LAWRENCE K. KARLTON, Senior District Judge.
Defendant moves to dismiss the amended complaint, asserting that it is preempted by federal law, and that it fails to state a claim. For the reasons that follow, the amended complaint will be dismissed with leave to amend.
Defendant, Smith & Nephew, Inc., is the manufacturer of the Birmingham Hip Resurfacing System ("BHR System"), a medical device.
The Approval Letter states that "[f]ailure to comply with any postapproval requirement constitutes a ground for withdrawal of approval of a PMA," and that "[c]ommercial distribution of a device that is not in compliance with these conditions is a violation" of the federal Food, Drug, and Cosmetic Act. Approval Letter at 7.
On July 11, 2009, plaintiff underwent surgery to replace a BHR System. FAC ¶ 10. Unbeknownst to plaintiff at the time, the BHR System leaks metal ions into the tissues, causing various types of serious injury. FAC ¶ 14. As a result, plaintiff suffered pain and symptoms of cobalt poisoning.
On June 20, 2012, plaintiff filed a complaint in state court alleging that defendant was strictly liable for the BHR System, under a "Product Liability" cause of action. ECF No. 1 at 15-16 (original complaint). Defendant answered, asserting, among other things, that the complaint was preempted by the Medical Device Amendments of 1976 ("MDA") to the Federal Drug and Cosmetic Act (the "Act"), 21 U.S.C. § 321 et seq., and federal regulations. Id., at 59-60.
Defendant removed the action to this court on December 19, 2012. Id., at 1. After defendant moved to dismiss the case based upon federal preemption, plaintiff amended his complaint. The amended complaint contains two common-law claims. The first claim alleges "Negligence," asserting that the device was designed or manufactured in violation of the MDA and its implementing regulations. The second claim alleges "Strict Products Liability," asserting, in addition to the negligence claims, that the device was "defective" and "unreasonably dangerous" when it entered the stream of commerce, due to defendant's alleged failures to comply with the MDA and regulations.
Defendant now moves to dismiss the amended complaint based upon preemption, and failure to state a claim.
A dismissal motion under Fed.R.Civ.P. 12(b)(6) challenges a complaint's compliance with the federal pleading requirements. Under Fed.R.Civ.P. 8(a)(2), a pleading must contain a "short and plain statement of the claim showing that the pleader is entitled to relief." The complaint must give the defendant "`fair notice of what the ... claim is and the grounds upon which it rests.'" Bell Atlantic v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)).
To meet this requirement, the complaint must be supported by factual allegations. Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Moreover, this court "must accept as true all of the factual allegations contained in the complaint." Erickson v. Pardus, 551 U.S. 89, 94, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007).
"While legal conclusions can provide the framework of a complaint," neither legal conclusions nor conclusory statements are themselves sufficient, and such statements are not entitled to a presumption of truth. Iqbal, 556 U.S. at 679, 129 S.Ct. 1937. Iqbal and Twombly therefore prescribe a two-step process for evaluation of motions to dismiss. The court first identifies the nonconclusory factual allegations, and then determines whether these allegations, taken as true and construed in the light most favorable to the plaintiff, "plausibly give rise to an entitlement to relief." Iqbal, 556 U.S. at 679, 129 S.Ct. 1937.
"There is a presumption against federal preemption of state laws that operate in traditional state domains." Stengel v. Medtronic Inc., 704 F.3d 1224, 1227 (9th Cir.2013) (en banc).
This lawsuit arises from the injuries allegedly caused by a BHR System, a Class III medical device.
The PMA process results in a denial, an approval or an approval "with conditions
Even after pre-market approval is granted, there are post-approval statutory and regulatory requirements the manufacturer must satisfy, in addition to any post-approval conditions the FDA imposes on the specific device subject to the PMA. In general, the manufacturer must refrain from manufacturing, packaging, storing, labeling, distributing or advertising the medical device "in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device." 21 C.F.R. § 814.80. In addition, the manufacturer must report deaths and serious injuries that the device "has or may have caused or contributed to" and certain device malfunctions, and it "must establish and maintain adverse event files," and "submit specified followup." 21 C.F.R. §§ 814.84(a) (must comply with Part 803 reporting requirements); 803.1(a) (general statement of reporting requirements).
The Medical Devices Amendments contain an explicit preemption clause which prohibits the States from establishing or continuing in effect:
21 U.S.C. § 360k(a). However, the FDA regulations provide that the MDA "does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act." 21 C.F.R. § 808.1(d)(2).
The Supreme Court has established a two-step framework for determining whether a state law claim is subject to preemption by the MDA.
