Michajlun et al v. Bausch & Lomb, Inc. et al, No. 3:2014cv01365 - Document 25 (S.D. Cal. 2015)
Court Description: ORDER Granting in part and Denying in part Bausch & Lomb's 15 Motion to Dismiss Plaintiff's First Amended Complaint. Bausch & Lomb's 16 request for judicial notice is Granted. (1) B&L's motion to dismiss Plaintiffs' cla ims for strict liability for failure to warn, negligent failure to warn, and loss of consortium is Denied. These claims survive to the extent that they are premised on B&L's alleged failure to warn the FDA. (2) B&L's motion to dismiss Plaintiffs' putative class claims under the FAL and UCL is Granted. These claims are dismissed without leave to amend. Signed by Judge Jeffrey T. Miller on 3/11/2015. (rlu)
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Michajlun et al v. Bausch & Lomb, Inc. et al Doc. 25 1 2 3 4 UNITED STATES DISTRICT COURT 5 SOUTHERN DISTRICT OF CALIFORNIA 6 7 IRENA MICHAJLUN and JAY MARKOFF, 8 9 10 CASE NO. 14-cv-1365 JM (JMA) Plaintiffs, vs. BAUSCH & LOMB, INC., Defendant. 11 12 ORDER GRANTING IN PART AND DENYING IN PART BAUSCH & LOMB’S MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT This order addresses Defendant Bausch & Lomb’s (“B&L’s”) motion 13 to dismiss Plaintiffs’ first amended complaint, (Doc. No. 15), and its request for 14 judicial notice, (Doc. No. 16). The matters were fully briefed and were found 15 suitable for resolution without oral argument pursuant to Local Civil Rule 7.1.d.1. 16 For the reasons set forth below, the court grants B&L’s request for judicial notice; 17 denies B&L’s motion to dismiss Plaintiffs’ claims for strict liability for failure to 18 warn, negligent failure to warn, and loss of consortium; and dismisses, without 19 leave to amend, Plaintiffs’ claims for deceptive advertising and deceptive business 20 practices. BACKGROUND 21 22 I. Plaintiffs’ Allegations1 23 This case involves a medical device manufactured by B&L called Crystalens. 24 (FAC ¶ 2.) Crystalens is an artificial lens that is surgically implanted in the eye 25 to replace a person’s natural lens after it is removed during cataract surgery. (Id.) 26 1 Except where noted, the facts in this section are drawn from Plaintiffs’ first 27 amended complaint (“FAC”) and the attached exhibits, (Doc. No. 14, Exhs. A–F). For purposes of this motion, Plaintiffs’ allegations are taken as true to the extent 28 that they are well pleaded. -1- 14cv1365 Dockets.Justia.com 1 Plaintiff Michajlun had cataract surgery on April 10, 2012, and had a Crystalens 2 implanted in her left eye. (Id. ¶ 29.) Soon after the surgery, she experienced a 3 condition called “Z syndrome.” (Id. ¶ 30.) According to Plaintiffs, Z syndrome 4 occurs when one of Crystalens’s arms that attach to the eye muscle detaches and 5 folds forward inside the eye, causing the lens to assume a “Z” shape and to stop 6 functioning. (Id. ¶ 17.) Plaintiffs allege that Michajlun suffered pain, discomfort, 7 and various financial losses, including the cost of surgical procedures to try to 8 correct the problem, and that her husband, Plaintiff Markoff, suffered a loss of 9 consortium. (Id. ¶¶ 30–32.) Michajlun claims that if she and her doctor had 10 known of the risk of Z syndrome, she would not have agreed to having Crystalens 11 implanted, and, on information and belief, her doctor would not have recommended 12 it. (Id. ¶ 46.) 13 Plaintiffs filed their initial complaint in San Diego Superior Court. 14 (Doc. No. 1.) After B&L removed the case to this court on the basis of diversity 15 jurisdiction, Plaintiffs filed the instant first amended complaint, asserting five 16 causes of action under California law: (1) strict liability for failure to warn; 17 (2) negligent failure to warn; (3) deceptive advertising in violation of California’s 18 False Advertising Law (“FAL”), California Business & Professions Code § 17500; 19 (4) deceptive business practices in violation of California’s Unfair Competition 20 Law (“UCL”), California Business & Professions Code § 17200; and (5) loss of 21 consortium. (FAC ¶¶ 33–66.) Plaintiffs seek to litigate the third and fourth claims, 22 under the FAL and UCL, as class claims on behalf of individuals who had 23 Crystalens implanted in their eye(s) between April 7, 2010, and April 8, 2014.2 24 (Id. ¶¶ 67–69.) Plaintiffs seek money damages on the first, second, and fifth claims, 25 and restitution or disgorgement on the third and fourth claims. (Id. ¶¶ 47, 51, 56, 26 62, 66.) 27 28 2 Plaintiffs do not identify the significance of these dates. -2- 14cv1365 1 Plaintiffs set forth the following general allegations: Crystalens is a Class III 2 medical device subject to regulation by the Food and Drug Administration (“FDA”). 