Case 1:13-cv-00278-HSO-RHW Document 1 Filed 07/01/13 Page 1 of 18 SOUTHERN INSTRICT OF MISSISSII FILED UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF MISSISSIPPI JUL 01 2013 SOUTHERN DIVISION T NOEILIN CLERK BY DEP SANDRA SANDERSON HAVENS, CASE NO. 1 1, 1.0 VI7IMOO Plaintiff, COMPLAINT VS. Product Liability Failure to Warn; Negligence; Product Liability Breach of Implied Warranty; Fraud; Constructive Fraud; Unjust Enrichment; PFIZER INC., Loss of Consortium, Punitive Damages Defendant. DEMAND FOR JURY TRIAL The Plaintiff Sandra Sanderson Havens ("Plaintiff'), residing at 1909 Summerlin Bayou Road, Vancleave, Mississippi in the county of Jackson, by and by through her undersigned attorneys, hereby sues the Defendant, Pfizer, Inc. ("Defendant" or "Pfizer"), which has its principal place of business at 235 East 42nd Street, New York, New York 10017, and alleges as follows: BACKGROUND I. This is an action for damages suffered by Plaintiff as a direct and proximate result of Defendant's negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, and/or sale of LIPITOR (also known as ATORVASTATIN CALCIUM and at times referred to as herein as "the subject product"). PARTIES 2. Plaintiff is a natural person and citizen of the United States, residing in Jackson County in the State of Mississippi. 3. At all times relevant to this action, Plaintiff Sandra Sanderson Havens was and remains a resident and citizen of Vancleave, Jackson County, in Mississippi. Thus, Jackson
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Case 1:13-cv-00278-HSO-RHW Document 1 Filed 07/01/13 Page 1 of 18
SOUTHERN INSTRICT OFMISSISSII
FILEDUNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF MISSISSIPPI JUL 01 2013SOUTHERN DIVISION
T NOEILIN CLERK
BY DEP
SANDRA SANDERSON HAVENS, CASE NO. 1 1,
1.0 VI7IMOOPlaintiff, COMPLAINT
VS. Product Liability Failure to Warn; Negligence;Product Liability Breach of Implied Warranty;Fraud; Constructive Fraud; Unjust Enrichment;
PFIZER INC., Loss of Consortium, Punitive DamagesDefendant.
DEMAND FOR JURY TRIAL
The Plaintiff Sandra Sanderson Havens ("Plaintiff'), residing at 1909 Summerlin Bayou
Road, Vancleave, Mississippi in the county of Jackson, by and by through her undersigned
attorneys, hereby sues the Defendant, Pfizer, Inc. ("Defendant" or "Pfizer"), which has its
principal place of business at 235 East 42nd Street, New York, New York 10017, and alleges as
follows:
BACKGROUND
I. This is an action for damages suffered by Plaintiff as a direct and proximate result
of Defendant's negligent and wrongful conduct in connection with the design, development,
manufacture, testing, packaging, promoting, marketing, distribution, labeling, and/or sale of
LIPITOR (also known as ATORVASTATIN CALCIUM and at times referred to as herein as
"the subject product").
PARTIES
2. Plaintiff is a natural person and citizen of the United States, residing in Jackson
County in the State ofMississippi.
3. At all times relevant to this action, Plaintiff Sandra Sanderson Havens was and
remains a resident and citizen of Vancleave, Jackson County, in Mississippi. Thus, Jackson
Case 1:13-cv-00278-HSO-RHW Document 1 Filed 07/01/13 Page 2 of 18
County, Mississippi, is where Plaintiff is domiciled and where Plaintiff Sandra Sanderson
Havens continues to reside.
4. At all times herein mentioned, Defendant was and is a corporation existing under
the laws of incorporation of the State of Delaware, with its principal place of business in New
York, New York, and doing business within this judicial district.
5. At all times herein mentioned, Defendant Pfizer, in interstate commerce and in
this judicial district, advertised, promoted, supplied, and sold to distributors and retailers for
resale to physicians, hospitals, medical practitioners, and the general public a certain
pharmaceutical product, LIPITOR.
