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When a patient is harmed by a pharmaceutical product and seeks to sue the manufacturer, there are specific legal standards and elements that must be met to recover damages. Drug companies have a legal obligation to ensure the safety of their products, but not all injuries result in liability.

The plaintiff in a defective drug lawsuit must prove existence of one or more of these elements:

1. Design defect — A drug may be considered defectively designed if, even when manufactured correctly and used as intended, it presents inherent risks that outweigh its benefits. For example, a medication might unpredictably cause severe organ damage in a significant proportion of patients, even when taken as prescribed. Plaintiffs can argue that there was a safer alternative design that would have prevented the injury.

2. Manufacturing defect — Sometimes, a well-designed drug is rendered dangerous by flaws in the production process. This could involve contamination, improper dosage or faulty packaging, leading to injuries that would not occur had the product been made according to specifications. To prevail on a claim of manufacturing defect, the plaintiff must demonstrate that the drug departed from its intended design when it left the manufacturer’s control.

3. Labeling defect (failure to warn) — Even a safe and properly made drug can be dangerous if patients and doctors are not adequately informed about its risks or correct usage. Warnings about side effects, contraindications, or interactions might be omitted or unclear. For example, a drug causing birth defects if taken during pregnancy must prominently warn of this risk.

The basic elements of a defective drug cause of action are:

• Duty of care — Drug manufacturers owe a duty of care to produce medications that are reasonably safe when used as directed and to warn users of any known or foreseeable risks.

• Breach of duty — If a manufacturer releases a drug with a design, manufacturing or labeling defect, or fails to adequately warn healthcare providers and the public, it may breach the duty of care. Not only manufacturers but also distributors, pharmacists and healthcare professionals may share responsibility depending on their roles.

• Causation — The plaintiff must clearly establish that the defect directly caused their injury. This usually requires medical records, physician testimony and, in some cases, epidemiological evidence to show a link between the drug and the harm suffered.

• Damages — The plaintiff must have suffered tangible harm, such as medical expenses, lost wages or pain and suffering. Without provable damages, there is no actionable claim.

Some form of physical injury must have resulted, such as severe side effects for which there were no adequate warnings. These can include:

• Organ damage, such as liver or kidney failure

• Severe allergic reactions (anaphylaxis)

• Birth defects if the drug was taken during pregnancy

• Blood clots or strokes

• Cancer, especially with prolonged use of certain drugs

• Neurological damage or cognitive impairment

• Psychiatric effects, such as suicidal ideation from antidepressants

Proving a drug injury case often requires gathering expert testimony as well as forensic evidence. An experienced defective drugs attorney will coordinate with medical experts, analyze your medical history and seek third-party reports of similar injuries to establish a pattern of harm or company negligence. 

At Walsh & Franseen in Edmond, Oklahoma, we are highly skilled at resolving complex drug injury cases so that our clients secure the compensation they deserve. Call us at 405-843-7600 or contact us online to schedule a free consultation.