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Data Privacy: The Next Frontier of Corporate Compliance
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Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
PREVENTING AND RESPONDING TO DATA BREACHES IN AN ERA OF CYBER INSECURITY
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
- 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
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
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 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
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
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
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
The First Circuit recently affirmed the dismissal of United States ex rel. Wilson v. Bristol-Myers Squibb, Inc. under the False Claims Act’s (“FCA”) “first-to-file” provision, which prohibits any person “other than the...more
On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more
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