Approval Letter at 4. In addition, the letter imposes requirements for prescription use, labeling, and sale, distribution and use of the BHR System. Id., at 5. The letter also requires that the manufacturer conduct specified studies and training. Id., at 5-6. The letter further requires that the manufacturer "provide an analysis of adverse
The second step is to determine whether plaintiff's state common-law claims are based upon California requirements "with respect to the device that are `different from, or in addition to' the federal ones, and that relate to safety and effectiveness.'" Riegel, 552 U.S. at 321-22, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)). The "requirements" can be established by the state's common-law, and include claims for negligence and strict-liability. Riegel, 552 U.S. at 327-30, 128 S.Ct. 999 (rejecting at length, the argument "that the duties underlying negligence [and] strict liability... claims are not pre-empted even if they impose `"requirements,"' because general common-law duties are not requirements maintained `"with respect to devices"'").
Plaintiff's claims are therefore subject to MDA preemption. However, the claims can be rescued from preemption if they only impose duties that "parallel" those imposed by the MDA.
Riegel, 552 U.S. at 330, 128 S.Ct. 999 (citing Lohr, 518 U.S. at 495, 116 S.Ct. 2240); Stengel, 704 F.3d at 1228 ("the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA"). The issue then, is whether the two state common-law claims plaintiff asserts — negligence and strict products liability — are for violating a state-law duty that parallels, and does not exceed, a federal-law duty under the MDA.
Defendant purports to make a preemption argument, asserting (in the titles to its arguments) that plaintiff fails to allege parallel claims. However, the text of defendant's arguments focus exclusively on plaintiff's alleged failure to comply with the pleading requirements imposed by Fed.R.Civ.P. 8, Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), and Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). According to defendant, the complaint "simply recited a laundry list of federal regulations supposedly violated" by the defendant, without pleading specific facts to show a deviation between the design or labeling approved in the PMA, and design or labeling he received.
Plaintiff argues that his claims are not precluded because he alleges state claims premised upon defendant's violation of the federal law and regulations.
Several other plaintiffs across the country (California, Illinois, Ohio and New York), have sued defendant over the BHR System. Defendant's attempts to have
In Chao v. Smith & Nephew, Inc., 2013 WL 6157587 (S.D.Cal.2013) (Huff, J.), plaintiff, a surgeon, sought indemnification from defendant Smith & Nephew, Inc. ("SNI"), after he injured a patient while implanting the BHR System. The surgeon claimed that SNI provided him with a defectively designed pair of surgical scissors, which caused the injury. The court granted defendant summary judgment on preemption grounds when defendant present undisputed evidence that "the FDA had approved the design of the scissors as part of the PMA process." Chao, 2013 WL 6157587 at *2.
The surgeon also claimed that SNI failed to train him in conformance with applicable FDA training standards. It was undisputed that "as part of the PMA process for the BHR, the FDA required Smith & Nephew to provide a surgical technique brochure and instructive training videos to surgeons who would be using the BHR system." Id., at *3. The court denied summary judgment because (1) plaintiff was asserting a state-law claim that paralleled the federal duty, and (2) there was a material dispute about whether the training provided complied with the PMA standards. Id.
In Comella v. Smith & Nephew, Inc., 2013 WL 6504427 (N.D.Ill.2013) (Zagel, J.), the plaintiff was injured by her BHR System implant. Three years after the implant, she suffered severe hip pain, and "highly elevated chromium and cobalt levels" in her blood, which left her unable to walk, and then unable to walk easily, for an extended amount of time.
The court denied SNI's motion to dismiss the common law claim that defendant violated a duty to warn the FDA about "dangers that became manifest after the product was put on the market." Such a duty parallels the federal post-PMA duty to report such dangers to the FDA. Comella, 2013 WL 6504427 at *2. However, the court dismissed, as preempted, plaintiff's common law claim that defendant failed to warn the public and the medical community of the dangers, because that would create "an additional requirement," beyond that imposed by the MDA. Id.
In Gale v. Smith & Nephew, Inc., 989 F.Supp.2d 243, 2013 WL 563403 (S.D.N.Y. 2013) (Briccetti, J.), plaintiff was injured by his BHR System implant. Three years after the system was implanted, he suffered total hip dislocations and acute renal failure from cobalt poisoning. Gale, 2013 WL 563403 at *1. The court dismissed as preempted, plaintiff's state claims that the device was defective, breached an implied warranty, and that defendant committed fraud on the FDA.
The court denied the motion to dismiss the claim that defendant mislabeled a component of the device with an incorrect size. Such a claim would parallel the FDA post-PMA labeling requirement. Id., at *6. The court also denied the motion to dismiss the claim that defendant failed to warn doctors that the BHR System could cause renal failure. This claim "successfully threads the needle" between Riegel and Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), by alleging that "he was injured based on S & N's failure to comply with the premarket approval's monitoring and reporting requirements." Id.
