JOSEPH R. GOODWIN, District Judge.
Pending before the court is defendant C. R. Bard's ("Bard") Motion for Summary Judgment [ECF No. 67]. As set forth below, Bard's Motion for Summary Judgment is
This case resides in one of seven MDLs assigned to me by the Judicial Panel on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse ("POP") and stress urinary incontinence ("SUI"). In the seven MDLs, there are more than 58,000 cases currently pending, approximately 8,000 of which are in the Bard MDL, MDL 2187. In an effort to efficiently and effectively manage this massive MDL, I decided to conduct pretrial discovery and motions practice on an individualized basis so that once a case is trial-ready (that is, after the court has ruled on all Daubert motions and summary judgment motions, among other things), it can then be promptly transferred or remanded to the appropriate district for trial. To this end, I ordered the plaintiffs and defendant to each select 50 cases, which would then become part of a "wave" of cases to be prepared for trial and, if necessary, remanded. See Pretrial Order ("PTO") # 102, No. 2:12-md-2187 [ECF No. 729]. This selection process was completed twice, creating two waves of 100 cases, Wave 1 and Wave 2. Ms. Reno's case was selected as a Wave 2 case by the plaintiffs. PTO # 118, No. 2:12-md-2187 [ECF No. 841].
Ms. Reno was surgically implanted with the Align TO Urethral Support System (the "Align") by Dr. Oanh Bui at the Cypress Fairbanks Medical Center in Houston, Texas. Compl. ¶¶ 9-12 [ECF No. 1]. As a result of complications allegedly caused by the Align, Ms. Reno brings the following claims against Bard: strict liability for design defect, manufacturing defect, and failure to warn; negligence; breaches of express and implied warranties; and punitive damages.
To obtain summary judgment, the moving party must show that there is no genuine dispute as to any material fact and that the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). In considering a motion for summary judgment, the court will not "weigh the evidence and determine the truth of the matter." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). Instead, the court will draw any permissible inference from the underlying facts in the light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587-88 (1986).
Although the court will view all underlying facts and inferences in the light most favorable to the nonmoving party, the nonmoving party nonetheless must offer some "concrete evidence from which a reasonable juror could return a verdict in his [or her] favor." Anderson, 477 U.S. at 256. Summary judgment is appropriate when the nonmoving party has the burden of proof on an essential element of his or her case and does not make, after adequate time for discovery, a showing sufficient to establish that element. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). The nonmoving party must satisfy this burden of proof by offering more than a mere "scintilla of evidence" in support of his or her position. Anderson, 477 U.S. at 252. Likewise, conclusory allegations or unsupported speculation, without more, are insufficient to preclude the granting of a summary judgment motion. See Dash v. Mayweather, 731 F.3d 303, 311 (4th Cir. 2013); Stone v. Liberty Mut. Ins. Co., 105 F.3d 188, 191 (4th Cir. 1997).
Under 28 U.S.C. § 1407, this court has authority to rule on pretrial motions in MDL cases. The choice of law for these pretrial motions depends on whether they concern federal or state law:
In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig., 97 F.3d 1050, 1055 (8th Cir. 1996) (internal citations omitted). To determine the applicable state law for a dispositive motion, I generally refer to the choice-of-law rules of the jurisdiction where the plaintiff first filed her claim. See In re Air Disaster at Ramstein Air Base, Ger., 81 F.3d 570, 576 (5th Cir. 1996) ("Where a transferee court presides over several diversity actions consolidated under the multidistrict rules, the choice of law rules of each jurisdiction in which the transferred actions were originally filed must be applied."); In re Air Crash Disaster Near Chi., Ill., 644 F.2d 594, 610 (7th Cir. 1981); In re Digitek Prods. Liab. Litig., MDL No. 2:08-md-01968, 2010 WL 2102330, at *7 (S.D. W. Va. May 25, 2010).
If a plaintiff files her claim directly into the MDL in the Southern District of West Virginia, however, as Ms. Reno did in this case, I consult the choice-of-law rules of the state in which the plaintiff was implanted with the product. See Sanchez v. Boston Scientific Corp., 2:12-cv-05762, 2014 WL 202787, at *4 (S.D. W. Va. Jan. 17, 2014) ("For cases that originate elsewhere and are directly filed into the MDL, I will follow the better-reasoned authority that applies the choice-of-law rules of the originating jurisdiction, which in our case is the state in which the plaintiff was implanted with the product."). Ms. Reno received the Align implantation surgery in Texas. Thus, the choice-of-law principles of Texas guide this court's choice-of-law analysis.
