Novartis Lawsuit Information

Most Novartis lawsuits have dealt with dangerous drugs, over inflating the price of drugs or patent infringements.



Novartis is a merger of Ciba-Geigy and Sandoz Laboratories, the largest corporate merger in history. The merger partners' combined histories span more than 250 years.

Novartis Problems & Legal Issues

In 2008 FDA inspectors found problems at the Novartis North Carolina plant. The FDA warned Novartis they haven't properly validated the manufacturing process for metoprolol succinate ER (generic Toprol XL) tablets before selling them. The FDA is also questioning whether Novartis should continue to distribute this product.

Furthermore there are concerns about the validation process for other drugs made at the same plant, indicating a possible problem with poor decision making with other product validations. There may be a Novartis lawsuit over this.

Galvus, a diabetic medication made by Novartis, is starting to present some problems. In high doses it apparently causes elevated liver enzyme levels. This glitch will likely delay the launch of this drug (until 2010) and may make its approval for the US market more difficult - particularly in light of the liver complications.

There are also some indications this drug may cause skin lesions. There are several more safety studies that have to be undertaken. If not thoroughly tested and cleared, this drug may contribute to more Novartis lawsuits in the future.

Novartis Lawsuits

A 2007 Wrongful Dismissal/Whistleblower Lawsuit dealt with Famvir, a genital herpes drug. It was alleged Novartis fraudulently inflated the price of the drug and then fired the employee who complained about it.

The employee had apparently been complaining about attempts to overstate the value of Famvir. Furthermore it was alleged the managers knew they overpaid for the drug in 2000 and that the investment could never be recovered. Other allegations centered around worthless clinical trials and overvalued future sales projections.

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A Class Action Lawsuit concerning discrimination in employment was filed against Novartis in 2007, $100 million in damages was sought. Nineteen current and former female drug sales people represent 4,000 to 5,000 current and former workers of Novartis dating back to 2002.

The women claim the company discriminated against them in pay, promotions and personnel evaluations, sometimes because they were pregnant or had recently given birth.

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They also had a patent infringement lawsuit with Watson Pharmaceutical concerning Exelon (rivastigmine), a tartrate for Alzheimer's. They settled the suit and Novartis granted Watson a license to its U.S. patents for a generic version of Exelon.

The settlement agreement states Watson won't market its generic version until sometime near the expiration of Novartis' patents covering Exelon.

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A Novartis lawsuit was filed for Zelnorm (tegaserod maleate), a drug used to treat Irritable Bowel Syndrome. It allegedly increased the risks of heart attacks and strokes ten-fold. It was taken off the market in 2007. Attorneys are asking anyone harmed by Zelnorm to contact them to have their case assessed.

Grounds for filing suit could include the questions of why it took so long for the drug to be taken off the market; why Novartis didn't clue into the problems earlier; and why, when the European Union refused to use Zelnorm because the "risks outweighed the benefits," did the FDA approve it and Novartis keep marketing it? (The third question relates to the drug studies that reportedly showed there were higher rates of heart attacks and other serious side effects, and yet only the drug's label was changed.)

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A Class Action Lawsuit was brought in 2006 by Novartis employees stating they were wrongly denied overtime. A former sales representative alleged they worked more than 40 hours a week and were denied overtime pay and time-and-a-half pay for holidays.

Sales reps are classified as exempt from this labor law, however the suit alleges the reps didn't sell drugs or receive commission and should not be exempt.

Other Novartis lawsuits:

* Pfizer (2007) - Zithromax/antibiotic - patent infringement. Pfizer settled its lawsuit against Novartis for alleged infringement of the US patent for the antibiotic Zithromax (azithromycin). Under the settlement, Pfizer and Novartis "have agreed to settle all claims" regarding the drug patent. Specific amounts and terms of the agreement were not revealed.

* Aredia/Zometa (2006) - bisphosphonates for osteoporosis causing osteonecrosis or Dead Jaw. In Tennessee plaintiffs sought an award for damages, as well as having the drugs declared "unreasonably dangerous or defective," and a dental monitoring program set up for the class members.

* Medicaid (2008) - fraudulently inflated drug prices. In Alabama the courts heard Novartis inflated prices paid by the state Medicaid program. The state's lawsuit says the drug makers overstated the average wholesale price used to calculate state Medicaid reimbursement rates to pharmacies. The Novartis settlement was $114 million.

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If your health has been negatively affected by taking a drug manufactured by Novartis, consider contacting a dangerous drug attorney to discuss your case. You may have grounds for filing a Novartis lawsuit.




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