Opinion
Case No: 6:12-cv-991-Orl-36DAB
04-08-2013
TRENT STOKES, Plaintiff, v. I-FLOW CORPORATION, Defendant.
ORDER
This cause comes before the Court upon Defendant I-Flow Corporation's ("Defendant") Motion to Dismiss Plaintiff Trent Stokes' ("Plaintiff") Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) and Motion to Strike pursuant to Federal Rule of Civil Procedure 12(f) ("Motion to Dismiss") (Doc. 14). Following the Court's Order to Show Cause (Doc. 22), Plaintiff filed a Response in opposition ("Response") (Doc. 23). With leave of Court, Defendant filed a Reply ("Reply") (Doc. 27). For the reasons that follow, the Court will grant Defendant's Motion to Dismiss.
I. BACKGROUND
The following statement of facts is derived from Plaintiff's Complaint (Doc. 1), the allegations of which the Court must accept as true in ruling on the instant Motion to Dismiss. Linder v. Portocarrero, 963 F.2d 332, 334 (11th Cir. 1992).
Plaintiff is a resident of Altamonte Springs, Florida. Doc. 1, ¶ 1. Defendant is a Delaware corporation whose principal place of business is in Lake Forest, California. Id. at ¶ 2. Defendant conducts substantial business in Florida by selling and distributing its pain pump products. Id.
On or about March 12, 2006, Plaintiff had arthroscopic surgery at the Lakeland Surgical and Diagnostic Center in Lakeland, Florida. Id. at ¶ 5. Following surgery, an "On Q Pain Buster Pain Pump" designed, manufactured, and marketed by Defendant ("Pump") was implanted in Plaintiff's right shoulder. Id. The Pump injected pain medication directly into Plaintiff's shoulder joint continuously for up to seventy-two hours following the surgery. Id.
As a result of the insertion of the Pump, Plaintiff received allegedly dangerous doses of continuously infused medication in his shoulder joint and developed a condition called chondrolysis. Id. at ¶¶ 7-9. Chondrolysis is characterized by stiffness of the joint, increased pain, clipping, popping and grinding of the joint, and decreased range of motion. Id. at ¶ 8.
Plaintiff was unaware of the connection between Defendant's alleged wrongdoing and his shoulder problems until November 2009 when the Food and Drug Administration ("FDA") issued warnings regarding the connection between pain pumps and chondrolysis. Id. at ¶ 10. Plaintiff alleges that the Pump was a substantial cause of injuries he suffered, including permanent loss of cartilage and loss of use of function in his shoulder and arm. Id. at ¶ 11. As a result of the narrowing of the joint space and/or chondrolysis caused by Defendant's Pump, Plaintiff will need additional surgery, and has suffered mental distress and anguish due to the permanent impairment to the use and function of his upper extremities. Id. at ¶ 12.
Plaintiff alleges that, at all relevant times, Defendant knew its Pump was not cleared by the FDA for use in joint space, and that the FDA has repeatedly denied requests by pain pump manufacturers for permission to market these devices in joint space. Id. at ¶ 13. Plaintiff alleges that Defendant actively promoted its pain pumps to orthopedic surgeons for the use in the joint space, despite the FDA's denial of permission to market this device for this indication. Id. at ¶ 15. Plaintiff alleges that Defendant did not warn him or his surgeon that the Pump had been denied clearance by the FDA for use in the joint space, or about the unreasonable risks and dangers of using anesthetic medications in this manner. Id. at ¶¶ 17-18.
B. Procedural History
On June 28, 2012, Plaintiff filed a Complaint alleging three state law claims for relief: (1) strict product liability based upon a design defect; (2) negligence; and (3) failure to warn. Id. at ¶¶ 20-41. Plaintiff seeks damages and reasonable costs and attorney fees for violation of the Florida Deceptive and Unfair Trade Practices Act ("FDUTPA"), although Plaintiff does not claim any FDUTPA violation. Id. at ¶ 43. The instant Motion to Dismiss ensued. Doc. 14.