The parties agree, as does this court, that these principles compel application of Texas law to the plaintiffs' claims. In tort actions, Texas adheres to the Restatement (Second) of Conflict of Laws (Am. Law Inst. 1975). Gutierrez v. Collins, 583 S.W.2d 312, 318 (Tex. 1979). Under section 145 of the Restatement (Second) of Conflict of Laws, the court must apply the law of the state with the most "significant relationship to the occurrence and the parties." Here, Ms. Reno resides in Texas, and the product was implanted in Texas. Thus, I apply Texas's substantive law to this case.
Bard argues that it is entitled to partial summary judgment in this case because the plaintiffs' claims lack evidentiary support. The plaintiffs have agreed not to pursue claims for manufacturing defect. Response 3 [ECF No. 120]. Accordingly, Bard's Motion on the plaintiffs' claims for manufacturing defect is
Texas has adopted the doctrine of strict liability for defective products set forth in section 402A of the Restatement (Second) of Torts ("Restatement"). See McKisson v. Sales Affiliates, Inc., 416 S.W.2d 787, 789 (Tex. 1967). Section 402A provides:
Restatement § 402A. "The concept of defect is central to a products liability action brought on a strict tort liability theory, whether the defect be in conscious design, or in the manufacture of the product, or in the marketing of the product." Turner v. Gen. Motors Corp., 584 S.W.2d 844, 847 (Tex. 1979).
In Texas, a plaintiff bringing a design defect claim under strict liability must prove by a preponderance of the evidence that (1) the product was unreasonably dangerous due to a defect, (2) "there was a safer alternative design," and (3) "the defect was a producing cause" of the damages. Tex. Civ. Prac. & Rem. Code Ann. § 82.005; Timpte Indus., Inc. v. Gish, 286 S.W.3d 306, 311 (Tex. 2009). To determine whether a product is unreasonably dangerous, Texas courts apply a risk-utility test that considers the following factors:
Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420, 432 (Tex. 1997); see also Hernandez v. Tokai Corp., 2 S.W.3d 251, 256 (Tex. 1999). Whether the product is unreasonably dangerous is generally an issue for the jury. Timpte Indus., 286 S.W.3d at 312; Am. Tobacco, 951 S.W.2d at 432.
Bard argues that comment k to section 402A bars the plaintiffs' design defect claims. Comment k exempts certain products from strict liability because they are "unavoidably unsafe."
I reject Bard's contention that Texas's absolute bar for FDA-approved prescription drugs applies here given that the Align is neither FDA-approved nor a prescription drug. See Lofton v. McNeil Consumer & Speciality Pharm., 682 F.Supp.2d 662, 679 (N.D. Tex. 2010) (refusing to "take a leap not taken by Texas courts" in applying comment k categorically outside the prescription drug context); see also Carter v. Tap Pharm., Inc., No. SA-03-CA-0182, 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) ("Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law.").
Bard also argues that the plaintiffs have presented no evidence of a safer alternative design. The plaintiffs, however, note that they have suggested that Bard's Align product could have been designed with larger pore sizes, could have been designed with rounder, thinner arms, or could have been made, in part, with native consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. Restatement (Second) of Torts § 402A cmt. k (1965). tissue. According to the plaintiffs, these design alternatives would have made the Align a safer product. Bard argues that these are new products, and such products do not demonstrate a "safer alternative design." See Massa v. Genetech, Inc., No. H-11-70, 2012 WL 956192, at *6 (S.D. Tex. Mar. 19, 2002) ("A plaintiff cannot demonstrate the existence of a `safer alternative design' by pointing to a substantially different product . . . ."). At a minimum, the plaintiffs have established that there is a genuine dispute over whether their suggestions for the Align amount to a safer, alternative design.
Bard presents no other argument on design defect. Thus, Bard has failed to meet its burden under the summary judgment standard of showing the absence of a genuine dispute as to any material fact. See Fed. R. Civ. P. 56(a); Adickes v. S.H. Kress & Co., 398 U.S. 144, 157 (1970), superseded on other grounds by Celotex Corp. v. Catrett, 477 U.S. 317 (1986). Therefore, Bard's Motion on the plaintiffs' claim of strict liability for design defect is
Texas, like most jurisdictions, follows the learned intermediary doctrine. See, e.g., Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir. 1974) (applying Texas law); Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 461-66 (Tex. App. 2000); Bean v. Baxter Healthcare Corp., 965 S.W.2d 656, 663 (Tex. App. 1998). Under that doctrine, when there is a patient-physician relationship, the manufacturer of a drug or medical device has a duty to warn that extends only to the physician. See Pustejovsky v. Pliva, Inc., 623 F.3d 271, 276 (5th Cir. 2010); Bean, 965 S.W.2d at 663. The manufacturer does not have a duty to warn the patient who receives the drug or device. Pustejovsky, 623 F.3d at 276.
