Washington Legal Foundation hosted a Web Seminar program yesterday, Physician Payments in the “Sunshine”: Implications of CMS Regulations for Businesses and the Future of American Health Care.
Speakers James Stansel and Meenakshi Datta of Sidley Austin LLP delved into the complicated and often vague data collection and reporting mandates required under the Physician Payment Sunshine Act and the regulations promulgated to implement it. They paid particular attention to how the mandates will impact research and development of new drugs, biologics, and medical devices, processes where physicians play an integral role.
The program is available as an on-demand file by clicking on the title above.
Click here for the slides our speakers utilized.
During the program, it was mentioned that WLF would be filing comments with CMS on the First Amendment problems with the Sunshine Act rules failing to exempt the sharing of medical textbooks and chapters of textbooks with doctors and teaching hospitals. Those comments can be downloaded here.
Cross-posted at WLF’s Forbes.com contributor page
Not even a year after fighting a bruising and costly battle over the “California Right to Know Genetically Engineered Food Act” (Proposition 37), proponents and opponents of mandatory biotech food labeling are poised for a rematch in the state of Washington. In February, the Secretary of State’s office certified ballot initiative I-522, The People’s Right to Know Genetically Engineered Food Act, and forwarded it to the legislature.
Under Washington law, the legislature can either enact it into law, reject it or refuse to act on it, or approve an amended initiative. If lawmakers don’t act on, it goes to a public vote in November. If the legislature alters it, then both the altered version and the original version go on the November ballot. The likeliest scenario is no legislative action, which puts I-522 in the voters’ hands.
The similarities between the defeated California initiative and the impending Washington proposal go beyond their titles. The Washington proposal, authored by an advertising executive, embraces the spirit, if not the letter, of many of Prop 37′s provisions. One provision it did not borrow from Prop 37 was that initiative’s prohibition of “Natural” and “All-Natural” on food labels.
Some initial thoughts on I-522: Continue reading
by John Andren*
Does a federal law making it a crime to destroy personal property or threaten an individual with a “reasonable fear of death” unconstitutionally chill free speech? It’s not surprising that the animal rights movement, whose most radical factions are prone to that sort of criminal behavior, thinks such a law does violate the First Amendment.
In late 2011, a number of these activists sued to overturn the Animal Enterprise Terrorism Act (AETA), claiming that fear of prosecution had chilled their First Amendment rights to free speech and peaceful protest.
On March 18, Federal District Court Judge Joseph Tauro dismissed the suit, finding that the plaintiffs lacked standing to challenge the law.
WLF is a staunch advocate for free speech and wary of laws which may adversely affect that liberty. But as Judge Tauro succinctly explained, the AETA properly targeted non-expressive behavior, activities of the type in which the plaintiffs claimed they did not wish to engage. Continue reading
After obtaining extension after extension from the U.S. Supreme Court (something our Rich Samp criticized here a few weeks ago), the time had come this week for the federal government to “fish or cut bait,” as it were, on whether it would urge reversal in one case involving the FDA’s graphic tobacco warnings, and oppose certiorari in another case.
As reported by several news outlets this morning, the Department of Justice announced that it would not seek Supreme Court review of the U.S. Court of Appeals for the D.C. Circuit’s R.J. Reynolds Tobacco Co. v. FDA decision. There, the court held in a facial challenge that the tobacco warnings violated the companies’ First Amendment rights. DOJ’s decision not to pursue reversal leaves in place a powerful precedent which businesses in other industries might deploy in situations where government labeling or warning requirements go beyond disclosure of pure, noncontroversial facts. The Washington Post story noted that FDA said it would “go back to the drawing board and ‘undertake research to support a new rulemaking consistent with the Tobacco Control Act.’” So that’s the end of the controversy for now, right?
Not necessarily. The government has until Friday to respond to a petition in the Supreme Court that it review another challenge to the graphic warnings, this one an “as applied” challenge rather than a “facial” challenge. The Sixth Circuit upheld the graphic warnings in American Snuff Co. v. United States. No doubt, the Solicitor General will argue that its decision not to appeal R.J. Reynolds Tobacco Co. obviates the need for the Court to grant certiorari in American Snuff. Will the justices take the government at its word that it now realizes the warnings can’t survive First Amendment scrutiny and that FDA will “go back to the drawing board”? If one were to look at the FDA web page on the graphic health warnings, one might question FDA’s interest in giving up the fight.
