Medical Devices Expert Witness Testimony Allowed in Drug Liability Case

Summary: Medical Devices Expert Witness testimony is granted in part and denied in part as the judge ruled that the expert was qualified to offer an opinion on the alleged inadequacy of the Injectafer label.

Facts:  This case (CROCKETT v. LUITPOLD PHARMACEUTICALS, INC. et al – United States District Court – Eastern District of Pennsylvania – February 23, 2023) involves a drug product liability claim.  The plaintiff, Katherine Crockett, claims that she sustained injuries after she was given Injectafer, an iron-replacement medication.  Crockett says that she developed hypophosphatemia after being given the drug.  The plaintiff hired Medical Devices Expert Witness George Samaras, Ph.D. to provide expert witness testimony to assist in her case.  The defendants have filed a motion to exclude this expert witness from testifying.

Discussion:  The defendants take issue with Samaras’s testimony regarding the alleged inadequacy of the labeling of the Injectafer as well as the defendants’ pharmacovigilance program.

First, the court states that Samaras draws numerable legal conclusions in his expert witness report which will be excluded as he is not permitted to do so.

The defendants allege that Samaras’s opinions on the alleged inadequacy of the Injectafer label because he does not have the qualifications to provide an opinion on prescription drug labeling.  The court agreed, stating that Crockett has not shown that Samaras is qualified to provide an expert opinion about the sufficiency of the wording on the label of the Injectafer.  The court opined that while he worked at the FDA, he did not work on specific prescription drugs.  In addition, the court notes that Samaras’ background in human factors and software engineering does not qualify him to provide an opinion on the adequacy of prescription drug labels.  Thus, Samaras’s testimony on the sufficiency of Injectafer’s label will be excluded.

In addition, the defendants argue that Samaras should not be allowed to provide an expert witness opinion on pharmacovigilance practices related to Injectafer.  The court disagreed, opining that his experience and qualifications in risk management and human factors engineering qualify him to provide an expert opinion on Injectafer’s pharmacovigilance practices.  The judge stated that any criticisms on this issue are best suited for cross-examination.

The judge also opined that the defendants argument that Samaras’s opinions are not reliable also fall short.

Conclusion:  The defendants’ motion to exclude the expert witness testimony of George Samaras, Ph.D. is granted in part and denied in part.