Health Law Daily FDA may have acted recklessly in NECC meningitis outbreak
Tuesday, April 25, 2017

FDA may have acted recklessly in NECC meningitis outbreak

Under Tennessee law, fault in a products liability action can be allocated to immune non-parties, including federal and state agencies. As a result, a surgical center and a physician who are among the defendants in the products liability suit related to 2012’s nationwide fungal meningitis outbreak may be able to assert that the FDA and the Massachusetts Board of Registration in Pharmacy (MBOP) owed a special duty of care to the public due to reckless misconduct (In re New England Compounding Pharmacy, Inc. Products Liability Litigation, April 24, 2017, Zobel, R.).

In 2012, more than 750 people in 20 states—64 of whom died—contracted fungal meningitis after receiving contaminated steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts (see FDA releases observations on conditions at New England Compounding Center, October 29, 2012; 25 counts of murder charged in nationwide fungal meningitis outbreak, December 18, 2014). Previously, the ensuing multidistrict litigation determined that physicians purchasing compounded drugs from NECC owed patients a duty to use reasonable care in assuring the quality and sterility of drugs purchased and administered (see Doctors face consumer fraud and negligence suits for use of contaminated drugs, January 15, 2015).

A group of defendants sought to allocate comparative fault to the FDA, MBOP, the Tennessee Board of Pharmacy, and the Tennessee Department of Health as an affirmative defense; the multidistrict litigation plaintiffs’ steering committee moved for judgment on the pleadings. The plaintiffs argued that under Tennessee’s public duty doctrine, the defendants cannot establish a prima facie case of negligence—a required element of comparative fault—against non-party governmental entities, and therefore, cannot establish the entities’ comparative fault.

The court found that although Tennessee’s public duty doctrine generally negates the duty element required to prove negligence, there is an exception for the case of a special duty owed to individuals rather than the public at large. The defendants specifically alleged that the FDA and MBOP received numerous complaints about NECC for almost a decade, but failed to take action to address the complaints. As a result, the court determined that there is sufficient information in the pleadings to state the existence of a special duty owed by the FDA and MBOP, causing the action of the two agencies to rise to the level of recklessness. However, the defendants did not plead that the two Tennessee agencies acted recklessly, and therefore, as a matter of law, cannot assert comparative fault against them.

The case is MDL No. 13-02419-RWZ.

Attorneys: Donna Mackenzie (Olsman MacKenzie & Wallace), Harold D. Gibson (Gentry Locke Rakes & Moore, LLP) and Harry M. Roth (Cohen, Placitella & Roth, PC) for Plaintiffs. Frederick H. Fern (Harris Beach PLLC) for New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center. Ingrid S. Martin (Collora LLP) and Matthew E. Mantalos (Martin, Magnuson, McCarthy & Kenney) for Ameridose LLC. Daniel M. Rabinovitz (Greenberg Traurig LLP) for Medical Sales Management, Inc. Franklin H. Levy (Lawson & Weitzen, LLP) for Alaunus Pharmaceutical, LLC.

Companies: New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center; Ameridose LLC; Medical Sales Management, Inc.; Alaunus Pharmaceutical, LLC; U.S. Food and Drug Administration; Massachusetts Board of Registration in Pharmacy; Tennessee Board of Pharmacy; Tennessee Department of Health; Specialty Surgery Center, PLLC; Calisher and Associates

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