For consumers who are injured by a drug or medical device, the first question that arises is often a simple one. They want to know how a product that was approved by the FDA could do them serious harm.
The simple answer is that Food and Drug Administration (FDA) approval of a drug or device does not guarantee safety for all.
In part, this is because FDA approval is not based on absolute safety, but rather reasonable safety. As the agency explains:
“The word safety means the relative freedom from harmful effects, direct or indirect, when a product is prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time.”
If a complete lack of side effects among all users under all circumstances was the FDA's safety standard, almost no products would reach the market. Safety, then, is balanced against product efficacy, or whether the product provides a measurable benefit.
The greater a product's benefit, the more of a risk the FDA is generally willing to accept as reasonable, particularly when the product is intended to treat severe, life-threatening conditions.
Imagine that a pharmaceutical company came up with a drug that could eradicate cancer, but that the drug also caused severe stomach pain. Obviously, regulators and cancer patients alike would accept this tradeoff. And in the real world, when it comes to choosing drugs and medical devices that can alleviate our pain and suffering, most of us are willing to accept certain side effects if it means an overall improvement in wellbeing.
That said, in order to properly make the assessment of whether a product's risks outweigh its benefits, the public must be made aware of potential side effects.
The FDA does not conduct its own product testing. Premarket studies are conducted by the product manufacturers themselves, and results are passed on to—and accepted in good faith by—the FDA. Due to a limited budget, it is simply not feasible for the FDA to conduct its own studies of all new products.
Upon FDA analysis of a product's known risks and benefits (as revealed through premarket studies), the agency decides whether or not to approve it. Any known side effects, furthermore, must be described in the product insert. Product literature must also contain instructions for which condition (or conditions) the drug/device is intended to treat and how it is to be used.
As long as the product is used as intended by the consumer and a manufacturer provides warning about a side effect, if harm resulting from that side effect occurs following proper product use, a consumer does not have cause for legal action.
For example, if a pain reliever stipulates that it can be taken twice per day for the treatment of minor aches and pains, and that users should not drink alcohol with the product because this can cause stomach bleeding, but the user drinks alcohol with it, the manufacturer is off the hook if the user develops stomach bleeding.
On the other hand, when a manufacturer specifies a product use and does not warn against a side effect resulting from that use, and a consumer uses the product as intended and suffers unexpected harm, the manufacturer can be held legally responsible.
To use the pain reliever example, if the manufacturer did not warn that bleeding can result from concurrent use with alcohol, the user would have no way of knowing about this potential side effect, and could blame the manufacturer for failure to warn.
Labeling on the product itself and written owners instructions must be clear and concise, and explain the dangers associated with the product. Additionally, physicians are required to explain the risks associated with a treatment or procedure, but how this is accomplished is left up to the physician's discretion. Manufacturers of medicines have also been held accountable to consumers for failing to warn of the risks associated with the drugs they produce. For cases where failure to warn plays a role in a product liability lawsuit, these questions are key:
• Did the product function as it was intended?
• Could the producer of the product have foreseen the dangers associated with its use?
• Would instructions or warnings have prevented what occurred?
A manufacturer cannot escape liability for a failure to warn simply because it was unaware of the risk. A manufacturer is under a duty to stay knowledgeable about its product. If it was possible to discover the risk through reasonable research, testing and investigation, the manufacturer will be held liable for failing to warn about a risk it should have known about.
Failure to warn is also known as a marketing defect. There are many products that have made it to market and were later revealed to produce serious side effects that manufacturers did not warn about. Users of some of these products have successfully sued manufacturers for failure to warn and recovered compensation for medical bills and other losses.
Not all severe side effects are cause for legal action, but some are. If you were injured by a drug or medical device, contact a personal injury attorney from Andrus Wagstaff, PC, to learn more about your legal options during a free case review.