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Third Circuit Tightens “Original Source” Requirement for Whistleblowers

Back in 2003 Karl Schumann filed a whistleblower suit alleging that as an executive with benefits company Medco, he learned that Bristol-Myers Squibb and AstraZeneca paid kickbacks to Medco to buy and recommend brand name...more

Health Alert (Australia) - October 20, 2014

In This Issue: Judgements, Legislation, and Reports. Excerpt from Judgments: Commonwealth - 15 October 2014 - Gray v Richards [2014] HCA 40 - In 2003, a 10-year-old girl...more

New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

Ninth Circuit Upholds Alameda Safe Drug Disposal Ordinance, Triggering Implementation of King County Secure Medicine Return Rule

On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the...more

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

Scripts Newsletter - October 2014

In this issue: - Health Care Decisions — Who Decides? - Medical Software Licensing — Tips from the Trenches - An Ounce of Prevention — The Importance of Periodic Corporate Audits - ACA -...more

Healthcare Legal News: Volume 4, Number 3 - Special Issue: HIPAA Update

Recent Trends in HIPAA Liability - Since the passage of the 2013 HIPAA Omnibus Rule, there has been a substantial increase in HIPAA enforcement actions brought by the Department of Health and Human Services, including...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

California Court Dismisses CMIA Claim Based on Possession of Stolen Medical Data

A health organization narrowly averted paying a potential $4 billion in damages under the California Confidentiality of Medical Information Act (CMIA) for losing the medical records of more than 4 million patients. Plaintiffs...more

HEAL Advisory: Whistleblowers Rewarded Again by SEC and the Judiciary

On August 29, 2014, two whistleblower developments of particular interest to health care and life science entities emerged from the Securities and Exchange Commission ("SEC") and the Eighth Circuit Court of Appeals,...more

Laboratory Discount Arrangements Survive Antikickback Statute Scrutiny

There has been question for some time whether in evaluating certain discount arrangements involving clinical laboratory tests under the federal antikickback statute (FAS), discount charges should be measured against the...more

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

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