The debate among Supreme Court Justices is in the matter of whether consumers have the right to sue drug companies when the FDA has approved a drug for use. The strength of the argument presented by Levine's lawyers is that Wyeth is attempting to use FDA labeling to deny her a Consumer’s right to hold a Pharma company liable.

This is not the first case of involving a Pharma company being sued for harmful and deadly side effects of their drugs. A few notable instances include, Glaxo for their drugs Paxil and Avandia, Purdue Pharma for Oxycontin, Merck & Co. for Vioxx. In some cases, deficient research led to serious risks that was overlooked. In others, misleading advertising that omitted possible risks was the basis of these lawsuits.

The issue of FDA labeling as insurance to preempt lawsuits by consumers is an important aspect of the Wyeth v. Levine case. The issue of preemption is supported by the current Bush Administration in its attempts to reduce lawsuits by consumers against drug companies. Pharmaceutical companies argue that stiffer regulations and standards inhibit their research of newer, more effective drugs.

In the Levine case, Wyeth's argument reduces the lawsuit to a simple case of medical malpractice. Surprisingly, the FDA stands with Wyeth in the argument. The Federal Agency that is supposed to be on the side of Consumers, feels that once the FDA approved the drug for use, extraordinary risks that may appear as a result of use at some later point should not be a consideration for lawsuits against drug companies that have received FDA approval and are labeled as such. This begs the question: Who should be liable and held accountable if the FDA and the pharmaceutical maker fails to catch something in trials or overlooks a deadly side effects, because of the rush to get a drug on the market?

Another valid point of the argument by Levine’s lawyers is that Wyeth did not advise physicians or consumers of the danger of using the "push" method of injection of Phenergan. It is safe to say, that maybe more people would have had second thoughts about using this drug, if they would have known about the additional dangers. Moreover, in another case, Pfizer's anti-nausea drug, Vistrol, caused gangrene when injected into the arteries and Wyeth should therefore have requested an FDA to change the label warning of this on their Phenergan label.

The State of Vermont awarded Levine $6.8 million. In preemption arguments, federal law supersedes state law. Justices Scalia, Alito and Roberts argued in favor of Wyeth while Bader-Ginsberg argued in favor of Levine.

It would be simple to view Wyeth's position as one of preemption vs. adequacy of disclosure. Ultimately, the Supreme Court must address the potential for future lawsuits of this nature. They must also address the issue of what happens if the drug company gives the FDA false or misleading information about a drug that later proves to be harmful to consumers. Consumer advocates everywhere are following this case closely. Let’s see if the Supreme Court can do the right thing and tell Wyeth and the FDA that they do not get a free pass in this case. They are responsible for the safety of drugs that are put on the market, even if the FDA gives the drug a stamp of approval.

Jacob Goldstein, Writer and Blogger for the WSJ Health Blog, shares a few insightful comments from Diana Levine in his blog post "Wyeth v. Levine: The Mother of All Preemption Cases". He also includes a nice candid photo of the woman who Wyeth is going after for fighting for her rights to hold them accountable for taking their migraine drug that caused her to have her arm amputated. All eyes are on the Supreme Court regarding the decision of this case.  Let's see if they can get it right and hold the Pharmaceutical companies liable for unreported risks and dangers associated with their drugs.
 

It is important to note that NHLBI officials stressed that they have been unable to link the increased deaths in the study to any drug, including Avandia. There are over 18 million Americans that have been diagnosed as having diabetes, with type 2 the most common form.

Click here to read more from the Associated Press and MSNBC on the recent deaths from dug intense therapy to lower blood sugar.

This new legislation may be able to prevent future repeats of what happened with Vioxx, the Merck & Co. painkiller, allegedly linked to heart attacks and strokes, and Avandia, GlaxoSmithKline Plc's diabetes pill linked in some studies to a risk of heart attacks.

I hope that  Representative Henry Waxman, a California Democrat, is correct in his assessment that the legislation ``provides FDA with critical tools the agency has been desperately lacking in its efforts to protect the American public from unsafe drugs". Now let's see if the Senate agrees.

Click here to read more on this new FDA legislation from Bloomberg News.

