rezulin lawsuit
Rezulin Site Summary

Homepage
Recall
Side Effects
  liver damage
  cirrhosis of the liver
Timeline
FDA Papers
Key Terms
About Diabetes
News Stories
FAQ's
Contact Us
Resources
Site Map

Rezulin Lawsuit

Notable Quotes

“The Times, citing Warner-Lambert emails and memos, said the company knew as early as 1993 of at least one case of a patient who showed liver damage after taking Rezulin.”

MSNBC, March 11, 2001

“I am writing to enlist your aid in convincing my superiors at FDA that Rezulin should be removed from the market because of its unacceptably high risk of causing liver failure.”

Dr. Robert Misbin, FDA medical officer and Rezulin reviewer
(CNN, 3-22-00)

“Easily more people have died between the time of our petition and when this belated…(FDA)…action was taken.”

Sidney Wolfe, Public Citizen director of the time it took the FDA to withdraw Rezulin and the July 1998 petition. (CNN, 3-22-00)

“The Echo Study was not properly conducted, according to the standard protocol. I was not made aware of the fact that the patients from this site, in particular, for whatever reason, whether it was due to technique or whatever, that they had increased left ventricular mass.”

Dr. Paresh Dandona, endocrinologist who served as Warner-Lambert’s principal investigator for the Buffalo Echo Study (studying Rezulin’s relation to heart damage).
(LA Times, 3-26-00)


Rezulin Causes Possible Heart Damage

Since Rezulin was approved on the fast track a complete clinical trial to determine possible heart damage caused by Rezulin was not completed. Instead, the Echo Study was put together to determine whether the use of Rezulin for 48 weeks would result in a change in the left ventricle. The endocrinologist who served as Warner-Lambert’s principal investigator for the Echo study in Buffalo, Dr. Paresh Dandona, said “The Echo Study was not properly conducted, according to the standard protocol. I was not made aware of the fact that the patients from this site, in particular, for whatever reason, whether it was due to technique or whatever, that they had increased left ventricular mass,” (LA Times, 3-26-00).

After the FDA approval of Rezulin on January 29, 1997, officials had negotiated a nonbonding pledge from Warner-Lambert to start a new study to assess Rezulin’s effect on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed. Rezulin patients did die of heart failure, but doctors claimed many of these patients had preexisting heart problems. Guston Turner, a pharmacist from the FDA’s scientific investigations division had found inconsistencies in research measuring Rezulin’s effect on the heart. Turner felt that the FDA “should have delayed approval of Rezulin until all the questions were addressed.”

click here to read the Effects of Rezulin. . .

top of page

 

rezulin lawsuitRezulin Lawsuit News

On March 21, 2000, the FDA announced the Rezulin recall after a whistleblower showed internal FDA email messages to an L.A. Times reporter. The diabetes drug was manufactured by Warner-Lambert to treat type-2 diabetes, which led to at least 90 cases of Rezulin liver failures, including 63 deaths. While this number is alarming, it reflects just 1-10% of actual fatalities according to experts. After speeding through the FDA approval process in just six months on the “fast track”, Rezulin had remained on the U.S. market for over three years after an estimated 2 million people were prescribed the controversial drug. Most pharmaceutical drugs take years to obtain FDA approval.

Deaths Linked to Rezulin

90 cases of Rezulin liver failure have been attributed to the diabetes drug. While this number is alarming, it reflects just 1-10% of actual fatalities according to experts. Of these 90 cases they have resulted in:

  • 63 deaths
  • 7 liver transplant survivors
  • 10 recoveries without a liver transplant
  • 10 people continuing to suffer from liver failure

Dr. David J. Graham, who is regarded as the FDA's top expert in assessing and preventing deaths related to the use of prescription drugs, concluded that patients taking Rezulin are 1200 times more likely to suffer liver failure. Graham noted that at least 430 Rezulin patients had suffered liver failure, most resulting in death or organ transplant. Rezulin was made by Warner-Lambert designed to treat those with Type II diabetes, or Adult-onset diabetes.

