Brown v. Depuy Orthopaedics, Inc.

Decision Date24 October 2013
Docket NumberCase No. 8:13–cv–734–T–33AEP.
Citation978 F.Supp.2d 1266
PartiesRamona K. BROWN, Plaintiff, v. DePUY ORTHOPAEDICS, INC., Defendant.
CourtU.S. District Court — Middle District of Florida


Bryan D. Caulfield, Perenich Caulfield, Avril & Noyes, Clearwater, FL, for Plaintiff.

David J. Walz, Edward W. Gerecke, Carlton Fields, PA, Tampa, FL, for Defendant.



Now before this Court is Defendant DePuy Orthopaedics, Inc.'s Motion for Summary Judgment (Doc. # 26), filed on June 25, 2013. Plaintiff Ramona K. Brown filed her response in opposition on July 25, 2013 (Doc. # 29), and DePuy filed a reply to Brown's response on August 15, 2013 (Doc. # 33). After due consideration and for the reasons stated below, the Court grants the Motion.

I. Background and Procedural History

On March 19, 2009, Brown underwent a knee-replacement procedure in which a P.F.C. Sigma Knee (RP Knee) was implanted in her right knee. (Stip. Facts Doc. # 28 at ¶¶ 1, 26; Doc. # 2 at ¶ 12). In her Complaint, Brown alleges that “the failure of the said device(s) has/have necessitated numerous visits by [Brown] to her physicians and other medical care providers/facilities for follow-up care and treatment because of continued problems in her right knee, including, but not limited to, severe pain, swelling, stiffness, limited range of motion, loss of mobility, and tenderness.” (Doc. # 2 at ¶ 13). Brown also claims that she “has required care including, but not limited to, medications, therapy, and nerve blocks, to treat the aforesaid problems in her right knee caused by her orthopedic right knee device” and that “additional surgical intervention is imminent given the state and continuing nature of [Brown]'s right knee problems.” ( Id. at ¶¶ 14–15).

The RP Knee implanted in Brown's right knee is a modular prosthetic knee system consisting of four basic components: (1) a femoral piece that the surgeon fits over the femur; (2) a patella; (3) a tibial piece that the surgeon fits onto the tibia; and (4) a disk-shaped tibial insert made of Ultra High Molecular Weight Polyethylene that the surgeon places into the tibial tray, and which lies at the point where the tibia and femur meet. (Stip. Facts Doc. # 28 at ¶¶ 1, 26). The RP Knee is a Class III medical device regulated by the Food and Drug Administration (FDA). ( Id. at ¶ 5).

According to § 515 of the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA), prior to marketing a Class III medical device, the product must gain premarket approval from the FDA. ( Id. at ¶ 6). On July 11, 1984, after reviewing DePuy's application for premarket approval, the FDA's independent advisory panel recommended approval of the RP Knee. ( Id. at ¶¶ 18–19). When originally considered by the FDA, the RP Knee was approved for use in the LCS Total Knee System. ( Id. at ¶ 20). In February of 2000, DePuy utilized the PMA process again and submitted a PMA supplement to secure FDA approval of the RP Knee for use in the P.F.C. Sigma Knee System. ( Id. at ¶ 21). On March 16, 2000, the FDA approved the PMA supplement. ( Id. at ¶ 22). DePuy has since submitted several supplements to the RP Knee PMA in 2000, 2006, and 2009; each of these supplements passed through the same FDA approval process. ( Id. at ¶¶ 23–24). Since issuance of the PMA and related supplements, the FDA still regulates the RP Knee by reviewing annual reports regarding the RP Knee. ( Id. at ¶ 25).

The FDA inspected a DePuy facility in Warsaw, Indiana on May 10, 2011, through June 7, 2011. (Warning Letter Doc. # 2 at 18). On December 8, 2011, the FDA issued a warning letter stating, among other things, that:

Our inspection revealed that some of the PFC Sigma Knee System components ... are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360(e)(a).... These devices are also misbranded under section 502 [of] the Act, 21 U.S.C. § 352( o ), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution....

( Id.).

On April 11, 2013, the parties stipulated to the dismissal of many of the original claims—as well as to the dismissal of one of the Defendants—listed in the Complaint. (Doc. # 13). Two claims remain: Brown alleges state-law claims for (1) strict liability and (2) negligence. (Doc. # 2). Under strict liability, Brown alleges defects in design and warnings. ( Id. at ¶¶ 27–30). Under negligence, Brown alleges defects in manufacture, design, and warnings. ( Id. at ¶¶ 35–36). Brown states that “the basis for her claims of negligence and strict liability against DePuy [are] largely based on the failures set forth in the ... FDA letter and whatever other facts that discovery would reveal.” (Doc. # 29 at 5).

