ORDER GRANTING MOTION FOR JUDGMENT ON THE PLEADINGS AND GRANTING MOTION FOR PARTIAL SUMMARY JUDGMENT
Plaintiff Robert Erickson (“Plaintiff’) sued Defendants Boston Scientific Corporation and Guidant Corporation (together, “Defendants”) for manufacturing and selling allegedly defective cardiac pacemakers that were surgically implanted in Plaintiff. Defendants now file a Motion for Judgment on the Pleadings and a Motion for Partial Summary Judgment. After reviewing the arguments and papers submitted, the Court GRANTS both motions.
BACKGROUND
Plaintiff has heart problems and has lived with a cardiac pacemaker since 1997. Plaintiffs first pacemaker — the VIGOR DR, Model 1232 pacemaker (“Vigor Pacemaker”) — was surgically implanted in 1997. Plaintiff alleges that although his doctors told him the Vigor Pacemaker would last ten years, it had to be removed after only four years and nine months. (Complaint ¶ 8.)
Plaintiff received his second pacemaker — the INSIGNIA Plus DR, Model 1298 pacemaker (“Insignia 1298 Pacemaker”)— in 2002. (Id. ¶ 9.) Plaintiff alleges that this pacemaker had to be removed in 2005 even though doctors told him it would last ten years. (Id.)
Plaintiff then received a third pacemaker — the INSIGNIA Ultra DR, Model 1290 pacemaker (“Insignia 1290 Pacemaker”). As with the first two pacemakers, Plaintiff alleges that although his doctors told him the Insignia 1290 Pacemaker would last ten years, it failed in less than five. (Id. ¶ 10.)
In 2005, after the Insignia 1290 Pacemaker was removed, Plaintiff received a fourth pacemaker — the ALTRUA 60 DDR, Model S606 pacemaker (“Altrua Pacemaker”). Though the Altrua Pacemaker is still in his body, Plaintiff alleges that its operation is “suspect.” (Id.)
Plaintiff alleges that Defendants “misrepresented the safety and quality of their pacemakers” and “actively concealed” defects in the pacemakers from the FDA and the general public. (Id. ¶ 12-13.) Plaintiff specifically alleges Defendants knew that the life expectancy of the pacemakers was significantly shorter than advertised. (Id. ¶ 15.) Based on these allegations and others, Plaintiff asserts the following five claims against Defendants: (1) “strict liability — failure to warn”; (2) “strict liability — design and/or manufacturing defect”; (3) negligence; (4) fraud; and (5) “gross negligence — malice.” (Id. passim.)
ANALYSIS
The Court first considers Defendants’ Motion for Judgment on the Pleadings before turning to Defendants’ Motion for Partial Summary Judgment.
1. MOTION FOR JUDGMENT ON THE PLEADINGS
1.1 Preliminary Matters
To support its Motion for Judgment on the Pleadings, Defendants request that the Court take judicial notice of the following six documents: (1) a June
Under Federal Rule of Evidence 201, “[a] judicially noticed fact must be one not subject to reasonable dispute in that it is either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Fed. R.Evid. 201. Courts may take judicial notice of “undisputed matters of public record,” but generally may not take judicial notice of “disputed facts stated in public records.” Lee v. City of Los Angeles,
The Court finds that the documents here meet the requirements of Rule 201. Accordingly, the Court GRANTS Defendants’ request.
1.2 Legal Standard
“After the pleadings are closed but within such time as not to delay the trial, any party may move for judgment on the pleadings.” Fed.R.Civ.P. 12(c). Rules 12(b)(6) and 12(c) are substantively identical. See William W. Schwartzer, A. Wallace Tashima & James M. Wagstaffe, Federal Civil Procedure Before Trial § 9:319. For a 12(c) motion, the Court accepts the allegations of the non-moving party as true. Hal Roach Studios, Inc. v. Richard Feiner & Co.,
A complaint need only include “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). “ ‘[Detailed factual allegations’ are not required.” Ashcroft v. Iqbal,
But the complaint must allege “sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Iqbal,
The Ninth Circuit recently addressed post -Iqbal pleading standards in Starr v. Baca,
“A district court may deny a plaintiff leave to amend if it determines that allegation of other facts consistent with the challenged pleading could not possibly cure the deficiency ... or if the plaintiff had several opportunities to amend its complaint and repeatedly failed to cure deficiencies.” Telesaurus VPC, LLC v. Power,
To comply with Fed.R.Civ.P. 9(b), a plaintiff must plead “with particularity” the time and place of the fraud, the statements made and by whom made, an explanation of why or how such statements were- false or misleading when made, and the role of each defendant in the alleged fraud. In re GlenFed, Inc. Sec. Litig.,
1.3 Preemption of State Law Claims
Defendants argue that Plaintiffs claims are preempted by the Medical Device Amendments of 1976 (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., 360 et seq. While acknowledging that state law claims involving FDA-approved medical devices are “generally pre-empted,” Plaintiff argues that his particular claims escape preemption for two reasons: because Defendants “have failed to prove or even allege” that its pacemakers were subject to rigorous Food and Drug Administration (“FDA”) approval, and because the pacemakers did not comply with FDCA requirements. (Opp’n at 2-3.) Before considering these arguments, the Court first discusses the scope of MDA preemption.
