Imagine that your doctor gives you a prescription drug to alleviate a persistent headache or cold, or recommends for you a new pacemaker or prosthetic joint. If your doctor’s prescription drug or medical device ends up injuring you—what do you?
The general rule is that a consumer who is injured by a prescription drug or medical device may be able to seek compensatory damages from the physician that prescribed that drug or device and from the manufacturer who manufactured that drug or device. For example, a doctor may be liable for a patient’s damages if he should not have prescribed the drug or medical device or if he failed to warn of a non-obvious risk. Likewise, the manufacturer could be liable if the product is unreasonably dangerous or if the manufacturer failed to warn of non-obvious dangers.
However, there’s an important exception regarding a drug or device manufacturer’s liability—the learned intermediary doctrine. A majority of states, including Louisiana, have adopted some form of the learned intermediary doctrine. The doctrine works as a shield to protect manufacturers from being liable for not informing the patient of the product’s risks if the manufacturer has adequately warned the patient’s physician of the risk. Essentially this means that a manufacturer has no duty to warn you- the patient; instead, the manufacturer must warn your physician of the drug or device’s dangers. The physician then becomes responsible for warning the patient of the risks. The physician is quite literally the intermediary between the patient and the manufacturer.
As the District Court for the Eastern District of Louisiana has made clear in Allgood v. Glaxosmithkline PLC, in Louisiana a patient must meet both parts of a two-pronged test to hold the manufacturer liable despite the learned intermediary principle: 1) “The patient must show that the manufacturer failed to warn (or inadequately warned) the physician of a risk associated with the product that was not otherwise known to the physician;” and 2) the patient must show the manufacturer’s failure to warn the physician was both the cause in fact and the proximate cause of the injuries.
In Talley v. Danek Med., Inc., the Court of Appeals for the Fourth Circuit explained that the rationale behind the doctrine is based on the fact that prescription drugs are likely to be complex medicines, “esoteric in formula and varied in effect.” Because of the drug or device’s complexity physicians are in the best position to understand the complex risks. Additionally, many risks depend on the medical history and condition of each particular patient, and the physician instead of the manufacturer is in the best position to offer personalized warnings to each patient, as each unique set of circumstances require.
How does the learned intermediary doctrine impact an injured patient’s lawsuit against the prescribing physician and manufacturer? Although the doctrine may seem to merely shift the duty to warn from the manufacturer to the physician the doctrine carries real consequences. A manufacturer will often have more funds available than an individual physician from which to satisfy the injured patient’s claims. Oftentimes a physician’s personal insurance policy will be insufficient to fully compensate the injured patient, leaving the patient under compensated unless the patient has other legitimate claims against another party.
There are various instances when the learned intermediary doctrine will not shield a manufacturer from an injured patient’s suit. One of the most common ways a patient can get around the doctrine and hold the manufacturer liable is to show that the manufacturer failed to adequately inform the physician of the drug or device’s unobvious risks.
That is exactly what happened to Rock P. Kampmann of Jefferson Parish in 2006. After suffering injuries caused by prescription drugs, Kampmann sued his doctor, pharmacist, and the drug manufacturer for failing to warn him of the risks. The Twenty-Fourth Judicial District Court of Louisiana found that the doctrine shielded the manufacturer because his duty to warn was to the physician and not the patient. The appellate court reversed because it found the manufacturer in fact failed to adequately inform the physician of the risks.
There are many case specific nuances to the learned intermediary doctrine. Speak with an attorney for more information about your rights as an injured party before ever agreeing to a settlement or damages.
If you have been injured by any prescription drugs or medical devices and need assistance in seeking compensation, contact the Berniard Law Firm at (504) 521-6000 where a qualified attorney will help you to secure the amount of compensation you deserve.