Can a Brand Drugmaker Be Sued If a Patient Is Harmed By the Generic Version?

The patient in the case, Rachel Hope Doran, was a 19-year-old student who had been suffering with some mental health issues while away at college. When home on a school break in December 2017, she met with a local psychiatrist who diagnosed her with bipolar mood disorder and issued a prescription for GlaxoSmithKline’s Lamictal. Miss Doran had the prescription filled at her nearby pharmacy, where it was filled with a generic version of the medication, lamotrigine, manufactured by TEVA Pharmaceuticals. One of the most serious risks associated with lamotrigine is hemophagocytic lymphohistiocytosis (HLH) which can lead to inflammation and death. 

In December 2017, Lamictal’s warning label did not warn of the risk of HLH. The US Food and Drug Administration issued a warning in April 2018, at which point GlaxoSmithKline was required to add a warning to the label.

In mid-July 2018, Miss Doran went to an urgent care clinic with pink eye and a sore throat. The following day, she went to the emergency department of a hospital after she developed a rash covering a significant amount of her body and causing blisters on her lips. Her physicians determined that her symptoms were consistent with Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and HLH. She was transferred to the hospital’s burn unit for several days. 

At the end of July, Miss Doran was transferred to another hospital where she underwent numerous painful and invasive medical procedures to treat her conditions, but treatments proved unsuccessful. Miss Doran died mid-August. Her father sued GlaxoSmithKline, claiming a violation of the state’s product liability act. GlaxoSmithKline filed a motion to dismiss, and the issue went before a US District Court judge. 

The drug manufacturer argued that it could not be liable because it did not manufacture, sell, or otherwise benefit from the generic medication that allegedly harmed Miss R. And while the Judge noted that this argument has “some initial intuitive appeal” since “the vast majority of product liability cases involve claims against a defendant who actually made or sold the product that caused a plaintiff's injury,” he ultimately rejected the drug manufacturer’s argument. Instead, he noted that “in cases like this, many courts across the country have considered a theory known as ‘innovator liability.’” Innovator liability recognizes that the brand name company has almost exclusive control of the design and content of warning labels that generic companies must use for their bioequivalent generic medications, and thus the brand name company is in the best position to prevent defects in product warnings.

“When a physician is selecting among a menu of possible therapies for her patient, a brand-name manufacturer not only foresees but presumably intends that the physician will rely upon information contained in the brand-name’s warning label and marketing materials. The brand-name manufacturer has succeeded when its warnings and advertisements induce the physician to prescribe drugs belonging to the same class as the brand-name’s product,” noted the Judge, who added that even then, “the brand-name manufacturer should foresee in light of drug substitution laws and prevailing market practices that the patient may ultimately receive a generic equivalent.”

The Judge allowed the case to proceed against GlaxoSmithKline, stating that “by recognizing a brand-name manufacturer’s duty of care vis-à-vis prescribers or consumers of generic bio-equivalents, brand-name manufacturers are encouraged to invest in product safety, including through updates to their warning labels.”