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Court Report - April 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teva Pharmaceuticals USA Inc. et al. v. Biocon Ltd. et al. 1:16-cv-00278; filed April 19, 2015 in the District Court of...more

Epic Verdict in Trade Secrets Case

Last week, a federal jury in Wisconsin awarded almost $1 billion to Epic Systems Corporation in its trade secrets case against Indian consulting company Tata Consulting Services, Ltd., and its American unit, Tata America...more

Not a Check-the-Box Exercise: Failure to Have Signed BAA Results in Substantial Fine

A group practice that was the victim of a silver-harvesting scam has agreed to pay the U.S. Department of Health and Human Services (“HHS”) $750,000 to settle charges that it released protected health information (“PHI”) of...more

Sequenom v. Ariosa Diagnostics: A Supreme Court Petition that Requests Clarification on the Patent Eligibility of Diagnostic...

UUnder the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Common exceptions to what can be patented include laws of nature,...more

Ex-Husband's Revenge Leads to HHS Trophy

Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurse, technicians, staff, management,...more

Appeals Court Confirms that HITECH Violations Do Not Violate FCA

In an important recent decision, the Sixth Circuit Court of Appeals confirmed that a qui tam relator's claim that her former husband improperly accessed electronic protected health information (e-PHI) of her and her relatives...more

Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of...more

21st Century Oncology data breach litigation update

We previously reported that 21st Century Oncology suffered a data breach affecting 2.2 million patients and has been sued in at least two class action lawsuits following notification to the patient....more

Sixth Circuit Affirms Dismissal of FCA Claim Based on Health Data Breaches

The U.S. Court of Appeals for the Sixth Circuit recently affirmed the dismissal of a False Claims Act (FCA) case premised on protected health data breaches. In United States ex rel. Sheldon v. Kettering Health Network, the...more

Alert: FTC Challenges "No-AG" Agreement as Illegal Reverse Payment

On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...more

Reformulated OxyContin Patents Invalid - Purdue Pharma L.P., et al. v. Epic Pharma, LLC, et al.

Addressing product-by-process limitations and inherent anticipation issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling that the asserted claims of Purdue Pharma’s patents covering...more

Class action suit filed against 21st Century Oncology for data breach

We previously reported that 21st Century Oncology had suffered a data breach and notified 2.2 million patients that it had been the victim of a hacking that exposed the names, Social Security numbers, physicians’ names,...more

Olympus to Pay $632.2 Million to Resolve Allegations of Kickbacks

Olympus Corporation of the Americas, the United States’ largest distributor of endoscopes and related medical equipment, recently agreed to pay $623.2 million to resolve criminal charges and civil claims, according to a...more

Federal Circuit Upholds Home Field Advantage in Generic Drug Cases

Under United States law, the holder of a patent on a brand-name, FDA-approved drug can bring suit for patent infringement against a generic drug manufacturer even before the generic manufacturer brings the drug to market....more

Sixth Circuit Rules That EHR Security Breaches Do Not Violate False Claims Act

On March 7, 2016, the Sixth Circuit Court of Appeals ruled that security breaches of individual electronic health records (“EHRs”) do not violate the HITECH Act and cannot support False Claims Act allegations. ...more

US District Court in Southern California Rules No Coverage for HIPAA Investigation

The District Court for the District of Southern California was asked to reconsider its prior decision issued on motions for summary judgment in coverage litigation between Millenium Labs, Inc. (“Millenium”), and its insurer,...more

Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government?

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more

Health Care Fraud and Abuse Control (HCFAC) Program Logs $2.4 Billion in Recoveries for FY 2015

The federal government won or negotiated more than $1.9 billion in judgments and settlements, and attained additional administrative impositions in health care fraud cases and proceedings in FY 2015, according to the latest...more

Washington Healthcare Update

This Week: Drug pricing remains a focus as CMS rolls out a demonstration project for Part B drugs... The Senate passes The Comprehensive Addiction and Recovery Act (CARA) and Senate Cures legislation moves forward... Senate...more

Health Alert (Australia) - March 14, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales 10 March 2016 - Jener Daluz v John McMahon [2016] NSWSC 2021 - The second defendant, South...more

Washington Healthcare Update

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

5 Questions About France’s New Health-related Class Action Law

The number of eligible associations and the law’s broad scope could portend a significant number of health-related class actions. A new law, referred to as Loi Santé No. 2016-41 and enacted on 26 January 2016, contains...more

Xarelto Litigation — An Update

On February 23, 2016, Judge Fallon held another status conference in the national litigation over Xarelto. There are now over 5,600 individual lawsuits pending in MDL No. 2952, the coordinated federal court proceedings...more

Ohio Willow Wood’s Appeal of IC Finding Goes Up In Smoke

On February 19th, the Fed. Cir. affirmed a District Court’s finding of inequitable conduct in Ohio Willow Wood Co. (OWW) v. Alps South (Alps), LLC, following the Fed. Cir.’s remand of summary judgment of no inequitable...more

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

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