On June 1, 2020, the Massachusetts Appeals Court affirmed Pharmacia & Upjohn Company LLC’s (subsidiary of Pfizer) summary judgment in a case involving allegations that two vials of Depo-Medrol®, an injectable corticosteroid, were contaminated during the manufacturing process and caused patient Laporte to develop an infection and subsequent leg amputation, and later death. This is the most recent of a series of dismissals of cases bringing product liability claims related to the use of Depo-Medrol®.
In Laporte v. Pharmacia & Upjohn Company LLC, the plaintiff, Laporte, the patient’s widower, alleged that the vials of Depo-Medrol® that were injected in Laporte’s left knee were contaminated during the manufacturing process. In addition, the plaintiff alleged that the treating doctor breached the standard of care by failing to inspect the Depo-Medrol® vials prior to administering the injection. The plaintiff brought product liability and wrongful death claims against Pharmacia, all of which were premised on a theory of manufacturing defect. The plaintiff disclosed one expert, specifically designated on medical causation. However, he also opined, based on his use of differential diagnosis, that the product was defectively manufactured and contaminated at the time that it left Pharmacia’s possession, causing the infection in patient Laporte’s knee and subsequent amputation, and death. Without any evidence of defect in the record or reliable scientific methodology to “rule in” the medication as one of the possible causes of Laporte’s infection, he proceeded to “rule out” some of the other possible alternatives except for Depo-Medrol®. He then summarily concluded that the medication was contaminated and caused the injury.
Pharmacia filed a Motion to Exclude Plaintiff’s Expert and a Motion for Summary Judgment. Pharmacia argued that the plaintiff’s expert was not qualified to opine on manufacturing defect and that his opinion that the Depo-Medrol® vials administered to Laporte were contaminated should be excluded because it was unreliable and not based on the record. Plaintiff failed to bring any evidence that Depo-Medrol® generally, let alone the two vials administered to Laporte, had ever been found to be contaminated. The evidence was undisputed that the product had passed all FDA requirements, including those for sterility, before it left Pharmacia’s control; that from 1959-2018, FDA had never found any issues with the manufacture of Depo-Medrol® related to sterility; and that no other patients at Tufts complained of any ill effects from Depo-Medrol® during the relevant time period. The Superior Court agreed with Pharmacia that the plaintiff’s expert was not qualified to opine on manufacturing defect and that his causation opinion was not based on reliable scientific methodology or principles, or on facts that would be admissible in evidence.
The plaintiff appealed the summary judgment order. After oral argument, the Massachusetts Appeals Court affirmed the grant of summary judgment as to all claims against Pharmacia. The Appeals Court found that, other than speculating that something might have gone wrong in the manufacture of the product, the plaintiff had failed to offer any evidence to establish that Depo-Medrol® had a manufacturing defect. The Appeals Court agreed that the record established that Depo-Medrol® had met all FDA requirements and there was no evidence of contamination in the product before it left Pharmacia’s control.
Drug & Device Law featured the decision in “Evidence of Nothing Overcomes No Evidence,” June 4, 2020, noting, “To win this kind of motion, concerning this drug, in this venue is a truly notable accomplishment.”
Law360 also reported on the victory in “Tufts Must Face Suit Over Patient’s Infection Death,” June 1, 2020.
The case is Donald J. Laporte v. Steven C. Vlad, case number 19-P-375 (Commonwealth of Massachusetts Appeals Court, June 1, 2020).