Beale v. Biomet, Inc.

• Decision Date: 15 June 2007
• Docket Number: No. 05-22941-GOLD.,05-22941-GOLD.
• Citation: 492 F.Supp.2d 1360
• Parties: Ruby BEALE, Plaintiff, v. BIOMET, INC., Biomet Manufacturing, Corp., Biomet Orthopedics, Inc., and Biomet South Florida, Defendants.
• Court: U.S. District Court — Southern District of Florida

492 F.Supp.2d 1360

Ruby BEALE, Plaintiff, v. BIOMET, INC., Biomet Manufacturing, Corp., Biomet Orthopedics, Inc., and Biomet South Florida, Defendants.

No. 05-22941-GOLD.

United States District Court, S.D. Florida.

June 15, 2007.

COPYRIGHT MATERIAL OMITTED

Allan Kanner, Cynthia S. Green, Kanner & Whiteley LLC, New Orleans, LA, Elizabeth Lineberger Tarumianz, Fred Thompson, III, Robin R. Anderson, Motley Rice LLC, Rhett D. Klok, Ness Motley Loadholt Richardson & Poole, Mt. Pleasant, SC, Roland W. Payne, Jr., Miami, FL, for Plaintiff.

Angela Teresa Puentes, Benjamine Reid, Gary Michael Pappas, Carlton Fields, Miami, FL, for Defendants.

ORDER GRANTING DEFENDANTS' MOTIONS FOR SUMMARY JUDGMENT; CLOSING CASE

ALAN S. GOLD, District Judge.

THIS CAUSE is before the Court on Defendants' Motion for Summary Judgment [DE 103], filed April 9, 2007. Defendants originally filed a Motion to Dismiss [DE 67], which I converted to a Motion for Summary Judgment. The Motion for Summary Judgment seeks judgment against Plaintiff Rudy Beale in this case, and against Plaintiffs Daniel and Nancy Erb in Case Number 06-20692. The two cases were consolidated per my Order Following Telephonic Status Conference and Consolidating Cases dated May 24, 2006 [DE 55]. Although the plaintiffs in the two cases differ, the legal issues apply equally to both cases. After considering the arguments contained in the parties' briefs, and after hearing oral argument, I grant the Motion for Summary Judgment.

I. BACKGROUND

The undisputed material facts are as follow:¹

Both of the consolidated actions concern the surgical implantation of a partial knee prosthetic device known as a Biomet Repicci II Unicondylar Knee ("the device"). In Daniel Erb's case, Dr. Diaz (a nonparty to either lawsuit) implanted the device into his left knee on December 6 2000. (Erb First Amended Compl. ¶ 60). Dr. Diaz implanted the device into Rudy Beale's left knee on June 28, 2001. (Beale Second Amended Compl. ¶ 60).

The Unicondylar Knee is a prescription medical device. (Plaintiff's Statement of Material Facts in Opposition to Defendant's Motion for Summary Judgment, ¶ 1). The device is suitable for certain patients who, in the treating orthopedic surgeon's judgment, are appropriate candidates based upon the surgeon's evaluation of variables such as the patient's medical history, physical examination, x-rays, disease progression, pain syndrome, gait, age, weight, and activity level.² (Id. ¶ 4). The package insert to the device contains warnings to surgeons regarding patient selection, including certain risk factors such as weight control, activity level, and device wear or failure. (Id. ¶ 8).

Dr. Diaz was the treating orthopedic surgeon for both Plaintiffs. (Id. ¶ 9). Dr. Diaz has over 36 years of experience performing hip and knee joint replacement surgeries. (Id. ¶ 10). He received his medical degree in 1957 and spent eleven years in orthopedic surgery residence and fellowship programs. (Id.). Dr. Diaz was Board Certified in orthopedic surgery in 1971. (Id.). He performed between 150 and 400 joint replacement surgeries per year in the West Palm Beach area through 2006. (Id.). During his career, Dr. Diaz has likely performed over 10,000 joint replacement surgeries. (Id.). Between 2000 and 2001, Dr. Diaz performed approximately 400 surgeries involving the device at issue in this case, and found that they worked well for his patients. (Id. ¶ 14). Dr. Diaz implanted the device at issue in this case in approximately 700 patients over the years, and still believes in the product. (Id. ¶ 15).

Plaintiff alleges, and Biomet does not dispute, that Biomet engaged in certain marketing efforts to promote the device. (Plaintiff's Opposition to Defendant's Motion for Summary Judgment, p. 12-20). These efforts included sales visits to surgeons, advertisements in orthopedic journals, presentations at meetings of orthopedic surgeons, video demonstrations and literature about the product. (Id., p. 13-16). Biomet also sponsored articles written about its product. (Id.). In addition to marketing its product to physicians, Biomet marketed its product to the consumers. (Id., p. 16-20). Biomet created a tri-fold brochure for patients to review about the product, which was placed in physician's offices. (Id., p. 16). Biomet also has a website containing information about its products. (Id., p. 17). Dr. Diaz's office, through his office assistant, held seminars for prospective patients, where Biomet's brochure was provided to attendees. (Id., p. 19).

