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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Generic Drug Companies Held to a Lesser Standard: It’s a Hard-Knock Life with Knock-off Brands

Posted in Generic Drugs, Preemption

Generic brands. Knock-offs. It’s probably safe to assume that all of us have used one at some point or another. Many of us use them on a regular basis. Why? Because, usually, a generic brand product is pretty much the same thing as its brand-name equivalent. The main (and sometimes, only) difference is price. Generic brands are often significantly less expensive than their brand-name counterparts. This holds true in many aspects of life—clothes, shoes, accessories, groceries, and medications.

But in addition to cost, when it comes to medications specifically, there is one other significant difference between generic brands and brand-name companies: Legally, manufacturers of generic brand drugs are held to a lesser standard.  For example, if you develop a disease as a result of taking a brand-name medication, you can sue the company that manufactured the drug; but on the other hand, if you go to the pharmacy and opt for the cheaper generic version of the drug, and develop the same disease or adverse side effect, you cannot sue the generic manufacturer.

The above logic seems counterintuitive. Yet, in a 5-4 decision last year, the Supreme Court ruled that generic drug companies cannot be held liable for medication design defects. The rationale goes something like this: Federal law requires generic companies to have a warning label that is identical to that of the brand-name drug.  Therefore, if a warning label on a generic drug contains false information, the generic drug company claims it isn’t responsible because it is copying the brand-name label.  The Supreme Court bought that argument, although the dissenting opinion describes the result as “absurd.”  And it is absurd that a generic drug manufacturer can know that the warning label is inadequate, sell the drug, and escape all liability.

Generic versions of drugs are beneficial to society in that they give patients the option to buy medications at a low cost, when they would otherwise simply go without filling their prescriptions at all. However, until manufacturers of generic brand drugs are held to the same legal standard as their brand-name competitors, patients are not truly protected. After all, if one is harmed by a generic drug, the cost savings of a generic drug disappears if consumers or taxpayers have to foot the bill for treatments of undisclosed-but-known side effects.