White Coat Notes

Investigation of deadly meningitis outbreak ‘moving forward’, US attorney says

Federal and state prosecutors said Monday they are making progress in their investigations of last year’s deadly fungal meningitis outbreak traced to a defunct Massachusetts speciality pharmacy, but are not ready to bring criminal charges.

“We are moving forward, but it is a very complex, wide-ranging investigation,” said Carmen Ortiz, the US Attorney General from Massachusetts at a joint press conference in Detroit with Michigan Attorney General Bill Schuette. Ortiz and Schuette announced that they plan to continue sharing information.

At least 64 people were killed and nearly 700 others were sickened in 20 states after receiving pain injections with tainted steroids made by Framingham-based New England Compounding Center, which has since surrendered its license and filed for bankruptcy.

Advertisement—Continue Reading Below

Grand juries in both Boston and Michigan, where 19 of the dead were treated, have been investigating whether there was any criminal wrongdoing.

Federal prosecutors are expected to focus on three potential charges against the pharmacy’s owners or employees: fraud; selling tainted drugs in violation of the federal Food, Drug, and Cosmetic Act; or defrauding the government Medicare or Medicaid health insurance programs. Those crimes carry maximum charges of three to 20 years in prison. Oritz said prosecutors are particularly looking at the fraud statute.

Meanwhile, the Michigan grand jury is expected to focus on whether the pharmacy broke any state laws by distributing tainted drugs to health care facilities in Michigan, which accounted for one-third of all the infections nationwide from the outbreak, more than any other state.

“Michigan is ground zero in this health emergency,” said Schuette. Though the grand jury’s six-month term is expiring, Schuette could petition a judge to reconvene the grand jury later as more evidence emerges.

To help speed their respective investigations, Schuette and Ortiz also pledged Monday to continue to work together and share information, something state and federal agencies often do for major cases.

“We have evidence, they have evidence,” Schuette said. “Two punches are better than one.”

Both officials said they couldn’t talk about what they have uncovered so far because of the secrecy rules surrounding grand jury proceedings, but Ortiz said investigators have executed search warrants, reviewed voluminous documents, and talked to “many, many” potential witnesses.

Federal investigators are also reaching out to victims to aid the investigation. The FBI has urged anyone who received an injection of 80 milligrams of preservative-free methylprednisolone acetate at selected facilities between May 1, 2012, and Oct. 15, 2012, to fill out a questionnaire by the end of this month. (Family members can fill out the form on behalf of relatives.)

State and federal regulators have already made damaging information about the pharmacy public.

After the outbreak a year ago, inspectors quickly found contamination in numerous vials made by the company. They also discovered evidence that the firm knew its clean room, where injectable products were mixed and supposed to be kept sterile, was dirty, and that it performed insufficient testing before shipping the drug to clinics.

In addition, state regulators have accused the company of shipping drugs in bulk without individual prescriptions for each patient—acting more like a manufacturer than a pharmacy — in violation of its Massachusetts pharmacy license.

Barry Cadden, the company’s main pharmacist and co-founder, declined to answer questions at a Congressional hearing last year, invoking his Fifth Amendment right to avoid incriminating himself. And a company spokesman declined comment Monday on the possibility of criminal charges.

Meanwhile, thousands of people who received the flawed injections are still waiting for compensation.

US Bankruptcy Court Judge Henry J. Boroff recently gave victims until Jan. 15 to file a claim, while a trustee has been negotiating with the pharmacy owners and sister companies to contribute money to a fund to aid victims.

In addition, plaintiffs attorneys in US District Court in Boston are trying to round up additional funds for victims from anyone else who could potentially share blame—from hospitals that administered the shots to companies that designed and maintained the pharmacy’s clean room.

The case has also inspired federal legislation designed to help prevent future deadly outbreaks by compounding pharmacies, which custom-make medications for individuals who need speciality drugs not available elsewhere, though critics complained it did not go far enough. The Senate passed the bill, known as the Drug Quality and Security Act, last week, sending it on to the White House for President Obama’s signature. Obama is expected to sign it into law.

Share