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Case 3:07-cv-05077-CRB

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FILED U.S. Cd RlC COUR T
IN THE DISTRICT COURT SOUTHERN DISTRICT OF GEORGI A WAYCROSS DIVISIO N

1 elf Y.

SEP 19 PH 2:26
CLERK SO. D(, OF GA.

CASE NO. :
WILLIAM GRIFFIN, widower, and as PERSONAL REPRESENTATWE OF THE ESTATE OF SHIRLEY GRIFFIN, deceased, Plaintiff,
vs .

CV506-07 5
Defendant . COMPLAINT AND JURY DEMAN D COMES NOW the Plaintiff, William Griffin, widower, and as a Personal Representative of

PFIZER, INC ., a foreign corporation,

the Estate of Shirley Griffin, by and through her undersigned attorneys, and brings this action against Defendant, Pfizer, Inc ., and alleges as follows : JURISDICTIONAL ALLEGATIONS AND PARTIE S 1 . This is an action for damages, which exceeds Seventy-Five Thousand Dollars ($75,000), relating to Defendant's design, manufacture, sale, testing, marketing, advertising, promotion and/or distribution of the unsafe medication Bextra 1z . Plaintiff alleges this is wrongful death action for damages, excluding fees and costs, that exceed $75,000 .00 . 2 . Plaintiff, William Griffin, is Personal Representative of the Estate of Shirley Griffin, deceased, and accordingly is the proper person to bring this lawsuit to recover damages for her death . 3 . At the time of her death, William and Shirley Griffin were legally husband and wife and resided in the State of Georgia . 4 . The following are survivors and beneficiaries of a recovery for the wrongful death of Shirley Griffin : a) William Griffin, husband ; b) Sylvia Curl, daughter ; c) Darryl M . Griffin, son ;

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d) The Estate of Shirley Griffin ; 5 . Defendant, Pfizer , Inc. ("Pfizer") is a Delaware corporation that maintains a principal place of business at 235 East 42a Street, New York, New York . At all times material , Pfizer was authorized to conduct business in the State of Georgia . 6. There is complete diversity of citizenship between the Plaintiff and the Defendant . This Honorable Court has subject matter jurisdiction over this matter pursuant to 28 U.S .C.A . $ 1332 (Diversity Jurisdiction), because the amount in controversy exceeds $75 ,000.00 and there is complete diversity of citizenship between Plaintiff and Defendant. 7. Pfizer is subject to the long-arm jurisdiction of this state pursuant to OCGA § 9-10-91, by reason of the following : a. Pfizer operated, conducted , engaged in and/or carried on a business or business venture in this state or had an office or agency in this state (OCGA § 9-10-91 (1)) ; b . Pfizer committed a to rt ious act within this state (OCGA § 9-10-91 (2)) ; c. Pfizer caused injury to persons within this state arising out of an act or omission by Defendant outside this state when , at or about the time of the injury , the Defendant was engaged in solicitation or service activities within this state and products , materials or things processed, serviced or manufactured by the Defendant anywhere were used or consumed within this state in the ordinary course of commerce, trade or use . (OCGA § 9-10-91 (3)); and d. Pfizer engaged in substantial and not isolated activity within this state (OCGA § 9-10-91 (3)) . 8 . Pfizer committed a tort within the State of Georgia and may be served with process in accordance with Rule 4 of the Federal Rules of Civil Procedure , through its registered agent for service of process .
9 . At all times material, Defendant was engaged in the manufacturing, packaging, marketing, distributing, promoting and the sale of the drug valdecoxib, under the trade name Bextra® .

10 . This action arises out of the Defendants' manufacturing, selling, distributing, marketing and/or otherwise promoting Bextra without notice to potential consumers of the dangers associate d 2

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with ingestion of this drug . Defendant continues to transact substantial business in the State of Georgia.
11 . The Plaintiff was prescribed, or otherwise lawfully provided with, Bextra in the State of Georgia .

12 . Defendant derives substantial revenue from pharmaceutical products used or consumed in the State of Georgia. Defendant expected, or should have expected, that its business activities could have consequences within the State of Georgia. 13 . Venue is proper in this United States Judicial District pursuant to 28 U .S.C.A. § 1391 . Plaintiff purchased the product, Bextra, in this District of Georgia and resides in this district, and Defendant marketed, advertised and distributed Bextra in this district, thereby receiving substantial financial benefit and profits from the product, Bextra, in this district . FACTUAL BACKGROUND 14. As a direct and proximate result of Defendant's negligence, as described herein, Shirley Griffin died November 26, 2004, as a result of ingesting Bextra when she suffered a heart attack caused by Bextra . 15. Bextra (Valdecoxib) is a prescription drug designed to treat pain through reduced inflammation agent (NSAID) . Defendant, Pfizer, did develop, manufacture, design, package, market, sell and distribute this drug in the State of Georgia at all times relevant to this action . 16. At the time Defendant developed and manufactured Bextra, Defendant intended to capture a portion of the consumer market for cox-2 specific inhibitors . 17. The scientific data available during and after Pfizer's approval process should have alerted Pfizer that its formulation of Bextra could cause a higher risk of blood clotting, stroke and/or myocardial infarctions among Bextra consumers . 18 . Despite the findings, Pfizer continued to conceal or minimize the cardiovascular risks associated with Bextra use . 19. Pfizer had control over the design, manufacturing, assembly, labeling, warning ,

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packaging, marketing, advertising, promotion, direct-to consumer advertising, and/or sale ofthe dru g Bextra. 20 . At all times material, Pfizer actually knew of the defective nature of its product, Bextra, yet continued to design, manufacture, market, promote, distribute and sell its product so as to maximize company sales and profits at the expense of consumer safety and health and in conscious disregard of the foreseeable harm caused by Bextra . 21 . Although Pfizer knew or should have known that dangerous cardiovascular risks were associated with the use of Bextra, it continued on its aggressive marketing campaign and continued to manufacture, package, distribute, promote and sell Bextra without adequate warnings of the serious side effect and risks . 22 . Plaintiff did not know of the potential connection between the use of Bextra and his wife's death until after the Food & Drug Administration ("FDA") issued its recommendation, on April 7, 2005, that Bextra be withdrawn from the market. 23 . Decedent, Shirley Griffin, used Bextra for its intended purpose . 24 . Decedent, Shirley Griffin, was not warned that Bextra was dangerous to her health . COUNT I STRICT LIABILITY 25 . Plaintiff incorporates by reference paragraphs 1 through 24 above . 26. Bextra was defective and unreasonably dangerous when it left the possession of the Defendant, Pfizer, in that : a. When placed in the stream of commerce, Bextra contained unreasonable dangers, design defects and was not reasonably safe as intended to be used, subjecting Plaintiff to risks which exceeded the benefits of the drugs ;
b. When placed in the stream of commerce, Bextra was defective in design and formulation, making use of the drug more dangerous than an ordinary consumer would expect and more dangerous than other risks associated with Plaintiffs conditions ;

c . Bextra contained insufficient warnings to alert consumers, the consumer's prescribing physicians and users of the severe, lifethreatening complications and side effects, including but not limite d 4

