Opinion
Case No. 6:20-cv-1469-CEM-EJK
2022-09-07
Kelly HOLLAND, Plaintiff, v. ABBOTT LABORATORIES, INC., Defendant.
Christopher H. Hunt, Craig Ronald Lynd, Jeffrey S. Kaufman, Jr., Kaufman & Lynd, Orlando, FL, for Plaintiff. Christina D. Olivos, Lisa M. Baird, Reed Smith LLP, Miami, FL, for Defendant.
Christopher H. Hunt, Craig Ronald Lynd, Jeffrey S. Kaufman, Jr., Kaufman & Lynd, Orlando, FL, for Plaintiff. Christina D. Olivos, Lisa M. Baird, Reed Smith LLP, Miami, FL, for Defendant.
ORDER
CARLOS E. MENDOZA, UNITED STATES DISTRICT JUDGE
THIS CAUSE is before the Court on Defendant's Motion to Dismiss ("Motion," Doc. 13). Plaintiff filed a Response (Doc. 18), and Defendant filed a Reply (Doc. 23). For the reasons set forth herein, the Motion will be granted.
I. BACKGROUND
This is a products liability case involving a spinal neurostimulator allegedly manufactured by Defendant. (Compl., Doc. 1-1, at 3). Plaintiff was implanted with the neurostimulator in 2015 and, according to Plaintiff, Defendant represented that the neurostimulator's battery had a five-year lifespan. (Id.). By 2017, the battery allegedly failed, and Plaintiff underwent surgery to have it replaced with a second battery. (Id.). By 2018, the second battery allegedly failed, and Plaintiff again underwent surgery to have it replaced with a third battery. (Id.). Plaintiff filed suit against Defendant alleging claims of strict liability, breach of implied warranty, and breach of express warranty. (Id. at 3-5). Defendant moves for dismissal of all claims. (Doc. 13 at 6, 19).
Plaintiff names Defendant as the "successor in interest to St. Judge Medical, Inc." (Doc. 1-1 at 2). Defendant explains that it is a "wholly owned subsidiary of Abbott Laboratories" and that a different subsidiary of Abbott Laboratories merged with St. Jude Medical, Inc. and became its successor in interest. (Doc. 13 at 6). This distinction is not relevant to the issues in this Order because Defendant does not dispute that it is the manufacturer of the medical device at issue.
II. LEGAL STANDARD
"A pleading that states a claim for relief must contain . . . a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). Pursuant to Federal Rule of Civil Procedure 12(b)(6), a party may move to dismiss a complaint for "failure to state a claim upon which relief can be granted." In determining whether to dismiss under Rule 12(b)(6), a court accepts the factual allegations in the complaint as true and construes them in a light most favorable to the non-moving party. See United Techs. Corp. v. Mazer, 556 F.3d 1260, 1269 (11th Cir. 2009). Nonetheless, "the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions," and "[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Furthermore, "[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.' " Id. (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. Ordinarily, in deciding a motion to dismiss, "[t]he scope of the review must be limited to the four corners of the complaint." St. George v. Pinellas Cnty., 285 F.3d 1334, 1337 (11th Cir. 2002).
III. ANALYSIS
Defendant argues for dismissal of Plaintiff's claims for three reasons. First, Defendant argues that all of Plaintiff's claims are preempted by federal law. Second, Defendant argues that Plaintiff's breach of warranty claims fail for lack of privity. And third, Defendant argues that the Complaint should be stricken as a shotgun pleading.
A. Preemption
1. Legal Standard
The Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360c et seq., gave the Food and Drug Administration ("FDA") the authority to regulate medical devices. Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1325 (11th Cir. 2017). "[T]he FDA classifies medical devices into three categories, depending on the level of risk presented," with "Class III" being "the highest category of risk." Id. (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); 21 U.S.C. § 360c(a)(1)). Class III devices are required to undergo the FDA's premarket approval ("PMA") process which reviews the medical device's safety and effectiveness and prevents a manufacturer from making post-approval changes without the FDA's consent. Id. (citing Riegel, 552 U.S. at 317-20, 128 S.Ct. 999; 21 C.F.R. § 814.1; 21 U.S.C. § 360e(d)(5)(A)(i)). The parties do not dispute that the device at issue is a Class III device that has been approved by the FDA through the PMA process.
