PPHN Paxil Birth Defect Complaint.wpd

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L.M. Goldman, Esq.

Barth Menzies, Esq.

Baum Hedlund, A Professional Corporation

12100 Wilshire Blvd., Suite 950

Los Angeles, California 90025

Telephone: 310.207.3233

Facsimile: 310.207.4204

Cara J. Luther, Esq.

cluther@...

Attorney ID # 52545

Baum Hedlund, A Professional Corporation

1500 Market Street, 12th Floor, East Tower

Philadelphia, Pennsylvania 19102 This Is Not An Arbitration Case

Telephone: 215.665.5659 An Assessment of Damages

Facsimile: 215.569.8228 Hearing Is Required.

Attorneys for Plaintiffs

_____________________________________________________________________

_________

, a Minor, by ) COURT OF COMMON PLEAS

and Boden, Guardians; and ) TRIAL DIVISION

and ) PHILADELPHIA COUNTY

Boden, Individually, )

) TERM

Plaintiffs, ) NO.

)

vs. )

)

Kline Beecham Corporation d/b/a, )

GlaxoKline, )

One lin Plaza ) IN RE: PAXIL

Philadelphia, Pennsylvania 19102-1225 )

)

Defendant. ) JURY TRIAL DEMANDED

)

COMPLAINT-CIVIL ACTION

Plaintiffs, , a minor, by and

Boden, Guardians, and

and Boden, individually, by their

attorneys, Baum Hedlund, and as for the

Complaint herein allege upon information and belief the following:

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STATEMENT OF THE CASE

1. This is a products liability and personal injury case arising

from a Paxil-induced

disorder suffered by as a result of his mother,

Boden, having been prescribed and

taking the prescription drug Paxil during her pregnancy. GSK did not

timely warn the medical

community and consumers generally that taking Paxil during pregnancy

is associated with a

significant increased risk of birth defects, respiratory problems

and abnormal development of the

unborn fetus.

PARTIES

2. Plaintiff is a minor child who was born in Denver,

Colorado on October

28, 2004. He is currently a citizen of Colorado, residing with his

parents, and

Boden in Denver. is represented in this action by his

parents, and

Boden, who are his next friend pursuant to Pa. R.C.P. No. 2026.

3. is a competent adult and the father of

plaintiff, .

He brings this action individually and on behalf of his minor son to

recover the medical and other

expenses incurred in treating and attempting to cure his son's

disorder and related illnesses and

general damages.

4. Boden is a competent adult and the mother of plaintiff,

. She brings

this action individually and on behalf of her minor son to recover

the medical and other expenses

incurred in treating and attempting to cure her son's disorder and

related illnesses and general

damages.

5. Defendant Kline Beecham Corporation d/b/a GlaxoKline

(hereinafter

referred to as " GSK " ) was and still is a corporation duly existing

under and by virtue of the laws of

the State of Pennsylvania with its principal place of business in

Philadelphia, Pennsylvania. At all

times hereinafter mentioned, defendant GSK was, and still is, a

pharmaceutical company involved

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in the research, development, testing, manufacture, production,

promotion, distribution, and

marketing of pharmaceuticals for distribution, sale, and use by the

general public, including the drug

Paxil (known generically as paroxetine), an antidepressant,

throughout the United States.

JURISDICTIONAL ALLEGATIONS

6. Jurisdiction is proper because GSK is a Pennsylvania corporation.

Venue is proper

in this District because GSK resides in this county for venue

purposes and a substantial part of the

events and omissions giving rise to plaintiffs' injuries occurred in

this District. See Pa.R.C.P. 2179,

as amended by 2003 Pennsylvania Court Order 8.

FACTUAL ALLEGATIONS

7. The drug " paroxetine " is manufactured, promoted, distributed,

labeled and marketed

by GSK under the trade name Paxil, Paxil Oral Suspension, and Paxil

CR, and is a member of a class

of drugs known as " selective serotonin reuptake inhibitors "

or " SSRIs. " Paxil was first approved

for use in the United States by the FDA in 1992 for the treatment of

depression in adults.

8. Ms. Boden took Paxil as prescribed by her treating physician

while pregnant with

.

9. Shortly after was born on October 28, 2004, in Denver, CO,

he began to suffer

from persistent pulmonary hypertension of the newborn ( " PPHN " ), a

life-threatening disorder in

which the newborn's arteries to the lungs remain constricted after

delivery, limiting the amount of

blood flow to the lungs and therefore the amount of oxygen into the

bloodstream.

10. Beginning from the time that developed this disorder, he

has gone through

several life-threatening procedures. Immediately after birth he was

placed on a ventilator and was

eventually placed on an oscillating ventilator which he remained on

for a month. Thereafter, he

underwent two cardiac catherizations, and a nissen fundoplication

procedure to combat gastral

reflux caused by being on a ventilator for an extended period of

time. He remains on oxygen and

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medications to help him breathe and continues to suffer from

associated eating and digestive

problems.

