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HIPAA Complaint Seeks Class Action Status

A complaint filed in the Superior Court of California on March 14, 2014, requested certification as a class action and sought a wide variety of damages arising from a breach of personal information. Doe vs. Sutherland Health...more

Data Breach Class Settlement Approved After Eleventh Circuit Held Identity Theft Following Breach Presents Cognizable Injury

Recently, the U.S. District Court for the Southern District of Florida approved a class settlement in a case in which the plaintiffs claimed financial harm from a health care company’s failure to protect their personal...more

No Harm, Still Foul? Florida Court Approves Data-Breach Class Action Settlement

Data-breach class action suits may have just gained significant traction. On Feb. 28, 2014, the U.S. District Court for the Southern District of Florida approved a first of its kind class action data breach settlement that...more

Take 5 Newsletter: 5 Employment Law Considerations in "The Cloud"

What is "the cloud," and what on Earth (pun intended) does cloud computing have to do with employment law? While many definitions abound, cloud computing at its core is a form of remote electronic data storage,...more

$1.2 Billion Medicaid Fraud Penalty Award Reversed and Claim Dismissed in Arkansas Appeal

In another decision narrowing the scope of state Medicaid fraud statutes, on March 20, 2014, the Supreme Court of Arkansas, in Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State of Arkansas, No. CV-12-1058, unanimously...more

Mayo, Myriad, and Multi-factor balancing tests

Updated subject matter eligibility guidance from the USPTO - On the same day that the Supreme Court’s opinion was handed down in Assoc. for Mol. Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), the U.S. Patent...more

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

Solicitor General Recognizes Conflict, but Recommends that Supreme Court Deny Review of False Claims Act Case Involving Rule 9(b)...

The United States Solicitor General has recommended that the Supreme Court deny certiorari in United States ex rel. Nathan v. Takeda Pharmaceuticals N.A. Inc., et al. (No. 12-1349), a False Claims Act (“FCA”) case involving...more

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

Fourth Circuit Affirms Dismissal of False Claims Act Suit Against Pharmaceutical Company, Rejects Theory of Liability Premised...

Last week, the United States Court of Appeals for the Fourth Circuit issued its opinion in United States ex rel. Rostholder, et al. v. Omnicare, Inc., et al. (No. 12-2431), affirming the district court’s dismissal of the...more

Genentech’s Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

On January 31, 2014, Phigenix, Inc. (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2,...more

The Louisiana Supreme Court's Decision In Caldwell v. Janssen And The Broader Implications

On January 28, 2014, the Supreme Court of Louisiana set aside a judgment of $257 million in civil penalties that a lower court had entered in favor of the state against Janssen under the Louisiana Medicaid false claims act,...more

Computer-Aided Selection Method Fails Patent-Eligibility

In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and...more

The $330-Million Dollar Question

The question every false claims defendant must face is whether to pursue litigation or simply concede and settle. While many shy away from litigation, opting for an expensive but certain resolution, for Johnson & Johnson and...more

Methods of Medical Treatment: Still Not an “Invention” in Canada

On January 27, 2014, the Federal Court of Appeal in Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Co., 2014 FCA 17 (Novartis), upheld the Federal Court’s denial of an application for a prohibition order under...more

Makena Drug Compounding Lawsuit Against FDA Gets New Life

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

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

Trends & Analysis: - We have identified 31 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only six were filed in 2013. The majority (14 cases) were filed in 2011 or 2012, with the...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

News from Down Under -- High Court of Australia Confirms That Claims to Methods of Medical Treatment Are Patentable in Australia

In the decision of Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (order), the High Court of Australia, Australia's supreme court, confirmed that methods of medical treatment are a "manner of manufacture" and...more

New Jersey Federal Court Applies Supreme Court’s Clapper Decision and Dismisses Data Breach Class Action

Relying in part on the recent United States Supreme Court’s ruling in Clapper v. Amnesty International, a federal judge in New Jersey dismissed a putative data breach class action against three healthcare entities and a...more

First Circuit Dismisses FCA Claim For Failure To Plead Fraud With Particularity And Denies Further Amendments Of Complaint

On December 6, 2013, in U.S. ex rel. Helen Ge, M.D. v. Takeda Pharmaceutical Company Limited (No. 13-1088), the First Circuit Court of Appeals affirmed the dismissal of Dr. Helen Ge’s qui tam actions against her former...more

Calif. Case Limits Health Care Data Breach Claims

The California Court of Appeal recently limited plaintiffs’ ability to state a claim under the California Medical Information Act (CMIA), Cal. Civ. Code §§ 56 et seq., and their ability to get statutory damages under the act....more

Eighth Circuit Addresses Scope of False Claims Act Liability

Last month, the Eighth Circuit Court of Appeals addressed the scope of “fraud-in-the-inducement” liability under the False Claims Act (FCA), 31 U.S.C. §§ 3729-3733, and, in doing so, reversed the dismissal of a claim related...more

Influential Appeals Court Rejects Attempt by Former In-House Counsel to Use Privileged Information Against Company in...

The pool of potential qui tam relators may have just shrunk a little, based on a recent decision by the 2nd Circuit Court of Appeals that has put the ability of in-house lawyers to become qui tam relators into serious...more

Second Circuit: in-house counsel may not seek to profit as whistleblowers against former employers

The United States Court of Appeals for the Second Circuit has issued an important ruling restricting in-house counsel from acting as whistleblowers in litigation against their current or former employers. ...more

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