IN THE UNITED STATES DISTRICT COURT

FOR THE MIDDLE DISTRICT OF ALABAMA

NORTHERN DIVISION

Robert Blankenship,

Plaintiffs,

v.

Pfizer, Inc.; Boehringer Ingelheim Pharmaceuticals, Inc.; David Rohling; Kmart of Michigan, Inc.; Art Redding; Kelli Strange; “A”, that person, corporation or other legal entity who designed, manufactured, sold, distributed and failed to warn of the 

potential complications associated with the use of the drug Mirapex; “B”, that person, corporation or other legal entity who failed to provide adequate warnings with respect to the complications associated with the use of the drug Mirapex; “C”, that person, corporation or other legal entity who provided information to treating physician or Robert Blankenship; “D” that person, corporation or other legal entity who failed to adequately warn Mr. Blankenship’s treating physician of the complications associated with the use of the drug Mirapex; “E”, that person, corporation or other legal entity who filled the prescription for Robert Blankenship for the drug Mirapex and failed to warn of the complications associated with use of the drug; “F”, that person, corporation or other legal entity who’s negligence, wantonness or other wrongful conduct combined with the negligence, wantonness or other 

wrongful conduct of other defendants to 

cause the damages alleged herein, all of said fictitious defendants are unknown 

to Plaintiff at this time but will be 

substituted by amendment when ascertained,

Defendants.

CIVIL ACTION NO.

2:06-cv-0648-VPM

Case 2:06-cv-00648-MHT-VPM Document 2 Filed 07/21/2006 Page 1 of 19
- 2 - ANSWER AND REQUEST FOR JURY TRIAL

Defendant Pfizer Inc. (incorrectly identified as “Pfizer, Inc.”), by its

undersigned counsel, hereby answers plaintiff’s Complaint in the above-captioned 

action (“the Complaint”) and asserts its affirmative and other defenses as follows:

STATEMENT OF THE PARTIES

1. Defendant is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 1, and therefore denies the

same.

2. Defendant admits that it is a U.S. corporation with its principal place

of business located in New York, New York and is authorized to do business in

Alabama. Defendant denies the remaining allegations of paragraph 2.

3. The allegations in Paragraph 3 are not directed to Defendant and, therefore, no response is required.

4. The allegations in Paragraph 4 are not directed to Defendant and, therefore, no response is required.

5. The allegations in Paragraph 5 are not directed to Defendant and, therefore, no response is required.

6. The allegations in Paragraph 6 are not directed to Defendant and, therefore, no response is required.

7. The allegations in Paragraph 7 are not directed to Defendant and, therefore, no response is required.

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8. The allegations in Paragraph 8 are not directed to Defendant and, therefore, no response is required.

9. The allegations in Paragraph 9 are not directed to Defendant and, therefore, no response is required.

10. The allegations in Paragraph 10 are not directed to Defendant and, therefore, no response is required.

11. The allegations in Paragraph 11 are not directed to Defendant and, therefore, no response is required.

12. The allegations in Paragraph 12 are not directed to Defendant and, therefore, no response is required.

13. The allegations in Paragraph 13 are not directed to Defendant and, therefore, no response is required.

STATEMENT OF THE FACTS

14. Defendant is without knowledge or information to form a belief as to

the truth of the allegations in paragraph 14, and therefore denies the same.

15. Defendant admits that Mirapex is the trade name for pramipexole

dihydrochloride. Defendant admits that Mirapex is indicated for the treatment of

the signs and symptoms of idiopathic Parkinson’s Disease. Defendant denies the

remaining allegations in paragraph 15. 

16. Defendant denies the allegations in paragraph 16.

17. Defendant admits that Mirapex belongs to the class of medications

known as dopamine agonists. Defendant admits that Parkinson’s Disease is a 

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chronic progressive neurological disease, and further states that the medical

symptoms, conditions or treatment of the disease have been described in the peer

reviewed medical literature. Defendant admits Mirapex binds with certain

dopamine receptors. Defendant denies the remaining allegations in paragraph 17. 

