Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Fearrington v. Boston Scientific Corporation

United States District Court, S.D. Texas, Houston Division

October 16, 2019




         Plaintiff Janet Fearrington ("Plaintiff") asserts claims against defendant Boston Scientific Corporation ("Defendant") for products liability, breach o f warranty, fraud, and negligence.[1] Pending before the court is Defendant Boston Scientific's Motion to Dismiss (Docket Entry No. 6) ("Defendant's Motion to Dismiss") . For the reasons explained below, Defendant's Motion to Dismiss will be granted in part and denied in part.

         I. Factual and Procedural Background

         Defendant is a manufacturer of medical devices. This action involves three devices produced by Defendant: the Obtryx Transobturator Mid-Urethral Sling System ("Obtryx"), the Polyform Synthetic Mesh ("Polyform"), and the Advantage Fit System ("Advantage Fit") (collectively, "Pelvic Mesh Products").[2]Defendant designed Obtryx and Advantage Fit to treat urinary incontinence and the Polyform to treat pelvic organ prolapse.[3] The devices contain polypropylene and are intended to be implanted permanently on or about the pelvic floor in women suffering urinary incontinence or pelvic organ prolapse.[4] Doctors implanted Plaintiff with Obtryx and Polyform on February 21, 2006, in Titusville, Florida.[5] Plaintiff was implanted with Advantage Fit on June 26, 2017, in Houston, Texas.[6]

         Plaintiff alleges that the Pelvic Mesh Products warp and shrink while inside a woman's body and that the polypropylene material is biologically incompatible with the body, leading to a high risk of injury.[7] She alleges that the Pelvic Mesh Products inflicted serious injury on her that she was not warned of and the risk of which was not justified.[8] Plaintiff filed this action against Defendant on July 1, 2019, seeking actual and punitive damages for her alleged injuries.[9] Plaintiff alleges several theories of recovery: products liability for marketing, manufacturing, and design defects; breach of express and implied warranties; negligence; and fraud, fraudulent concealment, and negligent misrepresentation.[10] Defendant moved to dismiss for failure to state a claim on July 31, 2019.[11]Plaintiff responded to the motion on August 21, 2019, [12] and Defendants replied on August 28, 2019.[13]

         II. Standard of Review

         The Federal Rules of Civil Procedure permit dismissal when a plaintiff fails to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b) (6). A Rule 12(b) (6) motion tests the formal sufficiency of the pleadings and is "appropriate when a defendant attacks the complaint because it fails to state a legally cognizable claim." Ramming v. United States, 281 F.3d 158, 161 (5th Cir. 2001), cert, denied sub nom. Cloud v. United States, 122 S.Ct. 2665 (2002). To defeat a motion to dismiss a plaintiff must plead "enough facts to state a claim to relief that is plausible on its face." Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1974 (2007). "Detailed factual allegations" are not required at this stage, but a complaint that establishes the grounds that entitle the plaintiff to relief "requires more than labels and conclusions, and a formulaic recitation of a cause of action's elements will not do." Id. In ruling on a Rule 12(b) (6) motion the court must "accept the plaintiff's well-pleaded facts as true and view them in the light most favorable to the plaintiff." Chauvin v. State Farm Fire & Casualty Co., 495 F.3d 232, 237 (5th Cir. 2007).

         Ill. Analysis

         A. Choice of Law

         As a preliminary matter the parties disagree whether Texas or Florida law applies to Plaintiff's claims. Plaintiff contends that because her physicians implanted Obtryx and Polyform in her in Florida in 2006 and all of her injuries resulted from that event, all of her claims should be governed by Florida law.[14] This would include alleged injuries sustained after physicians implanted Advantage Fit in Plaintiff in Texas in 2017, which Plaintiff argues would not have occurred but for Obtryx and Polyform's failures.[15]Defendant argues Texas law should apply because Plaintiff's factual allegations are insufficient to justify applying Florida law.[16]

         When different state laws may apply, federal courts exercising diversity jurisdiction apply the choice-of-law rules of the forum state. Mayo v. Hartford Life Insurance Co., 354 F.3d 400, 403 (5th Cir. 2004). Texas law requires a claim-by-claim choice of law analysis. Scottsdale Insurance Co. v. National Emergency Services, Inc., 175 S.W.3d 284, 291 (Tex. App.-Houston [IstDist.] 2004, pet. denied). Texas courts do not engage in choice-of-law analyses unless there is a conflict of laws that affects the outcome of the case. Duncan v. Cessna Aircraft Co., 665 S.W.2d 414, 419 (Tex. 1984) . Accordingly, the court will address the parties' choice-of-law arguments on a claim-by-claim basis.

