Pharmaceutical companies and medical device manufacturers have a responsibility to properly research the safety and effectiveness of their products and accurately report their testing results to the Food and Drug Administration (FDA) before receiving approval to market them to the public.
In addition to these initial requirements, manufacturers have two other important responsibilities. First, they must monitor any adverse reactions reported after their products enter the marketplace and promptly notify the FDA of any trends or concerns affecting product safety. Second, pharmaceutical companies cannot promote their drugs for uses that have not been authorized by the FDA.
When a drug or medical device manufacturer fails to accurately report test results, withholds information received from doctors or hospitals about potential problems, or promotes a drug for unauthorized purposes, the company may be held liable for the resulting harm.
In some cases, a defective drug or medical device may injure only one person. However, these products can also cause harm to hundreds or even thousands of individuals. When numerous people suffer similar injuries, a class action or other form of collective litigation may be appropriate to hold the manufacturer accountable.
Claims against pharmaceutical and medical device manufacturers fall under the category of product liability law. Unlike a defective vehicle, which may cause an accident or worsen an injury, a dangerous drug can cause harm simply through ingestion. For this reason, the FDA requires prescription drug manufacturers to demonstrate through adequate testing that their products are both safe and effective. Similarly, medical device manufacturers must demonstrate that their devices can serve their intended purposes without presenting unreasonable risks of harm.
Under Georgia law, manufacturers of defective products, including pharmaceutical drugs, may be held responsible under the legal principle of strict liability. This means that a manufacturer may be liable for injuries caused by a defective product even when there is no evidence of negligence in its design or manufacturing process. Strict liability can make it easier for injured individuals to establish a manufacturer’s responsibility.
A claim for damages may arise when a drug’s formulation is inherently dangerous and its potential risks significantly outweigh its benefits. Likewise, if a product becomes contaminated during the manufacturing process and causes injury, the manufacturer may be held liable for the resulting damages.
In certain cases, evidence may reveal that a manufacturer manipulated testing data or failed to disclose harmful side effects observed during clinical trials. Although these claims can be particularly difficult to prove, establishing such misconduct can significantly strengthen an injured person’s case.
A manufacturer’s responsibility does not end once a product reaches the marketplace. Pharmaceutical and medical device companies have an ongoing duty to monitor safety concerns and report newly discovered risks to the FDA. When adverse reactions or other harmful events are identified, prompt action may be necessary. Depending on the circumstances, this could include recalling the product or providing additional warnings to healthcare professionals and the public.
As with other product liability claims, cases involving pharmaceutical companies and medical device manufacturers require a thorough understanding of the applicable laws, regulations, and legal procedures. Having an experienced attorney is essential to effectively pursuing these complex claims and seeking compensation for the injuries suffered.
At A. Russell Blank, LLC, you can feel confident knowing you have an attorney committed to protecting your rights and pursuing accountability when a dangerous or defective drug or medical device causes harm.
