D R U G A N D M E D I C A L D E V I C EA plaintiff cannot establishthe essential element ofcausation if discovery hasyielded no evidence that adefendant’s product wasused by the plaintiff.courts have held that determining compliancewith Federal Rules of Civil Procedure11(b) and 8 require separate inquiries;merely alleging compliance with Rule 11does not release a party from the obligationto advance sufficient factual allegations tosatisfy Rule 8. Elan Microelectronics Corp.v. Apple, Inc., 2009 WL 2972374, at *4 (N.D.Cal. Sept. 14, 2009). <strong>The</strong> pain pump litigation,as well as other helpful cases, haveyielded numerous recent district courtopinions (regarding pharmaceuticals anddevices) dismissing cases at the initialstages due to failure to plead product identification.Wolicki- Gables v. Arrow International,Inc., 2008 WL 2773721 (M.D.Fla. June 17, 2008); Sherman v. StrykerCorp., 2009 WL 2241664 (C.D. Cal. Mar.30, 2009); Dittman v. DJO, LLC, 2009 WL3246128 (D. Colo. Oct. 5, 2009); Gilmore,663 F. Supp. 2d 856; Combs v. Stryker Corp.,2009 WL 4929110 (E.D. Cal. Dec. 14, 2009);Gomez v. Pfizer, Inc., 675 F. Supp. 2d 1159(S.D. Fla. 2009); Timmons, 263 F.R.D. 582;Haskins, <strong>2010</strong> WL 342552; Washington v.Wyeth, Inc., <strong>2010</strong> WL 450351 (W.D. La.Feb. 8, <strong>2010</strong>); Adams v. I-Flow Corp., <strong>2010</strong>WL 1339948 (C.D. Cal. Mar. 30, <strong>2010</strong>); Inre: Fosamax Products Liability Litigation,<strong>2010</strong> WL 1654156 (S.D.N.Y. Apr. 9, <strong>2010</strong>);Peterson v. Breg, Inc., <strong>2010</strong> WL 2044248(D. Ariz. Apr. 29, <strong>2010</strong>); Daughtery, <strong>2010</strong>WL 2034835; Kester v. Zimmer HoldingsInc., <strong>2010</strong> WL 2696467 (W.D. Pa. June 16,<strong>2010</strong>). But see Jozwiak v. Stryker Corp., <strong>2010</strong>WL 743834, at *5 (M.D. Fla. Feb. 26, <strong>2010</strong>)(plaintiffs plausibly established each defendants’relationship to the product atissue by alleging that each manufacturedand sold the product at issue; court rejected24 n <strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong>as premature and assuming of facts not inevidence the defendants’ argument thatboth could not have manufactured specificproduct); Koch v. I-Flow Corp.,F. Supp. 2d , <strong>2010</strong> WL 2265670 (D.R.I.June 7, <strong>2010</strong>).A defendant should further argue thata court should not allow a plaintiff additionaldiscovery. That “shoot first, aimlater” approach would violate Federal Rule8 and be antithetical to Federal Rule 11(b).As the advisory committee comment toRule 11 explained, “[t]ol er ance of factualcontentions in initial pleadings by plaintiffsor defendants when specifically identifiedas made on information and belief does notrelieve litigants from the obligation to conductan appropriate investigation into thefacts that is reasonable under the circumstances;it is not a license to join parties,make claims, or present defenses withoutany factual basis or justification.” Fed. R.Civ. P. 11 advisory committee’s note, 1993Amendments §§(b) and (c), 3 (West 2009)(emphasis added). <strong>The</strong> Supreme Court hasmade it clear that if a plaintiff fails tomeet the pleadings requirements of Fed. R.Civ. P. 8(a)(2) at the outset, a court shouldnot allow that plaintiff to proceed to thediscovery phase of the case in the hopethat discovery might provide the evidenceneeded to support a claim against the defendant.See Twombly, 550 U.S. at 559 (“[i]tis no answer to say that a claim just shyof a plausible entitlement to relief can, ifgroundless, be weeded out early in the discoveryprocess through ‘careful case management’…”);Iqbal, 129 S. Ct. at 1954–55(“[b]e cause [plaintiff’s] complaint is deficientunder Rule 8, he is not entitled to discovery,cabined or otherwise”). Grantinga plaintiff’s request for discovery “wouldallow plaintiffs to name anyone as a defendantin a lawsuit without making theallegations necessary to state a claim uponwhich relief might be granted and then toseek to discovery in hope of finding a basisfor a claim.” In re Rezulin Prods. Liab. Litig.,168 F. Supp. 2d 136, 141 (S.D.N.Y. 2001).It is widely held that although a districtcourt has discretion to allow leaveto amend a complaint under Fed. R. Civ.P. 15(a), if amendment is futile, dismissalwithout leave to amend is appropriate.See, e.g., U.S. ex rel. Roop v. HypoguardUSA, Inc., 559 F.3d 818, 822 (8th Cir. 2009)(“[f]u til ity is a valid basis for denying leaveto amend”). Drug and medical device casesare no different:Plaintiffs’ Complaint does not allege thattheir injuries were caused by [the defendant].<strong>The</strong>y admit in their Oppositionthat they do not know which entity manufacturedthe anesthetic administeredto [the plaintiff]. Thus, Plaintiffs admitthat they do not have the requisite evidentiarysupport to permit them in goodfaith to amend their Complaint to statea claim against [the defendant]. Consequently,leave to amend would be futile.Timmons, 263 F.R.D. at 585–86. See alsoCombs, 2009 WL 4929110, at *2–3; Sherman,2009 WL 2241664, at *5; Dittman,2009 WL 3246128, at *3 (all grantingmotions to dismiss with prejudice andwithout leave to conduct discovery oramend complaint).Many states have adopted what severalcommentators call the “Twiqbal” interpretationof Rule 8. See Iannacchino v.