Opinion
8:20CV349
2020-10-01
Vicki LANGNER, Plaintiff, v. BOSTON SCIENTIFIC CORPORATION, Defendant.
Andrew J. Cross, Pro Hac Vice, Jeffrey J. Lowe, Pro Hac Vice, Sarah Shoemake Doles, Pro Hac Vice, Carey, Danis Law Firm, St. Louis, MO, for Plaintiff. Daniel L. Willis, David A. Blagg, Ronald F. Krause, Cassem, Tierney Law Firm, Omaha, NE, James H. Keale, Michael A. Tanenbaum, Tanenbaum Keale, Newark, NJ, Jon A. Strongman, Shook, Hardy Law Firm, Kansas City, MO, Kevin L. Morrow, Faegre, Baker Law Firm, Chicago, IL, Mark J. Winebrenner, Pro Hac Vice, Scholastica Baker, Pro Hac Vice, Faegre, Drinker Law Firm, Minneapolis, MN, for Defendant.
Andrew J. Cross, Pro Hac Vice, Jeffrey J. Lowe, Pro Hac Vice, Sarah Shoemake Doles, Pro Hac Vice, Carey, Danis Law Firm, St. Louis, MO, for Plaintiff.
Daniel L. Willis, David A. Blagg, Ronald F. Krause, Cassem, Tierney Law Firm, Omaha, NE, James H. Keale, Michael A. Tanenbaum, Tanenbaum Keale, Newark, NJ, Jon A. Strongman, Shook, Hardy Law Firm, Kansas City, MO, Kevin L. Morrow, Faegre, Baker Law Firm, Chicago, IL, Mark J. Winebrenner, Pro Hac Vice, Scholastica Baker, Pro Hac Vice, Faegre, Drinker Law Firm, Minneapolis, MN, for Defendant.
MEMORANDUM AND ORDER
Robert F. Rossiter, Jr., United States District Judge
This matter is before the Court on defendant Boston Scientific Corporation's ("Boston Scientific") Motion for Summary Judgment on the statute of limitation (Filing No. 25) and Motion for Summary Judgment on the merits (Filing No. 26). For the reasons stated below, Boston Scientific's motion on the statute of limitation is denied, and the motion on the merits is granted in part and denied in part.
I. BACKGROUND
In early 2006, plaintiff Vicki Langner ("Langner") consulted with Dr. Emily Kean-Puccioni ("Dr. Kean") at Lakeside Hospital in Omaha, Nebraska, seeking treatment for stress urinary incontinence ("SUI"). To treat Langner's SUI, Dr. Kean recommended surgery to implant the Obtryz Transobturator Mid-Urethral Sling System (the "device"), which is manufactured by Boston Scientific. The device is a Class II medical device that was approved by the Federal Drug Administration ("FDA") in 2004 through the 510(k) process. The 501(k) process streamlines FDA approval for devices that are "substantially equivalent" to another legally marketed device. Boston Scientific's device was first marketed in January of 2006 and is available by prescription only.
Langner was made aware of some, but not all, of the possible side effects from the device implantation surgery, and she agreed to Dr. Kean's recommended treatment. Dr. Kean was experienced in implanting synthetic slings similar to the device, as she had performed this surgery over one hundred times prior to Langner's operation. The surgery took place on February 27, 2006. Initially, Langner recovered from the surgery and healed properly. However, by late 2006, Langner began experiencing back pain, joint pain, heavy and prolonged menstrual periods, and flu-like symptoms.
By 2008, Langner was experiencing many health complications, but she was unaware of the cause. She again sought treatment from Dr. Kean, this time for a vaginal bulge that required another surgery. At that time, Langner asked Dr. Kean if her condition was caused by the device. Dr. Kean assured her it was not. For the next several years, Langner sought treatment from multiple physicians for her health issues. Langner saw Dr. William Ostdiek ("Dr. Ostdiek") from 2006 to 2011. When she asked Dr. Ostdiek whether her health issues could be related to the device, he told her the device was not the cause of her deteriorating health.
