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Frequently Asked Questions about Pharmaceutical Liability

Q: What is "pharmaceutical liability?"

A: The term "pharmaceutical liability" refers to legal theories and ways to prove that a manufacturer of a pharmaceutical product, including prescription and over-the-counter medications, medical devices, dietary supplements and herbal remedies can be held responsible when its products injure people. The theories include strict products liability and negligence, though some states have statutes providing a single theory for recovering from a product manufacturer.

Q: Will I have to sue my doctor?

A: Your lawyer may conclude that your doctor might share the responsibility for your injuries. In some states, a jury may decide to assign the doctor a percentage of fault, even if the doctor is not sued, and you will not be able to collect the entire verdict from the manufacturer. In other states, the manufacturer may have to pay all your damages unless it persuades the jury that your doctor is at fault and will sue your doctor itself.

Adverse reactions to legal drugs are a leading cause of death in the United States. In fact, more people die from adverse reactions to prescription drugs than from illegal "street" drugs. Studies have concluded that 17% to 25% of all hospital admissions are related to adverse side effects.

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Prescription drugs, over-the-counter remedies, and herbal health supplements can have dangerous, sometimes life-threatening, side effects, including kidney failure, heart attack, stroke, and even wrongful death. Our attorneys have dealt with some of the largest mass tort cases in American history, and are currently working on cases involving the following dangerous drugs:

Accutane: Acne treatment; side effects include: birth defects, depression, suicide and more.
Bextra: Treatment for osteoarthritis, rheumatoid arthritis and dysmenorrhea. Linked to high incidences of heart attacks, strokes and the potentially fatal skin condition known as Stevens-Johnson Syndrome.
Fosamax: Bisphosphonate medication used for bone loss; linked to jaw bone death.
Ketek: Or telithromycin;& antibiotic treatment for respiratory infections. Linked to cases of liver toxicity.
Ortho Evra: Birth control patch - exposes 60 percent more estrogen. Greater risk for blood clots and strokes.
Paxil: (SSRIs) - prescribed anxiety disorder, OCD, depression and more. Linked to extreme acts of violent behavior.
Prisma Dialysis Recall: Kidney dialysis system, alerts caregiver of fluid imbalance. Linked to serious injury or death if not monitored properly.
ReNu Recall: ReNu with MoistureLoc potentially linked to blinding eye infection, Fusarium keratitis.
Stevens-Johnson Syndrome: Often caused by an allergic reaction to a drug or medication. SJS side effects: painful blistering skin rash, peeling skin, and blistering sores.
Tequin: Or gatifloxacin. Antibiotic associated with hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar).
Tobacco Litigation: Tobacco case information, articles, updates and more.
Trasylol: Drug, prevents bleeding during heart surgery. Risk of kidney failure, increase of heart attack, heart failure and stroke.
Viagra: Drugs increase blood flow; relief for erectile dysfunction. Linked to blindness.
Vioxx: rheumatoid arthritis treatment. Side effects include heart attack, stroke, even death.

Pharmaceutical Liability - An Overview

“Pharmaceutical liability” is a term used to describe the legal consequences a manufacturer of drugs may face if its products injure people. Cases involving injuries caused by drugs, medical devices and other pharmaceuticals are a subset of products liability cases. Plaintiffs can bring claims against the manufacturer based on theories of strict liability, negligence or for failing to warn about potentially dangerous side effects. In some states, however, a statute creates a single claim for product injuries, which may combine aspects of the two. A lawyer who has experience in pharmaceutical liability law can advise you about your rights and help you decide whether you can pursue a claim.

Building a Pharmaceutical Liability Case

Drugs and other medical products may suffer from a variety of defects, including design defects, manufacturing defects, problems with the testing of the drug or device, inadequate warnings or instructions for use, problems with the doctor's prescription or incorrect distribution by the pharmacist. Any of these defects can cause serious injuries. Adverse side effects are one of the most common problems with prescription and over-the-counter medications. Problems can also arise if the manufacturer failed to disclose adverse testing results or adverse reactions to the drug or if contaminates entered the product during manufacturing. If you believe that a medicine, nutritional supplement or medical device has caused you to suffer from serious, adverse side effects or other severe injuries, an experienced pharmaceutical liability attorney can evaluate your situation and explain your options for recovery.

Protecting Yourself Against Risks

From a prescription drug to help control high blood pressure to over-the-counter pain relievers, many people take medications every day. In addition, herbal and nutritional supplements are a part of life for many people. Although these medicines can help you feel better and manage your symptoms, they have risks as well as benefits. Just because a drug is approved by the Food and Drug Administration (FDA) does not mean it is free from risks. The FDA approves a drug and considers it safe when the benefits outweigh the known risks. In fact, many risks are only discovered after a drug has been on the market for an extended period of time and a much larger number of patients than participated in the clinical trials have used the drug. There are steps you can take to minimize your risk of adverse reactions. If you have experienced adverse side effects as a result of taking a drug or herbal supplement, contact a pharmaceutical liability attorney to discuss whether you may be able to recover for your injuries.

Dietary Supplements and Herbal Remedies

The production and sale of dietary supplements and herbal remedies is a huge and largely unregulated business in the United States. While dietary supplements and herbal remedies may be safe in most circumstances, they are not risk-free and can cause serious side effects, just as drugs do. The federal Dietary Supplement Health and Education Act of 1994 (DSHEA) governs the regulation of dietary supplements. DSHEA also sets forth rules for making claims about products and information that must appear on labels. A lawyer who is familiar with the statute’s requirements can help you determine whether you have a claim against a manufacturer and whether you can recover damages for your injuries.

Medical Devices

Claims for injuries caused by medical devices are also included under the heading of pharmaceutical liability. Under Section 201 of the federal Food, Drug and Cosmetic Act, a medical device is defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease." Examples of medical devices include: defibrillators, breast and other cosmetic implants, orthopaedic screws, hip implants, knee implants, heart valves and many other items. If you or a loved one has been injured by a medical device or experienced adverse side effects, you may be able to recover for your injuries. Medical device litigation is complex, and an experienced attorney can evaluate your situation and help you build a case.

Pharmaceutical Liability Resource Links

National Library of Medicine
This resource is part of the National Institutes of Health. Users can find information about drugs using either the generic or brand name. The site also contains warning and recall information.

US Food and Drug Administration/FDA Consumer
A searchable archive of the Food and Drug Administration's publication, "FDA Consumer," with information relating to health care, medications and other health-related issues.

MedWatch
MedWatch is the FDA's safety information and adverse event reporting program. Health care professionals can voluntarily report adverse reactions, product problems and errors related to drugs, medical devices and dietary supplements. The form can be printed out and completed or it can be completed and submitted online. Instructions are located at the FDA's web site.

Physician's Desk Reference
An online version of the Physician's Desk Reference, the "Bible" doctors consult about brand-name medications, dosages and uses. The site also contains the FDA-required patient information brochures and links to clinical trial information.

National Council on Patient Information
These resources are sponsored by the National Council on Patient Information and Education. There are links to information about antibiotics, flu shots, buying medications online and specific medications. There is also information about over-the-counter (OTC) medications, tips for selecting and using OTC medications, tips for parents, brochures in English and Spanish and a list of links to other resources.

Over the years, our firm has had the opportunity to assist in auto accident cases nationwide. Throughout Florida, our practice also encompasses Pensacola, Santa Rosa County, Panama City, Escambia, Calhoun, Gulf, Okaloosa, Walton, Holmes, Washington Bay, Jackson, and Tallahassee, FL, and our work extends to Mobile, Alabama and other communities in the southeastern United States. Click here for a free case evaluation.