Health Civil Procedure

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Micro-Units under the Microscope: The Second and Fifth Circuit Courts Consider Specialty Healthcare and Its Misapplication

Last week, the U.S. Court of Appeals for the Second Circuit joined the Third, Fourth, Fifth, Sixth, Seventh, and Eighth Circuits in upholding the Board’s Specialty Healthcare standard for determining appropriate bargaining...more

The ERISA Litigation Newsletter - November 2016

This month we review a recent Second Circuit decision addressing ERISA plan status as a class member in a securities shareholder class action. As discussed in the article, the decision exposes a potential conflict among the...more

The First Circuit Rules On Materiality And Rule 9(b) In Two FCA Opinions

On November 22, 2016, the United States Court of Appeals for the First Circuit issued two False Claims Act (FCA) opinions in the continuing debate over the parameters of the FCA. In United States ex. rel. Escobar et al. v....more

On Remand, First Circuit Finds Violations in Escobar Were Material

In June, the Supreme Court issued Universal Health Services, Inc. v. U.S. ex rel. Escobar, a landmark opinion in which the Supreme Court addressed the standard for pleading materiality in FCA implied certification cases. The...more

Pharmaceutical Product Liability Class Action Filed Relating to Olmetec Drug

Earlier this month a proposed class action was filed in Montreal by the Consumer Law Group alleging that Merck, Shering-Plough and Daiichi Sankyo (the Defendants) provided inadequate warnings about the drugs Olmetec and...more

House v. Burwell: Now or Never?

Attorneys for the United States House of Representatives (House), in U.S. House of Representatives v. Burwell, the case challenging certain cost-sharing subsidies in the Affordable Care Act (ACA), filed a motion asking the...more

Second Circuit Affirms Ruling that SPD Swiss Precision Diagnostics Falsely Advertised Clearblue Weeks Estimator Home Pregnancy...

In an important recent false advertising decision in a suit brought by home pregnancy test manufacturer Church & Dwight against its principal competitor SPD Swiss Precision Diagnostics, a Second Circuit panel unanimously...more

Awful Missouri Venue/Joinder Ruling Offers Way Out – Take It!

Even after having read it through twice, we find the result in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), hard to fathom, and even harder to stomach. For several years after...more

When Can Violation of a Condition of Participation Result in False Claims Act Liability? Update on Escobar’s Materiality Standard

In June, I published a blog article on a decision of the United States Supreme Court that appeared to change the law applicable to “false certification” in the 7th Judicial Circuit Circuit. The Supreme Court decision in...more

EMTALA Anti-Retaliation Rule Narrower Than You Might Think

Regional Care Hospital fired Marie Gillispie because she was outspoken in telling hospital management that it was required to report an incident of patient dumping and had violated EMTALA by failing to do so. At least that’s...more

8th Cir. Resists Opportunities to Nix Nursing Home Arbitration

The plaintiff offered the Eighth Circuit several reasons to rule that he needn’t arbitrate claims against his father’s nursing home. But, figuratively swimming against the juridical current, the Eighth Circuit rejected all...more

Don’t Underestimate the Statute of Limitations

As we hurtle into the holiday season, we are reminded that good things often come in small packages. That certainly was the case in a one-and-a-half-page opinion that the Ninth Circuit filed last week in a prescription...more

Seventh Circuit Recognizes “Substantial Truthfulness” Defense to Tortious Interference Claims under Wisconsin Law

As we wrap up another election cycle that has kept “fact checkers” working overtime analyzing the many dubious claims by candidates of all political persuasions, the Seventh Circuit has issued a decision that reminds us of...more

Mississippi District Court Halts Implementation of New CMS Rule Banning Use of Arbitration Agreements in Long-Term Care Facilities

Anyone familiar with long-term care litigation knows that the number of disputes regarding the use and enforcement of arbitration agreements in the context of assisted living/nursing home admissions has risen sharply over the...more

4 Steps to Setting Up Bellwether Trial Victories: Stock, Screen, Steer and Substitute

Upon creation of multidistrict litigation involving a drug or medical device, companies may contemplate the dreaded “S-Word” —“settlement.” While an early settlement program can sometimes serve as in-house counsel’s best...more

U.S. District Court Issues Preliminary Injunction Stalling and Possibly Precluding CMS’ Final Rule’s Ban on Long-Term Care...

On November 7, 2016, Judge Michael P. Mills of the United States District Court for the Northern District of Mississippi issued an Order temporarily preventing CMS from implementing its Final Rule banning pre-dispute...more

First Circuit Upholds Exclusion of Dual-Eligible Patients That Are Not Entitled to SSI Benefits from Both the DSH Medicaid...

The U.S. Court of Appeals for the First Circuit recently ruled in favor of HHS, overturning a $17 million district court decision, in a dispute dating back as far as the 1993 fiscal year over whether hospitals may include,...more

Ninth Circuit Considers Limits to DEA Access to Oregon PDMP

On November 7, 2016, the US Court of Appeals for the Ninth Circuit heard arguments in Oregon Prescription Drug Monitoring Program v. United States DEA, No. 14-35402 (9th Cir. 2016). Here, the Drug Enforcement Administration...more

D.C. District Court Bucks the Trend and Rules for Hospital in Provider Tax Case

Many states assess taxes against hospitals and other providers as a means of funding their Medicaid and other healthcare-related programs. The revenue generated by the taxes is used, with CMS’s approval, to fund Medicaid...more

Ninth Circuit Smells a Rat and Reinstates Claim That Pharmaceutical Company Failed to Disclose Cancers in Animal Testing

The Ninth Circuit recently revived a securities class action against Arena Pharmaceuticals, issuing a decision with important guidance to pharmaceutical companies speaking publicly about future prospects for FDA approval of...more

Federal Court Blocks CMS Ban on Pre-Dispute Nursing Home Arbitration Agreements Pending Legal Challenge: What the Ruling Means for...

Earlier this week, a federal court enjoined the federal Centers for Medicare and Medicaid Services (“CMS”) from enforcing a rule, promulgated on September 28, 2016, which barred pre-dispute arbitration agreements between...more

Federal Court Enjoins U.S. Agency’s Nursing Home Arbitration Agreement Ban

The Centers for Medicare and Medicaid Services (CMS), an agency within the U.S. Health and Human Services Department, recently issued a final rule prohibiting nursing homes and other long-term care facilities from utilizing...more

North District of California Misconstrues Express False Certification Liability

This summer, the Northern District of California issued an opinion in an intervened case that expanded the theory of express false certification to a startling degree. Ruling on a motion to dismiss, the court in U.S. ex rel....more

Clean Bill of Health for Tuberculosis Testing Patents in Eligibility Challenge

After the Supreme Court’s recent decisions in Alice, Mayo, and Myriad that narrowed the bounds of patentable subject matter, defendants have routinely asked courts to invalidate patents in certain technology areas—such as...more

"Escobar and the Implied Certification Theory: Initial Cases Raise the Bar on Materiality in False Claims Act Litigation"

On June 16, 2016, the U.S. Supreme Court in Universal Health Services, Inc. v. United States ex rel. Escobar1 (Escobar) unanimously upheld the implied certification theory of False Claims Act (FCA) liability and strengthened...more

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