Bayes v. Biomet, Inc.
| Decision Date | 28 August 2020 |
| Docket Number | Case No. 4:13-cv-00800-SRC |
| Parties | MARY BAYES and PHILIP BAYES, Plaintiff(s), v. BIOMET, INC., et al., Defendant(s). |
| Court | U.S. District Court — Eastern District of Missouri |
In 2008, Plaintiff Mary Bayes had both her hips replaced with artificial hip implants designed, manufactured, and sold by Defendant Biomet Orthopedics, LLC. After her hip replacements, she encountered severe complications requiring numerous additional hip surgeries. In 2013, she filed suit against Biomet seeking relief for her injuries. Today, 12 years after her hip replacements and seven years since she filed suit, Plaintiff's case is on the verge of trial. The parties have filed a bevy of motions, including cross-motions for summary judgment and eight different motions to exclude expert testimony. In this Order, the Court takes up [124] Biomet's motion for summary judgment and [107] Biomet's motion to exclude Plaintiffs' case-specific causation experts.
Mary's1 doctor implanted Biomet's M2a Magnum hip implants. In time, Mary began experiencing problems with her hips, and believing the Biomet implants were the cause, Mary and her husband, Philip Bayes, filed their Complaint in this Court. Doc. 1. Due to the volume ofBiomet hip-implant cases, an MDL was created in the United States District Court for the Northern District of Indiana to handle pretrial matters for all cases involving Biomet's M2a line. See Doc. 18. The Judicial Panel on Multidistrict Litigation transferred Plaintiffs' case to the MDL for pretrial matters. Doc. 11. In September 2018, the MDL Court remanded Plaintiffs' case to this Court for trial.
This Court must decide the remaining aspects of the case, including the present cross-summary judgment motions and several case-specific Daubert motions. Biomet moves to exclude Plaintiffs' case-specific causation experts and for summary judgment on all of Plaintiffs' claims. Because Biomet's motion to exclude Plaintiffs' causation experts is potentially dispositive of the summary judgment motion, the Court considers these motions together.
Mary began experiencing pain in her right hip in 2007, at age 58. She was referred to an orthopedic surgeon, Dr. Daniel Martin, for further evaluation. X-rays showed degenerative changes in Mary's right and left hips. Mary first began a course of non-operative treatment, including physical therapy. When her pain continued to worsen, Mary elected to undergo a total hip replacement of her right hip. Martin selected the Biomet M2a Magnum implant for Mary's hip replacement surgery.
Martin performed Mary's right total hip replacement in January 2008. Approximately four months later, Mary elected to also undergo a left hip replacement to address her worsening left hip pain. Martin performed Mary's left total hip replacement in April 2008, again using the Biomet M2a Magnum implant. A few years later, Mary began experiencing problems with her hips. Understanding the case requires the Court to explain the M2a Magnum hip implant and related issues, as well as Mary's post-implant symptoms and medical care.
The Court provides a somewhat simplified, plain-English explanation of a few basic hip-implant concepts. To begin, the femur—the bone going into the hip socket—moves in many directions: up and down (think of raising your knee), side to side (think of swinging your leg left to right), and it rotates (think of moving your leg in a circle). Next, the surgeon attaches the hip-implant pieces to parts of the patient's bones. Because the femur moves in so many directions, the angles at which the surgeon attaches the implant pieces to the bones matter: too much of an angle one way or the other can cause problems for the patient. Other issues can cause problems for the patient, too, such as the implant moving over time in the patient's body, causing the attachment angles to change. And, the hip implants themselves may have defects that cause problems. In this case, the Bayeses claim that defects in Biomet's M2a Magnum implant caused Mary's problems, while Biomet claims that the surgeon attached the implants at the wrong angles, which caused Mary's problems.
The M2a Magnum contains three components: a ball-shaped femoral head (which is attached to the end of the femur, the elongated bone extending from the hip to the knee), a taper insert (used to attach the head of the implant to the femur), and an acetabular cup (which is seated in the hip). The femoral head joins with the acetabular cup like a ball in a cup, forming the joint of the implanted hip replacement. The M2a Magnum's femoral head and acetabular cup are made from cobalt chrome molybdenum alloy. The taper insert is made of a titanium alloy. Because the M2a Magnum uses all metal components, it is referred to as a "metal-on-metal" implant. Some other hip implants available on the market use different material construction, including ceramic-on-ceramic, ceramic-on-polyethylene, and metal-on-polyethylene.