Cross-posted at WLF’s Forbes.com contributor page
When a litigant files a certiorari petition in the U.S. Supreme Court, seeking review of a lower court decision, the opposing party has 30 days to file a response. The Supreme Court Clerk’s office can and does grant extensions of time to file a response when counsel for the opposing party sets out “specific reasons why an extension of time is justified.” But one should reasonably expect complete candor from attorneys, particularly federal government attorneys, when requesting such extensions. Events this week call into question whether the United States is being completely candid in explaining its extension requests.
The U.S. Court of Appeals for the Sixth Circuit last May handed the federal government a major victory when it largely rejected First Amendment challenges to the new federal law that strictly regulates the labeling of tobacco products. The tobacco industry filed a Supreme Court certiorari petition in October, and the federal government’s brief in response to the petition was initially due on November 26, 2012. Since then, the Solicitor General’s Office has sought and received three successive extensions of time to respond, first to December 26, then to February 1, and then (in response to a request submitted just this week) to March 8. On all three occasions, the “specific reason” proffered for seeking an extension was that the government attorney assigned to the case was busy attending to other legal matters.
I have no inside knowledge regarding the workloads of government attorneys, but the too-busy-on-other-matters explanation is highly suspect in this instance. While the federal government routinely obtains one 30-day extension of filing deadlines in its Supreme Court cases and not infrequently obtains a second, the 98-day extension in this case is very unusual, even by federal government standards. Given the importance of the issues raised by the Sixth Circuit petition, entitled American Snuff Co. v. United States, and the Solicitor General’s ability to handle briefing in other cases, it does not seem plausible that his office could not have met the February 1 filing deadline. Continue reading
Cross-posted at WLF’s Forbes.com contributor page
Our 700th post!
The Federal Trade Commission’s decision last Thursday not to pursue a case under the Sherman Act or the Federal Trade Commission Act regarding Google’s online search business practices has elicited a wide range of opinions, including one particularly biting quip from within the Commission. Departing Commissioner J. Thomas Rosch noted in his statement of concurrence and dissent that “after promising an elephant more than a year ago, the Commission instead has brought forth a couple of mice.”
Perhaps that elephant was in the FTC press room last Thursday after all, however, in FTC’s resolution of its other investigation involving Google. Though it was completely unrelated to FTC’s online search practices inquiry, Chairman Leibowitz announced the same day that a formal Complaint and a Proposed Consent Order had been filed involving Google-owned Motorola Mobility’s standards-essential patents (SEPs).
Like it alleged in settlements involving Robert Bosch GmbH (November 2012) and Negotiated Data Solutions (2008), FTC concluded that Motorola’s refusal to license SEPs on fair, reasonable and non-discriminatory (FRAND) terms was “unfair” under FTC Act Section 5. The Commission’s use of Section 5 always raises eyebrows and motivates some to invoke the specter of the “National Nanny” FTC of the 1970s. We’re not sure if the Google/Motorola agreement will usher in an era of renewed “unfairness jurisdiction” cases, but it certainly raises some interesting issues and questions:
Regulatory Turf/Muscle-Flexing? FTC Act Section 5 provides the Commission with a unique regulatory weapon, and the Google SEPs case offered it a seemingly undeniable opportunity to sharpen this tool while also one-upping its counterparts at the Justice Department. When announcing its approval of Google’s purchase of Motorola Mobility last February, DOJ-Antitrust expressed “concern” that the company’s commitments to FRAND licensing of SEPs were “ambiguous” and that “how Google may exercise its patents in the future remains a significant concern.” Such concern did not rise to the level of a violation of the Sherman Act, so DOJ could only wring its hands. Continue reading
Cross-posted at WLF’s Forbes.com Contributor Page
Virginia’s controversial ban against alcohol advertisements in college newspapers is back before the U.S. Court of Appeals for the Fourth Circuit (Educational Media Co. at Va. Tech, Inc. v. Insley). Back in 2010, that court reversed a district court’s order overturning the ban for failing the third prong of Central Hudson—the “directly and materially advances” prong. In the view of the Fourth Circuit, the mere “common sense” connection between advertising and demand was sufficient for Virginia to ban alcohol advertising in college newspapers to further its interest in combating underage drinking.
That ruling involved only a facial challenge. The next phase of litigation involves an as-applied challenge and a claim that Virginia’s ban discriminates against a narrow segment of the media (both unsuccessful below), which are back before the appeals court. But as WLF argues in its amicus brief to the 4th Circuit, a lot has changed for commercial speech jurisprudence since 2010—most notably, the Supreme Court’s decision in Sorrell v. IMS Health Inc.
