By DAVID B. RIVKIN JR. And ANDREW GROSSMAN, May 21, 2015

We are free to tell you that a clinical trial shows the drug Vascepa to be an effective treatment for persistently high triglyceride levels. But should the drug’s manufacturer, Amarin, tell you or your doctor the same thing, the company would face criminal prosecution and civil liability. Therein lies a First Amendment anomaly, one that may finally be resolved by a lawsuit that Amarin filed earlier this month against the Food and Drug Administration.

The FDA has long banned promotion of drugs for uses other than those it has approved. Yet so-called off-label uses are legal and account for about 20% of all prescriptions. Some off-label uses of drugs have even become the standard of care for particular conditions.

But the drug’s manufacturer and its agents—and only them—cannot legally talk about this. Patients can—and do—discuss off-label uses of drugs endlessly in online forums. Doctors certainly exchange information about these uses.

But Amarin can’t say anything about the Vascepa trial. The drug is approved only as a treatment for “very high” triglyceride levels, not those that are merely persistently high. As a result, doctors and their patients are being kept in the dark about a treatment that, for some patients, has fewer side effects than other drugs.

The FDA claims its speech ban is a necessary part of its drug-approval process, which requires manufacturers to demonstrate efficacy for each intended use. The agency aggressively investigates and the government regularly prosecutes pharmaceutical companies and their representatives that promote off-label uses of their drugs. Yet once a drug is approved, doctors can prescribe it for any use—and the FDA recognizes, in its regulatory guidance—that such uses are essential to effectively translate medical research into improved health outcomes.

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By David B. Rivkin Jr. and Andrew M. Grossman — Sunday, April 19, 2015

First Amendment lawyers always get asked the same question: Is he really allowed to say that?

The “he,” inevitably, is some television pundit, newspaper columnist or blogger. And the “that” is a stream of invective. A pointed example is economist Paul Krugman’s characterization of Rep. Paul Ryan’s 2012 budget proposal: “The most fraudulent budget in American history. And when I say fraudulent, I mean just that.”

So if he meant “just that,” the question goes, isn’t that libel, and why isn’t Mr. Ryan suing him for damages?

And from time to time, we’ve heard the same question raised about one of our own cases, climate scientist Michael Mann’s lawsuit against detractors who harshly criticized his “hockey stick” research. We represent two of the defendants, the Competitive Enterprise Institute and its adjunct fellow, Rand Simberg. They called Mr. Mann’s work “intellectually bogus” and biased “data manipulation” done “in the service of politicized science.”

So is it libel? Some may respond with a smirk that truth is an absolute defense, but the answer is actually more basic: There’s nothing to be proven true or false.

Libel law is subject to the First Amendment. Its guarantee of freedom of speech wouldn’t be worth much if the government could authorize private citizens to sue one another over their views. At a minimum, a challenged statement must contain (in the Supreme Court’s formulation) a “provably false factual connotation.”

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By DAVID B. RIVKIN JR. And ELIZABETH PRICE FOLEY, April 9, 2015 6:53 p.m. ET

Debates about the Indiana and Arkansas Religious Freedom Restoration Acts, or RFRAs, have regrettably pitted religious freedom against gay rights. Critics claim the laws provide a license to discriminate against lesbian, gay, bisexual or transgender (LGBT) individuals. But this criticism shouldn’t be aimed at the religious-freedom laws, which don’t license discrimination based on sexual orientation or anything else.

Those wanting to advance LGBT rights should focus on enacting laws that bar discrimination. If there is a legal “license” to discriminate based on sexual orientation, it is because few jurisdictions today provide protection against such discrimination, or because the Constitution may immunize such behavior in certain circumstances.

There is no federal law prohibiting private discrimination based on sexual orientation. An executive order by President Obama in 2014 bans such discrimination only for federal workers and contractors. About 20 states and some municipalities prohibit sexual-orientation discrimination in workplaces and public accommodations. But the majority of states still don’t proscribe discrimination based on sexual orientation, though discrimination based on race, gender, ethnicity or national origin is banned.

The federal Religious Freedom Restoration Act was passed by overwhelming bipartisan majorities and signed by President Clinton in 1993. It represented a backlash against the Supreme Court’s 1990 decision in Employment Division v. Smith. That decision held that the First Amendment’s Free Exercise Clause doesn’t allow a religious exemption from laws of general applicability—e.g., compulsory military service, or prohibitions on drug use or animal cruelty—even if those laws substantially burden religious exercise.

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By DAVID RIVKIN and ELIZABETH PRICE FOLEY, March 11, 2015

Last Wednesday, the Supreme Court heard oral arguments in King v. Burwell, the latest challenge to the Affordable Care Act (ACA). The case centers on a provision of Obamacare that authorizes federal tax subsidies for individuals only if they purchase health insurance through an “Exchange established by the State.” If an individual purchases insurance through a federal-run exchange (in the event that the state opts out of setting up its own exchange), can she still qualify for Obamacare subsidies? The Obama administration says yes; the King plaintiffs say no. 

