Circumstantial Evidence Ruled Not Enough in Case Against Medical Device Manufacturer

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Frederick (Rick) Fern and the New York City Harris Beach Life Science Practice Group were successful in securing a summary judgment for medical device manufacturers Curlin Medical Inc., Moog Inc., and distributor B. Braun Medical Inc. in Niagara County, New York (Page v. Curlin Medical, B. Braun Medical and Moog, Inc, Niagara County Supreme Court, filed January 8, 2018) in an action involving allegations of patient controlled analgesia (“PCA”) pump malfunction causing morphine over-infusion and the resulting sequelae of opioid overdose, causing respiratory depression and subsequent anoxic brain damage.  The court agreed that without any evidence that the PCA pump delivered anything other than the prescribed dose, the mere fact that the plaintiff experienced respiratory depression, a well-known adverse effect of morphine, was insufficient to support a valid inference of a manufacturing defect.  The specific pump could not be identified as it was cleaned and returned to service, as none of the involved health care professionals thought it malfunctioned, as the infusion amount on the pump digital screen matched their personal observations of the remaining volume in the morphine bag.

While circumstantial evidence is permitted to prove a manufacturing defect under limited circumstances, New York’s highest court has set forth specific rules to safeguard against “pure speculation.”  See Ramos v. Howard Indus., Inc., 10 N.Y.3d 218, 223 (2008).  In cases “based entirely upon circumstantial evidence, it may be inferred that the product was defective … only if plaintiffs exclude all causes of the accident not attributable to the manufacturer.”  Nichols v. Agway, Inc., 280 A.D.2d 889, 889 (App. Div. 4th Dept. 2001).

In granting Harris Beach’s motion for summary judgment, Judge Sara Sheldon aptly noted that neither of the plaintiff’s two experts implicated the PCA pump as the cause of the plaintiff’s injuries.  In fact, the plaintiff’s and defendant’s medical experts were in agreement that multiple pre-existing risk factors predisposed the plaintiff to respiratory depression from opioids in therapeutic doses, including three decades of smoking, a complicated cervical disc surgery, extended general anesthesia, and interactions with other drugs on board, including other opioids infused on the day of surgery.

The plaintiff unsuccessfully attempted to raise an issue of fact as to design defect, “based upon speculation and a hope and a prayer” after the pump defendants established prima facie that the device was “state-of-the-art,” “functioned properly” and “dispensed to the plaintiff far less than the maximum dose of morphine prescribed by the plaintiff’s own doctor.”

The court denied the plaintiff’s cross-motion for summary judgment, based upon the doctrine of res ipsa loquitur, finding this was not an exceptional case where the plaintiff’s circumstantial proof was so convincing, and the inference of the defendant’s negligence was inescapable.

The plaintiff has appealed the dismissal to the Appellate Division, Fourth Department.  Page v. Niagara Falls Memorial Medical Center, New York Supreme Court, Niagara County (Index No. 143268).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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