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  • Writer's pictureKirk Hartley

Possible Consequences of Precise Electronic Records of Communications Between Drug Companies and Doc

Technology continues to create new topics for mass tort litigation. For example, there are now FDA proposals for electronic communication of drug warnings to doctors, as described in a December 29, 2014 post at Drug and Device blog.  The post sagely pointed out some of the resulting e-discovery that may emerge. Note, however, that some of the future possibilities already exist. How?  Through CRM software aimed at tracking intersections between doctors and drug company representatives. The provider company is known as Veeva – see www.

Also think another step down the road. When electronic warnings are put in place, how fast will the duty to warn attach when new information indicates a problem with a drug? And, what will happen when e-records show the doctor had NOT read the record when making a recommendation to a patient, and the doctor testifies that the substance of the warning was not yet actually known to her? What happens if aggregate data shows that most doctors in fact do not read warnings, or delegate the job to a nurse practitioner?

A further point. A company known as Flatiron is now working with some major cancer centers to compile anonymized medical records for use in cancer research. Flatiron scans and compiles both hard data (test results) and soft data (talks with patient). How soon will some groups in the US implement  a system in which medical files are read and a computerized warning is then automatically generated and sent to the doc. E.g. “Your records show patient X has a family history of XYZ cancer. Last week, XYZ cancer  was newly linked to a gene mutation that was previously unknown. You should consider genetic testing for the patient and family.”

Times change. So do liability risks, and so do the possible methods for reducing or eliminating risks.

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