Los Angeles, CAAttorney and SJS expert Brian Witzer says 85 percent of Stevens-Johnson Syndrome (SJS) cases his firm becomes aware of involve a precipitating drug of some kind, including Children's Motrin, Ibuprofen, Ketek and Dilantin. His firm is reviewing information on an ongoing basis to determine "whether the manufacturer of these drugs had significant warning in place to give consumers a basis for choosing that drug or going with an alternative which may have less propensity to cause SJS.
Witzer explains that his work typically involves reviewing the warnings that were in place at the time of ingestion or prescription. It further involves an in-depth evaluation of the material that had been made available to the prescribing physician (if there was one) and the FDA during the approval process.
"We also look at pre-market and post-market clinical studies which have proven invaluable in assisting us in the determination of what the manufacturer knew, or should have known, prior to going to market with the product," says Witzer.
"These drugs involve a wide array of pain medications or NSAIDs (Nonsteroidal anti-inflammatory drugs), antibiotics, anti-depressents and/or seizure medications. It is important that a professional, pharmaceutically-versed law firm becomes involved in the investigation as most of the materials are not available. As well, most of the materials necessary to make a decision about the prospects for successful litigation are not available to the consuming public.
Many of these products-- as part of their approval process-- involve a million documents plus. All of them would need to be reviewed, including adverse event reports and clinical trial results, all of which require a sophisticated eye to identify previous situations or patterns which would place the drug maker on notice. Reviewing the documents will trigger notice requirements on their behalf for disclosure to the FDA, and in extreme cases, warning changes."
Witzer, his staff and support personnel are experienced medical malpractice litigants. It is widely accepted that in medical malpractice cases, somewhere between 85 and 95 percent of those cases are defended; in other words, a finder of fact, be it a jury, judge or arbitrator find in favor of the defendant physician or medical provider or medical facility such as a hospital or clinic. "Even in the face of those statistics, our firm has a 95 percent success rate in that most difficult field," says Witzer. "Armed with the knowledge and ability to review and evaluate medical documents, our firm was well equipped to tackle the pharmaceutical industries' very insular method of going to market with the drug. Literally millions of documents require careful review, which our firm (uncharacteristically of others) reviews in total."
The makers of medications that have been associated with SJS are now facing numerous lawsuits, many filed by parents of children who suffered horribly after taking over-the-counter medications.
In 2005, one child suffered blindness and other health problems after taking Children's Motrin; the parents sued Motrin's manufacturer Johnson & Johnson. Incredibly, Johnson & Johnson had already settled a Stevens-Johnson Syndrome lawsuit filed by the parents of a nine-year-old girl who lived for 20 months after taking Children's Motrin. She was unable to speak, breathe on her own, or eat, before she finally died from the effects of Stevens-Johnson Syndrome.
A three-year-old child died just a week after taking Children's Advil, manufactured by Wyeth Consumer Health Care. The lawsuit claimed that the manufacturers of over-the-counter ibuprofen products, particularly those for children, should have warned about the dangers of Stevens-Johnson Syndrome and told users to discontinue the drug and seek medical help immediately if symptoms began.