Rhynes et al v. Stryker Corporation et al

RESPONSE

N.D. Cal.August 4, 2011

1 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 Steven R. Anthony [SBN 37778] Jane L. Trigero, Of Counsel [SBN 103575] Peter G. Washington [SBN 230514] ANTHONY & ASSOCIATES 1999 Harrison Street, #1620 Oakland, California 94612 Telephone: [510] 835-8400 Facsimile: [510] 835-5566 Attorneys for Plaintiffs GLORIA RHYNES AND DARRELL JENKINS UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA GLORIA RHYNES, Individually and on Behalf of the General Public, and DARRELL JENKINS, Plaintiffs, vs. STRYKER CORPORATION; STRYKER ORTHOPEDICS; and DOES 1 through 30, inclusive, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No.: C 10-05619-SC PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT Date: September 23, 2011 Time: 10:00 a.m. Courtroom 1 INTRODUCTION Defendants' motion to dismiss on preemption grounds relies on the hope that this Court will simply count the citations to authority and never consider what the cases actually say. As agreed by every court which has considered the scope of MDA preemption since the U.S. Supreme Court's decision in Riegel v. Medtronic (the cornerstone of defendants' argument), product liability claims which allege violations of the FDA's requirements are not preempted. The reason that the cases on which defendants rely were dismissed was that the plaintiffs in those cases were not able to allege such violations. Here, however, the plaintiff has alleged Case3:10-cv-05619-SC Document30 Filed08/04/11 Page1 of 9 2 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 such violations, so the motion to dismiss cannot succeed on preemption grounds. Alternatively, if the Court requires more specificity in the pleadings certainly leave to amend should be granted as this issue has been raised for the first time in this motion. As for the statute of limitations argument, defendants make the unwarranted logical leap that simply because she experienced pain; plaintiff must have suspected wrongdoing (despite the complaint's unequivocal allegations to the contrary.) There is no basis in fact, logic or law for defendants’ argument, and as the complaint alleges all elements of the discovery rule, the statute of limitations defense cannot succeed. ARGUMENT A. Plaintiff's Claims Survive MDA Preemption Because They Seek To Impose Requirements Which Are Parallel With, Not In Addition To, Federal Requirements Defendants move to dismiss pursuant to the MDA's express preemption clause, which states: “[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.” 21 U.S.C. § 360k(a). Defendants base their motion chiefly on the U.S. Supreme Court's holding in Riegel v. Medtronic, 552 U.S. 312 (2008). There, the Court did indeed hold that express MDA preemption is extensive when it comes to devices subject to the FDA's premarket approval (PMA) scheme. Preemption is not total, however, as was recognized in Riegel itself. Defendants conveniently neglect to mention the claims which were held not preempted in Riegel, even though that is precisely the sort of claim being made here. In Riegel, the plaintiffs had sued in U.S. District Court on a wide variety of products liability theories including claims based on alleged defects in the design, labeling and Case3:10-cv-05619-SC Document30 Filed08/04/11 Page2 of 9 3 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 manufacture of the product. The District Court held the design and labeling claims preempted. “It also held that the MDA pre-empted a negligent manufacturing claim insofar as it was not premised on the theory that Medtronic violated federal law.” Id. at p. 321 (emphasis added.) Thus, the claim for design defect did survive the preemption arguments raised at the pleading stage; not until later was that claim disposed of on summary judgment. The summary judgment was upheld on appeal, and that holding was not before the Supreme Court. Id., fn. 2. The reason that a manufacturing defect claim based on violation of federal law is not preempted is made plain by a later passage in the Riegel opinion: State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law. § 360k(a)(1). 