3 (Id. ¶ 12.) The FDA’s initial premarket approval (“PMA”) for Crystalens required 4 B&L, as a condition of continued approval to distribute Cyrstalens, to submit an 5 adverse-reaction report to the FDA within ten days after receiving information 6 concerning any injury attributable to the device if the injury was not addressed by 7 the device’s labeling, or if it was addressed by the labeling, if the injury was 8 occurring with unexpected severity or frequency. (Id. ¶ 22.) Similarly, the FDA 9 requires device manufacturers to establish internal procedures for reviewing 10 complaints and event reports, see 21 C.F.R. § 820.198(a),3 and to report to the FDA 11 within thirty days after becoming aware of information suggesting that one of the 12 manufacturer’s devices may have caused or contributed to a death or serious injury, 13 or has malfunctioned and would be likely to cause death or serious injury if the 14 malfunction were to recur, see 21 C.F.R. § 803.50(a).4 (Id. ¶ 39.) 15 /// 16 3 17 18 19 20 21 22 (a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that: (1) All complaints are processed in a uniform and timely manner; (2) Oral complaints are documented upon receipt; and (3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to the FDA under part 803 of this chapter, Medical Device Reporting. 4 23 24 25 26 27 21 C.F.R. § 820.198(a) provides: 21 C.F.R. § 803.50(a) provides: (a) If you are a manufacturer, you must report to us no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market: (1) May have caused or contributed to a death or serious injury; or (2) Has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. 28 -3- 14cv1365 1 In November 2008, an article called Two Cases of Z Syndrome with 2 Crystalens After Uneventful Cataract Surgery was published. (FAC ¶ 14; Exh. B.) 3 It reported that “[Z syndrome] is a unique complication with this type of hinged 4 accommodating [intraocular lens],” and it suggested steps that could be used to 5 minimize the risk of Z syndrome at the time of implantation. (Id.) According to 6 Plaintiffs, the article indicates that at least four incidents of Z syndrome had 7 occurred by the time the article was published. (Id. ¶ 24.) 8 In April 2009, B&L submitted an adverse-event report to the FDA reporting 9 an occurrence of Z syndrome. (FAC ¶ 19; Exh. D.) 10 In April 2010, an article called Z Syndrome Still Possible with Newer 11 Generation Crystalens was published. (FAC ¶ 23; Exh. C.) The article stated 12 that Z syndrome had been “reported in newer generations of the lens, including the 13 HD and 5-0,” and that one of the doctors quoted in the article, a Dr. Safran, was 14 “working with [B&L] to create an instrument to help aid the surgical correction 15 of Z syndrome.” (FAC ¶¶ 18, 23; Exh. C.) 16 In August 2010, B&L created an advertising circular to promote Crystalens. 17 (FAC ¶ 12; Exh. A.) The circular was placed in opthalmologists’ offices throughout 18 California for potential Crystalens buyers to read. (FAC ¶ 21.) It contains two 19 statements that Plaintiffs contend were false or misleading. 20 First, the circular states: “The risks of implantation with Crystalens are 21 generally the same potential risks that exist for implanting all intraocular lenses.” 22 (Id. ¶ 14.) Plaintiffs claim that this statement was false and misleading because, 23 as the 2008 article indicates, Z syndrome is a risk unique to Crystalens. (Id.) 24 According to Plaintiffs, B&L knew that the statement was false because, by the time 25 it created the circular, it had submitted the 2009 adverse-event report to the FDA 26 and, as of 2010, it was working with Dr. Safran to create a surgical tool to correct 27 Z syndrome. (Id. ¶¶ 18–19.) Plaintiffs contend that this statement thus constituted 28 /// -4- 14cv1365 1 misbranding,5 in violation of 21 U.S.C. § 352(q),6 21 C.F.R. § 801.6,7 and the FAL 2 and UCL. (FAC ¶ 15.) 3 Second, the circular states: “Only your surgeon . . . can explain the 4 applicable risks.” (Id. ¶ 28; Exh. A.) Plaintiffs claim that this statement was false 5 and misleading because B&L had failed to comply with its duty to file adverse6 reaction reports for all known incidents of Z syndrome. (FAC ¶¶ 23–28.) Although 7 the 2008 article indicated that there had already been at least four incidents of 8 Z syndrome, and the 2010 article stated that Z syndrome had also occurred in newer 9 models of the lens, and Michajlun herself experienced Z syndrome, Plaintiffs’ 10 search of B&L’s adverse-reaction reports for Crystalens uncovered only two 11 reports, one dated April 28, 2009 (before the 2010 article), and one dated December 12 13, 2010 (after the 2010 article).8 (Id. ¶¶ 23–25.) Plaintiffs contend that B&L’s 13 failure to comply with its reporting duty diminished physicians’ ability to assess 14 and warn of the risk of Z syndrome, so that this second statement also constituted 15 misbranding in violation of 21 C.F.R. § 801.6. (Id. ¶ 28.) 16 5 Plaintiffs do not identify what the effect of misbranding is under federal 17 law. Their claims appear to be related to 21 U.S.C. § 331(a), which prohibits “[t]he introduction . . . into interstate commerce of any food, drug, device, tobacco 18 product, or cosmetic that is adulterated or misbranded.” (Emphasis added.) 19 6 20 21 A drug or device shall be deemed to be misbranded . . . [i]n the case of any restricted device distributed or offered for sale in any State, if (1) its advertising is false or misleading in any particular . . . . 