Transcript Update on Hormone Replacement Therapy Litigation

Update on Hormone
Replacement Therapy
Litigation
Navan Ward Jr.
Beasley, Allen, Crow, Methvin,
Portis, & Miles, P.C.
Combination Hormone Therapy
To relieve menopausal symptoms,
physicians prescribe estrogen in order to
replace what the ovaries are no longer
producing.
 Physicians prescribe progesterone to
prevent the ingested estrogen from
causing endometrial cancer.
 Estrogen + Progestin = HRT

Combination Hormone Therapy

1984 – 1996: Estrogen and Progestin were
two different drugs.

1995: Wyeth introduced a new drug
combining both Estrogen and Progestin.

1996 – 2001: Estrogen and Progestin
combined into one pill - “PREMPRO”
Two Drug Companies
WYETH
Ayerst Laboratories
 Wyeth – Ayerst
 American Home
Products
 Wyeth

PFIZER

Pharmacia and
Upjohn Company, LLC

Greenstone, Ltd
IGORNED CONCERNS
Concerns arose over the potential
negative effect of HRT on the breasts.
 Neither Wyeth nor Pfizer ever studied the
Estrogen/Progestin combination to
determine whether they harmed the
breast.

IGNORED CONCERNS
WYETH

Internal Memo from Dr. Henry S. Perdue
stated, “…the results of the studies that
would be needed could turn out to be
embarrassing.”
Women’s Health Initiative Study

Sponsored by the National Institutes of
Health (NIH).

Designed to show that Hormone Therapy
prevented (or reduced problems of) heart
problems, osteoporosis plus Alzheimer’s.

Scheduled to last for 15 years.
WHI Study Results
Instead of cardiovascular benefit from the
combination drug, cardiovascular risks
were increased.
 No psychiatric benefit or benefit in
preventing onset of dementia was
demonstrated
 Increase in the incidence of breast cancer

WHI Study

Halted in July 2002 due to its results.

Studies revealed occurrences of breast
cancer at a rate of 1.24 at an average rate
of 4.4 years of usage.
Hormone Dependant Breast
Cancers Decline same time
as Number of Hormone
Therapy Prescriptions
Decline
Reported by the New England
Journal of Medicine (356;16) –
April 19, 2007
Litigation
Completed Trials/Settlements:
Reeves (AR) – Defense Verdict (8/22/06)
 Nelson I (PA) – Phase I Plaintiff Verdict –
Mistrial ($1.5 mil) (9/11/06)
 McCreary (NV) – Settled (10/9/06)
 Daniel (PA) – Plaintiff’s Verdict ($1.5 mil);
Punitives awarded by jury – JNOV for
punitives granted(confidential) (1/9/07)

Litigation
Completed Trials/Settlements:
Nelson II (PA) Plaintiff’s Verdict – JNOV
granted - $3 mil (1/11/07)
 Rush (AR) Defense Verdict (1/22/07)
 Simon (PA) Plaintiff’s Verdict – Pharmacia
for $1.5 mil; Defense Verdict – Wyeth
(4/16/07)

Litigation
Completed Trials/Settlements:
 Deutsch (NJ) Settled (7/16/07)
 Rowatt, Scofield, Forrester (NV)
Plaintiff’s Verdict ($135.5 mil total)
(9/10/07)
 Mill (PA) Dismissed – To be re-filed
(10/1/07)
Litigation
Upcoming Trials:
12/4/07: Scroggins (AR)
 1/7/08: Phillips (AL)
 1/8/08: Browning (KY)
 1/8/08: Trevino (TX)
 1/14/08: Briest (NJ)
 1/22/08: Reinhardt (NJ)

Litigation
Upcoming Trials:
1/28/08: Zandi (MN)
 2/4/08: Hill (AR)
 2/25/08: Bailey (NJ)
 3/31/08: Adams (TX)
 4/7/08: Deboard/Kositsky (NJ)
 6/9/08: Esposito (FL)

NAVAN WARD JR
Beasley, Allen et al.
[email protected]