1.3.1 Scope of MDA Preemption
The FDCA has long required the FDA to approve drugs and medical devices before they enter the market. Riegel v. Medtronic, Inc.,
[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.
Id. at 316 n. 1,
In Riegel v. Medtronic, the Supreme Court held that the MDA expressly preempts state law claims if “specific federal requirements apply to the particular medical device that is the subject of the state law claim,” and “the state-law tort claim imposes a standard of care or behavior that is ‘different from, or in addition to’ the specific federal requirements.” Id. at 322,
District courts in the this Circuit have applied Riegel to preempt a broad range of state law claims brought against FDA-approved Class III medical devices. See, e.g., Cohen v. Guidant Corp.,
Here, there is no dispute that specific federal requirements apply to Defendants’ pacemakers. Nor is there any doubt that Plaintiffs state law claims impose standards of care “different from, or in addition to” federal requirements. See Medtronic,
1.3.2 FDA Premarket Approval and Product Development Protocol
Some of Defendants’ pacemakers were not subject to the FDA’s PMA process, but were instead approved through the FDA’s supplemental Product Development Protocol (“PDP”). In Reigel, the Supreme Court stated that an application for supplemental premarket approval is “evaluated under largely the same criteria as an initial application.” Riegel v. Medtronic, Inc.,
In his four-page Opposition, Plaintiff never actually argues that claims against Class III devices subject to the PDP process are not preempted. Instead, Plaintiff argues that preemption would not apply to Defendants’ pacemakers if they “entered the market through the § 501(k) process.” Under the so-called “§ 501(k)” process, the FDA may approve new medical devices that are “substantially equivalent” to devices already in the market without putting them through the rigors of PMA or PDP approval. Riegel,
But Plaintiff never alleges that Defendants’ pacemakers entered the market through the § 501(k) process. And Defendants’ judicially noticed documents show that the Pacemakers were, in fact, subject to the PMA and PDP processes. The Court therefore rejects Plaintiffs implicit contention that preemption does not apply because the pacemakers were not subject to sufficiently rigorous FDA scrutiny.
1.3.3 “Parallel Claim” Exception to FDA Preemption
The Riegel decision left open a narrow exception to express preemption under the MDA. This “parallel claim” exception allows states to “provid[e] a damages remedy for claims premised on a violation of FDA regulations.” Riegel,
As more than one federal court has noted in the MDA preemption context, a plaintiff “cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.” Wolicki-Gables v. Arrow Int’l, Inc.,
Here, Plaintiff alleges only that the pacemakers “were designed and/or manufactured in a manner violative of the [FDCA]” and that “[t]he facilities or controls used by Defendants ... were not in
In its Opposition, Plaintiff argues that a product “recall” for the Insignia 1290 and 1298 Pacemakers establish that these devices violated FDA requirements. Plaintiff specifically argues that “logic and commons [sic] sense mandates [sic] that a product recall indicates that defendants did not comply with their PMA approval.” (Opp’n at 4.) Defendants contend that these “voluntary company-issued advisories]” do not defeat preemption, and the Court agrees.
Many courts have recognized that product recalls do not create a presumption that FDA requirements have been violated. See, e.g., Blanco v. Baxter Healthcare Corp.,
1.4 Fraud
Plaintiffs fraud claim is also deficient because Plaintiffs allegations of fraud are not pled with sufficient particularity. See Fed.R.Civ.P. 9(b) Plaintiff alleges that Defendants’ misrepresentations concerning the safety, effectiveness, and longevity of the pacemakers induced him to have them surgically implanted in his body. But the Complaint does not allege the specific content of these misrepresentations. Nor does the Complaint allege when and where the misrepresentations were made, or who made them. See Edwards,
Plaintiff also fails to sufficiently allege that Defendants fraudulently concealed information concerning defects in the pacemakers. To plead the existence of an omission sufficient to support a fraudulent concealment claim, a plaintiff “must describe the content of the omission and where the omitted information should or could have been revealed.” Marolda v. Symantec Corp.,
1.5 Conclusion
Plaintiffs state law claims are preempted under the MDA because the pacemakers were subject to the FDA’s PMA and PDP approval processes, and because Plaintiff has not sufficiently alleged that the “parallel claims” exception applies. Accordingly, Defendants’ Motion for Judgment on the Pleadings is GRANTED. Leave to amend is DENIED because amendment would be futile given the pre
2. MOTION FOR PARTIAL SUMMARY JUDGMENT
While the Court’s ruling on the pleadings likely renders Defendants’ summary judgment motion moot, the Court nevertheless finds it appropriate to consider the merits of Defendants’ motion given the late stage of the proceedings.
