Third Circuit Antitrust Decision Makes Pharmaceutical Patent Disputes Nearly Impossible to Settle

FTC_Man_Controlling_TradeThe U.S. Supreme Court’s 2013 FTC v. Actavis, Inc. decision held that “reverse payment” settlement agreements—in which a drug company suing a generic competitor for patent infringement pays the alleged infringer a substantial amount of cash to settle the litigation—are subject to antitrust scrutiny.  The Court reasoned that such reverse payments are unusual and may indicate that the generic company is really being paid not to compete.

An August 21, 2017 decision from the U.S. Court of Appeals for the Third Circuit has stretched the Actavis holding far beyond anything intended by the Supreme Court.  If the appeals court’s decision in In re: Lipitor Antitrust Litigation is allowed to stand, it may become virtually impossible for drug companies to settle patent-infringement litigation. Continue reading “Third Circuit Antitrust Decision Makes Pharmaceutical Patent Disputes Nearly Impossible to Settle”

Pending High Court Case Tests Congress’s Authority to Detain and Deport Criminal Aliens

supreme courtThe US Supreme Court on October 3, 2017 will hear oral arguments for the second time in an important immigration case, Jennings v. Rodriguez.  The Court was unable to reach a decision the first time around, apparently because it divided 4-4 on how to resolve the case.  A key issue in the case is which constitutional body—Congress or the federal courts—gets to make policy governing the treatment of aliens convicted of serious crimes.

An unbroken line of Supreme Court precedent (including 1976’s Mathews v. Diaz) provides a ready answer to that question: immigration policy is “so exclusively entrusted to the political branches of government as to be largely immune from judicial inquiry or interference.”  Congress determined that aliens convicted of serious crimes should be deported and should be detained pending final removal; courts should not be second-guessing that determination. Continue reading “Pending High Court Case Tests Congress’s Authority to Detain and Deport Criminal Aliens”

High Court Must Review ESA Decision that Endangers Ability to Appeal Agency Actions

st_tammany_navA group of Louisiana landowners is asking the Supreme Court to review a US Court of Appeals for the Fifth Circuit decision that dramatically expands the scope of the Endangered Species Act (ESA).  Weyerhaeuser Co. and Markle Interests, L.L.C.. v. U.S. Fish and Wildlife Service.  Their concerns are well-justified; the appeals court upheld land-use restrictions imposed by the Fish and Wildlife Service (FWS) for the purpose of protecting an endangered species of frog—even though the frog does not exist in Louisiana and could not live on the Petitioners’ land unless they substantially modified it.

But Supreme Court review is warranted for an additional and perhaps more important reason: the Fifth Circuit agreed with FWS that the Service’s refusal to undertake a cost-benefit analysis of its actions was not subject to judicial review.  As Judge Edith Jones stated in dissent, that decision plays havoc with administrative law and significantly undercuts the “strong presumption” that the actions of federal administrative agencies are subject to judicial review.

Worse still, the appeals court established a double-standard.  It permits environmental groups to seek judicial review when FWS invokes cost considerations as a reason not to impose land-use restrictions, but it denies landowners the right to go to court when FWS reaches the opposite conclusion.  That denial is particularly troubling, given that FWS’s own studies indicated that its land-use restrictions could cost landowners up to $34 million while providing no discernable benefit to the endangered frog. Continue reading “High Court Must Review ESA Decision that Endangers Ability to Appeal Agency Actions”

Forum-Shopping Plaintiffs Take a Major Hit in US Supreme Court

supreme courtForum-shopping plaintiffs’ attorneys have long sought to file their claims against large businesses in jurisdictions with reputations for favoring plaintiffs—without regard to whether the claims actually arose in those jurisdictions.  They justify their assertions of personal jurisdiction in such cases by arguing that a company that does business nationwide should be amenable to suit in any State in which it conducts substantial business.  In its 2014 Daimler AG v. Bauman decision, the US Supreme Court called into serious question the validity of such venturesome assertions of jurisdiction.  The Court’s decision last week in Bristol-Myers Squibb Co. v. Superior Court may have put such claims entirely to rest. Continue reading “Forum-Shopping Plaintiffs Take a Major Hit in US Supreme Court”

“Gordon v. CFPB” Provides a Good Vehicle to Rein in Executive Branch Authority

CFPB[Ed. Note: For more on the Gordon cert petition, watch WLF’s May 22 press conference, which featured former Solicitor General Gregory Garre, at our YouTube channel.]

The US Constitution imposes important checks on the exercise of executive power by the federal government.  In particular, Article II specifies that executive power may be exercised only at the behest of properly appointed “officers” of the United States, and it sets forth detailed requirements for the appointment and Senate confirmation of such officers.  However, a recent decision from the US Court of Appeals for the Ninth Circuit threatens to undermine those checks on federal power by permitting the Executive Branch to retroactively ratify actions taken by officials not properly appointed as “officers.”  The Supreme Court should review and overturn the appeals court decision, which is the subject of a pending certiorari petitionGordon v. Consumer Financial Protection Bureau, Case No. 16-673.  Washington Legal Foundation represents Mr. Gordon in the Supreme Court. Continue reading ““Gordon v. CFPB” Provides a Good Vehicle to Rein in Executive Branch Authority”

FEDERAL REGULATORY READING LIST: Resources for New FDA Drug and Device Regulators

FDAThe Food and Drug Administration (FDA) faces a difficult balancing act in its role as the federal regulator of drug and medical-device manufacturers.  On the one hand, it is charged with ensuring that medical products are both safe and effective for their intended uses.  On the other hand, it must avoid imposing overly stringent regulations, lest it harm public health by blocking or delaying access to life-saving products, or to truthful information about those products.

Through its public-interest litigating, publishing, and communications capabilities, Washington Legal Foundation has long been at the forefront of efforts to ensure that FDA maintains the proper balance.  Those activities have generated an impressive body of material that would be instructive for new FDA leadership to review.  We provide a summary of and links to those documents below (limited to WLF’s FDA-related work product in the past several years) to simplify access to that work product. Continue reading “FEDERAL REGULATORY READING LIST: Resources for New FDA Drug and Device Regulators”

California Supreme Court Continues Its “Grasping” and “Exorbitant” Personal Jurisdiction over Nonresident Defendants

California supreme courtIn its seminal 2014 decision, Daimler AG v. Bauman, the U.S. Supreme Court imposed strict limits on the authority of courts to exercise personal jurisdiction over out-of-state corporate defendants.  It condemned as “grasping” and “exorbitant” a California court’s efforts to exercise jurisdiction over claims lacking any connection with the State based solely on a corporate defendant’s regular conduct of business there.  But apparently the California Supreme Court did not get the message.  This week it ruled 4-3 that out-of-state plaintiffs whose tort claims arose outside the State could sue an out-of-state corporation in California courts simply because other plaintiffs who live in California have filed similar claims against the corporation.  Bristol-Myers Squibb Co. v. Superior Court (BMS).  That decision conflicts both with Daimler and basic notions of due process.  The U.S. Supreme Court ought to reverse it in short order. Continue reading “California Supreme Court Continues Its “Grasping” and “Exorbitant” Personal Jurisdiction over Nonresident Defendants”