18. Defendant denies the allegations in paragraph 18. 

19. Defendant denies the allegations in paragraph 19. 

20. Defendant denies the allegations in paragraph 20. 

21. Defendant denies the allegations in paragraph 21 

22. Defendant denies the allegations in paragraph 22. 23. Defendant denies the allegations in paragraph 23. 

24. Defendant is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 24 regarding Mr. Blankenship’s prescribing physicians. Defendant denies the remaining allegations

in paragraph 24.

25. Defendant is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 25 regarding Mr. Blankenship’s wealth and gambling history, and therefore denies same.

26. Defendant is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 26 regarding Mr. Blankenship’s gambling, and therefore denies same.

Case 2:06-cv-00648-MHT-VPM Document 2 Filed 07/21/2006 Page 4 of 19
- 5 - COUNT ONE

(Alabama Extended Manufacturer’s Liability Doctrine [AEMLD])

27. Defendant incorporates its responses to paragraphs 1-26 of the

Complaint as if fully set forth herein.

28. Defendant denies the allegations in paragraph 28, except admits that it

jointly promoted and marketed Mirapex with BIPI in the United States from July

1997 until May 2005 and manufactured Mirapex for BIPI.

29. Defendant denies the allegations in paragraph 29. 

30. Defendant denies the allegations in paragraph 30.

31. Defendant denies the allegations in paragraph 31.

32. Defendant denies the allegations in paragraph 32.

COUNT TWO

(Negligence)

33. Defendant incorporates its responses to paragraphs 1-32 of the

Complaint as if fully set forth herein

34. Defendant denies the allegations in paragraph 34.

35. Defendant is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 35 regarding Defendant

Rohling, and therefore denies same. 

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36. Defendant is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 36 regarding Defendants

Kmart, Redding and Strange, and therefore denies same. 

37. Defendant denies the allegations in paragraph 37.

COUNT THREE

(Wantonness)

38. Defendant incorporates its responses to paragraphs 1-37 of the

Complaint as if fully set forth herein

39. Defendant denies the allegations in paragraph 39.

40. Defendant is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 40 regarding Defendant

Rohling, and therefore denies same. 

41. Defendant is without knowledge or information sufficient to form a

belief as to the truth of the allegations in paragraph 41 regarding Defendants

Kmart, Redding and Strange, and therefore denies same.

42. Defendant denies the allegations in paragraph 42.

COUNT FOUR

(Fraud)

43. Defendant incorporates its responses to paragraphs 1-42 of the

Complaint as if fully set forth herein

44. Defendant denies making any misrepresentations and otherwise

denies the allegations in paragraph 44.

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45. Defendant denies the allegations in paragraph 45, except it admits it

had, at various times, duties related to Mirapex pursuant to a regulatory scheme

established by the United States Food and Drug Administration (“FDA”). 

46. Defendant denies making any misrepresentations and otherwise

denies the allegations in paragraph 46.

47. Defendant denies making any misrepresentations and otherwise

denies the allegations in paragraph 47.

48. Defendant denies making any misrepresentations and otherwise

denies the allegations in paragraph 48.

GENERAL DENIAL

Defendant denies all allegations and/or legal conclusions set forth in the

Complaint that have not previously been specifically admitted, denied or

explained.

AFFIRMATIVE AND OTHER DEFENSES

Without assuming the burden of proof of such defenses that it would not

otherwise have, in further response to the Complaint, Defendant pleads the

following affirmative and other defenses:

1. The Complaint fails to state a claim against Defendant upon which

relief can be granted.

2. The claims asserted in the Complaint are barred, in whole or in part, because Mirapex is comprehensively regulated by the FDA pursuant to the Federal

Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., and

regulations promulgated thereunder, and plaintiff’s claims conflict with the FDCA,

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- 8 - with the regulations promulgated by the FDA to implement the FDCA, with the

purposes and objectives of the FDCA and the FDA's implementing regulations, and with the specific determinations by the FDA specifying the language that

should be used in the labeling accompanying the products. Accordingly, plaintiff’s 

claims are preempted by the Supremacy Clause of the Constitution of the United

States, Article VI, clause 2, and the laws of the United States, including but not

limited to the FDCA and the regulations promulgated thereunder. Alternatively, Defendant is entitled to a presumption based on the FDA’s approval of Mirapex

that the product is not defective or unreasonably dangerous.