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. Lohr, 518 U.S., at 495, 116 S.Ct. 2240; see also id., at 513, 116 S.Ct. 2240 (O'Connor, J., concurring in part and dissenting in part). The District Court in this case recognized that parallel claims would not be pre-empted, see App. to Pet. for Cert. 70a-71a, but it interpreted the claims here to assert that Medtronic's device violated state tort law notwithstanding compliance with the relevant federal requirements, see id., at 68a. 552 U.S. at p. 330. As noted, defendants' motion fails entirely to mention this important aspect of the Riegel decision. Instead defendants present an impressively long list of cases in which “product liability actions involving the Trident(tm) System” have been dismissed following Riegel, dropping a footnote to concede (without citation) that “a small number of district courts have denied motions to dismiss claims relating to the Trident(tm) System.” (Defendants' motion at p. 6, fn. 5.) Those courts include the Eastern District of Missouri in Warren v. Howmedica Osteonics Corp., 2011 WL 1226975 (E.D.Mo. March 29, 2011), and the Southern District of New York in Gelber v. Stryker Corp., 2011 WL 1483927 (S.D.N.Y. April 18, 2011). Only one of the cases cited by defendants is more recent than Warren and Gelber: Wilhite v. Howmedica Osteonics Corp., 2011 WL WL 2530984 (N.D. Ohio June 20, 2011.) One other, White v. Stryker, 2011 WL 1131496 (W.D. Ky. Mar. 25, 2011) dates from a few days before Warren, Case3:10-cv-05619-SC Document30 Filed08/04/11 Page3 of 9 4 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 and one other, Funk v. Stryker, 631 F.3d 77 (5th Cir. 2011) – the only Circuit Court decision in defendants' list – is from earlier this year. Regardless of the timing or the court in which the cases were venued, all of these recent cases agree on the issue which, though defendants do not mention it at all, is central to this motion: that a manufacturing defect claim which is “parallel” to the FDA's requirements is not preempted by the MDA, because the claim does not seek to impose state-law requirements that are “different from, or in addition to” the requirements of federal law. The reason that some of these cases resulted in dismissal and some did not has to do with differences in the facts alleged by the plaintiffs (and, to a lesser extent, differing levels of pleading specificity required by the different courts under Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009) and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007).) Simply put, the plaintiffs in Wilhite, White and Funk did not allege violations of FDA regulations, or did not do so with any specificity; the plaintiffs in Warren and Gelber did. White, supra, contains a useful discussion of the federal circuit decisions concerning this issue in the wake of Riegel. 2011 WL 1131496 at p. 5. To summarize: in June 2010, the Sixth Circuit reversed a summary judgment, holding that a plaintiff's allegations that a knee device violated one of the FDA's particular “Good Manufacturing Practices” (“GMPs”) escaped preemption. Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436 (6th Cir. 2010) (unpublished). Next, the Eighth Circuit upheld a dismissal, finding that the plaintiffs in that case had not alleged a violation of FDA regulations with enough specificity. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010). Next, the Seventh Circuit – in a case involving the very same Trident(tm) device at issue here – reversed a dismissal, holding that the plaintiff's complaint sufficiently alleged a parallel claim despite not identifying the particular FDA regulations that had been violated. Bausch v. Stryker Corporation, 630 F.3d 546 (7th Cir. 2010). As explained in White, the Bausch plaintiff had included several key facts in her original complaint, including: that the FDA investigated the Trident prior to plaintiff's surgery and issued a letter warning to the defendant that the manufacturing methods were not in conformity with Case3:10-cv-05619-SC Document30 Filed08/04/11 Page4 of 9 5 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 regulatory standards; that the FDA's warning was for a Trident model bearing the same catalogue number as the one implanted in the plaintiff; and that the Trident implanted in the plaintiff was later recalled by the defendant. Id. at 559. The Court held that such facts made the plaintiff's “claim for relief 'plausible on its face' as required by Iqbal and Twombly.” 2011 WL 1131496 at p. 6. After Bausch came Funk, supra, in which the Fifth Circuit upheld dismissal of a claim on the grounds that the complaint “did not say 'how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.'” 