Cervical cancer vaccine may lead to lawsuits

Deaths and other bad reactions to the new cervical cancer vaccine may lead to lawsuits against its manufacturer.

A number of states have mandated Merck’s vaccine Gardasil be administered to school-aged girls. Designed to protect women between ages 9 and 26 from the human papillomavirus (HPV), which can cause cervical cancer, the vaccine has been controversial. Some have called for mandatory application, prompting criticism that it will encourage promiscuous sex in young girls.

Documents obtained from the U.S. Food and Drug Administration detail more than 3,000 reports of adverse reactions since Gardasil was approved – ranging from minor side effects such as nausea and dizziness to more serious problems like seizures, miscarriage, paralysis and death. The side effects announced by

Merck include flu-like symptoms, fainting, nausea and dizziness.

According to the National Conference of State Legislatures, at least 17 states have enacted legislation to require, fund or educate the public about the HPV vaccine, and in 2007 at least 24 states and the District of Columbia introduced legislation specifically mandating the HPV vaccine be required for students (California and Maryland later withdrew their bills).

Cancer victim wins $27M in hormone replacement lawsuit

A woman who developed breast cancer after using a combination of the hormone replacement drugs Prempro and Premarin won $27 million from the drugs’ producer, Wyeth Pharmaceuticals.

The lawsuit also named Upjohn Co., which manufactures a similar product called Provera.

Donna Scroggin of Little Rock, Ark., was diagnosed with breast cancer in 2000 after using Provera, Prempro, and combination therapy over several years to treat the symptoms of menopause. After being diagnosed with invasive cancer in both breasts, she underwent chemotherapy and a double mastectomy.

She filed a lawsuit after the Women’s Health

Initiative issued its watershed study in 2002 that concluded women who took the estrogen-progestin combination

faced a 24 percent higher risk of developing breast cancer.

The woman’s lawyer presented evidence that Wyeth concealed the risks the medication posed to patients, and that the label was confusing to her physician.

This case marks the second case in less than a year that Wyeth has lost a lawsuit over the Premarin/Prempro combination. In October 2007, a Nevada jury awarded $134.5 million to three Reno women who claimed the drugs caused their breast cancer. That award has since been cut to $58 million. Wyeth has lost four of the seven Prempro cases that have gone to trial since 2006 and there are nearly 7,000 cases still pending.

More than 6 million women have taken the medication.

Autism settlement adds new fuel to vaccine debate

The recent disclosure that the federal government quietly resolved a Georgia couple’s claim that vaccinations caused their daughter’s autism has reignited an intense debate about the safety of the National Vaccine Program.

At present, no scientific evidence of a link between vaccinations and autism exists, and researchers continue to publish reports supporting that position.

But thousands of families and their lawyers remain unconvinced and news of the settlement seemed to confirm their suspicions. It implies a connection between vaccinations and autism, although the exact nature of the link is subject to interpretation.

However, the director of the Centers for Disease Control, in commenting on the settlement, said “the government has made absolutely no statement indicating that vaccines are a cause of autism ... That is a complete mischaracterization of the findings of the case and a complete mischaracterization of the science that we have at our disposal today.”

The lawyer who represented the

family called the director’s comments “semantics.”

This was one of three test cases set for hearings before the U.S. Court of Federal Claims’ Vaccine Court, which has launched an “Omnibus Autism Proceeding” to gather testimony to determine whether vaccinations contribute to autism.

More than 4,900 families with autistic children are seeking compensation from the court, which was created by Congress in 1986 to resolve claims by those who may have been injured by vaccinations.

In December 2007, a court in Maryland issued the broadest rejection to date of the science purporting to establish the vaccine/autism link. The judge excluded testimony from a family’s expert on the evidence of a link, saying it didn’t meet the test for admissibility of scientific evidence. The ruling was the fourth in the last two years to reject expert witnesses in cases involving thimerisol, the vaccination at issue.

DNA testing can help win toxic tort cases

People suing over exposure to chemicals and toxins may soon be able to use DNA testing to prove they have been exposed and suffered injuries because of it.

With objective, scientific testing that can determine with near-100 percent accuracy whether someone has been exposed to a harmful toxin or chemical, long court battles may become unnecessary and settlements more frequent.

The testing would be most useful in toxic tort, workers’ compensation and environmental injury cases.

Current scientific studies are often ambiguous as to whether an individual has been exposed to chemicals or toxins, and whether symptoms are related to that exposure.

But DNA testing, which is even more accurate than what’s used in criminal cases, looks for tiny proteins produced by a person’s DNA when they have been exposed to harmful substances.

Presently, an individual test costs $12,500, but the cost is expected to decline as the technology used for the testing continues to improve.

DNA testing is no silver bullet. Even if an individual proves toxic exposure, the test can be challenged in court. Some toxins remain in the body for years without causing any harm, so victims who may have been exposed in multiple

places may still have to establish where and by whom they were injured.

Another concern is that no federal law prohibits genetic discrimination that could result if the testing finds a person has a genetic condition. The fear is that employers could use the tests to screen out potential applicants, determine whether they have already been exposed to a toxin, might be genetically predisposed to a certain illness, or create a baseline at hiring in case a worker is later injured.

Testing later in the employment period could lead to termination if an employer felt an employee’s toxin levels were too high or not safe.