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The Differences of Generic Drug Liability vs. Branded Liability in Alabama



The Differences of Generic Drug Liability vs. Branded Liability in Alabama

Much ado has been made in recent years over so-called innovator liability in Alabama. Innovator liability began as a reaction to the influential 2011 Supreme Court decision of Pliva v. Mensing, 131 S.Ct. 2567, 2571 (2011). In Mensing, the Supreme Court held that federal law “preempts any claim brought under state law” that alleges a generic drug did not come with adequate warning labels.

As such, state laws were preempted by the federal law, which served the purpose of protecting generic drug manufacturers from a given state’s failure to warn claims. The Mensing decision did not affect branded drug manufacturers, however, since they have the capacity to change warning labels when needed, according to federal law. As such, the same impossibility faced by a generic drug manufacturer is not applicable to branded manufacturers.

Even so, the outcome of the Mensing decision appalled consumer protection groups as well as personal injury lawyers across the country. While efforts to reverse the Mensing decision are ongoing, personal injury lawyers pursued additional liability theories to help injured victims recover compensation in generic drug cases. Innovator liability was one such theory, and it gained national attention after implementation in Alabama.

Alabama’s Innovator Liability

In 2013, in the wake of the Mensing decision, the Alabama Supreme Court heard the case of Wyeth Inc. v. Weeks, 159 So.3d 649 (2014). In this case, the court was faced with determining whether a branded drug company could be held liable for fraud or misrepresentation based on statements made in connection with the manufacturing or distributing of a brand-name drug by a plaintiff claiming an injury from a generic drug that was manufactured and distributed by a different company. What does all that mean?

In plain English, the court was deciding on whether brand-name manufacturers could be sued for ignoring their duty to warn all users of the drug, even users of a generic drug. The reasoning is based on a federal requirement which states that all generic labels must be identical to the brand-name label. This, in a nutshell, was Alabama’s innovator liability theory. It was based on the notion that the brand-name manufacturer’s label is the label doctors rely on when prescribing either the generic or brand-name drug. The Alabama court agreed with this theory in the Weeks case (as well as a follow-up case, Weeks II).

With this ruling, Alabama became the only state with a state supreme court that held an innovator (brand-name manufacturer) could be held liable for injuries caused by a generic drug because of the brand-name manufacturer’s labeling responsibility. This was of huge value to victims injured by generic drugs, but the legislature recently took steps to undo Alabama innovator liability. Alabama’s S.B. 80 effectively abolished innovator liability once it was passed and signed by Governor Bentley.

The statute took effect on November 1, 2015. In recent months, some of the last innovator liability lawsuits were filed. Now, it seems that there is no recourse under an innovator liability theory for those who are injured by a generic drug. It is advisable that you ask your doctor plenty of questions if you are prescribed a brand-name drug in light of the reversal on innovator liability.

Injured victims who take a brand drug will likely have a clear cause of action for injuries suffered from taking the drug. Sadly, users of generic drugs who are injured may have no such recourse. Take every effort to ensure you are taking  a brand-name drug to give yourself the legal protection you and your family deserve.


If you or a loved one has been injured by a brand-name or generic drug, contact Alabama injury attorney Noel B. Leonard to determine whether you are entitled to legal compensation for your injuries. Noel will let you know whether you have a winning case, and if you do, he will fight to ensure you receive the compensation you need as he works to hold negligent drug manufacturers accountable.

From his office in Foley, Noel provides legal representation to injured product liability victims in the city of Foley as well as those living in Baldwin, Mobile and Escambia Counties. For a legal consultation to discuss your product liability case, contact Noel B. Leonard or call 251-943-8638.

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