II. Legal Standard

Summary judgment is appropriate “if the movant shows 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). A mere factual dispute is not enough to defeat a properly pled motion for summary judgment; instead, only the existence of a genuine issue of material fact will preclude a grant of summary judgment. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

An issue is genuine if the evidence is such that a reasonable jury could return a verdict for the nonmoving party. Mize v. Jefferson City Bd. of Educ., 93 F.3d 739, 742 (11th Cir.1996) (citing Hairston v. Gainesville Sun Publ'g Co., 9 F.3d 913, 918 (11th Cir.1993)). A fact is material if it may affect the outcome of the suit under the governing law. Allen v. Tyson Foods, Inc., 121 F.3d 642, 646 (11th Cir.1997).

When considering a motion for summary judgment, the Court must draw all inferences from the evidence in the light most favorable to the non-movant and resolve all reasonable doubts in that party's favor. See Porter v. Ray, 461 F.3d 1315, 1320 (11th Cir.2006). The moving party bears the initial burden of showing the Court, by reference to materials on file, that there are no genuine issues of material fact that should be decided at trial. Hickson Corp. v. N. Crossarm Co., Inc., 357 F.3d 1256, 1260 (11th Cir.2004) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)). After a moving party has discharged its burden, “the non-moving party must then ‘go beyond the pleadings,’ and by its own affidavits, or by ‘depositions, answers to interrogatories, and admissions on file,’ designate specific facts showing that there is a genuine issue for trial.” Jeffery v. Sarasota White Sox, Inc., 64 F.3d 590, 593–94 (11th Cir.1995) (citing Celotex, 477 U.S. at 324, 106 S.Ct. 2548).

Furthermore, if there is a conflict between the parties' allegations or evidence, the non-moving party's evidence is presumed to be true and all reasonable inferences must be drawn in the non-moving party's favor. Shotz v. City of Plantation, Fla., 344 F.3d 1161, 1164 (11th Cir.2003). However, when a non-movant's response consists of nothing “more than a repetition of his conclusional allegations,” summary judgment is not only proper, but required. Morris v. Ross, 663 F.2d 1032, 1034 (11th Cir.1981), cert. denied, 456 U.S. 1010, 102 S.Ct. 2303, 73 L.Ed.2d 1306 (1982).

III. AnalysisA. The MDA and Class III Devices

The Food, Drug and Cosmetic Act (FDCA) requires FDA approval for the entry of new drugs into the market. 21 U.S.C. § 301 et seq.; Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). However, [u]ntil the statutory enactment of the [Medical Device Amendments of 1976(MDA), 21 U.S.C. § 360c et seq.], the introduction of new medical devices was left largely for the states to supervise as they saw fit.” Riegel, 552 U.S. at 315, 128 S.Ct. 999 (emphasis added). In 1976, Congress “stepped in with passage of the [MDA], which swept back some state obligations and imposed a regime of detailed federal oversight.” Id. With the passage of the MDA, [t]he regulation of medical devices entering the market is [now] governed by the FDCA,” as well. Kaiser v. Depuy Spine, Inc., 944 F.Supp.2d 1187, 1190 (M.D.Fla.2013).

Class III medical devices must be approved by the FDA through the premarket approval process, also referred to as “a PMA.” 21 U.S.C. § 360e. “The premarket approval process is a ‘rigorous' process in which manufacturers submit detailed information as to the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission.” Wolicki–Gables v. Arrow Int'l, Inc., 641 F.Supp.2d 1270, 1283 (M.D.Fla.2009) aff'd, 634 F.3d 1296 (11th Cir.2011) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)). “After the FDA completes its review, premarket approval is only granted if there is a reasonable assurance of the device's safety and effectiveness.” Stokes v. I–Flow Corp., No. 6:12–cv–991–ORL–36, 2013 WL 1715427, at *3 (M.D.Fla. Apr. 8, 2013) (internal quotations and citations omitted).

Once a device receives premarket approval, the manufacturer may not change its design, specifications, manufacturing processes, labeling, or any other attribute which would affect the device's safety or efficacy without FDA approval. 21 U.S.C. § 360e(d)(6)(A)(i). “If a manufacturer wishes to make such changes, an application for a supplemental PMA must be submitted, which is evaluated under the same criteria as the initial application.” Wolicki–Gables, 641 F.Supp.2d at 1283 (citing Riegel, 552 U.S. at 319, 128 S.Ct. 999). “Moreover, after premarket approval, manufacturers are subject to reporting requirements such as the obligation to inform the FDA of new clinical investigations or scientific studies, 21 C.F.R. § 814.84(b)(2), and incidents where the device may...

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