NOBLES v. DEPUY SYNTHES SALES INC (2020)

ORDER

This matter comes before the Court on Defendants’ motion for summary judgment, arguing that Plaintiffs have failed to offer sufficient evidence that the product in question, a mandibular reconstruction plate used as a temporary fixation device in complex cancer surgery, is defective and unreasonably dangerous or that Plaintiff's injuries were proximately caused by the alleged defect. (Dkt. Nos. 51; 51-20). Defendants further assert that Plaintiff's primary expert witness, Dr. Reed Ayers, PhD., a metallurgist and aerospace engineer, lacks sufficient knowledge, expertise and valid methods to offer reliable expert testimony regarding the product under challenge and his testimony should be disallowed under Rule 702 of the Federal Rules of Evidence. (Dkt. No. 51-20). Plaintiffs have filed a memorandum in opposition, arguing that Dr. Ayers’ opinions, experience and methods meet legal standards for reliable expert testimony and that there is a material dispute of fact regarding whether the product is defective, making disposition by summary judgment inappropriate. (Dkt. No. 54).

Factual Background

Plaintiff Michael Stewart Nobles underwent surgery at the Medical University of South Carolina on April 3, 2014 to remove a cancerous tumor from his mandible and to harvest bone from his left radius to replace bone destroyed by the cancer. (Dkt. No. 51 at 7). The surgery was described as “some of the longest done in modern medicine” and requires teams of surgeons to participate. (Dkt. No. 51-4 at 4–5). In Mr. Nobles’ surgery, seven centimeters of mandible bone had to be removed. (Id.) The mandibular reconstruction plate, the product at issue in this litigation, was then contoured intraoperatively into the patient's remaining mandible, with a gap in the middle filled by the harvested bone from the radius. (Dkt. No. 54-2 at 28–29). The plate was designed as a temporary device to hold the bones in the immediate operative area in place while the bones healed and adhered to the remaining portion of the mandible. (Dkt. No. 51-3 at 40–44).

The Defendants’ mandibular plate is made of pure titanium, a material that combines strong tensile strength with the ability of surgeons to contour the device into the specific physical space needed once the cancerous bone is removed. Pure titanium is widely used in the medical product field for mandibular reconstruction surgery because of its combination of strength and capacity to be manipulated by surgeons in the course of their procedure. (Dkt. No. 51-1 at 13–14, 16–17; 51-13 at 12–13).

It is well-known that any such temporary metal device can fail if normal healing does not occur. The package insert for the FDA approved product expressly warns that “[t]hese devices can break when subjected to the increased loading associated with delayed union or nonunion ․ If healing is delayed, or does not occur, the implant could eventually break due to metal fatigue.” (Dkt. No. 51-2 at 2).

Mr. Nobles followed his April 3, 2014 surgery with radiation therapy to attack and destroy any remaining cancer cells. The patient was informed beforehand that one of the risks of radiation treatment is that it can impair healing. (Dkt. No. 51-8 at 9–11). A CT scan of July 31, 2014 revealed that the plate had broken and was subsequently removed and replaced in another surgery in November 2014. (Dkt. No. 54-2 at 79–80; Dkt. No. 51-3 at 31). This new plate also required removal because of a lack of healing. The patient thereafter underwent hyperbaric oxygen treatments to address his ongoing problems with non-healing. (Dkt. No. 51-4 at 31–35). Additional surgery was performed in January 2016 in which bone was harvested from the patient's thigh, and this surgery developed post-operative complications in which Mr. Nobles was hospitalized for nearly two months. (Dkt. No. 51-3 at 56–58, 60–64).