Langner's health continued to get worse. By 2012, she was experiencing suprapubic abdominal pain, painful urination, increased urinary frequency, sustained back and joint pain, among other health complications. Sometime between 2012 and 2013, Langner saw television commercials regarding the device and other similar mesh slings used to treat SUI. Attorneys published these commercials to alert potential plaintiffs they may have a legal claim against the manufacturers of these devices. Langner admits the symptoms discussed in the commercials resonated with her, yet she denies the advertisements sparked her to see any causal connection between the device and her health issues. At approximately the same time, Langner sought advice from another physician, Dr. Ted Fritz ("Dr. Fritz"). Once again, she asked Dr. Fritz if her symptoms could be related to the device, and he denied the device could be the cause.
Langner maintains the first time she thought the device was causing her symptoms was in April 2016 when she sought treatment from Dr. Thomas Margolis ("Dr. Margolis"). Dr. Margolis was the first physician to advise Langner that her health problems could be caused by the device. Shortly thereafter, Dr. Margolis performed a revision surgery to remove part of the device. Langner had a second revision surgery in February of 2017.
Langner filed this action (Filing No. 1) on April 27, 2018, in the Southern District of West Virginia as part of the products liability multi-district litigation against Boston Scientific. Langner alleged claims for strict products liability (design defect, manufacturing defect, and failure to warn), negligence (design and manufacturing defect), breach of express warranty, breach of implied warranty, and fraudulent concealment. Boston Scientific simultaneously filed a Motion for Summary Judgment on Statute of Limitation and a Motion of Summary Judgment on all Langner's substantive claims on May 13, 2019. In her reply brief, Langner conceded her claims based on a manufacturing defect in strict products liability, breach of implied warranty, and fraudulent concealment. On August 13, 2020, the Southern District of West Virginia ordered the transfer of the case to this Court for resolution.
II. DISCUSSION
A. Standard of Review
Summary judgment is required "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 dispute is genuine "when the evidence is such that a reasonable jury could return a verdict for the non-moving party." Dick v. Dickinson State Univ. , 826 F.3d 1054, 1061 (8th Cir. 2016). "A fact is material if it may affect the outcome of the lawsuit." TCF Nat'l Bank v. Mkt. Intelligence, Inc. , 812 F.3d 701, 707 (8th Cir. 2016) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ).
When considering a motion for summary judgment, the Court "do[es] not weigh the evidence, make credibility determinations, or attempt to discern the truth of any factual issue." Thomas v. Corwin , 483 F.3d 516, 526-27 (8th Cir. 2007). The Court views all facts in the light most favorable to the nonmoving party and gives them the benefit of all reasonable inferences. Whitney v. Guys, Inc. , 826 F.3d 1074, 1076 (8th Cir. 2016). The moving party, however, " ‘must do more than simply show that there is some metaphysical doubt as to the material facts,’ and must come forward with ‘specific facts showing that there is a genuine issue for trial.’ " Torgerson v. City of Rochester , 643 F.3d 1031, 1042 (8th Cir. 2011) (en banc) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp. , 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) ). The Court will "not credit ‘[m]ere allegations, unsupported by specific facts or evidence.’ " Williams v. United Parcel Serv., Inc. , 963 F.3d 803, 807 (8th Cir. 2020) (quoting Thomas , 483 F.3d at 526-27 ).
"A principal purpose of the summary-judgment procedure ‘is to isolate and dispose of factually unsupported claims or defenses,’ " so if there is no factual dispute on any particular claim, the Court must determine whether the defendant is entitled to judgment as a matter of law. Bedford v. Doe , 880 F.3d 993, 996 (8th Cir. 2018) (quoting Celotex Corp. v. Catrett , 477 U.S. 317, 327, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) ).
