Chicago Prescription Error Lawyer

Problems With the FDA Approval Process

One example of the FDA’s flawed approach is its Abbreviated New Drug Application (ANDA) for the approval of generic drugs. Generic drug manufacturers are generally not required to provide preclinical (animal) and clinical (human) trial data to establish a product’s safety and effectiveness. Instead, “a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug).”

Even when a clinical trial is required, a clinical trial is limited in size. Serious side effects linked to a drug may not be detected until the drug has been used by the wider population.

When the FDA learns of drug injury and illness caused by a prescription medication, it may order changes to the product’s label changes and/or issue a warning. In some situations, the manufacturer may voluntarily recall the drug or be forced by the FDA to issue a prescription drug recall. However, by that point in time, millions of people may have been adversely affected.

The FDA published more than 40 drug recall notices on its website in 2011 and about 40 more in 2012. The FDA notes on the web page that, “The recalls on the list are generally Class I, which means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Legal Options for Illinois Drug Injury Victims

When a patient suffers adverse side effects from a defective drug, the consequences can be tragic. The condition the drug was intended to address may worsen. Additional illness may be caused by the initial drug-related injury, such as heart, kidney or other organ failure, or cancers caused by the drug. The patient may need to endure extensive hospitalization. A family may lose a loved one. Emotional harm often accompanies the patient’s physical suffering.

Patients injured by a dangerous drug, or those who lose a family member, may be able to seek compensation through a product liability lawsuit. There may be several reasons why the pharmaceutical company should be held liable, including:

• Designing and manufacturing a drug that is inherently flawed
• Selling drugs that fail to meet FDA standards, such as size and dosage specifications
• Inadequate testing of the drug’s safety and effectiveness
• Concealing negative results from the FDA or other approval agencies
• Promoting the drug for unapproved uses or downplaying its risks
• Failing to warn patients and doctors about known risks, complications and side effects linked to the drug, including the risks faced by certain types of patients or problems that can arise when it is combined with other drugs.

A dangerous drug lawsuit can be filed in either a state or a federal court. Because drug-injury cases often affect patients and families in multiple areas across the U.S., a class-action lawsuit may be more appropriate than an individual lawsuit. An individual’s lawsuit may be consolidated with other claims during pretrial proceedings in a process called “multidistrict litigation.” Even though many patients may be involved in a legal action against a pharmaceutical company, it’s important that each case receives the individualized attention it deserves.