Fitzsimmons v. Biomet Orthopedics, Inc.

MARK FITZSIMMONS, Plaintiff, v. BIOMET ORTHOPEDICS, INC., BIOMET, INC., and BIOMET MANUFACTURING CORP., Defendants.

Case No: 2:19-cv-182-FtM-29NPM

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA FORT MYERS DIVISION

January 21, 2021

OPINION AND ORDER

This matter comes before the Court on the defendants' Dispositive Motion for Summary Judgment and Memorandum of Law (Doc. #121) filed on October 2, 2020. Plaintiff filed a Memorandum in Opposition (Doc. #135) on October 16, 2020, to which defendants' filed a Reply (Doc. #140) on October 23, 2020. For the reasons set forth below, the motion is granted in part and denied in part.

I.

A. Factual Background¹

In December 2008, plaintiff Mark Fitzsimmons underwent asurgical procedure to implant an M2a Magnum hip device. (Doc. #121, pp. 2-3; Doc. #135, p. 1.) The M2a Magnum is a metal-on-metal articulating device designed, manufactured, and sold by defendants (collectively "Biomet"). (Doc. #1, ¶¶ 3-5; Doc. #121, p. 2; Doc. #135, p. 1.) The M2a Magnum consists of several components made of a titanium alloy and a cobalt-chrome-molybdenum alloy. (Doc. #121-4, p. 254.) Prior to the procedure, the implanting surgeon discussed the risks with plaintiff, but did not warn about the health effects of metal wear or metallosis. (Doc. #121, p. 2; Doc. #121-1, pp. 65-69; Doc. #121-3, p. 203; Doc. #135, p. 1.) Following the surgery, plaintiff was essentially pain free for approximately eight years. (Doc. #121-1, p. 81.)

In the summer of 2016, plaintiff began hearing a clicking and squeaking noise from his hip and started experiencing pain. (Id. pp. 83-84.) A subsequent blood test revealed plaintiff had "excessively high" metal ion levels. (Id. p. 88; Doc. #135-6, p. 68.) Specifically, plaintiff's cobalt serum level was 184.3 and his chromium serum level was 112.2 micrograms per liter; normal levels are .1 to .4 and less than 1.4, respectively. (Doc. #135-6, p. 69.) Based on these numbers, revision of the Magnum M2a was medically necessary and conducted in April 2017. (Id. pp. 69-71.) Plaintiff's postoperative diagnosis included a failed total hip, excessively high cobalt and chromium levels, and significant metallosis. (Id. pp. 71-72.)

B. Procedural Background

In May 2017, plaintiff filed a five-count Complaint against Biomet, alleging claims of (1) strict liability for (a) manufacturing defects, (b) design defects, and (c) inadequate warnings, (2) negligence, (3) breach of implied warranties, (4) breach of express warranty, and (5) failure to warn. (Doc. #1, pp. 7-14.) As relief, plaintiff seeks, inter alia, compensatory and punitive damages. (Id. p. 14.)

Plaintiff's case, one of thousands filed against Biomet, was consolidated for pretrial proceedings into a Multi-District Litigation (MDL) action in the United States District Court for the Northern District of Indiana. In re: Biomet M2A Magnum Hip Implants Prods. Liab. Litig., 896 F. Supp. 2d 1339 (J.P.M.L. 2012). After considerable pretrial proceedings in the MDL court, the case was transferred back to this district in February 2019. (Doc. #56; Doc. #57.) The parties then engaged in case-specific discovery until September 2020, and the matter is set for trial in June 2021. (Doc. #108; Doc. #150.)

On October 2, 2020, Biomet filed the summary judgment motion currently before the Court. (Doc. #121.) For various reasons, the motion argues Biomet is entitled to summary judgment on all of plaintiff's claims, and that the request for punitive damages should be dismissed. (Id. pp. 1-25.) In his Memorandum, plaintiff notes that he does not oppose summary judgment on the manufacturingdefect claim, nor the breach of implied and express warranty claims. (Doc. #135, p. 1.) However, plaintiff argues there are material disputes of fact preventing summary judgment on the design defect and failure to warn claims, as well as sufficient evidence to support an award of punitive damages. (Id. pp. 1-18.)

II.

Summary judgment is appropriate only when the Court is satisfied 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). "An issue of fact is 'genuine' if the record taken as a whole could lead a rational trier of fact to find for the nonmoving party." Hickson Corp. v. N. Crossarm Co., Inc., 357 F.3d 1256, 1260 (11th Cir. 2004) (citation omitted). A fact is "material" if it may affect the outcome of the suit under governing law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). "A court must decide 'whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.'" Hickson, 357 F.3d at 1260 (quoting Anderson, 477 U.S. at 251).