2011 WL 1131496 at p. 6 (internal citation omitted.) Finally, in March 2011 the Eleventh Circuit decided Wolicki-Gables v. Arrow International, Inc., 2011 U.S. App. LEXIS 4596 (11th Cir. Mar. 8, 2011). There a lower court dismissal was upheld, again because the allegations of FDA violations were generic and conclusory. It does not appear from defendants' papers, nor from plaintiff's counsel's research, that the Ninth Circuit has addressed this issue. Defendants cite only one district court case from within this circuit in their list of dismissed claims against the Trident(tm) system: Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho, Nov. 1, 2010.) Like all of the authorities discussed above, Cornwell acknowledged that a claim which is “parallel” to the FDA requirements would not be preempted. Indeed the court stated that the plaintiff had successfully pled such a claim – the case was decided at the summary judgment stage after discovery revealed that the factual basis of the parallel claim was inaccurate: Plaintiff's Complaint alleges a violation of FDA regulations based on Plaintiff's belief (at the time the Complaint was filed) that the Trident component was manufactured at the facility where a FDA warning letter and voluntary recall applied. Discovery has established the component was not manufactured at the Cork, Ireland facility, so Plaintiff's basis for an alleged violation of FDA regulations fails. Id. at p. 4. Nor do the California cases cited by defendants contain any contrary authority. In Robinson v. Endovascular Technologies, Inc., 190 Cal.App.4th 1490 (Ct. App. 2010), the claims were held preempted under Riegel because “plaintiff has not alleged that defendants Case3:10-cv-05619-SC Document30 Filed08/04/11 Page5 of 9 6 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 violated FDA regulations.” Id. at p. 1500. Likewise the court in McGuan v. Endovascular Technologies, Inc., 182 Cal.App.4th 974 (Ct. App. 2010) pointed out that the plaintiffs had “not allege[d] that defendants violated FDA regulations.” Id. at p. 983. Finally, in Blanco v. Baxter Healthcare, 158 Cal.App.4th 1039 (Ct. App. 2008), the court's decision rested upon the fact that “Blanco [did] not claim Baxter did not comply with the PMA process or the FDA administered recall.” Id. at p. 1054. Thus none of these cases involved a claim which was “parallel” to the FDA requirements. It is telling that defendants chose not to mention Bausch, supra, a case which is squarely on point as it concerns the same device at issue in this lawsuit, and the same defendants. As in Bausch, the plaintiff here has alleged that the FDA investigated the Trident, and found defendants to be in violation of FDA regulations (First Amended Complaint, para. 18d, 20). Should the Court decide to follow the holdings from other Circuits requiring more specificity in pleading, leave to amend should still be granted. As in Cornwell, supra, plaintiff here is prepared to allege that her device was manufactured at the Cork, Ireland facility during the time in which that facility was found by the FDA to have been violating its manufacturing standards, and to cite to particular violations in doing so. While the Court has already given leave to amend once, the earlier motion to dismiss was not made on preemption grounds; plaintiff should be given the opportunity to correct any perceived pleading defect as the issue has been raised now for the first time. B. Plaintiff's Claim Is Not Time-Barred Defendants once again assert that the claim appears time-barred on the face of the complaint. Not so. Defendants' arguments notwithstanding, the discovery rule is clearly applicable to this case. The First Amended Complaint states: The plaintiff was unaware of the injury from the defect until February, 2009 when the plaintiff had surgery that revealed the defective product that was improperly manufactured and as a result was defective. The plaintiff was unable to discover the defect at any time earlier since although she sought and engaged in other medical treatments as ordered by her physicians she was only able to Case3:10-cv-05619-SC Document30 Filed08/04/11 Page6 of 9 7 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 discover the defective product by undergoing a serious and invasive surgery which she undertook at the time prescribed by her treating physicians and after other treatment failed. (First Amended Complaint, para. 5.) This allegation satisfies the requirement of Grisham v. Philip Morris, 40 Cal.4th 623, 628 (Cal. 2007) that the plaintiff plead facts to show the time and manner of discovery, and the inability to have made an earlier discovery despite reasonable diligence. Nothing on the face of the complaint contradicts the straightforward allegations set forth above – that discovery was made in February 2009, by means of revision surgery, and could not have been made earlier. Defendants attempt to argue