In Sorrell, the Supreme Court overturned a Vermont law that prohibited the dissemination of certain prescriber-identifying information for pharmaceutical marketing purposes. In overturning that law, Sorrell made clear that where a law restricts truthful, non-misleading commercial speech on the basis of its content and the identity of its speaker, that law must be subjected to “heightened judicial scrutiny.” Sorrell also made clear that content- and speaker-based restrictions on commercial speech will fail such heightened scrutiny in the ordinary case. Continue reading
Cross-posted at Forbes.com on WLF’s contributor site
In the past month, two different federal circuits held that Seattle’s Yellow Pages are noncommercial speech (Dex Media West v. Seattle) and a Texas trial lawyer’s website address is (probably) commercial speech (Gibson v. Tex. Dept. of Ins.). These divergent rulings, and the differing level of First Amendment protection they impose, reinforce Washington Legal Foundation’s long-held opinion that the U.S. Supreme Court must reconsider its “commercial speech doctrine.” Below, we offer some thoughts on a different approach.
Line Drawing. U.S. Supreme Court precedent requires judges to draw lines around speech when analyzing government restrictions. Court rulings in 1976 and 1980 determined that speech which does “no more than propose a commercial transaction” is entitled to less First Amendment protection than “pure” political speech. Some communications, such as advertisements, obviously fit on the “commercial” side of the line. But other speech isn’t so easily categorized, leading to needlessly convoluted judicial review which can silence or chill valuable speech.
What are the Yellow Pages? For instance, in Dex Media West, the Ninth Circuit had to categorize Seattle’s Yellow Pages, the distribution of which the city wanted to curtail for environmental reasons. Common sense may dictate that the Yellow Pages are quintessentially commercial. But the circuit court concluded that the existence of some noncommercial information – maps, individuals’ phone numbers, government office locations – in the Yellow Pages rendered the entire volume noncommercial. Continue reading
Cross-posted at Forbes.com’s WLF contributor site
To find out what it means to the City by the Bay, read the request for rehearing en banc City Attorney Dennis Herrera filed October 19 with the U.S. Court of Appeals for the Ninth Circuit. The request seeks a full-circuit reconsideration of a Ninth Circuit panel’s September 10 per curiam, unpublished, three-page ruling on the city’s cell phone warning ordinance. As we noted in a previous Legal Pulse post, the panel reversed the District Court and held that a law requiring retailers to inform customers that cell phones may cause cancer violated retailers’ First Amendment rights.
San Francisco urged the Ninth Circuit to
order rehearing en banc to give this important constitutional issue the treatment it deserves, to give San Francisco’s democratically elected policymakers the respect they deserve, and to provide jurisdictions in the circuit with the guidance they deserve.” (our emphasis)
The same city which two years ago banned Happy Meals feels righteous about their progressive, precautionary cell phone warning. The Board of Supervisors jumped ahead of California and the federal government, neither of which has felt the need to warn consumers about the alleged risks. The World Health Organization had classified RF Energy—which cell phones emit—as a “possible carcinogen,” and that was good enough for San Francisco. So of course the city felt dissed by the appeals court’s cursory dismissal. Continue reading
Cross-posted at WLF’s Forbes.com contributor site
In a 1960 opinion, Judge Henry Friendly began by asking “what is chicken?” While an amusing question–even children know a chicken when they see one–the query was more nuanced as a matter of law. California courts are finding themselves asking a similar question: what is “natural?”
Some products are intuitively so: with raw apples, almonds, or broccoli, it seems apparent. But what happens when you make apples into apple juice, or roast those almonds, or blanch that broccoli before freezing it for later use? These finished products are widely considered wholesome, and many would argue an almond is an almond (with the exception of the raw foods movement.)
The dictionary has fifteen different definitions for “natural”. The first is: “based on an inherent sense of right or wrong”–an intrinsically subjective definition. Given the ambiguous nature of the term, it’s no wonder the federal Food and Drug Administration (FDA) has been loath to come out and define “natural” for advertising and promotional purposes. But when businesses are begging the FDA to come in and regulate them, something must be amiss. And indeed, it is. Lawsuits contesting food companies’ use of the term “natural” have proliferated, most notably in the “Food Court,” i.e. the U.S. District Court for the Northern District of California. Businesses now simply want clarity. And if these lawsuits are really driven by concern for consumers’ well-being, so should the plaintiffs. Continue reading