| LAWSUITS PLAGUE INDUSTRY|
|Drug makers faced the most product liability lawsuits last year of any industry.|
|Financial services|| 2,636|
|Source: Thomson West|
By Julie Schmit, USA TODAY
A new batch of drugs faces a barrage of lawsuits claiming that the drugs injured users and that manufacturers are to blame.
More than 6,000 lawsuits have been filed in recent years against four drugs taken by millions of patients: hormone-replacement drug Prempro, birth-control patch Ortho Evra, anti-psychotic Seroquel and anti-seizure drug Neurontin.
The plaintiffs claim drugmakers failed to disclose the drugs' risks or failed to properly test them, or both. The claims are similar to those against Merck's painkiller Vioxx, which faces 14,000 lawsuits. Unlike Vioxx, these drugs are still being sold, and the Food and Drug Administration considers their benefits worth their risks.
The first trials have begun or are near for Prempro and Neurontin. Johnson & Johnson has started settling some Ortho Evra cases, plaintiffs' lawyers say.
The lawsuits raise questions about whether drugmakers and the FDA pay ample attention to patient safety. Since 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 isn't likely to slow, given the number of drugs on the market, the millions of consumers taking 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.
Drugmaker Wyeth faces more than 5,000 cases for Prempro and Premarin, hormone-replacement drugs for menopausal symptoms. The first trial started Monday in Little Rock. Plaintiff Linda Reeves alleges she developed breast cancer as a result of taking the drugs from 1983 through 2000. Breast cancer accounts for the majority of claims.
Wyeth and plaintiffs' lawyers refused comment, citing a judge's gag order. Wyeth has said it did nothing wrong and that the drugs' warnings reflected available scientific data and FDA requirements.
A study halted in 2002, the Women's Health Initiative, found that Prempro patients had a higher risk of breast cancer, stroke and heart disease. Later that year, Wyeth added a boldface warning on Prempro, which combines estrogen and progestin, and on Premarin, an estrogen, regarding the study.
In 2003, the warnings were put in a box, making them more prominent. 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 adequate. The case is being appealed, the plaintiff's lawyer says.
Wyeth's exposure is not likely to be nearly as large as the $21 billion it's paying to settle tens of thousands of claims over former diet drug fen-phen, linked to heart and lung problems. Not only are there fewer cases, but also it's difficult to prove that a drug caused someone's cancer — a key hurdle in most drug lawsuits, Noah says.
Plaintiffs in the Neurontin lawsuits face a similar challenge, says lawyer Mike Papantonio of Levin Papantonio Thomas Mitchell Echsner & Proctor, which does not represent any Neurontin plaintiffs.
Neurontin plaintiffs' lawyer Andrew Finkelstein has advocated that the FDA require a black-box suicide warning on Neurontin, which has been taken by more than 10 million people and is widely prescribed for pain and bipolar sufferers. Drugmaker Pfizer says there's no scientific evidence linking Neurontin and suicide.
"It's a difficult thing to get your arms around," Papantonio says. "Like the hormone-replacement therapy cases, there are so many complicating factors."
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 to the FDA. The reports do not prove a drug was to blame.
In the Ortho Evra birth-control patch cases, plaintiffs allege that the company failed to adequately test the patch's safety. Many of the women claim they suffered blood clots as a result of using it.
"The plaintiffs tend to be younger women, and you don't normally see strokes or blood clots in that population," Noah says.
The FDA last year required a warning on the patch, saying users will be exposed to 60% more estrogen than with typical birth-control pills. The warning came after the FDA and the drugmaker compared estrogen levels for the patch vs. pills. The FDA also said increased estrogen may raise the risk of clots.
When the FDA approved the patch in 2001, however, an FDA approval document said the risks were "similar to the risks of using birth-control pills."
The patch delivers more estrogen into the bloodstream. With pills, some estrogen is lost in the digestive tract.
Ortho-McNeil Pharmaceutical, and parent Johnson & Johnson, refused to comment specifically on the lawsuit allegations. 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 took a $1 billion charge 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, the No. 1 anti-psychotic, with more than 16 million users since its 1997 launch. Plaintiffs' lawyers claim AstraZeneca downplayed the diabetes risks and hid 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 threat of litigation will do little to stop 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 eat into research funds but change consumer behaviors. She cites a 2003 Harris Poll, commissioned by her group, that found that almost four out of 10 doctors had patients stop taking 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."