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Louisiana Actos MDL First Trial Dates Scheduled
After studies showing that the use of Actos can increase the risk of bladder cancer, patients who have suffered from bladder cancer as a result of taking Actos have been filing lawsuits against Takeda pharmaceuticals, the manufacturer of Actos.
Up to 10,000 of these lawsuits are expected to be consolidated in a multi-district court in Louisiana (Re: Actos Products Liability Litigation, MDL 2299, U.S. District Court, Western District of Louisiana (Lafayette)). Judge Rebecaa Doherty, the judge in charge of the Actos litigation, announced on July 13th that the first Actos trial is scheduled in November 2014.
Nick Bruno is a Legal Assistant at Thompson & Tredennick
5 Retail Chains File “Pay for Delay” Suit Against Pfizer
Walgreen, Kroger, HEB, Safeway, and Supervalu filed a lawsuit in the US District Court in Trenton, New Jersey claiming that Pfizer engaged in patent fraud and anti-competitive conduct to keep a generic version of Lipitor off the market according a Houston Chronicle article on July 8th.
In a deal known as “pay for delay”, Pfizer, the manufacturer of Lipitor, a the world’s top selling drug, entered into a settlement with Ranbaxy Laboratories to pull their generic version of Lipitor off the market and to delay any further developments of generic Lipitor. The lawsuit filed by the five drug and grocery chains claims that this is “illegal, anti-competitive conduct.”
This case is similar to the K-Dur 20 case in which Schering-Plough Corporation payed Upsher and ESI to delay introduction of generic versions of K-Dur 20 to the market. The US Court of Appeals for the Third Circuit ruled earlier this week that such “pay for delay” deals are unlawful.
The plaintiffs claim that generic versions of Lipitor should have been available in the United States two years ago when the original patent expired. They claim that Pfizer engaged in anti-competitive practices to protect their profits from a drug that had peak sales of nearly $13 billion annually.
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Court Rules Against Pay for Delay
In a deal known as “pay for delay”, In 2005 Schering-Plough Corporation, the manufacturer of K-Dur 20, entered into a settlement with Upsher and ESI to delay any developments of a generic version of K-Dur paying Upsher $60 million to delay the generic until 2001 and ESI $15 million to delay its generic until 2004.
The Federal Trade Commission filed a suit against Schering, Upsher, and ESI in which it claimed that this settlement violated anti-trust laws. Other federal appeals courts have upheld these agreements and the District Court ruled that the deal was legal. However, earlier this week, the US Court of Appeals for the Third Circuit reversed the decision and ruled that such pay for delay deals are illegal. The court stated that future cases should use a
[Q]uick look rule of reason analysis based on the economic realities of the reverse payment settlement rather than the labels applied by the settling parties. Specifically, the finder of fact must treat any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market as prima facie evidence of an unreasonable restraint of trade, which could be rebutted by showing that the payment (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit.
FTC Chairman Jon Leibowitz commented on the decision:
These sweetheart deals are presumptively anticompetitive. As our Bureau of Economics has estimated, they cost consumers $3.5 billion a year in higher health care costs. Restricting these arrangements, as many in Congress have proposed, would reduce federal government debt by $5 billion over 10 years, according to the Congressional Budget Office. It’s time for the pharmaceutical companies to return to the side of consumers.
Thompson & Tredennick partner Ted Tredennick states, “Finally, the courts have come to their senses. These ‘pay for delay’ agreements are nothing short of fraud and are certainly anti-competitive. The government and consumers alike have been over-charged for years and its time Big Pharma was held accountable.”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Status Meeting on Zoloft MDL
An initial status conference on the Zoloft multi-district litigation began yesterday, July 12th. The plaintiff’s and defendant’s attorneys met with Judge Cynthia M. Rufe to “discuss an over of the litigation and assign leadership roles” according to an article from the Clark Law Firm.
In April 2012, a Zoloft MDL was established in the US District Court of the Eastern District of Pennsylvania. Plaintiffs are suing Pfizer, the manufacturer of Zoloft, for failing to warn of birth defects that are associated with the use of Zoloft.
While the US District Court of Eastern District of Pennsylvania has not yet posted a report of the meeting, the status meeting was expected to discuss the number of cases in the MDL, to set a schedule for filing and responding to complaints, and organizing discovery proceedings.
Nick Bruno is a Legal Assistant at Thompson & Tredennick
US Judicial Panel on Multidistrict Litigation to Decide on Pradaxa MDL
The U.S. Judicial Panel on Multidistrict Litigation will decide whether to consolidate Pradaxa liability cases in one central federal court on July 26th.
On May 30th, a motion was filed to consolidate all Pradaxa Product Liability cases in one central federal court. This motion follows numerous cases being filed against Boehringer Ingelheim, the manufacturer of Pradaxa. Lawyers expect as many as 500 cases to be filed against the manufacturer.
Plaintiffs are alleging the Pradaxa has led to serious bleeding and even death. Pradaxa actually leads all drugs in the US in the number of adverse drug reactions that patients suffer after taking these drugs.
