Pfizer sued over misleading Lipitor ads

So on the day Pfizer received an approval from the FDA to sell Lipitor to reduce the risk of stroke and heart attack in people with type 2 diabetes without evidence of heart disease but with other risk factors, the company also gets sued by Community Catalyst, Health Care For All, and Prescription Access Litigation Project (PAL), with the help of the law firm of Hagens Berman Sobol Shapiro.

What is the charge? Deceptive and misleading advertising for Lipitor. Pfizer is not new to this controversy. The company has been accused of misleading advertising for some of its other bestseller drugs like Celebrex, Bextra, and Viagra. The plaintiffs are saying that Pfizer misled consumers into using its anti-cholesterol drug Lipitor despite the absence of evidence from clinical trials that these drugs are of any benefit to large segments of the population.

Pfizer promoted Lipitor by claiming it prevents heart disease in women and the elderly, where no clinical test has established such a benefit. In fact, according to the complaint, women without heart disease taking Lipitor actually developed 10 percent ­more heart attacks than women treated with a placebo.

Lipitor is in the class of cholesterol-lowering drugs called statins and it is the best-selling drug in the world, with sales in 2004 of more than $10 billion. Lipitor and Crestor continue to be somewhat controversial drugs.

The proposed class action seeks to represent women who have taken Lipitor, people aged 65 and over, and third-party payers such as insurance companies, union health and welfare funds, and self-insured employers.

Related article: Pfizer sued for Viagra and blindness link

Heart patients victims of failed pacemakers and defribillators

First Guidant recalled several models of defribillators. That itself is not a major problem since companies often need to recall defective products when they are simply not aware of product problems unless they are used for a while. But the main problem was that Guidant continued to sell these defective products even when it knew they were failing.

Then one would expect that the FDA would let the American public know as soon as possible about any problems with the products that it monitors. On the other hand, FDA had reports of malfunctioning pacemakers and other heart devices but it never bothered to make the information public.

In the meantime, Americans were dying. From 1990 to 2002, there were approximately 2.25 million pacemakers (PMs) and 416,000 implantable cardioverter defibrillators (ICDs) implanted in the United States. During the same time period, 17,323 devices (8834 PMs and 8489 ICDs) were removed from patients due to confirmed device malfunction. The annual ICD malfunction replacement rate of 20.7 per 1,000 implants was significantly higher than the PM malfunction replacement rate of 4.6 replacements per 1000 implants. The PM malfunction replacement rate decreased significantly during the study. In contrast, the ICD malfunction replacement rate trended down during the first half of the 1990's but increased during the latter half of the study. In addition, more than 50% of the ICD malfunctions occurred during the last three years of the study.

PM or ICD malfunctions were directly responsible for 61 confirmed deaths out of the nearly three million devices implanted during this time period. However, the vast majority of reported malfunctions did not lead to death or serious injury, and were detected in time to ensure that patients would continue to receive therapy when it was needed, according to information released by the Agency after a long delay.

Unlike Guidant, which acted in a very irresponsible manner - more or less how Merck and Pfizer handled problems with Vioxx, Bextra, and Celebrex, Metronic, another maker of heart devices, is going to release the same data to doctors and patients that it provides the FDA.

What does it mean for you?

If you are a user of any heart device, you have enough reason to get worried. You may actually have a defective device and your doctor may not know about it and the manufacturer may be hiding that information from you.

More Canadian Vioxx victims sue Merck

Despite the fact that Canadian authorities may allow sale of Vioxx again, it does not mean that Canadians have not been hurt by the drug. And they are fighting back. Last month, The Electrical Industry of Ottawa Health and Benefit Trust Fund filed a class action lawsuit against the firm in Canada.

Now, like many other overseas victims of Vioxx, Canadians are suing Merck in the United States. According to Kenneth B Moll & Associates, they have filed the first class action lawsuit on behalf of all citizens of Canada who allegedly died or were seriously injured. "This is the first class action lawsuit filed on behalf of all Canadian consumers to seek compensation for serious injuries and deaths caused by a dangerous drug," said Mr. Moll. Previously, the law firm filed the first class action lawsuit against Merck, on behalf of all citizens of Italy, England, France and Australia.

Merck sued by State of Oregon over Vioxx

Merck, the maker of now-recalled drug Vioxx, is being sued left and right by Americans. As many as 60,000 may be dead in the US alone. After the Texas judgment, there has been a surge in number of lawsuits, particularly from victims overseas.

But individuals are not the only ones suing. Apart from many investigations underway by several government agencies, states are also suing the company for committing all kinds of fraud. For instance, while Vioxx victims in the state of Oregon are still not allowed to sue Merck, the State itself is not banned from asking for damages. Oregon State Treasurer Randall Edwards has filed two securities fraud lawsuits on behalf of the Oregon Public Employee Retirement Fund ("OPERF"). The suit seeks damages in excess of $15 million for violation of the Oregon Securities Law.

The complaint alleges that Merck and the individual defendants knew but failed to disclose that Vioxx caused a statistically significant risk of cardiovascular events, including heart attacks, strokes, and death. The State asserts that Merck knew of the medical risk even before the Food and Drug Administration approved Vioxx for use as a prescription drug in 1999.

Later studies performed by Merck and by others reinforced Merck’s knowledge. Yet Merck failed to disclose, and knowingly concealed, the risks created by Vioxx until September 2004 when it announced it would withdraw Vioxx from the market in response to what it claimed was "new evidence."

In reaction to Merck’s announcement, the stock price collapsed and has continued at a low level. The price fell further a month later, when the truth about Merck’s earlier failure to disclose the risks of Vioxx was publicly revealed. The lawsuit alleges that OPERF was harmed by Merck’s and the individual defendants’ failure to disclose important information about Vioxx because OPERF purchased over a million shares of Merck stock at inflated prices, before the truth was revealed.

Recommended article: Merck reaffirms its Vioxx legal strategy

Italian Vioxx users plan to sue Merck

As we had reported earlier, the Canadian victims have sued the Merck subsidiary there in the Vioxx recall case. As the Texas verdict was announced, there has been more news of lawsuits being filed. Since then the victims in France have already sued the company in US courts.

A new report says that a consumer rights group Codacons is helping Italian users sue Merck. A similar approach is also being taken in Puerto Rico.

According to Codacons estimates, as many as 3.5 million Italian nationals took Vioxx. The organization is also helping those injured by Bextra and Celebrex - two other drugs that are on the blacklist developed by the organization for dangerous drugs in Italy.

Recommended article: Merck reaffirms its Vioxx legal strategy