Written by Noah C. Lauricella, Partner at GoldenbergLaw, PLLC.
In Kimble v. Marvel Entertainment, LLC, United States Supreme Court Justice Elena Kagan quoted Stan Lee’s fictional Spider-Man comics writing that “with great power there must also come – great responsibility.” In the context of pharmaceuticals, brand-name manufacturers have been afforded such great power in that they alone are allowed to unilaterally modify the label of a pharmaceutical drug by adding to or strengthening a warning found on it. But until very recently, insufficient responsibility was assigned along with that significant power. As a result, individuals injured by generic pharmaceuticals had no legal recourse for insufficient warning labels. Given that roughly 90% of the prescription drugs currently sold in the United States are generics, huge numbers of consumers were being injured and left with no legal remedy.
However, in T.H. v. Novartis, the Supreme Court of California recognized the fundamental unfairness of such a situation and finally expanded brand-name manufacturers’ responsibility to appropriately match their power in the labeling context.
The Novartis case involved twins, T.H. and C.H., diagnosed with developmental delays and autism after their mother took the prescription drug terbutaline, a generic form of Novartis’ brand-name drug Brethine, to suppress premature labor during pregnancy. The case presented two questions regarding innovator liability for failure to warn. The first question was whether prescription drug innovators such as Novartis owe a duty to patients who use a competitor’s generic product never made or sold by the brand-name manufacturer, and the second question was whether Novartis and other prescription drug manufacturers continue to owe a duty to patients who use that competitor’s generic product even after the prescription drug innovator transfers the New Drug Application (NDA) and ceases sale of the original prescription pharmaceutical altogether.
Pursuant to FDA regulations, Novartis and other brand-name manufacturers meet their burden of accuracy and adequacy in labeling so long as the label is updated “as soon as there is reasonable evidence of an association of a serious hazard with a drug.” Prior to the Novartis decision, however, the vast majority of courts around the country had held that said burden only extended to the brand-name manufacturer’s own product and that warning label liability could not be imposed upon brand-name pharmaceutical manufacturers for injuries to patients prescribed the generic bioequivalent in reliance on the brand-name label. While such a position may at first blush seem perfectly reasonable given that the brand-name manufacturer was still being held liable for any deficiencies in its own product’s warning label, its insufficiency is apparent once the exclusivity of the brand-name manufacturers’ labeling powers is fully considered.
A generic manufacturer is “responsible only for ‘an ongoing federal duty of ‘sameness’’ – that is, ensuring that its warning label is the same as the brand-name manufacturer’s.” As such, “federal regulations granted the brand-name drug manufacturer – and no other manufacturer – control over the active ingredients in the generic drug and the content of the warnings included in the generic’s label.”
That exclusive power reserved to brand-name manufacturers, combined with the fact that generic manufacturers are totally immune from failure to warn lawsuits so long as their label matches the one written by the brand-name manufacturer, created a responsibility void in which individuals injured by generic bioequivalents as a result of improper labeling stemming from the original brand-name label found themselves unprotected. Furtherance of that void would have left T.H., C.H., and their parents in the same, powerless situation as so many similarly situated plaintiffs before them. They would have no available recourse against the company that actually manufactured and sold the generic drug taken by the twins’ mother under PLIVA, and they would have had no cause of action against the brand-name manufacturer responsible for the deficient warning language contained in the label under Foster and the myriad cases like it. Brand-name manufacturers would have continued to exercise exclusive power over the labels of both their brand-name pharmaceuticals and other companies’ generic bioequivalents while only having the attendant duty regarding appropriate warnings imposed upon them with regard to the former.
With Novartis, however, the Supreme Court of California recognized the fundamental unfairness visited upon so many prior plaintiffs in the twins’ situation. The court went against “the impressive case authority Novartis ha[d] collected on its behalf” in providing much-needed access to justice for patients prescribed generic pharmaceuticals by holding that “[i]t is the brand-name manufacturer that bears responsibility for the accuracy and adequacy of its label ‘as long as the drug is on the market.’” Neither use of the generic equivalent nor transfer of the NDA automatically ends that responsibility.
In answering “yes” to both questions presented, the Supreme Court of California broke new ground in tort liability and clarified the responsibility brand-name drug manufacturers should, and now do, shoulder in light of the significant authority granted them in the labeling context. Recently, the Supreme Judicial Court of Massachusetts similarly held that “a brand-name manufacturer that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury.” Unfortunately, the West Virginia Supreme Court of Appeals in McNair v. Johnson & Johnson recently went the other way in finding that no such duty exists.
It remains to be seen whether the Novartis holding will become the predominant approach in this country and fill the responsibility void previously enjoyed by brand-name manufacturers. In the interests of fundamental fairness and patient safety, let’s hope the momentum created by California and Massachusetts wins the day such that, in this context, patients’ reality becomes more like Mr. Lee’s fiction.
 135 S. Ct. 2401, 2415 (2015) (internal citations omitted).
 407 P.3d 18 (Cal. Dec. 21, 2017) (No. S233898).
 See id.
 See generally id.
 21 C.F.R. § 201.80(e) (2015).
 See, e.g., Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994).
 407 P.3d at 23 (internal citations omitted).
 Id. at 31.
 See PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).
 Novartis, 407 P.3d at 23 (internal citations omitted).
 See generally id.
 Rafferty v. Merck & Co., Inc., 92 N.E.3d 1205, 1219 (Mass. 2018).
 No. 17-0519, 2018 WL 2186550 (W. Va. May 11, 2018).