In a case alleging injuries due to off-label use, does a pharmacist have the requisite credentials to act as an expert witness?
Dr. Fink is professor ofpharmacy law and policy atthe University of KentuckyCollege of Pharmacy,Lexington.
In a case alleging damages to a patientarguably due to off-label promotion ofa federal legend medication, does apharmacist serving as an expert witnesspossess the specialized knowledge necessaryto aid the jury in determining legalcausation of the injuries?
The patient suffered recurring backpain and underwent 2 surgical proceduresto address the problem. Reportingthat he still had extreme pain, he receiveda prescription from his physicianfor a medication newly reported to workfor pain management. He was on and offthe medication for some period of timeand was using several other medicationsconcomitantly. The patient experiencedsevere weakness, lethargy, and nausea,leading to admission to an intensive careunit.
The patient and his wife researchedthe various medications on the Internet,encountering claims that the manufacturerof the pain medication was promotingthe product for off-label use.The lawsuit made 3 arguments: (1) afraudulent scheme was used to marketthe product; (2) the product wasnot safe and effective for treating pain;and (3) the illegal promotional activitiescaused the plaintiff's illnesses andhospitalization. The patient attemptedto apply legal theories related to unfairand deceptive trade practices used inthe alleged unlawful promotion of theproduct, arguing that the drug was theproximate or direct cause of his injuries.
As part of his case, he called a pharmacistto testify as an expert witness.The defendant manufacturer challengedthe use of a pharmacist to testify aboutmatters of pharmacology, arguing thathis background—BSPharm degree plus aPharmD and recognition as a board-certifiedpharmacotherapy specialist—didnot qualify him in the field of pharmacology.The defendant also challenged thebasis on which the expert witness hadreached his conclusions related to thecase.
The federal court in this southern statelooked at the ruling in a prior case fromthe US Court of Appeals with jurisdictionover that area of the country and ruledthat the pharmacist was not so qualified.It also took issue with the basis forthe expert witness' opinion. As a result,the court ruled in favor of the defendantmanufacturer's motion for a summaryjudgment, ending the case with a rulingagainst the plaintiff patient.
An expert witness can play severalroles in the course of pursuing a legalclaim, not the least of which is translatingand explaining to members of thejury technical matters associated withthe case. In essence, the specialist needsto be able to teach jury members the relevantscience and technology at a levelthey can understand. Communicationskills are key, along with specializedknowledge of the field.
The defendants' challenge of the particularexpert witness used by the plaintiffin this case prompted the judge toreview the witness' qualifications. Therequirement in this state was that thequalifications must be grounded in somespecialized skill, knowledge, or experience.Noting that the person beingoffered as an expert was neither a physiciannor holder of a degree in pharmacology,the judge ruled that the pharmacistcould not offer a relevant or reliableexpert opinion related to pharmacology.The judge looked at the precedent fromthe Court of Appeals case where apharmacist with a graduate degree intoxicology was not permitted to testifyon an issue of drug interactions withouta degree in medicine or pharmacology.He also referred to the decision of a federaltrial court in New York, which hadaccepted this distinction:
"Pharmacology can be described asthe study of the effects of drugs onliving organisms, while pharmacy,on the other hand, can be describedas the profession of reading prescriptionlabels (sic) and dispensingdrugs."
The judge here also ruled that evenif the credentials of the expert witnesswere in order, his opinion was unreliablebecause of the basis used to reach theconclusions. The expert had reviewedthe abstracts of 11 case reports, eachof which lacked peer review. The expertadmitted during his deposition that thecase reports were "not scientific proofof causation." Finally, the expert hadnever attempted to rule out alternativeexplanations for what had occurred,something that must be done for anexpert witness to have credibility and beacceptable. The possibility that some ofthe other medications being used by thepatient had caused the health problemshad not been considered.