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Lawyers want to settle tainted medication suit

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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.•

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  1. I like the concept. Seems like a good idea and really inexpensive to manage.

  2. I don't agree that this is an extreme case. There are more of these people than you realize - people that are vindictive and/or with psychological issues have clogged the system with baseless suits that are costly to the defendant and to taxpayers. Restricting repeat offenders from further abusing the system is not akin to restricting their freedon, but to protecting their victims, and the court system, from allowing them unfettered access. From the Supreme Court opinion "he has burdened the opposing party and the courts of this state at every level with massive, confusing, disorganized, defective, repetitive, and often meritless filings."

  3. So, if you cry wolf one too many times courts may "restrict" your ability to pursue legal action? Also, why is document production equated with wealth? Anyone can "produce probably tens of thousands of pages of filings" if they have a public library card. I understand this is an extreme case, but our Supreme Court really got this one wrong.

  4. He called our nation a nation of cowards because we didn't want to talk about race. That was a cheap shot coming from the top cop. The man who decides who gets the federal government indicts. Wow. Not a gentleman if that is the measure. More importantly, this insult delivered as we all understand, to white people-- without him or anybody needing to explain that is precisely what he meant-- but this is an insult to timid white persons who fear the government and don't want to say anything about race for fear of being accused a racist. With all the legal heat that can come down on somebody if they say something which can be construed by a prosecutor like Mr Holder as racist, is it any wonder white people-- that's who he meant obviously-- is there any surprise that white people don't want to talk about race? And as lawyers we have even less freedom lest our remarks be considered violations of the rules. Mr Holder also demonstrated his bias by publically visiting with the family of the young man who was killed by a police offering in the line of duty, which was a very strong indicator of bias agains the offer who is under investigation, and was a failure to lead properly by letting his investigators do their job without him predetermining the proper outcome. He also has potentially biased the jury pool. All in all this worsens race relations by feeding into the perception shared by whites as well as blacks that justice will not be impartial. I will say this much, I do not blame Obama for all of HOlder's missteps. Obama has done a lot of things to stay above the fray and try and be a leader for all Americans. Maybe he should have reigned Holder in some but Obama's got his hands full with other problelms. Oh did I mention HOlder is a bank crony who will probably get a job in a silkstocking law firm working for millions of bucks a year defending bankers whom he didn't have the integrity or courage to hold to account for their acts of fraud on the United States, other financial institutions, and the people. His tenure will be regarded by history as a failure of leadership at one of the most important jobs in our nation. Finally and most importantly besides him insulting the public and letting off the big financial cheats, he has been at the forefront of over-prosecuting the secrecy laws to punish whistleblowers and chill free speech. What has Holder done to vindicate the rights of privacy of the American public against the illegal snooping of the NSA? He could have charged NSA personnel with violations of law for their warrantless wiretapping which has been done millions of times and instead he did not persecute a single soul. That is a defalcation of historical proportions and it signals to the public that the government DOJ under him was not willing to do a damn thing to protect the public against the rapid growth of the illegal surveillance state. Who else could have done this? Nobody. And for that omission Obama deserves the blame too. Here were are sliding into a police state and Eric Holder made it go all the faster.

  5. JOE CLAYPOOL candidate for Superior Court in Harrison County - Indiana This candidate is misleading voters to think he is a Judge by putting Elect Judge Joe Claypool on his campaign literature. paragraphs 2 and 9 below clearly indicate this injustice to voting public to gain employment. What can we do? Indiana Code - Section 35-43-5-3: Deception (a) A person who: (1) being an officer, manager, or other person participating in the direction of a credit institution, knowingly or intentionally receives or permits the receipt of a deposit or other investment, knowing that the institution is insolvent; (2) knowingly or intentionally makes a false or misleading written statement with intent to obtain property, employment, or an educational opportunity; (3) misapplies entrusted property, property of a governmental entity, or property of a credit institution in a manner that the person knows is unlawful or that the person knows involves substantial risk of loss or detriment to either the owner of the property or to a person for whose benefit the property was entrusted; (4) knowingly or intentionally, in the regular course of business, either: (A) uses or possesses for use a false weight or measure or other device for falsely determining or recording the quality or quantity of any commodity; or (B) sells, offers, or displays for sale or delivers less than the represented quality or quantity of any commodity; (5) with intent to defraud another person furnishing electricity, gas, water, telecommunication, or any other utility service, avoids a lawful charge for that service by scheme or device or by tampering with facilities or equipment of the person furnishing the service; (6) with intent to defraud, misrepresents the identity of the person or another person or the identity or quality of property; (7) with intent to defraud an owner of a coin machine, deposits a slug in that machine; (8) with intent to enable the person or another person to deposit a slug in a coin machine, makes, possesses, or disposes of a slug; (9) disseminates to the public an advertisement that the person knows is false, misleading, or deceptive, with intent to promote the purchase or sale of property or the acceptance of employment;

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