         B. Marketing Defect

         Plaintiff alleges a strict liability claim against Defendant for alleged failure to warn of the alleged risks to use of the Pelvic Mesh Products.[17] Defendant contends the Plaintiff has not pled sufficient facts that could establish that the alleged failure to warn caused her injuries, especially in light of the learned intermediary doctrine that applies to drugs and medical devices.[18]Plaintiff concedes the learned intermediary doctrine applies but argues that pleading that Defendant knew of alleged dangers to the devices and failed to warn either her or her physicians shows a plausible claim.[19]

         A marketing defect occurs where a defendant markets a product without adequately providing warnings as to its dangers. Sims v. Washex Machinery Corp., 932 S.W.2d 559, 562 (Tex. App.-Houston [1st Dist.] 1995, no writ). To state a plausible claim, Plaintiff must plead facts that would show:

(1) A risk of harm inherent in the product or which may arise from the intended or reasonably anticipated use of the product;
(2) the product supplier actually knew or should have reasonably foreseen the risk of harm at the time the product was marketed;
(3) the product contains a marketing defect;
(4) the absence of a warning renders the product unreasonably dangerous to the ultimate user or consumer of the product; and
(5) the failure to warn must constitute a causative nexus in the product user's injury.

Wright v. Ford Motor Co., 508 F.3d 263, 274-75 (5th Cir. 2007) (citing Sims, 932 S.W.2d at 562). Under the learned intermediary doctrine a medical-device manufacturer satisfies its duty to warn by providing adequate warnings to the prescribing physician. In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, 888 F.3d 753, 775 (5th Cir. 2018); Guzman v. Synthes (USA), 20 S.W.3d 717, 720 n.2 (Tex. App.-San Antonio 1999, pet. denied); see also Beale v. Biomet, Inc., 492 F.Supp.2d 1360, 1373 (S.D. Fla. 2007) (recognizing the learned intermediary doctrine under Florida law). The learned intermediary doctrine is not an affirmative defense but part of the case Plaintiff must prove to establish Defendant violated an owed duty. Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 164 (Tex. 2012). Plaintiff therefore must also plead facts that would show her doctors were inadequately-warned and but for those inadequacies her doctors would have recommended different treatment or given Plaintiff counsel that would have led her to withhold consent. In re Depuy Orthopaedics, 888 F.3d at 775.

         To satisfy this standard in this type of case, a plaintiff must plead facts such as the actual warning given to physicians, that a different warning would have prevented her physicians from prescribing the Pelvic Mesh Products or at least led to them giving her different information that would have caused her to refuse consent. See Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F.Supp.2d 808, 818 (S.D. Tex. 2013) (dismissing a failure-to-warn claim where the plaintiff did not allege the warning to her physician was inadequate, identify the warning her doctor received, demonstrate a different warning would have changed the doctor's actions, or otherwise allege facts necessary to show the failure to warn caused the injury); cf. Ivory v. Pfizer Inc., Civil Action No. 09-0072, 2009 WL 3230611, at *4 (W.D. La. 2009) (concluding a failure-to-warn claim was adequately pled where the plaintiff provided the warning label and pled specifically how it was deficient).

         Plaintiff's Complaint does not identify her treating physicians or facts as to the allegedly deficient warnings Defendant provided to them. Plaintiff only alleges generally that some of the problems with the Pelvic Mesh Products "were made known to physicians [but] the magnitude severity, and frequency of these problems were not disclosed" and that "Defendant knowingly provided incomplete and insufficient training and information to physicians."[20] She then alleges that she "would not have consented to use Defendant's Pelvic Mesh Products had Defendant given adequate warnings to Plaintiff and Plaintiff's implanting physicians."[21] These conclusory assertions amount to a recitation of the requirements of the learned intermediary doctrine: that Defendant did not adequately warn Plaintiff's physicians, and that but for this failure she would not have been injured by the medical devices. The pleadings therefore do not comport with the pleading requirements established by Twombly and Iqbal and do not support a plausible claim that Defendant failed to warn Plaintiff's physicians and that this failure was the producing cause of her injury. See Gonzalez, 930 F.Supp.2d at 818.

