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Whistleblower Pays Price for Frivolous Suit

On Wednesday of this week, the federal court for the Southern District of New York rejected Fox’s plea to spare it from the $169,000 bill submitted by the white shoe law firm that successfully defended Managed Health Care...more

Second Circuit Hears Argument in People of the State of New York v. Actavis PLC

On April 13, 2015 the Second Circuit (Hon. Walker, Raggi, Droney) heard oral argument in People of the State of New York v. Actavis PLC. This case began in September 2014, when the New York Attorney General’s Office...more

FDA Approves First US Biosimilar but Court Action Could Delay Market Entry

On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more

Court Dismisses Data Breach Class Complaint For Lack Of Standing

On February 11, 2015, the U.S. District Court for the Southern District of Texas held that a plaintiff lacked standing to pursue claims for alleged violations of the Fair Credit Reporting Act, 15 U.S.C. § 1681 et seq....more

Preliminary Injunction Order in Actavis Casts a Skeptical Eye Toward the “Hard Switch”

Last week, we briefly reported on the injunction granted by the U.S. District Court for the Southern District of New York in the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest...more

Federal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more

Blog: Beth Israel To Pay $100,000 for Massachusetts Health Information Breach

Beth Israel Deaconess Medical Center (Beth Israel) reached a settlement with the Massachusetts Attorney General’s Office for a data breach in which a physically unsecured laptop was stolen containing personal and protected...more

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

New York Specialty Pharmacy Settles FCA Case

On October 9, 2014, New York’s Attorney General Eric T. Schneiderman announced an $846,000 settlement with New York specialty pharmacy Sorkin’s Ltd Rx. d/b/a CareMed Pharmaceutical Services (“Sorkins”) to resolve allegations...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

California Court Dismisses CMIA Claim Based on Possession of Stolen Medical Data

A health organization narrowly averted paying a potential $4 billion in damages under the California Confidentiality of Medical Information Act (CMIA) for losing the medical records of more than 4 million patients. Plaintiffs...more

News from the Health Law Gurus™

Chinese Hackers Infiltrate Health System Network Affecting 4.5 Million Individuals – Community Health Systems, Inc. (“CHS”) reported this week that the information of approximately 4.5 million individuals has been affected by...more

Whistleblower Receives More Than $17 Million in Omnicare Case

A decision has been made in the case against Omnicare, Inc. that will net a former Omnicare pharmacist more than $17.2 million in the ensuing settlement. The settlement with the Department of Justice orders Omnicare,...more

No Harm, No Foul – Appellate Court Finds No CMIA Claim Without Actual Injury

California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”), provides that an individual may recover $1,000 nominal damages (plus actual damages if any) based on the negligent release of...more

We Don’t Need No Intervention: Qui Tam Relator in Omnicare Wins Big Without DOJ

The United States Department of Justice (DOJ) recently announced the settlement of two qui tam whistleblower lawsuits against Omnicare Inc., the largest nursing home pharmaceutical and pharmacy services vendor in the nation....more

New Massachusetts Law Targets Self-Referrals of Clinical Laboratory Services

The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier in the week, included a broad prohibition on clinical laboratory self-referrals. This legislation (the “Bill”) originally...more

Even in Privacy Cases, Risk of Injury Does not Always Equal Injury

It’s an ancient conundrum; if a tree falls in the forest, and no one is there to hear it, does it make a sound? Privacy litigation may well offer the closest jurisprudential equivalent; if data is stolen, but no one does...more

False claims by any other name: Medtronic and Omnicare cases illustrate the interplay between the False Claims Act and other...

- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback...more

District Court Applies FCA's First-to-File Rule to Determine Relator's Entitlement to Settlement Proceeds

On June 23, 2014, a U.S. District Court in Pennsylvania held that the first relator to file a qui tam complaint under the FCA is the only relator eligible to recover a portion of the settlement, notwithstanding the existence...more

Jury Verdict Against Millennium Provides Insight on Definition of Remuneration

Ameritox won the latest volley of an ongoing legal battle with Millennium when a federal jury in Florida awarded it $14.75 million on June 16, 2014. Ameritox persuaded the jury that Millennium’s free point of care test (POCT)...more

California Court Limits Liability for Loss of Certain Patient Information under CMIA

California appellate courts are clarifying potential liability under California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”) of health care providers, health plans, pharmaceutical...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

Halifax Health Gets In More Hot Water

You probably didn’t think Florida’s Halifax Health could make its situation any worse. After all, only two months ago Halifax agreed to pay $85 million to settle just the first half of a Medicare fraud case. That still...more

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