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to stroke and adverse cardiovascular events ; d. There was misleading advertising and promotion concerning the benefits of using Bextra and ; e . There are inadequate post-marketing warnings or instructions, because Pfizer knew or should have known of the significant risks associated with the use of Bextra, Pfizer failed to provide adequate warnings to consumers and the consumer's prescribing physicians and Pfizer continued to aggressively promote and advertise, direct to consumers, the sale and use of the drug . 27 . Decedent, Shirley Griffin, used Bextra for its intended purpose . 28 . The Bextra products, sold to Decedent, Shirley Griffin, reached the Decedent without substantial change. Decedent, Shirley Griffin, was unaware of the dangerous propensities of the product at the time he ingested Bextra. 29 . Decedent, Shirley Griffin, ingested the Bextra without making any changes or material alterations to the product . 30. Prescribing physicians do not have substantially the same knowledge as manufacturers regarding prescription medication . Prescribing physicians rely on manufacturers to provide adequate and appropriate warning regarding their products . 31 . Pfizer had a continuing duty to provide accurate and adequate warnings to prescribing physicians of the dangers, risks and reactions associated with the use of Bextra . 32 . The warnings given by Pfizer, to prescribing physicians, regarding Bextra were deficient, inadequate, unclear, misleading and/or ambiguous . 33 . Decedent, Shirley Griffin, could not have discovered any defects in Bextra through the exercise of due care . 34 . As a direct and legal result of the defective condition of the drug Bextra, Shirley Griffin died prematurely, and the survivors have, to the extent governed by OCGA § 51-4-2, et seq ., ("Georgia Wrongful Death Act"), sustained the loss of Shirley Griffin's support and services, companionship and protection, while continuing to endure mental pain and suffering, anguish and emotional distress .

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35, As a result of the premature death of Shirley Griffin, the Estate of Shirley Griffin has sustained the costs of medical and funeral expenses , loss of earnings, net accumulations , the full value of the life of Shirley Griffin and other damages permitted by law . WHEREFORE, Plaintiff demands judgment against Pfizer , Inc ., for damages and costs in a sum in excess of the jurisdictional requirement of this cou rt. COUNT II NEGLIGENCE 36 . Plaintiff incorporates by reference paragraphs 1 through 35 above . 37 . At all times material hereto , Pfizer had a duty to exercise reasonable care in the design, m anufacture , testing, processing , labeling, packaging , adve rtising, marketing, distribution and sale of its products . 38 . Pfizer knew or should have known that Bextra caused unreasonably d angerous risks and serious side effects . Despite such knowledge, Pfizer aggressively advertised , marketed, sold and distributed Bextra, knowing that there were safer methods and products for use with pain and infl ammation . 39 . Pfizer was negligent and breached its duty in the following manner : a. Pfi zer failed to adequately and properly test its drug product, Bextra before placing Bextra on the market ; b. Pfizer failed to adequately , accurately and appropriately warn prescribing physicians of the significant ri sk of cardiovascular events associated with the use of Bextra. c . Pfizer concealed the dangerous prope rties of Bextra in order to increase Pfizer's market share .
40 . As a direct and legal result of the defective condition of the drug Bextra, Shirley Griffin died prematurely, and the survivors have, to the extent gove rned by OCGA § 51-4-2, et seq ., ("Georgia Wrongful Death Act"), sustained the loss of Shirley Griffin 's support and services, companionship and protection , while continuing to endure mental pain and suffering, anguish and emotional distress .

41 . As a result of the premature death of Shirley Griffin, the Estate of Shirley Griffin has

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sustained the costs of medical and funeral expenses , loss of earnings, net accumulations , the full value of the life of Shirley Griffin and other damages permitted by law . WHEREFORE, Plaintiff demands judgment against Pfizer, Inc ., for damages and costs in a sum in excess of the jurisdictional requirement of this cou rt . COUNT III NEGLIGENT MISREPRESENTATIO N 42. Plaintiff incorporates by reference paragraphs 1 through 41 above . 43 . At all times material hereto , Pfizer knew or should have known that its prescription medication , Bextra , caused unreasonable dangers, risks and serious side effects . 44 . Despite its knowledge , Pfizer aggressively adve rt ised , marketed, sold and distributed Bextra knowing there were safer methods and products for use with pain and inflammation . 45 . Pfizer negligently misrepresented to the Decedent , Shirley Griffin, and her prescribing physician the safety and effectiveness of Bextra and/or negligently misrepresented material information regarding the drug and/or negligently misrepresented adverse information regarding the safety and effectiveness of Bextra . 46 . Pfizer's misrepresentations were communicated to Decedent , Shirley Griffin's, prescribing physician with the intent that they reach the Decedent and that the effect of such representations would be that prescriptions would be written for the drug consuming public, including Decedent . 47 . Pfizer made these representations and actively concealed adverse information at a time when the Defendant knew, or should have known , that its drug product had defects, dangers, and characteristics that were other than what Pfizer and its representatives had represented to prescribing physici ans or other dispensing entities , the FDA and the consuming public, including Decedent, Shirley Griffin . 48 . The misrepresentations of Pfizer were perpetuated directly and/or indirectly by Pfizer and its employees , agents and/or other detail persons . 49. The misrepresentations by Pfizer constitute a continuing to rt. 7