JURISDICTION AND VENUE
6. This Court has jurisdiction over Defendant and this action pursuant to 28 U.S.C.
1332 because there is complete diversity of citizenship between Plaintiff and Defendant and
because the amount in controversy between Plaintiff and Defendants exceeds $75,000, exclusive
of internets and costs, and because, among other reasons, Defendant has significant contacts with
this district by virtue of doing business within this judicial district.
7. Venue is proper within this district pursuant to 28 U.S.C. 1391 because Plaintiff
resides in this district and because a substantial part of the acts and/or omissions giving rise to
these claims occurred within this district.
FACTUAL ALLEGATIONS
8. At all times herein mentioned, Defendant, by and through its agents, servants,
and/or employees failed to adequately warn physicians and consumers, including Plaintiff herein,
of the risk of developing diabetes from LIPITOR.
2
Case 1:13-cv-00278-HSO-RHW Document 1 Filed 07/01/13 Page 3 of 18
9. LIPITOR is an HMG-CoA reductase inhibitor and a member of the drug class
known as statins.
10. LIPITOR is prescribed to reduce the amount of cholesterol and other fatty
substances in the blood.
11. Parke-Davis Pharmaceutical Research, a division of Warner-Lambert Company,
obtained approval from the Food and Drug Administration ("FDA") to market LIPITOR on
December 17, 1996. Warner-Lambert entered into a co-marketing agreement with Pfizer to sell
LIPITOR, and thereafter those companies began distributing and selling LIPITOR throughout
the United States in 1997. On June 19, 2000, Pfizer acquired Warner-Lambert and all rights to
LIPITOR.
12. Despite its knowledge of data indicating that LIPITOR is causally related to the
development of type 2 diabetes and/or blood glucose levels diagnostic for type 2 diabetes, Pfizer
promoted and marketed LIPITOR as safe and effective for persons such as Plaintiff Sandra
Sanderson Havens in the United States as well as in this judicial district.
13. On August 11, 2011, the Division of Metabolism and Endocrinology Products of
the FDA requested that Defendant make labeling changes for LIPITOR based upon the FDA's
comprehensive review, including clinical trial data.
14. In February 2012, in response to the FDA's request, Pfizer added the following
language to its Warnings and Precautions Section: "Increases in HbAl c and fasting serum
glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR."
15. Until the February 2012 change, LIPITOR's label had never warned patients of
any potential relation between changes in blood sugar levels and taking LIPITOR.
3
Case 1:13-cv-00278-HSO-RHW Document 1 Filed 07/01/13 Page 4 of 18
16. Despite the February 2012 label change, LIPITOR's label continues to fail to
warn consumers of the serious risk of developing type 2 diabetes when using LIPITOR.
17. At all times material hereto, Defendant knew or should have known that the risks
of LIPITOR included the severe and life-threatening complications of type 2 diabetes.
18. At all times material hereto, Defendant, by and through its agents, servants, and/or
employees, negligently, recklessly and/or carelessly marketed, distributed, and/or sold LIPITOR
without adequate instructions or warnings of the drug's serious side effects and unreasonably
dangerous risks.
19. Plaintiff Sandra Sanderson Havens was prescribed LIPITOR and used it as
directed, starting in or around December 20, 2009.
20. Plaintiff was prescribed LIPITOR to lower her levels of low-density lipoprotein
("LDL") and as a primary prevention measure to decrease her risk of developing cardiovascular
disease ("CVD").
21. Plaintiff was healthy prior t o taking LIPITOR. She was physically active,
adhered to a healthy diet, and maintained a healthy weight.
22. In keeping with her healthy and proactive lifestyle, Plaintiff agreed to initiate
LIPITOR treatment in an effort to reduce her risk of developing heart disease. She relied on
claims made by Pfizer that LIPITOR has been clinically shown to reduce the risk of developing
heart disease.
23. Despite her healthy weight and diet, Plaintiff developed type 2 diabetes after
initiating her LIPITOR treatment.
24. Plaintiff was diagnosed with type 2 diabetes in or about April 6, 2012. As a result,
for the rest of her life she must undergo regular testing of her blood glucose levels, adhere to a
4
Case 1:13-cv-00278-HSO-RHW Document 1 Filed 07/01/13 Page 5 of 18
restrictive diabetic diet, and take medication to control her diabetes. Due to her diabetes, she is
now at markedly increased continued risk of heart disease, blindness, neuropathy, and kidney
disease.