22 7 23 24 25 21 U.S.C. § 352(q) provides in relevant part: 21 C.F.R. § 801.6 provides: Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic. 8 B&L asserts that “additional reports were submitted,” and it refers the court to the FDA’s Manufacturer and User Facility Device Experience (“MAUDE”) 26 database, at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. (Doc. No. 15-1 at 11 n.5.) However, B&L did not provide the court (or Plaintiffs) 27 with copies of the reports or any means of identifying them, and did not explain what the additional reports demonstrate. Accordingly, the court does not address 28 them here. -5- 14cv1365 1 II. B&L’s Motion to Dismiss and Request for Judicial Notice 2 B&L moved to dismiss Plaintiffs’ amended complaint on October 22, 2014, 3 (Doc. No. 15), and filed a separate request for judicial notice, (Doc. No. 16). The 4 hearing, which was initially scheduled for December 15, 2014, was continued for 5 good cause until February 9, 2015. (Doc. No. 20.) Plaintiffs filed an opposition on 6 January 26, 2015, (Doc. No. 22), and B&L replied on February 2, 2015, (Doc. No. 7 23). Neither party requested oral argument, and the court took the matter under 8 submission on February 3, 2015. (Doc. No. 24.) 9 DISCUSSION 10 I. Request for Judicial Notice 11 B&L asks the court to take judicial notice of two items: (1) the FDA 12 webpage containing links to the original PMA for Crystalens and all applicable 13 supplements; and (2) the FDA-approved patient labeling for Crystalens, which can 14 be downloaded from the FDA’s website. (Doc. No. 16 & Exhs. A & B.) 15 Federal Rule of Evidence 201 provides that courts may take judicial notice 16 of facts that are not subject to reasonable dispute because they are generally known 17 or are capable of accurate and ready determination. See Fed. R. Evid. 201(b). The 18 court may take notice of such facts on its own, and “must take judicial notice if a 19 party requests it and the court is supplied with the necessary information.” Fed. R. 20 Evid. 201(c). Matters of public record are proper subjects of judicial notice, but a 21 court may take notice only of the existence and authenticity of an item, not the truth 22 of its contents. See Lee v. City of Los Angeles, 250 F.3d 668, 689–90 (9th Cir. 23 2001). Under these rules, courts may take judicial notice of “the records and reports 24 of administrative bodies,” United States v. Ritchie, 342 F.3d 903, 909 (9th Cir. 25 2003) (quotation marks omitted), including documents and information posted on 26 the FDA’s public website, see Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868, 27 878–79 (N.D. Cal. 2013) (collecting cases). 28 Plaintiffs do not oppose B&L’s request, and the documents are available -6- 14cv1365 1 on the FDA’s public website and not subject to reasonable dispute. Accordingly, 2 the court grants B&L’s request for judicial notice of these items. 3 II. Motion to Dismiss 4 B&L contends that Plaintiffs’ claims must be dismissed for failure to state 5 a claim because they are expressly preempted by the express-preemption provision 6 of the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360k(a). 7 (Doc. No. 15-1 at 4–13.) Plaintiffs counter that their claims fall within the narrow 8 exception for “parallel” state and federal claims. (Doc. No. 22 at 3–6.) As set forth 9 below, one of Plaintiffs’ theories is preempted, but the other is not. Following that 10 discussion, the court addresses B&L’s additional arguments and the implications for 11 each of Plaintiffs’ causes of action. 12 A. 13 A motion to dismiss for failure to state a claim under Federal Rule of Civil Legal Standards 14 Procedure 12(b)(6) challenges the legal sufficiency of the pleadings. To overcome 15 such a motion, the complaint must contain “enough facts to state a claim to relief 16 that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). 17 “A claim has facial plausibility when the plaintiff pleads factual content that allows 18 the court to draw the reasonable inference that the defendant is liable for the 19 misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Factual 20 pleadings merely consistent with a defendant’s liability are insufficient to survive 21 a motion to dismiss because they establish only that the allegations are possible 22 rather than plausible. See id. at 678–79. The court should grant relief under Rule 23 12(b)(6) if the complaint lacks either a cognizable legal theory or facts sufficient to 24 support a cognizable legal theory. See Balistreri v. Pacifica Police Dep’t, 901 F.2d 25 696, 699 (9th Cir. 1990). 26 When ruling on a Rule 12(b)(6) motion, the court “must take all of the 27 factual allegations in the complaint as true,” but is “not bound to accept as true a 28 legal conclusion couched as a factual allegation.” Iqbal, 556 U.S. at 678. Further, -7- 14cv1365 1 the court “need not accept as true . . . allegations that contradict facts that may be 2 judicially noticed by the court, and may consider documents that are referred to in 3 the complaint whose authenticity no party questions.” Shwarz v. United States, 4 234 F.3d 428, 435 (9th Cir. 2000) (citations omitted). A court may look beyond 5 the complaint to matters of public record, including administrative records, without 6 converting the Rule 12(b)(6) motion into one for summary judgment. See Shawn 7 v. Hahn, 56 F.3d 1128, 1129 n.1 (9th Cir. 1995). 