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• Rapamune Lawsuit
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• Rapamune Off Label
• Rapamune Death

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A Rapamune® lawsuit can be filed on behalf of a patient or family who believes they’ve been harmed by the drug. To find out if you qualify, contact a Rapamune® lawyer today.

Rapamune® Injuries

Rapamune® is a drug taken by kidney transplant patients after transplant surgery to prevent rejection of the new kidney. The U.S. Food and Drug Administration (FDA) has approved the drug for this use.

But, off-label use — uses for which the FDA has not approved it — are causing serious side effects in some transplant patients. Patients who have been given Rapamune® following transplanted livers, lungs, pancreas’, hearts or islet cells have been having some serious reactions, including:

• Anemia
• Bone marrow suppression (the bone marrow is where the body makes its disease-fighting white cells)
• Suppressed wound healing
• Proteinuria (appearance of protein in the urine indicating kidney damage)
• Blood clots
• Leukopenia (low levels of disease-fighting white blood cells)
• Thrombocytopenia (reduced levels in the blood of thrombocytes, or platelets needed to make the blood clot such as after a wound)
• Liver failure
• Death

Rapamune® Lawsuits

A number of lawsuits have been filed against Wyeth (part of Pfizer) Pharmaceuticals, Inc., maker of Rapamune® for promoting off-label uses of the medication. Two sales representatives filed whistle-blower lawsuits against Wyeth, saying the company was marketing the drug for off-label uses.

Rapamune® Off-Label Use Spurs Lawsuits

The representatives, Marlene Sanders and Scott Paris, allege in their suit that company management “openly encouraged and directed their entire Rapamune® sales force” to promote to doctors and hospitals the drug for use after transplanting hearts, livers, pancreas’, and islet cells. These uses of Rapamune® never received FDA approval.

The representatives contended that Wyeth provided its sales force with off-label studies, abstracts, and lists of studies to tell doctors about when promoting the drug’s off-label uses. The federal government filed a motion with a U.S. federal court to become part of the whistle-blower lawsuit.

The U.S. attorney for Pennsylvania and 19 states, plus the District of Columbia filed a document in the U.S. District Court in Philadelphia that “the United States has established good cause to intervene…”

Wyeth also was accused of specifically marketing Rapamune® to African Americans by targeting two hospitals where the majority of patients were African American. African Americans are considered high-risk transplant patients because they mount a stronger immune response to organ transplants. The two hospitals were Einstein Medical Center in Philadelphia and SUNY Downstate Medical Center in New York.

If you took Rapamune® after a heart, liver, pancreas or islet cell transplant and experienced severe side effects, you might qualify to file a Rapamune® lawsuit. Contact us for more information.

"Rapamune® Off-Label Uses Spur Lawsuits"

The U.S. Department of Justice plus nine states and the District of Columbia last fall requested that they be allowed to intervene (participate) in a whistle-blower lawsuit against drug maker Wyeth. The lawsuit contends that the drug company illegally ...

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