Pennsylvania Record

Friday, February 28, 2020

Hip implant device manufacturer not at fault for failure of product, says federal court

By Nicholas Malfitano | Oct 11, 2016


PHILADELPHIA – Two separate courts have now found a patient who underwent total hip replacement surgery and was allegedly injured by the device implanted as part of that surgery, could not prove he was harmed by the device’s manufacturer.

Judge D. Brooks Smith said on Oct. 7 because plaintiffs Gregory and Cherrie Kline “failed to show that a reasonable jury could find that any unreasonable act or omission by Zimmer caused [Gregory] harm," the U.S. Court of Appeals for the Third Circuit would affirm the trial court judgment in this action, that of the U.S. District Court for the Western District of Pennsylvania.

“On Jan. 13, 2010, Gregory Kline underwent a total hip replacement. His surgeon implanted a Femoral Stem with Kinectiv Technology. On April 6, 2011, Kline’s hip replacement broke; the stem fractured at the neck,” Smith said. “Kline sued Zimmer Holdings Inc., Zimmer Inc., and Zimmer United States Inc. (collectively, Zimmer), alleging several state-law product liability claims.”

Smith explained by the time the case reached summary judgment, Kline’s only remaining claims were negligent design defect and negligent failure to warn, on the part of Zimmer. In the end, the District Court granted summary judgment to Zimmer on all counts, leading the Klines to appeal.

“To survive summary judgment, Kline has to show that there is a genuine issue of material fact that Zimmer acted unreasonably in designing the stem or failing to warn about the stem and that any unreasonable act was the cause of the harm to Kline. Kline failed to do so,” Smith stated.

“On appeal, Kline primarily contends the District Court erred because the District Court did not fully consider two affidavits filed after the Magistrate Judge first recommended granting Zimmer’s summary judgment motion. Because these affidavits do not advance Kline’s reasonableness or design causation arguments, they do not affect summary judgment,” Smith added.

Though Kline argued the failure of the Zimmer-manufactured device in another patient treated by Kline’s doctor – an issue raised in case affidavits – is important, Smith clarified evidence about this other patient’s device failure is not admissible.

“It did not “involve the same product under similar circumstances nor did it (1) show notice to the defendant of the danger, (2) show the existence of the danger, or (3) show the cause of the accident,” Smith pointed out.

“Here, the other patient’s device failure could not show notice of the danger because the allegedly related device failure occurred after the Zimmer device already had been implanted in Kline. The other patient’s device failure also does not prove the ‘existence of the danger’ or ‘cause of the accident’ because Kline fails to offer any sort of causation theory regarding the prior accident – let alone one related to any unreasonable act that affected his own device,” Smith said.

Smith said Kline’s lack of causation theory for the failure of the other patient’s device did not present “relevant similar circumstances.”

“With regard to the negligent design defect claim, the District Court held that plaintiffs’ experts, Mari Truman and Dr. Donald Koss, had waived Kline’s design defect claims in their depositions. In fact, Truman and Koss did raise design defect theories in their expert reports,” Smith stated.

“Although these theories were not waived, they fail at summary judgment. Truman and Koss’s design defect theories were that: Zimmer should have conducted more stringent tests; Zimmer could have used a different surface treatment; Zimmer should not have used the particular type of titanium it used; the device should not have been multimodular; the offset or size of the device was dangerous; or the device is inherently flawed. Kline failed to produce record evidence showing any of these design choices were unreasonable, thus causing his device to fail,” Smith added.

Despite Kline’s witnesses introducing the concept of new and foreseeable risks, Smith said such a risk could only be properly determined through a comparison of alternative risks and benefits, or proof that the new risk was “of such magnitude and likelihood that it was facially unreasonable.”

“Here, there is neither sufficient record evidence about the relative risks of an alternative design nor sufficient record evidence that the stem is so dangerous that a jury could find Zimmer’s design choices were unreasonable,” Smith said. “Moreover, to the extent Kline presented admissible causation evidence, that evidence does not support any of Kline’s theories of unreasonable design. For example, Truman failed to show how increased testing would have resulted in a design change.”

Smith added summary judgment was to be granted on Kline’s failure to warn claim as well.

“Kline’s theory, supported by Zimmer’s experts, was that an individual of Kline’s weight or body mass index who engaged in vigorous activity was at a higher risk of device failure. As Kline acknowledged, a package insert for Zimmer’s device warned about those risks, at least in general terms,” Smith stated.

“Truman opined that there were two defects with these warnings: (1) Zimmer should have contraindicated the device and (2) done so for use at specific weights, body mass indexes, and/or activity levels. Truman based her opinion on the fact that one of Zimmer’s competitors contraindicated specific combinations of weights and activity levels on the competitor’s device,” Smith added.

On behalf of the Court, Smith explained Truman’s opinion that the weaker warning was unreasonable was “unsubstantiated and therefore fails to create a genuine issue of material fact.”

“Truman did not indicate, among other things, that the competitor’s device was sufficiently analogous to Zimmer’s device, that the competitor’s warning was reasonable, that there were any particular weights or activity levels at which excessive risk existed, or that the likelihood of fracture was high enough to warrant the contraindication,” Smith said.

“Accordingly, there is no evidence in the record that the risk was of a magnitude to require a contraindication at any specific weight, body mass index, or activity level, except that the device broke in Kline. For the reasons set forth above, we will affirm the judgment of the District Court,” Smith concluded.

The plaintiffs are represented by Alan H. Perer, Diane W. Perer and Daniel J. Sammel of Swensen & Perer, in Pittsburgh.

The defendants are represented by Adrienne F. Busby, Mindy A. Finnigan and Patrick H. Reilly of Faegre Baker Daniels in Chicago, Ill. and Indianapolis, Ind., Carolyn Batz McGee of Cipriani & Werner in Pittsburgh, Lee. E. Walter, Mark E. Gebauer and William T. Polaski of Eckert Seamans Cherin & Mellott in Pittsburgh and Harrisburg.

U.S. Court of Appeals for the Third Circuit case 15-2854

U.S. District Court for the Western District of Pennsylvania case 2:13-cv-00513

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at

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