Ketek Class-Action Lawsuit Information
Find
class-action
lawsuit information against Sanofi-Aventis, the maker of
the the antibiotic Ketek here. Many medical experts believe there is a link
between Ketek use and liver failure. Plaintiff's attorneys are working on class-action lawsuits
on behalf of victims of Ketek.
Here is some information about liver failure, which has been associated in print with usage of Ketek (telithromycin).
Ketek has been associated with deaths from liver failure in young, strong individuals.
John Mack, who writes about the pharmaceutical industry, muses on Ketek safety issues in his Pharma Marketing blog.The Annals of Internal Medicine published an article describing liver problems associated with the antibiotic Ketek (telithromycin).
The article describes three cases, all being patients at Carolinas Medical Center in Charlotte, North Carolina. Each patient developed liver problems after taking Ketek.
One patient took Ketek for five days and died from liver failure two weeks later, another patient's liver failure required a liver transplant, and the third patient developed hepatitis after taking Ketek. This patient later recovered. The authors of the article note that three cases (which all occured at one medical center) do not prove that Ketek causes liver problems.
Class-Action News
Class Action Lawsuits
Antibiotic Ketek (telithromycin) and Liver Damage
Health authorities are investigating the use of antibiotic Ketek after one patient died and another required a liver transplant. Ketek is in a class of ketolide antibiotics used to treat bacterial infections such as pneumonia, chronic bronchitis, and acute bacterial sinusitis. Sanofi-Aventis launched Ketek in 2004 and currently distributes it worldwide. Other known side effects of Ketek include liver dysfunction, jaundice, drowsiness, dizziness, blurred vision or double vision, and nausea.
Parker & Waichman, LLP Retained by Patients Diagnosed with Liver Damage after Using Ketek
May 19, 2006 | Parker & Waichman, LLP announces that it has been retained by individuals who suffered liver damage and liver failure after using the antibiotic Ketek.
Sanofi, FDA in talks on Ketek label after concerns
May 19, 2006 | WASHINGTON (Reuters) - French drug maker Sanofi-Aventis and U.S. regulators are discussing potential revisions to prescribing instructions on antibiotic Ketek after safety reviewers said a strong warning may be needed about cases of liver failure, the Food and Drug Administration said on Friday...But she confirmed that the report called for new information on Ketek's label about liver injury reports. One possibility the reviewers raised was adding a "black box," the strongest warning possible for a prescription drug, Bro said....
An Individual Lawsuit is Better
May 24, 2006 | We believe that people who had a serious Ketek injury or suffered a death due to Ketek are better served when an individual lawsuit is filed on their behalf. A serious injury or death case should not be filed as part of any Ketek class action together with the claims of many other people who may have had different injuries caused by Ketek. (from Law Offices of Thomas Lamb)
World Health Newsletter, May 26
Sanofi-Aventis' antibiotic Ketek has been linked to several cases of acute liver failure, including four deaths. The Food and Drug Administration has suggested the addition of stricter warnings regarding Ketek's effect on the liver. If liver failure rates continue to rise, a memo suggests the FDA should consider restricting the use of Ketek, or even withdrawing it.
Ashcraft and Gerel, LLP
"...Our Ketek lawyers are prepared to file lawsuits and litigate Ketek cases around the country...On January 20, 2006, researchers reported three cases of severe liver problems associated with Ketek, including one death, in patients at a North Carolina Hospital. The fact that three cases were reported in one hospital was cause for great concern. The FDA issued a public health advisory as a result of the reporting of these cases. All three of the patients prompting the FDA's advisory developed jaundice and abnormal liver function. One patient recovered, one required a transplant, and one died. Since then, the FDA and the U.S. Congress have been investigating the approval, use, and potentially lethal side-effects of this drug...."
FDA News
June 8, 2006, New York Times | A U.S. Food and Drug Administration official called last month for the halt to clinical testing of Ketek on children because the drug could be deadly. The drug is being tested on 4000 children as a treatment for ear infections and tonsillitis. There is growing evidence that Ketek is unusually toxic, with 4 liver-failure-induced deaths in the U.S. attributed to it.Testing of Ketek on Children Halted
June 9, 2006, New York Times | The pharmaceutical company Sanofi-Aventis said yesterday that it had stopped enrolling children in studies of an antibiotic, amid reports that the drug could cause liver failure in adults...The company, based in Paris, said the food and drug agency did not request the action. It also said the suspension was not linked to a report in The New York Times yesterday that a food and drug agency official asked last month that the trials be halted because Ketek could be deadly...A spokeswoman for the company, Lisa Kennedy, could not immediately say how many children had been enrolled or when enrollment might resume...Safety issues about Ketek arose in January after researchers reported three cases of severe liver problems, including one death. Ketek's market share and prescriptions have plummeted since then...the agency had reports of 110 cases of liver problems associated with Ketek, and that the rate of acute liver failure connected to the drug was about four times the rate of such events seen in other antibiotics.Doctor Pleads Guilty to Falsifying Data
June, 2006, Boston Globe | Investigations continue to seek a face to face interview with an FDA special agent who looked into misconduct during the largest of three key trials to measure the safety of the antibiotic Ketek, made by Sanofi-Aventis. The doctor leading that clinical trial pleaded guilty to falsifying data, and was sentenced to 57 months. A linked internal FDA memo dated May 16 this year said Ketek patients have higher rates of acute liver failure and deaths than those using comparable antibiotic.Enrollment in drug study ends
June 11, 2006 | Sanofi-Aventis, the maker of the antibiotic Ketek, announced Friday that it will discontinue the use of children in their drug studies. The drug has been linked to liver failure in adults.The company will not acknowledge any wrong doing in the clinical studies involving children. The manufacturer will only comment that it is only trying to comply with FDA requirements regarding the testing of children.