Defendant asks the Court to take judicial notice of the fact that the medical device and its subsequent models were approved by the FDA through the PMA process and that this approval has never been revoked, withdrawn, or suspended. (Doc. 13 at 10; see generally Request for Judicial Notice, Doc. 15). In support, Defendant submitted three Premarket Approval Letters from the FDA, which are also available on the FDA's public database. (See generally Nov. 21, 2001 Letter, Doc. 15-1; Dec. 10, 2007 Letter, Doc. 15-2; Nov. 2, 2015 Letter, Doc. 15-3). Because Plaintiff does not dispute this request, the Court considers it unopposed. Foster v. The Coca-Cola Co., No. 6:14-cv-2102-Orl-40TBS, 2015 WL 3486008, at *1 (M.D. Fla. June 2, 2015) ("When a party fails to respond, that is an indication that the motion is unopposed."); Jones v. Bank of Am., N.A., 564 F. App'x 432, 434 (11th Cir. 2014).
"Courts in this circuit have routinely taken judicial notice of public records available on the FDA's website, without converting a motion to dismiss into a motion for summary judgment, because such documents satisfy the requirements of Rule 201." Marmol v. St. Jude Med. Ctr., 132 F. Supp. 3d 1359, 1364 (M.D. Fla. 2015). Upon review, the Court will grant Defendant's request to take judicial notice of the FDA documents that indicate the PMA status of the medical device at issue. Fed. R. Evid. 201(b)-(c) (dictating that a court must take judicial notice of a fact at the request of a party if it "is supplied with the necessary information" and the fact "can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned"); Kaiser v. Depuy Spine, Inc., 944 F. Supp. 2d 1187, 1192 n.2 (M.D. Fla. 2013) (taking "judicial notice of public records of the FDA relating to the medical device involved in th[e] case" on a motion to dismiss).
The MDA proscribes express and implied preemption for certain state law claims relating to medical devices. As to express preemption, "state-law claims that impose on the medical device a requirement different from or additional to federal requirements" and "which relate[ ] to the safety or effectiveness of the device" are barred. Id. at 1327 (citing Riegel, 552 U.S. at 321-22, 128 S.Ct. 999); 21 U.S.C. § 360k(a). As to implied preemption, "state-law claims that seek to privately enforce duties owed to the FDA" are also barred. Id. (citing Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001)); 21 U.S.C. § 337(a).
The interplay between these two provisions leaves a "narrow gap" through which plaintiffs may make medical device claims. Id. "To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption)." Id. (citation omitted). In other words, "a plaintiff may proceed on her claim so long as she claims the 'breach of a well-recognized duty owed to her under state law' and so 'long as she can show that she was harmed by a violation of applicable federal law.' " Id. (quoting Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010)). The claims that fit through this narrow gap are often called "parallel claims," because the state duties " 'parallel,' rather than add to, federal requirements." Riegel, 552 U.S. at 330, 128 S.Ct. 999 (Medtronic, Inc. v. Lohr, 518 U.S. 470, 495, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)).
2. Analysis
Defendant argues that all of Plaintiff's claims fall outside the permissible "narrow gap" and are expressly preempted or, if not expressly than impliedly preempted by the MDA. Plaintiff argues to the contrary. In evaluating whether Plaintiff's claims are preempted, the Court must first determine whether the claims are properly pleaded under Florida law and then decide if they are preempted. Mink, 860 F.3d at 1327-28 (citing Slack v. McDaniel, 529 U.S. 473, 485, 120 S.Ct. 1595, 146 L.Ed.2d 542 (2000)).
a. Strict Liability
First, the Court addresses Plaintiff's claim of strict liability. The Court starts by evaluating whether this claim is properly pleaded under Florida law. Mink, 860 F.3d at 1327-28. To prove a claim for strict liability involving a defect under Florida law "a plaintiff must show that the defendant manufactured or distributed the product in question, that the product has a defect that renders it unreasonably dangerous and that the unreasonably dangerous condition is the proximate cause of the plaintiff's injury." Marzullo v. Crosman Corp., 289 F. Supp. 2d 1337, 1346 (M.D. Fla. 2003) (citing Jennings v. BIC Corp., 181 F.3d 1250, 1255 (11th Cir. 1999); West v. Caterpillar Tractor Co., 336 So. 2d 80, 84 (Fla. 1976)). Plaintiff has sufficiently pleaded these elements and thus has properly pleaded a claim for strict liability under Florida law. (Doc. 1-1 at 3-4).
