Avandia Attorneys

Avandia Attorneys

 UPDATE: FDA Cites Cardiac Risks in Severely Restricting Avandia

Regulators in Europe have prohibited the sales and use of Avandia and in the US, the FDA only permits its use in cases where every other diabetic drug has failed. Use in the US will require attestation by both the patient and physician that no other drug is a viable option to the patient and the patient fully understands the risks.

Once the largest selling diabetes drug around the world and reaping GlaxoSmithKline over $5 billion, sales of Avadia will most assuredly drop to nearly nothing now that regulators have confirmed the substantial dangers recognized by researchers for sometime.

Steven Nissan, from the Clveleand Clinic, and FDA investigators have both been sounding the warnings for sometime concerning the significant cardiac risks associated with the drug.

A History of Danger

In May of 1999, Avandia was introduced to the market by GlaxoSmithKline (known as GSK), and, at its peak, had sales of $3 billion per year and was used by morethan 6 million patients.

On May 21, 2007, Dr. Steven Nissen and other researchers at the Cleveland Clinic published a study showing a 43% greater risk of heart attacks and a 64% increased risk of cardiovascular deaths in patients taking Avandia. These researchers cautioned patients to consider the potential for serious adverse effects by taking the drug.

The Cleveland Clinic study was actually a meta-analysis that reviewed and summarized the findings of 42 different clinical studies involving Avandia. In response to this independent analysis, GlaxoSmithKline sought to undermine the study, rather than acknowledge it as a potential signal of dangerous safety issues with its blockbuster diabetes drug and was successful in encouraging a number of physicians and patients to continue taking Avandia.

In July of 2007, at an FDA Advisory Committee meeting, a number of telling comments were made by physicians and scientists that now form the core of the case against GSK and the focus of concern for patients:

  1. 70 percent of patients with type 2 diabetes die of coronary heart disease. So, coronary heart disease is the leading killer of patients with diabetes.
  2. The main reason for treating diabetic patients really is the hope of reducing coronary heart disease occurrence and deaths.
  3. Any drug used for the treatment of diabetes that increases the incidence or severity of coronary heart disease in patients with diabetes is unacceptable.
  4. There is no evidence, none whatsoever, to support a benefit of Avandia with these cardiovascular outcomes.
  5. The Cleveland Clinic study shows that there have been about 80,000 excess cases of cardiac death and heart attack attributable to Avandia use over the past 7 ½ years. If we are to wait for the completion of further studies to substantiate the safety of the drug, another 1,600 to 2,500 patients each month will suffer needless cardiovascular events.

At the 2007 FDA meeting, the FDA was urged by its advisors, public health advocates, members of Congress, and others to pull the drug from the market in the face of evidence that:

(1) Avandia increased the risks of suffering cardiovascular events;

(2) there were other diabetes drugs that were helpful in controlling blood sugar without increasing cardiac risk to patients;

(3) Avandia offered no unique short-term benefits sufficient to justify its use in face of the risks known at that time.
Surprisingly, the FDA chose not to pull the drug from the market, and instead worked with the manufacturer to enhance the warnings.

On November 14, 2007, a “black box” (the strongest level of warning for a pharmaceutical product) was added to the warning label for Avandia informing physicians (and, in turn, patients) of the potential for the drug to cause heart attacks, congestive heart failure, and other cardiovascular injuries.

The patients and their prescribing physicians, who were fortunate enough to have learned about this enhanced warning in late 2007, discontinued Avandia at that time. Others, however, were lulled into a false sense of security by GSK’s concerted efforts to discredit the alarming safety data and the drug manufacturer’s reassurances to patients and physicians that the drugs were safe, including the publication of its own safety studies (which were of questionable merit and validity).

In 2010, GSK faces renewed attention brought about by new adverse studies showing increased cardiovascular risks associated with Avandia. And, another FDA Advisory Panel met to discuss whether to recommend that the FDA request that GSK pull the drug from the market. Avandia’s biggest competitor, Actos, has also joined the fray by running full-page newspaper advertisements touting its safety and efficacy benefits over the beleaguered Avandia.

The FDA Advisory Committee that met in July of 2010 recommended (by a slim and very controversial margin) that the drug be permitted to remain on the market with enhanced warnings and cautionary statements. They recommended it be made clear to patients and physicians that there exists only a very limited subset of patients for whom prescriptions of Avandia might be appropriate in light of the now-known risks.

The FDA, however, has not yet made a final decision on whether it will permit GSK to continue to sell the drug. Thankfully, most physicians and patients have finally received word about the safety issues and sales of Avandia have fallen precipitously since 2007.

The First Knowledge of Danger

The first public indications of cardiovascular health risks associated with ingestion of Avandia in 2007 were not a revelation to GSK. Internal GSK documents show that the manufacturer knew as early as April of 1999 (and prior to the drug being sold in the United States) that Avandia causes harmful changes in HDL (good cholesterol) and LDL (bad cholesterol) cholesterol levels, which, in turn, increases cardiac risks. At that time, some employees within the company recommended special warnings be given to prescribing physicians about these risks. Recommendations within the company were also made to pay for long-term safety studies to substantiate safety, but those recommendations were rejected. Instead, GSK, like many drug companies, funneled obscene amounts of money into launching, promoting and advertising its new “blockbuster” drug.

Status of Litigation

The litigation against GSK involving Avandia began in 2007. On October 16, 2007, a panel of federal judges (known as the Judicial Panel on Multi-District Litigation or JPML) decided to transfer all of the pending cases in the federal system to a single judge for oversight of pre-trial proceedings. This is a process known as multi-district litigation and is often utilized in mass torts cases where a number of claimants have been injured in a similar fashion by a drug, medical device, other product, pollution, airline crash, etc. MDL cases often include class action claims, but are generally aimed at managing a large number of individual lawsuits filed by Plaintiffs who have all suffered harm due to the same general conduct of the Defendants.

The judge assigned to the Avandia Marketing, Sales Practices and Products Liability Litigation MDL (MDL No. 1871) is Judge Cynthia M. Rufe from the United States District Court for the Eastern District of Pennsylvania in Philadelphia. Judge Rufe appointed a steering committee of lawyers to help streamline the cases when the MDL was established.

In the nearly three years since then, the steering committee and other attorneys have been working to review more than 6 million pages of documents and complete hundreds of depositions of fact and expert witnesses in preparation for the first Avandia jury trials. The first trials in the Avandia MDL are scheduled for the fall of 2010. However, GSK has begun settling a number of the filed cases, which may impact the timing for the first trials.

The uncertainty with regard to whether Avandia is going to be permitted to remain on the market as well as the recent additional studies confirming cardiovascular risks have led to a recent surge in lawsuit filings. Currently, there are more than 900 individual Avandia lawsuits filed in federal court, as well as cases pending in coordinated proceedings pending in state courts in Pennsylvania and California.

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