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Tainted steroid lawsuit on hold

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A Columbus woman’s lawsuit alleging she became ill from tainted steroid injections made by the New England Compounding Center is on partial hold in federal court in Indianapolis after the pharmacy filed for bankruptcy protection in Boston last month.

The complex case involving 47-year-old Natalie S. Copass is among an estimated 180 similar lawsuits nationwide that seek damages linked to a massive fungal meningitis outbreak last fall that the U.S. Centers for Disease Control and Prevention has linked to 40 deaths, including seven in Indiana.

New England Compounding Center of Framingham, Mass., sought Chapter 11 bankruptcy protection four days before Christmas, and a notice of stay was filed in the Copass case two days after the holiday, federal court records in Indianapolis show.

Copass’ attorneys still could try to advance their case against four other co-defendants, including two NECC directors individually, drug distributor Alaunus Pharmaceutical of Framingham, and drug repackaging company Ameridose LLC of Westborough, Mass., both of which worked closely with the New England Compounding Center.

Three of those defendants, Alaunus and the two pharmacy company directors, have asked the court to give them until Feb. 13 to respond to the lawsuit. Ameridose filed a response in court last month, saying it didn’t make any of the products in question and has no liability.

At the time of her initial lawsuit in mid-October, Copass’ attorneys said the woman had not been diagnosed with fungal meningitis but was showing symptoms of it.

Her lawyers did not return numerous phone calls over the past week, seeking an update on Copass’ current medical situation.

Their lawsuit says the woman, a factory worker and mother of two grown children, received a total of three steroid shots for back pain at a Columbus health clinic, Wellspring Pain Solutions, in July and August 2012. She later had intermittent headaches, blurred vision and discomfort when lowering her chin to her chest, the suit says.

Wellspring Pain Solutions was one of six clinics in Indiana known to have received shipments of tainted steroids last year.

The suit contends the defendants, including NECC, were negligent by not warning Copass about tainted drug dosages and the danger of contracting fungal meningitis, which can cause brain damage and death.

The three states most affected by last year’s meningitis outbreak were Michigan, with 234 infections and 11 deaths; Tennessee with 140 meningitis-related cases and 14 deaths; and Indiana with 70 reported cases and seven deaths, data released by the CDC show.

The Copass case started in October in Bartholomew County Superior Court, but it was transferred to U.S. District Court in Indianapolis after the pharmacy company’s attorneys pushed for that.

Attorney Dina Cox, representing New England Compounding Center, argued in county court that all the defendants in the Copass case were Massachusetts corporations or residents, and that a federal court was the only venue with enough perspective to wade through conflicting state and federal rules, Food and Drug Administration standards and conflicting case law to decide issues related to compounding pharmacies such as NECC.

Compounding pharmacies alter, mix and combine ingredients to create medications tailored to patients’ specialized needs, but they aren’t in the business of manufacturing “new” drugs as a major pharmaceutical firm might do, the industry argues.

Plaintiffs’ attorneys contend that definition has led to a hodgepodge of state rules and a general lack of oversight or health inspections to protect patients.

When New England Compounding Center filed Chapter 11 bankruptcy on Dec. 21, attorneys for the company said a bankruptcy case would allow the company to establish a fund to compensate people harmed by the 2012 meningitis outbreak in a quicker, fairer way than through dozens of lawsuits fought in separate federal or state courts.

But some plaintiffs’ attorneys have argued that the sheer volume of lawsuits against New England Compounding Center, coupled with its bankruptcy, will make it difficult for victims and their families to collect adequate damages if the pharmacy’s assets are liquidated to pay debts.

Last year, health investigators said patients around the country were injected with 14,000 epidural steroid treatments, leading to 664 people getting meningitis and related fungal infections. Florida, Maryland, New Jersey and Virginia were other states with 25 or more confirmed cases, CDC data show.

New England Compounding Center ended up recalling 17,000 vials of contaminated steroid injections, and shortly after that it shut down pharmacy operations.

More recently, some attorneys representing victims have started pursuing claims against individual owners and executives of New England Compounding Center, including several of its board members.

The Copass suit includes as co-defendants NECC company directors Gregory Conigliaro and Barry J. Cadden, for example.

Apart from the NECC bankruptcy, a federal panel already was considering consolidating the vast number of lawsuits against the pharmacy company into a single federal court district as allowed by special multistate litigation rules.

That possibility arose in a case against NECC in Florida, and a hearing was set to decide the issue late this month.

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