25. Had Defendant properly disclosed the risks associated with LIPITOR, Plaintiff
would have avoided the risk of diabetes by either not using LIPITOR at all or by closely
monitoring her blood glucose levels to see if the drug was adversely affecting her metabolism.
26. As alleged herein, as a direct, proximate, and legal result of Defendant's
negligence and wrongful conduct, and the unreasonably dangerous and defective characteristics
of the drug LIPITOR, Plaintiff suffered severe and permanent physical and emotional injuries,
including, but not limited to type 2 diabetes. Plaintiff has endured pain and suffering, has
suffered economic loss, including incurring significant expenses for medical care and treatment,
and will continue to incur such expenses in the future. Plaintiff seeks actual and punitive
damages from Defendant as alleged herein.
27. Plaintiff did not discover, nor did she have any reason to discover her diabetes
was a result of a defective product and/or the wrongful conduct of Defendant, as set forth herein,
until at least sometime in or about April of 2013.
COUNT ONE[Product Liability- Failure to Warn]
28. Plaintiff hereby incorporates by reference as if fully set forth herein, each and
every allegation contained in paragraphs 1 through 27 above.
29. Defendant has engaged in the business of selling, distributing, supplying,
manufacturing, marketing, and/or promoting LIPITOR, and through that conduct has knowingly
and intentionally placed LIPITOR into the stream of commerce with full knowledge that it
reaches consumers, such as Plaintiff, who ingested it.
5
Case 1:13-cv-00278-HSO-RHW Document 1 Filed 07/01/13 Page 6 of 18
30. Defendant did in fact sell, distribute, supply, manufacture, and/or promote
LIPITOR to Plaintiff and to her prescribing physicians. Additionally, Defendant expected the
LIPITOR that it was selling, distributing, supplying, manufacturing, and/or promoting to reach-
and LIPITOR did in fact reach- prescribing physicians and consumers, including Plaintiff and
her prescribing physicians, without any substantial change in the condition of the product from
when it was initially distributed by Defendant.
31. At all times herein mentioned the aforesaid product was defective and unsafe in
manufacture such that it was unreasonably dangerous to the user, and was so at the time it was
distributed by Defendant and ingested by Plaintiff. The defective condition of LIPITOR was due
in part to the fact that it was not accompanied by proper warnings regarding the possible side
effect of developing diabetes as a result of its use.
32. This defect caused serious injury to Plaintiff, who used LIPITOR in its intended
and foreseeable manner.
33. At all times herein mentioned, Defendant had a duty to properly design,
Case 1:13-cv-00278-HSO-RHW Document 1-1 Filed 07/01/13 Page 1 of 1
JS 44 (Rev. 12/12) CIVIL COVER SHEETThe iS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service ofpleadings•or o er pape1Ts requ ed byt1 VT, exce t asprovided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk ofCourt for thepurpose of initiating the civil docket sheet. (SEE INSTRUCTIONSONNEXTPAGE OF THIS FORM)
