McDonald v. Zimmer Inc.
| Decision Date | 30 December 2019 |
| Docket Number | No. A-1-CA-36565,A-1-CA-36565 |
| Citation | 461 P.3d 930 |
| Parties | Michael Brian MCDONALD, Ph.D, Plaintiff-Appellee, v. ZIMMER INC., and Zimmer Holdings Inc., Defendants-Appellants, and Lamorris Richard Herrin, Jr. and RK Orthopedics, LLC, Defendants. |
| Court | Court of Appeals of New Mexico |
McGinn, Montoya, Love & Curry P.A., Randi McGinn, Katie Curry, Albuquerque, NM, Kerry Kiernan, P.C., Kerry Kiernan, Albuquerque, NM, for Appellee
Rodey, Dickason, Sloan, Akin & Robb, P.A., Nelson Franse, Krystle A. Thomas, Edward Ricco, Albuquerque, NM, Faegre Baker Daniels LLP, Michael J. Kanute, Chicago, IL, Bruce Jones, Minneapolis, MN, for Appellants
{1} Zimmer Inc. and Zimmer Holdings Inc. (collectively, Defendants) appeal the district court’s finding of strict liability for a design defect in the hip prosthetic implanted in Brian McDonald (Plaintiff). Following a bench trial, the district court concluded that the design of the prosthetic was unreasonably dangerous, in that it shed excessive metal debris, causing poisoning and death of the soft tissue in Plaintiff’s hip joint, requiring Plaintiff to have additional hip surgeries and ongoing (potentially lifelong) antibiotic treatment. Defendants argue on appeal that (1) the district court erred in its findings and conclusions concerning a design defect; and (2) the hip prosthetic is an unavoidably unsafe product, for which adequate warnings were given, such that Defendants are not subject to strict liability, pursuant to comment k to the Restatement (Second) of Torts § 402A (1965). Defendants seek judgment as a matter of law, or a new trial. For the reasons set forth below, we affirm the district court.
{2} Plaintiff filed a lawsuit against Defendants, and co-defendants Lamorris Richard Herrin, Jr., and RK Orthopedics, LLC, on May 9, 2013. The complaint arose from Plaintiff’s injuries in connection with the failure of his hip implant, a prosthetic device designed and manufactured by Defendants. The claims tried before the district court in December 2016, in a bench trial, sounded in strict liability (design defect and failure to warn), negligence, breach of express and implied warranties, and punitive damages. The district court found Defendants strictly liable for a design defect in the prosthetic device, and dismissed all other claims, including those against co-defendants Herrin and RK Orthopedics.1
{3} In 2010 Plaintiff was diagnosed with severe osteoarthritis with flattening of the femoral head, osteophyte formation, and cystic formation. Plaintiff consulted with orthopedic surgeon Joshua Carothers, M.D., and elected to have total hip replacement surgery.2 Dr. Carothers had originally planned to use a single-modular prosthetic device for Plaintiff’s hip replacement—a Zimmer brand "M/L Taper with VerSys head." "Single-modular" describes a device with a fixed or solid neck-stem3 component (the component anchored to the femur) coupled with an artificial head (replacing the "ball" of the natural hip joint). Zimmer’s device, which included a titanium alloy neck-stem component, and a cobalt-chromium alloy (CoCr) head component, was (at the time) considered the "gold standard" in total hip replacement. However, during the surgery in June 2010, Dr. Carothers had to make certain adjustments to accommodate Plaintiff’s anatomy, and decided to use a dual-modular device instead: the Zimmer brand "M/L Taper Hip Prosthesis with Kinectiv Technology" (MLTK).4 The MLTK is a "dual-modular" device because the neck and stem components of the prosthetic are separate and can be adjusted, both in relationship to the head and to one another, to account for variations in joint configuration (e.g., leg length, offset, and version, which refers to the forward or backward rotation of the hip joint). In Plaintiff’s case, these options allowed Dr. Carothers to choose an anteverted neck (one with a forward rotation) for Plaintiff’s implant. Like the traditional M/L Taper, the MLTK’s neck and stem are made of titanium alloy. The MLTK can be used with either a CoCr head (such as the VerSys) or a ceramic head. Dr. Carothers used the CoCr head.