3. The conduct of Defendant in all activities with respect to Mirapex has

been and is under the supervision of the FDA and its Division of Drug Marketing, Advertising and Communications, which are charged with regulating prescription

drug product labeling, advertising and promotions. Thus, this action is barred by

the doctrine of primary jurisdiction and exhaustion of administrative remedies.

4. The claims asserted in the Complaint are barred, in whole or in part, by the doctrine of abstention, in that the common law gives deference to

discretionary actions by the FDA under the FDCA.

5. Plaintiff's injuries and damages, if any, may be due to idiosyncratic

reactions to Mirapex for which Defendant cannot be held responsible.

6. The claims set forth in the Complaint are barred because plaintiff’s

alleged injuries and damages, if any, may have been actually or proximately

caused or contributed to be caused by an act, omission of fault or by an intervening 

or superseding act of some person, entity or third party other than Defendant

and/or for whom Defendant is not legally responsible.

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7. The claims set forth in the Complaint are barred because the alleged

injuries and damages, if any, may have been caused by medical conditions, disease, illness or processes (whether pre-existing or contemporaneous) unrelated

to Mirapex.

8. The methods, standards, and techniques utilized with respect to the

manufacture, testing, design, and marketing of Mirapex, if any, including adequate

warnings and instructions with respect to the product’s use included in the

product’s package insert and other literature, conformed to the generally

recognized, reasonably available and reliable state of the knowledge at the time the

product was designed, tested, manufactured, and marketed.

9. The claims set forth in the Complaint are barred because the

foreseeable therapeutic benefits of Mirapex outweighed any foreseeable risks of

harm.

10. The claims set forth in the Complaint are barred under the doctrine of

estoppel, waiver, ratification, laches, unclean hands and by the applicable statutes

of limitations and/or repose and other related doctrines and principles or any one of 

them, and by plaintiff’s inequitable conduct, lack of diligence, delay and

inattention in pursuing such claims.

11. The claims set forth in the Complaint may be barred by the doctrine of 

informed consent and assumption of risks because plaintiff may have knowingly

and voluntarily assumed the risk of injury.

12. To the extent applicable, Defendant is entitled to contribution from

any person and/or entity whose negligence or other fault contributed to plaintiff’s

alleged injuries and damages.

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13. To the extent plaintiff obtains recovery in any other case predicated

on the same factual allegations, plaintiff is barred from seeking recovery against

Defendant based on the Complaint pursuant to the doctrines of res judicata and

collateral estoppel, and the prohibition on double recovery for the same injury.

14. The acts of Defendant alleged in the Complaint were not the direct

and proximate cause of any injury or damage to plaintiff.

15. The claims asserted in the Complaint are barred, in whole or in part, because plaintiff lacks an adequate scientific basis to demonstrate any resulting

harm or increased risk of future harm as a result of plaintiff’s alleged Mirapex use.

16. The claims asserted in the Complaint are barred, in whole or in part, because Mirapex was not unreasonably dangerous or defective, was suitable for the 

purpose for which it was intended, and was marketed with adequate and sufficient

warnings.

17. To the extent the claims asserted in the Complaint are based on a

theory providing for liability without proof of causation, the claims violate

Defendant’s rights under the Constitution of the United States and analogous

provisions of the applicable state constitution.

18. Plaintiff’s claims for damages may be barred, in whole or in part: (1)

because plaintiff failed to mitigate any damages, and such failure to mitigate

damages should proportionately reduce plaintiff’s recovery and the allocation of

any fault, if any exists, attributable to Defendant; (2) because plaintiff would be

unjustly enriched if allowed to recover any portion of the damages alleged in the

Complaint; (3) because the damages sought are speculative and remote and

because of the impossibility of ascertaining and allocating those alleged damages;

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(4) because plaintiff has failed to identify any purported injuries or damages with

sufficient particularity; and (5) the Complaint fails to state facts sufficient to

sustain a claim for, or recovery of, punitive damages.

