For The Defense, October 2010 - DRI Today

NDC numbers and the National Drug CodeDirectory, which the FDA updates regularly,is located on the FDA’s website. U.S.Food and Drug Admin., National DrugCode Directory, http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm. The fullysearchable National Drug Code Directoryis available online at http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm.Determining Product IdentityEven if your opposing counsel understandsdrug identification, you or a plaintiff’scounsel must still take steps to determineif the plaintiff’s medical provider can supplyevidence identifying the product at issue.Although you should obtain medicalrecords, as discussed below, those recordsmay not conclusively identify a product, requiringyou to search other types of records.Basic Medical RecordsObviously, the first step is to review therelevant medical records. It is necessaryto review the physician’s progress notesand the records of the pharmacy wherea prescription was filled. If a plaintiff’suse of a product stemmed from a hospitalsetting, relevant records would include(1) the physician progress notes, (2) nursingnotes, (3) the intra- operative report,(4) patient- specific billing records, and(5) patient- specific pharmacy records.Often a plaintiff’s insurance records willinclude a drug NDC number along with aproduct’s generic or trade name.A patient is typically entitled to obtainthese records without a subpoena, anddefense counsel should immediatelydemand, either informally or formally,such records. Occasionally, this is all thatis necessary because a provider’s recordsmay reveal the product’s trade name orNDC number. In those situations, Fed.R. Civ. P. 11 is clearly implicated becauseyour opposing counsel clearly has failed totake even this most basic step before filingsuit. If a plaintiff’s medical records revealthat the product at issue is not your client’s,and your opposing counsel refuses to voluntarilydismiss the suit, both a motionto dismiss for failure to state a claim anda sanctions motion may be warranted.Even with a voluntary dismissal, requestingcosts may be appropriate depending onthe law of the venue.Other RecordsIf basic medical records offer inconclusiveevidence that a provider used the drugor device at issue, you can request otherrecords, such as hospital or pharmacyinventory or national wholesale distributorshipping records. This strategy, however,has downsides. First, such recordsare never plaintiff- specific and can helpyou only if one single company suppliedthe relevant product or formulation to theprovider during the relevant timeframe.Second, if you engage in such discovery,it is difficult to contemporaneously arguein a motion to dismiss that a court shoulddismiss the complaint without leave toconduct further discovery or amend thecomplaint. However, depending on thecontrolling jurisdiction’s law, occasionallythe most cost- effective route to dismissalis conducting limited, product identification-onlydiscovery and, ultimately, filinga motion for summary judgment.Motion Practice UnderFederal Rules 8 and 12There is a developing body of case law thatsupports a swift motion to dismiss underFederal Rules of Civil Procedure 8 and 12.Rule 8 requires that a complaint set forth“a short and plain statement of the claimshowing that the pleader is entitled to relief.”Fed. R. Civ. P. 8(a)(2). To survive a motionto dismiss, “[f]act ual allegations mustbe enough to raise a right to relief above thespeculative level” and must state “enoughfacts to state a claim to relief that is plausibleon its face.” Bell Atlantic Corp. v. Twombly,550 U.S. 544, 555, 570 (2007). A complaintneed not contain detailed factual allegations,but must provide more than “a formulaicrecitation of the elements of a cause ofaction.” Id. at 555. And, as noted in Ashcroftv. Iqbal, “[a] claim has facial plausibilitywhen the plaintiff pleads factual contentthat allows the court to draw the reasonableinference the defendant is liable for themisconduct alleged.” Ashcroft v. Iqbal, 129S. Ct. 1937, 1949 (2009) (emphasis added).In filing a Rule 12 motion to dismiss inthis context, a defendant can argue that(1) the plaintiff has not demonstrated acausal connection between the defendant’sproduct and the alleged injury becausethe plaintiff’ failed to identify the specificmedication that the plaintiff received orthe specific manufacturer; (2) the pleadingsare formulaic, vague, and conclusory;(3) the allegations are not factually specificenough to state a plausible claim underFed. R. Civ. P. 8; and (4) the plaintiff hasfailed to plead individualized allegationsagainst multiple defendants. See Atuahenev. City of Hartford, 10 Fed. Appx. 33, 34 (2dCir. 2001) (affirming dismissal becauseThat “shoot first, aimlater” approach wouldviolate Federal Rule 8and be antithetical toFederal Rule 11(b).complaint “lump[ed] all the defendantstogether in each claim and pro vid[ed] nofactual basis to distinguish their conduct”).Another argument that you can offer isthat the plaintiff failed to plead facts sufficientto establish standing. See Daughteryv. I-Flow, Inc., 2010 WL 2034835, at *3 (N.D.Tex. April 29, 2010) (dismissing the plaintiff’scomplaint for lack of product identificationagainst named defendants, holdingthat plaintiff “has not pled facts sufficientto establish that he has Article III standingto pursue a direct claim against any of thedefendants for his own personal injury.”).Also, if a plaintiff does not adequatelyidentify the product at issue, fraud claims(which may lack the requisite particularityregardless of failure to plead product identification)are subject to dismissal underFed. R. Civ. P. 9(b). See Gilmore, 663 F.Supp. 2d at 860 (dismissing fraud claimsfor failure to comply with Rule 9(b)).A defendant can argue that a plaintiffhas either sued a host of defendants withoutalleging specific use of any particulardefendant’s product, or simply that theplaintiff has failed to plead in the complaintthat one particular defendant manufacturedthe product. In most cases, aplaintiff’s complaint will fall short of therequirements of Federal Rules of Civil Procedure8 and 11, even failing to plead a claim“upon information and belief.” Regardless,For The Defense n October 2010 n 23