Nick Bruno is a Legal Assistant at Thompson & Tredennick
GSK Settlement is a “Slap on the Wrist”
Last week in a settlement Deputy Attorney General James Cole called “unprecedented in both size and scope”, GlaxoSmithKline agreed to pay $3 billion over fraud regarding its drugs Paxil, Wellbutrin, and Avandia. The settlement received extensive media coverage from numerous news sources.
Yet, Larry Bodine, a former litigator at Stafford Rieser Rosenbaum & Hansen, former Editor of American Bar Association Journal, and Editor-in-Chief of Lawyers.com, a legal news blog, argues that this $3 billion fine is only a “slap on the wrist” for GSK. First, $3 billion is only a small percentage of the $44 billion of sales GSK had in 2011 alone. GSK had already set aside money to pay for any upcoming legal settlements such as the $3 billion settlement last week.
According to Bodine, Glaxo illegally promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved this use. Glaxo helped in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil was effective in treating depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the company hid data from two other studies in which Paxil also failed to help depression in minors.
Thompson & Tredennick partner Joel Thompson comments, “”Sure, its apparent GSK did a lot of things they shouldn’t have done. But what’s not getting mentioned too much in these articles is the thousands of children that are being forced to live their lives with birth defects caused by a GSK product. To me that’s what makes their actions not only disgusting, but criminal.”"
Nick Bruno is a Legal Assistant at Thompson & Tredennick
FDA Proposes New Label For Over-the-Counter Acetaminophen
Last week, the US Food and Drug Administration issued draft guidance on guidance for the industry on labeling for over-the-counter Acetaminophen products for comments and suggestions.
The current warning label reads:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ● More than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: "for this product"] ● With other drugs containing acetaminophen ● 3 or more alcoholic drinks every day while using this product.
The FDA is proposing removing “which is the maximum daily amount [optional: "for this product"]” as this has led to confusion among consumers for two reasons.
First, if the manufacturer publishes the maximum daily dosage of Acetaminophen (4,000 mg), consumers can mistakenly read the label to mean that 4,000 mg is the maximum daily dosage for the particular product rather than the total amount of Acetaminophen.
Second, if the manufacturer publishes the number of tablets as the maximum number of daily dosage units, patients may believe that a dosage lower than 4,000 mg is unsafe. According to the FDA, “As a result, stating the product’s maximum amount in tablets or dosage units instead of milligrams could be misinterpreted to suggest that consumers might suffer severe liver damage at a dosage much lower than the 4,000 mg maximum daily amount.”
The new proposed wording for the warning label reads,
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.
Thompson & Tredennick Partner Ted Tredennick agrees with the proposed label changes, “I agree with this change, but in a perfect world the label would read: “Exercise extreme caution when taking this medication. It can cause acute liver failure. TAKE AT YOUR OWN RISK!”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
CMAJ: Actos Increases Risk of Bladder Cancer by 22%
A new meta-analysis published in the Canadian Medical Association Journal (CMAJ) on July 3rd found that Actos increases the risk of bladder cancer. This study follows studies in the Diabetes Research and Clinical Practice Journal and BMJ which also found that Actos is linked to an increase in the risk of bladder cancer.
The CMAJ study examined 10 different studies on that thiazolidinediones, the class of drugs that includes Actos, with a total of 2.6 billion patients who took Actos including 3,643 people who were newly diagnosed with bladder cancer after taking Actos.
The CMAJ study found that thiazolidinedionesin general increase the risk of bladder cancer but found that Actos in particular increases such risk with Actos being associated with a 22 percent increase in the risk of bladder cancer according to Jeffrey A. Johnson, one of the authors of the study and a anada Research Chair in Diabetes Health Outcomes at the University of Alberta School of Public Health, in Canada.
Nick Bruno is a Legal Assistant at Thompson & Tredennick
GSK Will Plead Guilty and Settle with US Government Regarding Paxil, Wellbutrin, and Avandia
In a settlement “unprecedented in both size and scope”, GlaxoSmithKline will settle with the US government for $3 billion over fraud regarding its drugs Paxil, Wellbutrin, and Avandia. GSK will pay $1 billion in criminal settlements and $2 billion in civil settlements with the US government. According to the Department of Justice, the settlement and guilty plea is not final unless accepted by the US District Court.
Paxil
GSK pleaded guilty to illegally promoting Paxil for patients under 18 despite no FDA approval for pediatric use. In addition, the US government alleged that GSK had published a misleading article on Paxil and adolescent use.
Wellbutrin
Wellbutrin was approved by the FDA for depression. However, the US government alleged in 2003 GSK promoted Wellbutrin for off-label use (such as weight loss) spending millions for these promotions at meetings with doctors.
Avandia
The US alleged that GSK failed to report safety data during 2001 and 2007 to the FDA – data that would have led to “black box” warnings for Avandia.
In a statement on GSK’s settlement regarding Paxil, Wellbutrin, and Avandia, Deputy Attorney General James Cole remarked “Today’s multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud. At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust – and this historic action is a clear warning to any company that chooses to break the law.”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
