COA: Clinics that gave tainted steroid must face suit

After a widespread fungal meningitis outbreak killed nearly a dozen Hoosiers, the Indiana Court of Appeals decided Monday that the providers who injected the injured parties with a contaminated steroid that was purchased from a third party can be found to be negligent under the Indiana Medical Malpractice Act.

In 2012, an outbreak of fungal meningitis, fungal infections and other related complications caused at least 64 deaths in 20 states, including 11 deaths in Indiana. The outbreak was caused by a preservative-free steroid that was contaminated with a fungus, purchased from the New England Compounding Center and distributed in Indiana by a St. Joseph County clinic and the Orthopedic and Sports Medicine Center of Northern Indiana and its affiliates in Elkhart County to treat back pain and other spinal conditions.

Several individuals who were injured or families of those who died after being injected with the contaminated steroid brought negligence complaints against the clinic and orthopedic center, arguing that the health care providers should have evaluated the steroid and NECC before selecting them. However, some of the complaints were brought without following the procedures of the Indiana Medical Malpractice Act, so the defendants moved for either dismissal or summary judgment.

The Indiana Patient’s Compensation Fund, under the direction of Stephen W. Robertson, commissioner of the Indiana Department of Insurance, intervened and argued that he plaintiffs’ claims were of general negligence and not subject to the MMA. However, after the plaintiffs reversed their initial position, the St. Joseph and Elkhart superior courts agreed that the claims were governed by the MMA.

Robertson, acting as the PCF, appealed both county court decisions, and the two were consolidated into a single de novo appeal in Stephen W. Robertson, Commissioner, Indiana Department of Insurance, as Admin. Of the Indiana Patient’s Compensation Fund v. Anonymous Clinic, et al, 71A03-1512-CT-2199.

The PCF’s argument was based on the fact that the “general procurement of products that will eventually be used in the course of treatment does not qualify as ‘health care’ under the MMA.”

But Judge Cale Bradford wrote for the Court of Appeals, “We have little trouble concluding that the selection of preservative-free (steroids) … in favor of (steroids) with preservatives from other suppliers were actions that involved the exercise of professional medical skill and judgment, i.e., they qualify as the practice of medicine.”

The court further wrote that there are three parts to the practice of medicine, and the allegations in this case fall under the second part – selection of the proper remedy for a disease.

The PCF also argued that there was no causal connection between the treatment of any individual patient and the exercise of medical judgment by the defendants because the northern Indiana clinics decided to purchase the steroids from NECC years before the plaintiffs were treated.

“This position would seem to be based on the proposition that only decisions made by providers with specific patients in mind can be subject to the MMA,” the court wrote. “The language of the MMA is not so restrictive.”

Finally, the PCF argued that the alleged increase potential liability it would face due to this case would result in increased surcharges from healthcare providers to fund the PCF, thus jeopardizing their ability to obtain affordable medical malpractice insurance. But even if such a situation would come to pass, the appellate court wrote that it is not its position to try to save the PCF.