Report adverse events to
FDA's
MedWatch reporting system by completing a form on line at
FDA's MedWatch

Faxing (1-800-FDA-0178)

Mail using the postage-paid address form provided on line (5600 Fishers Lane, Rockville, MD 20853-9787)

Telephone (1-800-FDA-1088)

Preventable Adverse Drug Reactions

Over 2 MILLION serious ADRs yearly

100,000 DEATHS yearly

ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths

Nursing home patients ADR rate
350,000 yearly

Institute of Medicine, National Academy Press, 2000

Stevens Johnson Syndrome Articles

Lazarou J et al. JAMA 1998;279(15):1200 1205

Gurwitz JH et al. Am J Med 2000;109(2):8794

Stevens-Johnson Groups:

Ocular

Side Effects

Risk of SJS / TEN

A classification was developed for epidemiological purposes to distinguish between Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (TEN). This classification proposes that SJS is less than 10% of surface area of skin is involved; greater than 10%-29% is called SJS-TEN overlap; and 30% or greater skin surface involvement is considered TEN. ( Roujeau, 1995 ) Some epidemiology studies in the U.S. have reported an incidence of SJS to be 7.1 per 1 million persons, and as high as 49 persons per 1 million will develop erythema multiforme, which is a milder form of SJS.

Females appear to be twice as affected by SJS and TEN than males. Children taking NSAIDs (Motrin, Advil) and anticonvulsants have recently been reported to have an increased risk of SJS and TEN. ( Mockenhaupt, et. al. 2003; Lesko, et. al. 1995. )

Causes of SJS / TEN

Drugs cause over 80% of all cases of SJS / TEN. However, 90-95% of TEN cases are caused only by medications. While there have been very rare reports of infections causing SJS and TEN, most of those case reports were published long before scalded skin syndrome and Toxic Epidermal Necrolysis were distinguished by biopsy, making these cases more likely to have been caused by a drug. The rarity of these reports cast doubt on the reliability of information taken regarding drug intake, and doesn't change the fact that almost all cases of TEN are always caused by a single drug.

NSAIDs have recently been recognized by the scientific community to be one of the leading causes of SJS and TEN. A recently published study reported significantly increased risk for ibuprofen in an epidemiologic study published in 2003. ( Mockenhaupt, et. al. 2003 ; Lesko, et. al. 1995. ) Anti convulsants and antibiotics are the other leading causes of these diseases.

There is also some evidence to support that pre-existing infections coupled with the ingestion of one of these drugs mentioned above causes a synergistic effect that leads to SJS and Toxic Epidermal Necrolysis, including antibiotics and OTC medications like Children's Advil and Children's Motrin.

Treatment and Outcomes

Obviously, the identification of the responsible drug is important so that the causative drug can be withdrawn or the person can be instructed to stop taking it. One study has shown that the mortality rate can be reduced by 30% every day by stopping the drug responsible for the reaction. ( Garcia-Doval, 2000) The care of patients with SJS and TEN usually requires that they be placed in a burn unit, which is a highly specialized unit that cares for burn victims with the 2nd and 3rd degree burns that SJS and TEN causes all over the body.

IVIG treatment has shown to reverse the immunological cascade that promotes the spread of SJS and TEN, and meticulous wound care also reduces the morbidity and mortality associated with these diseases.

Experienced Stevens Johnson Syndrome Attorney

Keith Jensen is known for successes in litigating Stevens Johnson Syndrome and Toxic Epidermal Necrolysis cases, and has recently settled claims against some of the largest drug companies in the world for many SJS and TEN victims.

So when you are considering what law firm you are going to engage to represent you in your claims against the drug companies remember Mr. Jensen actually has obtained recoveries for Stevens Johnson Syndrome and Toxic Epidermal Necrolysis victims and their families across the country.

The Jensen Law Firm is dedicated not only to the investigation and prosecution of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis cases but the advancement of stronger warnings and greater consumer awareness regarding these conditions. It is our goal to use the law to reduce the number of people victimized by these lethal syndromes in the future. Drug companies have no shortage of resources or money. It is important that you hire a firm that has taken a massive drug company to court and prevailed. Keith Jensen has done so repeatedly. Should your case merit we will do all it takes legally and financially to bring your case to trial. We utilize state of the art exhibits, audio and video presenters and we retain highly qualified experts in the field of SJS / TEN.