B. Nebraska Law
The parties agree Nebraska law governs this diversity case. See Erie R. Co. v. Tompkins , 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938). When deciding issues of Nebraska law, the Court is bound by the decisions of the Nebraska Supreme Court. Packard v. Darveau , 759 F.3d 897, 901 (8th Cir. 2014). Where the Nebraska Supreme Court has not decided a relevant issue of state law, this Court "must try to predict how [it] would do so and decide the case accordingly." Topp's Mech., Inc. v. Kinsale Ins. Co. , 968 F.3d 854, 856 (8th Cir. 2020) (quoting Lindholm v. BMW of N. Am., LLC , 862 F.3d 648, 651 (8th Cir. 2017) ). In making that prediction, this Court "may consider relevant state precedent, analogous decisions, considered dicta, ... and any other reliable data." Packard , 759 F.3d at 901 (quoting Lindsay Mfg. Co. v. Hartford Acc. & Indem. Co., 118 F.3d 1263, 1268 (8th Cir. 1997)).
C. Statute of Limitation
Under Neb. Rev. Stat. § 25-224(1), all strict products liability claims "shall be commenced within four years next after the date on which the death, injury, or damage complained of occurs." The statute of limitation generally begins to run as soon as the cause of action accrues, and "an action in tort accrues as soon as the act or omission occurs." Shlien v. Bd. of Regents, Univ. of Neb. , 263 Neb. 465, 640 N.W.2d 643, 650 (2002). In some circumstances, Nebraska law applies an equitable tolling doctrine, known as the discovery rule, to causes of action arising under § 25-224. Condon v. A.H. Robins Co. , 217 Neb. 60, 349 N.W.2d 622, 627 (1984). Under that rule, "the 4-year statute of limitations set forth in § 25-224(1) begins to run on the date on which the party holding the cause of action discovers, or in the exercise of reasonable diligence should have discovered, the existence of the injury or damage." Id.
Boston Scientific maintains the statute of limitation has run on Langner's claims. Boston Scientific argues she was put on notice that her health complications may have been caused by the device by late 2006, just months after she had the implant surgery. Boston Scientific further contends that Langner was on notice, at the latest, by 2012 when she saw the attorney-published advertisements regarding potential mesh-sling litigation.
Langner argues her complaint was timely because she never directly connected the cause of her injuries to the device until she saw Dr. Margolis in 2016. In support, Langner has set forth facts illustrating her efforts to discover the cause of her symptoms: she sought the advice of three separate physicians, but all three advised her that her health issues were not caused by the device.
While Boston Scientific points to evidence suggesting Langner knew or should have known by 2006, or at the latest by 2012, that her symptoms may have been connected to the device, a genuine dispute of material fact remains. Although a close question, on this record Langner's discussions with various physicians, each of whom told her that her physical problems were unrelated to the surgery, creates a factual issue as to her reasonable diligence.
D. Strict Products Liability
1. Design Defect
In a strict products liability action in which the plaintiff alleges a design defect, Nebraska law requires the plaintiff to prove, by a preponderance of the evidence:
(1) the defendant placed the product on the market for use and knew, or in the exercise of reasonable care should have known, that the product would be used without inspection for defects; (2) the product was in a defective condition when it was placed on the market and left the defendant's possession; (3) the defect is the proximate or a proximately contributing cause of the plaintiff's injury sustained while the product was being used in a way and for the general purpose for which it was designed and intended; (4) the defect, if existent, rendered the product unreasonably dangerous and unsafe for its intended use; and (5) the plaintiff's damages were a direct and proximate result of the alleged defect.
Pitts v. Genie Indus., Inc. , 302 Neb. 88, 921 N.W.2d 597, 609 (2019).
Boston Scientific contends Langner's design-defect claim fails as a matter of law for two reasons. First, Boston Scientific claims that the device is not unreasonably dangerous to the ordinary user or consumer, and second, Langner failed to show that the device "was in a defective condition when it was placed on the market and left the defendant's possession." Id.