II. STANDARD
To survive a motion to dismiss, a pleading must include a "'short and plain statement showing that the pleader is entitled to relief.'" Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009) (quoting Fed. R. Civ. P. 8(a)(2)). Labels, conclusions and formulaic recitations of the elements of a cause of action are not sufficient. Id. (citing Bell Atlantic Corp., v. Twombly, 550 U.S. 544, 555 (2007)). Mere naked assertions, too, are not sufficient. Id. A complaint must contain sufficient factual matter, which, if accepted as true, would "state a claim to relief that is plausible on its face." Id. (quoting Twombly, 550 U.S. at 555). "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. (citation omitted). The court, however, is not bound to accept as true a legal conclusion stated as a "factual allegation" in the complaint. Id. at 1950. Therefore, although a complaint does not need detailed factual allegations to survive a challenge under Rule 12(b)(6), a plaintiff is still obligated to provide the "grounds" for his entitlement to relief. City of Winter Haven v. Cleveland Indians Baseball Co., LP, 2009 WL 1107670, *1 (M.D. Fla. 2009); see Iqbal, 129 S. Ct. at 1950 ("only a claim that states a plausible claim for relief survives a motion to dismiss.").
III. ANALYSIS
A. Statutory Framework of the Medical Device Amendments
The regulation of medical devices entering the market is governed by the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. The FDCA provides that the enforcement of violations "shall be by and in the name of the United States" 21 U.S.C. § 337(a). In 1976, Congress passed the Medical Device Amendments of 1976 ("MDA"), which amended the FDCA and imposed a regime of detailed federal oversight. See 21 U.S.C. § 360c et seq. The new regulatory regime separated medical devices into three classes based on the risks each pose to the public. Id.; Riegel v. MedTronic, Inc., 552 U.S. 312, 316 (2008); U.S. v. Endotec, Inc., 563 F.3d 1187, 1189-90 (11th Cir. 2009). Class I devices are those that present no unreasonable risk of illness or injury and are subject only to "general controls," such as labeling requirements. Riegel, 552 U.S. at 316 (citing 21 U.S.C. § 360c(a)(1)(A)). Class II devices possess a greater potential for danger and thus warrant "special controls" such as performance standards and postmarket surveillance measures. Id. at 316-17 (citing 21 U.S.C. § 360c(a)(1)(B)). The strictest regulation, Class III, is reserved for devices for which a less stringent classification could not provide reasonable assurance of safety and effectiveness. Id. at 317 (citing 21 U.S.C. § 360c(a)(1)(C)).
i. Premarket Approval
All Class III devices must undergo the "rigorous" premarket approval process by the FDA. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Premarket approval begins with the manufacturer submitting a multi-volume application, detailing a variety of information including the safety and efficacy of the device. Riegel, 552 U.S. at 317-18 (citing 21 U.S.C. § 360e(c)(1)). After the FDA completes its review, premarket approval is only granted if there is a "reasonable assurance" of the device's "safety and effectiveness." Id. at 318 (citing 21 U.S.C. § 360e(d)). The FDA may also condition approval on adherence to performance standards, restrictions upon sale or distribution, or other compliance requirements. Id. at 319 (citing 21 C.F.R. §§ 861. 1(b)(3), 814.82).
Even after premarket approval, manufacturers are forbidden to make changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness, without FDA permission. Id. (citing 21 U.S.C. § 360e(d)(6)(A)(I)). If a manufacturer wishes to make such a change to a device, it must submit an application for supplemental premarket approval, which is evaluated under identical criteria as the initial application. Id. (citing 21 U.S.C. § 360e(d)(6)). Moreover, after premarket approval, manufacturers are subject to reporting requirements such as the obligation to inform the FDA of new clinical investigations or scientific studies, 21 C.F.R. § 814.84(b)(2), and incidents where the device may have caused or contributed to death or serious injury, 21 C.F.R. § 803.50(a). Riegel, 552 U.S. at 319.
ii. Preemptive Effect of the MDA
Until the statutory enactment of the MDA, the introduction of new medical devices was left largely for the states to supervise as they saw fit. See Riegel, 552 U.S. at 315. However, the MDA "swept back some state obligations and imposed a regime of detailed federal oversight." Id. at 316. The MDA's express preemption provision provides that:
[N]o 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). In Riegel, the Supreme Court suggested that the MDA's preemption of certain state obligations in favor of more detailed federal oversight is justified because of the harm that would be caused by stifling innovation in medical devices if "juries were allowed to apply the tort law of 50 States to all innovations." 552 U.S. at 326 n. 5. The Supreme Court also noted that "[s]tate tort law that requires a manufacturer's [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme." Id. at 325.
