Ketek Lawsuit

A Brief Guide to Filing a Ketek Lawsuit:

What is Ketek?

Ketek, which is the brand name for Telithromycin, is used to treat certain forms pneumonia caused by bacteria. Ketek belongs to a class of medications called ketolide antibiotics; it is effective by terminating bacteria. Antibiotics, such as Ketek, do not kill viruses that cause the flu, colds or other infections.

Ketek Side Effects:

Ketek side effects may present themselves regardless of circumstance. If you experience any of the following Ketek side effects, please contact your doctor. Discontinue use if the following Ketek side effects are severe or persistent:

Common Ketek Side Effects include: nausea; diarrhea; vomiting; dizziness; headaches

Some Ketek side effects can be severe. Please tell your doctor if you experience any of these Ketek side effects or any reactions listed in the SPECIAL PRECAUTIONS section of your prescription package:

Serious Ketek side effects include: rapid or pounding heart beat; fainting; rash; itching; difficulty swallowing or breathing; swelling of the face, tongue, lips, eyes, feet, hands ankles or lower legs; hoarseness.

Ketek and the FDA:

In 2004, the FDA approved the antibiotic Ketek for manufacture and sale in the United States for the treatment of bacterial complications related to bronchitis, sinusitis and pneumonia. However, due to reports of serious Ketek side effects, the FDA changed its guidelines for safe use of the drug in 2007.

On February 12th of 2007, the United States Food and Drug Administration agreed to update Ketek’s label to narrow usage by dropping two previously approved indications—Ketek is no longer applied to treat acute bacterial sinusitis or chronic bronchitis due toStreptococcus pneumonia). The update also includes a boxed warning stating that no patient with myasthenia gravis should consume Ketek. Other than these warnings, the FDA has defined Ketek as a relatively safe drug. As a result, potential Ketek lawsuits are more likely to secure settlements for medical malpractice on part of the doctor or pharmacist.

Ketek Lawsuits:

As stated above, Ketek lawsuits concerning the drug’s side effects are rare. Listed below are some prominent Ketek lawsuits that were filed against prescribing doctors or pharmacists.

In 2003, a Ketek lawsuit was brought against a doctor responsible for supervising tests of the drug's safety--Dr. Marie Anne Kirkman Campbell was charged in this Ketek lawsuit with 57 counts of fraud. Among the Ketek lawsuit charges, Campbell was accused of falsifying results of the study to make the drug seem safer than it was. Her study concealed information that serious Ketek side effects were three times more likely to occur than treatment with other drugs designed to relieve respiratory infections.

Despite this conviction, the Ketek lawsuit did not lead to further testing. Instead, the medication was approved for sale. In April 26, the FDA reported that it was informed of Ketek side effects including 35 cases of liver failure or injury, four of which ended in death. These reports led the FDA to reconsider its approval of the drug.

Despite this evidence, no Ketek lawsuit regarding adverse effects has been successfully filed through court. In 2007, two attempts were made to file a class-action Ketek lawsuit. The first Ketek lawsuit, Austin vs. Sanofi-Aventis U.S. LLC, sought a Ketek settlement on the grounds of product liability. This unsuccessful Ketek lawsuit claimed that the manufacturer was negligent responsible for injuries by knowingly selling a dangerous product.

The other class action Ketek lawsuit was filed on the grounds of fraudulent marketing. Under the federal RICO laws, a Ketek settlement was sought on the grounds that Sanofi-Aventis was fraudulently marketed at inflated prices. The plaintiffs charged that by suppressing evidence, the company was engaging in consumer fraud by presenting the medication as safe and effective.

This effort was ultimately dismissed in 2011 as court claimed that the manufacturer's advertising and marketing of a defective product could not be deemed as the sole cause of Ketek side effects.

The lack of success with regards to Ketek lawsuits does not mean that future litigation will not be successful--you may still file Ketek lawsuits against the manufacturer or your doctor for negligently prescribing the drug.

Sources:

1. United States National Library of Medicine “Telithromycin” retrieved from:

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000270/

2. http://www.fda.gov/Drugs/DrugSafety/

PostmarketDrugSafetyInformationforPatientsandProviders/ucm107824.html