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50 . Pfizer had a continuing duty to warn Decedent, Shirley Griffin, and/or Decedent's prescribing physicians ] n a timely manner about the potential risks and complications associated with Bextra . 51 . As a direct and legal result of the negligent misrepresentation of Pfizer , Shirley Griffin died prematurely, and the su rv ivors have, to the extent govern ed by OCGA § 51-4-2, et seq ., ("Georgia Wrongful Death Act"), sustained the loss of Shirley Griffin' s support and services, companionship and protection , while continuing to endure mental pain and suffering , anguish and emotional distress . 52 . As a result of the premature death of Shirley Griffin, the Estate of Shirley Griffin has sustained the costs of medical and funeral expenses , loss of earnings, net accumulations , the full value of the life of Shirley Griffin and other damages permitted by law . WHEREFORE, Plaintiff demands judgment against Pfizer , Inc., for damages and costs in a sum in excess of the jurisdictional requirement of this cou rt . COUNT IV FRAUD 53 . Plaintiff incorporates by reference paragraphs 1 through 52 above . 54 . Pfizer fraudulently or intentionally misrepresented to the Decedent , Shirley Griffin, and/or Decedent ' s prescribing physician the safety and effectiveness of Bextra and/or fraudulently or intentionally concealed material information regarding the drug and/or fraudulently or intentionally misrepresented adverse information regarding the safety and effectiveness of the drug . 55 . Pfizer fraudulently or intentionally communicated misrepresentations to Decedent's prescribing physicians with the intent that they reach the Decedent . 56 . Pfizer knew that its representations were false . 57. Decedent' s prescribing physician and Decedent relied on the representations of Pfizer and approved the continuing use of Bextra by Decedent . 58 . Pfizer made the fraudulent or intentional misrepresentation and/or actively concealed adverse information with the intention and specific desire that the Decedent , Shirley Griffin, th e

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Decedent's prescribing physician and/or dispensing entities and the consuming public would rely on such false information in selecting Bextra for treatment of pain and inflammation . 59 . Pfizer made the fraudulent or intentional misrepresentations and actively concealed adverse information at a time when they knew that Bextra had defects, dangers and characteristics that were other than what Pfizer had represented to the prescribing physician or other dispensing entities, the FDA and the consuming public, including Decedent . Specifically, Pfizer fraudulently or intentionally misrepresented to and/or actively concealed from Decedent, Decedent's prescribing physician or other dispensing entities, the FDA and the consuming public the following adverse information regarding the drug Bextra, as ingested by Decedent : a. That Bextra carried risks of serious adverse effects ;
b. Despite knowing that there were serious risks of adverse cardiovascular events, Pfizer aggressively marketed, promoted advertising direct to consumer and/or sold the drug as if there was no risk ;

c . Failed to advise Decedent, Decedent's prescribing physicians and others that prior studies, research, reports and/or testing had been conducted linking the use of the drug to serious adverse cardiovascular events ; d. Represented that Bextra was safer than other alternative medications and fraudulently concealed information, which demonstrated that Bextra was not safer than alternatives available on the market. 60. The fraudulent or intentional misrepresentation and/or concealment by Pfizer constitute a continuing tort . 61 . Pfizer had a continuing duty to warn Decedent and Decedent's prescribing physicians of the drug product in their labeling, advertising, product inserts, promotional material, direct to consumer advertising or other marketing efforts . 62 . Pfizer fraudulently and intentionally misrepresented the safety and efficacy of Bextra in their labeling, advertising, product insert, promotional material, direct-consumer advertising or other marketing efforts . 63 . Decedent and Decedent's prescribing physicians and dispensing entities j ustifiably relie d

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to their detriment on and/or were induced by the fraudulent or intentional misrepresentations and/or concealment by Pfizer regarding the safety and effectiveness of Bextra . 64. As a direct and legal result of the fraudulent and intentional misrepresentation of Pfizer Shirley Griffin died prematurely, and the survivors have, to the extent governed by OCGA § 51-4-2, et seq ., ("Georgia Wrongful Death Act"), sustained the loss of Shirley Griffin's support and services, companionship and protection, while continuing to endure mental pain and suffering, anguish and emotional distress . 65 . As a result of the premature death of Shirley Griffin, the Estate of Shirley Griffin has sustained the costs of medical and funeral expenses, loss of earnings, net accumulations, the full value of the life of Shirley Griffin and other damages permitted by law . WHEREFORE, Plaintiff demands judgment against Pfizer, Inc ., for damages and costs in a sum in excess of the jurisdictional requirement of this court . COUNT V VIOLATION OF THE GEORGIA DECEPTIVE AND UNFAIR TRADE PRACTICES AC T 66. Plaintiff incorporates by reference paragraphs I through 24 above . 67. This is an action brought pursuant to Georgia Deceptive and Unfair Trade Practices Act contained at OCGA Article 15 of Chapter 1 of Title 1 0, et seq . 68 . Pfizer, through its agents, servants and employees, employed deception, fraud, false pretense, false promise, misrepresentation, unfair practice and the concealment, suppression and omission of material facts, in connection with the sale and/or advertisement of Bextra . 69. Such false and unfair practices violate the Georgia Deceptive and Unfair Trade Practices Act which makes it unlawful to engage in unfair methods of competition, unconscionable acts or practices and unfair or deceptive acts or practices in the conduct of any trade or commerce . OCGA Article 15 of Chapter I of Title 10 . 70. As a direct and legal result of the foregoing, Shirley Griffin died prematurely, and the survivors have, to the extent governed by OCGA § 51-4-2, et seq ., ("Georgia Wrongful Death Act") ,

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sustained the loss of Shirley Griffin's support and services, companionship and protection, while continuing to endure mental pain and suffering, anguish and emotional distress . 71 . Pursuant to Article 15 of Chapter 1 of Title 10 of the Official Code of Georgia Annotated of the Georgia Deceptive and Unfair Trade Practices Act, Plaintiff seeks the actual damages plus attorneys' fees and court costs for Pfizer's conduct that resulted in the premature death of Shirley Griffin, resulting in the Estate of Shirley Griffin sustaining the costs of medical and funeral expenses, loss of earnings, net accumulations, the full value of the life of Shirley Griffin and other damages permitted by law . WHEREFORE, Plaintiff demands judgment against Pfizer, Inc ., for damages and costs in a sum in excess of the jurisdictional requirement of this court . DEMAND FOR TRIAL BY JURY AND COST S Plaintiff, William Griffin, widower, and as Personal Representative of the Estate of Shirley Griffin, deceased, hereby demands a trial by jury of all issues herein so triable and, in addition, demands an award of attorneys' fees and costs incurred in prosecuting this action . SPO IL R, MAXWKL L P.A.

