Dangerous Drugs Pharmaceutical Drug Law: Accountability and Liability

  1. Lawsuits involving prescription drugs, medication and medical products usually concern product liability law. In general, product manufacturers are charged with a duty of care. They must make reasonable efforts to protect the consumer from harm.

    Drug Manufacturer Testing Requirements and FDA Approval


    Drug manufacturers must conduct appropriate testing of drugs and medications prior to making them available for use. The Center for Drug Evaluation and Research (CDER), the largest center of the Food and Drug Administration (FDA), ensures that drugs and medication are effective and safe for public consumption. The CDER is responsible for setting the prescription and nonprescription drug testing criteria to be used by pharmaceutical manufacturers.

    After the manufacturer tests a drug, the company files a New Drug Application with the FDA for approval which includes necessary information about the drug, such its effectiveness, potential risks and test results. FDA physicians and scientists must be convinced that the drug is reasonably safe and effective and that can be manufactured as a quality product. If so, the drug may be approved by the FDA and marketed in United States. The fact that a drug may be properly licensed by the FDA does not shield a drug manufacturer from a lawsuit. An injured plaintiff may still sue based upon a claim that the drug was defective.

    The Learned Intermediary Doctrine


    With the exception of over-the-counter (“OTC”) drugs, virtually all medical products pass from the manufacturer to the consumer through someone else who is knowledgeable. Under tort law, there is a legal defense for medical device and pharmaceutical manufacturers called the "Learned Intermediary Doctrine." Manufacturers are deemed to have fulfilled their duty of care when they provide all necessary and essential information to a "learned intermediary" who interacts with a consumer who uses the product.

    So who is a learned intermediary? It can be a doctor who prescribes medication for a patient. It can be a nurse who informs a patient about proper dosage. It may also be a pharmacist who fills a prescription and provides instruction concerning use of the medication. This learned intermediary relationship between drug manufacturer and consumer can complicate questions concerning liability in a defective medical or pharmaceutical product lawsuit. A skilled products liability lawyer is usually recommended given the specialized nature of such cases.

    Manufacturer's Duty to Warn


    A drug manufacturer who is aware of potential side effects associated with a drug has a duty to warn the public about known risks and dangers. A manufacturer will usually list them and pass that information along to a doctor or pharmacist. While the duty to warn may be discharged and shift to the learned intermediary, the drug manufacturer will still bear the responsibility of making sure that the information is accurate, adequate and up to date. Drug manufacturers must continuously update the information they provide to other medical professionals about the drugs they produce. While the duty of care does not require that all potential risks and side effects be listed, it does not mean that low or rarely occurring risks and side effects can be omitted.

    Unavoidably Unsafe Drugs


    Some drugs are inherently unsafe. A drug manufacturer simply cannot make them completely safe for use by consumers for their ordinary and intended purpose. If measures were taken to make the drug safe, the result would be that the drug would not be effective and capable of solving the problem that the drug is intended to remedy. For example, a sharp saw could be made safer by making the blade more dull. But doing so would defeat the purpose of having a sharp saw that more easily cuts through wood.

    Unavoidably unsafe drugs exist even though they are dangerous because they still may provide the best way to treat certain medical conditions. These drugs may potentially have a number of harmful side effects. Drug manufacturers usually take great care in the manufacture of unavoidably unsafe drugs and in creating adequate warnings. By doing so, it makes it difficult for an injured person to win a drug liability lawsuit by claiming that they were unaware of the risks involved in taking the drug.

    The National Childhood Vaccine Injury Act of 1986


    Vaccines which fight illness and disease will only be researched and produced if the effort is economically feasible for drug manufacturers. In order to reduce the liability associated with vaccine injury lawsuits to a manageable level, the National Childhood Vaccine Injury Act was enacted in 1986. It provides for cost-effective arbitration of vaccine injury claims. It also manages a federal no-fault system which compensates those who suffer a personal injury or death resulting from the use of a vaccine. The National Vaccine Injury Compensation Program ensures that vaccines are produced in adequate supply and also handle vaccine injury claims.

    Statute of Limitations Issues


    Calculating the time limit to file a lawsuit after an injury (also known as the “statute of limitations”) is not so simple when prescription medications are involved. There can be long stretches of time where an injured person is unaware that they may have been harmed by a drug. The harmful effects of exposure to asbestos is one such example, which may not manifest themselves for several years. Evidence may be difficult to obtain. As a result, the law may impose special remedies for plaintiffs. This could include burden shifting (requiring the defendant drug manufacturer prove they were not responsible) as well as the creation of a fund to compensate injury victims that is shared between all responsible drug manufacturers.

    Pharmaceutical Drug Law and Drug Injury Lawsuits


    Product liability actions involving personal injuries caused by defective drugs are not simple matters. They involve complex litigation, are highly specialized in nature and will almost always require the use of expert witnesses. Product liability law differs between states and different legal theories and causes of action may exist. An experienced product liability attorney who specializes in defective or dangerous drugs lawsuits is recommended.
    Accident & Injury Law:
    Dangerous Drugs

    Michael M. Wechsler

    Michael M. Wechsler
    Michael M. Wechsler is an experienced attorney, founder of TheLaw.com, A. Research Scholar at Columbia Business School and of-counsel to Kaplan, Williams & Graffeo, LLC. He was also an SVP and chief Internet strategist at Zedge.net and legal consultant at Kroll Ontrack, a leading service e-discovery and computer forensics service provider.

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