Expert witness admits to errors in Digitek case


CHARLESTON – David Bliesner, expert witness for a wrongful death trial against drug maker Actavis, admitted under oath that he signed a declaration full of errors under oath. "I don't think that there's any correlation between errors in a report and the overall conclusion in the end," he said at a deposition on Sept. 19. Bliesner works for Delphi Analytical Services in Indian Rocks Beach, Fla. The company's website says it offers "regulatory compliance products, services and instruction for the pharmaceutical and medical device industries. He bristled when a lawyer asked about his attention to detail and reliability. "Because there's errors in the written document after a review of various other documents that are all thrown together and handed out in piecemeal fashion and say that's because somebody has got poor analytical skills, that's just a total stretch and I won't stand for that," Bliesner said. Actavis filed a transcript with U.S. District Judge Joseph Goodwin on Sept. 27, as he prepared for trial on a claim that heart medicine Digitek killed Daniel McCornack of California. Goodwin, who presided over settlement of about 3,000 Digitek suits from many federal courts, now presides over the McCornack case and another that didn't settle. The McCornack family's lawyer, Don Ernst of San Luis Obispo, Calif., filed Bliesner's declaration under seal on Aug. 25. Actavis lawyer Richard Dean of Cleveland moved to strike it on Sept. 8, branding it as a sham affidavit and an improper supplement to Bliesner's expert report. Actavis then deposed Bliesner, in Florida, not for the McCornack case but for a suit in Oklahoma state court. Actavis lawyer Michael Anderton of Cleveland read a bullet point from the declaration confirming two batches of Digitek tablets with assays out of specification. Bliesner said, "That's an incorrect statement." Anderton said, "This is sworn testimony?" Bliesner said, "It is." Anderton read a bullet point about blend uniformity defects and asked if he told them it was defective. Bliesner said, "Did I tell them that what was defective?" Anderton said, "Plaintiff's lawyers in the MDL, that the standard deviation was a blend uniformity defect?" Bliesner said, "Not that I recall specifically." Anderton said, "But you signed sworn testimony indicating that it was." Bliesner said, "It's an error." Anderton asked if his indication that Actavis employed Dan Bitler continuously in charge of quality from 1995 to 2008 was another error. Bliesner said, "It's a typographical error, yes." Anderton said, "It's not a typographical error." He said, "You rely on the notion that Mr. Bitler was there for that extended period of time as part of the basis for your conclusion that Actavis's leadership somehow had something to do with their quality systems being deficient?" Bliesner said, "He was QA director in 2004, and we had the pharmacist complaint in 2004." Anderton said, "Where you say product was released to market on 5 December, 2007, that's not correct, is it?" Bliesner said, "It's an incorrect date." Anderton said, "On page four, where plaintiff's counsel in the MDL was kind enough to make that even stronger for you, it says, following a rapidly conducted visual inspection, the product is released to market on December 5, 2007." He said, "That's not correct, is it?" Bliesner said, "It is not." Anderton said, "How do you make a mistake like that, Dr. Bliesner?" Bliesner said, "When you're reviewing thousands and thousands and thousands of documents that have pages of documents that have no lineage or connection to it, it's very easy to get a date messed up." He said, "And then the basis for the report, errors are propagated and go into a summary like this." Anderton asked if counsel in the multi district litigation prepared the declaration. Bliesner said, "They didn't prepare it for me. We worked on it together." Anderton said, "So you're validating it?" Bliesner said, "No, it was a teleconference with my input as I said earlier." Anderton asked if he told them to include blending defects in the bullet point, and Bliesner said he didn't recall. Anderton said, "But you signed it with that language in there?" Bliesner said, "Yes I did." Anderton told him he said in sworn testimony that from March to May of 2008, the Food and Drug Administration inspected Actavis facilities due to significant deficiencies in prevention and remediation of double thick tablets and blending failures. Anderton said, "That is not why the FDA conducted that inspection, is it?" Bliesner said, "It's clearly not." Anderton said, "But you say due to significant -." Bliesner said, "It's an incorrect statement." He said, "As we talked about very early on in the deposition, I pointed out that I knew there were errors in this report." Anderton said, "At what point do the conclusions in your report crumble for the inaccurate data points?" Bliesner said, "Each of these data points has nothing to do with the accuracy and the overall conclusion of the report." He said, "There's a lack of compliance across the board from the beginning." He said, "There's been a continuous lack and failure of quality systems for many, many years." He said, "The fact that I have individual errors within a report or a declaration doesn't change those facts at all, not at all." He said, "Product that was out of specification, thick, thin or whatever, has made it to the market from very early on, probably as early as 2000 or something, all the way up to the last batch that was made and shipped out." He said, "I don't think you can argue with that, with the data, so to characterize errors within a single document that was done substantially after the original document was made that actually, in the grand scheme of things, if you look at it, has very few, is a total mischaracterization." Anderton said, "It says nothing about you attention to detail and reliability of your overall conclusion?" Bliesner said, "No, and I don't appreciate you characterizing me as having a lack of detail, or attention to detail." Anderton said his declaration indicated that after a recall of Digitek, Actavis didn't test or do anything to determine the magnitude of its manufacturing problem. Anderton said his declaration indicated they stored the recalled product in a warehouse and kept producing Digitek. Anderton said, "Did you sign that declaration with that statement in it?" Bliesner said, "I did." Anderton said, "They didn't make any other Digitek after the recall, did they?" Bliesner said, "They did not." He said, "That was my understanding, that they continued to produce. It's an error." Dean provided a transcript to Goodwin as highly relevant new evidence. "Dr. Bliesner's new testimony confirms his declaration is a sham affidavit," he wrote. "None of this testimony was in Dr. Bliesner's report; it was all drafted by plaintiffs' counsel and, unfortunately, validated by Dr. Bliesner in his lawyer prepared declaration," he wrote. "Dr. Bliesner now confirms it is all incorrect," he wrote.

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