Accordingly, "[t]he MDA expressly pre-empts only state requirements different from, or in addition to, any requirements applicable ... to the device under federal law." Wolicki-Gables v. Arrow Intern., Inc., 634 F.3d 1296, 1300 (11th Cir. 2011) (quoting Riegel, 552 U.S. at 312). However, because § 360k(a) only preempts state requirements to the extent that they are "different from, or in addition to the requirements imposed by federal law," state law claims premised on violations of FDA regulations that "parallel," rather than add to federal requirements are not preempted. Id. at 1300 (quoting Riegel, 552 U.S. at 330). In Wolicki, the Eleventh Circuit cites a Seventh Circuit case explaining the parallel claim principle:
In order for a state requirement to be parallel to a federal requirement, and thus not expressly preempted under § 360k(a), the plaintiff must show that the requirements are "genuinely equivalent ." State and federal requirements are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law.Wolicki-Gables, 634 F.3d at 1300 (quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)).
B. Adequacy of Plaintiff's Complaint
Plaintiff's Complaint alleges three counts against Defendant: (1) strict product liability based upon a design defect; (2) negligence; and (3) failure to warn. Doc. 1 at ¶¶ 20-41. Defendant argues that because Plaintiff is attempting to impose obligations that exceed those required by federal law, his claims are federally preempted and must be dismissed. Doc. 14, pp. 3-6 (citing Riegel, 552 U.S. at 329 (patient's common law claims of negligence, strict liability and implied warranty against the manufacturer were preempted by the FDCA)). In his Response, Plaintiff argues it does not attempt to impose additional obligations beyond those required by federal regulation, and thus his claims are not preempted. Doc. 23, p. 3. Specifically, Plaintiff maintains that Defendant was using a device that was not shown to be "substantially equivalent" to a predicate device for the "same intended use." Id. (citing 21 U.S.C. § 360c(i)(1)(A)); 21 C.F.R. § 801(4)).
Defendant argues that because Plaintiff failed to file a timely response, and failed to provide adequate "good cause" for its delay, its Motion to Dismiss should be considered without Plaintiff's Response. Doc. 27, pp. 1-2. Indeed, Plaintiff's response to the Court's Order to Show Cause merely cites "unintentional oversight" as the reason for its failure to file a timely response. Doc. 24, p. 1. Nevertheless, in an effort to dispose of cases on the merits, the Court will consider Plaintiff's Response.
i. Failure to state claim
As a preliminary matter, the Court reiterates that only the Federal Government is authorized to enforce FDA regulations. See Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 349 n.4 (2001). The Supreme Court has clarified that "[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions." Id.; see 21 U.S.C. § 337(a). In this action, Defendant maintains that contrary to Plaintiff's assertion, it received a specific indication from the FDA for orthopedic surgery applied to the Pump before Plaintiff's shoulder surgery. Doc. 27, p. 2 n.2. Regardless of whether or not this is true, the Court cannot hear any claims by private litigants to enforce the regulations of the FDA. See Riegel, 552 U.S. at 329; Buckman, 531 U.S. at 349 n.4; Wolicki, 634 F.3d at 1300. The FDCA expressly provides that all actions to enforce the Act "shall be by and in the name of the United States." 21 U.S.C. § 337(a).
In his Response, Plaintiff repeatedly emphasizes that Defendant failed to comply with the FDA's rejection of its particular marketing use requests. Doc. 23, pp. 3-5. Indeed, Plaintiff concedes that he "does not attempt to impose additional obligations beyond those required by federal regulation." Id. at 5. A review of the Complaint reveals the contrary. It is clear that Plaintiff cannot state a claim for violation of the FDCA or the FDA's implementing regulations. See 21 U.S.C. § 337(a); Wolicki, 634 F.3d at 1300; McClelland v. Medtronic, Inc., 2012 WL 5077401, *4 (M.D. Fla. 2012). Therefore, to the extent that Plaintiff bases his strict product liability, negligence, or failure to warn claims on Defendant's alleged violations of the FDCA or FDA's implementing regulations, these claims are dismissed for failure to state a claim.