Recent Rezulin
Lawsuit News

"Rezulin Lawsuits May Be Getting Harder to Fight Off"

BREAKING NEWS!!
September 8, 2003

New findings published in the Mayo clinic Proceedings show that diabetes drugs may cause heart failure and cause fluid buildup in some patients. The first drug in the newest class of diabetes drugs was Rezulin. In March 2000 regulators found the drug to pose such a great risk of adverse effects that a Rezulin recall was issued. The new information about popular type-2 diabetes drugs may have a high financial implication for Pfizer Inc., which owns Rezulin after purchasing Warner-Lambert company and is currently battling thousands of Rezulin lawsuits. Read Full Article....

If you, or a loved one, have been affected by the Rezulin recall, CONTACT A REZULIN LAWYER.

click here to read more news on the Rezulin recall. . .

top of page

March 22, 2000
Letter to the Department of Health and Human Services urging that they implement and enforce the Code of Ethics for Government (HRG Publication #1516)

Donna Shalala, Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC

Dear Secretary Shalala:

It is urgent for you and other leaders in HHS--and all government agencies--to re-read and strongly urge the implementation and enforcement of a 1958 Congressional Resolution entitled The Code of Ethics for Government Service (175 72 Stat B12, 1958) which states that "Any person in Government Service should put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department." In addition, the Code of Federal Regulations governing basic obligations of public service (5 CFR Subpart A section 2635b.101) states that government "employees shall disclose waste, fraud, abuse and corruption to appropriate authorities." These guidelines have not been followed by those FDA officials who have harassed FDA physicians in the context of the recent controversy concerning Rezulin.

Yesterday, Rezulin, the fourth drug of 39 new drugs approved in 1997--under conditions which many FDA physicians describe as lowered safety standards--was taken off the market. Rezulin has caused at least 63 people to die of liver failure and has been responsible for hundreds of other cases of severe liver toxicity. The number of drugs already pulled off the market (Posicor, Duract, Raxar and Rezulin) from those approved in 1997 is twice as many as in any previous year of approval, that having happened once, wherein two of the 30 drugs approved in 1985 have been taken off the market. In no other year of drug approvals between 1970 and now, has more than one drug eventually had to be removed from the market. A fifth drug also approved in 1997, Trovan, an antibiotic now banned in Europe, has been banned in this country except for hospitalized and nursing home patients. A sixth drug, approved in 1996--the weight reduction drug Redux--has also been banned because of often-fatal primary pulmonary hypertension and heart valve damage. In many of these cases, there was either opposition by FDA employees to the approval of these drugs (Redux and Rezulin), unsuccessful urging of stronger product warnings on approval (Duract) or inadequately-heeded opposition from several FDA advisory committee members (Posicor).

Rather than encouraging FDA physicians and other scientists to be vigilant and try to stop these disasters from occurring before approval or encouraging them to speak up to urge that if post-marketing dangers become apparent, drug withdrawal should occur, there have been several recent incidents in which FDA medical officers have been harassed because of their concerns about drug safety. Robert Misbin, MD. and Leo Lutwak, M.D., both medical officers in FDA's Metabolic-Endocrine Drug Division, have been summoned before an FDA Internal Affairs Committee because of their opposition to the continued marketing of Rezulin. Yesterday, the agency conceded that they were right.

The morale among FDA scientists in CDER (the Center for Drug Evaluation and Research) is lower than I have seen at any time in the last 29 years. A survey we did of FDA CDER medical officers in late 1998 found 27 instances in which the medical officer thought a drug should not be approved but it was, over their objection. These FDA doctors also cited 14 instances in which they were told not to present data at FDA advisory committee meetings which might adversely affect the chance of a drug being approved.

For many dedicated FDA scientists, the atmosphere has become poisoned and repressive. I strongly urge the widespread dissemination and discussion of the above Code of Ethics and obligations of public service and for sanctions to be brought against those agency personnel who are responsible for interfering with the duty of other employees to voice their concerns about serious problems with drug safety or other similar matters. Until this is done, the FDA will continue to make additional serious mistakes regarding drug safety and other issues, much to the detriment of the health of people in this country. I look forward to a prompt response to this letter.

Sincerely,

Sidney M. Wolfe, M.D.
Director
Public Citizen's Health Research Group

 

top of page