Felger v. Smith & Nephew, Inc.
Felger v. Smith & Nephew, Inc.
Opinion of the Court
ORDER
Motion to Dismiss
Defendant moves to dismiss plaintiffs complaint.
Background
Plaintiff is Kimerly Dale Felger. Defendant is Smith & Nephew, Inc.
Defendant designed, manufactured, and marketed the Birmingham Hip Resurfacing (BHR) System, which is used in total hip replacements (THR). The BHR System is a Class III medical device. “A Class III device is subject to a pre-market approval [PMA] process of the” Food and Drug Administration (FDA). Stengel v. Medtronic Inc., 704 F.3d 1224, 1226 (9th Cir. 2013).
The FDA’s pre-market approval process of a Class III device is rigorous. The FDA performs a risk-benefit assessment of the device and determines the adequacy of the manufacturer’s proposed label. The FDA then denies, approves, or approves with conditions on distribution, marketing, or sale.
Id. (citations omitted). “The FDA spends an average of 1,200 hours reviewing each [PMA] application and grants premarket approval only if it finds there is a reasonable assurance of the device’s safety and effectiveness[.]” Riegel v. Medtronic, Inc., 552 U.S. 312, 318, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) (internal citations omitted). The PMA application includes
among other things, full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a full statement of the device’s components, ingredients, and properties and of the principle or principles of operation; a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device; samples or device components required by the FDA; and a specimen of the proposed labeling.
Id. (citations omitted).
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);*750 803.1(a) (general statement of reporting requirements).
Herron v. Smith & Nephew, Inc., 7 F.Supp.3d 1043, 1048 (E.D. Cal. 2014).
The BHR was approved by the FDA on May 9, 2006, with conditions.
Plaintiff alleges, however, that defendant
failed to timely report adverse events; failed to timely conduct ... investigations and analysis; failed to timely report any and all information concerning product failures and corrections; failed to timely and fully inform [the] FDA of unanticipated adverse events, increases in the incidence of adverse effects, or device failures necessitating a labeling, manufacturing or device modification; failed to conduct necessary design validation; and sold a misbranded and adulterated product.[8 ]
On October 30, 2008, plaintiff underwent a left total hip replacement during which a BHR System was implanted.
[t]he defective design and manufacture of the BHR allows fretting and corrosion to occur at the junction of the head of the Birmingham cup and the Acetabular lining. The fretting and corrosion allows metal ions, including cobalt and chromium, to be released into the surrounding tissues. The fretting and corrosion and release of ions also manifest in increased cobalt and chromium blood levels of the patient. These cobalt and chromium ions destroy surrounding tissue and bone often causing pseudo tumors and a condition called metallosis.[10 ]
Plaintiff alleges that “[a]fter the surgery, fretting and corrosion from the BHR THR caused large amounts of toxic metal ions and particles to be released from the
Plaintiff alleges that her injuries “were caused by the defective design and construction, lack of adequate warnings, lack of adequate notice once problems with the BHR were known, and the unreasonably dangerous character of the BHR THR that was implanted,”
On October 9, 2015, plaintiff commenced this action in state court. On'November 2, 2015, defendant removed the action to this court on the basis of diversity jurisdiction. Plaintiffs complaint contains seven counts: 1) a strict products liability manufacturing defect claim, 2) a strict products liability design defect claim, 3) a strict products liability failure to warn claim, 4) negligence claims, 5) a negligent misrepresentation claim, 6) a claim pursuant to the Alaska Unfair Trade Practices and Consumer Protection Act (UTPA), and 7) a claim for punitive damages.
Pursuant to Rule 12(b)(6), Federal Rules of Civil Procedure, defendant now moves to dismiss plaintiffs complaint based on preemption grounds.
Discussion
“Rule 12(b)(6) is read in conjunction with Rule 8(a), which requires not only ‘fair notice of the nature of the claim, but also grounds on which the claim rests.” Zixiang Li v. Kerry, 710 F.3d 995, 998-99 (9th Cir. 2013) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 n.3, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). “To survive a Rule 12(b)(6) motion to dismiss, a ‘plaintiff must allege enough facts to state a claim to relief that is plausible on its face.’ ” Turner v. City and County of San Francisco, 788 F.3d 1206, 1210 (9th Cir. 2015) (quoting Lazy Y Ranch Ltd. v. Behrens, 546 F.3d 580, 588 (9th Cir. 2008)). “In assessing whether a party has stated a claim upon which relief can be granted, a court must take all allegations 'of material fact as true and construe them in the light most favorable to the nonmoving party; but ‘conclusory allegations of law and unwarranted inferences are insufficient to avoid a Rule 12(b)(6) dismissal.’ ” Id. (quoting Cousins v. Lockyer, 568 F.3d 1063, 1067 (9th Cir. 2009)). “ ‘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. (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009)). “This standard ‘asks for more than a sheer possibility that a defendant has acted unlawfully,’ but it ‘is not akin to a probability requirement.’ ” Id (quoting Iqbal, 556 U.S. at 678, 129 S.Ct. 1937).
