CHARLESTON – No one who claimed drug maker Actavis produced double thick pills of heart medicine Digitek brought such a pill to court, but a nurse swears she saw one.
On Aug. 25, Lynne Farrell signed an affidavit describing her discovery at Golden Living Center in Gloucester, Mass., on April 30, 2008.
"I personally saw and handled a card containing four remaining tablets of digoxin, and in the course of doing so, I noticed that one of the tablets in the card was double thick," she wrote.
She wrote that she immediately reported the finding to the nursing director of the center and the pharmacy director of her employer, GGNSC Clinical Services.
"The card containing the four remaining tablets was removed from the medication cart and placed in Golden Living Center-Gloucester's medication room pending further instructions from PharMerica, Golden Living Center-Gloucester's pharmacy services vendor, as to whether it should be returned to them," she wrote.
Lawyer Don Ernst of San Luis Obispo, Calif., submitted the affidavit in wrongful death suits for families of Mimi Rivera-Vega and Daniel McCornack.
The families opted out of a $10 million national settlement that U.S. District Judge Joseph Goodwin approved for about 3,000 plaintiffs last year.
The litigation fizzled largely because no one established that a single double thick pill ever reached the market.
In the cases of the families who opted out, Actavis moved for summary judgment.
Ernst submitted Farrell's affidavit after Actavis asked Goodwin to exclude electronic mail about her discovery from evidence.
Actavis challenges the e-mail as hearsay and unreliable expert testimony.
Ernst wrote, "Certainly an expert is not required to say one thing looks bigger than another."
He wrote that experts reviewed and relied on the e-mail.
"An expert is given leeway to rely on hearsay," he wrote. "This is a report of a potentially fatal defective tablet being reported by a medical professional in her capacity as a caregiver."
He filed responses to summary judgment and other motions under seal, with a blanket motion to keep them under seal.
Goodwin rejected his approach on Aug. 29.
"The request impinges on the right of public access to the docket," he wrote. "Little care was taken in seeking the sealing order."
He wrote that some of the documents were previously filed on the public record. He said Ernst sealed public documents such as a recall notice and a consent decree between Actavis and the United States.
"In light of the serious public access issues presented here, plaintiffs' approach is inexplicable," he wrote. "The public has a right to know what I considered in reaching a decision."
For each document, he directed Ernst and Actavis to remove the confidential marking, create a mutually acceptable redacted version, or find a method to avoid disclosure of confidential information during testimony.
"If there remains some small number of documents after those consultations where agreement cannot be reached, the sealing proponents must explain to me in detail, chapter and verse, why sealing or redaction is authorized by the First Amendment," he wrote. "They must do so no later than September 6."