Posts Tagged With: Supremacy Clause

Circling the Toilet Bowl: State court redress for generic pharmaceutical product liability gets flushed.

Have you ever been awake late at night due to your newborn baby crying for a diaper change, the earlier than expected walk of shame you decided to take back to your apartment so you wouldn’t run into your neighbors, or simply because you had a ton of work to do for that 9am presentation to land that big contract and promotion? Sure you have. Well, maybe you haven’t, but let’s pretend you fit in one of the scenarios. So you take a break and decide to turn on the television. Somewhere between you flipping back and forth between King of Queens, the Food Network, Sportscenter, and Adult Swim, you begin to notice that there are a ton of commercials on about various drugs.

Let’s say you decide that it would be a great idea to try one of these medicines because your back has been really hurting lately, and the next morning you decide that the first thing you are going to do is march right down to the CVS and purchase some of this medicine so you can rest better. You arrive at the CVS the next morning and decide that instead of buying that namebrand stuff that you will purchase the generic brand.  We all know that the generic brand generally has the same ingredients as the namebrand medicine and you are simply paying for a logo.

You go to work and return home later where you finally are able to use the medicine. Your husband/wife has cooked a nice dinner and you go to bed. The next morning you awaken to a burning sensation throughout your body and your skin peeling in lesion-like sections as if you have been severely burned in a housefire.

Now most Americans would assume that you can rightfully sue the makers of the generic brand of drug because they sold a defective product to you. However,  a 2011 Supreme Court precedent in a case called PLIVA v. Mensing, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011) now sharply limits a consumers’ ability to sue generic manufacturers over alleged injuries because federal law requires brand-name and generic drugs to carry the same label. A manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate. Id. at 584. This is typically achieved by mimicking the exact makeup of the name brand drug.

The current case before the Supreme Court of the United States, Mutual Pharmaceutical v. Bartlett, 2013 WL 602909 (2013), raises the question of whether federal law impliedly preempts state law design-defect claims targeting generic pharmaceutical products. The Obama Administration has naturally taken the side of the pharmaceutical companies because the U.S. government seeks to uphold the Federal Food, Drug and Cosmetic Act and the Drug Price Competition and Patient Term Restoration Act of 1984. The plaintiff in the case was awarded a 21 million dollar verdict in federal district court and the verdict was upheld in the First Court of Appeals. One of the distinctions being made is that the First Court of Appeals based its’ opinion on the inherent risk of the drug and not the label. In the aforementioned case, PLIVA v. Mensing ,131 S. Ct. 2567 the verdict was reached by the Supt. Ct. judges on the idea that “failure to warn” was an inadequate basis for consumer compensation for injury.

Of course, the difference in my somewhat weird scenario from the mentioned cases is that both involve prescription drugs and mine did not. However, the underlying premise is the same: It is becoming much harder for consumers to protect themselves from pharmaceutical drugs that may have deleterious effects on the unaware user.

Categories: Pharmaceutical Litigation | Tags: , , , , , , | Leave a comment

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