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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
Drug Recalls Continue to be a Problem
In a recent interview with ABC News, Dr. Steven Nissen addressed the fact that drug recalls continue to be a problem in the United States. Nissen criticized the regulatory process as being “far from perfect,” explaining that, “some drugs make it on the market without adequate information about their safety and efficacy.” Central to the problem is the surveillance system to determine unsafe drugs which, according to Nissen, is of “very poor quality.” Further, reporting to the FDA is only voluntary–practitioners are not required to report patients with serious adverse effects to a drug. According to Nissen, only 1-10% of all serious adverse effects are reported; the result is that “many drugs don’t get recalled until they cause considerable harm.”
Surprisingly relevant to his criticisms of the surveillance and reporting systems is Nissen’s alleged recent involvement in Takeda Pharmaceutical Company’s apparent violation of the Federal False Claims Act. In 2007, Nissen published a study finding an increased risk of acute myocardial infarction and cardiovascular death in patients prescribed Avandia, a diabetes drug manufactured by GlaxoSmithKline. According to the federal government, Nissen’s study encouraged increased reporting of adverse effects of Avandia which allowed Takeda to market Actos, a similar diabetes drug, as the safer alternative. The government alleged that Nissen’s 2007 study and the fact that he stood to profit financially by directly attacking Avandia since, at the time the study was published he was serving as the principal investigator of a Takeda-sponsored trial to show Actos lowered cholesterol, combined with Takeda’s failure to report adverse events in patients taking Actos, led to Actos’ fraudulent domination of the prescription drug market for type II diabetes treatment.
Kelsey Tissue is a Law Clerk at Thompson & Tredennick
Washington Post: Bisphosphonates among Drugs Doctors “Recommend When They Shouldn’t”
Previous posts have discussed the link between bisphosphonates and atypical fractures.
Less than a week after the Wall Street Journal published an article discussing a new study that found the bisphosphonates can increase the risk of atypical fractures, the Washington Post published an article describing the most typical drugs and procedures that are recommended by doctors which go against the practices that would be recommended based on current medical research. The article mentions that doctors commonly prescribe bisphosphonates such as Fosamax or Boniva for osteopenia although “there is little evidence that people with osteopenia benefit from the drugs.”
Not only do the drugs do little to help people with osteopenia but such prescriptions, according to the Washington Post, “pose numerous risks that include thigh fractures, throat or chest pain, and difficulty swallowing.”
Thompson and Tredennick partner Ted Tredennick comments, “The continuing media attention to the risk of bisphosphonates further highlights the dangers that continued use of bisphosphonates cause.”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Study: Spinal Cord Injury Patients at Risk from Wheelchair Breakdown
A report finds that spinal cord injury patients are at risk due to a rising number of wheelchair breakdowns.
The American Journal of Physical Medicine & Rehabilitation published a report found that 53% of those using wheelchairs during a 2006-2011 study had suffered a wheelchair breakdown in the last six months. This is up from 45% in a 2004-2006 survey. In addition, the average number of wheelchair reports per patient increased from 1.03 to 1.42 during these same time periods.
The increase in wheelchair breakdowns led to a higher number of injuries with adverse consequences rising from 22% to 30.5% of all breakdowns resulting in some sort of injury.
The study also found that current testing requirements do not ensure that wheelchairs meet basic safety requirements. According to Dr. Michael Boninger, the author of the study, “This paper should serve as a call to reevaluate and revise current policies and standards testing for wheelchair prescription in the United States.”
Thompson & Tredennick Partner Ted Tredennick who also serves as a Board Member of the National Spinal Cord Injury Association says, “As a manual wheelchair user myself, I understand how critical it is for one’s wheelchair to function properly. If my chair breaks down, everything stops, and I’m literally stuck. I’ve been lucky and the most pressing issue I’ve had to deal with is a couple of flat tires, but many are not – especially if you use a motorized chair. What’s really sad is that most insurance companies refuse to pay for standard maintenance on wheelchairs that can prevent a lot of these breakdowns.”
Nick Bruno is a Legal Assistant at Thompson and Tredennick
Z-Pak and Sudden Death
On May 17th, the New York Times published an article discussing the risks of the antibiotic azithromycin popularly known as the “Z-Pak”.
A new study published in the New England Journal of Medicine found that azithromycin could lead to sudden death by causing abnormal heart rhythms. The study examined 540,000 Medicaid patients and found 64.6 deaths per million prescriptions.
Over 55.3 million prescriptions were written for azithromycin in the US last year alone. Considering this high prescription rate, many doctors are especially concerned of the risk of death from abnormal heart rhytyms. Dr. John Bartlett, a professor at Johns Hopkins University School of Medicine says, “We use azithromycin for an awful lot of things, and we abuse it terribly. It’s very convenient. Patients love it. ‘Give me the Z-Pak.’ For most of where we use it, probably the best option is not to give an antibiotic, quite frankly.”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Welcome!
Welcome to the Thompson & Tredennick LLP Blog. We are a personal injury law firm based in Houston, Texas with clients from all around the country. We are involved with personal injury cases with practice areas ranging from burn injuries to pharmaceutical litigation. To read more about our law firm, please visit our website.
Thank you for visiting our blog! As time goes on, we plan on blogging about developments in the pharmaceutical tort arena and our involvement in these cases.