Except as provided in subsection (b) of this section, 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).
An implementing regulation provides that state and local requirements are only preempted by the MDA when the FDA “has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements.”
Perez, 711 F.3d at 1117 (quoting 21 C.F.R. § 808.1(d)).
“The Supreme Court has decided three preemption cases under the MDA. The rule that emerges from these cases is that the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.” Stengel, 704 F.3d at 1228. In other words,
[s]tate requirements are preempted under the MDA only to the extent that they are different from, or in addition to the requirements imposed by federal law. Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.
Riegel, 552 U.S. at 330, 128 S.Ct. 999 (citations omitted). But, “[i]f state law liability could be found notwithstanding compliance with the federal requirements, those state law duties are not parallel to the federal requirements and will be [expressly] preempted.” Eidson v. Medtronic, Inc., 40 F.Supp.3d 1202, 1215 (N.D. Cal. 2014) (Eidson II).
State-law claims may also be impliedly preempted. “The implied preemption statute, 21 U.S.C. § 337(a), states in relevant part: ‘[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.’ ” Beavers-Gabriel v. Medtronic, Inc., 15 F.Supp.3d 1021, 1030 (D. Hawai’i 2014) (quoting 21 U.S.C. § 337(a)). “[T]o avoid implied preemption, a cause of action must rely on traditional state tort law and not be based solely on a violation of federal law.” Id. at 1032. In other words, “a state law cause of action escapes implied preemption if it would state a claim under state law even in the absence of the FDCA.” Eidson v. Medtronic, Inc., 981 F.Supp.2d 868, 881 (N.D. Cal. 2013) (Eidson I).
“Together, express preemption and implied preemption provide only a ‘narrow gap’ through which a plaintiffs claims must fit in order to survive.” Eidson II, 40 F.Supp.3d at 1216 (quoting Perez, 711 F.3d at 1120). “ ‘The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by
Plaintiff contends that her claims survive preemption because they are based on post-PMA requirements. In order to determine whether plaintiffs contention is correct, the court must consider each of plaintiffs claims in turn.
In Count One of her complaint, plaintiff asserts a manufacturing defect product liability claim. Plaintiff alleges that “[t]he BHR components ... were defective in manufacture and construction when they left the hands of Smith & Nephew in that they deviated from applicable federal requirements for these medical devices and posed a serious risk of injury and /or death.”
Here, plaintiff has made a conclu-sory allegation that defendant “deviated from applicable federal requirements” in manufacturing the BHR components.
In Count Two, plaintiff asserts a design defect claim. Plaintiff alleges that the BHR was “defective in design” because the design “allows fretting and corrosion[,]” which was “the very condition
In Count Three, plaintiff asserts a failure-to-warn claim. Plaintiff alleges that defendant “failed to provide adequate and timely warnings or instructions regarding the BHR and its known defects.”
However, “[c]ourts have held that failure-to-warn claims based on failure to report adverse events to the FDA escape both express and implied preemption.” Martin, 32 F.Supp.3d at 1042 (citation omitted). Here, plaintiff makes conclusory allegations that defendant failed to report adverse events to the FDA, but plaintiff has not alleged any specific facts to support these allegations. It is also not clear whether plaintiff is referring to pre-or post-PMA adverse events. Plaintiffs allegations as to defendant’s failure to report adverse events are not sufficient to state a plausible claim.
Thus, plaintiffs Count Three is dismissed. Plaintiff is given leave to amend her failure-to-warn claim because it is possible to plead a failure-to-warn claim that survives preemption if such a claim is based on sufficient allegations that the defendant failed to report post-PMA adverse events to the FDA.
In Count Four, plaintiff asserts several negligence claims. Plaintiff alleges that defendant was negligent in the following respects:
a. Smith & Nephew failed to adequately design and manufacture the Defective Device[] to insure that it would not corrode, erode, deteriorate[,] fret, and induce severe metal toxicity in the patient. The flaws include, but are not limited to, the following:
i. Failed to accurately establish the in vivo life expectancy of the BHR, in violation of 21 C.F.R. § 820.30(f);
ii. Failed to validate the anticipate^] wear of the acetabular cup prior to release into commercial distribution in violation of 21 C.F.R. § 820.30(f);
iii. Failed to establish and maintain appropriate reliability assurance testing to validate the BHR design both before and after its introduction into the marketplace, in violation of 820.30(g);
iv. Failed to conduct adequate bio-compatibility studies to establish*755 the BHR’s propensity to effuse metallic contaminates into the human blood and tissue;
v. Failed to establish and maintain procedures for implementing corrective and preventable action in response to, inter alia, complaints regarding the BHR ... and other quality problems associated with the BHR in violation of 21 C.F.R. 820.100;
vi. Failed to appropriately respond to adverse incident reports that strongly indicated the acetabular component was [mjalfunctioning [as defined in 21 C.F.R. 803.3], or otherwise not responding to its Design Objective Intent in violation of 21 C.F.R. 820.198;
vii. Continued to inject the BHR into the stream of commerce when it knew of or should have known that the acetabular component was malfunctioning as defined in 21 C.F.R. 803.3 or otherwise not responding to its Design Objective Intent.
