Pharmaceutical Liability Information CenterBuilding a Pharmaceutical Liability CaseDrugs 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 at Dolan Law Firm in Miami can evaluate your situation and explain your options for recovery. Theories of LiabilityWhile all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians regarding the known risks associated with its drugs. If a manufacturer fails to do so, it may be liable to patients who were injured based on a product liability theory, for providing inadequate warnings. Drug manufacturers can also be held liable for injuries to consumers based on theories of negligence, or even intentional or malicious conduct. If you have taken a prescription drug, over-the-counter medication or herbal supplement and experienced any unusual side effects, you should contact your physician at once. In addition, you should contact an attorney experienced in pharmaceutical liability litigation to discuss potential legal claims you might have. Depending on the specific facts of your situation, your attorney may pursue a pharmaceutical liability claim using one or more of the following legal theories:
Proving Your CaseThe first step in establishing your case is to identify the defect or defects in the medication or medical device that caused your injury. It is possible that a particular drug is defective in more than one way. As a plaintiff, you have the burden of proving that the defect actually caused your injury. In order to prove causation, you will need the assistance of an expert witness, usually a doctor, who will testify that the drug caused your injury. Your attorney will collect information and evidence from the defendant through a process called discovery. In discovery, the parties can request documents from the other side and depose witnesses. Evidence that may be helpful to your case includes: correspondence between the defendant and the FDA, reports of adverse drug reactions, materials from clinical trials, laboratory studies, sales and advertising information, product labels and inserts, complaints the manufacturer received about the drug, information about prior lawsuits and medical or scientific studies funded by the defendant. Potentially Liable PartiesIn addition to the company that manufactured the drug or nutritional supplement that injured you, you may also be able to pursue pharmaceutical claims against the following parties:
Federal PreemptionAn issue for plaintiffs who seek to bring failure to warn claims against drug manufacturers is federal preemption. In January 2006, the FDA amended its labeling requirements for prescription drugs. In the preamble to these amendments, the FDA announced that failure to warn claims by injured plaintiffs against drug manufacturers conflict with, and are thus preempted by, the FDA’s regulation of prescription drug labeling under the Food, Drug and Cosmetics Act. If a court finds your claim preempted, it can dismiss the claim. However, state tort claims will not likely be preempted. ConclusionIf you suspect that a drug, dietary supplement or medical device injured you, it is important to seek medical assistance as soon as possible. It is also important to contact an experienced pharmaceutical liability attorney at Dolan Law Firm in Miami so that he or she can begin investigating whether you have a claim for damages against the manufacturer or another party. Copyright ©2009 FindLaw, a Thomson Business DISCLAIMER: This site and any information contained herein are intended for informational purposes only and should not be construed as legal advice. Seek competent legal counsel for advice on any legal matter. |




