Markets

A Sales Rep Leaves a Promo Leaflet and a Vaccine Lawsuit Is Born

By Jim Edwards

Updated on: August 3, 2010 / 10:43 AM EDT / MoneyWatch

A man who claims one of Pfizer (PFE)'s polio vaccines gave him cancer can take his case to a jury even though it is based only on a single promotional leaflet handed out by a pharmaceutical sales rep, a New Jersey appeals court has ruled.

The case creates a strange new liability risk for drug companies: There are no medical records proving that Jamie Gannon received the Orimune vaccine in the early 1970s, but Pfizer may still be sued because the only evidence in the case is a promotional "Immunization and Health Record" that sales reps asked doctors to give to parents even if they didn't receive the company's vaccines.

Gannon claims the Orimune vaccine he received was contaminated with SV40 simian virus, which caused him to develop an SV40 cancerous brain tumor. (Doubtless the case will be seized upon by the anti-vaccine crowd as yet more evidence that vaccines do more harm than good, but that's a separate issue.)

Gannon's doctor died and his medical office records were lost before the case started. The only evidence Gannon has is a patient promo handed out by sales reps for Lederle Labs (later rolled into Pfizer), the ruling says. The "Immunization and Health Record" was printed with Lederle's name and corporate logo, and the vaccines recorded on it included Lederle brand names "OrimuneÂ® Trivalent" and "TINE TESTÂ® (Rosenthal Lederle)":

Defendants produced a certification from David M. Standiford, who claimed to be district sales manager of the Philadelphia area between 1968 and 1979. Standiford identified the form as a "promotional" item given to doctors by his sales force, and it "w[as] not intended to be a doctor's official vaccination record." Indeed, immediately above Lederle's name and logo, the form provides that it "w[ould] be useful at school registration time," or "if you move," so that it could be "shown ... to your new doctor."
Standiford urged his sales representatives to distribute the forms "whether the particular doctor purchased Lederle products" or not.

It's conceivable that Gannon did not receive a Lederle vaccine, and the doctor simply used the Lederle leaflet to give his parents a record of his vaccinations (although the Lederle brand names listed on the form seem highly suggestive that Gannon did receive Lederle's Orimune).

There were only four companies that sold oral polio vaccines during the period when Gannon was inoculated, and Pfizer now owns them all: American Cyanamid and its Lederle Labs unit were acquired by American Home Products, which was acquired by Wyeth, which was acquired by Pfizer. The fact that Pfizer now carries liability for any polio vaccine made in the early 1970s is an interesting quirk of the case, but for drug companies generally the court's finding that a non-official promotional item counts as enough evidence to create liability for a jury to consider a vaccine case will be the most interesting part.

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Image by Flickr user Julien Harneis, CC.