Drugs and Medical Devices Information Center
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. If you believe you may have a claim against a drug manufacturer, you should not hesitate to seek legal advice from a lawyer at James F. Humphreys & Associates, L.C. in Charleston, West Virginia, who has experience in cases that involve defective or dangerous drugs or medical devices.
Testing
"Medical device manufacturers have the responsibility to perform reasonable testing prior to making a product and to discover risks and risk avoidance measures that such testing would reveal." Restatement (Third) of Torts: Products Liability § 6, the government requires drug and medical device manufacturers to perform adequate tests on their products. Although long-term effects of medical products cannot be known, this does not excuse manufacturers from their duty to conduct testing. Alternatively, if dangerous side effects are known in general and warnings on all products, the manufacturer does not have to conduct additional testing.
FDA
The FDA oversees the research, development, manufacturing and marketing of medical products. Once a product receives approval, the FDA also monitors products for unexpected risks and makes sure the warning labels, marketing and other information given to the public is accurate. Manufacturers must conduct testing and present their findings to the FDA when to show their product is safe and effective for the public. The manufacturer’s evidence is evaluated and scrutinized. The FDA also examines manufacturer’s records to ensure they are following FDA testing guidelines. In addition, the FDA has a set of regulations, Good Manufacturing Practices, which manufacturers must follow to receive approval.
Failure to Warn
Drug and medical device manufacturers, physicians and pharmacists all have a duty to warn. This duty may be to disclose information, make a patient aware of possible dangers or place warnings of dangerous side effects on prescription labels. Drug or medical device manufacturers have a duty to warn the physicians of any known risks associated with the product. These warnings allow the doctor or medical provider to know of unavoidable risks and to allow the patient to make an informed decision regarding their care and whether to use the drug or medical device. It is then the doctor’s duty to warn their patient of any risks. If the doctor fails to do so and their patient is injured as a result, the doctor may be liable for failing to inform their patient of known risks. A pharmacist may also be held liable for consumer injury, if the manufacturer adequately warned the pharmacy of any risks and the pharmacist did not relay the warnings to the consumer. If there was a failure to warn, the consumer must show that the lack of warning caused them to ingest the drug or use/misuse the medical device, which in turn caused their injury.
Strict Liability or Negligence
When a consumer is injured by a drug or medical device defect, claims will generally be based on strict liability or negligence. Strict liability focuses on the product and whether it is unreasonably unsafe. Negligence claims focuses on whether the manufacturer has taken reasonable care to develop and manufacture the device. The Food and Drug Administration (“FDA”) approves drugs and medical devices for sale, but it does not guarantee that a particular product is safe. Medical device defects are often categorized as either design defects (which are part of the basic design of the product) or manufacturing defects (which occur as an unintended consequence of the manufacturing process). Whether a claim is based on strict liability or negligence depends on the type of defect involved and the warnings that were given (or not given).
Conclusion
Lawsuits against manufacturers for injuries caused by defective or dangerous medical products are complex. Your attorney should have knowledge of this area of law to pursue your claim. An experienced medical liability attorney from James F. Humphreys & Associates, L.C. in Charleston, West Virginia, can work with you to pursue your case and to see that you receive what you are entitled to recover.
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