A version of this article appeared in the Riverside Lawyer Magazine, Volume 67, No. 1, Jan. 2017.
Generic or Brand? This is a question millions of Americans contemplate on daily basis when it comes to selecting their medications. For majority of people, the price difference is the major deciding factor. But could paying less for a drug affect how much you can recover in a liability case or maybe even bar you from having a claim for recovery?
Pharmaceutical Product Liability and Existing Loop Holes
Product liability is a form of personal injury case which arises when a consumer is injured by a defective or a dangerous product. In the case of pharmaceuticals, product liability cases fall into two main categories: 1) the drug was defectively designed or 2) the drug did not carry an adequate warning meaning the drug has side effects which the manufacturer did not warn about.
In case of generic drugs, the rules are a bit different. Generic drugs are required to have exact same formula and identical labels and warnings as to their brand name counterparts. Under federal laws, generic drugs must have the exact same chemical composition and the exact same labeling as the name-brand drugs. This limits what generic drug manufacturers can do regarding the labels and formulas of the drugs, even if they have knowledge of dangerous side effects that are not included on the label.
On the other hand, these laws also help limit liability for generic drug manufacturers. In 2011, in Pliva v. Mensing, the Supreme Court ruled that generic drug companies cannot be sued for inadequate drug warnings because the generic drug companies cannot control the warning. This case dramatically limited product liability lawsuits for consumers who took generic drugs instead of brand name drugs. Another blow to consumers came in 2013, in Mut. Pharm. Co. v. Bartlett. The Supreme Court ruled that generic drug companies could not be sued for defectively designed drugs because they are required by the FDA to use the exact same design that is used in the original drugs. Based on this, a drug company that only copies an innovation cannot be sued. The outcome of these two rulings in effect allowed the generic drug companies to enjoy all the profit from making the drugs without any liability.
New Case and Regulations
In the years since Mensing and Bartlett, the consumer attorneys have continued to find new legal theories under which to hold the generic drug manufacturers responsible. There have been some successes. One major area of success has been under the “failure to update” claims. These claims accuse the manufacturers of generic drugs of not updating and changing their labels quickly enough after the brand name drugs have changed their labels.
Another major success came in Alabama in 2013. In Wyeth v. Weeks, the Alabama Supreme Court held that a drug company can be held liable for alleged misrepresentations it made about its own name-brand drug, even when the plaintiff took another company’s generic equivalent because it was reasonably foreseeable that generic-taking patients and their doctors would rely on the name-brand manufacturer’s label. This “is not fundamentally unfair,” the court said, because the “alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.” The court emphasized that, under the circumstances of this case, liability is premised not on product defect, but on the alleged misrepresentations in the brand-name product's labeling, which FDA regulations require generic manufacturers to use. The court limited its ruling to prescription drug manufacturers operating under specific FDA regulations related to labeling requirements and made clear that it is not creating a new tort of “innovator liability.”
Although the outcome of Alabama case was a great success for consumers, it remains in the minority. To this date only a handful of states have followed similar paths: California (Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008)), Vermont (Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010)) and Illinois (Dolin v. SmithKline Beecham Corp., No. 12 C 6403, 2014 WL 804458 (N.D. Ill. Feb. 28, 2014)).
In federal landscape, the U.S. Department of Food and Drug Administration (FDA) has come up with a proposed rule which would allow generic drug companies to have more input on drug warnings. If passed, this will open generic drug companies up to lawsuits for inadequate warnings on medications. The proposed rule was scheduled to be finalized in summer of 2016 but for now, the FDA has announced the rules will not be finalized until April 2017.
Disclaimer: This post is meant for general informational purposes only, and it is not to be construed as legal advice. As with any laws, the information in this blog post may change at any time and may apply differently in different jurisdictions. The post may constitute Attorney Advertising as defined by the rules of professional responsibility of some jurisdictions. Holborn Law is based in Orange County and Riverside. The attorneys of Holborn Law APC are active members of the State Bar of California and licensed to practice law in California. All services relating to immigration and naturalization provided by Holborn Law APC are provided by active members of the State Bar of California or by a person under the supervision of an active member of the State Bar of California.
 21 U.S.C. § 355.
 Pliva v. Mensing, 131 S.Ct. 2567, 2571 (2011).
 Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).
 Wyeth v. Weeks, No. 1101397 (Ala. 2014).
 Thomas, Katie, “F.D.A. Rule Could Open Generic Drug Makers to Suits”, New York Times (July 3, 2013)