Drug Manufacturer Fails to Warn Patients of Medication Risks

Joseph O'Neill

Written by
— Updated on October 13, 2017

Warning Label Expert WitnessThis case takes place in Florida and involves the labeling protocols for a name-brand prescription drug and its generic equivalents. The original drug, developed and marketed over a decade ago, was designed to treat acute episodes of gastrointestinal distress. For the first few years of its commercial existence, the drug carried a warning label that indicated it was “not recommended” for extended use. Eventually, the drug came under scrutiny for causing permanent stomach injuries if used over an extended period of time. As a result, the original warning on the label was changed to indicate that the drug should never be used for an extended period of time. The company that originally developed the drug had correctly warned patients by instituting the labeling change – however, generic versions of the drug did not change their warning labels. This has resulted in multiple patients suffering permanent injury after taking the generic version of the drug for too long.

Question(s) For Expert Witness

  • 1.) What are the references that you would use to determine the obligation to warn for drug manufacturers?
  • 2.) Have you ever been the target of a malpractice / negligence claim?
  • 3.) Have you ever served as an expert witness on a related matter?

Expert Witness Response E-000718

I used multiple references during that time and now.  Facts and Comparisons was, and is, such a source.  The recommended use is a standard that I have attempted to rigorously adhere to due to the propensity of dose exposure side effects. I have been called as a witness in a case involving other prescription drugs, though I was never named as part of the suit.

Although I used Facts and Comparisons frequently during that time period, I would not have used it as my first source of information for Black Box Warnings. I would have relied primarily on the package insert for this information. The PDR would have been another source of information, as would other drug references available to me. I have not ever been the target of a malpractice or negligence claim. I am an expert witness for the estate of a woman who died after being prescribed and dispensed a non-FDA approved drug. I have been an expert witness on another matter related to an injury from a compounded eye drop, and I have been retained to review records from a pharmacy that dispensed contaminated sterile preparations.

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