The articles were discussing the newly released public notice from the FDA on the "Early Communication About an Ongoing Safety Review Omeprazole (Prilosec) and Esomeprazole (Nexium)"

In the FDA public notice there is an alarming statement as to increased heart attacks and heart failure. An excerpt from the FDA public notice states "The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery."

However, on the other hand,  Paul Seligman, an associate director in the FDA’s Center for Drug Evaluation and Research, tells reporters “It’s hard to know how this process will play out” and that “this is something of a moving target." This public notice was released to make the pubic aware the FDA is looking into this and will have results from more tests in about three months.

Should the public be alarmed? Is the FDA trying to prevent another Avandia? Time will tell.

On a positive note, it is good that the FDA released this public information rather than an independent source.  The FDA communicated this new information in a somewhat timely manner. On May 29, 2007, AstraZeneca, the manufacturer of Prilosec and Nexium sent FDA  their preliminary review of new data from two studies about the potential heart risks. Since that time, the FDA has been going over the data.

FDA "thank you" for making a bold step in sharing this information about Nexium and Prilosec to the public. We remain hopeful that you will honor your obligations to the public and find out if these two drugs are safe for the public or are they detrimental to increasing a patient's heart risks.

Let's all hope that Neium and Prilosec do not become the new Avandia.

Click Here to read more on Prilosec or Nexium from Forbes and from the  Star-Ledger of New Jersey's Pharmalot.com.

There has been controversy among regulators, drug company officials, physicians and advocates for patients, who have offered dueling interpretations of contradictory safety studies. Maybe it is because it is a "Billion Dollar Baby" for the North Carolina Drug Maker, GlaxoSmithKline. Last year, Avandia produced $3 billion in sales for the company. Today, stock for GlaxoSmithKline closed at $51.08, an increase of $1.64 per share. I think that shareholders must be happy with the news of the new FDA warning.

                                           
The company that produces Tums and other well known brands have been given another chance to make a difference in the lives of millions of people around the world. Let's hope that this miracle they received, will keep them in check and make them proactively share critical information to unsuspecting consumers before they take a GSK drug or product, instead of after the fact. Good corporate citizenship requires as much, if not more.Click Here to read more from the Washington Post on the Avandia FDA Warning.

The LaBovick Injury Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors. 

Avandia, a popular diabetes drug, has just been dealt another strike. A new report from the FDA on Wednesday, finds that  patients who take Avandia, face an increased risk of heart attacks over those who take Actos, a similar drug.  According to a recent New York Times article, one review in the study included the following statement: "Patients with heart disease and those taking insulin should not take Avandia". 

Avandia increases the risks of heart attacks by as much as 40 percent in most diabetes patients. In those taking insulin or nitrates, the risks are higher, according to the drug agency’s analysis.  Most diabetics die of heart disease. This news is unsettling, given that the drug was created to save lives, not help cause greater risks.

The FDA is stepping up and diligently trying to ensure the safety of Avandia patients. After the harsh but necessary criticism from Iowa Republican Senator  Charles E. Grassley. Mr. Grassley said. “If F.D.A. leaders are asleep at the switch, it’s a dereliction of duty. But if they’re knowingly suppressing information about risks to public safety, then it’s morally corrupt.” We need more lawmakers to stand up and hold agencies in charge with protecting the public accountable. This should be a bi-partisan issue. It affects everyone.

Unfortunately, this news does not bode well for the drug maker, Glaxo Smith Kline, since the drug is billion dollar producer for the company. Last year Avandia had sales over $3.4 billion. Upon news of this new report, the shares of stock fell $1.40, closing at $51.23.  I am sure the company executives and shareholders are nervous. If the full report that comes out on Monday, and shows more risks for Avandia patients, the drug could be in more danger.  All eyes are on Avandia and the FDA report that comes out on Monday. Should GSK be nervous?  Is there really a reason for this alarm?  Time will tell if GSK will hit a base hit or a sacrificed fly and score a run with this billion dollar drug? I don't really see how they can hit a home run with this one. The other side seems to have scored a few good runs, with these new findings.  Time will tell... Stay tuned....

Click Here to read more on Avandia from the New York Times article