Opinion
Case No: 8:19-cv-2657-T-60JSS
05-11-2020
ROBIN MARIE WARREN and LONNY WARREN, Plaintiffs, v. C. R. BARD, INC., Defendant.
ORDER GRANTING IN PART , AND DENYING IN PART, "DEFENDANT C. R. BARD INC.'S MOTION FOR SUMMARY JUDGMENT"
This matter is before the Court on "Defendant C. R. Bard Inc.'s Motion for Summary Judgment" and its memorandum in support, filed on May 13, 2019. (Docs. 39; 40). On May 24, 2019, Plaintiffs Robin and Lonny Warren filed their response in opposition to the motion. (Doc. 45). On June 3, 2019, Defendant filed a reply. (Doc. 52). On February 19, 2020, the Court held a hearing to address this matter. See (Doc. 71). After reviewing the motion, response, reply, legal arguments, court file and record, the Court finds as follows:
Background
This case is one of thousands of similar cases filed since approximately October 2010. Plaintiffs Robin Marie Warren and Lonny Warren directly filed this product liability case in the Southern District of West Virginia as part of the multidistrict litigation ("MDL") entitled In re: C. R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187. The case was not resolved by the MDL transferee court ("MDL Court"), and it was transferred at the conclusion of the coordinated pretrial proceedings as part of Wave 8.
In the seven MDLs, over 100,000 cases have been filed, approximately 15,000 of which are in the Bard MDL. See MDL 2187 (C.R. Bard) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2187; MDL 2325 (American Medical Systems) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2325; MDL 2326 (Boston Scientific) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2326; MDL 2327 (Johnson & Johnson, Ethicon) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2327; MDL 2387 (Coloplast) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2387; MDL 2440 (Cook Medical) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2440; and MDL 2511 (Neomedic) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2511.
On February 21, 2011, Ms. Warren was implanted with the Avaulta Solo Anterior Synthetic Support System ("Avaulta") device at a hospital in Brooksville, Florida. The Avaulta device was designed and manufactured by Defendant. On April 28, 2016, Plaintiffs filed suit directly in the MDL using a short-form complaint, alleging the following claims: Negligence (Count I), Strict Liability - Design Defect (Count II), Strict Liability - Manufacturing Defect (Count III), Strict Liability - Failure to Warn (Count IV), Breach of Express Warranty (Count V), Breach of Implied Warranty (Count VI), Loss of Consortium (Count VII), and Punitive Damages (Count VIII).
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 properly supported motion for summary judgment is not defeated by the existence of a factual dispute. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). Only the existence of a genuine issue of material fact will preclude summary judgment. Id.
The moving party bears the initial burden of showing that there are no genuine issues of material fact. Hickson Corp. v. N. Crossarm Co., 357 F.3d 1256, 1260 (11th Cir. 2004). When the moving party has discharged its burden, the nonmoving party must then designate specific facts showing the existence of genuine issues of material fact. Jeffery v. Sarasota White Sox, Inc., 64 F.3d 590, 593-94 (11th Cir. 1995). If there is a conflict between the parties' allegations or evidence, the nonmoving party's evidence is presumed to be true and all reasonable inferences must be drawn in the nonmoving party's favor. Shotz v. City of Plantation, 344 F.3d 1161, 1164 (11th Cir. 2003).
Analysis
Negligence (Count I)
Negligent Marketing, Labeling, Packaging, and Selling
Defendant seeks summary judgment on Count I to the extent the claim is based on negligent marketing, labeling, packaging, and selling. Defendant argues that Plaintiffs have failed to put forth any evidence in support of this claim. Defendant points out that the MDL court has repeatedly granted summary judgment under these circumstances where the plaintiff has failed to come forward with any evidence to support such claims. Plaintiffs indicate that they do not intend to assert separate and distinct legal claims for negligent marketing, labeling, packaging, and selling. However, they assert that evidence pertaining to Defendant's marketing, labeling, packaging, and selling of the Avaulta device should not be excluded because it is relevant to their negligent failure to warn claim.
Based on Plaintiffs' concession and the applicable case law, the Court finds that Defendant is entitled to summary judgment on this portion of Count I to the extent the claim is read to assert separate and distinct claims for negligent marketing, labeling packaging, and selling. Plaintiffs are not precluded from presenting evidence related to Defendant's marketing, labeling, packaging, and selling of the Avaulta device to the extent that such evidence is relevant to their remaining claims.