19. To the extent punitive damages are sought, plaintiff’s punitive

damages claims against Defendant: (1) have no basis in law or fact; (2) cannot be

sustained in that the allegations of the Complaint are legally insufficient to support

a claim for punitive damages against Defendant; (3) cannot be sustained because

laws regarding the standards for determining liability for and the amount of

punitive damages fail to give Defendant prior notice of the conduct for which

punitive damages may be imposed and the severity of the penalty that may be

imposed and are void for vagueness in violation of Defendant’s due process rights

guaranteed by the Fifth, Eight and Fourteenth Amendments to the United States

Constitution and the constitutions of any applicable states; (4) cannot be sustained

because any award of punitive damages exceeding the limits authorized by

applicable state laws or other comparable laws would violate Defendant’s due

process and equal protection rights guaranteed by the Fifth, Eighth and Fourteenth

Amendments to the United States Constitution and would be improper under the

constitutions, common law and applicable states’ laws; (5) cannot be sustained

because an award of punitive damages in this case, combined with any prior, contemporaneous, or subsequent judgments against Defendant for punitive 

damages arising from the design, development, manufacture, fabrication, distribution, supply, marketing, sale, or use of Defendant’s medicines would

constitute impermissible multiple punishments for the same wrong, in violation of

Defendant’s due process and equal protection rights guaranteed by the Fifth and

Fourteenth Amendments to the United States Constitution and would constitute

double jeopardy in violation of the constitutions, common law and statutory law of

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any applicable states’ laws; and (6) cannot be sustained because any award of

punitive damages, which are penal in nature, without according Defendant the

same protections that are accorded to all criminal defendants, including the

protection against unreasonable searches and seizures, the privilege against selfincrimination, and the right to confront adverse witnesses, a speedy trial, and the

effective assistance of counsel, would violate Defendant’s rights guaranteed by the

Fourth, Fifth, and Sixth Amendments as incorporated into the Fourteenth 

Amendment to the United States Constitution and would be improper under the

constitutions, common law and public policies of any applicable states’ laws.

20. To the extent punitive damages are sought, plaintiff’s claims for

punitive damages against Defendant cannot be sustained because an award of

punitive damages by a jury that: (1) is not provided constitutionally adequate

standards of sufficient clarity for determining the appropriate imposition of, and

the appropriate size of, a punitive damages award; (2) is not adequately instructed

on the limits of punitive damages imposed by the applicable principles of

deterrence and punishment; (3) is not expressly prohibited from awarding punitive

damages, or determining the amount of an award of punitive damages, in whole or

in part on the basis of invidiously discriminatory characteristics, including without

limitation the residence, wealth, and corporate status of Defendant; (4) is permitted

to award punitive damages under a standard for determining liability for punitive

damages that is vague and arbitrary and does not define with sufficient clarity the

conduct or mental state that makes punitive damages permissible; (5) is not

properly instructed regarding plaintiff's burden of proof with respect to each and 

every element of a claim for punitive damages; and (6) is not subject to trial court

and appellate judicial review for reasonableness and furtherance of legitimate

purposes on the basis of constitutionally adequate and objective standards, would

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violate Defendant's due process and equal protection rights guaranteed by the Fifth

and Fourteenth Amendments to the United States Constitution, and would be

improper under the constitutions, common law and public policies of any

applicable states’ laws.

21. Plaintiff’s demand for punitive damages is barred because Mirapex

and its labeling were subject to and received pre-market approval by the FDA

under 52 Stat. 1040, 21 U.S.C. § 301.

22. To the extent plaintiff makes a claim for punitive damages, Defendant

asserts that plaintiff has not complied with statutory requirements to recover

punitive damages.

23. To the extent punitive damages are sought, Defendant specifically

incorporates by reference any and all standards or limitations regarding the

determination and enforceability of punitive damage awards that arose in the

decisions of BMW of North America Inc. v. Gore, 517 U.S. 559 (1996); Cooper 

Industries, Inc. v. Leatherman Tool Group, 532 U.S. 424 (2001); and State Farm

Mutual Automobile Insurance Co. v. Campbell, 123 S. Ct. 1513 (2003).

