DOJ Expands FCPA-Violation Self-Disclosure Incentive to the Health Care Industry

Featured Expert Contributor, White Collar Crime & Corporate Compliance

Gregory A. Brower, a Shareholder with Brownstein Hyatt Farber Schreck, LLP in Las Vegas, NV and Washington, DC, with Erin M. Eiselein, a Shareholder in the firm’s Denver, CO office.

It has been a busy few months for the Fraud Section of the Department of Justice (“DOJ”) as the section continues its road show to educate the health care community on its recent Foreign Corrupt Practices Act (“FCPA”) guidance. As has been widely reported, DOJ announced a new policy (which took effect immediately) of applying its FCPA Corporate Enforcement Policy to health care companies. DOJ has focused considerable enforcement resources lately on health care companies’ alleged payment of bribes to foreign officials. Continue reading “DOJ Expands FCPA-Violation Self-Disclosure Incentive to the Health Care Industry”

HHS Drug Price Advertising Proposal Reveals Sweeping View of Government Power over Private Speech

Featured Expert Contributor, First Amendment

By Megan Brown, a Partner with Wiley Rein LLP, with Bert Rein and Steve Obermeier, Partners with the firm.

Ed. Note: This is Ms. Brown’s inaugural post as the WLF Legal Pulse’s latest Featured Expert Contributor.

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The Department of Health and Human Services has proposed a new rule to “require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC, or ‘list price’) of that drug or biological product.”  Put more simply, if a drug company runs a TV ad, it will have to include the “list price” of the drug, even though that is not what consumers or insurers would pay.  The proposed rule’s stated goal is to ensure that “beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize not only their out-of-pocket costs, but also expenditures borne by Medicare and Medicaid.” Continue reading “HHS Drug Price Advertising Proposal Reveals Sweeping View of Government Power over Private Speech”

U.S. ex rel. Rose v. Stephens Institute: The Ninth Circuit Considers Escobar and its Materiality Mandate

Stephen_Wood_03032014Featured Expert Contributor, False Claims Act

Stephen A. Wood, Chuhak & Tecson, P.C.

Ed. Note: This is Mr. Wood’s inaugural post as the WLF Legal Pulse‘s latest Featured Expert Contributor. Mr. Wood is a Principal in Chuhak & Tecson’s Chicago, IL office and chairs the litigation practice group. He has authored numerous WLF publications over the past five years on the False Claims Act and other complex litigation matters.

Ever since the Supreme Court issued its opinion in Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016), the lower courts have wrestled with the interpretation and application of the Supreme Court’s holding. The United States Court of Appeals for the Ninth Circuit became one of the latest reviewing courts to consider Escobar and its effect on that Circuit’s existing False Claims Act precedent.  The result in United States ex rel. Rose v. Stephens Institute, No. 17-15111, 2018 WL 4038194 (9th Cir. Aug. 24, 2018) was mixed.  The Court of Appeals held that Escobar overruled one precedent, but, in a sharply divided opinion, not another, thus demonstrating that Escobar continues to divide courts, especially over the element of materiality, foreshadowing further Supreme Court involvement in False Claims Act jurisprudence.  That involvement could come soon given that a petition for writ of certiorari is pending based on the Ninth Circuit’s decision in United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), a case that also turned on whether the defendant’s claimed violations were material.  Continue reading U.S. ex rel. Rose v. Stephens Institute: The Ninth Circuit Considers Escobar and its Materiality Mandate”

FDA-Mandated Listing of Drug Prices in Ads Would Flunk Legal and Constitutional Tests

first-amendmentWe’ve read with amusement the recent, overblown claims of some constitutional-law commentators and even U.S. Supreme Court justices that the First Amendment has been “weaponized” as a tool of deregulation. Of course, First Amendment challenges increasingly have become indispensable as politicians and regulators target more and more speech rather than regulate conduct directly.

