Oftentimes, when people experience some sort of health condition the most common answer is to take medication. Regardless of the degree of your condition, when you take medication the expectation is that it will improve your health condition. However, this is not always the case. Whether you are taking a prescription drugs or over-the-counter drugs (OTC), these substances can cause extreme side effects, illness, or wrongful death.
As mentioned above, there are two classifications of drugs: prescription only and over-the-counter (OTC). Prescription drugs are intended to be used by one individual patient and are only available with a valid prescription from a prescriber. In contrast, OTC drugs are available for purchase without a prescription and can be purchased right off the shelves at a store—without a prescriber. Both prescription drugs and OTC drugs require approval by the Food and Drug Administration (FDA) and are monitored for safety and side effects even after the drug is on the market. Although prescription drugs must pass through may clinical trial phases prior to approval, the FDA routinely issues drug recalls when medications pose a risk to patients. Yet, many recalls only happen after people have sustained injuries, which may not prevent all future harms. Additionally, OTC drugs could cause drug interactions with prescription medications.
Some of the common drug-related injuries people have experience include:
- Internal Bleeding
- Organ Failure
- Heart Attack
- Birth Defects
- Psychological Problems
- Muscle and Nerve Damage
- Wrongful Death
Prescription and OTC drugs should help you, not hurt you. When these drug-related injuries occur, they fall under the umbrella of personal injury claims called product liability. Product liability claims can be brought under a variety of different theories. In North Carolina, these theories include misrepresentation, breach of warranty and negligence. The plaintiff in a product liability claim must prove through the manufacturer’s negligence, the product was defective and that defect made the product unreasonably dangerous.
When evaluating the legal merits of a product liability claim, another aspect of the process is determining who the defendant or defendants will be. In most cases, the defendant in a drug-related injury will include the drug manufacturer and the prescribing doctor. Other, less often joined defendants, include the wholesaler of the drug, the retailer, hospital, nurse, pharmacist, and attending or treating doctor.
When holding the drug manufacturer liable for negligence under a product liability claim, the claim should show that the manufacturer deviated from the standard of care expected from the average drug manufacturer. A variety of theories may be asserted at this stage:
- Failure to test—meaning the manufacturer of the drug failed to adequately test the drug before it was marketed.
- Failure to inspect—the manufacturer failed to reasonably inspect the drug prior to marketing where reasonable inspection would have detected an impurity or its unmarketability.
- Failure to warn—the manufacturer failed to warn the FDA, the physician, and/or patient of dangers involved with the use of a drug. Knowledge of drug-related dangers could be established by the manufacturers own studies, reports, medical literature, and/or industry standards.
- Inadequate directions—the manufacturer of a drug is under a duty to provide adequate directions to the prescribing physician so the drug is properly used. Such directions include the amount to be administered, method of administration, how the drug should be stored or preserved, expiration dates, and contraindications.
- Design default—the manufacturer is under an obligation to design the drug so that it is reasonably safe for use. When the drug is manufactured according to defective designs, the drug composition can be unreasonably dangerous to consume or combine with other drugs.
In other cases, it may even be possible to assert a breach of warranty against the drug manufacturer in a drug-related product liability claim. A drug manufacturer may be liable for breaching an express warranty made to the physician, or in rare cases, to the patient. Or, in other instances, breach of implied warranty. Breach of implied warranty means that by virtue of holding a product for sale, the manufacturer makes an implied promise that the product is fit for the purpose for which it is sold, and the consumer relies on the skill and judgment of the seller. Therefore, if certain impurities or defects are found, then the drug may be in breach of the implied warranty, and found not be merchantable or reasonably fit for the intended purpose.
On other occasions, the prescribing physician may face liability. When this occurs, an experienced attorney will likely bring a medical malpractice claim. In simple terms, this means that the physician was negligent in some way which led to a prescription error. Prescription errors can occur in the following circumstances:
- The patient is administered the wrong medication
- The patient is given the incorrect dosage of medication
- The patient has contraindications, such as medical history, that indicates allergic reactions to certain drugs
- The physician fails to inform the patient of related side effects
- Medication is improperly labeled
With respect to side effects, one of two things typically occur. First, the drug company does not expend much effort in informing the medical profession about the drawbacks of its product, or second, certain serious side effect do not become apparent until widespread use of the drug has occurred. Furthermore, most of the injured parties involved in drug-related litigation complain of side effects that were first reported in the literature and in private reports to the drug company one to three years after FDA approval. In either occasion, an experienced attorney will thoroughly investigate all possibilities for a viable personal injury claim.
Some of the common drug-related injuries include the use of the following drugs:
If you or a loved one have suffered extreme side effects or wrongful death, and you believe these complications were caused by consuming a prescribed or OTC drug, please contact us. You will speak with a personal injury lawyer who can best answer your questions and provide options. There is no fee for the initial consultation.