Crawford v. Zimmer Biomet Holdings, Inc.
| Decision Date | 23 February 2023 |
| Docket Number | 1:21-CV-0988 AWI CDB |
| Parties | LATONIA CRAWFORD, Plaintiff v. ZIMMER BIOMET HOLDINGS, INC., et al., Defendants |
| Court | U.S. District Court — Eastern District of California |
(DOC. NOS. 34, 36)
This is a products liability case brought by Plaintiff Latonia Crawford against Zimmer Biomet Holdings, Inc., Zimmer Biomet Inc., and Zimmer Biomet U.S., Inc. (collectively “Zimmer”). In the operative First Amended Complaint (“FAC”), Plaintiff alleges state law claims based on strict products liability, negligence misrepresentation, and breach of implied and express warranties in connection with a hip replacement. Currently before the Court is Zimmer's Rule 12(b)(6) motion to dismiss and, in the alternative, Rule 12(f) motion to strike. For the reasons that follow, the motion to dismiss will be granted in part and denied in part, and the motion to strike will be denied.
Under Federal Rule of Civil Procedure 12(b)(6), a claim may be dismissed because of the plaintiff's “failure to state a claim upon which relief can be granted.” Fed.R.Civ.P. 12(b)(6). A dismissal under Rule 12(b)(6) may be based on the lack of a cognizable legal theory or on the absence of sufficient facts alleged under a cognizable legal theory. See Yoshikawa v. Seguirant, 41 F.4th 1109, 1114 (9th Cir. 2022). In reviewing a complaint under Rule 12(b)(6), all well-pleaded allegations of material fact are taken as true and construed in the light most favorable to the non-moving party. Benavidez v. County of San Diego, 993 F.3d 1134, 1144 (9th Cir. 2021). However, complaints that offer no more than “labels and conclusions” or “a formulaic recitation of the elements of a cause of action will not do.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Benavidez, 993 F.3d at 1145. The Court is “not required to accept as true allegations that contradict exhibits attached to the Complaint or matters properly subject to judicial notice, or allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences.” Seven Arts Filmed Entm't, Ltd. v. Content Media Corp. PLC, 733 F.3d 1251, 1254 (9th Cir. 2013). To avoid a Rule 12(b)(6) dismissal, “a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.” Iqbal, 556 U.S. at 678; Armstrong v. Reynolds, 22 F.4th 1058, 1070 (9th Cir. 2022). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678; Miller v. Sawant, 18 F.4th 328, 336 (9th Cir. 2022). Plaintiffs cannot “rely on anticipated discovery to satisfy Rules 8 and 12(b)(6); rather, pleadings must assert well-pleaded factual allegations to advance to discovery.” Whitaker v. Tesla Motors, Inc., 985 F.3d 1173, 1177 (9th Cir. 2021); see Mujica v. AirScan, Inc., 771 F.3d 580, 593 (9th Cir. 2014). If a motion to dismiss is granted, “[the] district court should grant leave to amend even if no request to amend the pleading was made . . . .” Ebner v. Fresh, Inc., 838 F.3d 958, 962 (9th Cir. 2016). However, leave to amend need not be granted if amendment would be futile or the plaintiff has failed to cure deficiencies despite repeated opportunities. Garmon v. County of L.A., 828 F.3d 837, 842 (9th Cir. 2016).
From the FAC, on November 11, 2014, Crawford underwent a left hip replacement with implants manufactured by Zimmer. The hip replacement involved implanting at least five components to form a new hip joint: a taberlock femoral (made of titanium alloy), a femoral head (made of a cobalt-chromium alloy), a low profile self-tapping bone screw, an acetabular liner (made of antioxidant infused polyethylene), and a 2-hole shell (made of a titanium alloy). These components are collectively referred to as the Hip System.[1] However, between November 11, 2014 and December 26, 2014, Crawford suffered dislocations in the left hip/Hip System. After various resets, it was determined that another surgery was needed to secure the left hip.
On December 26, 2014, Crawford had an open reduction and revision of the acetabular component in response to dislocations. During this surgery, at least three components were implanted: an acetabular lock ring (made of titanium), an acetabular liner (made of antioxidant infused polyethylene), and new femoral head (made of a cobalt-chromium alloy). During the surgical procedure, it was determined that the acetabular lock ring had displaced, the acetabular liner was too low and had to be rebuilt, and the femoral head was scuffed from prior dislocations and had to be replaced.
