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Michajlun v. Bausch & Lomb, Inc.

United States District Court, S.D. California

March 11, 2015

BAUSCH & LOMB, INC., Defendant.


JEFFREY T. MILLER, District Judge.

This order addresses Defendant Bausch & Lomb's ("B&L's") motion to dismiss Plaintiffs' first amended complaint, (Doc. No. 15), and its request for judicial notice, (Doc. No. 16). The matters were fully briefed and were found suitable for resolution without oral argument pursuant to Local Civil Rule 7.1.d.1. For the reasons set forth below, the court grants B&L's request for judicial notice; denies B&L's motion to dismiss Plaintiffs' claims for strict liability for failure to warn, negligent failure to warn, and loss of consortium; and dismisses, without leave to amend, Plaintiffs' claims for deceptive advertising and deceptive business practices.


I. Plaintiffs' Allegations[1]

This case involves a medical device manufactured by B&L called Crystalens. (FAC ¶ 2.) Crystalens is an artificial lens that is surgically implanted in the eye to replace a person's natural lens after it is removed during cataract surgery. (Id.) Plaintiff Michajlun had cataract surgery on April 10, 2012, and had a Crystalens implanted in her left eye. (Id. ¶ 29.) Soon after the surgery, she experienced a condition called "Z syndrome." (Id. ¶ 30.) According to Plaintiffs, Z syndrome occurs when one of Crystalens's arms that attach to the eye muscle detaches and folds forward inside the eye, causing the lens to assume a "Z" shape and to stop functioning. (Id. ¶ 17.) Plaintiffs allege that Michajlun suffered pain, discomfort, and various financial losses, including the cost of surgical procedures to try to correct the problem, and that her husband, Plaintiff Markoff, suffered a loss of consortium. (Id. ¶¶ 30-32.) Michajlun claims that if she and her doctor had known of the risk of Z syndrome, she would not have agreed to having Crystalens implanted, and, on information and belief, her doctor would not have recommended it. (Id. ¶ 46.)

Plaintiffs filed their initial complaint in San Diego Superior Court. (Doc. No. 1.) After B&L removed the case to this court on the basis of diversity jurisdiction, Plaintiffs filed the instant first amended complaint, asserting five causes of action under California law: (1) strict liability for failure to warn; (2) negligent failure to warn; (3) deceptive advertising in violation of California's False Advertising Law ("FAL"), California Business & Professions Code § 17500; (4) deceptive business practices in violation of California's Unfair Competition Law ("UCL"), California Business & Professions Code § 17200; and (5) loss of consortium. (FAC ¶¶ 33-66.) Plaintiffs seek to litigate the third and fourth claims, under the FAL and UCL, as class claims on behalf of individuals who had Crystalens implanted in their eye(s) between April 7, 2010, and April 8, 2014.[2] (Id. ¶¶ 67-69.) Plaintiffs seek money damages on the first, second, and fifth claims, and restitution or disgorgement on the third and fourth claims. (Id. ¶¶ 47, 51, 56, 62, 66.)

Plaintiffs set forth the following general allegations: Crystalens is a Class III medical device subject to regulation by the Food and Drug Administration ("FDA"). (Id. ¶ 12.) The FDA's initial premarket approval ("PMA") for Crystalens required B&L, as a condition of continued approval to distribute Cyrstalens, to submit an adverse-reaction report to the FDA within ten days after receiving information concerning any injury attributable to the device if the injury was not addressed by the device's labeling, or if it was addressed by the labeling, if the injury was occurring with unexpected severity or frequency. (Id. ¶ 22.) Similarly, the FDA requires device manufacturers to establish internal procedures for reviewing complaints and event reports, see 21 C.F.R. § 820.198(a), [3] and to report to the FDA within thirty days after becoming aware of information suggesting that one of the manufacturer's devices may have caused or contributed to a death or serious injury, or has malfunctioned and would be likely to cause death or serious injury if the malfunction were to recur, see 21 C.F.R. § 803.50(a).[4] (Id. ¶ 39.)

In November 2008, an article called Two Cases of Z Syndrome with Crystalens After Uneventful Cataract Surgery was published. (FAC ¶ 14; Exh. B.) It reported that "[Z syndrome] is a unique complication with this type of hinged accommodating [intraocular lens], " and it suggested steps that could be used to minimize the risk of Z syndrome at the time of implantation. (Id.) According to Plaintiffs, the article indicates that at least four incidents of Z syndrome had occurred by the time the article was published. (Id. ¶ 24.)

In April 2009, B&L submitted an adverse-event report to the FDA reporting an occurrence of Z syndrome. (FAC ¶ 19; Exh. D.)

In April 2010, an article called Z Syndrome Still Possible with Newer Generation Crystalens was published. (FAC ¶ 23; Exh. C.) The article stated that Z syndrome had been "reported in newer generations of the lens, including the HD and 5-0, " and that one of the doctors quoted in the article, a Dr. Safran, was "working with [B&L] to create an instrument to help aid the surgical correction of Z syndrome." (FAC ¶¶ 18, 23; Exh. C.)

In August 2010, B&L created an advertising circular to promote Crystalens. (FAC ¶ 12; Exh. A.) The circular was placed in opthalmologists' offices throughout California for potential Crystalens buyers to read. (FAC ¶ 21.) It contains two statements that Plaintiffs contend were false or misleading.