8 Federal Rule of Civil Procedure Rule 15 provides that courts should freely 9 grant leave to amend when justice requires it. Accordingly, when a court dismisses 10 a complaint for failure to state a claim, “leave to amend should be granted unless 11 the court determines that the allegation of other facts consistent with the challenged 12 pleading could not possibly cure the deficiency.” DeSoto v. Yellow Freight Sys., 13 Inc., 957 F.2d 655, 658 (9th Cir. 1992) (internal quotation marks omitted). 14 Amendment may be denied, however, if amendment would be futile. See id. 15 B. 16 Congress enacted the MDA to extend the coverage of the Food, Drug, Preemption Under the MDA 17 and Cosmetic Act (“FDCA”) to medical devices, after various states enacted laws 18 requiring premarket approval of medical devices. See Riegel v. Medtronic, Inc., 19 552 U.S. 312, 315–16 (2008). The MDA “imposed a regime of detailed federal 20 oversight.” Id. at 316. To that end, the MDA expressly preempts state requirements 21 that are “different from, or in addition to” federal requirements applicable to a 22 device: 23 24 25 26 27 28 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. -8- 14cv1365 1 21 U.S.C. § 360k(a) (emphasis added).9 2 In Riegel v. Medtronic, Inc., the Supreme Court specified a two-step 3 framework for determining whether a state-law claim is preempted under § 360k(a). 4 See 552 U.S. at 321–22. First, the court must determine “whether the Federal 5 Government has established requirements applicable to [the device at issue].” Id. 6 at 321. If it has, the court must then determine whether the plaintiff’s claims would 7 impose requirements “different from, or in addition to” the federal requirements. 8 Id. at 322. The MDA’s reference to state “requirements” includes not just duties 9 imposed by statute and regulation, but also those imposed by common-law tort 10 doctrines. See id. at 324–25. 11 Under this framework, the only state-law claims that are not expressly 12 preempted are claims premised on violations of state duties that “parallel” duties 13 imposed by the FDA. Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 (9th Cir. 14 2013) (en banc). The MDA thus “provides immunity for manufacturers of new 15 Class III medical devices to the extent that they comply with federal law, but it does 16 not protect them if they have violated federal law.” See Bausch v. Stryker Corp., 17 630 F.3d 546, 553 (7th Cir. 2010). 18 Claims related to medical devices may also be impliedly preempted by 19 the MDA if they seek to enforce a violation of the medical device provisions and 20 do not rely on traditional state tort law. See Buckman Co. v. Plaintiffs’ Legal 21 Comm., 531 U.S. 341 (2001); Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013). 22 Because only the FDA is authorized to enforce violations of the FDCA, “private 23 enforcement of the statute is barred.” Perez, 711 F.3d at 1119. Consequently, to 24 escape express and implied preemption under the MDA, “[t]he plaintiff must be 25 suing for conduct that violates the FDCA (or else his claim is expressly preempted 26 27 9 The exception in subsection (b) allows the FDA to exempt some state and local requirements from preemption. See Riegel, 552 U.S. at 316. Plaintiffs do not 28 contend that any exception in subsection (b) is relevant to the present analysis. -9- 14cv1365 1 by § 360k(a)), but the plaintiff must not be suing because the conduct violates the 2 FDCA (such a claim would be impliedly preempted under Buckman).” Id. at 1120 3 (internal quotation marks omitted). 4 5 6 C. Preemption in This Case 1. Federal Requirements Applicable to Crystalens As noted above, the first step is to ask whether the federal government has 7 established requirements applicable to the device at issue. See Riegel, 552 U.S. 8 at 321. In this case, there is no doubt that it has. Both parties agree that Crystalens 9 is a Class III device that was approved through the premarket approval process. 10 Because the premarket approval process entails a rigorous examination of nearly 11 every aspect of a device’s safety, and approval subjects a device to numerous post12 approval requirements, it necessarily establishes federal requirements applicable to 13 the device, thus allowing for preemption of state requirements that are “different 14 from, or in addition to” the federal requirements. See Riegel, 552 U.S. at 322–23. 15 16 2. Comparison of State and Federal Requirements The next step is to ask whether Plaintiffs’ state-law claims would impose 17 requirements “different from, or in addition to” the federal requirements. See 18 Riegel, 552 U.S. at 322. Plaintiffs’ claims rest on two theories. (See Doc. No. 22 19 at 4.) The court takes each of them in turn. 20 The first theory is that the advertising circular was false and misleading 21 because of the statements Plaintiffs take issue with: “The risks of implantation 22 with Crystalens are generally the same potential risks that exist for implanting all 23 intraocular lenses,” and, “Only your surgeon . . . can explain the applicable risks.” 