For The Defense, October 2010 - DRI Today

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. 2010) (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. For our clientsit is crucial to quickly and inexpensivelydispose of these ostensibly frivolous caseswhile preventing future filings. The federalrules specifically disallow baseless pleadingsand, courtesy of Twombly and Iqbal,Federal Rules of Civil Procedure 8 and 12now have some teeth. There 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., 2010 WL 342552 (D. Vt. Jan. 29,2010), the plaintiffs identified the anestheticat issue by compound name only—bupivacaine.The plaintiffs argued that their complaintsufficiently identified the product andproper defendant because the defendantwas the only bupivacaine manufacturernamed. The plaintiffs were claiming damagecaused by the administration of bupivacaine,and the relevant operative reportclearly identified the defendant’s product bybrand name. Id. at *1. The 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. The genericname is typically a shorthand version ofthe drug’s chemical name. The 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 versionFor The Defense n October 2010 n 21