Drug & Device News

And even though the defendants could not prove that the e-mails contained relevant information, the court was not deterred: “To shift the burden to the innocent party to describe or produce what has been lost as a result of the opposing party's willful or grossly negligent conduct is inappropriate because it incentivizes bad behavior on the part of would-be spoliators.” Judge Sheindlin imposed the sanction of adverse inference because “prejudice is presumed precisely because relevant evidence, i.e., evidence presumed to be unfavorable to the spoliating party, has been intentionally destroyed and is no longer available to the innocent party.” In addition, Sekisui was ordered to pay the defendants costs of litigating the sanctions motion.

FDA Announces New Boxed Warning Requirements for Certain Opioids

In September, the U.S. Food and Drug Administration announced it intention to begin requiring stronger warnings on all extended-release and long-acting opioid analgesics intended to treat pain. The new labeling will say that these products should be prescribed only when a patient's pain is severe enough that it requires long-term, round-the-clock management, and alternative treatments are inadequate to meet the patient's needs. Previous labels for these products indicated they could be appropriately used not only for severe pain but also for “moderate” pain. FDA Commissioner Margaret A. Hamburg, M.D, explained in a release: “The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities. Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”

In the same release, the FDA told the manufacturers of these drug products that they will be required to conduct postmarket studies to assess the long-term effects of opioid analgesic use. For more information, go to http://1.usa.gov/15ohp92.

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Spoliation Sanctions Imposed Despite Lack of Proof of “Malevolent Purpose”

Judge Shira Sheindlin, of the U.S. District Court for the Southern District of New York, has handed Japanese medical equipment manufacturer Sekisui Medical America an unusually stiff sanction for spoliation of electronic evidence. In Sekisui Medical America v. Hart, Judge Sheindlin went against the recommendation of a magistrate judge, who advised against sanctions because of a lack of evidence of “malevolent purpose” on the manufacturer's part in failing to put a litigation hold on its electronic records until 15 months after it filed suit against the former owners of a company it had purchased.

During that period, e-mailed correspondence between Sekisui and the defendant former owners of the purchased company were deliberately deleted. The defendants were unable to prove malice, but the court observed that “[t]he law does not require a showing of malice to establish intentionality with respect to the spoliation of evidence.” On the contrary, she wrote, “In the context of an adverse inference analysis, there is no analytical distinction between destroying evidence in bad faith, i.e., with a malevolent purpose, and destroying it willfully.”

And even though the defendants could not prove that the e-mails contained relevant information, the court was not deterred: “To shift the burden to the innocent party to describe or produce what has been lost as a result of the opposing party's willful or grossly negligent conduct is inappropriate because it incentivizes bad behavior on the part of would-be spoliators.” Judge Sheindlin imposed the sanction of adverse inference because “prejudice is presumed precisely because relevant evidence, i.e., evidence presumed to be unfavorable to the spoliating party, has been intentionally destroyed and is no longer available to the innocent party.” In addition, Sekisui was ordered to pay the defendants costs of litigating the sanctions motion.

FDA Announces New Boxed Warning Requirements for Certain Opioids

In September, the U.S. Food and Drug Administration announced it intention to begin requiring stronger warnings on all extended-release and long-acting opioid analgesics intended to treat pain. The new labeling will say that these products should be prescribed only when a patient's pain is severe enough that it requires long-term, round-the-clock management, and alternative treatments are inadequate to meet the patient's needs. Previous labels for these products indicated they could be appropriately used not only for severe pain but also for “moderate” pain. FDA Commissioner Margaret A. Hamburg, M.D, explained in a release: “The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities. Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”

In the same release, the FDA told the manufacturers of these drug products that they will be required to conduct postmarket studies to assess the long-term effects of opioid analgesic use. For more information, go to http://1.usa.gov/15ohp92.

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