More drugs prompt more lawsuits

As with the Gadolinium used in MRI exams, more drugs are being discovered to have negative effects on patients. This includes a new batch of drugs which face a bombardment of lawsuits claiming that the drugs caused injuries to  their users and that manufacturers are to blame.

In recent years, more than 6,000 lawsuits have been filed against four widely prescribed drugs.  Its estimated that these drugs were taken by millions of patients: hormone-replacement drug Prempro, birth-control patch Ortho Evra, anti-psychotic Seroquel and anti-seizure drug Neurontin.
The plaintiffs in these cases claim drugmakers failed to divulge the health risks associated with the drugs or failed to properly test them, or both. The claims are similar to those against Merck's painkiller Vioxx, which now faces 14,000 lawsuits. However, unlike Vioxx, these drugs are still being sold, and the Food and Drug Administration considers their health benefits worth their health risks.

Meanwhile, the first trials have begun for Prempro and Neurontin. Furthermore, Johnson & Johnson has started settling some Ortho Evra cases.
The lawsuits raise questions about whether pharmaceutical companies and the FDA pay adequate attention to patient safety. Is it their priority?  Since the year 2000, more than 65,000 product liability lawsuits have been filed against prescription drugmakers, the most of any industry, says researcher Thomson West.
The pace will more than likely remain steady, given the number of drugs on the market, the millions of consumers using them and the skill of plaintiffs' lawyers in finding consumers who suffered adverse reactions, says professor Lars Noah of the University of Florida College of Law.
"The lawyers have created almost an assembly-line approach to use ... against an industry that's in tobacco-land in terms of how much people hate it," Noah says.

Wyeth, maker of Prempro and Premarin, faces more than 5,000 cases for its hormone-replacement drugs for menopausal symptoms. The first trial started August 21, 2006 in Little Rock wherein Linda Reeves, the Plaintiff in the case, says she developed breast cancer as a result of taking the drugs from 1983 through 2000. It has been noted that breast cancer accounts for the majority of claims.
Wyeth and plaintiffs' lawyers refused to comment, citing a judge's gag order. However, Wyeth has said it did nothing wrong and that the drugs' warnings reflected the scientific data available and the FDA requirements.
A study in 2002, found that patients who took Prempro had a higher risk of breast cancer, stroke and heart disease. Consequently, later that year, Wyeth added a boldface warning on Prempro.
In 2003, the warnings were enclosed with the drug in the box, making them more prominent to the consumer. The drugs' combined sales fell to $909 million last year from $2 billion in 2001.

In March, Wyeth won the first state case when a New York judge issued a summary judgment, saying the drugs' warnings were indeed adequate.  However, the case is being appealed, the plaintiff's lawyer says.
There are fewer Wyeth cases and it's difficult to prove that a drug caused someone's cancer — a key hurdle in most drug lawsuits, Noah says.  Therefore, Wyeth’s exposure is not likely to be nearly as vast as the $21 billion it's paying to settle tens of thousands of claims over former diet drug fen-phen, which has been linked to heart and lung problems.
Plaintiffs in the Neurontin lawsuits face a comparable challenge.
Neurontin plaintiffs' lawyer Andrew Finkelstein has advocated that the FDA require a black-box suicide warning on Neurontin, which has been used by more than 10 million people and is widely prescribed for pain and bipolar sufferers. Drugmaker Pfizer says however, there's no scientific evidence linking Neurontin and suicide.
In December, Pfizer changed Neurontin's label to list "suicide" and "suicide attempt" as infrequent adverse events as opposed to "suicide gesture" as a rarer event. Pfizer says it made the change because of adverse event reports filed with the FDA. Nevertheless, the reports do not prove a drug was to blame.
In the birth-control patch cases, the plaintiffs claim that Ortho-McNeil failed to sufficiently test the patch's safety. Many of the women claim they suffered blood clots as a result of using it.  Many of the plaintiffs in these cases tend to be younger women; a demographic wherein stroke or blood clots is a rarity.
Last year, the FDA required a warning on the patch, saying users will be exposed to 60% more estrogen than with typical birth-control pills. This warning came after the FDA and the Ortho-McNeil compared estrogen levels for their birth control patch vs. pills. The FDA also said increased estrogen may raise the risk of clots.

Although, when the FDA approved the patch in 2001, an FDA approval document said the risks were "similar to the risks of using birth-control pills."
The Ortho Evra birth control patch delivers more estrogen into the bloodstream. With pills, some estrogen is lost in the digestive tract.
Ortho-McNeil Pharmaceutical, and parent company Johnson & Johnson, refused to comment specifically on the lawsuit allegations. Although, in a general statement, it said that more than 5 million women have used the patch and that, when used as labeled, it is safe.
Last year, drugmaker Eli Lilly spent approximately $1 billion to settle about 10,500 lawsuits claiming anti-psychotic Zyprexa caused diabetes or high blood glucose.
Similar claims have been made against AstraZeneca Pharmaceuticals' Seroquel, which is  the No. 1 anti-psychotic, with more than 16 million users since its 1997 debut. Plaintiffs' lawyers claim AstraZeneca downplayed the diabetes risks and purposely withheld important safety information from the FDA.
AstraZeneca is confident in the drug and plans to defend itself, says spokesman Jim Minnick. He says the same lawyers who filed suit against Zyprexa are coming after Seroquel hoping for a similar result — a charge plaintiffs' lawyers deny.
Professor Noah says the mere threat of litigation will do very little to prevent companies from pursuing future drugs with such big markets.
Seroquel had 2005 sales of $2.8 billion. Neurontin, pre-generic competition, also posted annual sales in excess of $2 billion, as did the hormone-replacement drugs.

But Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform, says litigation costs not only consume research funds but also change consumer behaviors. She cites a 2003 Harris Poll, commissioned by her group, wherein it was found that almost four out of 10 doctors had patients stop taking their necessary medications after they heard a drug was involved in a liability lawsuit.
She says plaintiffs' lawyers jam courts with so many lawsuits, many frivolous, that firms settle to avoid the expense and uncertainty of fighting them. "The situation has gotten out of hand," says Rickard, whose group is affiliated with the U.S. Chamber of Commerce.
Lawyer Papantonio says law firms stand to lose $3 million to $5 million by bringing drugmakers to trial and don't pursue frivolous cases. "If a product hurts enough people, it gets the attention of the lawyers."