- Attacking the Learned Intermediary Defense with Evidence of the Behavior of the Manufacturer's Representative
- November 28, 2006 | Author: Joseph P. McMenamin
- Law Firms: McGuireWoods LLP - Richmond Office ; McGuireWoods LLP - Chicago Office
In the event of a lawsuit, what your sales representative tells a physician about your medical product may be critical.
The Connecticut Supreme Court very recently reversed a summary judgment award to a medical device manufacturer that had been dismissed from a case on the basis of the learned intermediary doctrine. Under this doctrine, adequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn consumers directly. It is based on the principle that prescribing physicians act as learned intermediaries between manufacturers and consumers, and therefore stand in the best position to evaluate the risks and benefits of a particular course of treatment for a particular patient.
The Connecticut court found a question of fact in whether a pacemaker sales representative’s oral communications that were allegedly inconsistent with the device’s technical manual nullified the learned intermediary doctrine.
On behalf of their daughter, born with a congenital complete heart block, plaintiffs sued a pacemaker manufacturer under the Connecticut Product Liability Act, General Statutes, §52-572m, et seq., and the Connecticut Unfair Trade Practices Act (“CUTPA”), General Statutes §42-110a, et seq. The evidence showed that the child’s cardiologist asked a representative of the defendant device maker to attend an examination of the child to test her pacemaker’s battery. On the basis of information from the representative, the cardiologist concluded that the child needed a new pacemaker. The patient’s mother, however, refused to have the pacemaker replaced because she wanted it removed altogether. So, the physician decided to adjust the rate downward to evaluate the child’s ability to function at a lower heart rate and to obtain additional information to convince the mother to have the battery replaced. A slower rate would allow the battery to function longer. Plaintiffs alleged that setting the pacemaker at the slower rate caused brain damage in the child.
Undisputed evidence showed that the manufacturer’s technical manual comported precisely with FDA-mandated labeling approved in the course of the defendant’s pre-market approval submissions. A section of the manual entitled “Inhibited and Activity Mode Pacing for Diagnostic and Pediatric Uses” stated, in part, that “rates less than 40 [paces per minute] are intended primarily for diagnostic purposes…” Plaintiffs admitted that the pacemaker was accompanied by adequate warnings in the manual. They argued, however, that by his oral communications with the cardiologist, along with his physical adjustment of the pacemaker to 40 paces per minute, the defendant’s representative contradicted the manual, “thereby vitiating and nullifying the manual’s warning…” The trial court rejected plaintiff’s claim.
The appellate court, however, was persuaded that plaintiffs had presented an evidentiary foundation to demonstrate the existence of a genuine issue of material fact: whether the information the representative conveyed to the physician was in derogation of the technical manual. The finder of fact, said the court, will have to compare the manual’s written words with the representative’s oral communication in the context in which the latter occurred. The manual did state that rates below 40 could safely be used for diagnosis after the indicator had signaled that the battery was dying. The manual also stated that, when the battery was low, it should be replaced. The court wrote: “Although the evidence indicated that pacemaker adjustment can be performed for purposes of a diagnostic assessment, whether that was the operative reason in this case is something about which reasonable minds can differ.” Hurley v. The Heart Physicians, P.C., et al., No. SC-17463, CCH Products Liability Reports, ¶ 17,544 (2006).
It appears from the facts set out in the decision that it was the child’s cardiologist, not the manufacturer’s representative, who decided to pursue a diagnosis by slowing the pacer’s rate. There was no evidence to suggest that the manufacturer had engaged in communications directly with the patient or her parents. Nevertheless, said the court, if the finder of fact concludes that the doctor’s decision was influenced by the manufacturer’s behavior, the learned intermediary doctrine might not apply.
Under current law, only a few exceptions to the learned intermediary rule exist. Some courts refuse to apply it in vaccine cases, for example; others, in contraception cases. In New Jersey, but so far only in New Jersey, direct-to-consumer advertising can also thwart the learned intermediary defense to warnings claims. See Cara Houck, Legal Updates, “DTC Advertising: A Threat to the Powerful ‘Learned Intermediary Doctrine’ Defense?” 16 Oct. 2006. See also, McMenamin, J.P., Tarry, S.L., Jr. and Whelan, D.J., “How Perez v. Wyeth Laboratories Will Affect Direct-to-Consumer Drug Advertising” 18 (5) Leader Publications 7 (November 1999). In Hurley, Connecticut appears to be attempting to create a new exception. Makers of prescription products should monitor developments in this area. Depending on where they do business, they might want to instruct their representatives about risks implicated by Connecticut’s new case.