Plaintiffs filed suit against Defendants, manufacturers, and distributors of the mandibular reconstruction plate, asserting that the use of pure titanium, rather than a titanium alloy, rendered the product defective and unreasonably dangerous for its intended use. (Dkt. No. 1). Plaintiffs offered a single expert witness regarding product design, Dr. Ayers, a metallurgist, to attest to the defectiveness of the product based on the Defendants’ use of pure titanium instead of a titanium alloy in the product. As the Plaintiffs explained in their brief in opposition to the motion for summary judgment, their “theory is simple: the design of the subject device is defective because it is constructed from commercially pure titanium ․,” rather than a titanium alloy. (Dkt. No. 54 at 1–2).

Dr. Ayers makes no claim of any special expertise or specialized knowledge regarding the particular surgery in question or the demands on the surgeon to contour the plate in real time intraoperatively in the midst of this complex and physically demanding surgery. While Dr. Ayers has done some research and presented on the failure of spinal rods, he has done no prior work on mandibular reconstruction plates and reached his opinions regarding the need for titanium alloy metals for this product only after being retained by Plaintiffs. (Dkt. No. 51-12 at 10, 11–12, 14, 17, 18, 19–20, 21). He has presented no peer reviewed articles in the medical and medical product literature reaching such an opinion. He has also not tested the use of a mandibular reconstruction plate made of titanium alloy to determine if it would also fail under the specific forces at issue in Plaintiff's case, where non-union of the bone occurred. (Id. at 38).

Defendants’ primary product design expert, Dr. Jack E. Lemons, PhD., has served for over fifty years at the University of Alabama at Birmingham (“UAB”) in which his teaching and research have focused on the evaluation and testing of metallic implants similar to the product at issue in this case. (Dkt. No. 51-13 at 1–4, 8). In addition to his academic work as an engineer, he had participated in a fellowship in medicine sponsored by the National Institutes of Health and an additional fellowship in dentistry, which provides him a clinical understanding of medicine and dentistry. (Id. at 8). He served for many years as chairmen of the UAB Department of Biomaterials and director of its laboratory research program in orthopedic surgery. (Id.) Dr. Lemons’ work in the study of fatigue and corrosion of dental implants dates back to the 1960's. (Dkt. No. 51-13 at 2–3, 8).

Dr. Lemons stated that the use of pure titanium “was correct and appropriate for this device and treatment” because of prior successful clinical experience, the “consensus” use of the material in the device in the industry, and the ability of the material “for adaptation to the surgical site permitting necessary adjustments by the surgeon, such as bending, for placement at the time of surgery.” (Id. at 12-13). Defendants do not dispute that titanium alloy has greater tensile strength than pure titanium but assert that titanium alloy is inferior to pure titanium in the ability to perform intraoperative manipulation critical for the successful contouring of the plate. (Dkt. No. 51-1 at 12-14).

Defendants have moved for summary judgment, asserting that Plaintiffs’ sole product design expert lacks the requisite skill, knowledge and training to offer a reliable opinion and that such opinions are not based on reliable data and other evidence. (Dkt. No. 51-20 at 2–3). Plaintiffs oppose the motion, asserting the issue is a simple one that turns on the greater tensile strength of titanium alloy and that the use of pure titanium renders the product per se defective. (Dkt. No. 54 at 1–2).

Legal Standard

A. Summary Judgment

Summary judgment is appropriate “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). Only material facts—those “that might affect the outcome of the suit under governing law”—will preclude the entry of summary judgment. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 2148, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A dispute about a material fact is genuine “if the evidence is such that a reasonable jury could return a verdict for the non-moving party.” Id. At the summary judgment stage, the court must “construe the evidence, and all reasonable inferences that may be drawn from such evidence, in a light most favorable to the nonmoving party.” Dash v. Mayweather, 731 F.3d 303, 310 (4th Cir. 2013). However, the nonmoving party must rely on more than conclusory allegations, mere speculation, the building of one inference upon another, or the mere existence of a scintilla of evidence.” Id. at 311.

