Doran v. GlaxoSmithKline PLC
| Decision Date | 10 June 2022 |
| Docket Number | 3:21-cv-1228 (JAM) |
| Parties | DISTRICT ALAN DORAN, Administrator for the estate of Rachel Hope Doran, Plaintiff, v. GLAXOSMITHKLINE PLC et al., Defendants. |
| Court | U.S. District Court — District of Connecticut |
ORDER DENYING MOTION TO DISMISS
Rachel Hope Doran died after her doctor prescribed a brand-name drug known as Lamictal and after her pharmacy filled the prescription with a bio-equivalent generic drug known as lamotrigine. The brand-name drug that her doctor prescribed was manufactured and marketed by the defendants in this action-Glaxosmithkline PLC and Glaxosmithkline LLC (collectively, “GSK”). The bio-equivalent generic drug that Rachel received from her pharmacy and that she actually consumed was manufactured and sold by another company.
Rachel's father in his capacity as administrator of her estate has filed this action against GSK under the Connecticut Product Liability Act. The complaint principally alleges claims for design defect, failure to warn, and misleading advertising that caused Rachel's death.
GSK has moved to dismiss. GSK argues that it cannot be liable because it did not manufacture, sell, or otherwise benefit from the drug that Rachel used.
In cases like this, many courts across the country have considered a theory known as “innovator liability” or “warning label liability.” See Jenny Ange, Am I My Competitor's Keeper Innovator Liability in the Fifty States, 21 COLUM. SCI. & TECH. L. REV. 1 (2019). This theory posits that the inventor and manufacturer of a brand-name drug may be liable under certain circumstances for harm caused to a consumer by a bio-equivalent generic drug that was manufactured and sold by a different company.
Innovator liability allows a brand-name company to be liable for two main reasons. First, it recognizes that-by operation of federal law-the brand-name company has near-exclusive control of the design and warning labels that generic companies must use for bio-equivalent generic drugs. The brand-name company is in the best position to prevent design and warning defects. Innovator liability attributes responsibility to the brand-name company because of this control and possibly as well because of the brand-name company's continuing misleading promotion of its product.
Second innovator liability recognizes that federal law preempts state law claims against generic companies for design defects and failing to warn about the risks of a bio-equivalent generic drug. In light of the broad remedial purposes of product liability laws, innovator liability ensures that a victim of a defective product has a remedy against a brand-name company that defectively designs or fails to warn about the dangers of the drug in the first instance.
Although the Connecticut Supreme Court has yet to address the issue, I predict in light of the text and broad remedial purposes of the Connecticut Product Liability Act that it would adopt innovator liability and conclude that the complaint in this case states a valid claim for relief under Connecticut law. Accordingly, I will deny the motion to dismiss.
By way of background, I will first review the allegations of the complaint. Next, I will describe the basic structure and operation of the Connecticut Product Liability Act as well as the relevant federal regulatory framework that governs the duties and liabilities of brand-name and generic drug companies.
