Free Answer to Amended Complaint - District Court of Connecticut - Connecticut

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 1 of 19

UNITED STATES DISTRICT COURT DISTRICT OF CONNECTICUT _________________________________ J. W. R., PPA : CYNTHIA RAMATOWSKI, : CIVIL ACTION NO. CYNTHIA RAMATOWSKI and : 302CV01720 WWE JOHN J. RAMATOWSKI : : Plaintiffs : : VS. : : PHARMACIA CORPORATION, : PHARMACIA & UPJOHN COMPANY and : THE UPJOHN COMPANY : : MARCH 23, 2004 Defendants : _________________________________: DEFENDANTS' ANSWER TO PLAINTIFFS' AMENDED COMPLAINT COME NOW defendants, Pharmacia Corporation, The Upjohn Company and Pharmacia & Upjohn, Inc. ("Pharmacia"), and for their answer to plaintiffs' Third Amended Complaint, dated October 1, 2003, state as follows: COUNT ONE 1. sufficient Pharmacia to form is a without belief knowledge as to the or information of the

truth

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 2 of 19

allegations

contained

in

paragraph 1

of

Count

One

and

therefore denies the same. 2. Pharmacia admits the allegations contained in

paragraph 2 of Count One. 3. Pharmacia denies the allegations of paragraph 3

of Count One. 4. and The Pharmacia admits that Pharmacia & Upjohn Company Upjohn Company have conducted remaining business in

Connecticut.

Pharmacia

denies

all

allegations

contained in paragraph 4 of Count One. 5. and The Pharmacia admits that Pharmacia & Upjohn Company Upjohn Company manufactured, labeled, packaged,

distributed, marketed and sold Pharmacia denies all remaining

Cortef® Oral Suspension. allegations contained in

paragraph 5 of Count One and further states that Pharmacia Corporation is not a proper defendant in this case. 6. Pharmacia admits that Cortef® Oral Suspension

contained hydrocortisone cypionate and that Cortef® Oral Suspension was available for use only by the prescription

2

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 3 of 19

of

a

licensed

physician.

Pharmacia

denies

all

remaining

allegations contained in paragraph 6 of Count One. 7. sufficient allegations Pharmacia to form lacks a information as to the of or knowledge of the and

belief in

truth

contained

paragraph 7

Count One

therefore denies the same. 8. sufficient allegations Pharmacia to form is a without belief in knowledge as to the of or information of the and

truth

contained

paragraph 8

Count One

therefore denies the same. 9. sufficient allegations Pharmacia to form is a without belief in knowledge as to the of or information of the and

truth

contained

paragraph 9

Count One

therefore denies the same. 10. sufficient allegations Pharmacia to form is a without belief in information as to the of or truth knowledge of the and

contained

paragraph 10

Count One

therefore denies the same.

3

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 4 of 19

11. sufficient

Pharmacia to form

is a

without belief in

information as to the of

or truth

knowledge of the and

allegations

contained

paragraph 11

Count One

therefore denies the same. 12. Pharmacia admits that in November, 1999,

Pharmacia & Upjohn Company noted that several spontaneous reports of lack of effect and/or resuspendability had been received with the new formulation of Cortef® Oral

Suspension. Pharmacia denies the remaining allegations in paragraph 12 of Count One. 13. Pharmacia admits that Pharmacia and Upjohn

Company sent a "Dear Doctor" letter, signed by Dr. Rodney Carlson, to physicians in March 2000, and further states that such document speaks for itself. Pharmacia denies all remaining Count One. 14. Pharmacia admits that on or about July 18, 2000, allegations contained in paragraph 13 of

Pharmacia & Upjohn Company recalled certain lots of Cortef® Oral Suspension because it had determined that the then

4

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 5 of 19

current formulation of the product may not provide adequate control for the treatment of congenital adrenal

hyperplasia. Pharmacia denies all remaining allegations in paragraph 14 of Count One. 15. Pharmacia denies all allegations contained in

paragraph 15 of Count One. 16. Pharmacia admits that, at various times,

Pharmacia & Upjohn Company and The Upjohn Company received several spontaneous reports of lack of efficacy regarding Cortef® Oral Suspension. Pharmacia denies all remaining

allegations contained in paragraph 16 of Count One. 17. Pharmacia states that the prescribing information

and package inserts for Cortef® Oral Suspension speak for themselves. Pharmacia denies all remaining allegations

contained in paragraph 17 of Count One. 18. contained Pharmacia in denies each of and every allegation its

paragraph 18

Count One,

including

subparts (a.) through (j.).

5

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 6 of 19

19.

Pharmacia

denies

all

allegations

contained

in

paragraph 19 of Count One, including subparts (a.) through (d.). 20. Pharmacia denies the allegations contained in the

first sentence of paragraph 20 of Count One. Pharmacia is without belief knowledge as to the or information truth of the sufficient second to form a in

sentence

paragraph 20 of Count One and therefore denies the same. 21. Pharmacia denies all allegations contained in

paragraph 21 of Count One. 22. Pharmacia denies all allegations contained in

paragraph 22 of Count One. COUNT TWO 1-22. Pharmacia incorporates its responses to

Paragraphs 1-22 of Count One as though fully set forth herein. 23. Pharmacia denies the allegations contained in

Paragraph 23 of Count Two.

