William Cooper v. Smith & Nephew, Incorporated, and Smith & Nephew Richards, Incorporated Abraham Rogozinski Chaim Rogozinski James Walt Simmons American Academy of Orthopaedic Surgeons North American Spine Society Scoliosis Research Society Acromed Corporation, Charter Number 614043 Acromed Corporation,charter Number 816942 Acromed Incorporated, Charter Number 811415 Acromed Incorporated, Charter Number 816943 Acromed Holding Corporation, Charter Number 811416 Ace Medical Company Advanced Spine Fixation Systems, Incorporated Cross Medical Products Depuy-Motech, Incorporated Synthes Synthes, Incorporated Synthes North America, Incorporated Synthes A.G. Chur Danek Medical, Incorporated Sofamor, Incorporated Sofamor-Danek Group, Incorporated Sofamor, S.N.C. Youngwood Medical Specialties, Incorporated, Formerly Known as Stuart Medical Specialty, Incorporated, Formerly Known as National Medical Specialty, Incorporated Zimmer, Incorporated

Citations: 259 F.3d 194; 56 Fed. R. Serv. 1001; 2001 U.S. App. LEXIS 15408Docket: 00-2556

Court: Court of Appeals for the Fourth Circuit; July 9, 2001; Federal Appellate Court

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William Cooper filed a lawsuit against Smith & Nephew, Inc. alleging that a defective medical device, the Rogozinski Spinal Rod System, led to failed back surgeries and negative side effects. The United States District Court for the District of Maryland dismissed Cooper's claims, finding that he lacked admissible medical evidence to establish that the device was the proximate cause of his injuries. The appellate court affirmed this decision, concluding that the district court did not abuse its discretion in excluding the testimony of Cooper's medical expert on causation. The Rogozinski System, which includes various components used in spinal fusion surgeries, had been cleared by the FDA for certain spinal uses since 1990, but was not approved for pedicle fixation prior to the lawsuit. Pedicle fixation involves inserting screws into the pedicles of vertebrae to enhance spinal stability and promote fusion.

Once the FDA clears a medical device, physicians can use it off-label, meaning they can apply it in ways not specifically approved by the FDA, as highlighted in Buckman Co. v. Plaintiffs' Legal Comm. Many doctors utilized the Rogozinski System for pedicle fixation before it received FDA approval in 1998, which later acknowledged the safety and effectiveness of pedicle screw spinal systems for certain uses.

William Cooper suffered injuries from a slip and fall on January 28, 1990, leading to herniated disks and subsequent surgeries due to ongoing pain. An orthopedic surgeon, Dr. James Murphy, performed spinal fusion surgery on June 19, 1991, using the Rogozinski System across multiple vertebrae. Despite surgery, Cooper continued to experience pain, and further evaluations indicated a potential nonunion at the fusion sites. A second surgery on October 15, 1992, confirmed successful fusion at two levels but revealed complications at another. Dr. Murphy emphasized the importance of Cooper quitting smoking for future surgical success.

After multiple surgeries, including a final one in February 1995 that successfully fused the remaining affected vertebra, Cooper filed a nine-count complaint against S&N and other defendants on August 12, 1997. His claims included fraud, negligence, and strict liability. The case was initially transferred to multidistrict litigation, where conspiracy claims were dismissed. Ultimately, it returned to district court with only the claims against S&N remaining.

Cooper engaged Dr. William Mitchell and Dr. Harold Alexander to provide expert testimony linking the Rogozinski System to his injuries. Dr. Alexander, a biomedical engineering expert, was deemed unqualified to testify on individual causation or beyond orthopedic bioengineering in prior litigation. Dr. Mitchell, an experienced orthopedic surgeon, opined that the Rogozinski System failed to withstand stress, leading to a fractured pedicle screw and subsequent non-union at L5-S1, attributing all of Cooper's injuries to this failure. However, on November 20, 2000, the district court excluded Dr. Mitchell's medical causation testimony, acknowledging his qualifications but finding his testimony unreliable, consistent with other cases involving bone screw litigation. Consequently, as expert medical testimony was essential for Cooper's claims and Dr. Alexander was unqualified to provide it, the court granted S&N's summary judgment motion. Cooper is appealing this decision.

Under Federal Rule of Evidence 702, trial judges must ensure that scientific testimony is both relevant and reliable, acting as gatekeepers to prevent misleading evidence. The Supreme Court's Daubert ruling outlines criteria for evaluating an expert's testimony, including testability, peer review, error rates, and general acceptance in the scientific community. The proponent of the testimony must demonstrate its admissibility by a preponderance of the evidence.

