False Claims Act Defendants May Have Possible Counterclaims Against Whistleblowers

Although whistleblowers benefit from strong public policies protecting the means by which they assert and support their False Claims Act (FCA) allegations, a recent decision highlights a possible counterclaim theory that empowers defendants to assert claims against the whistleblower.  In U.S. ex rel. Notorfransesco v. Surgical Monitoring Association, Inc. et al., (E.D. Pa.),  the whistleblower was a former employee of the defendant, and the defendant asserted a counterclaim based on the former employee’s taking and disseminating confidential information from the former employer, including using that information in the qui tam complaint.  The counterclaim asserted breach of contract, implied contract and promissory estoppel theories.

The district court denied the whistleblower’s motion to dismiss the counterclaim, holding that the counterclaim raised claims that were independent of the FCA allegations and therefore were not against public policy.  The court also held that the defendant had plausibly asserted that it could be entitled to  injunctive relief and damages. Continue reading “False Claims Act Defendants May Have Possible Counterclaims Against Whistleblowers”

False Claims and Anti-Kickback Defendants Should Insist on Discovery from the Whistleblower/Relator

One arrow in the quiver for healthcare providers sued for violations of false claims and anti-kickback statutes is pressing for discovery from the whistleblower/relator, including a deposition of the relator.  The failure of the whistleblower to comply with the discovery obligations could result in meaningful sanctions, including dismissal.

In Guthrie v. A Plus Home Health Care, Inc. et al, 0:12-cv-60629-WPD (S.D. FL), the relator, William Guthrie, sued a home health care provider, its seven doctors, and their spouses, alleging that the doctors and their spouses implemented a fraudulent scheme of compensation and referral payments resulting in violations of the False Claims Act, the Stark Act, and the federal Anti-Kickback Statute. Continue reading “False Claims and Anti-Kickback Defendants Should Insist on Discovery from the Whistleblower/Relator”

Clinical trial sponsors can be liable for inadequate consent forms

Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so.  Federal law imposes several specific items to be included in the consent form.  Where all pertinent risks, benefits and alternatives have been disclosed, and the patient signs the form, the patient is said to have given “informed consent.”

A patient injured in a clinical trial studying a new therapy for Parkinson’s Disease sued the manufacturer of the equipment used in the procedure.  In addition to a claim of negligent design and manufacture of the equipment itself, the patient asserted that the manufacturer, as the sponsor of the clinical trial, was negligent in drafting and approving the informed consent documents that the patient signed to participate in the clinical trial.  Can a manufacturer be liable for an improperly drafted consent form? Continue reading “Clinical trial sponsors can be liable for inadequate consent forms”

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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