In early 2010, the FDA approved the new prescription drug Actemra (tocilizumab) for treatment of severe cases of rheumatoid arthritis. Since then, it has expanded its approval to treatment of moderate RA, giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA).
At the time Actemra was initially approved by the FDA for treatment of RA, many believed it would be superior to the alternatives already available because its potential side effects did not include heart attacks, heart failure, or serious lung injuries, as its competitors did. To this day, Genentech, which manufactures Actemra, warns only of the following potential side effects:
- Serious infections
- Stomach or intestinal tearing
- Changes in certain laboratory test results, including low neutrophil count (which reduces the body’s ability to fight off bacterial infections), low platelet counts (which reduces the ability of blood to clot and stop bleeding), and increased cholesterol
- Serious allergic reactions
- Nervous system problems
- Increased blood pressure
Yet, according to an analysis commissioned by Stat News, hundreds of Actemra patients have died from the same sorts of side effects that plagued its competitors at the time of its introduction, including heart failure. In fact, these problems were found to be about as frequent in Actemra patients as in patients being treated with competing drugs.
But there does remain one important difference between Actemra and its competitors: They warn about these risks, but Actemra does not.
This missing warning raises an important question: What remedies are available to Ohio patients who take a prescription drug and suffer a side effect they were never warned was possible? Answering that question requires a brief foray into the law of product liability.
Prescription Drugs and Product Liability in Ohio
When an individual is injured by a product — such as prescription drugs — he or she may have a product liability claim against the manufacturer. Product liability claims generally fall into one of three categories:
- Design defects, which refer to flaws in the way a product was designed;
- Manufacturing defects, which refer to flaws introduced during the manufacturing process of an otherwise well-designed product; and
- Marketing defects, which are failures to provide adequate instruction on how to use the product or failures to warn about the risks posed by the product.
Now, let’s focus on how dangerous drugs fit into Ohio product liability law.
O.R.C. § 2307.75 governs design defects. Subsection (D) provides that
An ethical drug … is not defective in design or formulation because some aspect of it is unavoidably unsafe, if the manufacturer … provides adequate warning and instruction under [O.R.C. § 2307.76] concerning that unavoidably unsafe aspect.
For a prescription drug, the “unavoidably unsafe aspect” would be the risk of dangerous side effects. As long as the manufacturer provides “adequate warning and instruction” regarding those side effects, they won’t be considered design defects. In other words, on this point, a design defect only exists if there is a marketing defect.
Marketing defects are governed by a neighboring section of the Ohio Revised Code, 2307.76. A marketing defect exists if, at the time the product left the manufacturer’s control or at “a relevant time” thereafter:
- The manufacturer knew or should have known of a risk posed by the product; but
- The manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have.
However, there is an exception from these normal rules for prescription drugs, commonly referred to as the “learned intermediary” doctrine. Subsection (C) explains that “an ethical drug is not defective due to inadequate warning or instruction” if:
- The manufacturer provides otherwise adequate warning and instruction to a patient’s prescribing doctor; and
- The FDA does not require the warning or instruction to be given directly to the patient.
The idea behind the “learned intermediary” doctrine is that a patient can’t access a prescription drug without a doctor’s prescription, and the doctor can be trusted to convey the manufacturer’s warnings to the patient. So, if the manufacturer warns the doctor of a risk (and the FDA doesn’t require a direct warning to the patient), the patient can’t complain about the manufacturer’s failure to warn him or her directly.
Ohio Law and Actemra’s Undisclosed Side Effects
What does this mean for Ohio residents injured by an Actemra side effect that Genentech doesn’t warn about — heart failure, for instance? Actemra would come within the exception of O.R.C. § 2307.75(D), meaning that a design defect exists only if a marketing defect exists.
At this point, Genentech might normally be able to rely on the “learned intermediary” doctrine in O.R.C. § 2307.76(C). But that exception would only apply if Genentech had warned doctors of the possibility that the side effect could occur. In reality, Genentech doesn’t warn anyone about the risk of heart failure (or the other side effects identified by Stat) from using Actemra.
That means that the normal rules that apply to marketing defects in product liability lawsuits will also apply to Genentech. If a plaintiff can prove that Genentech was aware of the risk that these side effects could occur and unreasonably failed to warn doctors and patients about that risk, then he or she will be entitled to compensation for the injuries caused by Actemra.
Have You Been Injured by Actemra?
As the above discussion makes clear, Ohio law provides a remedy for patients who take a prescription drug (like Actemra) and are injured by a side effect (like heart failure) that the manufacturer never warned anyone about.
If you or someone you love has been injured or killed while taking Actemra, contact us today for a free case review. We will help you understand your rights under Ohio law and pursue your claims in court, if necessary.