The FDA is warning that treatment with the anti-epileptic clobazam (Onfi) can cause potentially serious side effects, including fatal cases of SJS (SJS) and toxic epidermal necrolysis (TEN), especially during the first 8 weeks of treatment.
Prescribing doctors and patients are urged to consider alternative medications if possible to avoid the risks of severe drug reactions and patient injury. The Lyon Firm is dedicated to reviewing each injury case and to assist in the complex legal process of filing a lawsuit against large drug companies.
Joe Lyon is an experienced product liability lawyer and drug defect attorney representing plaintiffs nationwide in Onfi injury lawsuits.
The nation’s drug safety agency has approved changes to the Onfi label and medication guide to describe serious health risks to patients. Stevens Johnson syndrome is rare but the serious skin reactions can result in permanent harm and even death. The FDA approved changes to the Onfi drug label and the patient Medication Guide describe the risk of these serious skin reactions and Stevens Johnson Syndrome.
Stevens Johnson Syndrome has been linked to other drugs as well, including over the counter pain pills like ibuprofen, Motrin and Tylenol. More recent research and medical trials have tried to pinpoint certain triggers for SJS, and have gotten closer but can only say that medications may raise the risk of such rare conditions.
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during drug treatment. However, the likelihood of skin reactions is greater during the first 8 weeks of treatment or when Onfi is stopped and then re-started. All cases of SJS and TEN in the FDA case series have resulted in hospitalization, one case resulted in blindness, and one case resulted in death. See the FDA Drug Safety Communication for a Data Summary and additional information.
Patients taking Onfi should monitor their health and seek immediate medical treatment if they develop:
Due to serious side effects being reported, and consumer safety alerts, medical professionals should discontinue the use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related.
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.
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.
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.
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.
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.
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