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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.

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Update on Hormone Replacement Therapy Litigation

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  1. Update on Hormone Replacement Therapy Litigation Navan Ward Jr. Beasley, Allen, Crow, Methvin, Portis, & Miles, P.C.

  2. 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

  3. 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”

  4. WYETH Ayerst Laboratories Wyeth – Ayerst American Home Products Wyeth PFIZER Pharmacia and Upjohn Company, LLC Greenstone, Ltd Two Drug Companies

  5. 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.

  6. 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.”

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. NAVAN WARD JRBeasley, Allen et al. navan.ward@beasleyallen.com

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