b. Smith & Nephew failed to adequately test the Defective Device[ ] to insure that it would .not. corrode, erode, deteriorate, fret and/or induce severe metal toxicity in the patient;
c. Smith & Nephew failed to conduct anything other than bench testing so that ... patients became in essence the Smith & Nephew Defendant’s first clinical trial; [and]
[d.] Smith & Nephew failed to promptly act upon reports of early failure such that the BHR continued to be implanted in unknowing patients by surgeons well after it should have been recalled or sales suspended.[21 ]
Some of plaintiffs negligence claims are preempted. “Negligence in researching, manufacturing, selling,-labeling, testing, distributing, and analyzing [a medical device] are claims preempted by federal law because they all address the safety of the device in ways that the FDA considers as part of the PMA process.” Scovil, 995 F.Supp.2d at 1096. Plaintiffs claims in Count Four that are based on allegations that defendant was negligent in researching, manufacturing, selling, labeling, pre-PMA testing, distributing, and analyzing the BHR System are dismissed. Plaintiff is not given leave to amend these claims as amendment would be futile because it is not possible to plead such claims so that they survive preemption.
In Count Four, plaintiff has also alleged that defendant was negligent in its response to adverse events. A negligence claim that is premised on a failure to report adverse reports to the FDA is neither expressly nor impliedly preempted, in part, because it involves post-PMA conduct. Eidson I, 981 F.Supp.2d at 891. So, it follows that a negligence claim premised on a failure to respond to post-PMA adverse reports, would also not be preempted. However, plaintiffs negligence claim based on allegations that defendant failed to respond to post-PMA adverse events must still be dismissed because plaintiff has not alleged any factual support for this claim. Plaintiff has not identified any post-PMA adverse events or reports to which defendant failed to respond. Thus, plaintiffs claim that is based on allegations that defendant was negligent in its response to adverse events is dismissed. But, plaintiff is given leave to amend as to this claim because it is possible to plead such a claim so that it survives preemption.
In Count Five, plaintiff asserts a negligent misrepresentation claim. Plaintiff alleges that defendant misrepresented the risks of the BHR System to her, her physicians, the medical community, and the public.
In Count Six, plaintiff asserts a UTPA claim. Plaintiff alleges that defendant “misrepresent[ed] the characteristics, ingredients, uses, benefits, quality, standards and/or risks of the Defective Device[ ].”
Count Seven is plaintiffs “claim” for punitive damages. This count is dismissed because punitive damages are a form of relief, not a cause of action. Doe v. Colligan, 753 P.2d 144, 145 n.2 (Alaska 1988). Plaintiff is not given leave to amend as to Count Seven but she may include a request for punitive damages in her prayer for relief in her amended complaint, should she elect to file one.
Conclusion
Defendant’s motion to dismiss
. Docket No. 4. In deciding the motion to dismiss, the court has considered the supplemental authority submitted by defendant at Docket No. 12.
. Docket No. 8.
. Letter of Approval, Exhibit A, Smith & Nephew, Inc.'s Rule 12(b)(6) Motion to Dismiss, Docket No. 4. The court may consider the approval letter without converting the instant motion into a motion for summary judgment because its " ‘contents are alleged in a complaint’" and no party questions its authenticity. Knievel v. ESPN, 393 F.3d 1068, 1076 (9th Cir. 2005) (quoting In re Silicon Graphics Inc. Sec. Litig., 183 F.3d 970, 986 (9th Cir. 1999)).
. Conditions of Approval at 1, attached to Letter of Approval, Exhibit A, Smith & Nephew, Inc.’s Rule 12(b)(6) Motion to Dismiss, Docket No. 4,
. Letter of Approval at 2, Exhibit A, Smith & Nephew, Inc.’s Rule 12(b)(6) Motion to Dismiss, Docket No. 4.
. Id. at 3.
. Id.
. Complaint at 10-11, ¶ 34, attached to Notice of Removal, Docket No. 1.
. Id. at 5, ¶ 16.
. Id. at 4, ¶ 14.
. Id. at 5, ¶ 17.
. Id. at 6, ¶ 18.
. Id. at ¶ 20.
. Id. at 7, ¶ 23.
. Id.
. Complaint at 11, ¶ 37, attached to Notice of Removal, Docket No. 1.
. Id. at 11, ¶ 37.
.Id. at 5, ¶ 15.
. Id. at 12-13, ¶¶ 42-43.
. Id. at 14, ¶ 53.
. Id. at 15-17, ¶ 59.
. Id. at 18, ¶ 66.
. Id. at 19, ¶ 71.
. Id. at ¶ 72.
. Docket No. 4.
. Docket No. 11.
Reference
- Full Case Name
- Kimerly Dale FELGER v. SMITH & NEPHEW, INC.
- Cited By
- 1 case
- Status
- Published