In ruling on a motion for summary judgment, the Court views all evidence and draws all reasonable inferences in favor of the nonmoving party. Tana v. Dantanna's, 611 F.3d 767, 772 (11th Cir. 2010). However, "[i]f reasonable minds might differ on theinferences arising from undisputed facts, then the court should deny summary judgment." St. Charles Foods, Inc. v. America's Favorite Chicken Co., 198 F.3d 815, 819 (11th Cir. 1999) (quoting Warrior Tombigbee Transp. Co. v. M/V Nan Fung, 695 F.2d 1294, 1296-97 (11th Cir. 1983)). "If a reasonable fact finder evaluating the evidence could draw more than one inference from the facts, and if that inference introduces a genuine issue of material fact, then the court should not grant summary judgment." Allen v. Bd. of Pub. Educ. for Bibb Cty., 495 F.3d 1306, 1315 (11th Cir. 2007).

III.

A. Design Defect

The first count of the Complaint alleges strict product liability, asserting that the M2a Magnum "was in a defective and unreasonably dangerous condition at the time it was placed in the stream of commerce." (Doc. #1, ¶ 26.) Specifically, plaintiff alleges the M2a Magnum

was not reasonably safe for the intended use, subjecting Plaintiff and others to risks, including the risk that the acetabular component would not properly grow into the bone, causing the hip system to prematurely fail and requiring a complex, risky, and painful surgery to remove and replace the defective product[.]

(Id.)

A product may be defective by virtue of a design defect, a manufacturing defect, or an inadequate warning. Jennings v. BIC Corp., 181 F.3d 1250, 1255 (11th Cir. 1999). "In order to hold amanufacturer strictly liable for a design defect, the plaintiff must establish: (1) the manufacturer's relationship to the product in question; (2) a defect in the product; and (3) proximate cause between the defective product and the plaintiff's injury." Jozwiak v. Stryker Corp., 2010 WL 743834, *6 (M.D. Fla. Feb. 26, 2010) (citing West v. Caterpillar Tractor Co., Inc., 336 So. 2d 80, 87 (Fla. 1976)).²

Biomet first argues it is entitled to summary judgment on the design defect claim because of "lack of admissible expert testimony establishing medical causation." (Doc. #121, p. 8); see Payne v. C.R. Bard, Inc., 2014 WL 1887297, *2 (M.D. Fla. May 12, 2014) ("Expert testimony is generally necessary to prove that a complex product like a medical device is defective."); Savage v. Danek Med., Inc., 31 F. Supp. 2d 980, 983 (M.D. Fla. 1999) ("A defect must be proven by expert testimony."). Biomet argues that because the opinions of the two experts plaintiff has retained to opine ondesign defect and medical causation are inadmissible, plaintiff has produced no evidence of causation. (Doc. #121, pp. 9-10.) Biomet also argues it is entitled to summary judgment because plaintiff has failed to disclose any of his treating physicians as non-retained experts, and because the remaining evidence establishes that the M2a Magnum did not cause plaintiff's injuries. (Id. pp. 10-14.) The Court disagrees.³

The two experts at issue were retained by plaintiff to (1) determine if the M2a Magnum implanted in plaintiff was "unreasonably dangerous and defective in a manner that caused premature failure" (Doc. #124-1, p. 21), and (2) opine on, inter alia, injuries that may occur due to metal-on-metal bearing surface failures (Doc. #125-4, p. 146). Plaintiff's engineering expert concluded that all of Biomet's metal-on-metal hip systems, including the M2a Magnum, are defective in design, and that plaintiff's implant had several specific design defects. (Doc. #124-1, pp. 137-44.) Plaintiff's medical expert opined that plaintiff "sustained permanent and irreversible damage" to his hip caused by the M2a Magnum. (Doc. #125-4, p. 168.) Such opinions constitute evidence of both design defect and medical causation,and therefore preclude summary judgment. See Bayes v. Biomet, Inc., 2020 WL 5095346, *11 (E.D. Mo. Aug. 28, 2020) ("Biomet contends that Plaintiffs have failed to show that any design defect in the M2a Magnum caused Mary's injuries specifically. Biomet first argues that Plaintiffs cannot establish specific causation because [plaintiffs' medical causation experts'] case-specific opinions are inadmissible. . . . Because the Court has denied Biomet's motion to exclude the specific causation opinions of [the medical causation experts], this argument fails.").⁴ Furthermore, to the extent Biomet argues summary judgment should also be granted on plaintiff's standalone negligence claim (Count Two) due to lack of admissible expert testimony establishing medical causation (Doc. #121, pp. 1, 8), that argument is similarly rejected.

B. Failure to Warn

Count One of the Complaint alleges a claim of strict liability based on, inter alia, inadequate warnings. See Jennings, 181 F.3dat 1255 (noting that a product may be defective by virtue of an inadequate warning). Additionally, plaintiff asserts a standalone failure to warn claim in Count Five, which alleges Biomet had a duty to warn of the risks associated with the use of the M2a Magnum, that it failed to adequately warn plaintiff and his physician of such risks, and that such failure was the direct and proximate...