24 (FAC ¶¶13, 28 & Exh. A.) As explained below, any claims premised on this theory 25 are expressly preempted under § 360k(a). 26 As part of the premarket approval process, the FDA “must determine that 27 the proposed labeling is neither false nor misleading.” See Riegel, 552 U.S. at 318. 28 Once approval has been granted, manufacturers may not make changes to the - 10 - 14cv1365 1 labeling without the FDA’s permission, see id. at 319, and all advertising must 2 be consistent with the approved labeling, see 21 C.F.R. § 814.80.10 Although 3 manufacturers may issue additional post-approval safety warnings, they are not 4 required to do so. See 21 C.F.R. § 814.39(d);11 Stengel, 704 F.3d at 1234 (Watford, 5 J., concurring). 6 In this case, the FDA-approved patient labeling for Crystalens says essentially 7 what the circular says. As to the comparative risks of Crystalens, it states: “The 8 complications and side effects experienced during the clinical study were similar to 9 those experienced with other intraocular lenses and with routine cataract surgery,” 10 and, “The risks of implantation with the Crystalens are the same risks that exist for 11 all intraocular lenses.” (Doc. No. 16, Exh. A at 9.) And, regarding surgeons’ ability 12 to advise patients of the risks, the approved labeling states, among other things, 13 “Your doctor will perform a thorough examination and fully inform you of any 14 increased risk of a complication.” (Id., Exh. A at 14.) 15 Thus, the only way that Plaintiffs can prevail on the theory that the circular 16 was false and misleading is by showing that B&L had a duty to provide warnings or 17 advisories “different from, or in addition to,” those the FDA approved. Such claims 18 10 19 20 21 22 23 24 25 26 27 28 21 C.F.R. § 814.80 reads: A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device. 11 21 C.F.R. § 814.39(d) reads in relevant part: (d)(1) After FDA approves a PMA, any change described in paragraph (d)(2) of this section to reflect newly acquired information that enhances the safety of the device or the safety in the use of the device may be placed into effect by the applicant prior to the receipt . . . of a written FDA order approving the PMA supplement . . . . (d)(2) The following changes are permitted by paragraph (d)(1) of this section: (i) Labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction for which there is reasonable evidence of a causal association. . . . - 11 - 14cv1365 1 are expressly preempted by § 360k(a) because “[p]remarket approval established 2 the warning requirements applicable to the device and Defendants cannot be made 3 to go beyond those warning requirements.” Hawkins v. Medtronic, Inc., 2014 WL 4 346622, at *14 (E.D. Cal. Jan. 30 2014); see also Eidson, 981 F. Supp. 2d at 883–90 5 (same); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1177–78 (C.D. Cal. 6 2013) (same). 7 Plaintiffs appear to contend that the PMA has no preemptive effect in this 8 case because the PMA stated that “failure to comply with the conditions of approval 9 invalidates the approval order.” (Doc. No. 22 at 6.) But they do not offer any 10 argument or citation to authority to explain why this should affect the analysis. 11 The court, therefore, concludes that Plaintiffs’ claims are expressly 12 preempted to the extent that they rest on the theory that the Cyrstalens advertising 13 should have said something other than what it said. 14 Plaintiffs’ second theory is that B&L failed to comply with its duty to report 15 all adverse events to the FDA. To the extent that Plaintiffs’ claims rely on this 16 theory, they are not preempted, as explained below, because they fit within the 17 exception for parallel state and federal claims. 18 In Stengel v. Medtronic, Inc., the Ninth Circuit held that a claim for negligent 19 failure to warn under Arizona law was not expressly or impliedly preempted 20 because it was premised on the manufacturer’s failure to report adverse events to 21 the FDA. See 704 F.3d at 1233. The plaintiff had been paralyzed after receiving 22 treatment with a Class III medical device that had been approved through the 23 premarket approval process. See id. at 1226. He alleged that the manufacturer 24 “had violated a state-law duty of care by failing to report known risks associated 25 with use of its medical device to the [FDA].” Id. His failure-to-warn claim was not 26 preempted because Arizona products-liability law paralleled the FDA’s reporting 27 requirement, in that it required manufacturers to warn consumers of known dangers, 28 and a warning to a third party, such as the FDA, would satisfy the duty. See id. - 12 - 14cv1365 1 at 1233. 2 Similarly, in this case, Plaintiffs allege that B&L failed to comply with its 3 duty under federal law to report all adverse events to the FDA and, by doing so, also 4 violated its duty under California law to warn consumers of the risk of Z syndrome. 5 Like Arizona, California requires medical-device manufacturers to warn of known 6 or knowable risks, and they can do so by “fil[ing] adverse event reports with the 7 FDA if that is the only available method to warn doctors and consumers.” Coleman 8 v. Medtronic, Inc., 223 Cal. App. 4th 413, 429 (2014) (employing this analysis 9 under Stengel). 