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Ibuprofen Stevens Johnson Injury

Spread Awareness of Drug Risks & Outcomes

Stevens-Johnson Syndrome (SJS) is a skin disorder associated with the use of a variety of medications, including Ibuprofen, SJS, which have the active ingredient of acetaminophen. Acetaminophen is a common active ingredient to treat pain and reduce fever, included in many prescription and over-the-counter (OTC) drug products.

Ibuprofen, Tylenol and Motrin may cause severe allergic reactions that affect skin and mucous membranes, triggering severe burning and blistering of tissue. In the most serious cases, blindness and death may occur.

A search of the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System uncovered over 100 severe cases, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen.

Joe Lyon is a highly-rated Cincinnati personal injury lawyer and Ohio pharmaceutical attorney representing plaintiffs nationwide in a wide variety of toxic tort and product liability claims.

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

Symptoms of Stevens Johnson Syndrome

Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are both life-threatening skin reactions that can result in death.  They are medical emergencies that usually require hospitalization.

The conditions usually begin with flu-like symptoms, followed by rash, blistering, and detachment of the upper surface of the skin.  While much is still unknown, specialists believe the diseases are caused by allergic reactions to common medications such as Ibuprofen, Tylenol and Motrin.

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

•    Blisters
•    Rashes
•    Mouth ulcers
•    Swollen eyelids
•    Conjunctivitis
•    Flu-like symptoms

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

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 up to 30 percent of severe cases.

A serious skin reaction can occur at any time, even if you’ve taken acetaminophen (Tylenol or Motrin) previously without a problem. There is currently no way of predicting who might be at higher risk. These reactions can occur with first-time use of acetaminophen or ibuprofen.

Adverse Drug Reactions a Leading Cause of Death

According to researchers at the Mayo Clinic Medical Center, about 70 percent of the adult population, or almost 170 million Americans are prescribed at least one drug.

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.
Because less than one percent of adverse drug reactions are reported to the FDA, and although SJS is considered a rare disease, it may be more prevalent than previously thought.

photo of attorney Joe Lyon
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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

Do I have a case?

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 relate 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.

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.