A great deal is at stake here. If the plaintiffs win, individuals in 34 states—the states that have opted not to operate a state insurance exchange—will still be subject to Obamacare’s individual mandate, but they won’t qualify for federal tax subsidies. As a result, their insurance will cost more out-of-pocket. Moreover, because individuals in these 34 states won’t get tax subsidies, employers in these states won’t be subject to the employer mandate, so they won’t have to offer health insurance and can’t be taxed for failing to do so. And yet, those states would be able to continue registering their profound opposition to the entirety of the Obamacare regulatory scheme, thereby undermining its legitimacy. Given these consequences, supporters of Obamacare are pulling out all the stops to prevent a plaintiffs’ victory.

One recent attempt to save tax subsidies in these 34 states has come from an amicus brief filed on behalf of four law professors, two of whom are former clerks to Justice Ruth Bader Ginsburg. During the King oral arguments, it became apparent that their argument had found favor with Ginsburg and three other liberal justices and had gained some traction with the court’s centrist, Justice Anthony Kennedy.

Ironically, the centerpiece of their argument is federalism—the division of powers between state and federal governments—a concept that, while a key part of the Constitution’s separation of powers architecture, is not particularly favored by liberals. Specifically, the law professors’ claim that the court should rule in favor of the Obama administration by invoking the “clear statement rule,” a legal doctrine designed to protect state sovereignty.

However, applying this rule to the King case would be unprecedented and deeply antithetical to federalism. Read more »

By Elizabeth Price Foley and David Rivkin, March 3 2015, 11:57am

In Federalist No. 22, Alexander Hamilton observed, “Laws are a dead letter without the courts to expound and define their true meaning and operation.” In constitutional controversies, the judiciary’s role is even more profound. Last week, the Supreme Court heard arguments in Arizona State Legislature v. Arizona Independent Redistricting Commission, a case that will signal how willing the Court is to prevent separation of powers from becoming a dead letter.

Separation of powers protects individual liberty by preventing any one branch of government from amassing too much power. It also ensures that government functions effectively, by assigning to each branch those powers that are most appropriate to its nature. For example, legislating is best accomplished by a multi-member body that engages in extended debate and deliberation. By contrast, waging war requires timeliness, and is thus best given to a unitary executive.

The Arizona case involves a turf dispute between Arizona’s legislative and executive branches, but it’s unclear if the Court is amenable to refereeing this constitutional conflict.  The case is therefore a canary in the coalmine for “legislative standing,” which means a legislature’s ability to defend, in court, its lawmaking prerogative against executive assault.  This is important not only to Arizona’s legislature, but any legislature, including the U.S. Congress.

At issue in the case is the constitutionality of Proposition 106, a referendum passed by Arizona voters that divested the legislature of drawing the state’s congressional districts and gave that power to an independent commission. When the commission redrew the districts in 2012, the Arizona legislature filed suit, asserting that the commission had violated Article I, section 4, of the U.S. Constitution, stating, “the Times, Places and Manner of holding elections for … Representatives [in the House] shall be prescribed in each State by the Legislature thereof .”

Before the meaning of this language can be resolved by the Court, it must first find that the Arizona legislature has standing to sue. In over 225 years of constitutional history, the Court hasn’t definitely articulated when legislative standing is proper. Read more »

By DAVID B. RIVKIN JR. And LEE A. CASEY, Feb. 2, 2015 7:40 p.m. ET

A very public dispute broke out last week when Nevada Attorney General Adam Laxalt went against Gov. Brian Sandoval’s wishes and joined a lawsuit filed by 25 other states challenging President Obama’s imposition of his immigration reform policies by executive action.

Messrs. Sandoval and Laxalt are both Republicans who agree that the current immigration system is broken and that comprehensive reform is necessary. But Mr. Sandoval opposes litigation and has suggested that new immigration reform legislation is the best way to proceed.

Yet on Jan. 26 Mr. Laxalt announced that Nevada had joined the plaintiff states in Texas v. United States of America. “As Nevada’s chief legal officer,” he explained, “I am directed by Nevada’s Constitution and laws to take legal action whenever necessary ‘to protect and secure the interest of the state.’ ”

Mr. Laxalt was right to join the suit. Mr. Sandoval’s legislative path will neither solve America’s vexing immigration problems nor rein in a president who has ignored the Constitution’s limits on executive power.

Texas v. United States of America challenges the president’s use of an executive order to suspend federal immigration laws that require, among other things, deportation of undocumented immigrants and strict limits on who may lawfully work in the U.S. The Constitution requires that the president “Take care that the laws be faithfully executed,” and provides no exemption for laws with which the president disagrees.

As the Supreme Court stated in Youngstown Sheet & Tube Co. v. Sawyer (1952), ruling against President Harry Truman’s seizure of the nation’s steel industry during the Korean War, “the President’s power to see that the laws are faithfully executed refutes the idea that he is to be a lawmaker.” Read more »