The complaint
I accept as true the following facts as alleged in the complaint.[1] Lamotrigine is the active ingredient in a drug originally manufactured and marketed by GSK under the brand name Lamictal.[2] Lamictal and its generic equivalents are approved for the treatment of bipolar disorder.[3]
Among the most serious risks associated with lamotrigine is Hemophagocytic Lymphohistiocytosis (“HLH”).[4] HLH describes a wide array of dangerous conditions in which the body's immune system is excessively activated.[5] HLH's symptoms include fever, reduction in the number of mature blood cells, liver injury and swelling, lymph node disease, and impaired blood coagulation.[6] The severe inflammation caused by HLH can lead to hospitalization and death.[7]
Rachel Doran was a sophomore at Cornell University in March 2017 when she began receiving mental health care from the Cornell mental health office.[8] After returning home to Connecticut in December 2017, she met with a local psychiatrist who diagnosed her with a bipolar mood disorder and issued her a prescription for brand-name Lamictal.[9] The pharmacy filled the prescription with a generic version of lamotrigine manufactured by one of GSK's competitors, TEVA Pharmaceuticals.[10] When Rachel was first prescribed Lamictal in December 2017, the label did not warn of the risk of HLH.[11] But then the FDA issued a warning in April 2018 linking lamotrigine to HLH, and GSK was at the same time required to add a warning about the risk of HLH to its Lamictal label.[12] According to the complaint, GSK knew or should have known of the risk of HLH as of at least December 2017 when Rachel was first prescribed Lamictal.[13]
The complaint describes how Rachel suffered a severe and ultimately fatal reaction to lamotrigine. On July 12, 2018, she went to a clinic in New York City with symptoms of mucosal irritation, including pink eye and a sore throat.[14] Early the next morning, she went to the emergency room at Bridgeport Hospital, where she developed a rash covering much of her body and blistering on her lips.[15] She was released from the hospital but returned later the same day with additional symptoms.[16] Her doctors determined that her symptoms were consistent with Stevens-Johnson Syndrome (“SJS”) and Toxic Epidermal Necrolysis (“TEN”), and she was transferred to the hospital's burn unit, where she stayed for several days.[17]
On July 28, 2018, Rachel was transferred from Bridgeport Hospital to Columbia Presbyterian Medical Center, where she suffered from additional symptoms related to HLH.[18]She underwent numerous invasive and painful medical procedures to treat her SJS, TEN, and HLH, but the interventions were unsuccessful.[19] Rachel died on August 17, 2018.[20] Rachel's father as the administrator of her estate has filed this lawsuit against GSK claiming a violation of the Connecticut Product Liability Act. The case was first filed in Connecticut state court before it was removed by GSK to this Court.[21] As noted above, GSK has moved to dismiss on the ground that it may not be liable under the CPLA because it did not manufacture, sell, or benefit from the particular drug that harmed Rachel.[22]
The Connecticut Product Liability Act (“CPLA”) governs all claims arising under Connecticut law for injuries caused by any product. See C.G.S. § 52-572m et seq. The Act defines a “product liability claim” to include “all claims or actions brought for personal injury, death or property damage caused by the manufacture, construction, design, formula, preparation assembly, installation, testing, warnings, instructions, marketing, packaging or labeling of any product.” C.G.S. § 52-572m(b). Such claims “shall include, but [are] not limited to, all actions based on the following theories: Strict liability in tort; negligence; breach of warranty, express or implied; breach of or failure to discharge a duty to warn or instruct, whether negligent or innocent; misrepresentation or nondisclosure, whether negligent or innocent.” Ibid. A “product liability claim” must be asserted “in lieu of all other claims against product sellers, including actions of negligence, strict liability and warranty, for harm caused by a product.” C.G.S. § 52-572n(a).
Despite the Act's creation of an exclusive procedural vehicle for the assertion of product liability claims, the Act preserves the substance of an injured plaintiff's rights to recover under the common law. As the Second Circuit has explained, “the CPLA does not preempt all common law theories of product liability, ” but merely “bars separate common law causes of action in product liability cases.” Densberger v. United Techs. Corp., 297 F.3d 66, 70 (2d Cir. 2002) (emphasis omitted).[23]
In addition, “[c]ommon law theories . . . rather than being preempted by the CPLA, are incorporated into the statute unless they are expressly inconsistent with it.” Ibid. And because “the CPLA was not meant to eliminate common-law substantive rights but does not itself spell out the elements of the types of claims it consolidates, ” a court must “assess [a plaintiff's] theories of recovery in light of the Connecticut common-law requirements.” LaMontagne v. E.I. Du Pont De Nemours & Co., Inc., 41 F.3d 846, 856 (2d Cir. 1994); see also Leonard v. Gen. Motors L.L.C., 504 F.Supp.3d 73, 92 (D. Conn. 2020) ().
Consistent with this framework, the complaint in this case gathers multiple common law theories under a single umbrella for a cause of action under the CPLA. These theories in essence include strict liability and negligence claims for design defects, failure to warn, and misleading promotional statements about the safety of Lamictal.[24]
Federal regulatory framework for brand-name and generic drugs
The state law products liability claim in this case must be understood in the context of federal law standards that govern the manufacture and sale of medical drugs. When a company like GSK develops a new drug, the Federal Food, Drug, and Cosmetic Act (“FDCA”) requires the company to apply for approval of the new drug upon a showing based on extensive clinical...
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