24. Defendant affirmatively pleads that any punitive damages that

plaintiff may recover in this case should be capped in keeping with Alabama Code

§ 6-11-21 (1975), as amended in 1999 (Act. No. 99-358) and in the spirit of the

Alabama Supreme Court’s decision in Oliver v. Towns, 738 So. 2d 798 (Ala. 1999); see also Horton Homes, Inc. v. Brooks, 832 So. 2d 44 (Ala. 2001). Defendant adopts by reference the defenses, criteria, limitations, and standards

mandated by this Alabama statute. The Alabama Supreme Court’s action in

abolishing the legislatively created cap on punitive damages was unconstitutional

and is without effect. Under the Constitutions of the United States and the State of

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- 14 - Alabama, the Alabama Supreme Court cannot abolish the cap created by the

legislature on punitive damages through this judicial decision. See Honda Motor

Co., Ltd. v. Oberg, 512 U.S. 415, 114 S. Ct. 2331, 2340 n.9 (1994).

25. Defendant avers that any punitive damages award is subject to

limitation based on harm that has occurred and harm that is likely to occur. See 

TXO Prod. Corp. v. Alliance Resources Corp., 113 S. Ct. 2711 (1993).

26. Defendant avers that the method of imposing punitive damages

violates Amendment 328, Section 6.11 of the Constitution of Alabama, which

prohibits the use of a procedural rule to abridge, enlarge, or modify the substantive

right of any party. See Leonard v. Terminix Int’l Co., 854 So. 2d 529 (Ala. 2002).

27. The imposition of punitive damages is an act of policy making on the

part of the judiciary, in violation of Article III, Section 43 of the Constitution of

Alabama.

28. Defendant adopts the terms of any applicable legislative act or

Alabama Supreme Court decision which now or hereafter precludes punitive

damages or limits the amount of punitive damages that can be recovered in an

action at law in Alabama.

29. Plaintiff may not be the real party in interest who has the right to

prosecute these claims.

30. Plaintiff's claims are barred, in whole or in part, because Defendant

did not make any false, misleading, or deceptive statements to plaintiff in its

advertisements and/or promotional materials concerning Mirapex. As to any

statement asserted against Defendant that plaintiff alleges to be false, misleading, or deceptive, Defendant had no reasonable grounds to believe, and did not believe

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at the time such a statement was made, that the statement was false, misleading, or

deceptive.

31. Plaintiff’s claims may be barred, in whole or in part, due to lack of

standing.

32. Plaintiff’s claims may be barred, in whole or in part, due to failure to

join indispensable parties and/or bring claims against the real party in interest.

33. Plaintiff’s claims as set forth in the Complaint may be barred to the

extent plaintiff misused or abused Mirapex, failed to use Mirapex properly, and/or 

used Mirapex negligently or used Mirapex in any other way except that for which

it was intended.

34. To the extent applicable, Defendant specifically asserts the defense of

contributory negligence. 

35. Plaintiff’s alleged injuries and damages, if any, were the result of

independent, unforeseeable, superseding, and/or intervening causes unrelated to

any conduct of Defendant or plaintiff's alleged ingestion of Mirapex.

36. Plaintiff’s claims are barred pursuant to the Learned Intermediary

Doctrine.

37. Plaintiff’s claims against Defendant are barred under Section 402A, comments j and k of the Restatement (Second) of Torts and Sections 4 and 6 of the

Restatement (Third) of Torts: Products Liability.

38. Should Defendant be held liable to plaintiff, which liability is

specifically denied, Defendant would be entitled to a set-off for all sums of money

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received or available from or on behalf of any tortfeasors for the same injuries

alleged in the Complaint.

39. The claims asserted in the Complaint are barred, in whole or in part, because the manufacturing, labeling, packaging, and any advertising of the product

complied with the applicable codes, standards, and regulations established, adopted, promulgated, or approved by any regulatory body with jurisdiction over

the product, including but not limited to the United States, any state, and any

agency thereof.

40. The claims asserted in the Complaint are barred, in whole or in part, because Mirapex was designed, tested, manufactured, and labeled in accordance

with state-of-the-art and industry standards existing at the time of sale.

