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John Fratti: FDA Advocate for Levaquin and Drug Safety

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Hershey, PAJohn Fratti has been actively involved with Levaquin and other fluoroquinolone drugs since he was injured by Levaquin. Lawyers and Settlements first spoke with Mr. Fratti in July 2009. He is now a part-time government employee at the Food and Drug Administration as an "FDA Patient Representative for Drug Safety and Risk Management."

Fratti says he got the job by contacting the Office of Special Health Issues. "A doctor at the FDA arranged a meeting with several other FDA doctors this past July," he explains. "Two of those doctors feel that fluoroquinolone toxicity is a very legitimate issue that needs to be addressed. These doctors helped me write recommendations to the agency regarding Levaquin and other fluoroquinolones." (The FDA mandated a black-box warning for Levaquin in July 2008.)

Fratti had training to be a FDA Patient Representative, which explained what it is like to be on an advisory committee meeting. FDA Patient Reps represent the consumer perspective on issues and actions before the advisory committee and they are considered a "Voice for the Voiceless."

"I have an intermittent part-time position on FDA advisory committees when drugs or medical devices are at issue," says Fratti. "I have a vote, along with other medical people such as doctors, nurses, chemists, etc., about whether to keep a drug or medical device on the market, keep on the market with certain restrictions, or have it withdrawn. The FDA mails Patient Reps information to study at home. Supposedly the FDA "Safe Use" initiative is considering the recommendations for fluoroquinolones. I'm not sure how seriously they take me.

"I am scheduled to return to the FDA headquarters in Silver Spring, Maryland, next month for a "Safe Use meeting" and fluoroquinolones are registered as a topic for discussion. I hope to feel well enough to make it to the meeting, which is open to the public. My sister lives close to the FDA in Maryland which is helpful.…"

Fratti also went out on a limb and bought $3,000 dollars worth of Johnson & Johnson stock, which gives him proxy rights. "I went to the J & J annual shareholder meetings in 2009 and 2010 to ask the CEO to add further safety warnings for Levaquin," says Fratti, who wasn't the first fluoroquinolone victim to buy stock with this intent.

"One other injured person bought stock in J & J and attended the shareholder meeting the previous year," adds Fratti. "He received a standing ovation from J & J shareholders after his speech. At the 2010 meeting, I asked the J & J CEO to engage in research to help people who have been injured and disabled from Levaquin—research that is needed to help those injured try and regain some of their lost health. I feel that many of the shareholders are conscientious but the CEO and Board of Directors are not—they simply believe in profits over people.

"The reason I have this position with the FDA is to try and advance my advocacy with Levaquin and fluoroquinolones. My goal is to make sure people have informed consent and better disclosure about the potential irreversible damage from Levaquin and other fluoroquinolones. Other classes of antibiotics should be used before this class of drugs. Fluoroquinolones are meant to be reserved for serious and life-threatening infections rather than a first-choice option."

John Fratti is now reaching out to legislatures, asking them to write letters to the FDA to support this issue.


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Posted by

It is so unfair that most of those that have been injured by quinolones took the generic type which makes it impossible for us to recover damages. The public needs to be made aware that when they accept generic medications, they are giving away their right to seek compensation for their damages which many times are devastating.

Posted by

Hospital doctors seem to have discovered a new, secret, legal way to commit euthanasia--by using dangerous drugs to kill the patients. One of these doctors did that and killed my husband with Avelox, one of the fluoroquinolones. He prescribed the drug without diagnosis, without any lab tests for infective agents or drug sensitivities, and kept him on it for the duration of his hospital stay, even when the doctor said my husband was getting worse every day. He refused to change the antibiotic even when he had evidence it wasn't working. He ignored me when I asked him to try another antibiotic and when I told him about the Black Box warning on it. When we arrived in the hospital, the first words out of the doctor's mouth to me were, "Your husband's not going to recover from this." He had decided since my husband was older and had dementia that it was time for him to die and he would help him along. So, this is just something else to keep in mind with these dangerous drugs. They can now be useful to terminate patients that the doctors think should just die and leave them alone for more important work. And who's going to challenge them? Attorneys don't see enough money in it for them because of the patient's age and mental state, so that makes it legal, right? A new toy for the sick, demi-gods who don't even wash their hands. (I'm a microbiologist).

Posted by

I am a client of The Carey & Daney Law firm, who is representing me for compensatory and punitive damages for tendon tears in my right shoulder. The firm cannot tell me when J&J Pharmaceutical will settle my claim. I recently, submitted a interrogatory questionair from the defendant in full detail of my complaint. How much longer will this litagation process will take? Is there pretrial settlement option?


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