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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

Court Dismisses Data Breach Class Action for Lack of Article III Standing

Last month in its decision in In re Sci. Applications Int’l Corp. (SAIC) Backup Tape Data Theft Litigation, 2014 U.S. Dist. LEXIS 64125, the United States District Court for the District of Columbia dismissed all but two...more

Status of 340B “Mega-Rule” in Question as HHS Decides How to Proceed with Vacatur of Orphan Drug Rule

For over a year, participants in the 340B Drug Pricing Program (340B Program) and others have been waiting for the release of the so-called proposed “Mega-Rule” by the Department of Health and Human Services (HHS). The...more

HHS Poised For Round Two Of Orphan Drug Fight

HHS isn’t ready to throw in the towel in the fight over expansion of the 340B program under the Affordable Care Act (ACA). On Thursday HHS said in a court filing that it will appeal last month’s federal court ruling that...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

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

Recent Court Decision Limits HRSA's Authority Under the 340B Drug Discount Program - Will It Change the Impact of the Anticipated...

In the rapidly evolving landscape of the 340B Drug Discount Program, a recent court decision is the first to limit the rulemaking authority of the Health Resource and Services Administration (HRSA). This decision may...more

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

DC District Court Strikes Down 340B Orphan Drug Rule

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

Federal Court Vacates 340B Rule Regarding Orphan Drugs

On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. At...more

FTC Uses Its "Unfair Acts" Power to Go After PHI Security Breach

The Federal Trade Commission (FTC) is moving forward with an administrative action against a small medical laboratory that suffered two data security breaches, resulting in its patients’ protected health information falling...more

Halifax Health Gets In More Hot Water

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

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