In early 2015, Crawford's artificial hip again dislocated. The acetabulum was inspected and it was determined that the acetabular liner was fractured in multiple places. To correct the situation, Crawford underwent a surgical procedure to replace the acetabular liner. On February 24, 2015, the following components were implanted: a lock ring (made of titanium), a constrained liner (made of polyethylene and a titanium alloy constraint ring), and a modular head (made of a cobalt-chromium alloy). During this surgery, it was determined that pieces of the fractured polyethylene acetabular liner were within the acetabulum and that the ring lock mechanism had failed.
On November 23, 2019, Crawford had corrective surgery on her left hip. During the course of the surgery, it was discovered that: the Hip System had a broken metal head, the acetabular cup had broken; Crawford was suffering from metallosis (a type of metal poisoning that can occur when metal components of artificial joints fret/rub against each other and release microscopic metal particles into the blood and surrounding tissue; Crawford had pseudotumor formation round the hip and pelvis; the constrained liner was broken due to mechanical impingement with flexion; and the ring of the constrained liner was broken.
After the 2019 surgery, and in discussions with her surgeon, Crawford discovered that the Zimmer implants had failed. The failure resulted in multiple dislocations, repair surgeries, and metallosis (which is a chronic lifelong condition). Crawford never acted in a manner that contributed to the harms caused by Zimmer's implants.
The Zimmer implants used on Crawford had dissimilar metals, including titanium and cobalt-chromium alloys. The acetabular liners that failed were made of polyethylenes. Before designing the Hip System, Zimmer knew of the danger of cobalt-chromium metal debris if such debris were released into the body through fretting, corrosion, and micromotion. The Hip System has threading on the taper, and the threading has shallow grooves. The threading on the taper is for the use of a ceramic head. The taper threading protects ceramic heads and provides an interface at the junction with a metal head. However, the use of metal heads are much more likely to wear and produce debris from fretting. The threads were not designed to enhance the performance of metal heads. Zimmer's decision to allow the use of metals and cobalt-chromium heads instead of ceramic heads created an unreasonable risk and made the Hip System defective. The concept that corrosion might occur at the head-neck taper junction of a total hip prosthesis was first described in the early 1980's. Zimmer knew that the use of dissimilar metal alloys as well as taper size and geometry, trunnion surface finish, and flexural rigidity contribute to causing fretting and corrosion at the femoral head-neck/stem taper interface. Further, mechanically assisted crevice corrosion has been identified as a cause for symptomatic implant failure in metal-on-polyethylene hips. Mechanically assisted crevice corrosion produces cobalt and chromium ions and corrosive debris that can lead to adverse local tissue reaction.
Zimmer marketed its Hip System to surgeons and hospitals instead of end users like Crawford. The mechanical environment of the Hip System's junction creates an increased risk for failure due to pain, swelling, pseudotumor formation metallosis, tissue reaction, synovitis, osteolysis, and dislocation resulting from excessive wear debris, fretting, corrosion, and recurrent repassivation. Each interface introduces a contributing source for metal wear and debris generation. Each junction exponentially compounds and accelerates the wear debris generation process. Corrosion is time sensitive and accelerated with mechanical stresses. This phenomenon was known to Zimmer, or should have been known to Zimmer, at all relevant times. Zimmer also knew or should have known that the combination of metal alloys at a junction (such as the metal cobalt-chromium heads, cobalt-chromium neck/stem junctions, and/or titanium neck/stem junctions) for the Hip System generate excessive fretting, corrosion, and metal wear debris. However, Zimmer does not inform physicians or consumers that selection of a metal cobaltchromium head instead of a ceramic head to pair with either a cobalt-chromium or titanium neck/stem significantly increases the risk of toxic amounts of corrosion and metal debris, which in turn can cause pain, swelling, metallosis, trunnionosis, tissue necrosis, tissue reaction, osteolysis, dislocation, and/or the need for early revision surgery. Zimmer also did not inform physicians about its inadequate testing procedures with respect to its Hip System. Zimmer gave reassurances of product safety through promotional materials, direct promotional contact, and/or word of mouth. Despite the reassurances, the Hip System when used with a cobalt-chromium head generates excessive fretting and corrosion at the head-neck/stem taper junctions. The...
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