Pharmaceutical litigation has become a widely publicized area of law over the past decade. It seems like every three to four years a new drug is pulled off the market and a wave of class action lawsuits commence. Some of the major drugs that were pulled off the shelves were the weight loss pill Phen-Phen, some years later another weight loss and exercise aid known as Ephedrine and recently the pain killer Vioxx.
Many pro-pharmaceutical drug articles and advertisements made it a point to claim that these drugs were safe for the most part and that they were pulled in an act of over cautiousness to protect consumers. The ensuing legal claims against the drug companies were painted as litigious attorneys encouraging anybody who took the drug to file suit in hopes of getting some money. However, a simple overview of the rules that open up manufacturers and distributors of pharmaceutical drugs to liability makes it apparent that such liability is justified.
The Federal & State Legislatures and Courts understand that pharmaceutical drugs have great utility in our society. A person can see this dynamic in the drug penicillin. Although some people are allergic to penicillin and should not have it prescribed to them in any of its forms, the drug has saved countless lives and advanced medicine. Laws have been created to protect drugs that have a useful purpose in society as long as such drugs are reasonably safe or provide more benefit than harm to a class of patients.
However, the laws do hold a manufacturer and distributor liable in certain instances. The legal theory used to find liability is called Products Liability. The two main arguments used are “Design Defect” or “Inadequate Instructions or Warnings” for the drug.
Can a drug be found to have a design defect if it has any harmful side effects? The answer is no. Before explaining the rationale behind the answer, we should first note that there are two safety precautions set in place before a drug can be approved for distribution. These safety precautions are the government regulatory agencies and medical care providers. [This of course may not apply if the ingredient is considered a supplement and thereby does not come under the scrutiny of the government agencies or medical care providers].
Before a drug is every made available to the public it must go through a regulatory system (namely the F.D.A) that sets standards governing how a drug is made. Next the drug must pass the standards set by government regulatory agencies as to whether it is not unreasonably dangerous. If a drug is subsequently approved by the F.D.A. it still must gain the approval of what has been termed the “learned intermediary,” also known as the medical providers. Presumably medical care providers such as doctors, pharmacists and the like are in the best position to ascertain whether benefits to a patient will outweigh the known risks involved for that particular drug. It then becomes the medical care provider’s duty to inform the patient of the risks so that the patient can make an informed decision. As a further safe guard the pharmaceutical companies are required to provide warning of all known risks involved with that particular medication.
In a nutshell:
A prescription drug is not reasonably safe due to design defect if the foreseeable risks of the harm posed by the drug are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug for any class of patients.
-Restatement of Torts 3D
In other words a pharmaceutical company can only be held liable for Design Defect if: the F.D.A. and health-care providers find the drug has little to no benefit to any class of patients in comparison to its known or reasonably should have known risks. This is a difficult standard to prove because a manufacturer can defeat a design defect claim by establishing ANY context where a medical care provider would find it reasonable to prescribe the drug. Thus any claim that lawsuits against pharmaceutical companies for design defect of their drugs inhibit and prevent beneficial drugs from reaching patients in need is simply false.
It is a common misconception that pharmaceutical litigation involves patients suing for injuries due to side effects of the drug, despite the warning labels notification of such side effects. To understand the true nature of pharmaceutical litigation premised on inadequate warnings, we should first understand the purpose of a warning label.
Warning labels on prescription drugs are not intended to assist patients or doctors in reducing the risk of harm involved with taking the medication. Instead the purpose of a warning label is to allow the medical care provider and patient to make an informed decision as to whether or not the drug is right for them. Therefore a warning will be deemed inadequate if the drug does not come with instructions or warnings of the foreseeable risks or harm in taking the drug.
There are two instances where manufacturers and distributors of pharmaceuticals will be liable for inadequate warnings.
First if prescribing medical providers, who are in the position to reduce risks of harm, are not adequately warned. Second if the patient is not warned, when the manufacturer or distributors knows or has reason to know that medical-care providers are not in the position to risk harm in accordance with the instruction or warnings.
-Restatement of Tort 3D
Therefore the reality of pharmaceutical litigation is that most lawsuits seek damages from manufacturers and distributors for their failure (whether accidental or intentional) to notify consumers of known or knowable risks involved with taking the drug.
If you or a loved one has suffered harmful side effects, you may have a claim against the manufacturer or distributor. We would be happy to offer you a free consultation regarding your situation. If for some reason we cannot be of assistance, we will gladly recommend an attorney whom we respect that is best suited for your matter. To file out a intake sheet click here.