ii. Claim Preemption
Next, Defendant argues that Plaintiff's state law claims are expressly preempted because they satisfy both prongs of Riegel. Doc. 14, pp. 3-5; Doc. 27, pp. 1-3. In his Response, Plaintiff maintains that his claims are not preempted because the FDA did not approve the use of Defendant's Pump for orthopedic and intra-articular use in the shoulder joint. Doc. 23, pp. 3-4. As discussed, to the extent that Plaintiff alleges Defendant has violated FDA regulations, he does not state a claim upon which relief can be granted. See supra, III(B)(i). However, Plaintiff's state law claims are expressly preempted unless they are "parallel claims" to the federal regulations at issue. Wolicki, 634 F.3d at 1300.
In Riegel, the Supreme Court used a two-part test to determine when a state law claim was preempted: (1) determine whether the federal government has established requirements applicable to the medical device, and if so, (2) determine whether the state law claims are based upon requirements with respect to the device that are different from, or in addition to the federal ones, and that relate to safety and effectiveness. 522 U.S. at 321-22. Since premarket approval imposes device-specific requirements under the MDA, medical devices approved through the premarket process automatically satisfy the first prong. See id. at 322-323; McClelland, 2012 WL 5077401, *5. Thus, the Court must determine whether Plaintiff's claims seek to impose state law requirements that are in addition to or inconsistent with the federal requirements. See Riegel, 552 U.S. at 330. In order to allege a "parallel claim", the Eleventh Circuit reiterates that "Plaintiffs cannot simply incant the magic words '[Defendant] violated FDA regulations' in order to avoid preemption." Wolicki, 534 F.3d at 1301. Indeed, parallel claims must be specifically stated in the initial pleadings. A plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue, setting forth facts pointing to the federal requirements that have been violated. Id.
In Count I, which asserts strict liability for a design defect, Plaintiff alleges that Defendant's Pump was unreasonably and dangerously defective because its labeling failed to disclose its appropriate uses, and because Defendant did not "conduct adequate testing to determine whether pain pumps used with local anesthetics such as bupivacaine, with or without epinephrine and placed for infusion in the joint space, could cause damage to articular cartilage." Doc. 1 at ¶¶ 25-26. In Count II, Plaintiff alleges that Defendant breached its duty to exercise reasonable care in the design, manufacture, testing, sale and/or distribution of the Pump into the stream of commerce. Doc. 1, ¶ 29. Specifically, Plaintiff alleges that Defendant reasonably should have known that use of the pain pump in the joint space had been rejected by the FDA, and that the risk of chondrolysis and other serious post-operative problems outweighed the benefits of the Pump's use. Id. at ¶ 30. In Count III, Plaintiff alleges that Defendant's Pump was defective due to inadequate post-marketing warning or instruction because Defendant knew or should have known that its Pump was not safe for use in the shoulder joint space with continuous injections of certain anesthetics. Id. at ¶ 36.
In Wolicki, the Eleventh Circuit affirmed the trial court's conclusion that a fact finder could find liability under Florida design defect laws even if the manufacturer had completely complied with the FDA regulations. Wolicki, 634 F.3d at 1301; see Wolicki-Gables v. Arrow International, Inc., 641 F.Supp. 2d 1270, 1285-88 (M.D. Fla. 2009). Specifically, the District Court determined that Florida laws corresponding to strict liability for design defect and failure to warn, as well as for negligent design, manufacture and assembly, imposed requirements that were "different from, or in addition to" the federal requirements established for the premarket approval of the device at issue in that case. See Wolicki, 641 F.Supp. 2d at 1285-88. Accordingly, the District Court dismissed these claims as preempted by the federal scheme. Id. Similarly here, the Court finds it unlikely that Plaintiff could state a claim for strict liability due to design defect or negligent design that would not differ from the federal scheme and be preempted.