The use of Ketek has been shown to cause an increase in liver failure of almost 4 times the normal rate in adults. The end of these trials is a relief. Any testing that puts a minor at risk is not worth the harm that child might incur.
FDA Denies Sen Grassley Access To Ketek Investigator
06-14-06 06:55 PM EST | WASHINGTON (AP)--Federal health officials on Wednesday rebuffed a U.S. lawmaker's attempt to meet with a Food and Drug Administration special agent who is investigating an antibiotic linked to a dozen r eports of liver failure, including several deaths.Sen. Chuck Grassley, R-Iowa, said Health and Human Services Department officials denied him access to the agent. Grassley later said he may convene a Senate Finance Committee hearing as part of that staff's ongoing investigation into allegations of fraud connected with trials of the drug, Ketek.
"I smell a cover-up," said Grassley, who is chairman of the committee.
Liver-Damage Reports Prompt Antibiotic Label Change
June 29, 2006 | The labeling for the antibiotic Ketek (telithromycin) will be updated to reflect the possibility of severe liver damage, manufacturer Sanofi-Aventis said Thursday...An internal FDA memo says those injury reports, in proportion to the number of prescriptions written, exceed adverse reports for similar drugs, the AP said... The Senate Finance Committee is investigating allegations of fraud connected with the Ketek trials, the AP reported, without elaborating.New Drug Makers' Labeling Could Limit Product Liability
June 30, 2006 | Beginning June 30, drug manufacturers will be required by the Food and Drug Administration to provide more concise and better organized patient information package insert sheets. Any drug approved within the last five years will have new requirements implemented gradually over the next seven years.New evidence related to the drugs will be updated and available online free of cost to healthcare professionals and consumers at http://dailymed.nlm.nih.gov.
Dr. Dominick Trombetta, assistant professor of pharmacy practice at Wilkes University in Wilkes-Barre, Pa., believes this is a positive step in improving medication use, but has concerns about the current label changes that will make it more difficult to sue drug manufacturers over product liability. "FDA's response to drug manufacturer's concerns over increased liability was to include wording that would exempt them from state product liability," a decision that Trombetta anticipates will be challenged in court.
Though Dr. Trombetta believes the FDA's new rules are a positive step in improving medication use if fully utilized, he calls the limitations on product liability "extremely disturbing."
National Public Radio
July 19, 2006 | Today National Public Radio aired a segment on the Ketek controversy. The network has acquired private emails of internal discussion within the Food and Drug Administration.Op-Ed News
August 1, 2006 | "...We also hear big pharma behind FDA's controversial approval of the antibiotic Ketek, blamed in the death of four and liver injury or failure in 37 others since 2004.Like Vioxx, Ketek's potential deadly side effects were known to its French manufacturer Sanofi-Aventis early in clinical trials and covered up. Like Vioxx, it has no advantage over existing drugs except a slick ad campaign, including full page color ads in JAMA. And like Vioxx, Dr. David Graham of the Food and Drug Administration's drug safety office has outed it.
'It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin [Ketek] is concerned," he recently wrote in an internal document, recommending the drug's "immediate withdrawal.'"
FDA Still Dodging Bullets Over Ketek
September 27, 2006 | Washington, DC: In recent months Senator Charles Grassley (R-IA) has been like a dog with a bone when it came to investigating why FDA officials approved the antibiotic Ketek, despite its knowledge that the main pre-approval study on the drug was riddled with fraud.Ketek first sought approval in 2000, but approval was denied due to indications of side effects such as liver damage, blurred vision, and others found in a review of the clinical trials submitted by Aventis. The FDA requested more information so the drug maker hired Pharmaceutical Product Development to conduct a study known as 3014. Senator Grassley became alarmed after he learned that the FDA approved the drug knowing that some of the clinical trials involved in study 3014 were fraudulent.
FDA Limits Use of Ketek
February 13, 2007 | The Wall St. Journal today reports that Ketek antibiotic can no longer be marketed for sinusitis or bronchitis, and will get a strong new warning on its label. These moves are likely to sharply limit its use.
Ketek has been linked to cases of liver damage and failure, as well as severe risk to patients with myasthenia gravis, a neuro-muscular disease.
Witness Testifies Sanofi-Aventis Knew of Problem
February 14, 2007 | As reported in the Wall St. Journal on February 14, 2007, a former employee of a Sanofi-Aventis contractor testified that the company knew there was evidence of a problem before regulators discovered fraud. The witness testified before Congressional committee. A doctor who ran a test site for the drug pleaded guilty to fraud.
Conclusion
Check this site for latest information on class-action lawsuits filed on behalf of victims of Ketek.