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Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more

Federal Court Rejects Relator’s Swapping Allegations in False Claims Act Case

This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former...more

Audit Trails: Pitfalls of Electronic Medical Records, Part III

I do not profess to be an expert in the complexities of metadata in an electronic medical record (EMR). In simple terms, it is analogous to leaving footprints in the sand; although these do not wash away with high tide. In...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

California Court of Appeal Rules Damages Are Unavailable To Plaintiff Patients Where Patient Information On Stolen Computer Was...

Until last week, Sutter Health was looking at a potential jury verdict in excess of $4 billion against several of its affiliated hospitals in a class action suit filed under the California Medical Information Act, California...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - On Monday, July 28, the House Committee on Energy and Commerce, Subcommittee on Health will hold a markup to consider two bills: H.R. ____, a bill to require the Secretary of Health and Human...more

Appellate Court Rules Medical Information Must Actually Have Been Viewed by an Unauthorized Person for a Plaintiff to Recover...

The California Court of Appeal recently held that in order to recover under California’s Confidentiality of Medical Information Act (CMIA), Civ. Code §§ 56 et seq., a plaintiff must plead and prove that the “stolen medical...more

California Court Dismisses Data Breach Class Action

Last week, the California Third District Court of Appeal dismissed what may have been the largest health data breach class action in history. Consistent with a trend of similar dismissals, the California state appellate court...more

Lessons From Omnicare Settlement In 'Swapping' Cases

On June 25, the U.S. Department of Justice announced that it had settled with Omnicare Inc. in two matters alleging that kickbacks resulted from below-cost discounts offered to skilled nursing homes as an inducement to select...more

Health Alert (Australia) - July 28, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 22 July 2014 - Lane v Northern NSW Local Health District (No 3) [2014] NSWCA 233 - This...more

California Appellate Court Requires Actual Viewing of Confidential Information in Data Breach Case Under the California Medical...

In a case against Sutter Health involving records from a stolen office computer, the California Court of Appeal recently issued a decision limiting plaintiffs’ ability to state a claim and obtain statutory damages under the...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...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

California Court Grants Hospital Summary Judgment on Data Breach Claim

In its recent decision in Eisenhower Medical Center v. Superior Court, 226 Cal. App. 4th 430(Cal. App. 4th Dist. 2014), the Court of Appeal of California, Fourth District, had occasion to consider whether a medical facility’s...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

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

Healthcare Legal News - July 2014 • Volume 4, Number 2

In This Issue: - DO SUBSIDIZED HEALTH CARE PLANS PURCHASED UNDER THE AFFORDABLE CARE ACT TRIGGER THE ANTI-KICKBACK STATUTE? The advent of federally subsidized private pay health insurance under the Affordable...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Supreme Court Asked If State Universities Are Exempt From Claims Under the False Claims Act

A professor at the University of Texas Health Science Center has petitioned the U.S. Supreme Court to determine the standard for imposing liability on state universities (and their related entities, such as hospitals and...more

Data Breach Class Action Not Barred by Lack of Individual Injury in West Virginia

In a potentially groundbreaking decision, the Supreme Court of Appeals of West Virginia reversed a trial court’s order denying class certification in a data breach class action. The case, Tabata v. Charleston Area Medical...more

Anti-Kickback and Stark Law Violations Form Basis for Unfair Competition Claims

On June 16, 2014, a federal district court jury in Florida awarded $14.755 million to plaintiff Ameritox, Ltd., a Maryland-based clinical lab, for state law claims alleging tortious interference with business relationships...more

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

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