STEVEN-JOHNSON SYNDROME


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Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are skin disorders heavily associated with the use of a variety of medications.
Certain drugs can cause severe allergic reactions that affect skin and mucous membranes, triggering severe burning, blistering and sloughing of involved tissue. In the most serious cases, blindness and death may occur.

While much is still unknown about the disease, specialists believe the syndrome to be caused by severe allergic reactions to medication, including antibiotics and sulfa drugs.

Joe Lyon is a highly-rated Cincinnati recall lawyer and Ohio product liability attorney who has successfully represented plaintiffs throughout the United States in complex toxic exposure, negligence and liability cases. 


Stevens-Johnson Risks


According to researchers at the Mayo Clinic Medical Center, almost 170 million Americans take at least one prescription drug. That represents almost 70 percent of the adult population.

The U.S. Food and Drug Administration (FDA) estimates that over 20 percent of Americans take three or more different prescription drugs each month; and 10 percent take at least 5 different prescription drugs. There is a strong correlation between a rising number of drug users and the number of deadly adverse drug reactions. Each year, patients experience 2.5 million serious adverse drug reactions.

Many recently released drugs on the marketplace, like Bextra, Onfi, and Zyprexa can cause these conditions. This is an unnecessary risk; studies published by Harvard University suggest less than 15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs.


SJS Drug Reactions


Accounting for approximately 150,000 deaths per year in the U.S., drug reactions are one of the leading causes of death in the United States.
Yet, because less than one percent of adverse drug reactions are reported to the FDA, the problem is not well-known. So, although SJS is considered a rare disease, it may be more prevalent than previously thought.


Drugs Triggering Stevens-Johnson Syndrome


Almost any prescribed and over-the-counter drug, including adult and children ibuprofen products, can cause the onset of SJS. Stevens-Johnson syndrome has been associated with negative reactions to several different types of drugs, including:

•    Antibiotics
•    Anti-convulsants
•    Barbiturates
•    Nonsteroidal anti-inflammatory drugs (NSAIDs)
•    Sulfa or sulfa-containing drugs
•    Gout medications
•    Accutane
•    Penicillins


SJS Drug Warnings


•    Bextra—In 2005, the FDA requested that Pfizer remove its drug Bextra from the market after studies showed serious risks of developing SJS and other severe disorders.
•    Onfi—In 2014, the FDA warned that the antiepileptic drug Onfi (clobazam) could potentially cause cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). This prompted changes to the drug labels and medication guide, to better warn consumers of the risks.
•    Zyprexa—With a new FDA warning on Zyprexa causing serious skin reactions, there is concern in the medical community about new related cases of SJS as well.
•    Ziprasidone—There are reports of Stevens-Johnson symptoms induced by antipsychotic drugs in the past. The FDA warned in 2015 that cases of Stevens-Johnson syndrome have been reported with ziprasidone exposure, another antipsychotic medication.


Children’s Motrin Causes SJS


According to the World Health Organization (WHO) Website, the majority of Stevens-Johnson syndrome (SJS) cases are linked to drug exposures. Common over-the-counter medications like Motrin and Tylenol have added warnings to their labels regarding the use of their products, noting past cases of SJS. Ibuprofen, another common NSAID on the market, may also directly cause SJS, according to recent medical reports.

Stevens-Johnson is a severe blistering rash affecting both skin and mucous membranes. The reaction typically begins with burning and painful lesions on the face and torso and extends to the rest of the body. Patients have presented with fever, malaise, myalgia and ocular manifestations. SJS can be fatal, and death occurs in around 5 percent of known cases.

Stevens-Johnson affects people of all ages, but a large number of victims are children. In one high-profile lawsuit filed against Johnson & Johnson, a family was awarded $63 million after a young girl was left permanently blind, which the plaintiffs said was caused by Motrin.

The jury determined that Johnson & Johnson failed to provide sufficient warnings about the potential side effects of Motrin. In fact, as of 2003, the over-the-counter medication for children contained no warning at all.

In 2005, the US Food and Drug Administration instructed makers of ibuprofen and other common painkillers to amend the warning labels on their products.
Johnson & Johnson was found liable in at least two other major cases. In 2011, a California jury awarded a $48 million judgment, and in Philadelphia in the same year, a court awarded $10 million.


Ibuprofen Stevens Johnson


In about a 30-year period, Health Canada received 4 reports of SJS suspected of being associated with ibuprofen. The reports involved patients ages 13 to 34 years old. The ibuprofen daily dosages ranged from 200 mg to 1200 mg. The onset of reactions varied from the day of administration to approximately 15 days after starting ibuprofen use.

Ibuprofen has been available over-the-counter since 1989, and no warning label or health agency has mentioned a relation to SJS until recently. Cases of SJS are rare, although patients taking ibuprofen should discontinue use and seek medical attention if any rash or fever develop.