The central question in a strict-products-liability action based on a design defect is whether the product is unreasonably dangerous. Freeman v. Hoffman-La Roche, Inc. , 260 Neb. 552, 618 N.W.2d 827, 833 (2000) A product is considered unreasonably dangerous if "the product has a propensity for causing physical harm beyond that which could be contemplated by the ordinary user or consumer." Pitts , 921 N.W.2d at 609. Boston Scientific asserts that the ordinary user or consumer of the device is the implanting physician, not the patient. Boston Scientific offers no authority to support its contention.
Although not stated explicitly in Nebraska case law, it is implicit that the consumer or user of a medical device or prescription drug is the patient—not the physician. See , e.g. , Freeman , 618 N.W.2d at 840 (concluding the plaintiff alleged facts sufficient to show the drug was unreasonably dangerous to the ordinary consumer—users, like the plaintiff, who were unaware of the dangers of the prescription drug). Boston Scientific fails to provide any authority to the contrary. Thus, Langner is the "ordinary consumer" in this case, and she has presented a material factual dispute that the device caused her uncontemplated physical harm, such as complications from mesh shrinkage and multiple revision surgeries. See Pitts , 921 N.W.2d at 609 ("Whether a product is in a defective condition and is unreasonably dangerous to its users are generally questions of fact."). Accordingly, the Court concludes Langner has stated a plausible theory of recovery based upon a design defect.
2. Failure to Warn
In an ordinary strict products liability case, the manufacturer has a duty to warn the consumer of any potential dangers of its products. In cases involving pharmaceutical drugs and medical devices, Nebraska law applies the learned-intermediary doctrine. Freeman , 618 N.W.2d at 841 (adopting Restatement (Third) of Torts: Prod. Liab. § 6(d) (1998) ). The learned intermediary doctrine "is based on the premise that the patient's prescribing physician is in the best position to assess the risks and benefits of [the] drug or product" and can "make an individualized medical judgment, based on the patient's particular needs and susceptibilities, as to whether the patient should use the product." Id. at 841-42 (quoting Annot., 57 A.L.R.5th 1, 26 (1998)). The learned intermediary doctrine provides that the "duty to warn extends only to members of the medical profession and not to the consumer." Id. at 841. Thus, a plaintiff's claim for failure to warn is barred if the health care provider received adequate warnings. Id.
Under the learned intermediary doctrine, the failure of a manufacturer to provide the physician with adequate warnings must be the cause in fact and proximate cause of the plaintiff's injuries. Brinkley v. Pfizer, Inc. , 772 F.3d 1133, 1137 (8th Cir. 2014). In other words, the plaintiff must demonstrate that the treating physician would not have prescribed the medical device if the manufacturer had given a different warning. Ideus v. Teva Pharms. USA, Inc. , 361 F.Supp.3d 938, 946 (D. Neb. 2019) (citing Freeman , 618 N.W.2d at 842 ). In discussing the learned intermediary doctrine and proximate causation, the Eighth Circuit has stated:
The learned intermediary doctrine provides that the failure of a drug manufacturer to provide the physician with an adequate warning of the risks associated with a prescription product is "not the proximate cause of a patient's injury if the prescribing physician had independent knowledge of the risk that the adequate warnings should have communicated." Thus, the causal link between a
patient's injury and the alleged failure to warn is broken when the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer that should have been communicated to him.
Brinkley , 772 F.3d at 1137 (quoting Christopher v. Cutter Labs. , 53 F.3d 1184, 1192 (11th Cir. 1995) ).