"In order to recover for a failure to warn under the learned intermediary doctrine, a plaintiff must show: (1) the warning was defective; and (2) the failure to warn was a producing cause of the plaintiff's condition or injury." Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999) (applying Texas law). To prove causation, "the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would have not used or prescribed the product." Ackermann v. Wyeth Pharm., 526 F.3d 203, 208 (5th Cir. 2008) (quoting Dyer v. Danek Med., Inc., 115 F.Supp.2d 732, 714 (N.D. Tex. 2000)).
Bard argues that the plaintiffs' failure to warn claim fails under the learned intermediary doctrine because the plaintiffs cannot prove that a failure to warn caused Ms. Reno's injuries. In response, the plaintiffs note that Dr. Bui, Ms. Reno's implanting physician, stated that had he would have "probably not" implanted Ms. Reno had the warnings been different. Dr. Oan Bui Dep. 84:11-23 [ECF No. 120-2]. A review of the relevant briefs and deposition testimony demonstrates that the plaintiffs cannot put forth enough evidence to create a genuine dispute on whether the physician would have changed his decisions in regards to Ms. Reno's treatment had he received any additional warning. Accordingly, Bard's Motion on these points is
When the plaintiffs' claims for strict liability fail, then so too should the negligence claims. See Gerber v. Hoffmann-La Roche Inc., 392 F.Supp.2d 907, 923 (S.D. Tex. 2005) (holding that where summary judgment was proper as to strict liability claims for failure to warn, design defect, and manufacturing defect, then those same claims premised on negligence must also fail). Accordingly, based on the preceding rulings, Bard's motion for summary judgment is
Additionally, Bard contends that the plaintiffs' claims for negligent inspection, packaging, marketing, and selling of the Align fail for lack of evidence. The plaintiffs, in response, argue that there is ample evidence that demonstrate Bard breached a duty to the plaintiffs and that there was resulting harm from this breach. Response at 9 [ECF No. 126]. The plaintiffs state that Bard was negligent in failing to include adequate warnings, failing to include appropriate instructions for use, exaggerating the benefits of the Align, and marketing and selling the Align without adequate testing. Id. at 10. However, apart from reciting allegations that form the plaintiff's failure to warn and design defect claims, the plaintiffs do not offer any support that Bard breached a legal duty that caused the plaintiffs' injuries in their "inspection, marketing, labeling, packaging, or selling" of the Align. Accordingly, Bard's Motion on these points is
To recover for the breach of an express or implied warranty, Texas law requires that a plaintiff provide notice to the seller before filing suit. Section 2.607(c)(1) of the Texas Business & Commerce Code mandates that "the buyer must within a reasonable time after he discovers or should have discovered any breach notify the seller of breach or be barred from any remedy." Tex. Bus. & Com. Code Ann. § 2.607; see also Ackermann v. Wyeth Pharm., 471 F.Supp.2d 739, 745 (E.D. Tex. 2006) aff'd, 526 F.3d 203 (5th Cir. 2008) ("[T]he Court agrees that to maintain the claim for breach of warranty, notice was required."); Wilcox v. Hillcrest Mem'l Park, 696 S.W.2d 423, 424-25 (Tex. App. 1985) ("[S]ection 2.607(c)(1) requires that a buyer notify any seller . . . of the product's alleged defect within a reasonable time of discovering the defect and that failure to do so bars the buyer from any remedy for breach of warranty under the Texas Business & Commerce Code."). The rule applies to manufacturers as well as sellers. See U.S. Tire-Tech, Inc. v. Boeran, B.V., 110 S.W.3d 194, 199 (Tex. App. 2003) ("[U]nder section 2.607(c)(1), a buyer is required to give notice of an alleged breach of warranty to a remote manufacturer.").
Here, Ms. Reno has presented no evidence of pre-suit notice. Accordingly, Bard's Motion on the plaintiffs' warranty claims is
For the reasons discussed above, it is
The Court