Who is hurt most by unsafe drugs marketed to the public? A new report says women are most likely to be injured.
The report, The Bitterest Pill – How Drug Companies Fail To Protect Woman And How Lawsuits Save their Lives, is from the Center for Justice & Democracy, a New York based nonprofit group.
It was issued in advance of the Diana Levine case which appears before the U.S. Supreme Court on Monday, November 3d.
“Drugs are hyped and marketed to women. A disproportionate number of unsafe drugs and devices result in countless deaths and injuries,” co-author of the report Joanne Doroshow told IB News.
Many unsafe drugs marketed to women concern reproduction, injuring and making infertile otherwise healthy women.
Dangerous drugs for women have included:
- The Ortho-Evra Patch – A weekly birth control patch approved in 2002 and marketed using sexy broadcast ads. After litigation was filed it was revealed the patch caused blood clots, heart attacks and strokes.
- Dalkon Shield IUS – Dalkon Corporation/ A.H. Robins – Estimates are almost 3 million women used the Dalkon Shield. The IUD caused at least 17 American deaths and hundreds of thousands of pelvic diseases and infertility. The IUD was suspended after three years but they remained on the market for the next ten years. Lawsuits finally forced the company to urge women to have them removed and resulted in a $2.5 billion trust for injured women. Robins filed for bankruptcy.
- Copper-7 IUD – G. D. Searle - This IUD introduced in the mid 1970s was once the most popular IUD with about 10 million American women using it. It enjoyed FDA approval and health an estimated 350 lawsuits. The company failed to get adequate product liability insurance.
- Ortho-Novum 1/80 Birth Control Pill – The pill had high levels of estrogen resulting in blood clots and blood disorders. The manufacturer eventually lowered the estrogen levels.
- DES – A synthetic estrogen approved by the FDA to prevent miscarriage. Millions were prescribed the drug from 1938 to 1971. Instead it caused cancer, infertility for not just the pregnant women but the children they carried. Not only was the drug proven ineffective, but it continued on the market until DES lawsuits brought the issue to the forefront and it was pulled.
- Hormone Replacement Therapy (HRT) - Evidence since the 1930s showed that estrogen led to cancer but it wasn’t until 2002 when the NIH confirmed a significant increase in the risk of breast cancer, heart attacks, blood clots and strokes. Millions of women were given HRT.
Dangerous products marketed to women include a high absorbency tampon linked to toxic shock syndrome; the drug Parlodel which suppressed lactation after birth but caused heart attacks and strokes; the drug Accutane, known to cause birth defects if taken by pregnant women. Litigation is just underway in these cases.
Lawsuits have kept women and families safer, Doroshow says, because the unsafe drugs or devices were then pulled from the market.
“Blanket immunity for drug companies would be devastating for American women of all ages,” the group says in a statement.
Levine was injured by a drug given to stop nausea from demerol she received for a migraine. But the Wyeth drug, Phernergan, was improperly injected causing gangrene. Her right arm had to be amputated just below her elbow, essentially rendering her career as a musician over.
Levine won twice in lower courts on the argument that drug maker Wyeth failed to warn about the drug. Wyeth is appealing to the higher court on the basis of federal pre-emption, essentially that states should defer to the spremacy of the FDA in drug safety and labeling issues.
The Center for Justice and Democracy is a consumer-oriented group dedicated exclusively to protecting our civil justice system. #