Jury says doctors not at fault for using tainted steroids

By Douglas Levy
The Daily Record Newswire
Three years after an outbreak of fungal meningitis was traced to contaminated steroid injections, the first U.S. class-action jury trial to target a medical practice that exposed its patients via the injections resulted in a no-cause verdict.

The nine-day trial was heard in Grand Traverse County Circuit Court. It concerned approximately 170 Michigan residents who were given a preservative-free steroid compound manufactured by Massachusetts-based New England Compounding Center.

NECC in 2012 produced tainted batches of the compound, which killed 64 people and sickened more than 800 people nationwide.

Timothy J. Dardas, co-counsel for the defendants, said the defense’s theme was that the doctors exercised reasonable reliance and trust with NECC.

He said that the doctors had a right to rely on already existing safeguards as well as common sense when selecting, ordering and administering medications to their patients.

“I think the jury understood that,” said Dardas of Hackney, Grover, Hoover, & Bean PLC in East Lansing. “The burden that plaintiff tried to foist was an unreasonable one just by its very nature. These physicians aren’t there to be regulators or second guessers of every product that comes into their office.”

The plaintiffs’ class had sought to try the case as a general liability/ordinary negligence claim, arguing that the issue was a matter of law and not a question of fact.

The class argued that, by law, doctors can only buy from a licensed manufacturer. Because NECC was not a licensed manufacturer, the class contended that the defendant doctors could not buy large quantities of drugs from it as though it were licensed FDA-approved manufacturers.

But Judge Thomas G. Power ruled that defendants’ decision and method to buy from NECC was a question of medical judgment, rendering it a medical-malpractice case.

Dardas said the biggest obstacles in the case were volume and logistics: how to try a case with this many claimants in an efficient way without shutting down the doctors’ practice. He added that a class action in a med-mal context is unusual.

“At the time we turned this into a class action, we had no idea ultimately what the number of claimants would even be,” said Dardas, who tried the case with Foley, Baron, Metzger, & Juip PLLC attorneys Randall A. Juip and Kim J. Sveska.

“There were three specific lots that were contaminated; from that time to the time of the recall in September 2012 was basically a three-month window, so at least in theory there were a potential of three months’ worth of patients exposed, and a large number at that.”

The injuries ranged from economic damages such as lost wages for testing and CT scans, to death. No one in the Michigan class developed meningitis.

At least five lawsuits had been filed in Michigan, but the claimants also were part of a multidistrict litigation against NECC and affiliated parties, including a research laboratory that had reported the steroids as sterile and the company who built and cleaned the room where NECC manufactured the steroids. At the same time, NECC was undergoing bankruptcy proceedings.

With several different requirements and deadlines to juggle, Dardas said the class decided to exit the MDL and have all of its claims tried in Michigan so that the litigation could be streamlined. (The plaintiffs will still receive a portion of a $210 million fund created by the Federal Bankruptcy Court and the Judicial Panel on Multidistrict Litigation.)

That meant counsel had to meticulously and methodically organize data and details, as each lawsuit had its own world of discovery, depositions and medical records, along with NECC and MDL documents.

“There was so much in this. A tremendous amount of paper and data,” Dardas said.

Once trial commenced, Dardas said the defendants’ medical experts did “a wonderful job” of explaining why the doctors chose NECC’s preservative-free steroid methylprednisolone acetate (pf MPA), which was the only medicine the doctors bought from NECC.

“They picked it because they thought it was a better medicine, as it was preservative-free and would help avoid the risk of exposure to neurotoxicity for that group of patients who were getting fluoroscopically guided injections,” Dardas said.

The plaintiffs, who sought $45 million, asserted that the doctors didn’t take enough steps to make sure it was safe. But the defense told the jury that the doctors had been using the steroids for eight years without a single adverse event.

In addition, Dardas said, every order that the doctors ordered arrived with a certificate from a microbiology lab indicating the steroids were sterile — showing that the doctors had reasonable reliance.

“They didn’t know or have a reason to know that one day NECC would [release] three bad batches of medicines,” he said.

He added that once the recall was announced, the doctors immediately stopped using the steroids and sequestered and quarantined the remaining injections.

Dardas said that one of defendants’ experts, who practices physical medicine and rehabilitation, told the jury, in easy-to-understand terms, what a PMR physician’s
duty entails in selecting and administering steroids.

“[The doctor should] address the patient’s complaints of pain with a reasonable medication, for which pf MPA was, and to do the steroid injections in the manner they did, and it was a reasonable supplier with reasonable assurances of sterility,” Dardas said. “What the doctors did made sense and was within in the four corners of the standard of care.

“It was the simplicity of it in the face of, I think, plaintiffs’ incredible theory that doctors have a creative duty to go beyond being doctors and crown them to be regulators and investigators of their suppliers. It was a very clear theory for the jury to follow.”

The jury deliberated for less than three hours before determining that the defendants were not negligent.

Robert B. Sickels of Sommers Schwartz PC, one of five attorneys representing the plaintiffs’ class, said plaintiffs filed a motion for a new trial. The motion will be heard in February.

“The trial was about issues that should not have been tried,” he said. “The facts regarding the procurement of the drug were not contested. [Defendants] were obligated by regulations in law to use prescriptions. They didn’t do it. They were prohibited from buying large quantities of drugs from a compounding pharmacy. And NECC didn’t have a manufacturer’s license in the state of Michigan. That’s not an issue of fact; it’s a matter of law.”

Sickels said he does not believe the outcome in this trial has any implications for any case against other clinics that bought from NECC, as other states have different laws. For example, he said Tennessee has a claim that the matter falls under products liability.

“I would hope the real issues are actually tried in the other jurisdictions — that is, whether it was lawful to buy from NECC under the circumstances,” he said.