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Health Alert (Australia) - February 1, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Administrative Appeals Tribunal 22 January 2016 - JLSP and Innovation Australia [2016] AATA 23 This...more

Wright Medical Technology Files Brief In Support Of Post-Trial Motions In Hip Implant Case

A couple of months ago, we reported on a $10 million punitive verdict in the first hip implant case to go to trial against Wright Medical Technology. Last week, Wright Medical filed its opening brief in support of its...more

Statistical Sampling Debate: A Growing Web Of FCA Cases

The government and qui tam plaintiffs are increasingly employing statistical sampling in False Claims Act cases, particularly in cases where addressing and analyzing large numbers of allegedly false claims poses substantial...more

Texas Medical Board Appeals Immunity Ruling

In a notice of appeal filed on January 8, 2016, the Texas Medical Board appealed the Western District of Texas’s ruling that the Texas Medical Board was not entitled to state action immunity in an antitrust suit involving...more

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from...more

CAFA Settlement Trap: States As Absent Class Members

Will a Class Action Fairness Act (CAFA) notice of settlement bind a state as an absent class member? A Pennsylvania federal district court recently offered guidance on this issue. The case involved allegations that the...more

Quest Defeats Claims that It Conspired with Health Insurers

On November 25, District Court Judge William Orrick (N.D. Cal.) dismissed all claims in Eastman v. Quest Diagnostics, finding that the plaintiffs, a class of Northern California consumers who had utilized Quest's services,...more

Also In The News - Health Headlines - December 2015 #3

CMS Requests Feedback on Development of Clinician Quality Measures – On December 18, 2015, CMS requested feedback on its draft “Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive Payment...more

Update on Excellus data breach litigation

Excellus Blue Cross Blue Shield (Excellus) was hit with another proposed class action suit late last week. The case, filed by a New York woman, accuses Excellus BlueCross BlueShield of failing to prevent a massive data...more

Health Update - December 2015

Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal - Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more

First Circuit Applies Kellogg Brown & Root to Allow Relator to File Motion to Supplement Previously Dismissed Complaint

In United States ex rel. Gadbois v. PharMerica Corp., — F.3d —- (1st Cir. 2015), the First Circuit, in a matter of first impression, held that a relator’s complaint was not subject to dismissal under the first-to-file bar...more

Second Circuit tells pharmacies the antitrust claims they cooked up need more than a little Morton Salt

Cash & Henderson Drugs, Inc. v. Johnson & Johnson, recently decided by the Second Circuit, concerns Robinson-Patman Act claims that retail pharmacies brought against pharmaceutical manufacturers. The retail pharmacies alleged...more

Antitrust Suit Continues to Stymie New Texas Telemedicine Regulation

A federal district court denied the Texas Medical Board’s (the Board) motion to dismiss an antitrust suit filed by a telemedicine company (Teladoc), finding that the Board is not entitled to state action immunity because its...more

Texas Telemedicine Provider Survives Another Round

Teledoc, a telehealth services provider looking to do business in Texas, continued its winning streak in Texas federal court: on Monday, a judge rejected the Texas Medical Board’s motion to dismiss Teledoc’s antitrust...more

Laptop Security Breach Leads to $850,000 HIPAA Settlement Payout

On November 19, 2015, Lahey Hospital and Medical Center (“Lahey”) entered into an $850,000 settlement with the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) for alleged violations of...more

FDA Legal and Regulatory – 2015 Year In Review

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on...more

Amgen v Apotex - 180-Day Advance Notice of Biosimilar Marketing is Mandatory

The Federal Circuit in July said in its Amgen-Sandoz decision that declining to share information under the biosimilars pathway “patent dance” made the 180-day advance-notice provision mandatory; however, it left open the...more

Delaware Superior Court Cuts Punitive Damages In Transvaginal Mesh Case

Last week, we posted about a $10 million award of punitive damages in a product liability action against a manufacturer of hip implants.  We explained our view that the award was excessive, in part because hundreds of similar...more

Novartis Pharmaceuticals Settles $390MM FCA Allegations

Drugmaker Novartis Pharmaceuticals has agreed in principle to pay $390MM (including $20MM in civil forfeitures) to the Department of Justice. This payment, in addition to modification and an extension of Novartis’s existing...more

Abbott Secures Preliminary Injunction in Gray Market Case

On November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle...more

Litigation Alert: Federal Circuit’s Ariosa Decision, Good Chance for Rehearing En Banc

In June of this year, the Federal Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of...more

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

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