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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. Applause, applause, applause ..... but, is this duty to serve the constitutional order not much more incumbent upon the State, whose only aim is to be pure and unadulterated justice, than defense counsel, who is also charged with gaining a result for a client? I agree both are responsible, but it seems to me that the government attorneys bear a burden much heavier than defense counsel .... "“I note, much as we did in Mechling v. State, 16 N.E.3d 1015 (Ind. Ct. App. 2014), trans. denied, that the attorneys representing the State and the defendant are both officers of the court and have a responsibility to correct any obvious errors at the time they are committed."

  2. Do I have to hire an attorney to get co-guardianship of my brother? My father has guardianship and my older sister was his co-guardian until this Dec 2014 when she passed and my father was me to go on as the co-guardian, but funds are limit and we need to get this process taken care of quickly as our fathers health isn't the greatest. So please advise me if there is anyway to do this our self or if it requires a lawyer? Thank you

  3. I have been on this program while on parole from 2011-2013. No person should be forced mentally to share private details of their personal life with total strangers. Also giving permission for a mental therapist to report to your parole agent that your not participating in group therapy because you don't have the financial mean to be in the group therapy. I was personally singled out and sent back three times for not having money and also sent back within the six month when you aren't to be sent according to state law. I will work to het this INSOMM's removed from this state. I also had twelve or thirteen parole agents with a fifteen month period. Thanks for your time.

  4. Our nation produces very few jurists of the caliber of Justice DOUGLAS and his peers these days. Here is that great civil libertarian, who recognized government as both a blessing and, when corrupted by ideological interests, a curse: "Once the investigator has only the conscience of government as a guide, the conscience can become ‘ravenous,’ as Cromwell, bent on destroying Thomas More, said in Bolt, A Man For All Seasons (1960), p. 120. The First Amendment mirrors many episodes where men, harried and harassed by government, sought refuge in their conscience, as these lines of Thomas More show: ‘MORE: And when we stand before God, and you are sent to Paradise for doing according to your conscience, *575 and I am damned for not doing according to mine, will you come with me, for fellowship? ‘CRANMER: So those of us whose names are there are damned, Sir Thomas? ‘MORE: I don't know, Your Grace. I have no window to look into another man's conscience. I condemn no one. ‘CRANMER: Then the matter is capable of question? ‘MORE: Certainly. ‘CRANMER: But that you owe obedience to your King is not capable of question. So weigh a doubt against a certainty—and sign. ‘MORE: Some men think the Earth is round, others think it flat; it is a matter capable of question. But if it is flat, will the King's command make it round? And if it is round, will the King's command flatten it? No, I will not sign.’ Id., pp. 132—133. DOUGLAS THEN WROTE: Where government is the Big Brother,11 privacy gives way to surveillance. **909 But our commitment is otherwise. *576 By the First Amendment we have staked our security on freedom to promote a multiplicity of ideas, to associate at will with kindred spirits, and to defy governmental intrusion into these precincts" Gibson v. Florida Legislative Investigation Comm., 372 U.S. 539, 574-76, 83 S. Ct. 889, 908-09, 9 L. Ed. 2d 929 (1963) Mr. Justice DOUGLAS, concurring. I write: Happy Memorial Day to all -- God please bless our fallen who lived and died to preserve constitutional governance in our wonderful series of Republics. And God open the eyes of those government officials who denounce the constitutions of these Republics by arbitrary actions arising out capricious motives.

  5. From back in the day before secularism got a stranglehold on Hoosier jurists comes this great excerpt via Indiana federal court judge Allan Sharp, dedicated to those many Indiana government attorneys (with whom I have dealt) who count the law as a mere tool, an optional tool that is not to be used when political correctness compels a more acceptable result than merely following the path that the law directs: ALLEN SHARP, District Judge. I. In a scene following a visit by Henry VIII to the home of Sir Thomas More, playwriter Robert Bolt puts the following words into the mouths of his characters: Margaret: Father, that man's bad. MORE: There is no law against that. ROPER: There is! God's law! MORE: Then God can arrest him. ROPER: Sophistication upon sophistication! MORE: No, sheer simplicity. The law, Roper, the law. I know what's legal not what's right. And I'll stick to what's legal. ROPER: Then you set man's law above God's! MORE: No, far below; but let me draw your attention to a fact I'm not God. The currents and eddies of right and wrong, which you find such plain sailing, I can't navigate. I'm no voyager. But in the thickets of law, oh, there I'm a forester. I doubt if there's a man alive who could follow me there, thank God... ALICE: (Exasperated, pointing after Rich) While you talk, he's gone! MORE: And go he should, if he was the Devil himself, until he broke the law! ROPER: So now you'd give the Devil benefit of law! MORE: Yes. What would you do? Cut a great road through the law to get after the Devil? ROPER: I'd cut down every law in England to do that! MORE: (Roused and excited) Oh? (Advances on Roper) And when the last law was down, and the Devil turned round on you where would you hide, Roper, the laws being flat? (He leaves *1257 him) This country's planted thick with laws from coast to coast man's laws, not God's and if you cut them down and you're just the man to do it d'you really think you would stand upright in the winds that would blow then? (Quietly) Yes, I'd give the Devil benefit of law, for my own safety's sake. ROPER: I have long suspected this; this is the golden calf; the law's your god. MORE: (Wearily) Oh, Roper, you're a fool, God's my god... (Rather bitterly) But I find him rather too (Very bitterly) subtle... I don't know where he is nor what he wants. ROPER: My God wants service, to the end and unremitting; nothing else! MORE: (Dryly) Are you sure that's God! He sounds like Moloch. But indeed it may be God And whoever hunts for me, Roper, God or Devil, will find me hiding in the thickets of the law! And I'll hide my daughter with me! Not hoist her up the mainmast of your seagoing principles! They put about too nimbly! (Exit More. They all look after him). Pgs. 65-67, A MAN FOR ALL SEASONS A Play in Two Acts, Robert Bolt, Random House, New York, 1960. Linley E. Pearson, Atty. Gen. of Indiana, Indianapolis, for defendants. Childs v. Duckworth, 509 F. Supp. 1254, 1256 (N.D. Ind. 1981) aff'd, 705 F.2d 915 (7th Cir. 1983)

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