Health Law Daily Allegedly inadequate warnings not cause of patient’s injury
Friday, February 8, 2019

Allegedly inadequate warnings not cause of patient’s injury

By Matt Pavich, J.D.

Surgeon’s continued use of the product undermined the patient’s allegations, even though the patient needed a full revision surgery with a different implant system.

A patient failed to show that allegedly inadequate warnings on a knee implant device caused her injuries because the surgeon would have used the device regardless as evidence by his continued use of the product, a federal district court in New York has ruled. The court granted the manufacturer’s motion for summary judgment and struck an affidavit by the surgeon that was contradicted by his own deposition testimony (Webb v. Zimmer, Inc., February 4, 2019, Spatt, A.).

Background. In March 2011, the patient had a total knee replacement in which the surgeon, as was his regular practice, used the "Natural-Knee Flex System." The patient began complaining in April 2012 of recurring knee pain and the surgeon eventually performed a revision surgery in which he discovered that a piece of the product was broken. The surgeon performed a third surgery and eventually, a full revision surgery in which he replaced the product with a different system. The first two products the patient had contained inserts with a list of warnings, risks, and adverse effects.

The patient filed suit alleging that the product was defective and that the manufacturer violated its duty to warn. In opposing the manufacturer’s motion to exclude testimony by one of the patient’s experts, the patient included an affidavit by her surgeon. When the surgeon was re-deposed, he testified that he had not written the affidavit, acknowledged that he had not reviewed the other expert’s report, and confirmed that the affidavit had inaccuracies and errors. The manufacturer moved for summary judgment and to exclude the surgeon’s testimony.

Motion to exclude. The court granted the motion to exclude. The surgeon neither wrote, nor edited the affidavit. Moreover, he did not review the product’s package inserts that contained the warnings and acknowledged that his affidavit had numerous errors. In his second deposition, the surgeon contradicted much of what he had said in his affidavit. For example, he recanted his opinion that the manufacturer had a duty to warn patients with hyperextension. Having not read the package inserts, he could not opine as to their adequacy. The court reasoned that the surgeon could not offer opinions that he had specifically recanted in his deposition and granted the motion to exclude.

Causation. The court found that the product warnings were not adequate as a matter of law. The package inserts had warnings regarding dislocation and fracture/damage, but the court found that it was unclear whether the manufacturer adequately warned physicians as to the causes and whether the fracture and dislocation were foreseeable. In light of evidence that the manufacturer should have known that at least one of the patient’s conditions was foreseeable, but did not test the product for it, the court found that a jury could plausibly find that the manufacturer failed to warn about potential risks.

The court further found, however, that the possible failure to warn did not cause the patient’s injuries. The patient needed to show that had the manufacturer used a different warning, the surgeon would not have used the device. The record instead showed that the surgeon chose to the use the product for all his primary implant surgeries based on his comfort with the product, not on any marketing materials or warnings. Furthermore, even after the patient’s injuries, the surgeon continued to use the device. The court therefore found that the allegedly insufficient warnings did not cause the injuries and granted summary judgment.

The case is No. 2:14-cv-01106.

Attorneys: Nancy I. Maltin (Silverson, Pareres & Lombardi LLP) for Elizabeth Webb. Minji Kim (McCarter & English, LLP) and Peter A. Meyer (Faegre Baker Daniels LLP) for Zimmer, Inc., Zimmer Holdings, Inc. and Zimmer Orthopaedic Surgical Products, Inc.

Companies: Zimmer, Inc.; Zimmer Holdings, Inc.; Zimmer Orthopaedic Surgical Products, Inc.

MainStory: TopStory MDeviceNews PLDeviceNews NewYorkNews

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