First, the circular states: "The risks of implantation with Crystalens are generally the same potential risks that exist for implanting all intraocular lenses." (Id. ¶ 14.) Plaintiffs claim that this statement was false and misleading because, as the 2008 article indicates, Z syndrome is a risk unique to Crystalens. (Id.) According to Plaintiffs, B&L knew that the statement was false because, by the time it created the circular, it had submitted the 2009 adverse-event report to the FDA and, as of 2010, it was working with Dr. Safran to create a surgical tool to correct Z syndrome. (Id. ¶¶ 18-19.) Plaintiffs contend that this statement thus constituted misbranding, [5] in violation of 21 U.S.C. § 352(q), [6] 21 C.F.R. § 801.6, [7] and the FAL and UCL. (FAC ¶ 15.)

Second, the circular states: "Only your surgeon... can explain the applicable risks." (Id. ¶ 28; Exh. A.) Plaintiffs claim that this statement was false and misleading because B&L had failed to comply with its duty to file adverse-reaction reports for all known incidents of Z syndrome. (FAC ¶¶ 23-28.) Although the 2008 article indicated that there had already been at least four incidents of Z syndrome, and the 2010 article stated that Z syndrome had also occurred in newer models of the lens, and Michajlun herself experienced Z syndrome, Plaintiffs' search of B&L's adverse-reaction reports for Crystalens uncovered only two reports, one dated April 28, 2009 (before the 2010 article), and one dated December 13, 2010 (after the 2010 article).[8] (Id. ¶¶ 23-25.) Plaintiffs contend that B&L's failure to comply with its reporting duty diminished physicians' ability to assess and warn of the risk of Z syndrome, so that this second statement also constituted misbranding in violation of 21 C.F.R. § 801.6. (Id. ¶ 28.)

II. B&L's Motion to Dismiss and Request for Judicial Notice

B&L moved to dismiss Plaintiffs' amended complaint on October 22, 2014, (Doc. No. 15), and filed a separate request for judicial notice, (Doc. No. 16). The hearing, which was initially scheduled for December 15, 2014, was continued for good cause until February 9, 2015. (Doc. No. 20.) Plaintiffs filed an opposition on January 26, 2015, (Doc. No. 22), and B&L replied on February 2, 2015, (Doc. No. 23). Neither party requested oral argument, and the court took the matter under submission on February 3, 2015. (Doc. No. 24.)


I. Request for Judicial Notice

B&L asks the court to take judicial notice of two items: (1) the FDA webpage containing links to the original PMA for Crystalens and all applicable supplements; and (2) the FDA-approved patient labeling for Crystalens, which can be downloaded from the FDA's website. (Doc. No. 16 & Exhs. A & B.)

Federal Rule of Evidence 201 provides that courts may take judicial notice of facts that are not subject to reasonable dispute because they are generally known or are capable of accurate and ready determination. See Fed.R.Evid. 201(b). The court may take notice of such facts on its own, and "must take judicial notice if a party requests it and the court is supplied with the necessary information." Fed.R.Evid. 201(c). Matters of public record are proper subjects of judicial notice, but a court may take notice only of the existence and authenticity of an item, not the truth of its contents. See Lee v. City of Los Angeles, 250 F.3d 668, 689-90 (9th Cir. 2001). Under these rules, courts may take judicial notice of "the records and reports of administrative bodies, " United States v. Ritchie, 342 F.3d 903, 909 (9th Cir. 2003) (quotation marks omitted), including documents and information posted on the FDA's public website, see Eidson v. Medtronic, Inc., 981 F.Supp.2d 868, 878-79 (N.D. Cal. 2013) (collecting cases).

Plaintiffs do not oppose B&L's request, and the documents are available on the FDA's public website and not subject to reasonable dispute. Accordingly, the court grants B&L's request for judicial notice of these items.

II. Motion to Dismiss

B&L contends that Plaintiffs' claims must be dismissed for failure to state a claim because they are expressly preempted by the express-preemption provision of the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360k(a). (Doc. No. 15-1 at 4-13.) Plaintiffs counter that their claims fall within the narrow exception for "parallel" state and federal claims. (Doc. No. 22 at 3-6.) As set forth below, one of Plaintiffs' theories is preempted, but the other is not. Following that discussion, the court addresses B&L's additional arguments and the implications for each of Plaintiffs' causes of action.

A. Legal Standards

A motion to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6) challenges the legal sufficiency of the pleadings. To overcome such a motion, the complaint must contain "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Factual pleadings merely consistent with a defendant's liability are insufficient to survive a motion to dismiss because they establish only that the allegations are possible rather than plausible. See id. at 678-79. The court should grant relief under Rule 12(b)(6) if the complaint lacks either a cognizable legal theory or facts sufficient to support a cognizable legal theory. See Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir. 1990).

When ruling on a Rule 12(b)(6) motion, the court "must take all of the factual allegations in the complaint as true, " but is "not bound to accept as true a legal conclusion couched as a factual allegation." Iqbal, 556 U.S. at 678. Further, the court "need not accept as true... allegations that contradict facts that may be judicially noticed by the court, and may consider documents that are referred to in the complaint whose authenticity no party questions." Shwarz v. United States, 234 F.3d 428, 435 (9th Cir. 2000) (citations omitted). A court may look beyond the complaint to matters of public record, including administrative records, without converting the Rule 12(b)(6) motion into one for summary judgment. See Shawn v. Hahn, 56 F.3d 1128, 1129 n.1 (9th Cir. 1995).

Federal Rule of Civil Procedure Rule 15 provides that courts should freely grant leave to amend when justice requires it. Accordingly, when a court dismisses a complaint for failure to state a claim, "leave to amend should be granted unless the court determines that the allegation of other facts consistent with the challenged pleading could not possibly cure the deficiency." DeSoto v. Yellow Freight Sys., Inc., 957 F.2d 655, 658 (9th Cir. ...

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