The Court now turns to the issue of preemption. Plaintiff's strict liability claim asserts that Defendant's creation, manufacture, and distribution of the neurostimulator caused it to be "defective and unreasonably dangerous" and resulted in injuries to Plaintiff. (Id. at 3). Because these allegations challenge the safety and effectiveness of a medical device that has been approved through the PMA process the claim is within the purview of § 360k(a). However, strict liability claims may survive express preemption if they are properly pleaded as parallel claims. Godelia v. Doe, 881 F.3d 1309, 1319 (11th Cir. 2018) (reversing the district court's dismissal of the plaintiff's strict liability claim because it was sufficiently pleaded as a parallel claim); Mink, 860 F.3d at 1331 (same).
Defendant argues that Plaintiff's strict liability claim fails to plead a parallel claim because Plaintiff did not sufficiently allege what federal regulation or requirement Defendant allegedly violated. Mink, 860 F.3d at 1327 (explaining that in pleading a parallel claim a plaintiff must, in part, allege "conduct that violates a federal requirement" in order to escape express preemption). The Court agrees. A plaintiff "cannot simply incant the magic words '[Defendant] violated FDA regulations' in order to avoid preemption." Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011). Rather, a plaintiff must "plead specific violations of federal regulations" or requirements. Godelia, 881 F.3d at 1319; Mink, 860 F.3d at 1331 (finding a parallel claim was properly pleaded when the plaintiff "pointed to device-specific federal requirements . . . as well as a number of other specific federal regulations" that were allegedly violated).
Here, Plaintiff's strict liability claim is devoid of any allegations that Defendant violated a specific federal regulation or requirement in designing or manufacturing the neurostimulator. In fact, Plaintiff does not even attempt to "incant the magic words '[Defendant] violated FDA regulations,' " Wolicki-Gables, 634 F.3d at 1301, because there is no mention of the FDA at all in the Complaint. This is clearly insufficient to plead a parallel claim under the Eleventh Circuit's standards. Consequently, Plaintiff's strict liability claim is expressly preempted by § 360k(a) because it does not allege a violation of federal regulations or requirements but rather seeks to impose common-law requirements that are "different from or additional to" those provided by the FDA. Rowe v. Mentor Worldwide, LLC, 297 F. Supp. 3d 1288, 1300 (M.D. Fla. 2018) (finding that because the plaintiff's strict liability allegations "fail to identify a federal regulation that was violated, the Complaint fails to state a parallel claim, and the Court concludes th[e] claim is expressly preempted" under § 360k(a)); Wigginton v. Hologic, Inc., No. 5:20-cv-322-30PRL, 2020 WL 13093771, at *2-3 (M.D. Fla. Sept. 3, 2020) (dismissing all of the plaintiff's products liability claims as expressly preempted under § 360k(a) where "the complaint [was] silent as to any applicable federal regulation that was violated"). Plaintiff's strict liability claim will be dismissed.
Because the claim is expressly preempted, the Court need not reach the issue of implied preemption.
b. Breach of Warranty
Next, the Court turns to Plaintiff's breach of implied warranty and breach of express warranty claims. The Court first evaluates whether these claims are properly pleaded under Florida law. Mink, 860 F.3d at 1327-28. On this issue, Defendant argues that both claims should fail for a lack of privity. Plaintiff disputes that privity is required for implied warranty claims, but Plaintiff does not address Defendant's challenge to her breach of express warranty claim.
A claim for breach of implied warranty under Florida law requires privity, as set out in the Florida Supreme Court case Kramer v. Piper Aircraft Corporation, 520 So. 2d 37, 39-40 (Fla. 1988). See also Amoroso v. Samuel Friedland Fam. Enters., 604 So. 2d 827, 833 (Fla. 4th DCA 1992), approved, 630 So. 2d 1067 (Fla. 1994). Plaintiff's argument to the contrary misunderstands the holding of Kramer. Plaintiff argues that Kramer stands for the proposition that a breach of implied warranty claim does not require privity "where strict liability claims are not applicable." (Doc. 18 at 12). By contrast, the Kramer Court explained that, in clarifying its prior decision in West v. Caterpillar Tractor Company, Incorporated, 336 So. 2d 80 (Fla. 1976), the claim of strict liability "supplants" non-privity implied warranty claims, while leaving intact contract-based implied warranty claims where privity is shown. Kramer, 520 So. 2d at 39 (quotation omitted). Thus, the Supreme Court of Florida delineated two avenues for which a breach of implied warranty claim may be brought: (1) a strict liability claim where no privity is required, or (2) a breach of implied warranty claim where privity is required. Amoroso, 604 So. 2d at 833 (explaining that "in [Kramer] the [Florida] [S]upreme [C]ourt held that a no-privity claim for breach of implied warranty was abolished by the adoption of strict liability in Florida in [West]" and therefore privity is a requirement for a breach of implied warranty claim); Cooper v. Old Williamsburg Candle Corp., 653 F. Supp. 2d 1220, 1225 (M.D. Fla. 2009) ("To sustain a claim for breach of implied warranty under Florida law, the plaintiff must demonstrate that [s]he is in privity with the defendant." (citing T.W.M. v. Am. Med. Sys., Inc., 886 F. Supp. 842, 844 (N.D. Fla. 1995) (citing Kramer, 520 So. 2d at 39))).
