Drugs and Medical Devices

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Frequently Asked Questions about Drugs and Medical Devices

Q: Who is liable for harm suffered from prescription drugs?

A: Depending on the facts of your case, liable parties can range from drug and medical device manufacturers, to your treating physician, to the pharmacy that dispensed the medication.

Q: How can I find out if a medication I have been prescribed is dangerous?

A: Always ask your physician questions you have about medications he or she prescribes you. Also ask your pharmacist about possible risks and instructions on how to take your medications. If you are already taking a medication and would like to make sure it is still safe, check with the FDA Web site or the MedWatch Web site for updates on dangerous drugs.

While prescription medications are usually beneficial, they can be dangerous. Your doctor is responsible for prescribing the right medication, and your pharmacist is in charge of filling the prescription.

Your doctor must inform you of the risks involved in the use of any prescribed medication, as well as the risks involved in any medical procedure, and you have the right to refuse consent for any medical procedure or treatment.

Medications that have not been approved for sale in the United States may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.

Medical tools and devices such as syringes, hip implants, pacemakers, or surgical instruments can result in injury if they are used or manufactured improperly.

Drugs and Medical Devices - An Overview

The costs of defective drugs and medical devices are great. Having defective drugs and medical devices on the market can lead to significant health risks in consumers. Risks can cause serious injury, disabilities and hospitalization. In some cases, injuries lead to more intensive surgeries than were originally necessary to correct the damage caused by the defect. Some harms caused by defective prescription drugs and medical devices also cause death. Fatal injuries caused by defects have been on the rise the past decade. This increase has lead to drugs being pulled off the markets, class action lawsuits, safety concerns and liability issues; we want to know who to blame.

Defective Drugs

When a consumer receives a prescription for medication from his or her physician he or she would likely believe that drug is safe. However, safe does not necessarily mean harmless. According to the US Food and Drug Administration, “safe” means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use. A defective drug is one whose potential risks offset its anticipated benefits. Likewise, a defective drug is one whose potential risks outweigh its possible benefits to the consumer.

Defective Medical Devices

Medical devices are used to ease pain, help with disabilities and save lives. However, when these devices are flawed they may cause serious injury and death. Some medical device defects may include faulty design or insufficient manufacturing quality and are considered instruments used for treatment, diagnosis or prevention of disease or injury. The FDA categories of devices are complex and widely varied and many of the adverse effects of medical devices are preventable.

Legal Duty of Manufacturer

We all rely on medications and medical products to help gain a higher quality of life or better health. However, not all drugs or medical products are helpful. Some may have been defectively manufactured or may be unsafe. These medical products may pose dangerous risks or injury. Drug and medical device manufacturers have a legal duty to make a safe product, test their products, meet FDA standards and approvals for their products (prior to entering the market) and to issue the appropriate warnings for any risks associated with their products. Likewise, physicians and pharmacists have a duty to relay manufacturers’ warnings to their patients or consumers when it is necessary and appropriate to avoid consumer injuries. If you have been injured by a drug or a medical device, you may be entitled to compensation for your injury.

What Can You Do?

Manufacturers, physicians and pharmacists may be held liable for certain drug and medical device defects, but ultimately you are responsible for your own health. Keep yourself aware and knowledgeable of your medical treatment. You are accountable for taking your prescription correctly, taking the right dosage and not abusing your medications.

Drugs and Medical Devices Resource Links

United States Food and Drug Administration (FDA)
The FDA is the main federal agency charged with drug and medical device safety. The FDA's Web site includes news, product reports and approvals, safety alerts and recalls.

MedWatch
This Web site contains the FDA safety information and adverse event reporting program used by consumers to report defective drugs or medical devices or to check the status of medical products.

Breast Implants on Trial
From PBS's Frontline, this Web site includes news, documents, studies and other information related to breast implant defects and litigation.

Institute for Safe Medication Practices
The Institute for Safe Medication Practices is a nonprofit organization devoted to medication safety and serving health care providers and consumers.

RegSource.com
this Web site offers regulatory information and news on drugs, biologics, medical devices and pharmaceuticals.