B. Expert Testimony

It is well settled under South Carolina law that expert testimony is required where the subject is beyond the common knowledge of the jury. Babb v. Lee County Landfill SC, LLC, 405 S.C. 129, 747 S.E.2d 468, 481 (S.C. 2013). The trial court determines whether expert testimony is required, based on the particular facts of the case, including the “complexity and technical nature of the evidence to be presented ․” Id.

Under F.R.E. 702, the Court acts as a gatekeeper, “to verify that expert testimony is based on sufficient facts or data.” E.E.O.C. v. Freeman, 778 F.3d 463, 472 (4th Cir. 2015). The expert testimony must be shown to be “not only relevant, but reliable.” Daubert v. Merrell Dow Pharm. Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). “Because expert witnesses have the potential to be both powerful and quite misleading, it is crucial that the district court conduct a careful analysis into the reliability of the expert's proposed opinions.” United States v. Fultz, 591 Fed. Appx. 226, 227 (4th Cir. 2015).

The trial court must ensure that (1) “the testimony is the product of reliable principles and methods,” (2) “the expert has reliably applied the principles and methods to the facts of the case,” and (3) the “testimony is based on sufficient facts and data.” F.R.E. 702(b), (c), (d). “This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid,” Daubert, 509 U.S. at 592-93, 113 S.Ct. 2786, and whether the expert has “faithfully appl[ied] the methodology to the facts.” Roche v. Lincoln Prop. Co., 175 Fed. Appx. 597, 602 (4th Cir. 2006). Additionally, the Court must evaluate any proposed expert testimony under the standards of F.R.E. 403 to determine whether the probative value of the evidence, if relevant, is substantially outweighed by the risk of misleading or confusing the jury.

Factors to be considered in assessing the reliability of technical or scientific evidence include “whether a theory or technique ․ can be (and has been) tested,” “whether the theory or technique has been subjected to peer review and publication,” the “known or potential rate of error,” the “existence and maintenance of standards controlling the technique's operations,” and whether the theory or technique has garnered “general acceptance.” Daubert, 509 U.S. at 593–94, 113 S.Ct. 2786. The Daubert factors are not exhaustive and illustrate the type of factors “that will bear on the inquiry.” United States v. Hassan, 742 F.3d 104, 130 (4th Cir. 2014). Courts have also considered whether the “expert developed his opinions expressly for the purposes of testifying or through research conducted independent of litigation.” Wehling v. Sandoz Pharm. Corp., 162 F.3d 1158, 1998 WL 546097, at *3 (4th Cir. 1998); Daubert v. Merrell Dow Pharm. Inc., 43 F.3d 1311, 1317 (9th Cir. 1995) (on remand). The proponent of the expert testimony carries the burden to establish the admissibility of the testimony by a preponderance of the evidence. Cooper v. Nephew, Inc., 259 F.3d 194, 199 (4th Cir. 2001).

Discussion

Under South Carolina law, “in order to find liability under any products liability theory, a plaintiff must show: (1) he was injured by the product; (2) the injury occurred because the product was in a defective condition, unreasonably dangerous to the user; and (3) that the product at the time of the accident was in essentially the same condition as when it left the hands of the defendant.” Bragg v. Hi–Ranger, Inc., 319 S.C. 531, 462 S.E.2d 321, 326 (1995). “Product liability actions require proof that the ‘injury occurred because the product was in a defective condition, unreasonably dangerous to the consumer.’ ” Jones v. Danek Med., Inc., No. 96-3323-12, 1999 WL 1133272, at *6 (D.S.C. 1999) (quoting Bragg, 462 S.E.2d at 326). To establish defect and unreasonable danger in a medically complex case, plaintiff must come forward with relevant and reliable expert testimony on these issues. See Daubert, 509 U.S. at 589, 113 S.Ct. 2786.