         C. Manufacturing Defect

         Plaintiff alleges a products liability claim against Defendant for defective manufacture of the Pelvic Mesh Products.[22] Defendant contends this claim must be dismissed because Plaintiff has alleged no facts as to how the Pelvic Mesh Products allegedly deviate from their intended specifications.[23] Plaintiff argues that her allegations that the products deform while within the body suffice to maintain her manufacturing defect claim.[24] She also contends that under Florida law applicable to her claims there is no requirement to identify or allege the specific defect that caused the injury.[25]

         In Texas a manufacturing defect results when a product deviates "from the specifications or planned output in a manner that renders it unreasonably dangerous." Ford Motor Co. v. Ridgway, 135 S.W.3d 598, 600 (Tex. 2004). "A plaintiff must prove that the product was defective when it left the hands of the manufacturer and that the defect was a producing cause of the plaintiff's injuries." Id. Likewise in Florida a manufacturing defect results when it differs from its intended design and fails to perform as safely as its intended design would have. Zanakis v. Scanreco Inc., No. 1:18-cv-21813-UU, 2019 WL 2215816, at *3 (S.D. Fla. 2019) (citing In re Standard Jury Instructions in Civil Cases-Report No. 13-01 (Products Liability), 160 So.3d 869, 880 (Fla. 2015); Wright v. Howmedica Osteonics Corp., Case No: 5:17-cv-459-OC-30PRL, 2017 WL 4555901, at *2 n.5 (M.D. Fla. 2017) . Plaintiff must therefore allege facts that would show the Pelvic Mesh Products deviated from their planned output or intended design to plausibly allege a manufacturing defect claim under either Texas or Florida law.

         Plaintiff relies on Bailey v. Janssen Pharmaceutica, Inc., 288 Fed.Appx. 597, 605 (11th Cir. 2008), to argue that there is a conflict of laws because Florida does not require her to show the products deviated from their intended design. That case involved a plaintiff who pled a claim in strict products liability without specifying a type of defect, which led the district court to dismiss the suit for failure to state a claim. Id. at 601, 604. The Eleventh Circuit held that since Florida law did not rigidly distinguish between theories of strict products liability there was no requirement for the pleading to segregate marketing, manufacturing, and design defect theories of liability. Id. at 605-06. The circuit court then analyzed the factual allegations in the complaint and concluded the plaintiff had alleged sufficient factual allegations that could support a manufacturing or design defect claim but not a marketing defect claim. Id. at 608-09. Although Bailey teaches that plaintiffs should be afforded flexibility in pleading a Florida strict products liability claim, the court must still analyze the facts pled and determine whether they state a claim under a valid theory of liability. Bailey also predates revisions the Florida Supreme Court made to the Florida Standard Jury Instructions that clarified that a manufacturing defect theory of products liability requires a deviation from the product's intended design, and other federal courts have held a manufacturing defect claim requires facts pled that would satisfy-that element. E.g., Wright, 2017 WL 4555901, at *2 n.5.; see also In re Standard Jury Instructions, 160 So.3d at 880. The applicability of Florida or Texas law therefore does not affect Plaintiff's federal pleading burden under Rule 8, and the court need not decide choice-of-law on this issue at this stage.

         Plaintiff relies on her allegations that the Pelvic Mesh Products were susceptible to deformation and degradation once placed inside the body to state her claim for a manufacturing defect.[26] But Plaintiff has not alleged in any detail the Pelvic Mesh Products' intended designs or specifications, how their manufacture deviated from those designs or specifications, or how such a deviation caused the alleged susceptibility once within the body. Plaintiff's manufacturing defect allegations are therefore impermissibly conclusory and vague, and Plaintiff has not properly stated a claim under Twombly and Iqbal under either Texas or Florida state law. Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011); Wright, 2017 WL 4555901, at *2 n.5.

         D. Design Defect

         Plaintiff alleges a products liability claim against Defendant for defective design of the Pelvic Mesh Products.[27] Defendant contends this claim must be dismissed because Plaintiff does not plead facts that would show the design was unreasonably dangerous and that a safer alternative design existed.[28]

         "To recover for a products liability claim alleging a design defect, a plaintiff must prove that (1) the product was defectively designed so as to render it unreasonably dangerous; (2) a safer alternative design existed; and (3) the defect was a producing cause of the injury for which the plaintiff seeks recovery." Timpte Industries, Inc. v. Gish, 286 S.W.3d 306, 311 (Tex. 2009). Determining whether a product's design is unreasonably dangerous requires a risk-utility analysis that considers:

(1) the utility of the product to the user and to the public as a whole weighed against the gravity and likelihood of injury from its use;
(2) the availability of a substitute product which would meet the same need and not be unsafe or unreasonably expensive;
(3) the manufacturer's ability to eliminate the unsafe character of the product without seriously impairing its usefulness or significantly increasing its costs;
(4) the user's anticipated awareness of the dangers inherent in the product and their avoidability because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions; and
(5) the expectations of the ordinary consumer.

Id. The plaintiff must also show that a safer alternative design was available as an element of the ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.