Health Civil Procedure

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District Court Allows Medicare Beneficiary Class Action to Proceed

On February 8, 2017, the United States District Court for the District of Connecticut declined to fully dismiss allegations filed by a class of Medicare patients against HHS in Alexander et al. v. Cochran (formerly Bagnall et...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

Florida Supreme Court Rules That Hospital "Adverse Medical Incidents" Reported to a PSO Are Not Privileged From Discovery: Impact...

Southern Baptist Hospital of Florida (Hospital) was sued in a medical malpractice action in which the plaintiff sought to discover records relating to "adverse medical incidents" that occurred at the Hospital and involved any...more

Proof by Proxy in FCA Suits? District Court Says It Depends

Admissibility of statistical sampling to prove liability in FCA suit is fact dependent. In a February 14, 2017 decision, the Fourth Circuit declined to rule on the question of whether statistical sampling can be used to...more

Florida Supreme Court Rejects More Rigorous Expert Testimony Standard

The federal court system and 36 states have adopted the so-called Daubert standard in place of the Frye standard when it comes to qualifying expert witnesses under the rules of evidence. In 2013, the Florida Legislature...more

Healthcare Litigation - February 2017

HCQIA Preemption of State Physician Whistleblower Statutes - Medical professionals who are subject to adverse actions following peer review often seek to sue the peer review participants (including the individual...more

Fourth Circuit Takes a Pass on Statistical Sampling, Finds DOJ's Settlement Veto Authority Unreviewable

After granting the relators’ petition for an interlocutory review of the district court’s rejection of the use of statistical sampling to establish FCA liability, the Fourth Circuit ultimately declined to reach that issue in...more

ERISA: Winning Tactic on Summary Judgment to Prove Claimant Received the Policy: Get Key Evidence into the Administrative Record

You know that to apply an exclusion in a policy, the claims administrator must show that the claimant received the policy. But what happens when the claimant submits a declaration disputing your proof that she received...more

Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude...more

Fourth Circuit Permits DOJ to Reject an FCA Settlement, But Punts Decision on Statistical Sampling

In a closely watched False Claims Act (“FCA”) case, the Fourth Circuit Court of Appeals decided that the Department of Justice (“DOJ”) has an unreviewable right to object to a proposed settlement agreement between a relator...more

Non-Physician Learned Intermediaries

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...more

When 30 Days Is Not 30 Days

Concerned about a surgeon’s skill, a hospital ordered him to “have five bowel surgery cases proctored,” specifying no time limit. After a month, when the surgeon hadn’t met the five-case requirement, the hospital filed an...more

TCPA Violations Claimed Against Rady Children’s Hospital in San Diego

Rady Children’s Hospital-San Diego (Rady) was hit with a proposed class action in California federal court this week for alleged violations of the Telephone Consumer Protection Act (TCPA) for autodialed debt-collection calls...more

What Is “Product Liability”?

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

False Claims Act Alert: Fourth Circuit Punts on Sampling and Extrapolation

Tuesday, the Fourth Circuit Court of Appeals ruled in the interlocutory appeal in United States ex rel. Michaels v. Agape Senior Community, Inc.. In an opinion considering two significant questions arising under the qui tam...more

Fourth Circuit Sidesteps Statistical Sampling Issue

In a decision issued yesterday, the United States Court of Appeals for the Fourth Circuit dismissed an appeal that would have addressed one of the most pressing unresolved issues in False Claims Act jurisprudence: whether...more

Briefing Complete in Appeal in Amgen v. Apotex

The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in September 2016 the District Court for...more

The Anthem Breach – A Retrospective (Part II)

We published Part I of our “Anthem Breach Retrospective” in January 2017. Coincidentally, at around the same time several plaintiffs in one of the earliest filed cases arising out of the Anthem data breach voluntarily asked...more

Another Court Agrees That A Difference Of Opinion On Medical Necessity Is Insufficient to Show Falsity Under the False Claims Act

Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of...more

Recent Arizona appellate decisions of note to providers

With change, breaking news, and uncertainty dominating the legal concerns of health care providers on a federal level, it remains important to review and refresh on state-level concerns and legal rules. This is especially...more

Client Alert: Florida Supreme Court Broadens Patient Access to Adverse Incident Reports

A recent decision by the Florida Supreme Court has significant implications regarding certain adverse incident reports previously viewed as outside the scope of permitted discovery. Florida health care providers currently...more

Nursing Home Arbitration Agreements: A Changing Landscape

Because arbitration proceedings often offer a less costly and more efficient alternative to the burdens of protracted courtroom litigation, arbitration agreements are increasingly common in the nursing home industry. However,...more

CBAs Must Specifically State Intent to Arbitrate Statutory Rights

Seyfarth Synopsis: The Court of Appeal has held that unless a collective bargaining agreement includes an explicitly stated, clear and unmistakable, intent to waive the right to a judicial forum for statutory causes of...more

Amendment 7 Prevails Over Patient Safety Work Product Protections

On January 31, the Florida Supreme Court ruled that the “Patient Safety Work Product” privilege cannot shield Florida health care providers from Amendment 7 requests. The court’s decision in Charles v. Southern Baptist...more

Update: Praluent® Injunction Stayed by Fed. Circuit

On February 8, the Federal Circuit issued a stay of the permanent injunction granted against the sale of Sanofi and Regeneron’s Praluent® (alirocumab). The injunction was to have become effective on February 21, 2017, but as...more

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