INFORMATION ABOUT
OVER-THE-COUNTER DRUGS MALPRACTICE

We hope that the questions and answers presented here will assist you in familiarizing yourself with the issues surrounding over-the-counter drugs malpractice. While the material below attempts to answer common questions in this area, nothing provided here is a substitute for the advice of competent counsel. We strongly urge you to consult with an attorney licensed to practice in your state about any particular legal problem you may have.

WHAT ARE OVER-THE-COUNTER DRUGS?

Over-the-counter (OTC) drugs are medicines that are sold without the need of a doctor's prescription. They are therefore also called "non-prescription drugs" or "non-prescription medicines". The Food and Drug Administration (FDA), the federal agency responsible for approving drugs, has loosened regulations over the past few years, thereby allowing pharmaceutical companies to offer more drugs over-the-counter to consumers without a prescription. As a consequence, many of the warnings relating to side effects and complications do not appear on the labels of these medicines. The doctor's knowledge and responsibility relating to side effects, drug and food interactions, and complications when prescribing these same medicines is thus bypassed.

DO PHARMACEUTICAL COMPANIES HAVE TO WARN ME ABOUT DRUG EFFECTS AND PROBLEMS?

No. When a doctor prescribes a drug, the pharmaceutical company must warn the physician of problems and interactions relating to the drug. The doctor has a duty to evaluate and discuss with the patient the relevant warning information about the drug. This protection is lost when the drug is released and purchased OTC.

Manufacturers do have a duty to warn consumers about risks associated with their products, however. An example of this duty is the warning stickers in cars regarding airbags. The duty of a pharmaceutical company, as manufacturer of OTC drugs, to warn consumers is less clear. This can create a potentially dangerous situation in view of the extensive potential interactions relating to medicines. Information concerning adverse drug reactions is not usually contained on the OTC drug label. It should be noted that a printed drug label containing adverse reactions is a requirement imposed upon the pharmaceutical manufacturer by the FDA with prescription drugs.

WHY DO PHARMACEUTICAL COMPANIES WANT TO SELL DRUGS OTC?

Medications sold over-the-counter are less expensive. This is a true benefit to the public. The expensive work force employed by the pharmaceutical company required to visit and educate healthcare professionals regarding prescribing their medicines, side effects, and drug interactions is not necessary with OTC drugs. Less money can be spent advertising directly to consumers. This direct advertising serves to increase sales and profits. Also, the drug company does not have to rely on the physician to prescribe, and thereby sell, the medication. This creates a big incentive to drug manufacturers to market drugs OTC. The doctor's protection to the patient is lost in the process.

CAN I SUE THE PHARMACEUTICAL COMPANY IF I SUFFER A REACTION FROM AN OTC MEDICINE?

Yes. The push by drug manufacturers to get their products OTC is a recent development. There have been a few cases recently where a person suffered an injury because of a drug reaction involving an OTC drug. In one, the drug manufacturer tried to argue that the doctor had a duty to discuss the drug reactions with the person and that the said person should have called the treating doctor. The court determined that where a pharmaceutical company advertises and sells directly to consumers, thereby bypassing the protection regarding medication side effects and interactions that doctors provide, then the company is responsible for the injuries to the patient.

If you think you are having a reaction, drug interaction, or side effect from an OTC medication, contact your doctor immediately. Tiredness, rashes, interactions with prescription medications, and even bleeding internally are only a few problems that can occur with taking OTC medications without medical supervision. The pharmaceutical manufacturer may be responsible to you. If you have suffered as a result, you should certainly consult with an attorney.

DO I NEED AN ATTORNEY?

Yes. In order to prove negligence, you will need to retain experts to testify on your behalf about what occurred, from a technical sense. The negligent party will then retain its own experts to contest everything you say. The attorney will be able to help you find experts and cross-examine the other party's experts as well. It would be most difficult, if not impossible, for a non-lawyer to handle an over-the-counter drug malpractice case.

HOW DOES MY ATTORNEY GET PAID?

Most attorneys review potential over-the-counter malpractice cases on a contingent or percentage fee basis. This means that the attorney's fee will be a percentage of the amount recovered on your behalf. If there is no recovery, then you will not owe any fee to the attorney. Most attorneys will even advance the expenses needed to bring the case to trial, and then get reimbursed for those expenses from the recovery. All of these details regarding the fee and cost arrangements should be worked out with your attorney in advance, before any work is done on the case. You should review all of these details completely with the attorney and have the fee arrangements put into writing.

If you have other questions or comments about this area or any other area in which we practice, please send us an E-mail message with your questions or comments and we will be happy to try to assist you.

LINKS TO OTHER INTERESTING INFO

Healthtouch Online
Mayo Clinic Medicine Center

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