Defendants move for summary judgment on two of the four pacemakers — the Vigor 1232 Insignia 1298 Pacemaker — arguing that statute of limitations on Plaintiffs claims involving these pacemakers expired before this action was filed in June 2010. In his five-page Opposition, Plaintiff argues that the two-year statute of limitations does not bar his claims on these pacemakers because the statute did not start to run until November 2009 when Defendants’ technician allegedly told Plaintiff that the pacemakers were covered by a five-year warranty. Defendants contend that the statute of limitations expired in 2007 based on evidence that the Plaintiff suspected that the pacemakers were defective in 2005. The Court agrees with Defendants.
2.1 Legal Standard
Summary judgment is appropriate only where the record, read in the light most favorable to the non-moving party, indicates that “there is no genuine issue as to any material fact and ... the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(c); see Celotex Corp. v. Catrett,
The burden initially is on the moving party to demonstrate an absence of a genuine issue of material fact. Celotex, 477 U.S. at 323,
2.2 Statute of Limitations
California Civil Procedure Code § 335.1 sets a two-year statute of limitations on claims like those Plaintiff asserts. Section 335.1 bars untimely personal injury claims based upon defective products regardless of the particular legal theory invoked. See, e.g., Soliman v. Philip Morris, Inc.,
Under California’s Discovery Rule, “the statute of limitations begins to run when the plaintiff suspects or should suspect that her injury was caused by wrongdoing .... ” Jolly v. Eli Lilly & Co.,
As noted in the Background Section, Plaintiff received his first pacemaker, the Vigor 1232 Pacemaker, in 1997. Plaintiff alleges that his doctor told him that the Vigor 1232 Pacemaker was supposed to last ten years, but that it “failed to operate properly” and “required replacement at physicians’ direction” after only four years and nine months. (Complaint ¶¶ 7-8.) Likewise, Plaintiff alleges that his physicians told him in 2002 that the Insignia 1298 Pacemaker should last ten years, but that it “failed to operate properly” and “required replacement at physician’s direction” in 2005, less than three years after it was implanted. (Id. ¶ 9.)
Defendants argue that Plaintiffs allegations establish that Plaintiff knew, or should have known, that the Vigor and Insignia 1298 Pacemakers were allegedly defective in 2002 and 2005 — when they were surgically removed from his chest. Yet despite the allegedly premature failure of these two pacemakers, Plaintiff claims that he never suspected anything was wrong with them. Plaintiff further claims that his doctors never told him why these pacemakers didn’t last ten years, and that he never asked his doctors why they failed so soon. (Opp’n at 4.)
A reasonable person in Plaintiffs position may have asked his doctor why removal and replacement was necessary after such an unexpectedly short time. A reasonable person may also have investigated publicly available information concerning the pacemakers. But the Court need not base its finding on what a reasonable person would have done under the circumstances because Plaintiff himself admitted that he thought the Insignia 1298 Pacemaker might be defective as early as 2005. At his June 15, 2011 deposition, Plaintiff stated that he “suspect[ed]” that there was something wrong the Insignia 1298 Pacemaker on February 17, 2005— the day the Insignia 1298 Pacemaker was removed.
While acknowledging that he thought “maybe something was wrong” in 2005, Plaintiff argues that these concerns have no bearing on the statute of limitations because “[they] were never communicated to the doctor.” (Opp’n at 3:21-22.) But Plaintiff cannot prevent the statute of limitations from starting simply by refusing to investigate his suspicions. As the California Supreme Court stated in Jolly, “[o]nee the plaintiff has a suspicion of wrongdoing, and therefore an incentive to sue, she must decide whether to file suit or sit on her rights. So long as a suspicion exists, it is clear that the plaintiff must go find .the facts; she cannot wait for the facts to find her.” Jolly,
Finally, Plaintiff argues that Defendants are estopped from relying on the statute of limitations defense because “they actively concealed the actual expected length of use of the pacemakers.” But Plaintiff provides no evidence supporting this allegation. In fact, Plaintiffs evidence leads to the oppo
Eventually, yes. You pacemaker runs on a battery. Like all batteries, the battery in your device will be used up over time.... When the battery power reaches a certain point, your pacemaker needs to be replaced. How long your pacemaker’s battery lasts depends upon the settings your doctors programs and how much therapy you receive. Pacemakers today typically last 6 to 8 years.
(Swenson Decl. Ex. 2 (emphasis added).) Defendants, on the other hand, provide extensive evidence showing that the lifespan of its pacemakers are unique to each individual patient, and that this information was distributed publicly.
Defendants have shown that no genuine issue of material fact exists as to when Plaintiff first suspected that the pacemakers were defective, and Plaintiff has not provided evidence sufficient to rebut this showing. The Court therefore GRANTS Defendants’ Motion for Partial Summary Judgment as to the Vigor and Insignia 1298 Pacemakers.
DISPOSITION
The Court GRANTS Defendants’ Motion for Judgment on the Pleadings without leave to amend. The Court also GRANTS Defendants’ Motion for Summary Judgment as to the VIGOR DR, Model 1232 Pacemaker and INSIGNIA Plus DR, Model 1298 Pacemaker. Defendants shall promptly submit a proposed judgment consistent with this Order.
IT IS SO ORDERED.