CellCept and MyFortic are brand name transplant drugs made by Genentech and Novartis. They are given to patients receiving organ transplants to suppress the immune system and increase the odds that the body will not reject the new organ. The generic name for the drug is mycophenolic acid and it has been in use for transplant surgeries in the U.S. since the 1990s.

While an immunosuppressant like mycophenolic acid is essential in helping a patient make the transition to a new organ, it is not all risk-free. There are some serious potential side effects of this drug that may lead to CellCept and MyFortic lawsuits in the future. Novartis has already faced lawsuits over fraud in how it marketed MyFortic and suits brought by individuals harmed by it or by CellCept may not be far behind. If you suffered any of the serious complications associated with these drugs, you may have a case to make with the help of a legal professional.

What Is Mycophenolic Acid?

Both CellCept and MyFortic are made from the same generic drug, mycophenolic acid. This is not a new compound, as it was first discovered 100 years ago as an antibiotic and a medication that could treat fungal infections. Testing in South Africa in the 1970s led to the discovery that this compound could also act as an immunosuppressant, a drug that limits the action of the immune system.

Immunosuppressant drugs are important for organ transplant surgeries because the body’s immune system is designed to attack anything foreign, including a new organ. By dialing down the immune system with a drug like mycophenolic acid, a patient has a better chance of tolerating the new organ and of having a successful transplant.

The U.S. Food and Drug Administration (FDA) first approved mycophenolic acid for transplants in 1995. The agency approved it to be used in patients receiving kidney, liver, or heart transplants. It is indicated for these uses in conjunction with corticosteroids and other drugs that help make the transplant successful.

Complications of Mycophenolic Acid

Transplant surgery is always risky and the use of products like CellCept and MyFortic is supposed to increase the odds that it will be successful. However, these medications don’t come without their own risks, which some patients may file lawsuits over, feeling they were not adequately warned about them before going through with the surgery.

The risk of an infection is a huge potential problem with using mycophenolic acid. Because it suppresses the immune system, it puts patients at risk for developing infections that can become life-threatening. One of the most serious of these is called progressive multifocal leukoencephalopathy, or PML. The infection causes symptoms like difficulty thinking and confusion, weakness and apathy, and loss of muscle control. It can quickly become fatal if not treated. People on mycophenolic acid are also at risk for less serious infections like yeast infections, shingles, viruses, hepatitis, herpes, and others.

Another serious complication that can be caused by mycophenolic acid is a condition called pure red cell aplasia. This is a type of anemia in which a person has too few red blood cells. It causes lethargy, weakness, fatigue and other symptoms. The makers of mycophenolic acid products reported that some patients developed this condition while using the drug, but the reports didn’t come out until 2009, years after it had already been in use. Stopping use of mycophenolic acid can bring relief from pure red cell aplasia, but doing so puts the transplant at risk.

One of the most troubling of all risks of using CellCept or MyFortic, and which may eventually lead to the most lawsuits is the potential for birth defects. The FDA required that these products carry a black box warning because the risk is serious that a woman using them while pregnant will have a miscarriage or have a child born with defects. The agency also started a registry site for women who have to take mycophenolic acid and become pregnant. The FDA hopes to collect more information about the risk of birth defects.

Lawsuits over Complications

Many of the possible complications of using CellCept or MyFortic are serious and have potentially devastating consequences. A patient could die from a serious infection, become very sick with anemia, or even have a miscarriage or a child with birth defects that may affect that child for life. It may just be a matter of time before individuals harmed by these drugs start CellCept and MyFortic lawsuits to seek compensation for their suffering. If you have developed any of the serious complications associated with mycophenolic acid, you too may want to consider making a case against Novartis or Genentech.

Fraud Lawsuit

The federal government has already filed and won a settlement with Novartis over fraud associated with sales of MyFortic. At the start of the lawsuit the U.S. government sought more than $3 billion in civil fines and damages from Novartis under the False Claims Act. The trial was supposed to start in November of 2015, but before it could begin the drug maker decided to settle for $390 million, just a fraction of what it might have paid if the trial went in favor of the government.

The lawsuit was over false claims and fraud. It was started in 2010 by a whistleblower who worked for Novartis. He claimed that Novartis was paying kickbacks to pharmacies to use MyFortic over competitors like CellCept and others. Novartis had been giving pharmacies rebates every time they convinced a patient to use MyFortic for transplant treatment. The company also billed Medicare and Medicaid, federal programs. The government joined the whistleblower lawsuit and added other charges to the case including fraud and schemes aimed at increasing sales of another Novartis drug.

CellCept and MyFortic lawsuits may not be limited to whistle-blower and government fraud cases. In the future, individuals may file suits alleging that the companies marketed drugs to them without adequately informing them of the risks of serious complications. Anyone harmed by these drugs should seek professional legal advice about what to do next.