Roger 7~ Georgia Florida BF-N-63 . 02UX4 1 Floyd L. Matthews, Jr., Esquire Florid ar No. 18251 1 701 dam s St . Adams Jacksonville FL 32204 (904) 354- 8310 Telephone (904) 358 - 6889 Facsimil e email : fmatthews @swmmlaw .com and Donald Black , Esquire Florida Bar No . 227791 Harrell & Harrel l
4735 Sunbeam Road Jacksonville , FL 3225 7 Attorneys for Plaintiff

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J -25-2005 1! :29 _ .~ ~du1F~5

908 P . 21

(I1E

JtIY NU of 1.11 A TI & 13'ut

pubre Nr YSb»cr

Far:f agq'DcuR Ad~v+r non puivN~; : AdG 20857

TR"S, GT:ED EYFACSLNEL E

Raymgnd V. G,flmartio prctidts 1 and CEO Merck & Ca,, Inc . ?.0 . Day two. =BC-lo North Wstet, PA 19454109 9

S :F 17 2M

R.E . NDA 22-04 2
V;oxx (roikcoxab) lablets MAC C5 1D 19456

WARNING LETTER
Dew Mr. Gilmartin : Thus Wuaing Lent: aoncerta Mack & Ca Inc.'s (Mack) promot oxul yctivities mcii0axedala for the marketing alYoxx (rofecoxtb) tablets . Specially, wercfor to pmatotiosal audio q eranccs oa b calf of Merck by Pet er Holt. MD, a pros release. and oral r up eseasatioas rteai4e!Yy Merck tag= re Presnt bvea to promtrto Vin As pars of its routine monitoring tad amrveM=t pxa®rM- tbo Diviaian of Drug lt4:rfetir+g. Advatirin$, and Commtmicsdaos (DDbiAC) ksas te+ieaed rant promotional sctivitles and rastcials sod bas concluded that they ass tstlse, la=1®g In fsh ba *^c· or ocherwise mialexfing in yiolscion of the edit Food. Drttg, . and Cosn flc Act (tors Act) and applicable regulations- Set 21 U-S .C . 1133 1 (a) and (b) . 352(a) . (1). sad (n), and 3 IS- (&). You have engaged in a promotional ataxpaign for Y,oxx that miri=ires the poteatiifly aeuous cardlovascW r findings that were observed in the V'laxz Qa.svrolnustiaal On ere, gactadr (VIGOR) study , and thus, mixepreeessts the safety pta ]a for Yost Specifically, your pcar3rtitirsds2 t~tapsa adiscooats the fact that in the V1:0OR study, patients as Via= we observed to bsv'e x forte to five fold iacsatc in myacardlal tafu at or 1Is) coroparul to pancuts as the coatparx1ar ntsn stctnidsi s n if intlararatory drag (NSA]D). Nagrosyn (nsproxen) Althoulb the exact reason for the IIrrrsscd rate aI MIs obsuvtd in the Vic Reatme~t gxnup is unknown, your prornatlona] campaign scloctivcly praana the funowtag hypotL-&Zj mrplanshou far the observed iicrrsc in MIs_ You assa-t that Via= does not incrcsie the risk of M1 mad that the VIGOR Grading is coas ;stent with aagroxrn's 3brliry to block platelet aggtgadau 1 ]Ae aspirin Tat is a possible cxplan,tioo, but you fail to disclose that your exptcnrcaon is hypothcticatl, has not be,= dcaro[str2ted by substantial evidcocc, acid that tSer is another roasonable explanation, that Vioxcc ntjq hevc pm-t&ro^ .ebo'.ic prDpertia .

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J * -25-2005

11 :30

L JJ/ RE·tD S

Raymood V. Giiwartin Merck & Co .. Inc . NDA 21-042
You hi ve also anpged in promodouai activi ti es the; minimize :ba ViaXX ! Cot73ns n,CvTirFaSa) &V_R 5 7 txm' >± Dd interac tion, omit imporuot risk iniurrrarion, matte ums .rUnti.eted aope iorrty dime i NSAIDa, and aromotc Via= for uvaporaved wa ud an noeoproved dosing regunea- in addict= Its rttisrepracadag the Vimc / wufanu drug intemctioe you also misteprvscat Via='& sifaty pro5le by riuimiing the po='.iai :y se sus rs,Z of cigaucan : ble.iing that ere ;, resuslt t9cm using Viosx end wcfasin concorni:7Atty.

Yaw minimizing These potential ricks and misstprrsees dag the safety pro5le Bar V"sdidx'r#ise tipdilan t public healt h and =R:,y coecein . Your misreprewoudaa of the safety probe for Nri'04 t Is . particularly troahlcyorae becsttac we have previously , in an snarled lerc, objee+rdl j rr enctaocaI matcrida for Viox that also winaprnen;ed Vi='s sifrty praile.