In Kumho Tire Co. v. Carmichael, the Supreme Court clarified that the factors from Daubert for assessing expert testimony are not exhaustive and depend on the specific context, expertise, and subject matter. The court emphasized that the Daubert standard aims to ensure that experts apply rigorous intellectual standards in court, mirroring their professional practices. Appellate courts review trial court decisions on expert testimony admissibility under an abuse of discretion standard, granting trial judges significant leeway in determining reliability.

In the case at hand, S&N challenges Dr. Mitchell's qualifications to testify about the medical cause of Cooper's injuries. While the court assumes Dr. Mitchell is qualified, it must evaluate whether his testimony is reliable, ultimately finding it inadmissible. Cooper argues that Dr. Mitchell employed a differential diagnosis method, which has been recognized as reliable. Differential diagnosis involves identifying potential causes of symptoms and systematically ruling them out. However, the court agrees with the district court's assessment that Dr. Mitchell's application of this method was unreliable.

Dr. Mitchell's opinion was deemed conclusory and based on personal beliefs rather than valid scientific methods, as he has never used pedicle screw devices due to his belief in their dangers, contradicting FDA views and the consensus among his peers in the orthopedic community. The FDA had noted that the use of pedicle screws became common practice outside of approved studies and was considered the standard of care by the surgical community by 1992.

Dr. Mitchell testified that the Rogozinski System is defective if it fails to prevent spinal motion 100% of the time, leading to a nonunion. He argued that since a nonunion occurred in Cooper's case, the device was defective and caused Cooper's injuries. During his deposition, he affirmed that a lack of fusion indicates defectiveness, while a successful fusion does not imply a defect. However, the court found that Dr. Mitchell’s methodology did not provide medical evidence for the specific causation of Cooper's injuries, relying solely on the occurrence of a nonunion. This reasoning was deemed insufficient, especially since nonunion is a known risk in spinal fusion surgeries, regardless of the devices used. Dr. Mitchell acknowledged that the likelihood of successful fusion decreases with the number of levels fused and estimated Cooper's chance at 25%. Additionally, he did not account for S&N's claim that the screw fracture might have resulted from the nonunion rather than being a defect. The Rogozinski System's insert notes that failed fusion can lead to screw breakage. The screw fractured over six months post-surgery, raising further questions about causation. The district court noted Dr. Mitchell's generalized objections to spinal devices lacked scientific reliability. S&N's experts suggested alternative causes for the nonunion, particularly Cooper's smoking, which is documented to increase nonunion risks. The district court criticized Dr. Mitchell for dismissing the impact of smoking, leading to concerns about the reliability of his diagnosis, while Cooper argued the court misfocused on the conclusion instead of the methodology.

Medical expert opinions based on differential diagnosis should not be excluded solely because the expert has not ruled out every alternative cause of a plaintiff's illness. Instead, the presence of alternative causes typically influences the weight of the testimony rather than its admissibility. However, if an expert fails to seriously consider alternative causes or cannot justify why these alternatives are not the sole cause, the court may exclude their testimony. In this case, substantial evidence suggests that smoking is a significant cause of nonunion, supported by both medical literature and the plaintiff Cooper's own history as a long-term smoker. Dr. Murphy, Cooper's treating physician, indicated that smoking was likely the primary reason for the nonunion and emphasized the need for Cooper to stop smoking before additional surgeries. Conversely, Dr. Mitchell dismissed the role of smoking without thoroughly reviewing relevant literature and did not conduct a physical examination or consult Cooper’s treating physicians. His rejection of smoking's impact lacked a solid basis and rendered his opinion speculative. According to established legal precedent, merely asserting an opinion without rigorous examination and consideration of relevant data is insufficient for admissibility under the standards of expert testimony.

Dr. Mitchell acknowledged that his evaluation methodology for Cooper diverged from his standard practice, which typically includes a physical examination. He emphasized the necessity of a hands-on exam to determine bodily issues. Despite having access to Cooper, Dr. Mitchell opted not to perform a physical exam for litigation purposes, which contributed to the district court's assessment of his testimony as unreliable. Consequently, the court exercised its discretion to exclude Dr. Mitchell's testimony, leading to Cooper's inability to establish causation. As a result, the district court granted S&N's motion for summary judgment on all claims, affirming its judgment.

Moreover, the legal context is shaped by Rule 702, amended to align with Supreme Court rulings in Daubert and Kumho Tire, which delineate the criteria for expert testimony's admissibility. Cooper's claim of "fraud-on-the-FDA" was dismissed, as the Supreme Court ruled such claims are preempted by federal law. Additionally, the district court excluded Dr. Murphy's statement, clarifying it was an improper deposition rather than an affidavit, as it did not meet the standards outlined in the Federal Rules of Civil Procedure.