In the case, the plaintiff developed inflammation in her shoulder after having arthroscopic surgery that involved the implantation of a medical device to temporarily stabilize the affected shoulder. Alleging that her shoulder pain continues to this day, the plaintiff brought suit against the device’s manufacturer and the doctor who implanted the device. Plaintiff’s other claims were all disposed of on summary judgment, but the trial court allowed plaintiff’s failure to warn claim to go forward. The device manufacturer and operating doctor appealed.
On appeal, the appellate court reversed the trial court and directed the clerk to enter judgment in favor of the defendants. In its decision, the court highlighted a number of the most significant principles governing failure to warn claims under New York law:
• A plaintiff must prove that the product in question “did not contain adequate warnings
and that the inadequacy of those warnings was the proximate cause of the injuries” in
question.
• “The manufacturer’s duty . . . is to warn the medical community, not the patient of the
product’s risk” and the warning given “must provide sufficient information to the class
of prescribing physicians ‘who may be expected to have the least knowledge and
experience with the’ product.”
• “[A] manufacturer’s duty is to warn only of those dangers it knows of or [that] are
reasonably foreseeable.” Where the manufacturer lacks actual or constructive
knowledge of a danger inherent in a product, no failure to warn claim can arise.
• Once the manufacturer meets its “threshold burden of showing it adequately warned
prescribing physicians of all the known risks from using” a product, the burden shifts to
the plaintiff to “create a material issue of fact by showing the warnings were deficient.”
• A plaintiff may only prevail on a failure to warn claim if she shows that “had a different
warning been given, [she] would not have used the product that caused her injury.”
Having reviewed New York law in the area, the court found that no material issues of fact existed as to the following dispositive matters: (1) the manufacturer adequately warned physicians of all known or reasonably foreseeable risks of the product; (2) plaintiff failed to show that the manufacturer had either actual or constructive knowledge that the type of injury suffered could result from using the product; and (3) plaintiff failed to show that she would not have used the product had the manufacturer warned of the unknown risk.