Backgroun d
Vlorct is & NSAID with selective cyeloazyljrazze 2 (COX-2) inhibitory pn pe.-des_ -it" W iaiagp s ound as May 20,1999, for the n atment of primary dysmenorrha, for the manag ueut of aim pals ist·t . and for raGef of the signs and aymppioms of oateoyrhxiti$. _ Prior to spprovsl, andoseopy studies wern submined to tbo origimt1 NDA datnbue ilea 4atdegst2nt trwratmt with, Vii= 25 m` or 50 mg daily was usoc atcd with a eigailic=dy lavivt . of endoscopicafy apparent Cutroduadeaal ulcers than ttett»snt with ibupm(co, 2400 Wgdwlhj~ tdouaasrt the correlation be wee lha ding, o(cadoseopie studies sod the teLative incide of stoiutor upper pstroimtesminat) (Cl) crests eras unknown, after approval, Merck speasosad *a' 1GOAtit wylo obtain iofonnetion mprdin : clinically mcsniogfu1 upper Gl cvc end to develop & la r a can !fed database for ovtnll safety ua ttoune*+t_ 7be VIGOR study included approximately 4000 pwticau per tresunart arxa (Viozx· SO,tRigaday at aapruxan 1000 mg a day) treetcd for a median time of 9 monde The primary endpoi4t a(rde amdy wars the relative ciaTC of confirmed PUHs (pertorarions, sytnptotratia ulcers, and M b}ceds) its pedants + with then atoid arthritis taking Via= 50 tug daily (two to foar tirrte7 the apptared dazing etegMaco fie Via: in or zadniti sl can>prred to patients W;iag napratxn . 1000 rag daily, The a Wy silo .o compared the aafcry sad tolerability of the two treatmmq in puicnu with th euntstaed ai$sdd .. The relies of the study dewowttnccd that p . tieots on Vim--- bad a sigziEcz uiy low= CnXMiI a ib dC=w ; .Ia of FlIS' a en euparad to patients on uaprvx= (2 .08% and 4,49% fbr Vioxx and tT ti nppistadvcI)l). =g Other importstor resudu guts the VIGOR study included the onez zeczed f dings tliasint w epor; ed serious txrdtavs ,ecular events occsaod In 101 paticaU (2.5%) In the V1oxz iCri;ssWIaot pgt compared to 46 paticnu (1 . I Ys) in the uaproxen n armene group, and MIs txraurvd Ii 20 patiieats eracog 4047 in the Vloxx ere:aaettt group (05%), eoaspautd to four padeou among 4029 In the nap7oRe Iratmect group (0 .1 %) . These uacxpecred .5ndings wtro txtensivaty disvu4sw4 at the FDA' Anhrrot Adr'sory Com ir_c McS ..ig c=Yrb nary 8,100! . Atl:cZght, the reason for ttheao diircmccs is not clear. pesstblo cx-planations include both no ability of naproxeu to fraction a a cardioY utcctivc z,en : wcul a prg-rltrombgucprcpcry of Yio .z .

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AN-25- 2005 1i :30

LEE r",c

S

906 P . iii

Raymond Y . Cilmrstin Merck 4 Co, inc . NIOA 21 .04 2

?15e 3

Promotional Audio Conferences
W: are twin of six promouonai aedia coofctcace, presented an beaaif of Mea ;c by Psta Holt, MD that are in violation of the Ac : and its irapicrocating regulations. Tneae audio confereoces .ware hdd ac imsc 8, 2000, )we 13 .2000, lure 16, 2000, zed three on Juno 2 L . 2080, s_rrd were rrtode'n!eea by Me. empioyeea.
0o Dc rmbe 12, 2000, we ae a : you z writiee inquiry about your invot ent with rJ,rd inflt wax an the iniduioo, prepar+tion, development, and publication of audio mttferencx : given VA. Hatt. We e aiso asked you to dcscrbc the nature of the relationship betwen you and Dr. Holt_ Iap = ra3tpemst dated lamrary5.2001, you stated tbeT, "Dr . Holt etuered Into a speaker contract whit Maces eta lost. nntned thr we cringed for Dr. Hale m apeuk a w . 4 1999.` Yon aloe stated that, "Merck bat d m audio confereeccs is 2000. Merck B naineea Magagers provided bin with the topic for·the radio eoaf ancCS and, for two of the audio coati= , azle d hue !o adcress the safety, ptnMM Or'%r z and o6cr NSAJDs. The promotional audio eonfexenesa idcati$ed above, anunged by, and presented orZtie adf of Mt' orett Elise or mislcatdcrs in that they mtx+ ta,ty..t the Mi traultt of !lac VIGOR atody: .> dd the V' . / Cournadin d,ru6 int e-actaa, amiaed aaportaut risk information readewso . eau~d supx rio ityel aians, and promoted 'Viorra: foruzxpprovcduses and an rmzpproved doting regimen Ow apoaiilc objections follow. '~ttnir*+ririon of ki'I tt~+ar .

S tatemuats made dtuiag the prvmatfaaal audio maafexmcm idend.Ocd above ntln~,dtapc
serious M7 risk that may be asaodatc4 with Vloxx therapy. For ==pit, in your Jung , 2060, soma coofereoca you bets your diiwassioa of the Ml rates observed is the V10O11, study l y .apag·, "WbM you looked at the MY rate the tats was diQeeat t r the two grnops. Time MI rsrt= for Yi ~qac Was C 4 pntieot axtd if you looked at the Naproayst arm it wu 0 . t peecnt, sn than gait a redza Lind la )dts its the Neorasyn group." You this presextt yocs ezplanauan as to why the VIo= ttnatiz w aztm hM stn a i creased rare of MLs compared to the naprnxm rraemeat artm. Spcx:Zdiy, yon state that,

Vlore is a wonderl 1 . effectrtG selective COX-2 inhibitor that inhibits COX-2-tut to tbs d used does not inhabit COX-1 . So therefore without the COX-1 inhrbWoc yad.ddmt't hAft pUtelcts, you don't prolezta bleerfmg time and therefore it cannot he used its s cU40v>wcalr protective mg, Nspn nyu on the other hand is a woodcrvl platelet i )iibitar praloap
b! -gig C : c sad iababita p?atze=s :dent city w r~airi . Ob .-iausly the biaaaiag with k4gm tt . is rc"e_-sible and with aspirin is irtavorsibla , but the effcet on platelets and blaodk# thus is identical in team of its effect and thert(ore fuadimss as a woadertW drug for csrdio msl dff prapbylaxia . So basically the M1 ratej are in sync with wba : we know about Vim rod rlrt wt know about Naprozyn . in Pact, the situation is oat at all clear. Third are no adcgrieie sod wcU-enrolled atniiic, ofzxPrUx= that support your usernon that aaprozen' s transient lea ibition of platelet aggtegxdoit ft pbnrmocadyn tuicn1ly comparable to aspirin or ei .'niu,lly :T-ttvt in dccrasing tb risk of )d1s, TM^ftrt yo r,r-sc at; dor_ tbet ua,,ci x= prolongs bidding t;rc and itEM3 pleuzliU Wegdcta1y to aspirin is svslcadi_g, and rcai;aixes the poceacal scr o c: or LE L nding. Ar yep know. tba

