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Williams v. Bayer Corp.

Court of Appeals of Missouri, Western District, Fourth Division

December 5, 2017

JESSICA WILLIAMS, Appellant,
v.
BAYER CORP., ET AL., Respondents.

         APPEAL FROM THE CIRCUIT COURT OF BOONE COUNTY, MISSOURI THE HONORABLE CHRISTINE CARPENTER, JUDGE

          Before Mark D. Pfeiffer, Chief Judge, Gary D. Witt, Judge and Edward R. Ardini, Jr., Judge.

          EDWARD R. ARDINI, JR., JUDGE.

         Jessica Williams (Williams) brought this cause of action in the Circuit Court of Boone County alleging fourteen separate claims against Bayer Corp. (Bayer) related to its Essure contraceptive device along with a variety of counts against her treating physicians. Bayer filed a Motion to Dismiss on the basis that the claims directed against it were preempted under federal law which was granted by the trial court. Williams now appeals arguing that the trial court erred in dismissing those claims on preemption grounds and in not granting her leave to file an amended petition. We affirm in part and reverse and remand in part.

         Factual and Procedural Background

         Williams became pregnant with her fifth child sometime in late 2012. After consulting with her physicians, she made the determination to undergo a tubal ligation in conjunction with the delivery.[1] However, in late April of 2013, Williams's physicians determined the umbilical cord had prolapsed around her fetus and she required an immediate caesarian section. Due to the emergency nature of the caesarian section, the tubal ligation was not performed. Following the birth, her physicians recommended Williams consider using Essure as an alternative to tubal ligation. Essure is a medical device manufactured and sold by Bayer that is implanted in a woman's fallopian tube for the purpose of causing inflammation and promoting the growth of scar tissue. This scar tissue blocks the fallopian tube, thereby achieving sterilization. After considering the recommendations of her physicians and reviewing the information provided on the Essure website, Williams agreed to undergo the Essure procedure.

         During the procedure to place the Essure device, Williams began to experience severe abdominal pain and requested her physicians stop. As a result, the procedure was abandoned after only one of the two devices was inserted. Williams continued to experience significant pain following the procedure and, after several months, requested her physicians remove the Essure device. An x-ray performed during the attempt to remove the Essure device revealed that it had broken apart and perforated Williams's uterine wall. Consequently, pieces of the Essure device were left in Williams's body. Williams continued to experience pain and underwent further surgery to remove one of her fallopian tubes along with a hysterectomy.

         On July 29, 2015, Williams filed a petition alleging multiple claims against Bayer as well as additional claims directed at several of her physicians. One month after filing her initial petition, Williams filed an amended petition that included the same causes of action against Bayer. Bayer thereafter filed a Motion to Dismiss arguing, among other things, that all of Williams's claims were expressly or impliedly preempted by federal law. After extensive briefing, the trial court heard oral argument before taking the matter under advisement. On March 17, 2016, the trial court issued an order granting Bayer's Motion to Dismiss finding all of the claims asserted against Bayer were preempted under federal law.[2] Williams subsequently filed Plaintiff's Motion to Amend Judgment that included a request for leave to amend her petition along with a proposed Second Amended Petition, which the trial court did not grant. Williams appeals.

         Discussion

         Williams's First Amended Petition included fourteen counts directed against Bayer: (Count 1) violation of the Missouri Merchandising Practices Act (MMPA), (Count 2) fraudulent misrepresentation, (Count 3) negligent misrepresentation, (Count 4) breach of express warranties, (Count 5) breach of implied warranty of merchantability, (Count 6) negligence per se, (Count 7) strict product liability - defective manufacturing, (Count 8) negligent manufacturing, (Count 9) strict products liability for failure to warn - off-label use, (Count 10) failure to warn - post premarket approval risks, (Count 11) negligent training, (Count 12) negligently supplying a product for use, (Count 16) civil conspiracy, and (Count 17) res ipsa loquitur. The trial court found that each of these claims were expressly or impliedly preempted by the federal Medical Device Amendment of 1976, 21 U.S.C. §360c, et seq., and dismissed each with prejudice. Williams's first point on appeal argues that the trial court erred in reaching this conclusion.

         We review the granting of a motion to dismiss de novo. Armstrong-Trotwood, LLC v. State Tax Commission, 516 S.W.3d 830, 835 (Mo. banc 2017). We assume all facts alleged in the petition are true and liberally construe all reasonable inferences in favor of the plaintiff. Smith v. Humane Soc'y of United States, 519 S.W.3d 789, 798 (Mo. banc 2017). "[T]he petition is reviewed in an almost academic manner, to determine if the facts alleged meet the elements of a recognized cause of action, or of a cause that might be adopted in that case." Id. (quoting Nazeri v. Mo. Valley C., 860 S.W.2d 303, 306 (Mo. banc 1993)).

         Background regarding the Medical Device Amendment of 1976

         "The Federal Food, Drug, and Cosmetic Act (FDCA) has long required FDA approval for the introduction of new drugs into the market." Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008) (internal citations omitted). The same cannot be said of medical devices, however, which the act initially "did not authorize any control over." Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996). Instead, "the introduction of new medical devices was left largely for the States to supervise as they saw fit." Riegel, 552 U.S. at 315. However, this changed following the highly publicized failure of several medical devices in the 1970's, the most notable being the Dalkon Shield intrauterine contraceptive device. See Riegel, 552 U.S. at 315; Lohr, 518 U.S. at 476. In response to these failures, Congress passed the Medical Devices Amendment of 1976, 21 U.S.C. §360c, et seq., (MDA), which established a comprehensive scheme of federal oversight regarding the introduction of new medical devices. Riegel, 552 U.S. at 316.

