For The Defense, October 2010 - DRI Today

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D R U G A N D M E D I C A L D E V I C Eunder its “official” generic name, which itreceived when the FDA first approved it, ora company manufacturing a generic versioncan create its own trade name, referredto as a branded generic, but it cannot usethe trade name developed by the originalpatent holder. Once a drug patent expires,the original innovator may market thecompany’s original product under eitherOccasionally the mostcost- effective route todismissal is conductinglimited, productidentification-only discovery.the generic name or the trade name. As aresult, the same generic drug may be soldunder either the official generic name orone of many trade names.Occasionally, you can simply tell anopponent that your client never sold thetype of product at issue or, at least, did notsell it during the relevant time frame. Mostcompanies publish a product guide, whichlists all of the products sold and distributedby a particular company and their NationalDrug Code numbers. Much of this informationis also available in the Physicians’Desk Reference (PDR), a widely available,annually updated, commercially publishedcompilation of manufacturers’ prescribinginformation on prescription medications.The Orange BookA lesser known source of product identificationinformation than the PDR is theApproved Drug Products with TherapeuticEquivalence Evaluations—commonlyknown as the “Orange Book.” Under federallaw, no one may market or distribute a drugthat it is not authorized to market or distribute.21 U.S.C. §355(a). The companies authorizedto market and distribute particulardrugs are listed in the Orange Book, whichfederal law requires the FDA to publish andupdate every 30 days. 21 U.S.C. §355(j)(7)(A)(ii); Eisai Co., Ltd. v. Mut. Pharm. Co.Inc., 2007 WL 4556958, at *1 (D.N.J. Dec.22 n For The Defense n October 201020, 2007) (explaining that all drug manufacturersmust submit a new drug applicationto the FDA for approval and that onceapproved, the FDA lists the drug informationin the “Approved Drug Products withTherapeutic Equivalence Evaluations, commonlyknown as the ‘Orange Book’”); In reK-Dur Antitrust Litig., 2009 WL 508869, at*2 (D.N.J. Feb. 6, 2009). The informationmaintained in the Orange Book is basedon the FDA’s own records and research.21 U.S.C. §355(j)(7)(A); 45 Fed. Reg. 72582(“[a]ll drug products on the List have beenfully reviewed and approved for safety andeffectiveness by the FDA”); see also Merck &Co. Inc. v. Hi-Tech Pharmacal Co., Inc., 482F.3d 1317, 1318 (Fed. Cir. 2007) (recognizingthat the Orange Book is a register publishedby the FDA that provides notice of patentscovering name brand drugs).The Orange Book can be very helpful indemonstrating to opposing counsel, or acourt, that your client did not market, sellor distribute either the compound at issueor a particular trade name product in therelevant time frame, but rather, the relevantproduct was sold in the United Statesexclusively by others. The Orange Bookprimarily lists all prescription drugs bychemical name. Under each chemical namecategory the book lists the various tradenames and formulations and the distributorsof each. It also includes an appendixsorting product names by applicant, listingall of the products that a particular manufactureris authorized to distribute.The Electronic Orange Book (EOB) isupdated daily and is searchable by activeingredient, proprietary name, patent,applicant holder, and application Number.U.S. Food and Drug Admin., ElectronicOrange Book: Approved Drug Products withTherapeutic Equivalence Evaluations, http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. The most recent Annual Edition andthe Current Cumulative Supplement arealso available in PDF on the FDA website.U.S. Food and Drug Admin., Orange BookPublications, http://www.accessdata.fda.gov/scripts/cder/ob/eclink.cfm. Prior to 2005, whichis when the Annual Edition and CurrentCumulative Supplement were made availableexclusively electronically, librariesdesignated as federal repositories receiveda copy of the Orange Book on microfiche.Subsequently, many of these libraries continuedto print and maintain copies fromthe Internet. Interested parties can obtaincopies of the relevant years’ Orange Booksdirectly from those libraries for copyingcosts or through the Freedom of InformationAct (FOIA), although these requestsoften take several months to process. FederalDepository Library Directory, http://catalog.gpo.gov/fdlpdir/FDLPdir.jsp.Courts may take judicial notice of theOrange Book because it is “not subject toreasonable dispute in that it is… capable ofaccurate and ready determination by resortto sources whose accuracy cannot reasonablybe questioned.” Fed. R. Evid. 201(b);see also Timmons, 263 F.R.D. at 585 (takingjudicial notice of the Orange Book andholding that “judicially- noticeable factsdemonstrate that AstraZeneca did notmanufacture or sell Marcaine in the UnitedStates during the relevant time period”);Horne v. Novartis Pharm. Corp., 541 F.Supp. 2d 768, 777 (W.D.N.C. 2008) (statingthat a court “may take judicial notice of andconsider the public records of the FDA…without transforming this motion into amotion for summary judgment”).National Drug Code SystemAnother useful tool in identifying a specificproduct and seller of a product at issue in asuit is the National Drug Code (NDC) number.The Drug Listing Act of 1972 requiresregistered drug establishments to providethe FDA with a current list of all drugsmanufactured, prepared, propagated, compounded,or processed by it for commercialdistribution. 21 U.S.C. §360. Drug productsare identified and reported using a unique,three- segment number, the NDC number,which is a universal product identifier forhuman drugs. 21 C.F.R. §§207.25, 207.35.A drug’s NDC number identifies thelabeler, product, and trade package size.The first segment, the labeler code, isassigned by the FDA. 21 C.F.R. §207.35(b)(2)(i). A labeler is any entity that manufactures,including a repacker or relabeler, ordistributes, under its own name, a drug.The second segment, the product code,identifies a specific strength, dosage form,and formulation for a particular firm. Thethird segment, the package code, identifiespackage sizes and types. The product andpackage codes are assigned by the entity. 21C.F.R. §207.35(b)(2)(ii). Information about
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
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