Posts Tagged ‘ Stevens Johnson Syndrome ’

Week Adjourned: 11.4.11

November 4th, 2011. By LucyC

Top Class Actions

Could this mean resolution for thalidomide victims?…New research suggests that thalidomide—a drug that caused thousands of horrific cases of deformities in children—caused far more deformities in the U.S. than were reported during the height of the pharmaceutical crisis of the early 1960s.

Invented by German drug company Grunenthal, thalidomide was widely used throughout Europe during the late 1950s and early 1960s, resulting in thousands of deaths and extreme, disfiguring birth defects when used by women during pregnancy. The drug was never approved in the United States, but the new lawsuit filed late October 2011 alleges that as many as 2.5 million doses of the drug were distributed by more than 1,200 doctors to more than 20,000 people, including pregnant women.

Newly discovered and translated documents reveal that Smith, Kline and French (SKF), now owned by GlaxoSmithKline (GSK)conducted a trial of the drug in 1956 and 1957, but buried the evidence, allegedly resulting in a missed opportunity to save thousands of lives.

Instead, according to the filed lawsuit, brought on behalf of 13 men and women with severe birth defects, SKF concealed the results of its trial from the public, allowing another company, Richardson-Merrell, now owned by Sanofi-Aventis to move ahead with large-scale “clinical trials” that involved more than 20,000 people, including pregnant women.

The lawsuit also claims that conclusions made in the early 1960s about the types of birth defects caused by the thalidomide were incorrect.

According to legal counsel, researchers concluded that thalidomide causes bilateral birth defects, such as two missing or shortened arms or hearing loss in both ears. As a result, babies born with unilateral defects, such as one deformed limb, or hearing loss in only one ear were not deemed thalidomide victims, even when their mothers were given the drug while pregnant.

However, new research involving thalidomide as part of a treatment regimen in cancer patients show that many of the assumptions used in the 1960s are incorrect. The thalidomide lawsuit alleges that this new understanding of the drug means that many individuals who experienced unilateral defects may have been misdiagnosed when their doctors told them thalidomide could not have been the cause.

“Among other things we intend to show in court that thalidomide does not work through a neural mechanism as previously thought, but affects the vascular system,” a lawyer for the plaintiffs said.

The complaint claims that the defendants are either guilty of or liable for a civil conspiracy, failing to report and covering up evidence that thalidomide was harmful, especially when taken during the early stages of pregnancy. The lawsuit also says that the defendants were negligent in continuing to manufacture, test and distribute the drug.

Top Settlements

Motrin SJS Verdict. This is one for the books. Let’s hope it makes a difference. On October 3, 2011, a Los Angeles jury returned a record-setting verdict against Johnson & Johnson and their fully owned subsidiary McNeil Consumer Healthcare for $48.2 million—with pre-interest and cost of judgment it’s expected to reach $60 million. The lawsuit alleged that Motrin caused SJS/TENS or Stevens Johnson Syndrome (SJS), also known as Erythema Multiforme, Leyll’s Syndrome, and in its later stages, Toxic Epidermal Necrolysis (TEN). SJS/TEN is a serious and potentially life-threatening disease that causes large areas of the skin to become detached and lesions to develop in the mucous membranes.

The verdict was based on findings of malice towards the consumers of the over-the-counter drug Motrin, specifically for not putting a warning label on the product that could have spared Trejo’s and others’ health. This is believed to be the first verdict of its kind involving punitive damages associated with this over-the-counter temporary pain reliever.

At age 16, Christopher Trejo, who is now 22 years old, took some Motrin as directed on the label for less than one week, but contracted TEN. It caused a severe inside-out exfoliating reaction affecting all of his mucosal membranes, which is equivalent to second- and third-degree burns over 100% of his body. The TEN reaction also caused severe pulmonary damage, near-blindness, infertility, whole-body scarring and a hypoxic brain injury. Trejo’s abilities to see, hear, smell, taste and touch have been severely diminished.

After hearing the evidence, the jury found that the labeling on Motrin was inadequate and should have been changed years earlier to properly educate and alert consumers to the developing signs of severe reactions, which include skin reddening, rash and blisters. Early detection and treatment of these symptoms can prevent TEN or SJS.

Apple Playing the Same Old tune? Apple, Inc., has agreed to settle a consumer fraud class action lawsuit that could amount to over $50 million dollars in payouts—but before you get all excited know this “Apple has agreed to provide an iTunes® Store credit in the amount of $3.25 to all settlement class members who qualify and submit a valid claim form. ” That’s the skinny.

