D R U G A N D M E D I C A L D E V I C EWhat Happenedto Rule 11?By Amy K. FisherBaseless Pleadingsand ProductIdentification<strong>The</strong> “sue first andinvestigate later”mentality abusesthe judicial processand drains ourclients’ resources.<strong>The</strong> Federal Rules of Civil Procedure require attorneysand their clients to “stop, think, investigate, and research”before filing papers to initiate suits or to conduct litigation.Gaiardo v. Ethyl Corp., 835 F.2d 479, 482 (3d Cir. 1987).Specifically, Fed. R. Civ. P. 11 requires anattorney—or a party, personally, if unrepresented—tosign every pleading to certifythat “to the best of the person’s knowledge,information, and belief, formed after an inquiryreasonable under the circumstances:… the factual contentions have evidentiarysupport or, if specifically so identified, willlikely have evidentiary support after a reasonableopportunity for further investigationor discovery[.]” Fed. R. Civ. P. 11(b)(3).<strong>Defense</strong> lawyers and our clients generallyassume that plaintiffs first obtain the relevantmedical records and contact medicalproviders to identify relevant products beforefiling suit. See Aaberg v. ACandS Inc.,152 F.R.D. 498, 501 (D. Md. 1994) (there isa “reasonable expectation[]… that a complaintat least identify… the specific products…that, plaintiff claims, caused hisinjury”). Yet many litigants commence legalactions without conducting research touncover the necessary information to identifythose products. Perhaps counsel signedup a client over the Internet, without screeningthe records or speaking with the client.Perhaps he or she was motivated by a rapidlyrunning statute of limitations. Perhapsplaintiff’s counsel only dabbles in pharmaceuticallitigation and has no concept of thesteps necessary to identify a product. Perhapsa provider’s notes do not definitivelyidentify a product, instead only mentioninga general, or generic, product name.Regardless of the reason, Fed. R. Civ. P. 11requires more effort—either an investigationof a patient’s pharmacy and billing recordsor a discussion with the health careprovider about a product’s identity.Nonetheless, it is in vogue in the plaintiffs’bar to file claims against a slew ofpotential defendants and sort out theright ones during discovery—an approachthat completely nullifies Fed. R. Civ. P.11(b), which mandates that before initiatinga suit, a plaintiff should engage inan “inquiry reasonable under the circumstances”to find evidentiary support for allfactual contentions. Fed. R. Civ. P. 11(b)(3). Just this year, a California district court20 n <strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong>■ Amy K. Fisher is a partner in the Indianapolis office of Ice Miller LLP. She serves as national, coordinating, and local counselfor a variety of pharmaceutical and device manufacturers in nation- wide, complex multi- district litigation involving mass-tort andclass action product liability claims. She was recently named a <strong>2010</strong> Indiana Super Lawyers Rising Star. Ms. Fisher is a memberof <strong>DRI</strong>.
expressly held that those tactics ran afoulof Rule 11 when it rejected the plaintiffs’request for leave to conduct further discoveryin an attempt to amend their complaintto identify the specific medications at issueand the responsible defendants:Despite alleging no factual basis for theirclaims against [defendant] and indeedadmitting that they have none, Plaintiffsrequest discovery in order to identify theanesthetic used, arguing that discoverymay reveal which one of the eight anestheticmanufacturer defendants theysued, if any, manufactured the anesthetic[plaintiff] received. However, a plaintiffwho fails to meet the pleading requirementsof Rule 8 is not entitled to conductdiscovery with the hope that it mightthen permit her to state a claim. Further,allowing plaintiffs to file first and investigatelater, as Plaintiffs here would havedone, would be contrary to Rule 11(b),which mandates an “inquiry reasonableunder the circumstances” into the evidentiarysupport for all factual contentionsprior to filing a pleading.Timmons v. Linvatec Corp. et al., 263F.R.D. 582, 585 (C.D. Cal. <strong>2010</strong>) (citationsomitted).As mass tort litigation has blossomedover the years, so have the number of casesin which product identification is an issue.Sadly, our pharmaceutical industry clientscan spend enormous amounts of time andmoney defending cases in which the productsat issue were not theirs. <strong>For</strong> our clientsit is crucial to quickly and inexpensivelydispose of these ostensibly frivolous caseswhile preventing future filings. <strong>The</strong> federalrules