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Health Care Market Intelligence: Post-Acute Care Summary Report - Q2 2016

Key Findings - - CMS proposed an $800-million Medicare payment increase for SNFs in FY 2017, a 2.1% increase from this year, while hospice payments would rise by $330 million, or 2%. Home healthcare agencies may see a...more

July 2016: Product Liability Update

Curbing False Claims Act Liability for Off-Label Promotion. As class actions have become harder to certify following Wal-Mart v. Dukes and Comcast v. Behrend, the plaintiffs’ bar has increasingly turned to qui tam litigation...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...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

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

In 10-1 Verdict, Jury Finds No FCA Violation by Abbott Laboratories

On April 7, 2016, after just three hours of deliberations following a three-week trial, a federal jury dismissed False Claims Act (“FCA”) claims against Abbott Laboratories brought by a whistleblowing former employee.  The...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

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

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

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

Government Contracts Quarterly Update February 2016

The Government Contracts Quarterly Update is published by BakerHostetler’s Government Contracts Practice team to inform our clients and friends of the latest developments in federal government contracting. In This Issue...more

Aviation Contractor Glides Away From Liability After Receiving Unsolicited Email Containing Trade Secrets

If a third party sends you someone’s trade secrets, and you delete them as soon as you know they’re trade secrets, you’re off the hook for misappropriation. That, in a nutshell, is what a Florida federal judge held on...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

D.Mass. Invokes Public Disclosure Bar, Demands Specificity, and Refuses to Second-Guess FDA in Dismissing Axium/Onyx Qui Tam Case

It’s not as if the standard for amending pleadings is a particularly hot DDL topic, but here we go for the second time this week discussing a case where precisely that was at issue. This time the case was U.S. ex rel....more

D.Mass. Invokes Public Disclosure Bar, Demands Specificity, and Refuses to Second-Guess FDA in Dismissing Axium/Onyx Qui Tam Case

It’s not as if the standard for amending pleadings is a particularly hot DDL topic, but here we go for the second time this week discussing a case where precisely that was at issue. This time the case was U.S. ex rel....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

Wrong Defendant, Wrong Court: Plaintiff Wrongly Targets Government Contractors Instead of U.S. Government - Astornet Technologies...

In a case addressing whether a patent holder can sue government contractors in district court, the U.S. Court of Appeals for the Federal Circuit upheld the dismissal of Astornet’s claims against three government contractors...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

U.S. Government Patent Infringement Precludes Induced Infringement

In Astornet Technologies, Inc. v. BAE Systems, Inc., the Federal Circuit affirmed the district court’s dismissed of actions for induced infringement where the alleged direct infringer was the U.S. government. In particular,...more

OPM update: OPM hit with another class action suit—this one filed by a Judge

Ho hum. Another class action filed against OPM for its massive data breach. The interesting fact here? The suit’s named plaintiff is a Judge with the Social Security Administration. On Friday, August 7, Social Security...more

What to Do if You Receive a Subpoena for Documents From the US Department of Justice

Receiving an unexpected Department of Justice (“DOJ”) subpoena for documents and testimony is a jarring experience for anyone in Government contracting. But more and more contractors may receive such subpoenas as the...more

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

Successful Rule 9(b) Defense of False Claims Act Whistleblower Litigation

The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

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