The lawsuit claimed that Apple advertised and sold gift cards which stated that if one purchased and used the gift card, all songs purchased at Apple’s online iTunes® Store would cost 99¢ per song. The lawsuit further claimed that in April, 2009, Apple raised the price of certain songs at the iTunes® store, yet refused to honor the promised 99¢ price when the gift cards were redeemed. In addition, the company continued to sell iTunes® gift cards with the phrase, “Songs are 99¢” printed on them.

Consumers who were overcharged for iTunes songs while using iTunes® 99¢ gift cards are now eligible to receive an iTunes® Store credit in the amount of $3.25 after completing the simple iTunes® class action lawsuit online claim form. Millions of e-mails are currently being sent to persons who may have used affected gift cards to purchase songs from the iTunes® Store.

You can find out how to make an Apple iTunes lawsuit claim here.

Ok—That’s enough for this week. See you at the bar—don’t forget your iPod.

Tags: Apple, birth defects, Class Action Lawsuit, Glaxo Smith Kline, iPod, iTunes, iTunes Gift Card Lawsuit, Johnson & Johnson, Motrin, Motrin Verdict, Settlement, SJS, Smith Kline French, Stevens Johnson Syndrome, Thalidomide, Thalidomide Lawsuit
Posted in Class Action, Drugs/Medical, lawsuits, Settlement, Week Adjourned | 9009No Comments »Week+Adjourned%3A+11.4.112011-11-04+23%3A01%3A16LucyC

Week Adjourned: 1.21.11

January 21st, 2011. By LucyC

Top Lawsuits

Dilantin on the Defense. Pfizer, Parke Davis and Warner Lambert are facing a drug-related class action—this time over the alleged development of what can be a fatal skin disease—Stevens Johnson Syndrome (SJS) or Toxic Epidural Necrolysis (TEN)—associated with the use of drugs that contain Dilantin.

The defendants make drugs used to treat epilepsy that contain Dilantin. The plaintiffs claim that it caused them or their deceased relatives to develop SJS/TENS.

Just in case you’re wondering what SJS/TENS is—it is characterized by the discoloration or exfoliation of skin, the shedding of hair and nails, hives or burns to the body, loss of eyesight and/or damage to internal organs, according to the suit. And it turns out that certain racial groups can be more susceptible to SJS/TENs that others.

The suit claims that despite mounting evidence of Dilantin’s risks, especially to different populations, the defendants aggressively marketed their products and failed to report associated severe reactions. The plaintiffs allege they were unaware of how dangerous their prescriptions containing Dilantin could be. One plaintiff was originally prescribed a medication containing Dilantin over 10 years ago, but claims that the statute of limitations has not expired because he was not aware of the source of his injuries until within the last two years.

The list of allegations reads like a rap sheet—strict products liability, negligence, failure to warn, negligence in bringing Dilantin to market, negligent misrepresentation, misrepresentation by omission, negligence per se, fraud and misrepresentation, fraud by concealment, violation of the Illinois Consumer Fraud Act and wrongful death.

Top Settlements

Is the tide finally turning? With BP and the Gulf Oil Spill at front of mind—this possible Read the rest of this entry »

Tags: Buzzards Bay oil spill, Dilantin, National City Bank, Overdraft fees, PNC Bank, SJS, Stevens Johnson Syndrome, TEN, Toxic Epidural Necrolysis
Posted in Week Adjourned | 6577No Comments »Week+Adjourned%3A+1.21.112011-01-21+20%3A45%3A39LucyC

Week Adjourned: 9.10.10

September 10th, 2010. By LucyC

Top Class Actions

Veterans PTSD. An announcement was issued this week, about an extension of time for veterans to join or opt in to a class action lawsuit over Post Traumatic Stress Disorder (PTSD). Given that tens of thousands of troops deployed to Iraq are ending their tours, the timing of this couldn’t be better.

The lawsuit that was brought on behalf of veterans who served on active duty in the U.S. Army, Navy, Marine Corps, or Air Force and were found by a Physical Evaluation Board (“PEB”) to be unfit for continued service due, at least in part, to the individual’s PTSD, were assigned a disability rating for PTSD of less than 50%, and, as a result, were released, separated, retired, or discharged from active duty on or after December 17, 2002 and before October 14, 2008 (regardless whether such release, separation, retirement, or discharge resulted in the individual’s placement on the Temporary Disability Retirement List), has been extended to November 10, 2010, according to an Order entered by federal Judge George W. Miller.

