-September 1, 2006
Thousands of product liability lawsuits have been filed in recent years over four drugs prescribed to millions of patients, raising serious concerns as to whether drug companies and the FDA are doing enough to ensure patient safety.
The four drugs include Prempro, Ortho Evra, Seroquel, and Neurontin. The lawsuits filed against the makers of these drugs generally claim one of three things – the drugmaker failed to provide adequate warnings on the drug’s labeling, failed to conduct enough testing, or both.
Vioxx, Merck’s once popular painkiller, faces 14,000 lawsuits, which make similar claims. However, Vioxx was pulled from the shelves in light of its dangers. These four drugs remain on the market.
Prempro Under Fire
Prempro and Premarin, both hormone-replacement drugs manufactured by Wyeth, currently face more than 5,000 lawsuits – the first of which went to trial last week. The majority of these claims cite breast cancer as a result of taking the drugs.
In 2002, a study was halted after researchers found that patients taking Prempro had a significantly increased risk of developing breast cancer, heart disease, and stroke. Heightened warnings were subsequently added to the drug’s labeling.
Neurontin Suicide Risk
Neurontin has been the subject of much controversy in recent times, particularly because of Pfizer’s illegal, off-label marketing campaign. However, the drug has also been linked to an increased risk of suicide.
In December 2005, Pfizer added the risk of “suicide,” “suicide attempt” and “suicide gesture” to the drug’s warning label. Neurontin is widely prescribed for a number of uses, including for pain and bipolar disorder. More than 10 million people have taken the drug.
Ortho Evra Controversy
Last year, the FDA required the Ortho Evra birth control patch to carry a heightened warning label, advising users of the risk of potentially life threatening blood clots. Numerous women have filed lawsuits claiming they suffered blood clots and strokes as a result of using the patch.
“The plaintiffs tend to be younger women, and you don’t normally see strokes or blood clots in that population,” said professor of law, Lars Noah.
The patch delivers 60 percent more estrogen into the body because it is delivered directly into the bloodstream, whereas the estrogen in pills is filtered through the digestive tract. Estrogen increases the risk of blood clots.
According to Johnson & Johnson, maker of the patch, more than 5 million women have used the patch since it received FDA approval five years ago.
Seroquel Dangers
Since its launch in 1997, AstraZeneca’s anti-psychotic Seroquel has been prescribed to more than 16 million patients. Many users have developed diabetes, they claim, as a result of taking the drug.
They further claim that the drug maker intentionally mitigated the risk of diabetes and concealed this information from the FDA. Similar claims were made against Eli Lilly with regard to its popular anti-psychotic Zyprexa.
Eli Lilly recently settled 10,500 Zyprexa lawsuits for approximately $1 billion.
The Implications
Researchers believe that this trend isn’t likely to slow anytime soon. The drug company is rapidly gaining a reputation on par with that of the tobacco industry. In fact, in the past six years, more than 65,000 lawsuits have been filed against pharmaceutical companies.
Moreover, with the growing number of drugs on the market and millions of consumers taking them, the risk of injury is significantly increased. If you have been injured as the result of a defective drug, please contact us to learn more about your legal rights and options.
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