11. The disorder suffered by was a direct result of his

mother's ingestion of Paxil

during her pregnancy in a manner and dosage recommended and

prescribed by her doctor.

12. Prior to Ms. Boden becoming pregnant with , GSK knew or

should have known

that children born to women who took Paxil during pregnancy were

developing PPHN.

13. Prior to Ms. Boden becoming pregnant with , GSK knew or

should have known

that Paxil crosses the placenta, which could have important

implications for the developing fetus.

14. Prior to the time that Ms. Boden ingested Paxil during her

pregnancy with , GSK

knew or should have known that Paxil posed an increased risk of

congenital heart defects.

15. During the entire time Paxil has been on the market in the

United States, FDA

regulations have required GSK to issue stronger warnings whenever

there existed reasonable

evidence of an association between a serious risk and Paxil. The

regulations specifically state that

a causal link need not have been proven to issue the new warnings.

Further, the regulations

explicitly allowed GSK to issue such a warning without prior FDA

approval.

16. Thus, prior to Ms. Boden's pregnancy with , GSK had the

knowledge, the means

and the duty to provide the medical community and the consuming

public with a stronger warning

regarding the association between Paxil and birth defects and other

disorders that could effect the

unborn fetus, through all means necessary including but not limited

to labeling, continuing

education, symposiums, posters, sales calls to doctors, etc. GSK

failed to do any of those things.

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COUNT I

NEGLIGENCE & NEGLIGENCE PER SE

17. Plaintiffs repeat and reiterate the allegations previously set

forth herein.

18. At all times mentioned herein, GSK was under a duty to exercise

reasonable care in

advertising, marketing, promotion and labeling of Paxil to ensure

that Paxil's use did not result in

avoidable injuries.

19. Plaintiffs' injuries as described herein were caused by the

negligence and

misrepresentations of GSK though its agents, servants and/or

employees acting within the course and

scope of their employment including among other things:

(a) Carelessly and negligently researching, manufacturing, selling,

merchandising, advertising, promoting, labeling, analyzing, testing,

distributing, and

marketing Paxil;

( Failing to fully disclose the results of the testing and other

information in its

possession regarding the possibility that Paxil can interfere with

the proper

development of an unborn fetus;

© Being careless and negligent in that GSK knew or should have

known that

Paxil was a substance that would be actively transported through the

placenta during

pregnancy and could inhibit the health and development of the fetus;

(d) Negligently and carelessly failing to adequately warn the

medical community,

the general public, and plaintiffs of the dangers of using Paxil

during pregnancy;

(e) Negligently and carelessly representing that Paxil was safe for

use during

pregnancy, when in fact, GSK knew or should have known that it was

unsafe for this

use;

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(f) Negligently and carelessly promoting Paxil as safe and effective

for use with

pregnant women when, in fact, it was unsafe;

(g) Negligently and carelessly failing to act as a reasonably

prudent drug

manufacturer;

(h) Negligently and carelessly over-promoting Paxil in a zealous and

unreasonable way, without regard to the potential danger that it

poses for an unborn

fetus.

(i) GSK promoted Paxil for use with pregnant women despite the fact

that GSK

knew or should have known that Paxil is associated with an increased

risk of

congenital abnormalities and pulmonary problems.

20. Furthermore, GSK's negligence was an un-excused breach of

statutory duty

established by federal regulations because plaintiffs have suffered

from the kind of harm the

regulations were designed to prevent and plaintiffs are members of

the particular class of persons

that those regulations were set out to protect.

21. At all times herein mentioned, upon information and belief, the

above-described

culpable conduct by GSK was a proximate cause of plaintiffs'

injuries. GSK knew or should have

known that Paxil could be dangerous and unsafe for pregnant women

and the developing fetus.

22. As a direct and proximate result of the aforesaid conduct of

GSK, plaintiff

has sustained pecuniary loss resulting from the pain and

suffering from PPHN, by the

surgeries and procedures he has already undergone, and the surgeries

and procedures that he will

need to undergo in the future, as well as his inability to enjoy his

life as a normal child without the

presence of PPHN, and additional general damages in a sum in excess

of the jurisdictional minimum

of this Court.

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23. As a direct and proximate result of the aforesaid conduct of

GSK, plaintiffs

and Boden have incurred general and medical

damages and related

expenses in an amount in excess of the jurisdictional minimum of

this Court.

WHEREFORE, for the above reasons, plaintiffs demand judgment in

their favor and against

GSK for an amount in excess of $50,000.00, compensatory damages and

costs of suit in an amount

to be determined upon the trial of this matter.

COUNT II

NEGLIGENT PHARMACO-VIGILANCE

24. Plaintiffs repeat and reiterate the allegations previously set

forth herein.

