In Re: Tepezza Marketing, Sales Practices, and Products Liability Litigation
1:23-cv-03568
N.D. Ill.Jan 10, 2025Background
- Plaintiffs in a multidistrict litigation (MDL) allege hearing-related injuries (hearing loss/tinnitus) from the drug Tepezza (teprotumumab) used to treat thyroid eye disease (TED), manufactured by Horizon Therapeutics USA, Inc.
- The case concerns whether Horizon's label/literature adequately warned of hearing risks, whether the drug was defectively designed, and whether Horizon fraudulently misrepresented safety/efficacy.
- The FDA approved Tepezza in January 2020; the initial label included a 10% hearing impairment risk. Later studies suggested the rate could be as high as 40%.
- Post-approval, Horizon updated the label (not until July 2023) to include stronger, clearer warnings about the risk and permanence of hearing loss and need for audiological monitoring.
- This opinion rules on Horizon's motions to dismiss failure-to-warn, design defect, and fraudulent misrepresentation claims in 11 bellwether cases, plus one Plaintiff's late motion to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Failure-to-warn preemption | Horizon had enough info (from studies, etc.) for earlier CBE | CBE change not allowed—insufficient new data before 9/2022 | Denied dismissal; complaint plausibly alleges CBE was available before Plaintiffs' treatments |
| Design defect pleading | Defect = excessive dose; safer alternative (half-dose); discovery will reveal more | Claims are conclusory, not enough facts on defect or alternative design | Dismissed with prejudice; allegations too speculative, not plausible or supported |
| Fraudulent misrepresentation | Label (and omissions) overstated benefit, understated risk, failed to disclose new info | Insufficient particularity; rate in label was accurate; no duty to disclose | Dismissed in part (preemption unresolved); omissions claims against the label survive but not overstatements of efficacy or numeric risk |
| Leave to amend (Kanesta-Rychner) | Omitted claims in error; no prejudice in amending | Missed deadline, no diligence | Denied; lack of diligence and no good cause shown |
Key Cases Cited
- Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019) (analyzed impossibility preemption for branded drug labeling)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (preemption when private compliance with state and federal law impossible)
- Wyeth v. Levine, 555 U.S. 555 (2009) (manufacturers can update warnings without prior FDA approval via CBE if new info arises)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (complaint requires factual plausibility)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility pleading standard for Rule 12(b)(6))
- Robinson Helicopter Co. v. Dana Corp., 34 Cal. 4th 979 (Cal. 2004) (fraudulent misrepresentation elements)
- Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (Pennsylvania doesn't allow fraud claims based solely on failure-to-warn)