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Judge lets plaintiffs' experts inspect site of meningitis outbreak
The National Law Journal
A Boston federal magistrate judge is allowing plaintiffs' experts to conduct "destructive" testing, including inspection of walls and ductwork, at New England Compounding Pharmacy Inc., a company linked to a fungal meningitis outbreak that caused 37 deaths.
In addition, the federal judge running the consolidated docket of District of Massachusetts cases for pretrial purposes, In Re New England Compounding Pharmacy Cases, has remanded two of the cases back to state court.
New England Compounding's injectable steroids from three recalled lots of preservative-free methylprednisolone acetate have been linked to a multistate outbreak of fungal meningitis and other infections. The Centers for Disease Control and Prevention counts 590 cases and 37 deaths associated with the outbreak.
In a Dec. 10 order, U.S. Magistrate Judge Jennifer Boal of the District of Massachusetts granted plaintiff Chad Green's motion to conduct inspections and tests.
In the inspection order, Boal wrote, "Time is of the essence. Several months have passed since the relevant events and the passage of time will only make it more difficult for Green to obtain scientifically valid information."
In arguing for the testing, Green claimed his expert could identify the age of mold, use samples collected on site "to determine whether an area has had a consistent presence of fungal spores and ascertain if the facility complies with pharmaceutical compounding standards."
Boal wrote that Green's proposal to conduct "minimally invasive" testing seems "reasonable, necessary and relevant."
The proposed testing includes "sampling of wall, roof, ceiling and foundational assemblies and cavities, interior mechanical systems, including, but not limited to HVAC systems and its ductwork and plumbing systems," plus sampling of carpet edging and testing of the clean room.
Boal also wrote that the defendants and their expert may attend the inspection, conduct similar tests or take their own samples and have access to the results of Green's tests.
She ordered Green to confer with other plaintiffs, the defendants, and the U.S. government, which is conducting an investigation of allegations about the company. If the parties cannot agree on a protocol, each must file their own proposal by Dec.14.
Boal also established numerous ground rules for Green's inspection and testing.These include a four-day time limit; on-site supervision by the U.S. attorney's office and/or federal law enforcement; no removal of drugs; no access to locked drug vaults; no testing of drugs; and no testing of drugs returned by customers and/or picked up and processed by federal agencies.
Boal also required Green to share the results of the testing with other parties, any federal or state agencies that request them and any future plaintiffs.
The ground rules also call for Green to try to reach agreement with the U.S. government on the scope of the destructive testing.
"We're really happy that the judge has allowed us to do that. We have no alternative way of getting this evidence," said Kim Dougherty, a Boston trial attorney at Janet Jenner & Suggs and one of Green's lawyers on the case. Dougherty said her firm also represents other plaintiffs that have not yet filed lawsuits.
The team will look for water damage and evidence that the HVAC system is bringing mold and spores into the facility, she said.
The inspection "will produce some evidence that is going to be usable in the case even though everyone acknowledges that the conditions of the premises aren't exactly as the way were when the contaminated lots occurred," said Rick Ellis, of Boston's Ellis & Rapacki. Ellis represents George Cary and Robert and Margaret Schroder,
"We are working right now to coordinate with a number of plaintiffs counsel to see if they're interested in participating in the inspection," Ellis said.
On Tuesday, Judge F. Dennis Saylor IV remanded the cases filed by Cary and the Schroders to Massachusetts state court. In both orders, Saylor ruled that the case at hand "does not refer to federal law or any potentially applicable federal regulation or standard."
Ellis said his clients are pleased with Saylor's remand orders. He said that change would avoid delays, while the MDL panel rules on the consolidation motions.
"The plaintiffs here chose their forum, a Massachusetts state court, and this ruling will be cited by many others who also would rather have a state, rather than a federal, forum," Ellis said.
The District of Massachusetts had consolidated 13 cases against New England Compounding and related companies and individuals for pretrial purposes. The individual cases remain active for case filings. On Jan. 31, the judicial panel on multidistrict litigation (MDL) is scheduled to rule on consolidating cases. To date, the MDL docket lists 80 cases, not including the two just remanded.
Other plaintiffs firms in the consolidated case include several Boston firms: Brown Rudnick; Meehan, Boyle, Black & Bogdanow: Parker Scheer; Shapiro Haber & Urmy; Sheff Law Offices; Sugarman, Rogers, Barshak & Cohen; Thornton & Naumes and Kyros Law Offices in Hingham, Mass.
Plaintiffs firms from elsewhere in the country include: Hagens Berman Sobol Shapiro of Seattle; Winer & Bennett of Nashua; and Mark Zamora & Associates of Atlanta.
New England Compounding's lawyers Alan Winchester, a New York partner at Harris Beach of Rochester, N.Y. and Chicago-based Hinshaw & Culbertson did not respond to requests for comment.
The plaintiffs have also sued sister company Ameridose LLC, which closed last month during a government investigation and Medical Sales Management Inc. The cases also name six individual defendants, including Barry Cadden, an owner, president, head pharmacist and director of pharmacy at New England Compounding until recently.
In November, Saylor IV ordered the attachment of $5 million of the company's assets.
Sheri Qualters writes for The National Law Journal, a Daily Report affiliate.