Langner alleges, and the Court accepts as true, that Boston Scientific did not disclose all the risks in the device's product brochure or the package insert. As Langner sees it, this failure to warn Dr. Kean—the prescribing physician who implanted the device—prevented her from making an informed decision. However, it is equally as clear from Dr. Kean's deposition that further warnings in the brochure or package insert would not have altered her decision to treat Langner's SUI by implanting the device. Dr. Kean testified she had ample knowledge of the potential side effects based upon the warnings provided by Boston Scientific, her own experience, discussions with other medical professionals in the field, and by reading medical journals regarding the use of polypropylene mesh midurethral slings to treat SUI. Dr. Kean unequivocally stated she would still recommend the same course of treatment if Langner approached her for treatment today.
Based upon all the evidence, Langner cannot demonstrate a causal connection between Boston Scientific's alleged failure to warn of all potential side effects and her injuries. Ideus , 361 F.Supp.3d at 946. Therefore, summary judgment is properly granted in favor of Boston Scientific on this claim.
E. Negligent Manufacture and Negligent Design
In a products-liability claim based on negligence, the primary inquiry is "whether the manufacturer's conduct was reasonable in view of the foreseeable risk of injury." Jay v. Moog Auto. Inc. , 264 Neb. 875, 652 N.W.2d 872, 879 (2002). This requires a showing of "some evidence of duty, breach, causation, and damages." Id. ; see also Ribeiro v. Baby Trend, Inc. , 2017 WL 11485739, *3 (Neb. 2017) ("To prevail, a plaintiff must show that the product was manufactured, sold and distributed by the defendants; that the defendants failed to use reasonable care to see that the product was safe for the use for which it was made; and that the failure to use such reasonable care was the proximate cause of the plaintiff's injuries.").
Langner has established that Boston Scientific did, in fact, manufacture and distribute the device at issue, but she fails to provide the Court with facts to show Boston Scientific acted unreasonably or failed to take care in the manufacture of the device. Boston Scientific alleges in its brief that Langner "offers no evidence that Boston Scientific's conduct was unreasonable in the design or manufacture of the device at issue." In response, Langner merely notifies the Court she "will proffer considerable evidence of Defendant's unreasonable conduct" at some later unspecified date. That is not enough. Langner's pledge to provide evidence later is insufficient to withstand summary judgment, as no jury could reasonably find in her favor. Bedford , 880 F.3d at 997 ; see also Nationwide Prop. and Cas. Ins. Co. v. Faircloth , 845 F.3d 378 (8th Cir. 2016) ("Although the burden of demonstrating the absence of any genuine issue of material fact rests on the movant, a nonmovant may not rest upon mere denials or allegations, but must instead set forth specific facts sufficient to raise a genuine issue for trial.").
F. Breach of Express Warranty
Boston Scientific argues Langner's breach of express warranty claim is barred because she did not give timely notice, as required under the Nebraska Uniform Commercial Code § 2-607(3)(a). It is undisputed that Langner failed to provide pre-suit notice to Boston Scientific. Langner asserts filing the lawsuit alone provided sufficient notice to Boston Scientific of its breach. Under § 2-607(3)(a), "[w]hen tender has been accepted ... 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." "Whether the notice given is satisfactory and whether it is given within a reasonable time are generally questions of fact to be measured by all the circumstances of the case." Fitl v. Strek , 269 Neb. 51, 690 N.W.2d 605, 608 (2005).
The Nebraska Supreme Court has not expressly decided whether pre-suit notification is required under § 2-607(3)(a), and jurisdictions are split on the issue. See Gazal v. Boehringer Ingelheim Pharm., Inc. , 647 F.3d 833, 841 (8th Cir. 2011) (noting the majority position is to require pre-suit notice for a breach of express warranty claim); In re Bridgestone/Firestone, Inc. Tires Prods. Lib. Litig. , 155 F.Supp.2d 1069, 1110 (S.D. Ind. 2001), reversed in part on other grounds , 288 F.3d 1012 (7th Cir. 2002) ("Courts vary widely in their interpretation of § 2-607(3)(a). For example, some courts have held ... the filing of a lawsuit can, at least in some instances, satisfy the notice of breach requirement.... Other courts have reached the opposite conclusion.") (internal citations omitted). Thus, this Court must predict whether the Nebraska Supreme Court would find filing a suit as sufficient notice under § 2-607(3)(a). The Court concludes it would not and would instead require pre-suit notice as a condition precedent to filing a breach of express warranty claim.