I. (a) PLAINTIFFS DEFENDANTSSandra Sanderson Havens PFIZER, INC.
(b) County of Residence of First Listed Plaintiff Jackson County, MS County of Residence ofFirst Listed Defendant New Castle. DE(EXCEPT IN US. PLAINTIFF CASES) (INUS. FFCASES ONLY
NOTE: IN LAND CONDEMNATHE TRACT OF LAND OLVED 1 I rt
(c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (IfKnown)Davis & Crump, P.C. JUL 01 20131712 15th StreetGulfport, MS 39501
J T NoBLIN cum(
IL BASIS OF JURISDICTION (Place an "X" in One Box Only) Iii. CITIZENSHIP OF PRINCI -1146------7.-7—• :oxforPlainqf(For Divenity Cases Only) and One Boxfor Defendant)
O 1 U.S. Government 0 3 Federal Question PTF DEF PTF DEFPlaintiff (US Government Not a Parry) Citizen ofThis State X 1 CI 1 Incorporated or Principal Place 0 4 0 4
of Business In This State
0 2 U.S. Government X 4 Diversity Citizen of Another State 0 2 0 2 Incorporated ondPrincipal Place 0 5 X 5Defendant. (Indicate Citizenship ofParties in Item III) of Business In Another State
Citizen or Subject of a 0 3 CI 3 Foreign Nation 0 6 0 6
IV. NATURE OF SUIT (Place an "X" in One Box Only)
O 110 Insurance PERSONAL INJURY PERSONAL INJURY il 625 Drug Related Seizure 0 422 Appeal 28 USC 153 0 375 False Claims AuO 120 Marine 0 310 Airplane CP 365 Personal Injury of Property 21 USC 881 0 423 Withdrawal 0 400 State ReapportionmentO 130 Miller Act 0 315 Airplane Product Product Liability CI 690 Other 28 USC 157 0 410 AnntrustO 140 Negotiable Instrument Liability XI 367 Health Care/ 0 430 Banks and BankingO 150 Recovery of Overpayment 0 320 Assault, Libel & Pharmaceutical mom )1 rte3...I T.E I e t.:. 0 450 Commerce
& Enforcement ofJudgment Slander Personal Injury 0 820 Copyrights 0 460 DeportationO 151 Medicare Act 0 330 Federal Employers' Product Liability CP 830 Patent 0 470 Racketeer Influenced andO 152 Recovery ofDefaulted Liability CI 368 Asbestos Personal CI 840 Trademark Corrupt Organizations
O 153 Recovery ofOverpayment Liability PERSONAL PROPERTY 0 710 Fair Labor Standards 0 861 HIA (1395ff) CI 850 Securities/Commodities/of Veteran's Benefits 0 350 Motor Vehicle 0 370 Other Fraud Act CI 862 Black Lung (923) Exchange
CI 160 Stockholders' Suits 0 355 Motor Vehicle 0 371 Truth in Lending 0 720 Labor/Management 0 863 DIWC/DIWW (405(g)) CI 890 Other Statutory ActionsO NO Other Contract Product Liability 0 380 Other Personal Relations 1 864 SSID Title XVI CI 891 Agricultural ActsO 195 Contract Product Liability 0 360 Other Personal Property Damage 0 740 Railway Labor Act 0 865 RSI (405(g)) 0 893 Environmental MattersO 196 Franchise Injury 0 385 Property Damage 0 751 Family and Medical CI 895 Freedom ofInformation
0 362 Personal Injury Product Liability Leave Act ActMedical Mal iractice 0 790 Other Labor Litigation CI 896 Arbitration
8X8C4REaff,,9111,fini.lan!trarLi al t i ".‘ranuta z:rz.7175ttlia. ^.3` I II CI 791 Employee Retirement MI'''=”:17:4IM D 899 Administrative Procedure0 210 Land Condemnation 0 440 Other Civil Rights Habeas Corpus: Income Security Act 0 870 Taxes (U.S. Plaintiff Act/Review or Appeal ofEl 220 Foreclosure 0 441 Voting 0 463 Alien Detainee or Defendant) Agency Decision0 230 Rent Lease & Ejectment CI 442 Employment CI 510 Motions to Vacate 0 871 IRS—Third Party 0 950 Constitutionality ofO 240 Torts to Land (7 443 Housing/ Sentence 26 USC 7609 State Statutes0 245 Tort Product Liability Accommodations CI 530 GeneralO1 290 Alt Other Real Property 0 445 Amer. w/Disabilities CI 535 Death Penalty i'l':.4ilLAWIIIG.CATIQKLigg.14
Employment Other: 0 462 Naturalization Application0 446 Amer. w/Disabilities 0 540 Mandamus & Other 0 465 Other Immigration
Other CI 550 Civil Rights Actions0 448 Education CI 555 Prison Condition
0 560 Civil DetaineeConditions ofConfmement
V. ORIGIN (Place an "X" in One Box Only))11 1 Original 0 2 Removed from 0 3 Remanded from 0 4 Reinstated or 0 5 Transferred from 0 6 Multidistrict
Proceeding State Court Appellate Court Reopened Another District Litigation
the U.S. Civil Statute under which you are filing (Do not cite jurisdktionalstatutes unless diversity):VI. CAUSE OF ACTION.13rief description of cause:
Lipitor pharmaceutical personal injury product liability claimVII. REQUESTED IN 10 CHECK IF THIS IS A CLASS ACTION DEMAND CHECK YES only ifdemanded in complaint:
COMPLAINT: UNDER RULE 23, F.R.Cv.P. JURY DEMAND: )51 Yes CI No