25. GSK has an ongoing duty of pharmaco-vigilance. As part of this

duty, GSK is

required to continually monitor, test, and analyze data regarding

the safety, efficacy, and prescribing

practices of its marketed drugs, including Paxil. GSK continually

receives reports from its own

clinical trials, practicing physicians, individual patients, and

regulatory authorities of adverse events

that occur in patients taking Paxil and its other marketed drugs.

Furthermore, GSK continues to

conduct clinical trials for its marketed drugs long after the drug

is approved for use. GSK has a duty

to inform doctors, regulatory agencies, and the public of new safety

and efficacy information it

learns, or should have learned, about its marketed drugs once that

information becomes available to

GSK, whether through GSK clinical trials, other outside sources, or

pharmaco-vigilance activities.

Specifically, when GSK learns, or should have learned, of new safety

information associated with

its marketed drugs, it has a duty to promptly disseminate that data

to the public. GSK also has a duty

to monitor epidemiological and pharmaco-vigilance data regarding its

marketed drugs and promptly

report any safety concerns that arise through epidemiologic study or

data.

26. GSK breached this duty with respect to plaintiffs. GSK, through

various sources,

including but not limited to, clinical trials and other adverse

event reports, learned that there was a

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substantial risk of pulmonary problems and birth defects associated

with Paxil use during pregnancy

and failed to inform doctors, regulatory agencies, and the public of

this risk. GSK had the means

and the resources to perform its pharmaco-vigilance duties for the

entire time Paxil has been on the

market in the United States.

27. As a direct and proximate result of the aforesaid conduct of

GSK, plaintiff

has sustained pecuniary loss resulting from the pain and

suffering from PPHN, by the

surgeries and procedures he has already undergone, and the surgeries

and procedures that he will

need to undergo in the future, as well as his inability to enjoy his

life as a normal child without the

presence of PPHN, and additional general damages in a sum in excess

of the jurisdictional minimum

of this Court.

28. As a direct and proximate result of the aforesaid conduct of

GSK, plaintiffs

and Boden have incurred general and medical

damages and related

expenses in an amount in excess of the jurisdictional minimum of

this Court.

WHEREFORE, for the above reasons, plaintiffs demand judgment in

their favor and against

GSK for an amount in excess of $50,000.00, compensatory and costs of

suit in an amount to be

determined upon the trial of this matter.

COUNT III

FAILURE TO WARN

(Restatement Second of Torts §388)

29. Plaintiffs repeat and reiterate the allegations previously set

forth herein.

30. At all times herein mentioned, Paxil was unsafe for use by

pregnant women, and GSK

knew or should have known that said product was unsafe.

31. At all times herein mentioned, using Paxil during pregnancy was

associated with a

significantly increased risk of serious pulmonary problems and birth

defects and GSK knew or

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should have known that said product is unsafe when taken during

pregnancy because of the said

effects.

32. At all times hereinafter mentioned and before Ms. Boden's

ingestion of Paxil during

her pregnancy, neither members of the medical community nor members

of the general public knew

the dangers existed with respect to Paxil's association with birth

defects.

33. Ms. Boden used Paxil in the manner in which GSK intended it to

be used.

34. Ms. Boden used or otherwise ingested Paxil in the amount and

manner and for the

purpose recommended by GSK.

35. At all times material hereto, U.S.-marketed Paxil was not

accompanied by complete

and proper warnings for safe, informed use; the labeling

accompanying Paxil did not warn physicians

in general, or plaintiffs in particular, of the dangers inherent in

its use, particularly of the drug's

association with PPHN and birth defects. Further, the labeling

failed to adequately inform

physicians in general, or plaintiffs in particular, of Paxil's

association with a significantly increased

risk of birth defects and other disorders effecting the unborn fetus

if a woman ingests Paxil during

her pregnancy and oversold Paxil's benefits, thus depriving

physicians of necessary information

needed to perform an adequate risk/benefit analysis. Furthermore,

GSK failed to adequately warn

doctors and the medical community of this dangerous risk using the

other mediums at its disposal,

including, but not limited to, medical journal articles, sales

representatives, Dear Doctor letters,

presentations, conferences, medical school information, and all of

its promotional material and

activities.

36. GSK promoted and maintained Paxil on the market with the

knowledge of Paxil's

unreasonable risk to the public in general and specifically to

plaintiff.

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37. Paxil, as used by Ms. Boden during her pregnancy with , was

defective and

unreasonably dangerous when sold by GSK, who is liable for the

injuries arising from its

manufacture and Ms. Boden's use.