6

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 7 of 19

GENERAL DENIAL Pharmacia allegation in specifically plaintiffs' denies Complaint each not and every

specifically

admitted herein. PREAMBLE TO AFFIRMATIVE DEFENSES Pharmacia reserves the right to rely upon any of the following or additional defenses to claims asserted by

Plaintiffs to the extent such defenses are supported by information developed through discovery or by evidence at trial. By setting forth these defenses, Pharmacia does not

assume the burden of proving any fact, issue or element of a claim where such burden properly belongs to plaintiffs. First Affirmative Defense Plaintiffs' Complaint fails to state a claim upon

which relief can be granted. Second Affirmative Defense If Plaintiffs sustained injuries as alleged, those

injuries were not due to or caused by the fault, lack of

7

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 8 of 19

care, negligence, strict liability, or any other breach of duty on the part of Pharmacia. Third Affirmative Defense If Plaintiffs sustained injuries as alleged, those

injuries were the result of intervening and/or superseding causes, and not as a result of Pharmacia's acts or

omissions. Fourth Affirmative Defense Cortef® Oral Suspension was approved as a prescription medical product by the United States Food and Drug

Administration and was tested, manufactured and labeled in accordance with FDA standards, pursuant to 21 U.S.C. § 301 et seq. Consequently, Plaintiffs' claims are barred in

whole or in part by the doctrine of preemption under the Supremacy Clause of the United States Constitution. Fifth Affirmative Defense Pharmacia has complied with the applicable federal

statutes and regulations and is therefore not liable for punitive damages.

8

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 9 of 19

Sixth Affirmative Defense Plaintiffs' claims are barred in whole or in part by estoppel, laches, and/or other equitable doctrines. Seventh Affirmative Defense Plaintiffs' claims are barred by virtue of the

intervention of a learned intermediary or intermediaries to whom Pharmacia discharged its duty to warn. Eighth Affirmative Defense If Plaintiffs sustained injuries as alleged, those

injuries were caused in whole or in part by the conduct of one or more persons or entities for whose conduct Pharmacia was not responsible and with whom Pharmacia had no legal connection. Ninth Affirmative Defense If Plaintiffs sustained injuries as alleged, the

injuries resulted from the pre-existing and/or unrelated medical, genetic, and/or environmental conditions,

diseases, or illnesses of J. R.

9

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 10 of 19

Tenth Affirmative Defense Plaintiffs' recovery, if any, is barred entirely, or should be reduced by the comparative negligence, fault,

responsibility or causation attributable to Plaintiffs. Eleventh Affirmative Defense Cortef® product that Oral was Cortef® to Suspension neither Oral was a prescription nor was medical

defective Suspension

unreasonably at all safe times and

dangerous. material

Plaintiffs'

Complaint

reasonably

reasonably fit for its intended use, and the warnings and instructions accompanying Cortef® Oral Suspension at the time of the occurrence of the injuries alleged by

Plaintiffs were legally adequate. Twelfth Affirmative Defense Plaintiffs because Cortef® cannot Oral recover Suspension under was their Complaint in

manufactured

accordance with the state of the art at the time it was manufactured.

10

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 11 of 19

Thirteenth Affirmative Defense Cortef® Oral Suspension was neither defective nor

unreasonably dangerous because it was a product which falls within the "comment k exception" to strict tort liability defined Torts. Fourteenth Affirmative Defense Plaintiffs' claims are barred under Sec 6 et seq of the Restatement (Third) of Torts: Products Liability. Fifteenth Affirmative Defense Plaintiffs' claims are barred by the applicable in Section 402A of the Restatement (Second) of

statutes of limitations. Sixteenth Affirmative Defense Plaintiffs' alleged injures and/or damages were not proximately caused by any act or omission of Pharmacia. Seventeenth Affirmative Defense Plaintiffs' alleged injuries and/or damages, if any, were not the result of any act or omission on the part of Pharmacia but exist by reason of operation of nature or

11

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 12 of 19

idiosyncratic reaction, over which Pharmacia had and has no control and for which Pharmacia is not responsible. Eighteenth Affirmative Defense The product which is the subject of this lawsuit was put to abnormal and/or unintended use. Nineteenth Affirmative Defense Plaintiffs' alleged injuries and/or damages, if any, were not caused by any failure to warn on the part of Pharmacia. Twentieth Affirmative Defense The altered, product modified at or issue in this case may to a have form been not

otherwise

rendered

substantially similar to its form when it left the custody or control of the manufacturer, by others over whom

