By David Yucht, J.D.
Although a treating surgeon admitted that he did not read the warnings included with an artificial hip he implanted in a patient, the patient’s estate presented admissible expert testimony that the manufacturer did not properly communicate the device warnings, enabling the estate’s failure to warn claims to survive summary judgment.
After precluding portions of the testimony of several expert witnesses, a federal district court in Georgia determined that there was sufficient evidence presented by the estate of a deceased hip-transplant patient to sustain its design defect and failure to warn claims. Consequently, the device manufacturer’s motion for summary judgment as to those claims was denied (Hardison v. Biomet Inc., July 27, 2020, Self, T.).
The Biomet M2a Magnum Hip System (M2a) is an artificial hip implant designed, manufactured, and sold by Biomet, Inc. The M2a is a metal-on-metal implant. Biomet included instructions inside the M2a packaging that advised the operating surgeon of risks and adverse side effects. One of the warnings indicated that excessive weight was implicated in premature failure of the implant. The patient in this case, who was described by his physician as being "obese," was implanted with an M2a. His physician did not recall reading the warnings. Five years later, increased cobalt and chromium levels were detected in the patient’s blood. The following year, the patient experienced an increase in right hip and lower back pain. Revision surgery was performed on his right hip. The surgeon noted apparent "metal on metal bearing surface wear reaction" with "soft tissue reaction." After this revision surgery, the patient developed a postoperative infection and required follow-up surgeries. Asserting that the release of cobalt and chromium debris and metal ions into the patient’s body—caused by the device failure—resulted in significant harm, his estate sued, as part of a multi-district litigation, alleging among other claims, negligence in design and warnings and strict liability—design defect and failure to warn. After pretrial proceedings, the case was transferred to the federal district corut in Georgia. Thereafter, Biomet moved to preclude testimony of the estate’s experts and for summary judgment. The estate moved to preclude the testimony of Biomet’s experts.
Expert testimony. The court was required to assess the admissibility of the testimony of various expert witnesses offered by both sides. The court precluded a portion of the testimony of the estate’s expert orthopedist concerning the failure to warn claim. His testimony about the substance of the warning was irrelevant because the surgeon who implanted the device never read the warning. Concerning how the warnings were delivered, he lacked a regulatory background, he was unfamiliar with Food and Drug Administration (FDA) regulations, and he did not introduce any industry standard except his own belief. Moreover, the court excluded the orthopedist’s opinions that the patient’s other medical conditions did not contribute to the premature failure of the device, the metal from the device negatively affected tissue, and the revision surgery complications and the patient’s post-revision falls exacerbated other health conditions. The orthopedist, however, was permitted to testify that metal debris in the patient’s body came from the M2a device and the revision surgery caused an infection, several months of treatment, and two follow-up surgeries.
The court did not preclude testimony from a pathologist who opined that the metal debris found in the patient’s body lead to necrosis which led to long-term muscle damage. However, given the patient’s multiple health conditions, the court found that the pathologist’s opinion was overly speculative as to the patient’s immobility causing his general health decline. Also, a biomedical engineer was not qualified to offer a medical causation opinion, but the court would not preclude her from testifying that the medical device corroded due to design defect. The court excluded the engineer’s testimony that parts of the device were mismatched as being overly speculative because she admitted to not knowing for sure whether there was a significant mismatch in this case. The court did not preclude the patient’s treating physicians from testifying about diagnosis and treatment.
In addition, the court would not exclude the opinion of a biomedical expert retained by Biomet that identified factors contributing to higher than normal wear of the patient’s hip implant. The court found that he sufficiently identified factors that could result in greater than normal wear and he explained his rationale for why those factors could have applied to the patient in the case at bar. However, this expert’s inability to quantify the extent to which these factors caused metal debris rendered his opinions too speculative as to whether they could have been the sole cause of higher than expected wear. Likewise, the court excluded the manufacturer’s engineer’s opinion that an alternative hip implant would not have averted the need for revision surgery. The court also found that Biomet’s pathologist could render an opinion about the patient’s diabetes and a possible pre-implant infection.
Design defect. The court denied Biomet’s motion for summary judgment as to the estate’s claims for design defect. Biomet argued that it was entitled to summary judgment on the design defect claims because the estate could not prove medical causation. The court noted that the estate submitted three experts to testify regarding specific causation. The court found that sufficient causation testimony linking a defect in the device to some of the patient’s injuries also was provided. A biomedical engineer opined that a device defect caused the device to fail. Moreover, the estate’s medical experts sufficiently opined that the metal debris resulted in necrosis, tissue damage, need for revision surgery, and post-revision surgery medical issues.
Failure to warn. The court also denied Biomet’s motion for summary judgment as to the failure to warn claims. Georgia's learned-intermediary doctrine does not require a medical device manufacturer "to warn the patient of the dangers involved with the product." Instead the manufacturer "has a duty to warn the patient's doctor, who acts as a learned intermediary." Although the patient’s treating orthopedist admitted that he did not read the warnings that were inserted in the device packaging, the estate presented admissible expert testimony that Biomet did not properly communicate the device warnings, that a surgeon would not have used the M2a if given a proper warning, and this failure to communicate lead to the patient’s injuries.
Other issues. The court denied the manufacturer’s motion for summary judgment as to the derivative loss of consortium claim. Additionally, without prejudice to a possible future motion, the court refused to grant summary judgment dismissing punitive damages. The estate’s wrongful death claim failed because there was no admissible evidence of medical causation to show that the implant caused the patient’s death.
The case is No. 5:19-cv-00069-TES.
Attorneys: Joseph P. Miller (Beasley Allen Law Firm) for Gail Dean Hardison. Adrienne Franco Busby (Faegre Drinker Biddle &Reath LLP) for Biomet Inc. and Biomet Orthopedics LLC.
Companies: Biomet Inc.; Biomet Orthopedics LLC
MainStory: TopStory CausationNews DesignManufacturingNews WarningsNews ExpertEvidenceNews DamagesNews MedicalDevicesNews GeorgiaNews
Interested in submitting an article?
Submit your information to us today!Learn More
Product Liability Law Daily: Breaking legal news at your fingertips
Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on product liability legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.