Lawyers want to settle tainted medication suit

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Indiana Lawyer Focus

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

fungal-factbox.gifThe 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.

Contamination found

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.•


  • Paid for tainted shot
    I received one of the tainted steroid shots from OSMC in Elkhart. I had flu like symptoms, didn't suffer horribly like others did. I found it insulting that OSMC didn't refund those who got the NECC tainted steroid for the procedure or the cost of the medicine. That would admit wrongdoing on their part, which I'm sure they would like to avoid until litigation is over. Unfortunate, their are a lot of good people who work there, but someone really dropped the ball on quality control and I haven't heard of any losing their job over this.

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  1. If a class action suit or other manner of retribution is possible, count me in. I have email and voicemail from the man. He colluded with opposing counsel, I am certain. My case was damaged so severely it nearly lost me everything and I am still paying dearly.

  2. There's probably a lot of blame that can be cast around for Indiana Tech's abysmal bar passage rate this last February. The folks who decided that Indiana, a state with roughly 16,000 to 18,000 attorneys, needs a fifth law school need to question the motives that drove their support of this project. Others, who have been "strong supporters" of the law school, should likewise ask themselves why they believe this institution should be supported. Is it because it fills some real need in the state? Or is it, instead, nothing more than a resume builder for those who teach there part-time? And others who make excuses for the students' poor performance, especially those who offer nothing more than conspiracy theories to back up their claims--who are they helping? What evidence do they have to support their posturing? Ultimately, though, like most everything in life, whether one succeeds or fails is entirely within one's own hands. At least one student from Indiana Tech proved this when he/she took and passed the February bar. A second Indiana Tech student proved this when they took the bar in another state and passed. As for the remaining 9 who took the bar and didn't pass (apparently, one of the students successfully appealed his/her original score), it's now up to them (and nobody else) to ensure that they pass on their second attempt. These folks should feel no shame; many currently successful practicing attorneys failed the bar exam on their first try. These same attorneys picked themselves up, dusted themselves off, and got back to the rigorous study needed to ensure they would pass on their second go 'round. This is what the Indiana Tech students who didn't pass the first time need to do. Of course, none of this answers such questions as whether Indiana Tech should be accredited by the ABA, whether the school should keep its doors open, or, most importantly, whether it should have even opened its doors in the first place. Those who promoted the idea of a fifth law school in Indiana need to do a lot of soul-searching regarding their decisions. These same people should never be allowed, again, to have a say about the future of legal education in this state or anywhere else. Indiana already has four law schools. That's probably one more than it really needs. But it's more than enough.

  3. This man Steve Hubbard goes on any online post or forum he can find and tries to push his company. He said court reporters would be obsolete a few years ago, yet here we are. How does he have time to search out every single post about court reporters and even spy in private court reporting forums if his company is so successful???? Dude, get a life. And back to what this post was about, I agree that some national firms cause a huge problem.

  4. rensselaer imdiana is doing same thing to children from the judge to attorney and dfs staff they need to be investigated as well

  5. Sex offenders are victims twice, once when they are molested as kids, and again when they repeat the behavior, you never see money spent on helping them do you. That's why this circle continues