Case 3:07-cv-05077-CRB

Document 1

Filed 10/02/2007

Page 15 of 19

JaN-25--2005 1 : :31

L ;P L

9108 P, 24

Raymond V . Gilmici n Marc & Co., inc. NAA 2l-0d2

Paige 4

r ssou for the diffcTncc be .we--r Vic= am nsproxee b et: not beta dctorndned; it is elan posaible did Viol 12S F-0--t i botic propenirs . Attu, the Mt rwo t11a1 you re par . for Vioxx·4 laect uritc the } 4I rata for Vioxt in the VIGOR stud)' we . 20 tvt:.s among 4047 pstieuL (0 .5%·), not 0 .4%j a3 you rtated. YOU Miaitai:. 6 n of the s :, C sous 0"w! 1rf1 ,-tcs oSse-,e1 iT, the Via L-G-ir. .r± of the . VIGOR trial is further reftdorctd in you: audio coati ences by your dsatssion oft . retxr dive aoal-yVls of this triiL For example, in your lime 21, 2000, audio anfemoce, you atate .hat, . . .Merck weal and pulled out they pmLtie is that again wt mrolkd in VIGOR. an4 Wed the question, who were those patients than rally needcd secondary ea rdlovudrlirpsophykxie frato the get go, and W, tssdcd ap bet ig four porccn of the study gioup jt (3'OF, *aad m wbctber they vas s prior MI, rttoke, TLS an one, CABCI m-TT^Ck- .Now if you look at ft rtstuinatg put of VIGOR, which is 96 pezeat of the VIC-0R pope or, aod'ciacc spigt looked far the MI rate baweaa Naprosya arid Vjosz, there's no stalistiaLl y ti . am difference in the M7 rite bctweeu Neprosyu and Vi= . In fact, I·Ian[otyu is 0,2 paced wW Vivxt it 0.1 per ccns. Your chap that the Mt tote for taprox:i outs 0 .2 pertcat Lad for Yox% ws b .1 Per'*W-jl wain inac tram Contrary to your claim that then was a higher rate of MB In the nupmxea : X tuci compered to for Vioxx group, the MI rue for Vwxz is this tubpopulaticu was 12 MIA emong 3&77 pdimats (0.1%) u t :ompued to 4 MIs among 3575 pitieat3 (0 .1%) for naproxer . Moreover, you agm mirk the V io z .z MX rare observed in the VIGOR trudy bi you aamprd is of this rate to the rate of kilo ob=ved for Cdebrea (cetxoYab) in the Cdebxcc Ingg-T.mra Arihxids Safety Study (CLASS) . For example, in yoar June 21, 2000 . audio con-re=ux y= de4xq "Now if ) resuasnbcr the crude MJ rate of Viol x in VIGOR that number was 0.d patens which I;s·bstsdtatlytbe mme or in feet s, link bit lass than the Cede Mt rain of Colebrex la CLASS whtctt is 6 .5 pa c u.1 Your ekaim that the MI testa o(v9ut e compared to Cot& :rx van b*sterttly the tR7 . br In ho a Ilsda bit less" is nolalading. You are paring MI rates from two d lifbrmt trials wino dWematpaLtcnt populadow. For eumplc, patience wbo had engine or coag s iTe hew kzihm with %xz Occurred at zest or minimal activity axed patience taking upirir, indudi g low-doss :(32S WC rite lad daily or ever other dry) or other antiptatelet Agcats (eg ., tfclopidine) were otaltded Onto tb. VlGOR . alai. The CLASS trial in coetrist, did not tcclude patients of ibis typo . Tho CLASS trill tbm my have includcdpatients at a higher risk for Ills . Mitva7ization of) ggx C rtid 6t Interaetla n Statemau made dario your proutntional audio wah.· satccs slam minimiz e the nsk .atVlttru therip in parents who etc taking *&-faria. For example, in your limo 16, 2000, sadlo (;6ufr>'r.ntx yea riatad that ". ._If you kvk at the thtumbocmbolic events it's very :tear that tope srdccdvv .cox-2 b9dbildaa have the benefit ofnot baring plarclet eggrcgaticm sod blecdiog time, and therofarv canbe bated tatf* in terms of post-up and with Ccxuaadln ." Your sutcment that Vioxx can be used safely wids vizc5aiia minIjrur es the prccsution In the PI that starts rhst, . .in poi--marketing tarpaicacr,, litcediageredb . have been reported, predormn-ty in the elderly, in assrctsaon with inerassees inptotbtutabin time M pencr ts nxeiving Vioxx coocucer t!y with c.'rfinn." Your promotion m =, r4L in g the-siak of using Vim and wufarui co :catty is psrticuloxty tranbluomc beectue Mack wr.s awwt of t purcatislly dar.geror:s drug in!c.actiou in 199 ;, wc1 bcrorc tb sc vdio wnfuucc oceoue d. In &Cis

Case 3:07-cv-05077-CRB

Document 1

Filed 10/02/2007

Page 16 of 19

;~ JAN-25-23 11 :33 L Ea F RD.

909 P, 25

Raymond V . Gilmara Mack & Co., Inc . NDA 21442

Page 5

M-rek begat dixse.-anarigg a revised ?I in October 1999, wbih i'nc)vdcd new informatioan about this risk . Tat =dausncss of this inteedan is ttrthtw minitrittd by your suggestion the: COXrZ·lnbibitous, ...,nsc it tree tai : beae5z afoot !laving plste'.et including Vio:c t, c:a oe ue ; safely wit: wr est be agg, talion and bler&,g time ." This clairr . implies that Viozx is =far than othaNS)i DS used in n combination with werfiu nL Howeve Viaz. he.s not be= studied in head-to-beid tills praap=tivdy desipa`i to assess this specific endpoint Your ; superiority claim is therefore taisles.dlag.