10 B&L contends that Stengel is distinguishable because here, unlike in 11 Stengel, the FDA has not found any violation or taken any action against B&L. 12 (Doc. No. 23 at 3–4.) The court need not address the argument because it was 13 raised for the first time in B&L’s reply brief, and it is unsupported by any authority 14 or explanation. See Zamani v. Carnes, 491 F.3d 990, 997 (9th Cir. 2007) (“The 15 district court need not consider arguments raised for the first time in a reply brief.”). 16 Regardless, at least one circuit has expressly rejected the contention that FDA 17 action is an “implicit precondition” to this kind of suit. Hughes v. Boston Scientific 18 Corp., 631 F.3d 762, 772–73 (5th Cir. 2011). The court is not, therefore, persuaded 19 that this is a meaningful distinction. 20 Accordingly, the court concludes that under Stengel, Plaintiffs’ claims are 21 not expressly or impliedly preempted to the extent that they are premised on B&L’s 22 alleged failure to comply with its parallel state and federal duties to report adverse 23 events to the FDA. “Most lower courts—both federal and state—that have analyzed 24 and applied Stengel to [such claims] have held that the claims escape both express 25 and implied preemption.” Eidson v. Medtronic, Inc., — F. Supp. 2d —, 2014 WL 26 1996024, at *20 (N.D. Cal. May 13, 2014) (citing examples). 27 /// 28 /// - 13 - 14cv1365 1 D. 2 Causation is an essential element of a products-liability claim, see Bunch Causation 3 v. Hoffinger Indus., 123 Cal. App. 4th 1278, 1302 (2004), and a prerequisite for 4 standing to sue under the UCL and FAL, see Cal. Bus. & Prof. Code §§ 17204, 5 17535. Because the only unpreempted theory is that B&L failed to warn the FDA 6 (as opposed to warning consumers or doctors directly), there is a “causation hurdle 7 that would not otherwise exist.” Stengel, 704 F.3d at 1234 (Watford, J., concurring). 8 “To prevail, [Plaintiffs] will ultimately have to prove that if [B&L] had properly 9 reported the adverse events to the FDA as required under federal law, that 10 information would have reached [Michajlun’s] doctors in time to prevent [her] 11 injuries.” Id. 12 As to causation, Plaintiffs allege that if B&L had communicated the adverse- 13 event reports to the FDA as required, it “would have effectively warned surgeons, 14 including [Michajlun’s] surgeon of those adverse events . . . both directly and 15 through discussion of those events that would have followed in the literature and 16 at meetings [her] surgeon attended, as well as more complete information through 17 the FDA’s MAUDE database, which is available to the public at large.” (FAC 18 ¶ 44.) Further, she “would not have agreed to the Crystalens implant, and, upon 19 information and belief, [her] surgeon would not have recommended [it] but for 20 [B&L’s] underreporting adverse events with the Crystalens, i.e., Z syndrome.” 21 (Id. ¶ 46.) 22 B&L contends that although Plaintiffs generally allege that the failure to 23 submit the additional adverse event reports caused the injury, they “do not state with 24 any specificity how it caused the injury.” (Doc. No. 15-1 at 11.) Specifically, they 25 contend, Plaintiffs “have not alleged how the four (at most) incidents that [B&L] 26 purportedly did not report had any causal effect on her injuries.” (Id.) As support, 27 B&L cites Hawkins, 2014 WL 346622, at *8, and Eidson, 981 F. Supp. 2d at 889, 28 which dismissed failure-to-report claims because the plaintiffs in those cases had - 14 - 14cv1365 1 not identified the relevant dates of the failures to report, so that there was no way to 2 evaluate the causal connection. 3 This case does not suffer from a similar defect, as Plaintiffs have alleged 4 relevant date ranges for the allegedly unreported adverse events that occurred prior 5 to Michajlun’s surgery. And B&L does not explain how these cases otherwise 6 inform the present analysis. Based on the court’s own research, some courts have 7 found causal allegations resembling Plaintiffs’ plausible. See Eidson, 2014 WL 8 1996024, at *20; Comella v. Smith & Nephew, Inc., 2013 WL 6504427, at *4 (N.D. 9 Ill. Dec. 11, 2013). In the court’s view, the limited number of unreported incidents 10 alleged provides a thin causal connection, but a plausible connection nonetheless. 11 Perhaps these cases are distinguishable because they involved allegations of large12 scale failures to report, but that is an issue for a later date. At this point, construing 13 the allegations in the light most favorable to Plaintiffs, and in light of B&L’s failure 14 to offer any authority to the contrary, the court declines to dismiss Plaintiffs’ claims 15 for insufficient causal allegations. 16 E. 17 In addition to the arguments addressed above, B&L contends that Plaintiffs’ B&L’s Additional Arguments 18 claims must all be dismissed because the advertising circular’s statements were 19 not misleading as a matter of law and because the allegations do not meet the 20 heightened pleading standards for averments of fraud under Federal Rule of Civil 21 Procedure 9(b). (Doc. No. 15-1 at 13–16.) 