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Pharmaceutical Liability Building A 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, call us and we will evaluate your situation and explain your options for recovery.
Theories of Liability
While 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:
- Inadequate warnings or a failure to warn about a drug's potential to harm or cause side effects (including reactions with other medications)
- Inadequate testing on a medication prior to its use
- Over-promotion and aggressive marketing and advertising efforts by the manufacturer has led to a corresponding increase in liability for injuries attributed to the drugs being marketed
- Defective design of the drug, one that is arguably unfit for its intended purpose
- Tainted or contaminated drugs
Proving Your Case
The 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, pro
Potentially Liable Parties
In 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:
- Physician who prescribed the medication
- Company that distributed the medication
- Pharmacist who dispensed the medication
- Nurse who administered the medication
- Hospital that employed the physician, nurse or registered pharmacist
Federal Preemption
An 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.
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