Negligent Manufacturing Claim
Defendant also seeks summary judgment on Plaintiffs' negligence claim to the extent that it involves an alleged manufacturing defect. Although Plaintiffs indicate that they do not intend to pursue a manufacturing defect theory, they assert that evidence relating to Defendant's manufacturing process should not be restricted in any way at trial.
Based on Plaintiffs' concession and the applicable case law, the Court finds that Defendant is entitled to summary judgment on this portion of Count I. Plaintiffs are not precluded from presenting evidence pertaining to Defendant's marketing, labeling, packaging, and selling of the Avaulta device to the extent that such evidence is relevant to their remaining claims.
Strict Liability - Design Defect (Count II)
In its motion, Defendant argues that it is entitled to summary judgment on Plaintiffs' strict liability design defect claim. Specifically, Defendant contends that Plaintiffs have failed to provide any admissible evidence to support their design defect claim under either the consumer-expectations test, the risk-utility test, or both.
Upon review, the Court finds that Plaintiffs have provided sufficient admissible evidence to support their design defect claim. Among other things, Dr. Zipper and Dr. Hoyte have opined about several features and characteristics of the Avaulta Solo that they believe constitute design defects that cause pain and complications in patients, including Ms. Warren. See (Doc. 45-4; 45-5). Additionally, Dr. Zipper has opined to a reasonable degree of medical certainty that the defective nature of the Avaulta design is the cause of Ms. Warren's injuries. See (Doc. 45-4). This type of evidence has been found sufficient to support a design defect claim. See Cisson v. C. R. Bard, Inc., No. 2:11-CV-00195, 2013 WL 5700513, at *1, *4 (S.D.W. Va. Oct. 18, 2013), aff'd sub nom. In re C. R. Bard, Inc., MDL. No. 2187, Pelvic Repair Sys. Prod. Liab. Litig., 810 F.3d 913 (4th Cir. 2016). Consequently, Defendant's motion for summary judgment is denied as to Count II.
Strict Liability - Manufacturing Defect (Count III)
Defendant moves for summary judgment on the strict liability manufacturing defect claim in Count III. Specifically, Defendant contends that Plaintiffs have failed to provide any admissible evidence to support their manufacturing defect claim. Defendant further points out that the MDL court has routinely granted motions for summary judgment on manufacturing defect claims in other pelvic mesh cases, holding that the plaintiffs' complaints were actually about the design of the products rather than a defect in the manufacturing process. Plaintiffs assert that they will not pursue Count III as to composition or construction defects, and therefore do not object to its dismissal. However, Plaintiffs do not waive any right to rely on evidence relating to Defendant's manufacturing process and raw materials to support their remaining claims.
Based on Plaintiffs' concession and the applicable case law, the Court finds that Defendant is entitled to summary judgment on Count III. This ruling does not preclude Plaintiffs from relying on evidence relating to the manufacturing process and raw materials to the extent that such evidence is relevant to their remaining claims.
Strict Liability - Failure to Warn (Count IV)
In its motion, Defendant contends that the failure to warn claim in Count IV fails because Plaintiffs cannot establish proximate causation. Defendant's argument is based on two prongs - (1) Dr. Zipper's opinions are unreliable and contradict those of the implanting physician, and (2) the failure to warn claim is barred by the learned intermediary doctrine because Ms. Warren's implanting physician would not have changed his decision if given additional warnings or risk information.
First, Defendant argues that Dr. Zipper's opinions on the Avaulta Solo instructions for use ("IFU") "are not based in fact and . . . fly in the face of medical records and testimony by Plaintiff's implanting physician." Defendant argues, therefore, that these opinions should be recognized as inadequate, and summary judgment should be granted in its favor. The Court has considered the testimony of Dr. Zipper and has determined that some of his opinions concerning the IFU - including whether the risks he perceives as a practicing physician are in fact warned about in the IFU - are admissible. (Doc. 81). The Court notes that Dr. Hoyte has also been designated to provide expert testimony in this action, and he also identifies several specific deficiencies in the IFU. (Doc. 45-5). Consequently, there is an evidentiary basis to support the failure to warn claim. The question of whether the warnings are adequate in this case is a matter for the jury. See, e.g., Adams v. G.D. Searle & Co., 576 So. 2d 728, 731 (Fla. DCA 1991); Zansuri v. G.D. Searle & Co., 748 F. Supp. 1511 (S.D. Fla. 1990).