Biomet included Instructions for Use with Mary's M2a Magnum implants. The Instructions for Use note that implantation of the M2a Magnum can result in particulate wear debris leading to "material sensitivity reactions" including osteolysis (bone degeneration), genotoxicity (damage to genetic information in cells), and metal hypersensitivity (immune disorder associated with contact with certain metals). Doc. 148-10. The Instructions for Use also note elevated metal ion levels as a possible adverse effect, but state that the long-term effects of metal ions are "unknown." Id. Other possible adverse effects listed in the Instructions for Use include infection and allergic reaction, loosening or migration of the implants, fretting and crevice corrosion, and wear and/or deformation of articulating surfaces. Id. The Instructions for Use also warn that improper alignment of the M2a Magnum components "may lead to excessive wear and/or failure of the implant or procedure." Id. Martin did not read the M2a Magnum Instructions for Use before either of Mary's hip replacement surgeries.
Biomet also provides a Surgical Technique for use with the M2a Magnum, which among others explains angles at which the surgeon should attach the implant pieces to the patient's body: "Placing the cup at 40-45 degrees of abduction and 15-20 degrees of anteversion should provide optimal range of motion." Doc. 168-1. The "cup" part of a hip implant resembles a hollow sphere cut in half. Abduction and anteversion angles measure the position of the open side of the cup when it is implanted in the hip. A higher abduction angle means the open side is more vertical in the body. Similarly, anteversion measures the left-to-right rotation of the open side of the cup. While the parties dispute whether the angles stated in the Surgical Technique are the "correct" or the "optimal" angles, suffice it to say thatthe angles of attachment play a role in the patient's experience with the implant. The record contains no evidence that Martin reviewed Biomet's M2a Magnum Surgical Technique.
Mary had no input in selecting the implant used for her hip replacement surgeries. She trusted Martin to make that decision. Mary did not review any Biomet promotional material or speak to any Biomet representatives before her hip replacement surgeries.
Martin testified that he selected the Magnum M2a in part because he believed, at the time of Mary's hip implants, that metal-on-metal devices generated a smaller volume of wear debris than other devices. Doc. 148-14 at 22:23-23:5. The record contains no evidence that Martin ever reviewed advertisements or other promotional material regarding the M2a Magnum. He testified that advertisements from device manufacturers "don't change [his] method of practice." Doc. 126-3 at 11:13-20. Biomet produced a marketing brochure for the M2a Magnum. The brochure included a graphic depicting two piles of particles, one far larger than the other. Doc. 148-20. A caption under the graphic states: "The above photos are representative of 25-years cumulative metal-on-metal wear debris vs. 25-years of cumulative polyethylene wear debris." Id.
Martin testified that he relied on professional meetings and medical literature to alert him of the potential risks of implant devices. Doc. 148-14 at 62:15-23. He also testified that he consults manufacturer sales representatives if an implant uses "different technology" or requires a novel surgical technique. Id. Martin interacted regularly with a Biomet sales representative, Jacob Weible. Weible testified that he could not recall ever receiving training from Biomet about the risks associated with elevated metal ion levels. Doc. 148-16 at 28:10-29:11. Sometime prior to 2004, Biomet sent a field communication to its sales representatives instructing them to "change the subject" if doctors raised metal ion concerns. Doc. 148-19.
Martin implanted the M2a Magnum in Mary's left hip on April 28, 2008. The same day, his colleague reviewed Mary's post-surgery X-rays and determined that the left hip was in the "expected radiographic position." Doc. 148-9. At Mary's two-week follow-up, Martin noted that the left hip implant was "in good position." Id.
Around three years later, Mary began experiencing progressively worsening pain in her left hip. In November 2010, Mary sought a second orthopedic surgeon opinion from Dr. Jeffrey Martin. On X-rays, Dr. Jeffrey Martin observed that Mary's left acetabular cup was abducted 60-65 degrees and the right cup was abducted approximately 45 degrees. Dr. Jeffrey Martin noted concern that Mary "may have an issue with metal-on-metal...
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