The product-liability litigation arising from the outbreak of fungal meningitis across the United States that infected nearly 100 Hoosiers has become mixed with a bankruptcy, a possible criminal investigation and a desire by plaintiff attorneys to reach a settlement soon so their clients can get restitution.
On Nov. 5, the plaintiffs’ attorneys filed a master complaint in U.S. District Court, District of Massachusetts which listed the unaffiliated defendants, including the specific clinics where tainted steroids were administered.
The individual product-liability claims for personal injury and wrongful death filed across the United States were consolidated into a multidistrict litigation in February 2013 for pretrial proceedings. If the parties do not agree on settlement terms, the cases will return for trial to the federal courts in each state where a claim was filed.
Price Waicukauski & Riley LLC in Indianapolis and Foley & Small in South Bend are co-chairs of the multidistrict litigation in Indiana.
Neither the New England Compounding Center, which has been identified as the source of the tainted methylprednisolone acetate, nor its owners were listed as defendants in the master complaint. The Massachusetts-based company filed for Chapter 11 bankruptcy in December 2012 and all liability claims against them are currently being handled through the bankruptcy court.
Currently, the plaintiffs’ steering committee is trying to get the clinics to agree to mediation, according to Jamie Kendall, attorney at Price Waicukauski & Riley. The hope is the master complaint naming the clinics will spur the defendants to the negotiation table.
“We want to get this litigation wrapped up as quickly as possible,” Kendall said, explaining since bankruptcy indicates NECC has few resources, the attorneys want to have the available money go to their clients. “Everyone involved wants to get this done as soon as possible so no more funds go to handling the litigation.”
Clients have suffered since they were infected with fungal meningitis, Kendall said. They were miserably sick which led to “outrageous medical bills” and lost income. One client has to learn to walk again after being in a coma.
These people, Kendall said, walked into a doctor’s office with a backache and their whole lives changed.
At the clinics
The first case of fungal meningitis reported to the Centers for Disease Control and Prevention came from Tennessee in September 2012. There, a patient had developed the infection after being injected with an epidural steroid.
Fungal meningitis infects the protective membranes covering the brain and spinal cord. Usually the fungus is spread through the blood of the spinal cord. The CDC stated that many patients with fungal meningitis experience only mild symptoms such as a headache, fever and nausea.
Quickly the outbreak spread, eventually engulfing 20 states and putting an estimated 13,500 patients at risk, according to the CDC. To date, 751 patients in the United States have contracted fungal meningitis and 64 have died as a result.
Indiana has the third-highest number of cases and deaths at 93 and 11, respectively. Michigan leads with 264 cases and 19 deaths while Tennessee is second with 153 cases and 16 deaths.
Six clinics in the Hoosier state have been identified by the CDC as having received the recalled lots of the contaminated medicine.
OSMC Outpatient Surgery Center in Elkhart logged the largest use of the product of any health care facility in Indiana, according to Foley & Small attorney Doug Small. The attorney identified in court documents as representing OSMC in the litigation did not respond to a phone call seeking comment.
According to Small, the plaintiffs are arguing the clinics should have known there were problems at the compounding pharmacy because of the bulk shipments they were receiving.
Typically, compounding pharmacies prepare the medication especially for individual patients. OSMC and The South Bend Clinic, Small said, received 100 vials of the steroid, far more than needed for the number of patients they had listed on the order form. Patients are recommended to receive no more than two or three epidural injections each year.
There is no evidence, Small said, that anyone at the clinics believed they had a badly contaminated product. Also, there’s no contention of malpractice in administering the shots.
Yet, the clinics should have suspected that something was wrong because they were getting far more product than they were able to use, Small continued. The contention is the clinics should have known NECC was not operating as a legitimate compounding pharmacy and done their due diligence.
Large amounts of the steroid were shipped to Indiana and used, which does raise eyebrows, Kendall said. But there is no explanation as to why so much of the product came here.
The master complaint’s allegations against the clinics include negligence, battery, failure to warn and wrongful death.
Ordinarily, pharmaceutical suits revolve around allegations that the manufacturer failed to provide adequate warnings of side effects. The question is whether the company knew or should have known the drug would cause health problems.
Andy Campbell, partner at Faegre Baker Daniels LLP, has defended drug companies in litigation. These cases involving an allegation of an inadequate warning can be complex and bring a parade of experts into the courtroom to prove – and disprove – causation.
The fungal meningitis complaint is different because the charge is the medication was contaminated. This may affect how the case is litigated, Campbell said, since the dispute could be more about a manufacturer-defect issue rather than a failure to warn.
An investigation of NECC by the U.S. Food and Drug Administration and the Massachusetts Department of Public Health found visible contaminants in the drug products and noted the clean rooms were not appropriately sealed to prevent contaminants from infiltrating.
NECC surrendered its pharmacy license and recalled its products in October 2012.
The master complaint noted the U.S. Department of Justice and the Commonwealth of Massachusetts are pursuing criminal investigations. Kendall said the FBI has recently asked to talk with all her plaintiffs.
In addition to restitution for her clients, Kendall would like the litigation to bring better regulation and oversight to compounding pharmacies. The master complaint referred to reports dating back to 2002 from the CDC and the FDA raising concerns about contamination and risks.
Despite their stories of struggles with fungal meningitis, plaintiffs would not be assured success if these cases do go to trial. The knee-jerk reaction is that juries would be more sympathetic to the injured party than to the pharmaceutical company, Campbell said, but that is not always so.
“I think juries, at least in my experience, are very thoughtful in these cases,” Campbell said.•