         Under the MDA, medical devices are divided into one of three classes. "Devices that present no unreasonable risk of illness or injury are designated Class I and are subject only to minimal regulation by 'general controls.'" Lohr, 518 U.S. at 476-77 (citing 21 U.S.C. § 360c(a)(1)(A)). These devices include such things as elastic bandages and examination gloves. Riegel, 552 U.S. at 316. "Devices that are potentially more harmful are designated Class II" and may "still be marketed without advance approval, " but "must comply with federal performance regulations known as 'special controls.'" Lohr, 518 U.S. at 477 (citing 21 U.S.C. § 360c(a)(1)(B)). This class includes such devices as powered wheelchairs and surgical drapes. Riegel, 552 U.S. at 316. "Finally, devices that either 'presen[t] a potential unreasonable risk of illness or injury, ' or which are 'purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, ' are designated Class III." Lohr, 518 U.S. at 477 (citing 21 U.S.C. § 360c(a)(1)(C)). Class III medical devices include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators. Riegel, 552 U.S. at 317. Essure is a Class III device.

         Class III devices are subject to the highest level of scrutiny under the MDA. Id. "Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a 'reasonable assurance' that the device is both safe and effective." Lohr, 518 U.S. at 477. The method of providing this "reasonable assurance" is known as "premarket approval" or PMA. Id. "Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Riegel, 552 U.S. at 319. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). "If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application." Id. (citing 21 U.S.C. § 360e(d)(6); 21 CFR § 814.39(c)).

         Express Federal Preemption

         The MDA includes an express preemption provision that provides:

no State or political subdivision of a state may establish or continue in effect with respect to a device intended for human use any requirement-
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. §360k(a); Id. at 316. The United States Supreme Court discussed this provision at length in Riegel v. Medtronic, Inc. and set forth a two-step analysis for determining whether a state law claim is expressly preempted under it.[3] Riegel, 552 U.S. at 321-22. First, the court must determine whether the federal government established requirements applicable to the medical device. Id. at 321. Second, the court must determine whether the state law claim would impose requirements "different from, or in addition to, " the federal requirements. Id. at 321-22. If both of these questions are answered in the affirmative, then the state law claim is expressly preempted. Id. at 321-25; see also Zaccarello v. Medtronic, Inc., 38 F.Supp.3d 1061, 1066 (W.D. Mo. 2014) (stating same).

         However, the Supreme Court's Riegel decision also specifically found that not all state law claims would be preempted under the MDA. Riegel, 552 U.S. at 321-22. Rather, the Supreme Court noted that the MDA's express preemption provision "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations." Id. at 330. In such cases, the Supreme Court concluded the state claims "'parallel, ' rather than add to, federal requirements." Id.

         Implied Federal Preemption

         In addition to expressly preempting certain state law claims, the United States Supreme Court has also found that the MDA implicitly preempts some claims. The MDA states that all actions to enforce FDA requirements "shall be by and in the name of the United States." 21 U.S.C. §337(a). The Supreme Court has held that this language means that state law based fraud-on-the-FDA claims were implicitly barred under the MDA. Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 348 (2001). In other words, "a claim that 'exist[s] solely by virtue' of federal requirements (such as a claim for fraud in submissions to the FDA during the premarket approval process) is impliedly preempted by the MDA, while claims that rely on 'traditional state tort law' may proceed (to the extent they can overcome express preemption)." De La Paz v. Bayer Healthcare LLC, 159 F.Supp.3d 1085, 1091-92 (N.D. Cal. 2016) (quoting Buckman, 531 U.S. at 349).

         When the Supreme Court's decisions of Riegel and Buckman are read together, they "create a narrow gap through which a plaintiff's state-law claim must fit" in order to fully avoid preemption. In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1204 (8th Cir. 2010) (quoting Riley v. Cordis Corp., 625 F.Supp.2d 769, 777 (D. Minn. 2009). "The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman)." Id. (quoting Riley, 625 F.Supp.2d at 777). At least one court has gone as far as comparing the difficulty of this task to navigating the treacherous passage between the mythical monsters Scylla and Charybdis. Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340 (10th Cir. 2015). Nevertheless, Williams asserts that her claims against Bayer securely fit within this gap. We proceed to consider the merits of her arguments.

         Count 1 - Missouri Merchandising Practices Act

         In her first count, Williams alleges that Bayer violated the MMPA by making several representations on its website concerning the Essure device that she argues were false or deceptive.[4] In order to determine if this claim is expressly preempted, we must first look to see if the FDA has established requirements applicable to Essure. In Riegel, the Supreme Court recognized that specifications listed in a premarket approval of a Class III medical device constituted federal requirements applicable to that device. Riegel, 552 U.S. at 322-23. There is no dispute in the present case that Essure is a Class III medical device that has been subject to premarket approval. Therefore, we conclude that the first step of the preemption analysis is ...


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