Consider, for instance, the advertising-disclosure requirement floated last May as a part of the Department of Health and Human Services’ (HHS) blueprint to lower prescription drug prices. HHS asked the Food and Drug Administration (FDA) “to evaluate the inclusion of list prices in direct-to-consumer advertising.” The proposal appears to be under serious consideration. HHS Secretary Alex Azar has specifically invoked it when briefing the press and testifying before two Senate committees (here and here). And FDA Commissioner Scott Gottlieb indicated (in a May interview) that an agency working group will soon study the idea.

If that study includes a dispassionate legal and constitutional analysis, the working group should recommend that HHS scrub the list-price mandate from its policy blueprint. Not only does FDA lack the statutory authority to impose the mandate, but even if it could legally do so, the regulation cannot survive a First Amendment challenge. Continue reading “FDA-Mandated Listing of Drug Prices in Ads Would Flunk Legal and Constitutional Tests”

‘Merck, Sharpe & Dohme v. Albrecht’: The Supreme Court’s Chance to Re-Open a Preemption Door the Third Circuit Tried to Close Forever

Joe_Hollingsworth_thumbnail 1Featured Expert Contributor, Litigation Strategies

By Joe G. Hollingsworth, Partner, Hollingsworth LLP, with Stephen A. Klein, Partner, Hollingsworth LLP

*Ed. Note: This is Mr. Hollingsworth’s inaugural post as the WLF Legal Pulse’s newest Featured Expert Contributor. He is a nationally renowned courtroom advocate who specializes in trials and appeals and leads a practice group of seventy-five attorneys. 

No one ever said preemption should be easy.  But then there’s the U.S. Court of Appeals for the Third Circuit’s preemption decision last year in Merck, Sharpe & Dohme v. Albrecht, 852 F.3d 268 (3d Cir. 2017).  Continue reading “‘Merck, Sharpe & Dohme v. Albrecht’: The Supreme Court’s Chance to Re-Open a Preemption Door the Third Circuit Tried to Close Forever”

Update: Federal District Court Rejects Minority View on Pharma “Innovator Liability”

pillsIn a recent post, West Virginia’s High Court Rejects Novel Theory of “Innovator Liability”, WLF Senior Litigation Counsel Cory Andrews discussed a state court decision that declined liability on a pharmaceutical manufacturer for alleged harms caused by a drug it did not produce. In doing so, the West Virginia Supreme Court of Appeals parted company with the highest courts of two other states, California and Massachusetts, which earlier this year embraced the minority view that plaintiffs can recover damages from so-called branded pharmaceutical companies for harms allegedly caused by the generic copy of the the brand-name drug.

On May 21, a U.S. District Court for the District of Massachusetts judge overseeing a multidistrict litigation, In re: Zofran (Ondansetron) Products Liability Litigation, followed the majority view of innovator liability and dismissed three claims filed by plaintiffs who had only ingested the generic version of Zofran. Continue reading “Update: Federal District Court Rejects Minority View on Pharma “Innovator Liability””

West Virginia’s High Court Rejects Novel Theory of “Innovator Liability”

west vaShould the law recognize a plaintiff’s tort claims against a branded drug manufacturer when the drug that allegedly caused the plaintiff’s injuries was manufactured and sold by the defendant’s generic competitor? State and federal courts have been grappling with this novel question of “innovator liability” ever since the U.S. Supreme Court held, in Pliva and Bartlett, that such tort claims against generic manufacturers are preempted under federal law.

At bottom, innovator liability seeks to hold innovator drug manufacturers liable for injuries resulting from products they neither manufactured nor sold. Such “deep pocket jurisprudence,” as a recent Washington Legal Foundation paper by Shook Hardy & Bacon’s Victor Schwartz explains, marks a radical departure from long-settled principles of product liability premised on a naked policy decision that shifts financial responsibility onto a third party with the deepest pockets. Continue reading “West Virginia’s High Court Rejects Novel Theory of “Innovator Liability””