By David Yucht, J.D.
Patient’s failure to warn claim failed, however, as he could not prove that additional warnings on the device would have prevented his injury.
A federal magistrate judge in Iowa found that a patient, who claimed to have been injured by surgically implanted metal-on-metal hip replacement devices, sufficiently demonstrated a design defect claim as it pertained to the device implanted in his left hip. Consequently, the court denied the manufacturer’s motion for summary judgment as to that claim. However, the court determined that there was insufficient proof of the patient’s design defect claim as it pertained to the other hip, as well as his failure to warn claim. Those claims were therefore dismissed (Wessels v. Biomet Orthopedics, LLC, June 22, 2020, Mahoney, K.).
The patient underwent two hip replacement surgeries, one for each side, with metal-on-metal hip implants. Eight years later, he developed hip pain and required irrigation and debridement surgery to remove fluid and necrotic muscle tissue from both hips. Metal fragments were found in the removed tissue. The patient ultimately had multiple revision surgeries to remove the metal-on-metal hip replacements and replace them with a different kind of implant. He sued the manufacturer, alleging strict liability and negligence for design defect sand failure to warn. The manufacturer moved to preclude his expert’s testimony on causation and for summary judgment.
Expert evidence. Although critical of the form of the expert’s report, the judge determined that it sufficiently provided the manufacturer with notice of his theory and alerted the manufacturer of potential rebuttal and cross-examination that counsel would need to prepare. Consequently, any noncompliance with the expert-disclosure rule was harmless. The court agreed with the manufacturer that the causation opinions related to the patient’s right hip were unreliable. During his deposition, the expert agreed with opposing counsel and advised that he wanted to "with draw" his causation opinions related to the right hip and that any such opinions were not to a reasonable degree of medical certainty. Consequently, his opinions regarding the right hip were ruled inadmissible. However, the court found that the expert’s opinions concerning the left hip were reliable and therefore admissible.
Design defect—causation. The court denied the manufacturer’s motion as it related to the design defect claim for the left hip. It dismissed the claim as to the right hip. Iowa nearly always requires expert testimony to prove medical causation because of its complexities. Because the court determined that the causation expert’s testimony related to the patient’s right hip implant should be excluded, the manufacturer was entitled to summary judgment regarding the right hip.
Concerning the left hip implant, the patient’s general causation expert’s report, in combination with the report of the specific causation expert, established causation. There is no case law supporting the idea that causation must be established by only one expert who testifies that the design defect caused the injuries. Here, the evidence from the general causation expert supported the claim that metal-on-metal hip implants, such as the one involved here, were defectively designed because they caused bone and tissue damage. The specific causation expert testified that the patient’s hip implant caused bone and tissue damage in his left hip. A jury could reasonably find, based on these opinions in combination, that the defective design of the hip implant caused the injuries necessitating left hip revision surgeries. Consequently, the manufacturer was not entitled to summary judgment for the design defect claim as it related to the left hip.
Failure to warn. The court granted the manufacturer’s motion for summary judgment on the failure to warn claim. A failure to warn claim requires proof of two types of causation: that the product caused the alleged injuries and that lack of appropriate warnings proximately caused those injuries. The learned intermediary doctrine applied in this case. The manufacturer had to adequately warn the patient’s surgeon—not the patient himself—about the risks of the hip implant. Here, no evidence established how additional warnings might have reached the patient’s surgeon and altered his decision. Because the surgeon testified that he did not read the product’s instructions for use, and no evidence established that he would have otherwise encountered additional warnings, the patient could not prove that additional warnings would have prevented his injury.
The case is No. 18-CV-97-KEM.
Attorneys: Gary J. Shea (Shea Law Offices) for Richard Wessels. Thomas J. Joensen (Faegre Drinker Biddle & Reath LLP) for Biomet Orthopedics, LLC, Biomet U.S. Reconstruction, LLC and Biomet LLC. Erin Linder Hanig (Ladue Curran & Kuehn LLC) for Biomet, Inc.
Companies: Biomet Orthopedics, LLC; Biomet U.S. Reconstruction, LLC; Biomet LLC; Biomet, Inc.
MainStory: TopStory MedicalDevicesNews CausationNews ExpertEvidenceNews WarningsNews DesignManufacturingNews IowaNews
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