22 In light of the preemption analysis, however, it is unnecessary to address 23 these arguments. At this point, the remaining theory is completely uncoupled 24 from the advertising circular,12 so whether the statements were misleading does not 25 matter. And, as set forth in the next section, simple products-liability claims for 26 12 Although it would not change the analysis, the court notes that Plaintiffs 27 do not allege that the circular would have read differently if B&L had reported the adverse events as required, and, as B&L points out, they also do not allege that 28 Michajlun ever saw the circular or relied on it. - 15 - 14cv1365 1 failure to warn are all that remain. These causes of action, which are for strict 2 liability and negligence, do not depend upon intentional deceit. 3 F. 4 With these discussions in mind, the court addresses each of Plaintiffs’ causes Plaintiffs’ Causes of Action 5 of action. 6 7 1. Strict Liability for Failure to Warn To state a claim for strict products liability for failure to warn, a plaintiff 8 must allege that the defendant failed to adequately warn of a known or knowable 9 risk and that the failure caused the plaintiff’s injuries. See Chavez v. Glock, Inc., 10 207 Cal. App. 4th 1283, 1304 (2012). 11 On this claim, Plaintiffs allege that Crystalens was defective and 12 unreasonably dangerous because of inadequate post-PMA warnings; that B&L 13 had parallel duties to warn physicians and Michajlun about the risk of Z syndrome, 14 which were known to B&L; and that B&L breached those duties by failing to 15 submit adverse-reaction reports to the FDA as required. (FAC ¶¶ 36–38.) B&L 16 counters that this claim fails for the reasons addressed above. 17 This claim is expressly preempted to the extent that it rests on the theory that 18 Cyrstalens advertising should have said something other than what it said. It is not 19 preempted to the extent that it rests on the theory that B&L failed to comply with 20 its duty to file adverse-event reports with the FDA, and at the same time breached 21 its state-law duty to warn of dangerous product defects. The surviving aspect of 22 this claim is supported by plausible causal allegations, so B&L’s motion to dismiss 23 it is denied. 24 25 2. Negligent Failure to Warn To state a claim for negligent failure to warn, the plaintiff must allege “that 26 a manufacturer or distributor did not warn of a particular risk for reasons which fell 27 below the acceptable standard of care, i.e., what a reasonably prudent manufacturer 28 would have known and warned about.” Id. at 1305 (internal quotation marks - 16 - 14cv1365 1 omitted). The same analysis that applies to Plaintiffs’ strict-liability claim applies 2 here. Accordingly, B&L’s motion to dismiss this claim is also denied. 3 4 3. Deceptive Advertising California’s False Advertising Law prohibits any “unfair, deceptive, untrue, 5 or misleading advertising.” Cal. Bus. & Prof. Code § 17500. To prevail on this 6 claim, Plaintiffs would have to show that B&L should have provided warnings to 7 the public “different from, or in addition to” those approved by the FDA. This 8 claim is expressly preempted by the MDA, and nothing remains. It is, therefore, 9 dismissed without leave to amend. 10 11 4. Deceptive Business Practices California’s Unfair Competition Law prohibits any “unlawful, unfair or 12 fraudulent business act or practice.” Cal. Bus. & Prof. Code § 17200. This claim 13 is subject to the same analyses that apply to Plaintiffs’ products-liability claims. 14 Here, however, two additional considerations not relevant to the common-law 15 claims compel the conclusion that this claim must be dismissed without leave 16 to amend. 17 First, B&L contends that this claim must be dismissed without leave to 18 amend13 because the equitable relief Plaintiffs seek is unavailable as a matter of law. 19 (Doc. No. 15-1 at 16–17.) It argues that the UCL provides only equitable relief; 20 equitable relief is available only when money damages are inadequate; California 21 courts have extended this principle to claims under the UCL; and Plaintiffs have not 22 shown that money damages would be inadequate. (Id.) In support, B&L cites a 23 case that dismissed a UCL claim because money damages would adequately redress 24 the plaintiffs’ injuries if they were to prevail on other causes of action. See Rhynes 25 v. Stryker Corp., 2011 WL 2149095, at *3–4 (N.D. Cal. May 31, 2011). That case, 26 in turn, relied on Prudential Home Mortgage Co. v. Superior Court, 66 Cal. App. 27 13 B&L asserts that dismissal should be with prejudice, which the court 28 construes as a request for dismissal without leave to amend. - 17 - 14cv1365 1 4th 1236 (1998), which held that statutory relief under the UCL “is subject to 2 fundamental equitable principles, including inadequacy of the legal remedy.” 3 Id. at 1249. 