Upon a review of the record in a light most favorable to the non-moving party, Plaintiffs have failed to proffer the expert testimony that is required to establish that the mandibular reconstruction plate was defective and unreasonably dangerous, and that the product was the proximate cause of the alleged injuries. A careful review of this record reveals that the choice of metal to be used in a mandibular reconstruction plate is a complex, multi-dimensional decision in which the product's tensile strength must be balanced against the practical need of the surgeon to manipulate and contour the plate in the midst of a long and demanding cancer surgery. Plaintiff's expert, Dr. Ayers, while unquestionably an able metallurgist, treats this issue as a one-dimensional problem, the relative strength of titanium alloy vs. titanium. He does not meaningfully address the need for contourability of the plate or the challenges of the surgeon to mold the plate into place intraoperatively because he has no substantial professional knowledge or expertise in this field. He points to no peer reviewed article reaching his conclusion that a mandibular reconstruction plate made of pure titanium is per se defective, and his own opinions were formed and reached in this matter only after being retained by Plaintiffs as an expert. While widespread acceptance of a particular product design is not the end of the discussion about the reliability of an expert's opinion, the lack of limited or no support in the field for the expert's opinion can properly cause a court to look with skepticism regarding the proffered expert's opinions. Daubert, 509 U.S. at 594, 113 S.Ct. 2786.

The Court finds, pursuant to F.R.E. 702, that the opinions of Dr. Ayers regarding the alleged defect in the product due to the use of pure titanium are not reliable. The Plaintiffs’ expert lacks the professional expertise to address this multi-dimension problem, and his approach of simply looking at tensile strength has the potential of misleading the jury. Dr. Ayers has not employed proper methods and has not marshalled adequate data and other evidence to support his opinions. His opinions have not adequately addressed the complex demands of the mandibular reconstruction surgery, which are plainly beyond his training and expertise. This finding of lack of reliability provides a sufficient basis alone to disallow the testimony of Dr. Ayers in this matter. Disher v. Synthes (U.S.A.), 371 F. Supp. 2d 764, 770–71 (D.S.C. 2005) (rejecting expert's assertions regarding product's internal titanium alloy and screw holes as conclusory and insufficient to withstand summary judgment in part because expert was a metallurgist with no experience designing medical implants and expert failed to perform meaningful risk-analysis test that a feasible alternative design existed.). The Court further finds that Dr. Ayers’ opinions should be disallowed under F.R.E. 403 because any probative value is substantially outweighed by the danger of misleading and confusing the jury.

A second and independent basis to disallow Dr. Ayers’ testimony is that he has not performed sufficient testing of his opinions to determine whether a different result would have occurred if titanium alloy had been used in this product. All recognize that metal fatigue can occur with any titanium or titanium alloy product. Dr. Ayers has not undertaken any testing regarding whether the use of titanium alloy would have produced a different result and can point to no such testing by others. As the Supreme Court observed in Daubert, “[o]rdinarily, a key question to be answered in determining whether a theory or technique is scientific knowledge that will assist the trier of fact will be whether it can be (and has been) tested.” 509 U.S. at 593, 113 S.Ct. 2786. In the absence of such testing, Dr. Ayers’ opinions represent little more than a hunch or hypothesis, which are certainly not a sufficient basis for an expert witness to offer an opinion under F.R.E. 702.

The issues of the proper design of the product in question and whether the use of pure titanium renders the product defective are matters outside the lay expertise of jurors. Consequently, with the disallowance of Dr. Ayers’ expert testimony, Plaintiffs lack an expert witness to render a legally acceptable opinion under Rule 702 regarding any alleged defect in the design of the product. Disher, 371 F. Supp. 2d. 764 (explaining that to survive summary judgment it is crucial that a Plaintiff also demonstrate that a “feasible” or workable, design alternative exists under the circumstances). As such, Defendants are entitled to summary judgment.

Conclusion

Based on the foregoing, Defendants’ motion for summary judgment (Dkt. No. 51) is GRANTED. This case is dismissed with prejudice.

AND IT IS SO ORDERED.

Richard M. Gergel, United States District Judge