specifically disallow baseless pleadingsand, courtesy of Twombly and Iqbal,Federal Rules of Civil Procedure 8 and 12now have some teeth. <strong>The</strong>re are several approachesdefense counsel can take in casessuch as these. Client goals and case- specificfacts dictate which strategy is optimal.Typically, when product identificationis an issue, a complaint’s lack of specificitywill range from identifying only a classof products to a compound name or varioustrade names. Multiple manufacturersare often named as defendants, clearly indicatingthat counsel has not conclusivelyestablished product identification and thatfurther investigation or motion practice iswarranted. If a complaint names only onedefendant but fails to identify the productby trade name, while one could assumethat the product has been identified, thecomplaint may still fail to meet pleadingrequirements. In Haskins v. Zimmer HoldingsInc., <strong>2010</strong> WL 342552 (D. Vt. Jan. 29,<strong>2010</strong>), the plaintiffs identified the anestheticat issue by compound name only—bupivacaine.<strong>The</strong> plaintiffs argued that their complaintsufficiently identified the product andproper defendant because the defendantwas the only bupivacaine manufacturernamed. <strong>The</strong> plaintiffs were claiming damagecaused by the administration of bupivacaine,and the relevant operative reportclearly identified the defendant’s product bybrand name. Id. at *1. <strong>The</strong> court disagreed:Plaintiffs’ arguments reveal a fundamentalmisconception of the pleadingrequirements. A document not attachedto the complaint cannot save deficientlypleaded claims. Whether AstraZenecaknows which medication was administeredto Plaintiff following her surgeryis irrelevant and does not affectwhether Plaintiffs adequately pleadedtheir claims in the complaint. Further,rather than expecting the Court to ‘inferthat [AstraZeneca] is the proper defendant,’to survive a motion to dismissPlaintiffs must at least allege in theircomplaint that an AstraZeneca productwas administered to Ms. Haskins via thepain pump following her surgery. Thisthreshold allegation is necessary to showa plausible entitlement to relief.Id. at *2 (citations omitted). See also Gilmorev. DJO Inc., 663 F. Supp. 2d 856, 862 (D.Ariz. 2009) (court disregarding extrinsicevidence on motion to dismiss “becauseeven if the [defendant] knew which medicationhas been used that would not meanthat plaintiffs’ claims were adequatelypleaded.”)Educating Plaintiffs’ CounselWhile the naming convention for drugs iselementary for defense lawyers in this practicearea, many plaintiffs’ counsel experimentingwith pharmaceutical litigationmay lack even a basic understanding ofhow drugs are named or identified. A clientmay resist doing an opposing counsel’swork for him or her, but it may be necessaryto either personally conduct product identificationresearch or educate a plaintiff’sMultiple manufacturersare often named asdefendants, clearlyindicating that counsel hasnot conclusively establishedproduct identification.counsel on how products receive namesand how to identify them.An initial pre- or postservice letter toopposing counsel, enclosing a company’sproduct guide and relevant portions ofsome or all of the items discussed below,such as a copy of an entry from the Physician’sDesk Reference, or the National DrugCode number, threatening motion practicebased on a complaint’s failure to allegea causal relationship between a productand your client, will occasionally result ina quick and clean voluntary dismissal. At aminimum, an initial meet- and- confer letteris often required by local practice priorto filing a motion to dismiss.Primer for Rookie OpposingCounsel on Drug IdentificationDrugs often have several names, and anycombination may be found in medicalrecords. A drug has a chemical or compoundname, which describes the atomicor molecular structure of the drug. Whena drug is approved by the Food and DrugAdministration (FDA), it receives a genericname and a trade name, also referred to asthe proprietary or brand name. <strong>The</strong> genericname is typically a shorthand version ofthe drug’s chemical name. <strong>The</strong> trade nameis provided by the company requestingapproval for the product and identifies theproduct as the exclusive property of thatcompany. While a drug is under patent protection,the company that holds the patentmarkets the drug under its trade name.After a patent has expired, other companiesmay produce and sell a generic versionof the drug with FDA approval. A genericdrug maker can sell the generic version<strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong> n 21