that under Rivas v. Safety-Kleen Corp., 98 Cal.App.4th 218 (Ct. App. 2002), Jolly v. Eli Lilly & Co., 44 Cal.3d 1103 (Cal. 1988) and Knowles v. Superior Court, 118 Cal.App.4th 1290 (Ct. App. 2004), the limitations period in this case was triggered as soon as the plaintiff experienced physical pain after surgery. This is not the law, though; as set forth in defendants' own moving papers, Rivas, Jolly and Knowles explicitly require that for the cause of action to accrue, it must be the case that the plaintiff “'suspects or should suspect' that his or her injury was 'caused by [someone's] wrongdoing ….'” Rivas, supra, 98 Cal.App.4th at p. 228, quoting Jolly, supra. Certainly the First Amended Complaint does not allege that plaintiff suspected wrongdoing any earlier than February 2009. Defendants therefore seem to argue (though they do not explain themselves) that allegations elsewhere in the complaint somehow imply that she should have suspected wrongdoing at an earlier time. Specifically, defendants point to the allegation that the acetabular shell loosened, and that when the shell loosens, it results in intense physical pain. “Thus,” defendants triumphantly declare, “prior to her revision surgery in February 2009, plaintiff suffered intense physical pain.” (Defendants' Motion at p. 10.) From Case3:10-cv-05619-SC Document30 Filed08/04/11 Page7 of 9 8 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 this they appear to deduce that she should have suspected wrongdoing – though, again, they do not spell this argument out, choosing instead to simply skip ahead to the conclusion. The fact that plaintiff suffered pain did not, however, put her on notice of wrongdoing “The best medical treatment sometimes fails, or requires long and difficult recuperation, or produces bad side effects.” Gutierrez v. Mofid, 39 Cal.3d 892 (Cal. 1985). The mere fact that an operation does not produce hoped-for results does not signify negligence and will not cause commencement of the statutory period. Kitzig v. Nordquist, 81 Cal. App. 4th 1384 (Ct. App. 2000). Nor was plaintiff under some duty to investigate. “So long as a suspicion exists” then the “plaintiff must go find the facts”. Jolly, supra, 44 Cal. 3d 1103. The law does not provide that an investigation is required prior to the plaintiff suspecting some wrongdoing. There simply is no authority for the proposition that any time a surgical patient experiences pain, she must investigate whether it was the result of wrongdoing; such a rule would set the duty of diligence unreasonably high. The statute of limitations commences to run once the plaintiff “…has the opportunity to obtain knowledge from sources open to his investigation …” Sanchez v. South Hoover Hospital, 18 Cal. 3d 93, 101 (Cal. 1976). In addition, no plaintiff is “required to discover the negligent cause of her injuries at all costs to her own health and welfare.” Hills v. Aronsohn, 152 Cal. App. 3d 753 (Ct. App. 1984). In Hills, the court held that the statute of limitations did not begin to run for a plaintiff who had negligently administered silicone injections in 1966, but did not commence a lawsuit until 1978 even though she noticed problems in 1974. The defense argued that in order to show requisite due diligence, the plaintiff needed to undergo a drastic surgery. The Court held that the plaintiff is only required to take reasonable steps and is not forced to Case3:10-cv-05619-SC Document30 Filed08/04/11 Page8 of 9 9 PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ FIRST AMENDED COMPLAINT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A N T H O N Y & A S S O C IA T E S 19 99 H A R R IS O N S T R E E T , S U IT E 1 62 0 O A K L A N D , C A 9 46 12 take extraordinary or risky measures. Here, the defense proposes a rule that to pursue a claim for relief, the plaintiff was required to investigate the cause of her pain even if the only means of discovery (as the complaint unambiguously alleges) was the extraordinary, painful and risky step of revision surgery. There is no such requirement in the law. The motion should be denied, as the First Amended Complaint contains perfectly adequate allegations of the elements of the discovery rule. CONCLUSION Defendants' preemption argument entirely sidesteps the critical issue, and their limitations argument is based on flawed logic. The motion should be denied. Dated August 4, 2011 Respectfully Submitted, ANTHONY & ASSOCIATES By: /s/ Jane L. Trigero Steven R. Anthony Jane L. Trigero Attorneys for Plaintiffs GLORIA RHYNES and DARRELL JENKINS Case3:10-cv-05619-SC Document30 Filed08/04/11 Page9 of 9