We note that anther in your Jtme 16,20M . prooaotianal 4n3io cumretmcc yw state, "a lt ran be used in people with Cowna6r,, sithough with Caumedie you've got o check thti M. thm atxd far days afo' you add the Cox inhibitor to the Couatadtn beeanse'tharc tray Sc i buaxp in the P 4P-* This diselosutc does not court the ovc . aU mislending message, baweve nor does it correct-your suogestoo that Viox is sxfcr that otbc NSAls in puicnts a dnt warfarin. Orirsion oflrnaorunt Risk Inform lio n
Your promotional au dio ean ferencea fail to pre= aeriow and vigxifcant risks usotisstexd viola Vioxz thespy. For e:. emple, your pr=&ionat asuiio eoaf.reoea Guy to a ;rtc that Viiotec is,cisritinttiar6dtad in padeiw who have expo eats.-d asthma, arti=in, or aitcrgic ·type rr_rcriorn zit r takii{p sisp4d or oaLax NSAIDa. You also fat to presetu the gastrciatnta ai (GI) waasiag about the posxabfltty arscriow GI toxicity such as blccdio;, eiceradoq or perforation in patients taJgng Vioxx. Moreover, you Cssi to prmeat Vioxz' s prm=6ans fur use in paiicnts who have liver cad kidney discos, snot l uA above patient populatia is in whidt Vioxx's use i s tot recoouneodcd. tech as wvweu in late ·pr Vw=y, and .brftumation about Vioxx's most common adverse events. !ip ibttan sated Swe ioritY Claim s You Bake several a thstntiated r.Darioriry claims for Vl axz tbrooghou: your praruotigad ssedga eouferenees . For --- 1c, in your Jtme 16, 2000, audio taonfereace, yce ci im turn;,, "'I c· pupa ce of (VIGOR and CLASS] L that tic data is ;osg to rcaUy help change I br iicvr the; pagaago cots for [Vioxz and Celearez) down the road became it really shown once again that they airs Wetthaa r st oidaia .' Your n: jearon that COX -2 iuhxblton, locdudi g Vlozz, have to overall! lei ypwE2. that is nrpc ri or to other NSAID !s mitrleadhi because such an advtauta g e her tsotbcei dananW*eod In tact, in the VIGOR study the incidence of serious adverse events was higher in ttta Yaoatat OrratmaeW jpmup than in the napro:et uutment group (93% and 1 .8% for Ytoxx and meptexea, tespectirr1y),

The results of safety anaiysa that were pre·specifd in the protocol for the VfGOILtr3t1, stick as CU . . related advessa events and discondnn*tlons due to cdaaa- tc!aied adverse events, he*c -dated
adverse events, bypertcnxioa-rciesul adverse events, utc =a-re'ud advers e events -,v00 on nwnericuily higher (in some cases statistically signJraody hither) in the Vioxx ft-VA pant soap than in tkt mprvzen ;: :: .rani group. Furtbetmorc, your delta that the VIGOP. and CUSS tYic1a show once again that they are mfrs than non-steroldals" is also misleading became it avspties that the res its of the VIGOR trial (i .e., patents ou Viorx had a significantly tower c'uinulativc irwidcoce ofl the than pa ic>;ts an naproxca) cal be applied w Ito enure class of NSAL t .
in your Juae ! 5, 2000, audio conferee : ycu s'stc, " . ._if you look it he thxacvboc .-nbalic eteoa it's vc:7 _Ic~ lbe : thci- COX-2 inhibitors have ti : : be c : o`ZOc',-aving pivte! ct a t3atipn and

Case 3:07-cv-05077-CRB

Document 1

Filed 10/02/2007

Page 17 of 19

.C5 JAN-25-2025 1. i 34 LEGAL . PEZOR

`n

P . iG

Raymond V, Gilmartin .Merck do Co ., Inc. ·NDA 21442 ble:d;ng time, and therefore, W. be used s3Scly is taro of post-on ad with Cotuuudia -" This ClAim . saggesu tlut Viozx is safe:, or h dJ fewe.· side effects, than oche NSAIDs used in tlu paitOp( : do aot al0cct platelet aggrcgstion and bleeding tiri »i Viop has tort setting b=us COX-2 ialubitgc. b= studied, bowevtr. , in head-to-head 66 prospectively desigoui to urea its sth y cusp red to other NS,+.ID3" in the post-opcr' ivc a tt~ng . Your supe.rioriry claim is thertfore misltxcli & F.>ither, t xampl es of your onsubstastiatcd superiority clz;ru include your ci im d4 "Iq less s ofbalf kit Vioxt has a holf life of 17 hours and is truly s ow-- a day drug, waeteas Cdcbc' train A baltlifs of 11 bows and is a BD (twice t day) drag- surest in your fuse 16, 2000, audio eonfcttflCC. Thus C6g0 is misleading beer uje tr sugg its that Celeorez mast be dosed twice a day for awls of its apptvvad iwficationi. In fact, Celcbroc is approvd for use etc r twice a day, or once & day, for the wamx= of is a "DID drug" u res ssleadiing. . osrcoarthritis . Tbcsufirr:, your claim It= Cel e Pramouon Cf Unaanroved Uses ' Your audio cnnlercarcs are misleadiag bcctuc they promote Viaxx for unvpprovedvFor sample, its yowr lone 21, 2000, coafarence, you claim that in the VIGOR study, " ._ .il}4 Viaxx SO milligrams a day r-sd the Naprosyry a gr7tm a day, we a lutdy gonlly offoctive brAooas of tasatixrg the panda with rbcet .atoid arthritic" Your claim is misleading be auso it mg,"-dsta,tbirt Vlcoiz b c ve for the tren7mmt olzbeornstoid aNuitis when this ban oot been drsaonatrsbod., Do VIC3OR study was not d--Recd to assets the efficacy CIVIC= for the treatment of rheumatoid artaid Tow claim chit Via= is "absohutdy oquafy effe;tint:" to uprozen in acarias patieatt with tl iammatoid arthritis is also misleading because this boa not been deruoasnvted by adequire and vel3weta mDW clinical seadies, sad because the VIGOR study wu not capable of -messing tbeu comparative c6'cctivenas. Your promotional audio cat ierences are als . t misleading because they susscst th t VWitkig stafs aaad affective for other unapproved uses such as the prevctdoo of c nc and irmssive csgcrr, a d 1artha treatancar of Alzheimer' s dlseasc And gout L zn plcs of c Minims that promote Vioxi fos' ttngiproved uses, ino&udc, but art not limited to, your cl zi s is your lure 16, 2000 audio confaunco il: " . . .COX·2 tea to be abIc to ; nrcfcte wit's . . _acngr mad r_$ desalt. Themfoce, you'get this increased cr11 wth which all.owz polpe to form, cancer and then invutve esncet. And by blodoing COX-2 you csc ac-ma y prevent the de elopmeat of colon polyps , cancer and invasive erects.' Additional pl xAW ( cs include your claims that "So we tried it (Ywssj Oar Vitrex was teetIs' ad really within one or two plus acute Acts ks of gout were being shut down." and '"Specifically, ifyott looked at potential uses of these drags, the mast exciting ngbt now I goers In two alto, am is Alzbtvace s disease- . . . "

Press Releas e
We hay : identified a Merck prat release entitle{, "Merck Can6 .'7n3 Favar2blo Calth4 a az1 Witty Profile cf Vioxr,," dated Map 22, 2001, that is aso false or misleading for nrnilar rtalt' s rtttttrsi aboyg,, Additionally, your claim in the press rclcase that V;oxz has a "Sverabue cardiovucasti ta,fttypat f
is simply ieeosnnrehensibtc, Ltiven the rate ofMT .ud sccioua cudlvvucuJar meets pee -wad to napraxto . The Implication char Vlouck's cariiovascvlar prot.le is superior to ocher NSATJs is misteAding it fact, serious eardiovz3 :alar c',ei s' c twice u frwi ant in the VIOX.C t;attencat group ( ;,I ; events, 2 .5%.) ·s in tie naoraxrs treaLncnt group'4t evcnu, I . . ",~) ^ ttrel!IGOStattuty.

