When your doctor prescribes medication for you, your pharmacist will often fill that prescription with a generic version of the drug prescribed, rather than the brand-name drug. Brand-name medicines are so called because they were the first of that type of medicine to hit the market, and so their brand name is most closely associated with the drug. (Think Tylenol for acetaminophen.)
Generic drugs come later, after the brand-name drug’s patent expires. Generic drugs use the same active ingredients as their brand-name counterparts and act in the same way, but are often cheaper than the branded medicine.
But just because generic drugs are effectively the same as the brand-name version doesn’t mean the law treats them the same way in all cases. In Ohio product liability cases, prescription drugs in general — both brand-name and generic —are subject to special rules under state law, and generic drugs get special treatment under federal law.
This post explores some of the issues that arise in product liability cases in Ohio involving prescription drugs and, more specifically, generic medications.
Product Defects and the Ohio Product Liability Act (OPLA)
In Ohio, the Ohio Product Liability Act protects people who are injured by a defective product, including defective medicine. It does this by allowing them to sue over personal injuries caused by one of four types of product defects:
- Defects in manufacture or construction: This refers to defects introduced during the manufacturing process, regardless of how well a product was designed.
- Defects in design or formulation: These are defects that existed in the original design of a product, regardless of how well it was manufactured.
- Defective due to inadequate warning or instruction: Some products pose risks to consumers even when they are not defective in design or manufacture. If the manufacturer fails to warn consumers about those risks, or fails to include instructions on how to use a product safely, then the product may be defective as a result of that failure.
- Defective due to a failure to conform to representations: Finally, a product can be defective if it does not match what the manufacturer said about it.
Medicine and Product Liability
Although medicine is a “product” under the OPLA, the law applies special rules to claims involving some medicines. These rules stem from special provisions of the OPLA and federal law and can make it harder to sue for injuries caused by medicine than for those caused by other products.
‘Ethical Drugs’ in the OPLA
The OPLA recognizes a special category of products that it calls “ethical drugs.” These are prescription drugs that are prescribed or dispensed by someone legally authorized to do so (e.g., a physician or pharmacist). Two rules differentiate the OPLA’s treatment of ethical drugs from its treatment of other products:
- O.R.C. § 2307.75(D) says that an ethical drug is not defective in design or formulation because some aspect of it is unavoidably unsafe (e.g., potential side effects) if the manufacturer provides adequate warning and instruction about that unsafe aspect. In short, an ethical drug can’t have a design defect unless its warnings are defective.
- O.R.C. § 2307.76(C) then provides that the manufacturer of an ethical drug can satisfy its duty to provide adequate warnings and instructions by giving those warnings to the person prescribing the drug, unless the U.S. Food and Drug Administration (FDA) requires the instruction or warning to be given to the patient him- or herself.
These two rules apply to all prescription drugs, whether brand name or generic. That second rule also serves as a reminder that state laws governing drugs do not exist in a vacuum—the federal government also extensively regulates them.
See also: 5 Dangerous Drug Cases to Watch in Ohio
Federal Regulation of Medicines
Before a drug can be sold, it must first be approved by the FDA. This process differs for brand-name and generic manufacturers. To be approved, the manufacturer of a new brand-name drug must prove that the drug is safe and effective, but the manufacturer of a generic drug only needs to prove that it is equivalent to an already-approved brand-name drug.
Federal law also treats brand-name and generic drugs differently with respect to warning labels. A brand-name manufacturer must prove that its label is accurate and adequate. In contrast, the manufacturer of a generic drug need only prove that its label is identical to the label of its brand-name counterpart.
Generic Medications and Federal Preemption
This brings us to a potential conflict between how state and federal law govern generic-drug labels: To avoid liability, the OPLA requires generic-drug manufacturers to provide warnings or instructions about the risks associated with their drugs, but federal law requires their warning label to be identical to their brand-name counterpart.
So, what happens if a new risk is discovered that affects both the brand-name and generic drug, but the brand-name label has not yet been updated? The OPLA seems to say that the generic-drug company had better update its label to warn about the newly discovered risk, but federal law says that they can’t — not yet, at least. Which law controls?
According to the U.S. Supreme Court in 2011, federal law controls. Because a manufacturer in that circumstance could not comply with both the OPLA and federal law, and because federal law is the “supreme law of the land” under the Constitution, the manufacturer is protected against liability so long as it complies with federal law, regardless of what the OPLA says. In technical terms, the OPLA would be preempted by federal law.
What does this mean for you?
This discussion has been a bit technical, so what does it mean in practical terms? Here are some key takeaways:
- Ohio law lets you sue when you’re injured by a product, but applies special rules for prescription drugs. These special rules may change what you need to prove to prevail in a lawsuit against a drug manufacturer.
- Federal law may preempt your OPLA claim for defective warnings and instructions. Or, at least, the manufacturer may argue that it does. To succeed on your claim, you’ll need to be prepared for that argument and understand how to overcome it.
- You may have other claims against the manufacturer or others. Even if one type of claim is unavailable under the OPLA’s special rules for prescription drugs or because it is preempted, you may have other valid claims against the manufacturer or others. For example, your injury might have been caused by a manufacturing defect, or perhaps your doctor failed to warn you about potential side effects.
The bottom line is that this area of law is complicated, and choosing the right strategy requires a thorough understanding of state and federal law. Generic medication claims are not the sort you should try to pursue on your own. An experienced and knowledgeable Ohio product liability lawyer can dramatically improve your chances of success.
If you’ve been injured by a defective brand-name or generic drug, contact the lawyers of Plevin & Gallucci for a free consultation today.