Many people in the United States take medications, both over-the-counter and prescription, assuming that their benefits will outweigh the risks. Everyone who takes medications counts on pharmaceutical companies to provide them with accurate information about the side effects and risks that are present.
When a medication causes harm that wasn’t clearly disclosed, there’s a chance that a product liability claim might be forthcoming. This type of legal action can hold a pharmaceutical company, manufacturer and even sellers liable for damages.
3 types of defects related to pharmaceuticals
Three main types of defects can lead to liability: design defects, manufacturing defects and marketing defects. Design defects occur when a drug is inherently dangerous even if manufactured correctly, often leading to cases where a drug’s side effects outweigh its benefits. Manufacturing defects arise during the production process, resulting in a harmful drug due to some deviation from the intended design. Marketing defects, also known as “failure to warn,” involve inadequate instructions, warnings, or recommendations regarding drug use.
Legal standards for establishing liability
For a pharmaceutical company to be held liable, the complainant must typically prove that the drug caused harm and was defective. This often requires demonstrating negligence in the drug’s design, manufacture, or marketing. The rigorous testing and approval process by regulatory bodies like the U.S. Food and Drug Administration (FDA) complicates these cases. FDA approval doesn’t shield a company from liability, but it can influence the court’s view of whether a drug’s benefits outweigh its risks.
Impact of pharmaceutical regulations on liability cases
Regulatory compliance plays a significant role in shaping pharmaceutical liability. While adherence to FDA guidelines can help defend against liability claims, it isn’t a fail-safe. However, regulatory violations or evidence of non-compliance can be a powerful factor in establishing liability.
Challenges and defenses in pharmaceutical litigation
Pharmaceutical companies often employ several defenses in these cases. They might argue that the complainant misused the drug, that the harm was due to an underlying health condition or that the side effects were known but deemed an acceptable risk given the drug’s benefits. Proving a link between a drug and an adverse effect can be challenging, especially when long-term effects are involved.
Due to all that is at stake, injured parties should work with a legal representative who can stand up for their rights when a need to file such complicated cases arises as a result of harm caused.