The Nebraska Supreme Court has pointed out that filing a breach of warranty claim is more onerous than filing a tort claim, in part because the U.C.C. requires the plaintiff "under section 2-607(3)(a), U.C.C., to give the defendant notice of breach." Hawkins Const. Co. v. Matthews Co. , 190 Neb. 546, 209 N.W.2d 643, 652 (1973). It therefore follows that the Nebraska Supreme Court views the notice requirement in § 2-607(3)(a) as mandating something more than simply filing a lawsuit. Indeed, to properly state a claim under § 2-607(3)(a), a "purchaser must plead that he gave timely notice of the breach." Timmerman v. Hertz , 195 Neb. 237, 238 N.W.2d 220, 225 (1976) (emphasis added) (citing Hrdlicka v. Allen , 179 Neb. 250, 137 N.W.2d 725, 727 (1965) ).
The Nebraska Supreme Court tends to strictly construe the Uniform Commercial Code, including notice provisions within it. Allis-Chalmers Corp. v. Haumont , 220 Neb. 509, 371 N.W.2d 97, 99 (1985) (interpreting the "reasonable notice" requirement in Neb. U.C.C. § 9-102(1)(a) and opining "that compliance with the notice provisions of the Uniform Commercial Code is a condition precedent" to recovery and "[t]he failure to give the requisite notice is an absolute bar to recovery." (quoting Borg-Warner v. Watton , 215 Neb. 318, 338 N.W.2d 612, 615 (1983) )).
Boston Scientific also relies on the Nebraska Supreme Court policy statement regarding § 2-607(3)(a) to support its assertion that Langner's claim is barred. In discussing this notice requirement, the Nebraska Supreme Court opined the condition serves three purposes: (1) to provide the seller with an opportunity to cure the breach of warranty issue, (2) to aid the seller in preparation for negotiation and litigation, and (3) to protect against stale claims. Fitl , 690 N.W.2d at 608. Boston Scientific argues notice through filing a lawsuit "runs counter to the purpose behind the notice requirement." Without prior notice, Boston Scientific had no opportunity to cure its alleged breach or ascertain facts in preparation for negotiation.
Given the Nebraska caselaw and the Nebraska Supreme Court's iteration of the policy goals of § 2-607(3)(a), the Court concludes the Nebraska Supreme Court would strictly construe the notice provision in § 2-607(3)(a) and require a plaintiff to provide the defendant pre-suit notice of the warranty issue. Langner's claim is barred under § 2-607(3)(a) because she did not provide notice.
III. CONCLUSION
Langner has shown genuine disputes of material fact to overcome Boston Scientific's motion for summary judgment based upon the statute of limitation and her claim for a design defect in strict products liability. The Court finds Langner's other claims—failure to warn in strict products liability, negligent design, negligent manufacture, and breach of express warranty—do not raise factual dispute and fail as a matter of law.
Accordingly,
IT IS ORDERED:
1. Defendant Boston Scientific Corporation's Motion for Summary Judgment on Statute of Limitations (Filing No. 25) is denied.
2. Defendant Boston Scientific's Motion for Summary Judgment on the merits (Filing No. 26) is granted in part and denied in part.
a. The motion is denied as to summary judgment on design defect in strict products liability.
b. The motion is granted for summary judgment with respect to (1) failure to warn in strict products liability, (2) negligent manufacture and negligent design, and (3) breach of express warranty.
3. Plaintiff Vicki Langner also concedes her claims for manufacturing defect in strict products liability, breach of implied warranty, and fraudulent concealment in her brief. These claims are dismissed.