Case 3:07-cv-05077-CRB

Document 1

Filed 10/02/2007

Page 18 of 19

JPN--25-2605

. 11 :34 L -E G!L RT .,,=.a

'

. P· 27

Raymond V . Gdilm:.tia Merck & Co ., inc . NDA 21-04 2
Cr Z1

Palo 7

Rep : ue~tatl ons

Merck sn!cs rprtsentativ= have engages it raise o- misleading pyomotior el : ctivities tune also minimize the poteatielly s :rioui MI result: observed in the VIGOR trial . Spc66cn11y; Mes* yaks reprusentarive4 made take ormisie ding ustematls to DDMAC reviewer it two di faraot professional mcatings . At your exhibit booth dmiag the 119" A=ual Moth of the Mitryland Pha nx6tu Anodatiou (1 PbA), it facet Ciry, Msrykttd, Jano 9 - line 12, 200I . yt r reyresrptstive sated that the increased 1C racy Seer; in patiwnts an Vtozx in the VIGOR snsdy is be tto the fad ( bat naproxca worsra juz like sspitin (ie, inhibits clotting .id ptateie agicgitioo} IV addieor; during the Auoaal Mcsnng of the Amcnc= Society ofHealt)-Syslcma Pbars pa (AI=, In Us Angeles, California, June 3 - itme 6, 2001, ycu rCpreccrative a tatod that Vbd=bad s Scadw Ml rat e tc the VIGOR trial bcnawc uapraxe t is at rdi.opt-jeectivr, havigg plaids! a FE- -1 sbnax to aspirin- Thes : sL,Jemata made by your Bala re rrseotativc arc mia 1ez4ng for the tam mp Dazed above

Concluxiorra and Requested Actiu m
Tn: promotions: activities and materials ddxcnbed above toinioiiz e the pa(caWally se iaus esrdiov2cuta findings that wee observed in the VIGOR, study, mixi~ (be Vic, '% C a s &m cscus iattnrzlon. omit crucial tick itlforsnatien sssoantcd with Via= therapy, vcmosin urisz ed camparativt claims, and promote unapproved Uses. On Dce fiber 16, 1999, we slag owamd b soar d .:,,,±* atiou of promotional matcria]a for Vim= tun : tmisrcprrsestted Vionz's saFady¢ro6le. card umvbsuntiatcd eaviparztwe claim, and Iackad fair belane a

Due to the sedousaas of alaesc violations , and the fact that your viaLative pttunotion -ofyi-Q t hats coutiiaued densitc our priar vmaea aod5auion regudsng siulilar vioLi ons , we mg(tsse thauty ttu ptvvidc a doaiiled r sponge to the issum raised in this Wamm% bite r on or befccaAcivber I .100l . ';"hit tccpouse sbaaid coot" an action pl an that mantis a ccAOpmheusive plan to dissimiertlr eorrectlvs tacsssages about the issues disasse+d in this letter lai th e ani ma a that neeeivsd tbeaa mislcstdiag Messages . 7 r ccrectve acrion plaasbould also ia cfud= l»uvediaLE ) y ceasing all violative promotional actlvft ) ri . and the dissaaioat; ott of iotativo promotional tustcriaLs for Via=2. lmring a 'Des; Bei1thexre provide{ lcticr to wat ::~t false or xnialeading itaptes ' os't4od infonnatiort This pm posed ;ester should be subraitic ,' to u for review prior to itx·srfezsa , Alter agrxmser-t is sr3cbed on the toot gad gudicrca , the letter should be dlaae~tpaitcd ydlity~maul to all heaJthcsre providers who wen, or o:ay have been rxposod to the riotative ps'ttbnoltozi.

3 . A written statement ofycur intent to cowpiy with "?" zs:d °2." tbove . Your writtco rmponst should L c rcccivai no Jet - t han pctcb 1, 22'01 . ii you 11ava airy goc*4otos or carnments, ploasc contact Leslcy Frik, Pb1), ID, by l crimfc at (301 ) 594--6771, drat-the Food essd DesE Adntinistri ri , Divisiou o : Drug M rketmg. Adv sin ; and Coouounicuion 1 WD .4Z .1Ctn .
3 79-20, 5600 Funcx Large, Rock' iilo, MI) 20857 . We runicd you that only whiles comnmrdeaa6o at eom ;do ez ofl vial .

Case 3:07-cv-05077-CRB

Document 1

Filed 10/02/2007

Page 19 of 19

JAN-2S-20a5 11! 35

LcGRL FF ;GRJS

908 P . 28

R,ayntond V. Gilmar tin Muck Sc Co., Inc . , NDA 21-042

hP _

In all future eorretpoodence rsga^ding this p.. tmcut;r mattes, plwa rifer to MAO &S 1) 9456 in addition to the NDA cu iber_

The vialouow disc=ussed in this tease do not nee wily eoastie tc an czbanstive tit We am contiaui g to eveluetc other espec s of your promodonal c=paige for Yioxr_gad qiiy ddamin 69 additional rt cdiai mcasages will be necessary to fully carrec the false or roide4diag nsaafptst tcwliing thorn your vial arava conduc t Fsilwr to respond to this letter may rtistt in reau .luo ry action, inc!ading seisms or ajuaetioo. wWwd 5trt cr notice.

Sincerely, (See appended dsctrorricrig> rd 1 pd v) Thomas W. Abrams, R-Ph., 2v1 A pirctior Division of Dmg Msr riding, : r Advertising, said [-·,.,·,,*,*+intie~i

I