If your case has sufficient merit we will not refer your case to another attorney capable of trying a case against a major drug company, because Keith Jensen is an attorney who can do just that.

Unfortunately, a lot of drugs cause SJS and TEN. Mr. Jensen has invested in and acquired scientific databases which identify most or all of the adverse event reports associated with what is believed to be virtually every drug sold that has been reported in association with SJS and TEN. This is another example of the fact that Keith Jensen will leave no stone unturned in handling meritorious SJS and TEN cases.

While there are other firms that consider cases involving Stevens Johnson Syndrome and Toxic Epidermal Necrosis. Mr. Jensen has invested the time and resources necessary to understand these often catastrophic syndromes, what causes them, how devastating they can be to both the victim and the family and how to find the best medical care for you or your loved one. He is committed to his clients, and offers not only quality legal services, but also a genuine concern for the welfare and wellbeing of those that seek his counsel.

Our law firm is dedicated to providing you the most up-to-date information about your legal rights, medical and scientific issues and how to find the best medical care for your loved one.

Keith Jensen's recent experience against big drug companies

In 2004, Mr. Jensen, and one other attorney, tried the third "Round 2" fen-phen case in the country against one of the largest drug companies in the world. The case was tried in Texas against Wyeth, formerly, American Home Products Corporation.

Wyeth had a dream team of 16 attorneys, including defense attorney Dan Webb, famous for representing GE, Microsoft & Big Tobacco. In the third week of trial the dream team was scheduled to bring two doctor-witnesses. They brought zero, they relented, they settled.

In 2005, Mr. Jensen tried a fen-phen case for four weeks in Philadelphia. This time the drug company brought 23 attorneys to oppose Mr. Jensen and one other attorney. On June 8, 2005, Bloomberg news reported: "The confidential settlement comes shortly before a Philadelphia jury was set to find the women were entitled to $6 million."

In 2006, Mr. Jensen filed over fifteen (15) Stevens Johnson Syndrome and Toxic Epidermal Necrolysis lawsuits against major drug companies and twelve (12) of his clients claims were settled without the need to pick a jury or even appear in Court. Some of these cases were settled within four (4) months of the Jensen Law Firm being hired.

In 2007, Mr. Jensen’s resolved five (5) major SJS/TEN cases against one of the largest drug companies in the world.  These five clients are the first known people to ever recover from the manufacturer on SJS/TEN claims for the culprit drug involved.

In 2008, Mr. Jensen was set to start a trial in Boston (beginning 1/3/08) against one of the largest drug companies in the world. The case settled for a very significant confidential sum.

The Jensen Law firm knows that finding and receiving expert care after a person develops SJS and TEN is important medically and legally. So we work with doctors who specialize in the treatment of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (burn surgeons, eye surgeons, dermatologists and others) in order to provide you and your family with the knowledge necessary to help your loved ones survive this tragedy, and to best represent you against the drug companies who caused the tragedy.

Visit here often for online resources & information on all health care crises involving Stevens Johnson Syndrome.

What drugs have reportedly been associated with Stevens-Johnson Syndrome? Ask our recognized medical experts in the field or our outstanding dermatology and epidemiologists experts in the scientific community.

You have a real risk from drug treatments that have severe side effects that can cause debilitating injury or death. The drug companies should be held responsible for the damages to the patient and to the patient's family after such preventable tragedies.

Stevens Johnson Syndrome
News & Events

As part of its efforts to make crucial health information easily available to consumers, FDA has launched two new online features: Web page -- Called "Consumer Health Information for You and Your Family," the page presents important public health developments in easy-to-read language.

It also links to other government health information and online Spanish-language publications. FDA Consumer E-newsletter --"FDA Consumer Health Information" replaces the agency's print publication, FDA Consumer.

Remarks by Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific Affairs

As you know, issues relating to the safety of new medical products, and in particular new drugs, have been at the forefront of recent policy making at FDA and discussion inside Washington... www.fda.gov

Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/pds.1193

Purpose Black box warnings (BBWs) are the Food and Drug Administration's (FDA) strongest labeling requirements for high-risk medicines. It is unknown how frequently physicians prescribe BBW drugs and whether they do so in compliance with the warnings...

FDA Science & Mission Risk
Report of the Subcommittee on Science and Technology
Prepared for FDA Science Board

Major Findings.
1.2.1 The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.

1.2.2 The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.

1.2.3 The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.

3.1.2 Finding: The development of medical products based on “new science” cannot be adequately regulated by the FDA.

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