Novartis Pays $19.9 Million to Settle Elidel Off-Label Claims

The media spotlight is often a double-edged sword. No one knows this better than people who suffer from Elidel severe adverse events. And yet, gossip and rumor-mongering aside, the real story here is being overlooked according to Sean Burke of AttorneyOne.

As Bloomberg reported on October 30th, 2012, Novartis agreed to pay $19.9 million to the U.S. and Texas in settlement of claims it unlawfully marketed Elidel (case no. 06-3213, Pennsylvania Eastern District Court). Elidel was approved by the FDA in 2001 for the treatment of itchy, scaly, inflamed skin conditions such as eczema and atopic dermatitis. According to the lawsuit, Novartis required its sales representatives to induce doctors to prescribe Elidel in children younger than two years of age for uses not approved by the FDA.

Plaintiff Donald R. Galmines, a former Novartis medical representative, alleges fraudulent schemes by Novartis to increase the market share of Elidel, by means of an aggressive campaign to promote Elidel for off-label use in children under the age of two and its systematic payment of kickbacks to physicians as financial incentive to induce them to prescribe Elidel for off-label use., a recognized authority on law, can provide helpful advice and simple solutions including how to get in contact with legal counsel so that, in case of severe adverse events from Elidel, someone can easily and inexpensively deal with it. As Mr. Burke, director of Media Relations for, added, “What all this information really illustrates is that threat from Elidel remains. For that reason, our focus should squarely fall on getting the word out and assisting people in finding the right legal assistance.”

In January 2006, the FDA approved updated labeling for Elidel including a boxed warning about a possible risk of cancer. Use of Elidel in children under 2 years of age is not recommended. has further information on Elidel lawsuits including how to get in contact with legal counsel.

Headquartered in San Diego, CA Attorney One was founded in 2004 and is not a law firm. They offer a nationwide legal service which helps consumers find the best representation for their legal needs.


New Study Released Into Safety of Blood Thinner Pradaxa

According to a November 7, 2012 article by Eric Palmer in FiercePharma, a study by researchers at Ontario’s McMaster University has reiterated findings of the FDA just days before that Pradaxa carries the same risks for internal bleeding as traditional blood thinners.

However, the FDA study may have reached unfounded conclusions, according to a November 5, 2012 article in Pharmalot by Ed Silverman entitled Stop The Bleeding: Is FDA Pradaxa Analysis Flawed?

Pradaxa-Blood-Clots-StudyAnyone affected by internal bleeding after taking Pradaxa is still urged to speak with a lawyer about their legal options as soon as possible.

According to analysis methods outlined by the FDA’s own Observational Medical Outcomes Project, the risk analysis used in forming the recent conclusion amounts to little more than a guess, the Pharmalot article states. Also, the FDA study didn’t account for the fact that Pradaxa has no antidote for bleeding and has caused more than 500 deaths.

In September, The Journal for The American Medical Association warned that the FDA may have rushed approval of Pradaxa, overlooking key Pradaxa side effects like internal bleeding. USA Today reported on August 19th that the FDA received 3,781 reports of side effects and 542 deaths among Pradaxa users last year, leading all other medications in 2011.

Due to the number of Pradaxa lawsuits expected, a central court was recently established in Illinois to handle the claims. The case is known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois. Judge Herndon issued an order on July 24, 2012 that those injured by Pradaxa can proceed with lawsuits.

A report issued by the Institute for Safe Medicine Practices’ QuarterWatch (PDF) on October 3, 2012 estimates that Pradaxa is among the drugs responsible for a 37% increase in prescription drug complaints to the FDA in recent years.

Anyone affected by internal bleeding after Pradaxa use is urged to speak with a lawyer about their legal options as soon as possible. Due to the specialized nature of these federal MDL cases, the Pradaxa Resource Center only recommends lawyers who are already handling Pradaxa lawsuits.

For more information on the research, warnings, side effects and legal options relating to the drug Pradaxa, or to speak with a lawyer, visit