Under the Rules of the United States Court of Federal Claims, the Court has reportedly allowed the class action lawsuit to be a class action on behalf of the following individuals who choose to opt in:

All individuals who (a) served on active duty in the U.S. Army, Navy,Marine Corps, or Air Force, (b) were found by a Physical Evaluation Board to be unfit for continued service due, Read the rest of this entry »

Tags: autism, Breast Cancer, Michaels Stores, SJS, Stevens Johnson Syndrome, Vaccinations, Veterans PTSD
Posted in Emerging Issues, Week Adjourned | 4948No Comments »Week+Adjourned%3A+9.10.102010-09-10+20%3A43%3A30LucyC

Stevens Johnson Syndrome Increasing?

June 8th, 2010. By janem

Many health practitioners still believe that Stevens Johnson Syndrome is a “rare skin disorder” but with the increase in adverse drug reactions (Health Canada reports adverse drug reactions are up 35 percent), this life-threatening disease is not as rare as we have been led to believe.

The Stevens Johnson Syndrome Foundation says it hears of 15 new cases a week and that is likely the tip of the iceberg—not everyone diagnosed with SJS has internet access or is aware of the foundation. As well, drug companies are required to tell the FDA (and other health agencies, such as Health Canada) about any reports of serious adverse reactions they receive, but not every doctor or patient takes the time to report side effects. This means that adverse reactions to certain drugs can go unnoticed for a long time.

And to this day, some doctors don’t know what SJS is, even when it’s staring them in the face. When their patient is covered in the most horrific sores and blisters, they might even prescribe the same medication to treat the disease that caused SJS in the first place!

According to Public Citizen, about 1.5 million hospitalizations a year were caused by adverse drug reactions—that’s more than 4,000 patients per day. It gets worse: 57 percent of these adverse drug reactions were not recognized by the attending physician at the time of admission. Many of these admissions should have been prevented. And many patients develop adverse drug reactions while they are in hospital.

“770,000 additional patients a year—more than 2,000 patients a day—suffer an adverse event caused by drugs once they are admitted,” said the not-for-profit agency. In 2004, the Centers for Disease Control (CDC) reported that more than 40 percent of Americans were taking at least one prescription drug. People develop SJS from commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such as Ibuprofen and Motrin. Age is no barrier: Numerous children’s medications have caused SJS.

But countless medical facilities and doctors don’t recognize SJS in the early stages because they aren’t familiar with the symptoms. Until SJS turns into TEN and usually by that time, it’s too late. It boggles the mind: why aren’t all health practitioners given mandatory training to recognize this life-threatening disease? Don’t they read drug labels or their Blue Book before prescribing drugs? It’s like a toss of the dice. When a drug such as Bextra has been known –since 2002—to cause SJS, perhaps the doctor believes the good outweighs the risk.

Just last August Tibotec Therapeutics reported postmarketing cases of SJS with its Intelence drug and the FDA’s MedWatch said “Intelence therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop.” How about adding, “get thee to a burn unit, fast.” And bring along a list of drugs that may have caused the reaction.

Tags: adverse drug reactions, Bextra, SJS, Stevens Johnson Syndrome
Posted in Drugs/Medical | 3901No Comments »Stevens+Johnson+Syndrome+Increasing%3F2010-06-08+18%3A07%3A30janem

10 Things to Know about Stevens-Johnson Syndrome

April 20th, 2010. By AbiK

1. Stevens-Johnson Syndrome (SJS) is a potentially life-threatening form of adverse reaction to medication. The more severe form of SJS is called Toxic Epidermal Necrolysis (TEN). Some drugs that have been connected to SJS are Children’s Motrin, Ketek, Advil, Ibuprofen, Bactrim, Daypro, Cipro, Bextra and Dilantin.

2. While target lesions are typically associated with Stevens-Johnson Syndrome (SJS), they are not always seen. SJS symptoms include: rash, blisters or red blotches on skin; persistent fever; blisters in the mouth, eyes, ears, nose and genital area; swelling of eyelids or red eyes; conjunctivitis; flu-like symptoms;

3. The SJS disease process typically begins with a nonspecific upper respiratory tract infection. Studies show that more than half of SJS patients report a recent upper respiratory tract infection.

4. A diagnosis of either SJS or TEN is based on degree of body surface detachment (i.e., skin detachment). The classifications are as follows:

Stevens-Johnson Syndrome: Less than 10% body surface detachment

Overlapping SJS/TEN: 10% – 30% body surface detachment

Toxic Epidermal Necrolysis: More than 30% body surface detachment

5. There are approximately six cases of SJS per million persons per year. For TEN, it’s approximately 1-2 cases per million persons per year.

6. There is a correlation between the amount of body surface detachment and mortality. For SJS, studies have shown the mortality rate to be approximately 1% – 5%. If body surface detachment Read the rest of this entry »

Tags: SJS, Stevens Johnson Syndrome
Posted in Drugs/Medical | 33776 Comments »2010-04-20+21%3A02%3A15AbiK