1992). The ensuing legal actions were numerous and costly, with over a thousand pending nationwide as of February 1991 (Squires 1991). Of high relevance for the area of research liability were the awards for battery made to women involved in clinical trials of DES who had not been informed that they were part of a study (IOM 1994a). The experience encouraged exclusion of pregnant and potentially pregnant women from clinical research and the writing of FDA guidelines to reinforce that practice (IOM 1994a).

  • 11.  

    Dow Corning was to be the largest contributor ($2 billion) to the $4.2 billion class action settlement reached in 1994 among breast implant manufacturers (including Bristol-Myers Squibb, Minnesota Mining and Manufacturing, and Baxter International) and the approximately 400,000 women signed up to participate in the settlement. However, Dow filed for bankruptcy in May 1995 and withdrew. The settlement remains the largest liability settlement in U.S. history and, since an additional 7,000 women are filing individual suits (Kolata 1995), the costs can only rise.

  • 12.  

    This failure rate is based on clinical trials with two types of Norplant capsules: the original hard capsules and newer soft capsules. Cumulative failure rates through the end of five years were 4.9 percent for the hard capsules and only 1.6 percent for the capsules made of soft tubing (Sivin 1988). Leiras Oy, Norplant's manufacturer, now only uses soft tubing.

  • 13.  

    MDL = Multidistrict litigation.

  • 14.  

    In February 1996, Huhtamaki Oy announced that negotiations were under way on the sale of its pharmaceutical division, Leiras, to an international pharmaceutical company. ". . . The operating environment for Leiras has changed, hence our decision to concentrate on the foods division." This may have a major impact on the availability and/or price of Norplant implants for public sector purchasers of the product. It is not clear at the time of this writing whether the decision is in any way related to the company's experience with Norplant and what that might imply.

  • 15.  

    The FDA estimates that implementation of nutrition labeling required under the recently enacted Dietary Supplement Health and Education Act will cost that industry from $52 to $85 million to implement (Food Labeling and Nutrition News 1996).

  • 16.  

    According to medical textbooks, pregnancy begins when the process of implantation of the ovum in the uterine wall is complete. Implantation is not generally regarded as complete until 28 to 31 days from the first day of a woman's last menstrual period, assuming regular cycles (Cunningham 1993; Holt 1995). This prevailing medical opinion has been followed by policy makers and courts in Europe and the United States (e.g. , Brownfield v. Daniel Freeman Marina Hosp. , 256 Cal. Rptr. 240 , 245 [Ct. App. 1989]; Margaret S. v. Edwards , 488 F. Suppl. 181 , 191 [E.O. La. 1980].

  • 17.  

    The pediatric vaccines accounted for over 60 percent of that market, U.S. sales for slightly under half. The market is expected to enter a period of more modest growth through the 1995-1999 forecast period, followed by a second surge after the year 2000, fueled by the introduction of vaccine products to treat diseases for which there is now no preventive vaccine, the growth of mega- or multivalent vaccines, and the WHO "supervaccine" (FIND/SVP 1996).

  • 18.  

    Acute infantile gastroenteritis; DTaP-HIB; DTaP-IPV-HIB; group A and group B streptococcus; hemophilus influenzae type B; malaria; meningococcus A,B, and C; pertussis; pneumoccocal disease; polio; pseudomonas infections; and respiratory syncytial virus.

  • 19.  

    Cholera; dengue fever; gonorrhea; group B streptococcus; helicobacter pylori; hepatitis A, B, C, D, E, and X; herpes virus; human B19 parvovirus vaccine; influenza; Lyme disease; rheumatoid arthritis; staphylococcus aureus infections; traveler's diarrhea; and a range of new adjuvants.

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