<strong>For</strong>d Motor Company, 888 N.E.2d 879, 890(Mass. 2008) (“retiring” previous standardfor evaluating adequacy of complaint articulatedby Conley v. Gibson and formallyadopting Twombly standard). Many othershave equally valuable pre-”Twiqbal” decisions.See Bockrath v. Aldrich Chem. Co.,21 Cal.4th 71, 80 (Cal. 1999) (holding thatCalifornia law requires plaintiffs to pleadthe identity of the specific, alleged injurycausingproduct, as well as the specific defendantwho manufactured and distributedthe product). Consequently, defense lawyershave forceful tools for motion practicein both federal and state courts.Summary Judgment MotionsUnfortunately, not all jurisdictions requirea plaintiff to identify a product at the initialpleadings stage. See Koch, <strong>2010</strong> WL2265670, at *4 (“Defendants’ assertion thatRhode Island products liability law requiresproduct identification is mistimed. Yes, theproduct must be identified, but failure to doso is not fatal at the initial pleading stage.”)In those cases, consider filing for summaryjudgment after obtaining all of the records.It is well established that to survivesummary judgment a plaintiff assertingproduct liability claims against a manufacturermust establish that the injury-causingproduct was manufactured, designed,
or distributed by the defendant whom he orshe has sued. See, e.g., Garcia v. Pfizer, Inc.,268 Fed. Appx. 270 (5th Cir. 2008) (holdingit insufficient for plaintiff to demonstratethat Wyeth distributed a substantial numberof doses of relevant vaccine to the stateduring relevant time period; rather plaintiffmust produce evidence Wyeth actuallysupplied the vaccine she ingested andwhich allegedly caused her injury); Whitev. Celotex Corp., 907 F.2d 104, 105–06 (9thCir. 1990) (affirming summary judgmentwhere plaintiffs “were unable to identifyany of the Defendants as having manufactured,sold or distributed any particular…product with which [the decedent]came in contact”). A plaintiff must demonstratethat there is at least a genuine issueof material fact about whether his or herinjuries were caused by a named defendant’sproduct. As a matter of law, a plaintiffcannot establish the essential elementof causation if discovery has yielded no evidencethat a defendant’s product was usedby the plaintiff. If awarded summary judgment,the moving party can often submit abill of costs under local rule to recover certaincosts.Costs and Sanctions MotionsIn addition to dispositive motion practice,a motion for costs or sanctions may be warranted.A courts can award attorneys’ feesand sanctions for a violation of Fed. R. Civ.P 11(c), which may be justified if the plaintiffand his or her counsel have failed tocomply with “Rule 11’s obligation to conducta reasonable inquiry into the law andfacts before signing papers filed with thecourt…” Rentz v. Dynasty Apparel Industries,Inc., 556 F.3d 389, 401 (6th Cir. 2009).Defendants must be sure to comply withFed. R. Civ. P. 11’s “safe harbor” provisionrequiring that a party seeking sanctionsfirst serve the motion to the opposing partyand then wait at least 21 days, or anotherperiod designated by the court, before filingthe motion. Fed. R. Civ. P. 11(c)(2).Moreover, a Fed. R. Civ. P. 11 motion forsanctions must be made separately fromany other motion.Courts strongly disfavor Rule 11motions, especially when used as a “bargainingchip… in hopes of securing astrategic advantage.” Bartonics, Inc. v.Power-One, Inc., 245 F.R.D. 532, 538 (S.D.Ala. 2007). <strong>Defense</strong> counsel should employRule 11 motions sparingly and considerother options, such as seeking attorneys’fees or costs under local rules or statuteswithin the body of substantive motions.Electronic Device FailureX-ray Computed Tomography (CT) scanning providesa complete 3D digital model of both the internal andexternal features of almost any part or object withoutdestroying it.CT allows you to view internal features of an objectfrom any angle with the click of a button, possiblyrevealing hidden information that may change theoutcome of your case.North Star Imaging’s Inspection Services Group canassist with:- Root Cause Analysis- Products Liability- Failure Analysis- and more...Potential PitfallsWatch out for several pitfalls when plaintiffshave inadequately identified specificproducts in their complaints. To avoid dismissal,they may try to (1) argue that theyNorth Star Imaging, Inc.is the nation’s leadingmanufacturer of X-ray andComputed Tomography Systems.North Star Imaging - Inspection Services Group • 763-463-5696www.xrayinspectionservice.comMedical Device Inspection<strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong> n 25
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