Defendant's principal argument ignores the plain language of the complaint. The complaint does not simply list federal statutes and regulations and allege that defendant violated them. It alleges specific facts that are alleged to be in violation of the laws and regulations listed. For example, the complaint alleges that the defendant "[f]ailed to accurately label the carton containing the acetabular cup, in violation of 21 C.F.R. 820.120." FAC ¶ 18(i) (negligence claim) & 24(i) (strict product liability claim).
This plainly satisfies Rule 8, because it puts defendant on notice of exactly what it is alleged to have done. Defendant can defend against the allegation by, for example, providing specimens of the labels, or the testimony of employees who created or affixed the labels, and the PMA statement specifying what must be on the labels. Defendant's argument that plaintiff "merely recites a conclusory laundry list of federal regulations supposedly violated by Smith & Nephew" leaves the court with the definite impression that defendant must be referring to a different complaint than the one at issue here.
The allegation satisfies Twombly and Iqbal as well, as there is nothing "implausible" about an allegation that a carton was mis-labeled, in violation of the law. The same applies to most of the remaining allegations, namely, Complaint ¶¶ 18(a)-(c), (h)(m), and 24(a)-(c), and (h)-(m).
As for Complaint ¶¶ 18(d)-(g) and 24(d)-(g), plaintiff alleges that defendant failed to identify, capture and correct "the component discrepancy," in violation of 21 C.F.R. § 820.80(c) and (d). The court has no idea what "the component discrepancy" is, and it is nowhere explained in the complaint, the briefs or 21 C.F.R. § 820.80(c) or (d).
The more serious Rule 8 argument is that there is no way to tell if plaintiff is attempting to impose requirements on defendant that exceed those of federal law. If true, the claims are preempted. The problem here is that some of the allegations are ambiguous, preventing defendant and the court from determining whether plaintiff is attempting to impose additional requirements on the device, or rather, is claiming that defendants have violated the requirements imposed by the PMA.
For example, plaintiff alleges that "[t]he BHR implanted in Plaintiff on July 11, 2009, was designed and/or manufactured in violation of the Act and regulations promulgated pursuant to it." Complaint ¶¶ 16 & 23. If plaintiff means by this that the device he received (and was implanted in him) differed in design and manufacture from the device that received pre-market
However, if plaintiff means that he was implanted with the device whose design and manufacture received pre-market approval, then the claim for negligent design and manufacture is preempted. In that case, he is using state common law to impose a higher standard on the device than the MDA imposes. In Riegel, "[t]he court held that plaintiffs' claims were expressly preempted by the MDA because state law imposed a more stringent safety requirement than federal law." Stengel, 704 F.3d at 1230 (citing Riegel, 552 U.S. at 325, 128 S.Ct. 999).
Otherwise, plaintiff is asserting that the FDA did not do its job. That is also preempted. Only state claims that rely on "traditional state tort law which... predated the federal enactments" are not preempted. See Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 353, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). A claim premised upon the assertion that the FDA is not properly enforcing the MDA has that federal enactment as "a critical element in the[] case," and is therefore preempted. Id.
Some of the other allegations suffer from this same ambiguity. See Complaint ¶¶ 18(d)-(j) and 24(d)-(j). The alleged failures and misconduct there could possibly be referring to conduct where plaintiff disagrees with the FDA's conclusions, or it could refer to post-PMA activities where defendant acted contrary to the PMA's conditions. For example the allegation discussed above, that defendant "[f]ailed to accurately label the carton containing the acetabular cup, in violation of 21 C.F.R. 820.120," is ambiguous. Does it mean that the FDA erred by allowing the inaccurate label to be placed on the carton? If so, the claim is preempted. Or does it mean that defendant changed the label after PMA approval, and placed a different, inaccurate, label on the carton? The latter is not preempted. These allegations must be re-pled (or omitted if they are preempted).
Other allegations clearly apply to post-PMA activity. See Complaint ¶¶ 18(k)-(m) and 24(k)-(m). These allegations refer to events that are reasonably read as occurring post-PMA, namely, responding to "adverse incident reports," investigating "returned BHR and components," and continuing to "inject BHR systems into the stream of interstate commerce when it knew, or should have known, that the BHR system was malfunctioning." However, the allegations could be clearer, by expressly specifying that they refer to post-PMA activities.
Plaintiff's claims may or may not be partly preempted. Certainly, some portion of both claims are not preempted, because they are based upon state claims that parallel the federal requirements of the MDA and its implementing regulations. The remaining allegations are so ambiguous, it is not possible to tell if plaintiff is taking issue with the results of the PMA process, in which case they are preempted, or if he is taking issue with how defendant carried out PMA-imposed responsibilities, in which case, they are not preempted.
Accordingly, the court orders as follows:
2. Plaintiff shall file his Second Amended Complaint within fourteen calendar days after the date of this order.
IT IS SO ORDERED.
