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Meningitis lawsuits target physicians

Safety flaws found at compounding firm that made steroids

Meningitis lawsuits target physicians

More doctors, clinics and other health care providers are likely to be sued in the deadly meningitis outbreak linked to fungus-contaminated steroids as plaintiffs attorneys search for deep pockets, legal experts say.

While most legal observers say such defendants are unlikely to be found liable, some say liability might be established to the extent that the physicians were aware that steroids distributed by the New England Compounding Center violated regulations by preparing the drug in bulk rather than on a patient-specific basis with a prescription.

While numerous lawsuits have been filed, the situation still is developing.

“The facts are just starting to come out,” said defense attorney Charles E. Joern Jr. of the Oak Brook, Ill.-based Joern Law Firm.

About 14,000 patients may have received injections of a steroid compounded and distributed by the Framingham, Mass.-based New England Compounding Pharmacy Inc.

As of last week, more than 300 cases of meningitis, including two dozen deaths, had been reported in 18 states as a result of fungal infections linked to injection of the steroid, according to the U.S. Centers for Disease Control and Prevention.

Separately, the Massachusetts Department of Public Health issued a report last week saying the compounding facility, which has been shut down, failed to await the results of sterility testing before distributing the steroid; there was visible black particulate matter in several sealed recalled vials of the steroid; and a leaking boiler adjacent to the requisite clean room created an environment susceptible to contaminant growth, among other problems.


A lawsuit filed Oct. 16 in New Jersey Superior Court in Bridgeton, Jennifer L. Marko and Robert Marko v. New England Compounding Pharmacy Inc. et al., also named as defendants Vineland, N.J.-based Premier Orthopedic and Sports Medicine Associates of Southern New Jersey L.L.C., its surgical center and staff doctor Dr. Kimberly Yvette Smith.

Ms. Marko, who is suffering symptoms including severe headaches and slurred speech, is at increased risk of contracting meningitis from a steroid injection she received in September or October, according to the lawsuit.

A Premier spokesman could not be reached.

The compounding pharmacy “probably has limited insurance even if they have an excess policy, so what the lawyers are going to do is look for other deep pockets who may be responsible,” said plaintiff attorney David Jaroslawicz a principal partner at Jaroslawicz & Jaros L.L.C. in New York, who said his firm was exploring whether to file litigation in the matter.

Observers generally say, however, that suits against doctors, clinics and other medical providers are unlikely to be successful.

Assuming medical providers had no advance knowledge of the contamination, “the prospects of ultimate liability would be fairly small,” said defense attorney James M. Beck, of counsel at Reed Smith L.L.P. in Philadelphia.

“If they're prescribing or filling prescriptions and have no knowledge of the contamination, they would have pretty good defenses,” said defense attorney Kenneth M. Argentieri, a partner at Duane Morris L.L.P. in Pittsburgh. “But obviously it would depend on what the facts are in the individual cases.”


If the physicians “have no reason to believe the medicine they are giving their patients is contaminated, it probably absolves them of liability,” said plaintiff attorney Derek Merman of Houston-based Merman Law Firm P.C.

Grounds on which lawsuits could be filed against medical providers include medical malpractice and product liability.

Defense attorney George R. Talarico, a partner at Edwards, Wildman, Palmer L.L.P. in Madison, N.J., said to meet a strict product liability standard, plaintiffs would have to prove the product was defective, and that the defendant “engaged in the business of selling that product.”

However, most courts have held that physicians and clinics are “not product sellers, that they're providing services,” Mr. Talarico said. It would be even more difficult to establish there was medical negligence, where it must be proved the provider's actions were below the accepted standard of care, he said.

“I think that the plaintiffs may find themselves having a very, very difficult time sustaining any claims” other than those related to the compounding pharmacy, said defense attorney Anne R. Myers, a partner at Kaufman Dolowich Voluck & Gonzo L.L.P. in Blue Bell, Pa. This has been the case in analogous lawsuits, such as those involving tainted blood, she said.

However, defense attorney George F. Indest III, president and managing partner of Altamonte Springs, Fla.-based The Health Law Firm, said there could be a viable cause of action if the physicians knew the compounding pharmacy was not filling prescriptions individually, but distributing the steroid in mass quantities.

“I have to assume, because of the quantities involved, that physicians may very well have known, or should have known, what was going on,” Mr. Indest said.


Anne Andrews, a plaintiffs attorney at Irvine, Calif.-based Andrews & Thornton, said medical providers that received shipment of the steroid reportedly filed prescriptions and other paperwork after the fact. But she also said she “wouldn't want to leap to any conclusions at this point.” There are “some gray areas,” pertaining to the law concerning compounding pharmacies, she said.

David A. Oliver, a partner at Vorys, Sater, Seymour & Pease L.L.P. in Houston, said he would not be surprised to see health care providers charged with simple negligence on the basis they “knew or should have known that such products are often contaminated.”

“It's going to be tough,” the defense attorney said.