Ketek is the trade name of Telithromycin, an antibiotic which is now used only to treat mild to moderate pneumonia contracted outside of a nursing home or hospital. It is not effective if a person’s lung infection is caused by a virus and not the kind of bacteria that Ketek was designed to treat. It was first approved for use in patients by the federal Food and Drug Administration (FDA) in April of 2004.
Ketek is a medicine that can only be obtained with a prescription from a licensed physician. It is not supposed to be taken by anyone who is under the age of 18, so it should be prescribed for adults only.
What Went Wrong with Ketek?
After it was introduced to the market in 2004 by its manufacturer, Sanofi-Aventis, Ketek was prescribed widely by many doctors. Because the manufacturer promoted it so heavily, doctors prescribed it for “off-label” uses, i.e., for the treatment of conditions other than those for which it was approved by the FDA. In its first two years on the market, doctors wrote more than 5.6 million prescriptions for Ketek in the United States.
However in 2006, researchers reported that three patients in a North Carolina hospital who took Ketek developed severe life-threatening liver problems and liver failure. One patient required a liver transplant. Another patient contracted drug-induced hepatitis, and a third patient died in the hospital.
In 2007, a subcommittee of the U.S. House of Representatives held FDA safety oversight hearings to investigate the process by which the FDA had approved Ketek. The subcommittee wanted to learn why the medication was approved when it was known to increase the risk of liver damage which could lead to death.
It was suggested that the FDA and the manufacturer of the antibiotic, Sanofi-Aventis, did not question whether the risks of Ketek’s side effects outweighed the benefits of the drug before it was approved.
What Did the Evidence Show about Ketek?
During testimony before the House subcommittee, a former employee of Sanofi-Aventis said that the drug maker knew that there were problems with the Ketek research study that had been used to gain FDA approval. It was only after the FDA approved the drug that FDA regulators discovered that fraud had been committed in connection with the research on Ketek.
Specifically, a doctor admitted to falsifying data which would have shown that the drug was far less safe than its manufacturer claimed. The doctor pleaded guilty to fraud, and served a prison sentence for that crime.
Other testimony given at the hearings accused the FDA of approving the antibiotic despite knowledge that Ketek liver damage side effects would kill people. As noted above, after it was approved, there were reports of liver failure and death linked to the antibiotic.
These injuries could have been prevented if information regarding the Ketek dangers had been made public earlier, as there are safer antibiotics which could have been prescribed to treat most of the conditions for which Ketek was then used.
In addition, experts claimed that Sanofi-Aventis had not provided enough evidence that Ketek was as safe and effective as antibiotics already on the market in 2001 and 2003 when it originally sought FDA approval for the drug.
Is Ketek Still Available Now?
Ketek is now known to have caused severe liver problems in a small number of patients, including 4 deaths. Since this revelation, the FDA has limited the illnesses for which Ketek is an approved treatment. The FDA also now requires a stronger “black-box” warning label on the bottles in which it is sold to patients.
If a person has suffered any of the following side-effects after taking Ketek, they may have a cause of action against its manufacturer for failure to warn or against the doctor who prescribed the drug to them for medical malpractice.
The most dangerous side-effects are the following:
- Liver Damage;
- Liver Failure;
- Acute Respiratory Failure;
- Aggravation of Myasthenia Gravis;
- Death.
However, the most dangerous side-effects should be avoided in the vast majority of cases if the prescribing doctor and the patient inform themselves about the side-effects, the limitations on the conditions for which Ketek should be used and limitations on the patients who should take it.
Who Should Not Take Ketek?
A person should not take Ketek under the following conditions:
- They have ever had an allergic reaction or liver problems caused by telithromycin or similar antibiotics;
- They also take cisapride or pimozide;
- They have kidney or liver disease AND are also taking colchicine;
- They have myasthenia gravis. Some people who suffer from myasthenia gravis have developed serious or fatal lung problems while taking Ketek.
As with all antibiotics, a person should take Ketek for the complete prescribed length of time. A person’s symptoms may improve before the infection is completely cured but should continue taking the medication until it has been used up. Skipping doses or failing to finish a course of antibiotics can lead to the risk of further infection that is resistant to antibiotics.
Who Can Be Liable for Injuries Caused by Ketek?
Both lawsuits by individuals and class action lawsuits on behalf of groups of people who suffered from the side-effects of Ketek have been brought against the manufacturer. The cases alleged that the risks of taking the medication outweighed the minimal benefits it provided. In addition, they claim that the manufacturer concealed known dangers when it first marketed the medication.
To address the problems with Ketek, the FDA now requires that it have a warning label that tells consumers about the risks of Ketek. Specifically, the FDA now indicates that Ketek should not be prescribed for any condition other than pneumonia acquired outside of a hospital or nursing home.
Also, Ketek should only be prescribed for pneumonia that is caused by the type of bacteria that Ketek can address. It is not effective against all bacteria. Ketek should also not be prescribed for conditions other than pneumonia, because the risk of liver damage from taking it outweighs any potential benefits for treating such illnesses as sinusitis or bronchitis. These illnesses are less serious than pneumonia.
In addition, pneumonia can be caused by a virus, and viral pneumonia is not cured by taking antibiotics.
What Effect Does the Warning Have on the Liability of the Drug Manufacturer and Doctors?
Many product liability lawsuits regarding prescription drugs allege that the drug manufacturer failed to warn of a certain risk. However, an injured person cannot bring a failure-to-warn lawsuit only because the drug manufacturer failed to include a warning in a black box. In fact, the FDA has stated that, “to ensure the significance of boxed warnings in drug labeling, they are permitted only when specifically required by FDA.”
On the other hand, black box warnings do often limit the liability of drug manufacturers. It is almost impossible to succeed with a failure-to-warn lawsuit regarding a condition or side-effect that is the subject of a warning in a black box on the drug label.
However, if a doctor were to prescribe Ketek to a patient who should clearly not take it, the doctor might be liable for medical malpractice. This might happen if the doctor fails to review the patient’s history for allergies or potential interactions with other drugs. Or, a doctor may have prescribed the medication for a person under 18.
If a doctor makes an error of this kind, the patient might then suffer the serious liver or kidney conditions that gave rise to the black box warning for Ketek. A pharmacist might also be liable if they failed to spot the error.
Do I Need the Help of a Lawyer for My Ketek Lawsuit?
Of course any lawsuit for strict product liability, especially against a large pharmaceutical manufacturer, or medical malpractice is going to be a long and complex process. The patient will have to show that their injuries were caused by taking Ketek and that the black box warning does not protect the manufacturer from liability. In a suit for medical malpractice the victim would have to prove that the doctor who prescribed the medication made a medical error.
Only a qualified class action attorney can determine if a Ketek patient has a good chance of winning a lawsuit or reaching a settlement. A lawsuit involving Ketek requires the expertise of an experienced personal injury lawyer. Your lawyer will know how to enlist the help of experts whose testimony would be necessary to winning the case. Your personal injury lawyer knows how to work with the best experts to ensure that your rights are protected.