The FDA has issued SJS-related warnings on the following:

  • Advil Allergy Sinus Tablets
  • Advil Cold & Sinus Tablets
  • Advil Liqui-Gels
  • Advil Migraine Capsules
  • Tolectin 600 Tablets
  • Tolectin DS Capsules
  • Children’s Motrin Chewable Tablets (50 mg ibuprofen)
  • Motrin Junior Strength Chewable Tablets (100 mg ibuprofen)
  • Motrin Cold & Sinus

What is Stevens Johnson Syndrome?


SJS is a rare condition, which is usually a reaction to a medication or an infection. It presents with flu-like symptoms, followed by a painful rash that spreads and blisters. The top layer of the affected skin dies, sheds and then heals.

SJS is a medical emergency that may require hospitalization. Treatment focuses on eliminating the underlying cause, controlling symptoms and minimizing complications. Recovery can take weeks to months, depending on the severity of the reaction.

Stevens-Johnson syndrome is a rare and unpredictable reaction, usually triggered by a medication or an infection. A reaction to medication may start while you’re using it or up to two weeks after you’ve stopped using it. Drugs that may cause Stevens-Johnson syndrome include:

  • Anti-gout medications—allopurinol
  • Seizure medications
  • Anticonvulsants and antipsychotics
  • Pain relievers, such as acetaminophen (Tylenol), ibuprofen (Advil, Motrin IB) and naproxen sodium (Aleve)
  • Antibiotics and anti-infection medications, such as penicillin

Stevens-Johnson Syndrome Symptoms


If the condition progresses untreated, symptoms can increase and worsen over time. Such signs and symptoms include:

•    Blisters
•    Rashes
•    Mouth sores
•    Swelling of eyelids
•    Conjunctivitis
•    Flu-like symptoms (fever, fatigue, headache, sore throat, cough)


Because many physicians and medical personnel are not familiar with the symptoms, treatment of SJS is frequently delayed, worsening the condition. Severe cases may lead to serious health consequences. SJS can cause blindness and results in death in 10 to 30 percent of cases. Further complications can include:

•    Permanent blindness
•    Dry-eye syndrome
•    Photophobia
•    Lung damage
•    Chronic obstructive pulmonary disease (COPD)
•    Asthma
•    Permanent loss of nail beds
•    Scarring of the esophagus and other mucous membranes
•    Arthritis
•    Chronic fatigue syndrome.


Stevens Johnson Lawsuits


Following any drug-related injury, including cases of SJS and other unusual health conditions, injured plaintiffs should contact a medical professional and product liability attorney to determines the root cause of an ibuprofen Stevens Johnson injury and to work toward a medical and legal solution.

The Lyon Firm has experience engaging large drug corporations in defective drug cases and has obtained large injury settlements that have in turn helped victims pay for medical expenses and lost wages due to illness.

Joe Lyon works with pharmaceutical experts and is well-versed in a variety of areas in toxic tort and product liability litigation, and is prepared to represent injured plaintiffs in seeking the maximum benefit following preventable ibuprofen Stevens Johnson injuries.

Drug companies have a duty to properly test their products in trials before they release dangerous drugs to the public, even over-the-counter, where consumers risk their good health.

photo of attorney Joe Lyon
A Voice for Those who have suffered 

Why are these cases important?

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

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Questions about Pharmaceutical Litigation

What is Pharmaceutical Litigation?

When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a  certain drug. 

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

How does the drug label come into play?

In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit.  As a result, there is a financial incentive not to strengthen the warning label.

However, the label is the source of information that physicians and patients rely upon when making these important health decisions.  There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.

How does this related to the FDA?

Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.

While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.

Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product.  The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.

Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.

What are some examples of Pharmaceutical Settlements?

The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis. Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.

It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients. A few examples of drug injury:

Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.

AntibioticsAntibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.

Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.

Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.

Opioid Painkiller Lawsuits: Purdue Pharma, Johnson & Johnson and other large drug companies are deep in pharmaceutical settlement talks many years after the beginning of the opioid addiction crisis. Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.

Depo Provera: Confidential settlement from Pfizer to resolve all of the claims currently pending in the New Jersey State coordinated litigation. Joseph Lyon represented 13 females who suffered osteoporosis due to the failure of Pfizer to properly warn them and their physicians.

Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.

Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol.  Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.

In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure.  After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.

Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement.  In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.

Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.

How are the cases handled?

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

What is an MDL?

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

Why Hire the Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Pharmaceutical Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Pharmaceutical lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world 

Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a drug to obtain just compensation under the law. 

IN RE: VIOXX

Nationwide Consolidation in U.S. District Court, E. Dist. of LA. 

This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.

IN RE: TRASYLOL

Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA. 

A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.

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