Featured Expert Contributor — Antitrust & Competition, U.S. Department of Justice
Anthony W. Swisher, a Partner in the Washington, DC office of Squire Patton Boggs (US) LLP
In April of this year President Obama issued an executive order designed to “protect American consumers and workers and encourage competition in the U.S. economy … .” The order aimed to expand competition policy beyond just the Justice Department Antitrust Division (DOJ) and the Federal Trade Commission (FTC), and encouraged every federal agency to consider ways to enhance competition when drafting and enforcing each given agency’s regulations. A notable element of the President’s executive order was the promotion of competition in labor markets. The order asserted that the economic growth that flows from competitive markets “creates opportunity for American workers,” and that anticompetitive practices can reduce those opportunities. Continue reading
By Burt M. Rublin, Partner, and Daniel L. Delnero, Associate, Ballard Spahr LLP
Prior restraints on speech are highly disfavored and presumptively unconstitutional. See Tory v. Cochran, 544 U.S. 734, 738 (2005) (“Prior restraints on speech and publication are the most serious and the least tolerable infringement on First Amendment rights.”). Yet the Consumer Financial Protection Bureau (CFPB) proposed exactly that in its Proposed Rule Relating to Disclosure of Records and Information (Proposed Rule), CFPB-2016-0039, 81 Fed. Reg. 58310 (Aug. 24, 2016). CFPB seeks to prohibit the recipient of a civil investigative demand (CID) or letter from the agency providing notice and opportunity to respond and advise (NORA letters) from disclosing the CID or NORA letter to third parties without prior written consent of a high-ranking CFPB official. In effect, this would constitute a “gag” rule that would stifle constitutionally protected speech.
The proposed gag rule is not only ill-advised as a matter of public policy, it is also unconstitutional both as a prior restraint on speech and a content-based restriction. It would be subject to strict scrutiny, and the CFPB would have to show a compelling government interest to justify it, which it could not. Indeed, CFPB has not claimed, nor could it claim, that the absence of a similar gag rule since the creation of CFPB has hindered or impaired its effectiveness. Continue reading
By Eric D. Miller, Partner, Perkins Coie LLP*
A pending petition for a writ of certiorari presents the United States Supreme Court with an opportunity to clarify whether a state may exercise personal jurisdiction over a nonresident defendant based solely on the defendant’s sale of components to third parties who incorporate those parts into finished products that are then sold in the forum State.
That question has divided the lower courts since Asahi Metal Industry Co. v. Superior Court, 480 U.S. 102 (1987). In that case, Asahi, a Japanese manufacturer, had delivered tire-valve assemblies to a Taiwanese tire manufacturer that sold tires throughout the world, including in California. After a California resident was injured in an accident caused by a defective valve, he sued Asahi in California state court. The Supreme Court held that Asahi was not subject to personal jurisdiction in California, but no rationale commanded a majority of the Court. Justice O’Connor, writing for four justices, concluded that the connection between the defendant and the forum state necessary to establish specific personal jurisdiction “must come about by an action of the defendant purposefully directed toward the forum state.” In her view, placing a product “into the stream of commerce, without more,” is not such an act. Justice Brennan, on the other hand, wrote for four justices who believed that placement of goods into the stream of commerce, with the knowledge that they will ultimately be sold in a state, can be sufficient for jurisdiction in that state. Continue reading
Featured Expert Contributor – Intellectual Property (Patents)
Jeffri A. Kaminski, Partner, Venable LLP, with Ryan T. Ward, Associate, Venable LLP. Mr. Ward was a Judge K.K. Legett Fellow at the Washington Legal Foundation in the summer of 2009 prior to his third year at Texas Tech School of Law.
The Federal Circuit continues to struggle with determinations of patentability under 35 U.S.C. § 101 in the wake of the Supreme Court’s Alice decision (Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014)). The most recent decision, Intellectual Ventures, LLC. v. Symantec Corp., (Intellectual Ventures) indicates a developing schism between the newer members of the court and the old guard. Continue reading
Featured Expert Column: Judicial Gatekeeping of Expert Evidence
By Evan M. Tager, Mayer Brown LLP, with Carl J. Summers, Mayer Brown LLP
Nearly a century ago, in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), the federal appeals court in the District of Columbia—the US Court of Appeals for the DC Circuit—announced the general acceptance test for evaluating the admissibility of expert testimony. Over the next several decades, the general acceptance test itself became generally accepted. But since the US Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and the adoption of that standard in Federal Rule of Evidence 702, many states have replaced Frye with Daubert. In Motorola, Inc. v. Murray, __ A.3d __, 2016 WL 6134870 (D.C. Oct. 20, 2016), the en banc District of Columbia Court of Appeals (the District of Columbia’s appellate court, distinct from the federal DC Circuit) expressly dispensed with the Frye standard and adopted Rule 702. Continue reading
Today, the US Food and Drug Administration (FDA) will hold a long-awaited public meeting to consider how off-label information about medicines can be shared with physicians. Washington Legal Foundation staff attorney Greg Herbers will testify at the meeting, which FDA has entitled “Communications Regarding Unapproved Uses of Approved Medical Products.”
Since WLF’s landmark victories in the Washington Legal Foundation cases, courts have consistently upheld the First Amendment right to communicate truthful and non-misleading information about the off-label uses of medical products. For instance, in US v. Caronia, WLF represented an industry employee convicted of discussing a drug’s off-label benefits and won a reversal from the US Court of Appeals for the Second Circuit on First Amendment grounds. WLF filed an amicus brief in a second case, Amarin Pharma v. FDA, in which a US federal district court followed the rationale of Caronia. Those decisions presumably played a major part in FDA’s decision to reevaluate its approach to off-label communication.
The text of WLF’s testimony is available here. WLF will also submit written comments to FDA in December.