4 Plaintiffs counter only that B&L has mischaracterized Plaintiffs’ claims as 5 claims for money damages, when in reality they seek restitutionary disgorgement of 6 the profits B&L earned from its sales of Crystalens. (Doc. No. 22 at 12.) Plaintiffs 7 do not address Rhynes and do not attempt to explain why money damages on their 8 common-law claims will not adequately redress their injuries. 9 By failing to address B&L’s argument in any meaningful way, Plaintiffs have 10 effectively waived the issue. See Stichting Pensioenfonds ABP v. Countrywide 11 Fin. Corp., 802 F. Supp. 2d 1125, 1132 (S.D. Cal. 2011) (“[I]n most circumstances, 12 failure to respond in an opposition brief to an argument put forward in an opening 13 brief constitutes waiver or abandonment in regard to the uncontested issue.” 14 (internal quotation marks omitted)). 15 Second, although not raised by the parties, the court concludes that the 16 surviving theory cannot support a cognizable claim under the UCL. As discussed 17 above, all that remains is the theory that B&L violated its duty under California law 18 to warn the FDA (a common-law claim), and at the same time ran afoul of FDA 19 reporting requirements (a claim that B&L violated FDA regulations). Plaintiffs 20 assert that this theory “has nothing to do with false or misleading ad literature,” 21 and is brought under the “unlawful” prong of the UCL. (Doc. No. 22 at 9–10.) 22 At first glance, this approach should work. According to California courts, 23 the “unlawful” prong of the UCL proscribes “anything that can be properly called 24 a business practice and that at the same time is forbidden by law.” Farmers Ins. 25 Exchange v. Superior Court, 2 Cal. 4th 377, 383 (1992). It prohibits “any practices 26 forbidden by law, be it civil or criminal, federal, state, or municipal, statutory, 27 regulatory, or court-made.” Saunders v. Superior Court, 27 Cal. App. 4th 832, 28 838–39 (1994) (emphasis added). - 18 - 14cv1365 1 But, despite this sweeping language, courts have held that common-law 2 claims unaccompanied by a violation of some other law cannot support a claim 3 under the “unlawful” prong of the UCL. See Shroyer v. New Cingular Wireless 4 Servs., Inc., 622 F.3d 1035, 1044 (9th Cir. 2010) (“[A] common law violation such 5 as breach of contract is insufficient [to allege a violation of the “unlawful” prong 6 of the UCL].”); TreeFrog Devs., Inc. v. Seidio, Inc., 2013 WL 4028096, at *5 (S.D. 7 Cal. Aug. 6, 2013) (“Because Defendant’s allegation of Plaintiff’s ‘unlawful’ act 8 rests entirely on common law theories, Defendant fails to sufficiently allege a UCL 9 claim under the ‘unlawful’ prong.”). For this reason, some courts have rejected 10 UCL “unlawful” claims premised on products-liability claims. See Hartless v. 11 Clorox Co., 2007 WL 3245360, at *5 (S.D. Cal. Nov. 2, 2007) (common-law 12 products-liability claim was insufficient to support a UCL claim); Klein v. Earth 13 Elements, Inc., 59 Cal. App. 4th 965, 969 (1997) (same). 14 Here, Plaintiffs combine products-liability claims with alleged violations 15 of FDA regulations. They thus appear to present the kind of allegations that can 16 support a claim under the “unlawful” prong of the UCL. 17 The problem, however, is that private claims to enforce violations of the 18 FDCA are impliedly preempted because the FDA alone is empowered to enforce it. 19 See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001); Perez v. Nidek 20 Co., 711 F.3d 1109 (9th Cir. 2013). “Although citizens may petition the FDA to 21 take administrative action, private enforcement of the statute is barred. . . .” Perez, 22 711 F.3d at 1119 (citation omitted). 23 Because common-law claims cannot be the basis of a UCL “unlawful” claim, 24 and private actions to enforce the FDCA are barred, combining them cannot result 25 in a viable claim under the “unlawful” prong of the UCL. See Cel-Tech Commc’ns, 26 Inc. v. Los Angeles Cellular Tel. Co., 20 Cal. 4th 163, 182 (1999) (“A plaintiff may 27 . . . not plead around an absolute bar to relief simply by recasting the cause of action 28 as one for unfair competition.”) (internal quotation marks omitted). - 19 - 14cv1365 1 Accordingly, for both of the reasons discussed above, this claim is dismissed 2 without leave to amend. 3 4 5. Loss of Consortium Markoff’s claim for loss of consortium is contingent on Michajlun’s claims. 5 See Tucker v. CBS Radio Stations, Inc., 194 Cal. App. 4th 1246, 1256 (2011). 6 Because two of Michajlun’s claims remain, this claim also remains. 7 8 CONCLUSION B&L’s request for judicial notice, (Doc. No. 16), is GRANTED. Its motion 9 to dismiss Plaintiffs’ first amended complaint, (Doc. No. 15), is GRANTED IN 10 PART AND DENIED IN PART as follows: 11 1. B&L’s motion to dismiss Plaintiffs’ claims for strict liability for 12 failure to warn, negligent failure to warn, and loss of consortium is 13 DENIED. These claims survive to the extent that they are premised 14 on B&L’s alleged failure to warn the FDA. 15 2. B&L’s motion to dismiss Plaintiffs’ putative class claims under the 16 FAL and UCL is GRANTED. These claims are dismissed without 17 leave to amend. 18 IT IS SO ORDERED. 19 DATED: March 11, 2015 20 21 Hon. Jeffrey T. Miller United States District Judge 22 23 24 25 26 27 28 - 20 - 14cv1365
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