At deposition, Dr. Diaz testified to the following: (1) he read the package insert included with the device (Plaintiffs Statement of Material Facts in Opposition to Defendant's Motion for Summary Judgment, ¶ 16); he was aware of the risk that his patients might experience no improvement in their knee function after having the device implanted (Id. ¶ 20); he was aware of the risk that his patients would not be able to engage in impact sports, and might not be able to engage in non-impact activities (Id. ¶ 21); he was aware that his patients might not obtain the pain relief the hoped for (Id. ¶ 23); he was aware that his patients could not withstand the activity level of a person with healthy bone and tissue, and that excessive physical activity and trauma could cause the device to fail, break apart, or wear out (Id. ¶ 24); he was aware that a patient's excessive weight could cause the device to fail, break apart, or wear out (Id ¶ 25); he was aware of the risk that if a component of the device failed or broke apart, it could cause further damage to the patient's knee (Id. ¶ 26); he was aware of the risk that his patients might need to have the device replaced in the future, and that they were merely postponing total knee replacement (Id ¶ 27); he informed all of his patients that they were postponing the need for a total knee replacement (Id. ¶ 28).³

Dr. Diaz also testified that he was not influenced by Biomet or any Biomet literature in his determination of which patients were appropriate candidates for the device. (Id. ¶ 41). Instead, he relied upon his education, training, and experience. (Id. ¶ 47).⁴ Biomet never made any representations that Dr. Diaz was its agent, and Dr. Diaz never consented to be the agent of Biomet, nor made any representations to that effect.⁵ (Id. ¶¶ 49-51).

Both Plaintiffs allege that following the implantation surgery they experienced severe pain, and eventually needed revision surgery on their knees. (Beale Compl. ¶¶ 61, 62; Erb Compl. ¶¶ 61, 63).

Beale and Daniel Erb (together with his wife, Nancy Erb) brought separate lawsuits against Defendants in the Eleventh Judicial Circuit in and for Miami-Dade County. Defendants removed the lawsuits to this Court pursuant to 28 U.S.C. §§ 1441(a) and 1446 on the basis of diversity of citizenship.

Both Complaints allege the following four causes of action against Defendants: negligence/gross negligence; strict product liability; a violation of Florida Statutes § 501.201 et seq. (Florida Deceptive and Unfair Trade Practices Act, "FDUTPA")⁶; and negligent misrepresentation. In addition, Plaintiff Nancy Erb, wife of Plaintiff Daniel Erb, brings a claim for loss of consortium against Defendants.

II. LEGAL STANDARD FOR SUMMARY JUDGMENT

Rule 56(c) of the Federal Rules of Civil Procedure authorizes summary judgment when the pleadings and supporting materials show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986). The court's focus in reviewing a motion for summary judgment is "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." Anderson, 477 U.S. at 252, 106 S.Ct. at 2512; Bishop v. Binningham Police Dep't, 361 F.3d 607, 609 (11th Cir.2004).

The moving party bears the initial burden under Rule 56(c) of demonstrating the absence of a genuine issue of material fact. Allen v. Tyson Foods, Inc., 121 F.3d 642, 646 (11th Cir.1997). Once the moving party satisfies this burden, the burden shifts to the party opposing the motion to go beyond the pleadings and designate "specific facts showing that there is a genuine issue for trial." Celotex v. Catrett, 477 U.S. 317, 324, 106 S.Ct. 2548, 2553, 91 L.Ed.2d 265 (1986). A factual dispute is genuine only if the evidence is such that a reasonable fact finder could return a verdict for the non-moving party. Anderson, 477 U.S. at 248, 106 S.Ct. 2505; Denney v. City of Albany, 247 F.3d 1172, 1181 (11th Cir.2001).

In assessing whether the movant has met its burden, the court should view the evidence in the light most favorable to the party opposing the motion and should resolve all reasonable doubts about the facts in favor of the non-moving party. Denney, 247 F.3d at 1181. In determining whether to grant summary judgment, the court must remember that "[c]redibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge." Anderson, 477 U.S. at 255, 106 S.Ct. 2505.

Upon review of the record and the parties' arguments, I grant Biomet's motion for summary judgment.

III. ANALYSIS

A. Application of the Learned Intermediary Doctrine

Biomet moves for summary judgment on the basis of the "learned intermediary doctrine." Florida recognizes the learned intermediary doctrine, which provides that, in cases of prescription drugs, the manufacturer's duty runs to the physician, rather than the patient. Felix v. Hoffmann-LaRoche, Inc. 540 So.2d 102 (Fla.1989).⁷ Pursuant to the doctrine, a manufacturer has a duty to give a physician adequate warning of the risks associated with a prescription drug. Buckner o. Allergan Pharmaceuticals, Inc., 400 So.2d 820, 822 (Fla. 5th DCA 1981). How...