Second, Defendant argues that Plaintiffs cannot establish proximate causation due to the learned intermediary doctrine. Specifically, Defendant claims that Plaintiffs have not provided evidence that a different warning or additional warnings would have changed Ms. Warren's treating physician's decision. According to Defendant, Dr. Spires - the implanting physician - testified that he was fully aware of the risks of pelvic surgery, including those with transvaginal mesh, at the time of Ms. Warren's surgery, and he warned Plaintiffs of various risks associated with the procedure and devices. Defendant argues that Dr. Spires has testified that he still feels Ms. Warren was an appropriate candidate for the Avaulta device, and that he has not testified that he would have changed his decision to implant the device had different warnings been provided.
"In the case of prescription medical devices, Florida applies the learned intermediary doctrine, which directs the manufacturer's duty to warn to the prescribing physician rather than the ultimate consumer or patient." Eghnayem v. Boston Scientific Corp., No. 1:14-cv-024061, 2016 WL 4051311, at *9 (S.D. Fla. Mar. 17, 2016). As a result, to establish proximate causation, "a plaintiff must show that her treating physician would not have used the product had adequate warnings been provided." Id. (citing Hoffmann-La Roche Inc. v. Mason, 27 So. 3d 75, 76 (Fla. 1st DCA 2009)). Under Florida law, the learned intermediary defense is a fact-intensive affirmative defense. See MacMorris v. Wyeth, Inc., No. 2:04-cv-596-FtM-29DNF, 2005 WL 1528626, at *3 (M.D. Fla. 2005).
The Court has reviewed the deposition of Dr. Spires and finds that although he testified he knew what was contained in the IFU, he has not specifically testified that he possessed the same knowledge an adequate warning would have provided. See (Doc. 45-6). Plaintiffs have also identified statements in Dr. Spires' deposition that demonstrate the alleged inadequacy of the warnings. See (Doc. 45 at 10). Furthermore, Plaintiffs' experts opine that the IFU warnings were inadequate and deficient. Construing these facts in light most favorable to Plaintiffs, as it is required to do at this stage of the proceedings, the Court finds that there are genuine issues of material fact as to proximate causation and the applicability of the learned intermediary doctrine in this case. See, e.g., Resendez v. C. R. Bard, Inc., No. 5:19-cv-299-BO, 2020 WL 1916690, at *1 (E.D.N.C. Apr. 20, 2020) (finding that plaintiff's negligent failure to warn claim was not barred by the learned intermediary doctrine); Wortman v. C. R. Bard, Inc., No. 1:19-cv-3273-JMS-DLP, 2019 WL 6329651, at *8-9 (S.D. Ind. Nov. 26, 2019) (concluding that the learned intermediary doctrine did not preclude failure to warn claim). As such, Defendant's motion for summary judgment is denied as to Count IV.
Breach of Express Warranty (Count V) and Breach of Implied Warranty (Count VI)
In its motion, Defendant moves for summary judgment on Plaintiff's breach of express warranty and breach of implied warranty claims in Counts V and VI. Defendant argues that Plaintiffs cannot prevail on these claims because they were not in privity of contract with Defendant. Plaintiffs indicate that they will not pursue Counts V and VI. Consequently, the Court finds that Defendant is entitled to summary judgment on Counts V and VI.
Punitive Damages (Count VIII)
Defendant moves for summary judgment on Plaintiffs' punitive damages claim in Count VIII. Defendant argues that if the Court grants the motion for summary judgment as to all other claims, the punitive damages claim must fail because it cannot independently stand. However, because the Court has declined to enter summary judgment in Defendant's favor on each of the other counts, there is a possible basis for punitive damages. Consequently, Defendant's motion for summary judgment is denied as to Count VIII.
Accordingly, it is
ORDERED, ADJUDGED and DECREED:
1. "Defendant C. R. Bard Inc.'s Motion for Summary Judgment" (Docs. 39; 40) is hereby GRANTED IN PART and DENIED IN PART.
2. Defendant's motion for summary judgment is GRANTED as described herein to the extent that judgment shall be entered in favor of Defendant, and against Plaintiffs, on Count I in part (negligent marketing, labeling, packaging, and selling claim and negligent manufacturing claim), Count III, Count V, and Count VI.
3. Defendant's motion for summary judgment is DENIED in all other respects.
DONE and ORDERED in Chambers, in Tampa, Florida, this 11th day of May, 2020.
/s/ _________
TOM BARBER
UNITED STATES DISTRICT JUDGE