Second, in its claim for negligence, Plaintiff has failed to set forth any problem or failure to comply with a federal regulation that could be linked to the injury alleged. Wolicki,634 F.3d at 1301-02 (citing Ilarraza v. Medtronic, Inc., 677 F.Supp. 2d 582, 589 (E.D.N.Y. 2009)). In its negligence claim, Plaintiff simply claims that Defendant had a duty to exercise reasonable care in the design, manufacture, testing, sale and distribution of its Pump, and based upon what Defendant should have known, it was negligent for failing to warn the public that the Pump's safety had not been established for use in the joint space. Id. at ¶¶ 29-31. However, Plaintiff has not directed the Court to any FDA regulation that requires a device manufacturer to contact doctors or patients, let alone "the U.S. medical community" regarding a potential device defect without FDA involvement. Doc. 1, ¶¶ 31, 37-39. Indeed, the FDA regulations regarding manufacturer reporting requirements refer to reporting to the FDA, not doctors or patients. See 21 U.S.C. § 360i; 21 C.F.R. § 803.50(a); 21 C.F.R. § 806.10(a); 21 C.F.R. § 814.84(a); and 21 C.F.R. §§ 820.198(a), (c); see also Leanord v. MedTronic, Inc., 2011 WL 3652311, *9 (N.D. Ga. 2011) ("Given that Plaintiffs have not identified any federal law requiring manufacturers to warn individual doctors about the safety and effectiveness of a device, their claim would hold [Defendant] liable under state law without having violated an equivalent federal law.").
The Court finds that Plaintiff's state law claims meet the second prong of Riegel. First, Plaintiff's Complaint does not identify particular federal regulations or set forth facts pointing to the federal requirements that have been violated. See Wolicki, 534 F.3d at 1301. Second, the Eleventh Circuit has already found that the Florida state law claims for strict liability for design defect and failure to warn are not "parallel claims" to the federal system for medical devices. Id. Third, Plaintiff's claim of negligence clearly imposes requirements which are "different from, or in addition to" the federal requirements. Id. at 1301; U.S.C. § 360k(a)(1). Thus, Plaintiff's Complaint will be dismissed as he has failed to plead a non-preempted claim.
Other courts have found that common law strict liability imposes different specific requirements than the federal requirements for medical devices. See, e.g. Yost v. Stryker Corp., 2010 WL 1141586, *2 (M.D. Fla. 2010).
C. Plaintiff's prayer for costs and attorney fees under FDUTPA will be stricken
Plaintiff's attempt to seek damages pursuant to FDUTPA is inappropriate and will be stricken. First, Plaintiff does not make any FDUTPA claim, and thus his request for damages is superfluous. See Fed. R. Civ. P. 12(f). Further, even if Plaintiff had made a FDUTPA claim, such a claim would be precluded because FDUTPA does not apply to claims for personal injury. See Fla. Stat. § 501.212(3) ("This part does not apply to ... (3) A claim for personal injury or death or a claim for damage to property other than the property that is the subject of the consumer transaction."); see Barrow v. Bristol-Myers Squibb Co., 1998 WL 812318, * 46 (M.D. Fla. 1998) (dismissing FDUTPA claim because Plaintiff cannot recover for personal injuries pursuant to that statute).
IV. CONCLUSION
To the extent that Plaintiff seeks to enforce provisions of the FDCA or the FDA's implementing regulations, his claims are dismissed for failure to state a claim. Also, Plaintiff's state law causes of action are expressly preempted because they fail to allege a parallel claim. See Riegel, 522 U.S. at 321-22. Rather, they appear to impose state law requirements which are inconsistent with the federal requirements imposed. Additionally, Plaintiff's claim for FDUTPA relief is precluded because that statute does not apply to claims for personal injury.
Accordingly, it is hereby ORDERED:
1. Defendant I-Flow Corporation's Motion to Dismiss Plaintiff Trent Stokes' Complaint, pursuant to Federal Rule of Civil Procedure 12(b)(6) (Doc. 14) is GRANTED.
2. Plaintiff Trent Stokes' Complaint (Doc. 1) is DISMISSED. Although the Court recognizes that, pursuant to Riegel and Wolicki, a narrow gap exists for Plaintiff's state law claims if they are to avoid preemption, per his request, Plaintiff is granted leave to file an Amended Complaint within fourteen (14) days from the date of this Order which cures the deficiencies addressed in this Order. Failure to file an Amended Complaint within the time provided will result in this case being closed.
DONE and ORDERED in Orlando, Florida on April 8, 2013.
/s/_________
Charlene Edwards Honeywell
United States District Judge Copies furnished to:
Counsel of Record
Unrepresented Parties