Wall Street Journal
October 23, 2012
The compounding pharmacy at the center of a deadly meningitis outbreak is facing a wave of lawsuits from patients who received steroid injections made by the pharmacy.
At least 10 lawsuits, including one seeking class-action status, have been filed against the New England Compounding Center (NECC) of Framingham, MA. Scores more plaintiffs have retained attorneys to commence litigation.
The scope of the legal threat surrounding the meningitis outbreak is significant. As of Sunday, 23 people had been confirmed dead out of 284 meningitis cases in 16 states. Authorities estimate 14,000 or more patients were exposed to doses from the infected steroid lots, and some recipients of injections who have yet to get a meningitis diagnosis have already filed suit.
“Anyone who got an injection could file a claim,” said attorney Anne Andrews of Andrews & Thornton of Irvine, CA. She predicted that could lead 5,000 patients or more to file suit over the outbreak.
Those cases that are already filed mostly name NECC as sole defendant. The pharmacy produced injectable methylprednisolone tainted with fungus that caused sometimes-lethal meningitis. But lawyers said they expect other defendants will be named soon, including the pain clinics and surgery centers where injections were administered, doctors who gave injections and any suppliers of bulk chemical that constituted the steroid.
An official of the Food and Drug Administration said last week there wasn’t any evidence so far that would implicate suppliers of bulk raw materials. Cosmo Macero, an attorney for NECC, didn’t comment on the litigation. The company isn’t currently operating.
Cases are known to have been filed in Indiana, Michigan, Massachusetts, Virginia, Florida, New Jersey and Minnesota. Some plaintiffs have confirmed meningitis, while others simply allege they suffered “bodily harm, emotional distress and other personal injuries,” as one complaint is worded. The case filed in Massachusetts state court seeks to freeze the assets of NECC and its officers.
At least four plaintiffs already are jockeying for position with other possible future plaintiffs at the Judicial Panel on Multidistrict Litigation in Washington, D.C., which assigns mass tort cases to individual federal district judges.
The four plaintiffs so far are seeking to have the meningitis cases assigned to federal district court in Minneapolis, in large part because of the expertise of judges there in handling past consolidated multidistrict litigation. Those judges in Minnesota have previously handled suits over Medtronic Inc. and Guidant Corp. heart defibrillators and wires, St. Jude Medical Inc. heart valves and a range of drug-liability matters.
In the past, litigation in which hundreds or thousands of cases are consolidated in one court has often resulted in mass settlements of hundreds of millions or billions of dollars. The meningitis cases don’t appear to be of that scope thus far. To date, plaintiffs have said NECC’s insurance coverage is inadequate to cover the extent of the liability.
Macero had no comment, but Hunter J. Shkolnik of the firm Napoli Bern Ripka Shkolnik in New York described the cases against NECC as “run-of-the-mill negligence cases.” But he said if the steroid still is “sitting in doctor's offices and now gets used” after word has gotten out about meningitis, “that’s a classic malpractice case.”
The numbers of deaths and illness are still rising, and many of those who are ill may suffer significant mental and physical deficits even though they survive, doctors said. “There is the likelihood of long-term disability,” said Robert A. Cramer Jr., professor of immunology and microbiology at Dartmouth’s Geisel School of Medicine. “Most of the people perishing are perishing from strokes.”
He said speech, physical and memory impairment are all possible stroke effects of this fungal meningitis. “My guess is there will be significant legal aspects of this case that go on for a long time,” he said.
Wendy R. Fleishman, a New York attorney with the San Francisco firm Lieff Cabraser Heimann & Bernstein, said 33 prospective plaintiffs have approached her firm, among them two instances in which patients died. Melvin Wright, an attorney with Colling Gilbert Wright & Carter in Orlando, FL, said he has 16 clients already.
Another factor that could expand the litigation is that the FDA has said other NECC injectable products—including ophthalmic drugs, cardioplegia for heart surgery and another steroid called triamcinolone—are potentially dangerous and shouldn’t be used. The New England firm has recalled all such products.
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