Modern medicine is unlike anything the world has seen. Medication currently exist that can completely eradicate some of what were once the deadliest diseases in the world. And soon medicines will likely exist to cure currently incurable ailments. With the rapid evolution of medicine has come an increase in injuries caused by these medications. Below is an overview of lawsuits that arise from medication errors.
Medications sold to patients must be safe and not defective. When medications cause harm to a patient because of a defect, the injured patient can recover from any member of the chain of commerce for the medication. This means the manufacturer and the retailer can be liable for the defect, even though only the manufacturer made the drug. Under Kansas law, medication can be defective in three ways. First, the medication can be defectively designed. In these instances, the medication is more dangerous than an ordinary user would anticipate. In the context of medicine, many times the product cannot be made perfectly safe; instead, warnings will have to suffice. The least common type of defect is a manufacturing defect. A manufacturing defect exists when a drug is not manufactured as planned. This will occur when incorrect amounts of ingredients are used to make the drug. Basically, a mistake has to have occurred for this type of defect to exist.
The final and most common type of defective is inadequate warnings. A medication must have warnings for non-obvious dangers and side effects. For medications, almost every danger will be non-obvious to a normal consumer. This makes warnings vitally important. However, unlike almost every other product, an exception exists for warnings involving prescription medications. This rule is known as the learned intermediary rule. It provides that a drug manufacturer satisfies the obligation to warn if they provide all necessary warnings to a physician. It then becomes the physician’s responsibility to warn the patient of the potential dangers and side effects. If insufficient warnings are given by the physician, the patient may bring suit against the doctor, but not the drug manufacturer. However, the learned intermediary rule does not apply when the drug is marketed directly to the general public.
Errors by Doctor or Medical Staff
As outlined above, a doctor is under an obligation to warn of dangers and side effects when prescribing medications. A doctor is also under an obligation to always prescribe medications with the care, knowledge, and skill of a reasonable doctor. When a doctor fails to adhere to these standards, any injuries caused by the improper medication can be redressed by suing the physician for medical malpractice. Keep in mind these claims will only work when the medication is safe to begin with; the doctor won’t be negligent if he or she was unaware of a danger posed by the medications because of defect. Instead, medical malpractice claims arise from a doctor disregarding a risk posed by prescribing medications.
Finally, when a patient is required to stay in the hospital or a nursing home, the patient may be completely dependent on the nursing staff for receiving medications. The nursing staff is under an obligation to exercise the level of care and knowledge of other nurses in administering these medications. When nursing staff fails to adhere to this level of care and administers incorrect medications, liability can attach to any injuries suffered by patients. This is true whether the mistake is giving the wrong medication or failing to adhere to a necessary medication schedule.
Limitations on Claims Imposed by Federal Law
In the United States, citizens live under “dual sovereigns” in the state and the federal government. This concept—known as federalism—is unique to America. One aspect of federalism is conflict between state and federal laws. The Constitution contains a provision known as the Supremacy Clause, which serves to preempt—or cancel out—state laws that conflict with federal laws. In the context of medications, the Supremacy Clause has the effect of potentially cancelling out state law claims for defective medications. In Wyeth v. Levine, the United States Supreme Court narrowly held that a drug manufacturer does not escape potential liability for failure to warn about dangers or side effects of medication simply by gaining approval from the Food and Drug Administration for the labels used on its drugs. Instead, a manufacturer is required to prove that complying with FDA regulations and state product liability law is impossible to defend against being sued. Anything less than impossibility is not considered preemption and the manufacturer would be liable for inadequate warnings.
When the drug is a generic version, federal law makes things much more complicated. Under current federal law 21 USC § 355(j)(2)(A), a generic version of a drug must exactly mirror the warnings of the name-brand drug. In Mutual Pharmaceutical Co. v. Bartlett, the United State Supreme Court held that this requirement preempted any state law claims for inadequate warnings because the generic drug manufacturer has no say in what the label says. The effect of Wyeth and Bartlett together is beyond bizarre: an injured patient is free to bring a claim for inadequate warnings against a name-brand manufacturer, but completely prevented from bringing the exact same suit on the exact same facts if the drug is a generic. This stark contrast is made even worse by the fact that a patient does not always have a say in whether they receive the name brand or generic drug. That decision is often determined by the pharmacist or the insurance company. Yet it can mean the difference between compensation for injuries and nothing.
Medication errors can result in serious injuries to those that depend upon medications. Whether the injury is caused by a dangerous medication, a careless prescription, or careless administration of the medication, the law may offer redress for injuries arising from the wrong of others. In this area, the interplay between federal and Kansas law may have a serious effect on claims for medication errors. Therefore, it is extremely important to contact experienced legal counsel that can navigate this complex interplay of competing bodies of law. If you are injured as a result of a medication error, capable counsel can make the difference in successful recovery and being left with nothing.