Evans v. Gilead Scis., Inc.
| Decision Date | 31 August 2020 |
| Docket Number | Case No. 20-cv-00123-DKW-KJM |
| Parties | BRIAN EVANS, Plaintiff, v. GILEAD SCIENCES, INC., Defendant. |
| Court | U.S. District Court — District of Hawaii |
This product liability case involves pro se Plaintiff Brian Evans' use of Truvada®, an FDA-approved prescription drug designed and manufactured by Defendant Gilead Sciences, Inc., for the prevention and treatment of HIV. Gilead has moved to dismiss the complaint for failure to state a claim, Dkt. No. 20, arguing that the claims are preempted by the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., and that Evans has failed to adequately allege facts to support the elements of his claims for failure-to-warn, fraud, and breach of express and implied warranty.
First, Evans' design defect claims are preempted under the FDCA because it was impossible for Gilead to comply with both Hawaii tort law and the FDCA's design approval requirements. Federal regulations, however, permitted Gilead to unilaterally change its Truvada labeling and, thus, Evans' failure-to-warn claims are not preempted. Second, Evans has failed to sufficiently allege that the inadequacy of the Truvada labeling proximately caused his injuries. Third, Evans has not pled his fraud claim with "particularity" as required by Federal Rule of Civil Procedure 9(b). Lastly, Evans' warranty claims are dismissed as vague and conclusory. Accordingly, Gilead's motion to dismiss Evans' first amended complaint, Dkt. No. 20, is GRANTED. Evans is granted leave to amend all but his federally preempted design defect claims.
The following facts are drawn from the allegations in the first amended complaint, "documents incorporated into the complaint by reference, and matters of which a court may take judicial notice." Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007).
At all times relevant, Defendant Gilead Sciences, Inc. (Gilead) manufactured and marketed the brand-name prescription drug Truvada. See Dkt. No. 8 at 1, 3.1 Truvada contains two active ingredients, one of which is relevant here: Tenofovir disoproxil fumarate (TDF). Id. at 4.2 TDF was approved by the Food and DrugAdministration (FDA) in October 2001. Dkt. No. 8 at 4.
On August 2, 2004, the FDA approved Truvada for the treatment of HIV infection in adults.3 On July 16, 2012, the FDA approved Truvada for use by HIV-negative adults as a Pre-Exposure Prophylaxis (PrEP) taken daily to reduce the risk of becoming infected with HIV.4
Plaintiff Brian Evans was prescribed Truvada in October 2018. Dkt. No. 8 at 4. Evans alleges that as a result of taking Truvada, he "has now suffered irreversible damages to his bones." Id. at 5. Evans also alleges that he now suffers from, and has been diagnosed with, diffuse arthralgia (i.e., joint pain) and is unable to work. Id. at 2, 7.5
Evans asserts that, as early as 1997, studies had associated TDF with bone and kidney damage. See Dkt. No. 8 at 7-8. In one study, patients who had taken Truvada demonstrated accelerated losses of bone density, resulting in "Osteoporosis [and]other joint and bone conditions." Id. at 2-3. By 2001, Gilead allegedly knew that Truvada had to be taken by consumers in high doses to be effective, and thus, patients taking Truvada were at a higher risk for bone and kidney damage. Id. at 2, 4, 7.
The Truvada labeling in effect at the time Evans was prescribed Truvada (October 2018) was approved by the FDA on May 15, 2018. Dkt. No. 20-2.6 The FDA-approved patient labeling states, in relevant part, Id. at 37 (emphasis in original).
The Truvada labeling also provides information for physicians prescribing Truvada. On the first page, under "WARNINGS AND PRECAUTIONS," the label notes, inter alia, "[d]ecreases in bone mineral density (BMD): Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss." Id. at 1. Under "DRUG INTERACTIONS," it provides that Id. at 1. In a separate section, entitled "Bone Loss andMineralization Defects," it states:
In clinical trials in HIV-1 infected adults and in a clinical trial of HIV-1 uninfected individuals, TDF (a component of TRUVADA) was associated with slightly greater decreases in bone mineral density (BMD)[.]
. . . .
Assessment of BMD should be considered for adult and pediatric patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss.
. . . .
Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with TDF use [see Adverse Reactions (6.1)]. Arthralgia and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy. Hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving TDF-containing products [see Warnings and Precautions (5.3)].
Dkt. No. 20-2 at 7-8 (brackets in original); see also id. at 8 (); id. at 12 ().
The "PATIENT COUNSELING INFORMATION" in the label further instructs physicians to "[a]dvise the patient to read the FDA-approved patient labeling (Medication Guide)," id. at 32, "[i]nform patients that decreases in bone mineral density have been observed with the use of TDF or TRUVADA," and "[c]onsider bone monitoring in patients and uninfected individuals who have ahistory of pathologic bone fracture or at risk for osteopenia [see Warnings and Precautions (5.5)]," id. at 33 (brackets in original).
Evans alleges the warnings "partially disclosed material facts" and were "contrary to those [Gilead] gave with respect to the exact same drugs in [Europe]." Dkt. No. 8 at 8.
In April 2001, scientists published research for a different chemical known as tenofovir alafenamide fumarate (TAF). Dkt. No. 8 at 4. TAF, as compared to TDF, was allegedly shown to be substantially more effective against HIV with far less toxicity. Id. at 5. Evans alleges Gilead began clinical trials for TAF but kept the results secret until it announced in October 2004 (shortly after Truvada was first FDA-approved) that Gilead was abandoning its research on TAF. Id. According to Evans, Gilead "purposefully withheld" TAF, knowing that it was "safer" than TDF, so that the company could "make more money" by continuing to sell Truvada until the Truvada patents expired and the medication could be purchased from generic prescription drug manufacturers. See id. at 5, 7; id. at 2. In 2010, Gilead began publishing the results of its earlier studies on TAF. See id. at 5. Between November 2015 and February 2018, the FDA approved at least four TAF-containing medications manufactured by Gilead. See id. at 5.7
As noted, in October 2018, Evans was prescribed Truvada. Id. at 4.8
Although the complaint lacks focus and Evans' claims concerning Truvada are difficult to deconstruct, heeding the obligation to construe his complaint liberally, Evans' theory of liability is twofold. First, Evans alleges Gilead failed to adequately disclose on its prescriber and patient labeling for Truvada that: (a) the drug "could cause damage to the kidneys and to the bones of those who ingest it," including "the problems that [Evans] is now suffering" (i.e., diffuse arthralgia); and (b) doctors should "monitor all TDF patients, on a frequent, specific schedule, for the adverse effects of TDF-associated bone and kidney toxicity." See id. at 2, 6-7. Evans also alleges Gilead failed to issue any such "warnings until 2018, despite knowing of these effects since 2001." Id. at 6. Second, Evans asserts "Gilead purposefully withheld the TAF design, which it knew was safer than TDF, to makemore money." Id. at 7; see also id. at 6, ¶ 2. Evans' complaint asserts the following product liability claims sounding in negligence and strict liability: (1) "Strict Products Liability - Failure to Warn"; (2) "Negligence and Gross Negligence - Design Defect and Failure to Warn"; (3) "Fraud"; and (4) "Breach of Express and Implied Warranty." Id. at 1, 8.
Because Evans filed this lawsuit pro se, seeking to proceed in forma pauperis, the Court conducted its mandatory, sua sponte screening of the complaint pursuant to 28 U.S.C. § 1915(a) and dismissed the complaint with leave to amend for failure to state a claim upon which relief may be granted. Dkt. No. 7 at 6; 28 U.S.C. § 1915(e)(2)(B); Denton v. Hernandez, 504 U.S. 25, 32 (1992). Evans filed an amended complaint, Dkt. No. 8, which the Court held "may proceed such that Gilead may be served," but noted that "Gilead . . . may still challenge Evans' claims through any means procedurally permitted by the Federal Rules." Dkt. No. 9 at 5.
Pursuant to Federal Rule of Civil Procedure 12(b)(6), Gilead has moved to dismiss all claims. Dkt. No. 20.
"Federal Rule of Civil Procedure 8(a)(2) requires only 'a short and plain statement of the claim showing that the pleader is entitled to relief,' in order to 'give the defendant fair notice of what the . . . claim is and the grounds upon...
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