On March 23, 2017, a Colorado medical malpractice jury returned its verdict against the defendant ambulatory surgery center for the permanent paralysis suffered by a patient who was given a drug during an epidural steroid injection procedure that the manufacturer of the drug specificity warned against using in epidural injections. The manufacturer of the drug, Kenalog, had sought and obtained permission from the FDA two years before the plaintiff’s epidural steroid injection procedure in 2013, to place a warning on its label that it was “Not for Epidural Use.”
The 57-year-old Colorado medical malpractice plaintiff and her husband were never told about the warning that the drug used during her epidural injection was not for epidural use. Shortly after the plaintiff received her epidural injection, she became paralyzed from the waist down due to a spinal cord infarction, which was one of the serious risks warned about on the drug’s label. Her paralysis is permanent. Her husband had to retire so that he could take care of his wife because she requires assistance and care twenty-four hours a day.
The plaintiffs’ Colorado medical malpractice lawyer stated after the Colorado medical malpractice jury returned its verdict in his clients’ favor, “We hope this is a wake-up call for ambulatory surgery centers and the people who run them. It’s one thing to say that patient safety is your first priority; it’s another thing to actually make it your top priority. It’s one thing to say that patients have a right to participate in their healthcare decisions; it’s another thing to actually give patients the information they need to be fully informed of what they’re getting into.”
Kenalog’s manufacturer, Bristol-Myers Squibb Company, states in large, bold print on the package insert for Kenalog – 40 Injection: NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE. The package insert states under the heading “WARNINGS” “Serious Neurologic Adverse Reactions with Epidural Administration”: “Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids (see WARNINGS: Neurologic). Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.”
The Colorado medical malpractice plaintiff suffered one of the specific neurological injuries that the drug’s manufacturer warned about: spinal cord infarction. Now, the plaintiff will live the rest of her life in a wheelchair as a result.
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