Avandia, the popular Type 2 Diabetes drug, stands accused of heart related deaths and injuries, despite conflicting data. Lawsuits filed in the United States and Canada contend that pharmaceutical company, GlaxoSmithKline, failed to adequately test Avandia, or to warn of possible health risks and heart related deaths. Claimants say they misrepresented the drug as being safe.
About Avandia and GlaxoSmithKline:
Rosiglitazone maleate, more commonly known as Avandia, was created to treat Type 2 Diabetes in1999, by SmithKline Beecham, a pharmaceutical company based in the UK.
Avandia is used orally as an anti-diabetic agent. GlaxoSmithKline explains that Avandia increases insulin sensitivity which helps the body to use its own insulin. Avandia was approved for use by the U.S. Food and Drug Administration (FDA) in 1999, with Health Canada issuing its approval in 2001.
In 2000, SmithKline Beecham merged with Glaxo Wellcome to become GlaxoSmithKline, who continued the sale of Avandia, with milestone sales of over one million prescriptions in the U.S. recorded. Two years later, in 2002, sales increased to over 20 million prescriptions in the U.S.
Concerns about dangerous side effects surface:
In 1999, Dr. John Buse, a researcher with SmithKline Beecham, publicly brought to light his concerns of dangerous side effects from the use of Avandia, including an increased risk of heart attack. He addressed his concerns in a letter to the FDA in March, 2000. In 2001, the FDA issued a reprimand to GlaxoSmithKline for downplaying the risks to sales representatives and undercover investigators at a medical conference.
Dr. Stephen Nissen joined the chorus of concern in an article he wrote and published in the May, 2007, issue of the New England Journal of Medicine. It is available online at: < http://content.nejm.org/cgi/content/full/NEJMoa07276 1.
He concluded that Avandia needed more study to clarify risks of heart attack or congested heart failure, based on research data indicating that patients who took Avandia had a 43% higher risk for a heart attack. Public Citizen noted a decrease in Avandia usage after Dr. Nissen's article was published. The first lawsuit was filed in May, 2007, in the U.S. District Court for the District of Puerto Rico.
Finally in May, 2007, the FDA issued a safety warning for Avandia. Then, under increased pressure, the FDA issued its strongest warning, a "black box warning," in August, 2007, to note the increased risk of congestive heart failure, followed by a revised black box warning in November, 2007. You may read a copy of the black box warning at < http://www.fda.gov/cder/foi/label/2007/021071s028lbl .pdf>. At that time, the FDA concluded there wasn't enough evidence that Avandia had greater risks than any other similar diabetes drug. They requested a new study be undertaken by GlaxoSmithKline.
In June, 2007, a Congressional investigation began. A hearing was called by Rep. Henry Waxman of the House Committee on Oversight and Government Reform to discuss the FDA's safety assessment of Avandia. Dr. John Buse and Dr. Stephen Nissen were called as witnesses. Dr. Buse acknowledged that he had felt intimidated by Glaxo when he raised concerns about the risks of Avandia. The head of the FDA at the time, Dr. Andrew Von Eschenbach testified that Glaxo provided reports from studies about Avandia in 2006. Since the results from the studies were inconsistent, the FDA began their own investigation to determine risks associated with the drug.
The latest Avandia label revision was in October, 2008. Today, it carries a strong warning of serious side effects including new or worse heart failures, an increase in the risk of heart problems associated with a reduced blood flow to the heart, and other serious side effects.
Recent Court Actions:
With multiple lawsuits filed all over the United States, a motion was made to The United States Judicial Panel on Multidistrict Litigation (the MDL Panel) to determine if there was merit in transfering them to one federal district. The suit titled, Avandia Marketing, Sales, Practices and Products Liability, was assigned a docket number, MDL No., 1871. The case was filed in the U.S. District Court for the Eastern District of Pennsylvania, where GlaxoSmithKline is headquartered, in October, 2007, under Judge Cynthia M. Rufe. The Case Management Order, Tolling Agreement, and Plaintiff Fact Sheet Documents are available to the public online at: < http://www.paed.uscourts.gov/mdl1871.asp>.
In a press release dated, December, 2007, GlaxoSmithKline states: "Across multiple sources of data, there is no consistent or systematic evidence that rosiglitazone increases the risk of myocardial ischemic events or death in comparison to other anti-diabetic agents".
A pretrial conference was held in April, 2008, to discuss procedures for the discovery phase to decide on transferring suits to the U.S. District Court.
In May, 2008, a Memorandum & Order Regarding Consolidated Filing by Plaintiffs was filed to rule on whether multiple plaintiffs' suits could be joined into one complaint. This document is available online at: <http://www.paed.uscourts.gov/documents/opinions/08D0 540P.pdf>
In August, 2008, another class action lawsuit was filed in Canada.
In January, 2009, a hearing was scheduled where it was revealed that three plaintiff suits were in opposition to being transferred to the U.S. District Court. The document is available at: <http://www.jpml.uscourts.gov/Hearing_Info/HearingOrd er1-29-09.pdf>
In February, 2009, the Memorandum Opinion and Order of the court stated that seventeen of the many individual suits had been transferred to an MDL docket. The Memorandum Opinion and Order document is available online at: < http://www.paed.uscourts.gov/documents/opinions/09D0 206P.pdf>
Further action is pending in California for thirteen cases remanded back to the state. The rest will be heard in Federal court when the MDL trials begin in mid 2010.