Health Civil Remedies

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The United States’ First-Ever Biosimilar Reaches the Market

Today, Sandoz (a Novartis subsidiary) launched the first biosimilar approved under the BPCIA: the cancer drug Zarxio (filgrastim-sndz), which is a biosimilar version of Amgen’s Neupogen. The launch follows the Federal...more

Whistleblower Filed Too Early & Too Late for Share of $322M SCAN Scam Recovery

During his days as a data encounter manager at SCAN, Jim suspected the company had been double-billing Medicare and Medicaid for years. He expressed his concerns within SCAN. When he refused a job reassignment, he was fired....more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

The Difficulty Of Challenging FCA Fine As Excessive

Last month, in U.S. ex rel. Drakeford v. Tuomey, No. 13-2219, (4th Cir. July 2, 2015), the Fourth Circuit affirmed a False Claims Act verdict against a nonprofit hospital in Sumter, South Carolina. In an area of the law where...more

Hospital Chain Pays Heavy Price for Being Too Clever

Finding that Community Hospital Systems had been “too clever by half” in negotiating a global settlement agreement for seven whistleblower suits, a federal judge ordered the chain to pay the attorneys’ fees of all the...more

Be Careful What You Say: Allegations Of Worker Misconduct Might Be Defamation

Healthcare institutions have a moral and legal obligation to promote patient safety as an essential component of patient care. Supervisors and managers must be supportive of their staffs while remaining vigilant about the...more

Court Adopts Tough Interpretation of 60-Day Repayment Rule

New York’s Mt. Sinai Hospitals can’t seem to catch a break in its long-running battle with whistleblower Bob Kane. First, the government joined the case and wanted not just the $1,000,000 in Medicaid overpayments, but an...more

Health Care Providers Lacked Standing to Sue as ERISA Beneficiaries: Rojas v. Cigna Health and Life Insurance Company

The U. S. Court of Appeals for the Second Circuit has affirmed a dismissal of claims by two physicians and their medical practice asserting standing under ERISA to enjoin an insurer from removing them from its coverage...more

Federal Circuit Amgen Case Clarifies Important Aspects of the Biologics Price Competition and Innovation Act

On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more

Circuit Court Affirms $237.5 Million Judgment Against Tuomey

On July 2, 2015, the Fourth Circuit affirmed a $237,454,195 judgment against Tuomey Health Care System (Tuomey) for violations of the Federal False Claims Act (FCA), which liability arose from violations of the Stark law....more

Beware of Nurses Bearing Gifts

Alisia and David blew the whistle on their former employer, Nurses’ Registry & Home Health, for sending gift baskets and ticket events to doctors who referred patients to the home health operation. Their qui tam suit alleged...more

Attacking Patents on Written Description & Enablement Grounds in Inter Partes Review

Although Inter Partes Review (IPR) is limited to grounds of unpatentability based upon prior art references, it is nevertheless possible to raise issues of written description or enablement by applying intervening prior art...more

Mintz Levin Health Care Qui Tam Update - July 2015

Trends & Analysis - ..We have identified 36 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of these cases, eight were filed within the last year. A number...more

Fourth Circuit Upholds $237M Verdict Against South Carolina Hospital System for Stark Law Violations

On July 2, 2015, the United States Court of Appeals for the Fourth Circuit affirmed a $237 million judgment against Tuomey Healthcare System, Inc., in a federal False Claims Act (FCA) case arising out of violations of the...more

Health Alert (Australia) - July 13, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: United Kingdom (UK) 7 July 2015 - Ross v A [2015] EWCOP 46 The England and Wales Court of Protection has held that a...more

The Revolution that Wasn’t: New Jersey’s Direct-To-Consumer Exception to the Learned Intermediary Doctrine

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

Medical Malpractice Damage Caps — A Balance of Justice

In a recent landmark decision for the citizens in the State of Florida, Florida’s Fourth District Court of Appeals, the appellate court for Palm Beach, Broward, and the counties to their north, issued an opinion finding the...more

A “Too Old” OTC Product Does Not A Class Action Make

This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy. We volunteered to photograph the event, because the usual photographer was not able to attend. And...more

Federal court blocks rule restricting telemedicine practice in Texas

A federal court has temporarily enjoined the Texas Medical Board (TMB) from implementing and enforcing a rule restricting the practice of telemedicine pending resolution of an antitrust lawsuit filed by Teladoc, Inc. The...more

TelaDoc Wins Injunction Against Texas Medical Board re: Telehealth Restrictions

The Federal District Court of the Western District of Texas has ruled against the Texas Medical Board and granted TelaDoc’s Motion for a Preliminary Injunction prohibiting the Texas Medical Board from enforcing new rules...more

The False Claims Act – the Basics Every Provider Should Know, Part Two

FCA penalties are harsh, as they are designed to truly deter attempts to defraud the federal government. The penalty for an FCA violation begins with treble damages, requiring the offender to pay three times the amount of the...more

Wyoming Federal Court Dismisses Hip Case for Lack of Defect

"And what is so rare as a day in June?" How about a drug and device law opinion out of Wyoming? We do not often get the chance to discuss Wyoming products law. That is not terribly surprising, given that Wyoming is the...more

Texas Telemedicine Rule Delayed by Antitrust Suit

A Texas Medical Board rule requiring a physician to conduct an in-person evaluation before prescribing certain drugs will not go into effect today, June 3, as originally planned. A federal court granted a preliminary...more

Actavis Loses Nameda® Appeal Over “Hot Documents”

The U.S. Court of Appeals for the Second Circuit’s opinion (issued May 22, 2015 with a public, redacted version available May 28, 2015), affirming the district court’s grant of a preliminary injunction in State of New York v....more

The Medicaid Fraud Control Units: Fiscal Year 2014 Report

The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2014 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCUs)...more

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