Plaintiff primarily cites preWest cases in arguing that privity is not a requirement. The Florida Supreme Court revised Florida's common law regarding breach of implied warranty claims in West, to which this Court will adhere.
While Kramer did not address express warranty claims, in general, Florida law also requires privity for breach of express warranty claims. Kaiser v. Depuy Spine, Inc., 944 F. Supp. 2d 1187, 1193 (M.D. Fla. 2013) ("It is well established law in Florida that warranty-based claims, including breach of express warranty, require privity of contract between the parties."); Intergraph Corp. v. Stearman, 555 So. 2d 1282, 1283 (Fla. 2d DCA 1990) ("Privity is required in order to recover damages from the seller of a product for breach of express or implied warranties."); Weiss v. Johansen, 898 So. 2d 1009, 1012 (Fla. 4th DCA 2005) ("[I]n order to recover for the breach of a warranty either express or implied, the plaintiff must be in privity of contract with the defendant." (citations omitted)).
In exceptional cases, Florida courts have found the privity requirement alternatively satisfied where a buyer has substantial communications directly with the manufacturer or where a manufacturer has heavy involvement with a transaction between the buyer and third-party distributor. See, e.g., Cedars of Lebanon Hosp. Corp. v. European X-Ray Distribs. of Am., Inc., 444 So. 2d 1068, 1072 n.4 (Fla. 3d DCA 1984); New Nautical Coatings, Inc. v. Scoggin, 731 So. 2d 145, 147 (Fla. 4th DCA 1999). However, these exceptions do not appear to be applicable on the face of the Complaint nor have they been addressed by either party.
Here, Plaintiff has not pleaded any allegations that she purchased the neurostimulator directly from Defendant. Privity has therefore not been established for either warranty-based claim. Kaiser, 944 F. Supp. 2d at 1193 (dismissing a breach of warranty claim "where [the] plaintiff did not purchase the product from the defendant" and thus could not establish privity); Jackmack v. Bos. Sci. Corp., No. 2:20-cv-692-SPC-NPM, 2021 WL 1020981, at *2 (M.D. Fla. Mar. 17, 2021) (dismissing a breach of express warranty claim for lack of privity where the plaintiff "did not, nor can she, allege that [the plaintiff] bought the medical device directly from [the defendant]").
Absent allegations of privity between herself and Defendant, Plaintiff fails to state plausible breach of implied warranty and breach of express warranty claims under Florida law, so these claims will be dismissed. The Court therefore need not address preemption on this issue.
B. Leave to Amend
Throughout her Response, Plaintiff requests leave to amend the Complaint should this Court find dismissal appropriate. Federal Rule of Civil Procedure 15(a)(3) dictates that the "court should freely give leave when justice so requires." While Plaintiff provides little argument to support this request, the Court finds that under the liberal standard of Rule 15(a)(3), and given this is Plaintiff's first such request, the granting of leave is appropriate. The Court will grant Plaintiff leave to file an amended complaint that is consistent with this Order.
Because the Court will grant leave to amend, it need not address the shotgun pleading arguments.
IV. CONCLUSION
In accordance with the foregoing, it is ORDERED and ADJUDGED as follows:
1. Defendant's Motion to Dismiss (Doc. 13) is GRANTED.
2. Defendant's Request for Judicial Notice (Doc. 15) is GRANTED.
3. The Complaint is DISMISSED.
4. On or before September 21, 2022, Plaintiff may file an amended complaint. Failure to timely file an amended complaint will result in dismissal of this case with prejudice without further notice.
DONE and ORDERED in Orlando, Florida on September 7, 2022.