious questions about the ability of health professionals to provide their patients with relevant health information.

Public health professionals have long viewed gun safety as a major public health problem. Likewise, many physicians believe that good primary care includes questioning and counseling patients, especially those with children, about firearm safety, just as they talk to patients about seatbelts, cigarettes, and the need to exercise. […]

Read the full post here.

Abortion Derangement Syndrome, Missouri Edition

Flickr/Creative Commons—Nicola
Flickr/Creative Commons—Nicola

By Gregory M. Lipper

Although the biggest abortion-related news last week came from the U.S. Supreme Court, a Missouri state senator (turned Attorney General candidate) took the prize for most bizarre.

Senator Kurt Schaefer—chairman of the Missouri Senate’s interim “Committee on the Sanctity of Life”—wrote a stern letter to the University of Missouri; he suggested that state law prohibited a Ph.D student from researching the effects of Missouri’s mandatory 72-hour waiting period for women who want to have an abortion. The law he cited provides, “It shall be unlawful for any public funds to be expended for the purpose of performing or assisting an abortion, not necessary to save the life of the mother, or for the purpose of encouraging or counseling a woman to have an abortion not necessary to save her life.”

This farfetched attempt to censor academic research on the effects of government policy raises a pair of legal issues (and one psychological observation…).

First, Senator Schaefer’s interpretation of the statute is, to put it mildly, a stretch. The student isn’t going to be “performing or assisting an abortion”; she’s going to be studying abortion—more precisely, the 72 hours between when a woman seeks an abortion and is allowed to have an abortion.

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A Circuit Split on Contraceptives Coverage

Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate.  Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.

First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.

Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met.  So far, so good.  But that’s the end of my agreement.

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Government Regulation of Commercial Speech: is Amarin Pharma’s Breakout Moment?

By Ryan Abbott

Government regulation of off-label promotion by pharmaceutical companies is now an important First Amendment issue. The Food and Drug Administration (FDA) has historically restricted truthful and non-misleading speech by pharmaceutical companies under the Food, Drug and Cosmetic Act (FDCA). The FDCA prohibits introducing “misbranded” products into interstate commerce. The FDA has interpreted this to prohibit pharmaceutical companies recommending uses not already approved by the agency (these uses appear in a drug’s labeling). Drugs promoted for unapproved uses may also be considered “new” drugs which require FDA approval. Pharmaceutical companies can also face liability under the False Claims Act for off-label promotion.

United States v. Caronia was the first time the FDCA’s misbranding provisions were successfully challenged under the First Amendment. In 2012, the Second Circuit held that the FDA’s regulations failed the test for commercial speech announced in Central Hudson. Namely, the Court held that restricting truthful speech did not directly advance a government interest (rather, the regulations paternalistically prevented dissemination of truthful information), and the Court held that the FDA’s regulations were more extensive than necessary. The Court did not even analyze the regulations under the test announced in Sorrell v. IMS Health, decided by the Supreme Court in 2011, which held that heightened scrutiny was warranted where restrictions are content- and speaker-based. The FDA did not seek en banc review or writ of certiorari.

Almost immediately, the case was heralded as a landmark decision that would have a profound impact on drug regulation. However, that has yet to occur. Since the case was decided the FDA has already generated large settlements with companies like Amgen for violating agency regulations on off-label promotion. That may be because of uncertainty regarding Caronia’s reach, and because for large companies a relatively cheap settlement makes more sense than risking felony indictments and exclusion from government programs. For the agency’s part, it has tried to avoid fully vetting constitutional issues surrounding its regulations. The FDA stated after Caronia that the ruling would not alter its enforcement policy. Although, the agency has stated it is developing new guidances concerning off-label promotion.

The newest development in this story came last month in Amarin vs. United States. Read More

North, West, and the Direction of FDA Enforcement in the Social Media Age

By Christopher Robertson

Co-blogged with University of Arizona Fellow, Jonathan Loe

Breathlessly, many news outlets reported yesterday that Kim Kardashian West was in trouble with the FDA for misleading social media advertising of the drug Diclegis. For example, the reliably hyperbolic Daily Mail led with “Kim Kardashian slammed by FDA.” 

As followers of this blog may not know, Mrs. Kardashian West is pregnant with her second child.  Following on the disappointing news that the soon-to-be sibling of baby “North West” will not be named South, the celebrity-for-celebrity’s-sake shared a post on Instagram (and Facebook, and linked to from Twitter, naturally).  The post announced for the world that “OMG” her “#morningsickness” had benefited from a prescription of Diclegis—with “no increased risk to the baby.” The FDA issued a warning letter, because the social media post failed to communicate any risk information.

But is the FDA really concerned with people, however famous, commenting on their personal experiences with drugs?

The answer is…

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Call for Abstracts: Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics & Tobacco Products

The Food and Drug Law Journal is pleased to announce a forthcoming symposium—Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products—to be held at the Georgetown University Law Center (GULC) on Friday, October 30, 2015, and co-sponsored by the Food and Drug Law Institute and GULC’s O’Neill Institute for National and Global Health Law.

The deadline for submitting abstracts is June 1, 2015. Download more information about the symposium here.

Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?

Given that it was the subject of my first ever blog post on Bill of Health, I am very pleased to share my new paper: “Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?” which has just been published in the Journal of Law, Medicine, and Ethics (it is behind a paywall, but there is a version they have allowed me to post on SSRN that has all the text but not the formatting that can be freely downloaded).

This paper is likely to piss off people both on the Left and the Right of the abortion issue, which I think of as a feature not a bug ;), but in any event I hope will prompt a good conversation. Here is the abstract:

There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot” to the center and get away from the statements of those like Todd Akin who made comments about how in cases of “legitimate rape,” the victims’ bodies “have ways to try and shut that whole thing down.” The way Romney did his pivot was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy among those who oppose abortion. Read More

Managing Off-Label Drug Use

Guest Post by Marc Rodwin

Last year Endo Pharmaceuticals paid just under $182 million to settle a Department of Justice prosecution over its illegal marketing of Lidoderm for uses that the FDA had not approved.[1]  This settlement reflects a widespread practice in which pharmaceutical firms illegally promote drugs for off-label uses. In recent years, pharmaceutical firm settlement agreements for off-label promotion have included Johnson and Johnson ($2.2 billion for off-label promotion of Risperdal, Invega and Natrecor);[2] Pfizer ($2.3 billion for off-label promotion of Bextra);[3] and GlaxoSmith Kline ($3 billion for off-label promotion of Avandia).[4]  However, the problem of off-label drug use is more complex than it appears.

Manufacturers are prohibited from marketing drugs off-label, that is, for purposes that the FDA has not found to be safe and effective. However, physicians may prescribe drugs off-label for a different therapeutic purpose, with a different dose or for a different category of patients than that on which the drug was tested. Physicians—with the manufacturer’s encouragement—prescribe off-label much more frequently than is justifiable and risk harming their patients. In fact, 70 percent of off-label uses lack significant scientific support.

Physicians value the right to prescribe off-label, but it is the pharmaceutical firms’ incentive to increase sales that drives this practice. More sales means increased profits, so manufacturers have financial incentives to promote off-label use. The First Amendment protects certain off-label promotion as commercial free speech. Furthermore, manufacturers sometimes engage in illegal off-label promotion when the expected revenue exceeds potential penalties.

Unmanaged off-label drug use compromises good medical practice and the FDA’s ability to protect consumers from unsafe and ineffective drugs. Yet typical reform proposals, such as stronger sanctions for illegal promotion, don’t eliminate the problem. Public policy should manage off-label drug use by tracking off-label prescribing, removing economic incentives to sell off-label, and evaluating the safety and effectiveness of off-label uses.

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Recommended Reading: New Empirical Analysis of False Claims Act Whistleblower Litigation

By Kate Greenwood
[Cross-posted at Health Reform Watch]

Late last year, the Columbia Law Review published David Freeman Engstrom’s Private Enforcement’s Pathways: Lessons from Qui Tam Litigation, the fourth in a series of articles Professor Engstrom has written on the growth and evolution of qui tam litigation. (My colleague Associate Dean Kathleen Boozang wrote about the first three at Jotwell, here.) Private Enforcement’s Pathways, like the articles that precede it, brings a welcome dose of data and empirical analysis to a controversial area of the law, the debate over which has at times generated more heat than light.

Professor Engstrom’s analysis rests on a database he built containing information on the roughly 6,000 unsealed FCA cases that have concluded in a litigated judgments or settlement since 1986. In response to Freedom of Information Act requests, the Department of Justice provided information on the judicial district in which each case was filed, the date that DOJ decided whether or not to join each case, and the outcome of each case (including the amount, if any, that the government recovered and the whistleblower’s share of that recovery). DOJ also provided the date of filing for the 3,000 cases filed since 1986 that remain under seal, as well as for the 6,000 unsealed cases. From PACER, Professor Engstrom retrieved information on the parties, law firms, and individual lawyers involved in each unsealed case. Read More

A Chief Privacy Officer’s Take on the Chanko Case

Earlier this month, Charles Ornstein explored a New York City family’s charge that their privacy was violated by a local hospital and a reality television show in ProPublica. More specifically, he details how the death of one Mr. Mark Chanko was filmed at NY Presbyterian Hospital without the family’s consent, and then nationally aired on ABC’s NY MED over a year later. Mr. Chanko’s face was blurred for viewers but he remained recognizable to family and friends who watched the show. Since the broadcast, the family has pursued legal action through several New York courts with little success thus far.

The piece has already been commented upon by several smart people, most recently Kay Lazar of the Boston Globe. Just one day after Ornstein’s piece went to press, the Dean of Harvard Medical School Jeffrey Flier (@jflier) tweeted “How could this be allowed to happen?” only to be informed by the Chair of Surgery at Boston Medical Center, Gerard Doherty, (@GerardDoherty4) that three Harvard-affiliated hospitals are in fact currently hosting camera crews for a similar series. The ensuing conversation reminded me just how limited a platform Twitter is for tricky conversations about health care law and ethics. So I did what any self-respecting millennial would do – I went home for the holidays and asked my mom to help me understand what the internet couldn’t.

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