Pharmacia had no control and whose conduct Pharmacia had no reason to anticipate. Twenty-First Affirmative Defense Based on the state of scientific, medical, and

technological knowledge available at the time the product

12

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 13 of 19

which is the subject of this lawsuit was distributed, it was reasonably safe for its normal and foreseeable use at all relevant times. Twenty-Second Affirmative Defense Plaintiffs' claims are barred, in whole or in part, because the manufacturer complied with all applicable

statutes and with the requirements and regulations of the Food and Drug Administration. Twenty-Third Affirmative Defense Based upon the state of scientific skill and knowledge at the time the product that is the subject of this lawsuit was distributed by the manufacturer, the product was

reasonably safe and the benefits of the product exceeded any risk associated with it. Twenty-Fourth Affirmative Defense Should Pharmacia be held liable to plaintiffs, which liability is specifically denied, Pharmacia would be

entitled to a set off for all sums of money received or

13

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 14 of 19

available from or on behalf of any tortfeasors for the same injuries alleged in the Complaint. Twenty-Fifth Affirmative Defense Plaintiffs' claims are barred, in whole or in part, because of Plaintiffs' failure to mitigate damages. Twenty-Sixth Affirmative Defense Pharmacia intends to rely upon, reserves its right to assert, and hereby pleads such other and related defenses as may become available in the event of a determination that the action, or some part thereof, is governed by the substantive law of a state other than Connecticut or a foreign country. Twenty-Seventh Affirmative Defense Plaintiffs' Complaint fails to state facts sufficient to entitle Plaintiffs to an award of punitive damages

against Pharmacia. Twenty-Eighth Affirmative Defense The imposition of punitive damages in this case would violate the due process and equal protection clauses of the

14

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 15 of 19

Fifth

and

Fourteenth

Amendments

of

the

United

States

Constitution as well as the applicable provisions of the Connecticut Constitution. Twenty-Ninth Affirmative Defense Plaintiffs' claims for punitive damages cannot be

sustained because an award of punitive damages by a jury that (1) is of not provided constitutionally for adequate the

standards

sufficient

clarity

determining

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 expressly of punishment from and deterrence; punitive (3) is not or

prohibited

awarding

damages,

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 Pharmacia; (4) is permitted to award punitive damages under a standard for determining liability for punitive damages that is vague

15

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 16 of 19

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

Plaintiffs' burden of proof with respect to each and every element of a claim for punitive damages; and/or (6) is not subject review to for on trial court and de novo appellate of judicial

reasonableness the basis of

and

furtherance

legitimate and

purposes

constitutionally

adequate

objective standards, would violate Pharmacia's due process and equal protection rights guaranteed by the Fifth and Fourteenth Amendments to the United States Constitution and applicable provisions of the Connecticut Constitution. Thirtieth Affirmative Defense Plaintiffs' claims for punitive damages cannot be

sustained because the standards for determining liability for and the amount of punitive damages failed to give

Pharmacia prior notice of the conduct for which punitive damages may be imposed as well as the severity of the

penalty that may be imposed, and are void for vagueness in

16

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 17 of 19

violation of Pharmacia's due process rights guaranteed by the Fifth and Fourteenth Amendments to the United States Constitution and applicable provisions of the Connecticut Constitution. Thirty-First Affirmative Defense Plaintiffs' sustained because the claim any trial for award and punitive of damages cannot be

punitive all

damages punitive

without damages

bifurcating

trying

issues only if and after liability on the merits has been found, would violate Pharmacia's due process rights

guaranteed by the Fifth and Fourteenth Amendments to the United States Constitution and applicable provisions of the Connecticut Constitution. Thirty-Second Affirmative Defense Pharmacia reserves the right to amend this Answer and to add affirmative defenses after it has had an opportunity to discover all facts relevant to this action. WHEREFORE, Pharmacia requests that this Court enter judgment in favor of Pharmacia and against the Plaintiffs,

17

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 18 of 19

dismissing Plaintiffs' claims with prejudice and further awarding Pharmacia its costs and such other and further relief to which Pharmacia may be entitled. DEMAND FOR JURY TRIAL Pharmacia hereby requests a trial by jury as to all issues triable. THE DEFENDANTS, PHARMACIA CORPORATION, PHARMACIA & UPJOHN COMPANY, THE UPJOHN COMPANY

By__________________________ Timothy W. Donahue DELANEY, ZEMETIS, DONAHUE, DURHAM & NOONAN, P.C. 111 South Main Street Wallingford, CT 06492 203-269-1441 Federal Bar No. CT04339

18

Case 3:02-cv-01720-WWE

Document 25

Filed 03/25/2004

Page 19 of 19

C E R T I F I C A T I O N This is to certify that a copy of the foregoing has been mailed, postage prepaid, on this 23rd day of March, 2004, to: Margaret Doherty, Esq. Tinley, Nastri, Renehan & Dost, LLP 60 North Main Street, Second Floor Waterbury, CT 06702 Andrew See, Esq. Shook, Hardy & Bacon, LLP One Kansas City Place 1200 Main Street Kansas City, Missouri 64105-2118 William H. Pickett, Esq. 600 Griffith Building 405 East Thirteenth Street Kansas City, Missouri 64106 Stephen E. Scheve, Esq. Shook, Hardy & Bacon, LLP JP Morgan/Chase Tower 600 Travis Street, Suite 1600 Houston, Texas 77002

___________________________ Timothy W. Donahue

19