41. Notwithstanding plaintiff’s claims and contentions, plaintiff received

all or substantially all of the benefit of Mirapex that he had intended to receive, and 

to that extent any damages and/or restitution that plaintiff might be entitled to

recover from Defendant must be correspondingly reduced.

42. Venue in this district and/or division may be improper and/or

inconvenient.

43. To the extent that plaintiff is alleging fraud or similar conduct, plaintiff has failed to plead fraud with sufficient particularity.

44. Plaintiff’s claims are barred, in whole or in part, by the Alabama

Product Liability Act, ALA. CODE §§ 6-5-500 to 6-5-525. 

45. Any verdict or judgment rendered against Defendant must be reduced

under federal law and/or the laws of the State of Alabama by those amounts which

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have been, or will, with reasonable certainty, replace or indemnify plaintiff, in

whole or in part, for any past or future claimed economic loss from any collateral

source such as insurance, social security, worker’s compensation or employee

benefit programs.

46. Defendant hereby gives notice to the extent the sophisticated

purchaser doctrine is applicable to any of the allegations contained in the

Complaint, it intends to rely upon same in defense of this action.

47. The claims asserted in the Complaint are barred, in whole or in part, because plaintiff would have taken the product even if the product labeling

contained the information plaintiff contends should have been provided.

48. The claims asserted in the Complaint are barred, in whole or in part, because the advertisements, if any, and labeling with respect to Mirapex, was not

false or misleading, and therefore constitute protected commercial speech under

the applicable provisions of the Constitution of the United States.

49. Defendant denies that Mirapex created any liability under the

Alabama Extended Manufacturer’s Liability Doctrine.

50. Plaintiff’s claims based on negligence are subsumed by the Alabama

Extended Manufacturer’s Liability Doctrine.

51. With respect to each and every purported cause of action, the acts of

Defendant were at all times done in good faith and without malice.

52. Defendant reserves the right to raise additional affirmative and other

defenses as may be established by discovery and the evidence in this case. Defendant further reserves the right to amend its Answer and to add such

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counterclaims as may become necessary after reasonable opportunity for

investigation and discovery.

REQUEST FOR JURY TRIAL

Defendant requests a trial by jury on all issues triable.

PRAYER FOR RELIEF

WHEREFORE, Defendant respectfully requests that the Court:

1. Enter judgment in its favor on all claims alleged in the Complaint;

2. Award Defendant the costs, disbursements and reasonable attorneys’ 

fees associated with these proceedings; and

3. Grant Defendant such other and further relief as the Court may deem 

just and proper. 

This, the 21st day of July 2006.

Respectfully submitted,

s/ Kimberly Martin Kimberly Martin (BES002) BRADLEY ARANT ROSE & WHITE LLP

200 Clinton Avenue West, Suite 900 Huntsville, AL 35801-4900

Telephone: (256) 517-5100

Facsimile: (256) 517-5200

E-mail: kmartin@bradleyarant.com

Of Counsel: 

Andrew B. Johnson 

BRADLEY ARANT ROSE & WHITE LLP

One Federal Place 

1918 Fifth Avenue North 

Birmingham, AL 35203

Telephone: (205) 521-8000

Facsimile: (205) 521-8800

E-mail: ajohnson@bradleyarant.com

Case 2:06-cv-00648-MHT-VPM Document 2 Filed 07/21/2006 Page 18 of 19
- 19 - CERTIFICATE OF SERVICE

I hereby certify that on July 21, 2006, I electronically filed the

foregoing with the Clerk of the Court using the CM/ECF system which will send

notification of such filing to the following:

J. Greg Allen BEASLEY, ALLEN, CROW, METHVIN, PORTIS & MILES, P.C. P.O. Box 4160

Montgomery, Alabama 36104

S. Shane Seaborn

PENN & SEABORN, LLC

P.O. Box 688

Clayton, Alabama 36016

Counsel for Plaintiff

and I hereby certify that I have mailed by United States Postal Service the

document to the following non-CM/ECF participants:

NONE

s/ Kimberly Bessiere Martin

Of Counsel

3/193532.1

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