{4} Plaintiff initially recovered well, but by early May 2011, Plaintiff was experiencing hip pain, groin pain, and loss of flexibility. Dr. Carothers commenced an established series of tests to determine the cause of Plaintiff’s pain, which showed, inter alia, that Plaintiff had elevated levels of C-reactive protein (indicating tissue necrosis, or tissue death), and a pseudotumor5 forming in the hip joint. Plaintiff then saw Christopher Beauchamp, M.D., at the Mayo Clinic in Phoenix, Arizona, on September 2, 2011, where Dr. Beauchamp diagnosed Plaintiff with an adverse reaction to metal debris, associated with the MLTK implant, and scheduled Plaintiff for revision surgery. Dr. Beauchamp ordered a blood serum test, which revealed slightly elevated chromium levels, and significantly elevated (tenfold the normal level) cobalt levels. Dr. Beauchamp performed a revision surgery on Plaintiff’s right hip joint on October 4, 2011, during which he discovered corrosion6 and metal debris at the taper junction of Plaintiff’s MLTK prosthetic, as well as burnishing on the neck component at the second (neck-stem) junction, necrotic (dead) tissue, and turbid (cloudy) joint fluid. Dr. Beauchamp’s pre-operative and post-operative diagnoses were failed total hip replacement secondary to adverse reaction to metal debris caused by the CoCr head on the hip prosthetic articulating with the titanium trunnion (the top of the neck, where it couples with the head). Such adverse reaction is also known as metallosis or adverse local tissue reaction.
{5} Dr. Beauchamp revised the hip by exchanging the CoCr head for a ceramic head; he also replaced the Kinectiv neck component and the polyethylene liner (which rests between the head and the cup). Dr. Beauchamp was unable to remove all of the necrotic tissue around Plaintiff’s right hip, because removing too much tissue leaves a patient at risk for joint dislocation ; however, retaining necrotic tissue poses a risk of infection, given the lack of blood circulation to the dead tissue. In fact, Plaintiff developed an infection following this revision surgery, requiring a second revision surgery, performed by Dr. Carothers. Dr. Carothers performed an irrigation and debridement for the infection and replaced the Kinectiv neck and polyethylene liner. He also replaced the ceramic head from the first revision surgery with a new ceramic head.7 Plaintiff has required and may permanently require antibiotic therapy due to his continued risk for infection. It is probable that Plaintiff will require a third, more complicated revision surgery in the future to eradicate the infection.
{6} Single-modular hip prostheses have been widely used since the early 1980s, but dual-modular prostheses were not developed until approximately twenty years later. Indeed, when Defendants launched the development of the MLTK in 2001 (through a project known as "G2"), it was a new design and a "new frontier" for Defendants. Defendants employed multiple engineers and approximately twenty consulting surgeons on the design team. The MLTK was intended to be minimally invasive, to offer a wider range of adjustments to surgeons, and to provide greater flexibility within the joint. Defendants designed the titanium neck and stem components to be used with either a CoCr or a ceramic head component. The MLTK offers a total of sixty possible configurations.
{7} Hip implants fail for a variety of reasons, including but not limited to dislocation, fracture, loosening, infection, and metallosis. Some degree of corrosion occurs in all modular hip implants. Although there is no consensus as to why some patients with a corroding implant develop metallosis, while others do not, it is well understood that more corrosion/metal debris increases the risk of developing metallosis. Defendants were aware the particular characteristics of the MLTK would increase the risk of micro-motion, and therefore corrosion and liberated metal debris from junctions of the prosthetic. Specifically, the MLTK features (1) two modular junctions, and therefore an additional location where corrosion may occur; (2) a junction between two dissimilar metals (known to generally pose a higher risk of corrosion than junctions between similar metals); (3) a neck that is thinner in two planes and more flexible8 than a traditional neck (increasing the likelihood of fretting corrosion); and (4) optional adjustments in length and version that may increase the bending moment9 in the neck (further increasing the likelihood of fretting corrosion).
{8} Accordingly, one of the design goals for the MLTK was to minimize corrosion at the head-neck and neck-stem junctions, with the goal that the metal debris released by the device would be within "known acceptable levels." However, no reasonable level for wear debris was, in fact, known. Defendants elected to define "known acceptable level[s]" through a "clinically proven" predicate device: the traditional M/L taper with a CoCr (VerSys) head, and six-inch tapered titanium neck (a single-modular device). This device, according to Defendants’ research report on the MLTK, had a "long clinical history of exhibiting some debris generation without adverse clinical effects." Defendants therefore designed a test (known as an accelerated corrosion fatigue test10 ) that would quantify the "worst case" metal debris released by the predicate device, which was determined to be 5.62 milligrams. Defendants reasoned that, if the debris generated by the "worst case" orientation of the MLTK in a similar environment was below 5.62 milligrams, the MLTK would, like the predicate device, avoid adverse clinical effects.11
{9} At trial Defendants explained that they ran corrosion fatigue testing on the two...
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