Why Do We Pursue Cases?
The decision to pursue product liability lawsuits can be driven by a number of factors. Most often, legal investigations are prompted by warnings, updates or alerts issued by the U.S. Food & Drug Administration (FDA), as well as drug and medical device recalls announced by the agency or a manufacturer.
FDA Warnings and Alerts
Many of Bernstein Liebhard LLP’s legal investigations are prompted by notifications issued by the FDA. In the U.S., this agency is charged with regulating the safety of medications and medical device, as well as most foods, cosmetics, dietary supplements and tobacco products. Because all possible side effects or complications can’t be anticipated prior to drug and device approvals, the FDA maintains a system of postmarketing surveillance and risk assessment programs to identify problems that only become apparent once a product is on the market, including design defects, side effects and adverse reactions.
When the FDA’s surveillance programs detect a worrisome trend with a medication, the agency may choose to issue a “Drug Safety Communication” to alert the public. Initially, these communications may announce that the FDA has begun a review of that particular problem. If the review confirms that an issue exists, the agency will issue an update to the communication. The FDA issues similar alerts when problems arise with medical devices.
FDA Recalls
Our Firm may also choose to begin investigating a drug or device when the FDA announces a recall of the product. Recalls can be issued for a number of reasons, including design or manufacturing defects, or when the risks associated with drug or device clearly outweigh its benefits.
The FDA categorizes recalls into one of three classes, according to the severity of the hazard:
- Class I: Dangerous or defective products that are likely to cause serious health problems or death.
- Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
- Class III: Products that are unlikely to cause any health problems, but that violate FDA labeling or manufacturing laws.
Were You Harmed by Medical Product Named in an FDA Alert? Contact Our Office Today.
Bernstein Liebhard LLP offers free legal review to individuals who were harmed by drugs and medical devices named in FDA alerts, warnings and recalls. To arrange for a case consultation, please contact our office at (888) 994-5118.
- FDA (2016) “How does FDA monitor safety after drugs are approved and marketed?” http://www.fda.gov/AboutFDA/Transparency/Basics/ucm305058.htm
- FDA (2016) “Device Postmarket Surveillance” http://www.fda.gov/MedicalDevices/Safety/CDRHPostmarketSurveillance/default.htm
- FDA (2015) “FDA 101: Product Recalls” http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm
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