38. As a direct and proximate result of the aforesaid conduct of

GSK, plaintiff

has sustained pecuniary loss resulting from the pain

and suffering from PPHN, by the

surgeries and procedures he has already undergone, and the surgeries

and procedures that he will

need to undergo in the future, as well as his inability to enjoy his

life as a normal child without the

presence of PPHN, and additional general damages in a sum in excess

of the jurisdictional minimum

of this Court.

39. As a direct and proximate result of the aforesaid conduct of

GSK, plaintiffs

and Boden have incurred general and medical

damages and related

expenses in an amount in excess of the jurisdictional minimum of

this Court.

WHEREFORE, for the above reasons, plaintiffs demand judgment in

their favor and against

GSK for an amount in excess of $50,000.00, compensatory and costs of

suit in an amount to be

determined upon the trial of this matter.

COUNTS IV & V

BREACH OF EXPRESS AND IMPLIED WARRANTY

40. Plaintiffs repeat and reiterate the allegations previously set

forth herein.

41. At all times hereinafter mentioned, upon information and belief,

defendant, by

directly and indirectly advertising, marketing, and promoting Paxil

for the treatment of women

during pregnancy and by placing this drug in the stream of commerce

knowing that Paxil would be

prescribed to pregnant women in reliance upon the representations of

defendant, expressly warranted

to all foreseeable users of the drug, including Ms. Boden, that

Paxil was safe and effective for the

treatment of women during pregnancy and without significant risk to

the fetus.

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42. The defendant impliedly warranted in manufacturing,

distributing, selling,

advertising, marketing and promoting Paxil to all foreseeable users,

including Ms. Boden, that Paxil

was safe and effective for the purposes for which it had been placed

in the stream of commerce by

defendant, including for the treatment of pregnant women, and that

Paxil was reasonably safe,

proper, merchantable and fit for the intended purpose, including for

the treatment of pregnant women

and without significant risk to the fetus.

43. That at all time hereinafter mentioned, plaintiffs relied upon

the aforesaid express and

implied warranties by defendant.

44. That at all times hereinafter mentioned, Ms. Boden's use of

Paxil was consistent with

the purposes for which defendant directly and indirectly advertised,

marketed and promoted Paxil,

and Ms. Boden's use of Paxil was reasonably contemplated, intended,

and foreseen by defendant at

the time of the distribution and sale of Paxil by defendant, and,

therefore, Ms. Boden's use of Paxil

was within the scope of the above-described express and implied

warranties.

45. Defendant breached the aforesaid express and implied warranties

because Paxil was

not safe and effective for the treatment of women during pregnancy

because it exposed the

developing fetus to a significant risk of serious injury, and

because Ms. Boden's use of Paxil for

treatment during her pregnancy caused 's disorder.

46. As a direct and proximate result of the aforesaid conduct of

GSK, plaintiff

has sustained pecuniary loss resulting from the pain

and suffering from PPHN, by the

surgeries and procedures he has already undergone, and the surgeries

and procedures that he will

need to undergo in the future, as well as his inability to enjoy his

life as a normal child without the

presence of PPHN, and additional general damages in a sum in excess

of the jurisdictional minimum

of this Court.

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47. As a direct and proximate result of the aforesaid conduct of

GSK, plaintiffs

and Boden have incurred general and medical

damages and related

expenses in an amount in excess of the jurisdictional minimum of

this Court.

WHEREFORE, for the above reasons, plaintiffs demand judgment in

their favor and against

GSK for an amount in excess of $50,000.00, compensatory damages and

costs of suit in an amount

to be determined upon the trial of this matter.

PRAYER

WHEREFORE, Plaintiffs pray for judgment against Defendant as follows:

1. For general damages in a sum exceeding this court's

jurisdictional minimum;

2. For reasonable medical expenses according to proof;

3. For all damages as allowed by law;

4. For prejudgment interest and post-judgment interest as allowed by

law;

5. For delay damages pursuant to Pa. R.C.P. No. 238;

6. For punitive and exemplary damages as allowed by law;

7. For the costs of suit herein incurred; and

8. For such other and further relief as this Court may deem just and

proper.

Dated: October 16, 2006 Respectfully Submitted,

Cara Luther (P.S.B. #52545)

cluther@...

Baum Hedlund, A Professional Corporation

1500 Market Street, 12th Floor, East Tower

Philadelphia, Pennsylvania 19102

Telephone: 215.665.5659

Facsimile: 215.569.8228

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L. M. Goldman, Esq.

rgoldman@...

Barth Menzies, Esq.

kbmenzies@...

Baum Hedlund, A Professional Corporation

12100 Wilshire Blvd., Suite 950

Los Angeles, California 90025

Telephone: 310.207.3233

Facsimile: 310.207.4204

Attorneys for Plaintiffs

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JURY TRIAL DEMAND

Plaintiffs herein invoke their right to a trial by a jury of 12

persons.

Dated: October 16, 2006 Respectfully Submitted,

Cara J. Luther, Esq.