748 F.Supp.3d 1
D. Mass.2024Background
- Plaintiffs Brian Corrigan and Sheri Bement sued Covidien and Medtronic, alleging product liability regarding a surgical stapler used in Corrigan’s 2019 surgery.
- Claims included failure to warn, negligent misrepresentation, unfair/deceptive trade practices (Mass. Gen. L. c. 93A), and loss of consortium.
- Plaintiffs argued Covidien underreported adverse events to the FDA through the ASR program, depriving Corrigan’s surgeon (Dr. Rose) of vital risk information.
- Dr. Rose testified he was aware of stapler risks but did not review event reports, device instructions, or FDA warnings before the surgery.
- The Court had already dismissed the defective manufacture/design claims and denied multiple prior motions to amend the complaint.
- Defendants moved for summary judgment; plaintiffs moved for leave to further amend their complaint, both of which are the subject of this decision.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Failure to warn (traditional) | Covidien did not adequately warn of stapler risks to Dr. Rose | Covidien’s duty was met; warnings not read/no causation | No causation; summary judgment for Covidien |
| Failure to warn (underreporting/ASR) | Covidien underreported adverse events, depriving Dr. Rose of info | No state-law duty to report to FDA/public; Dr. Rose wouldn’t have relied | No such duty and no causation; summary judgment |
| Negligent misrepresentation | Covidien misrepresented/omitted information about stapler risks | No reliance by Dr. Rose on any misstatement or omission | No causation; summary judgment |
| Leave to amend (add new theories/claims) | New evidence may support additional defect/failure-to-warn theories | No new evidence; amendments would be futile and unsupported by record | Amendment denied as futile/unsupported |
Key Cases Cited
- Hoffman v. Houghton Chem. Corp., 434 Mass. 624 (Mass. 2001) (sets same standard for negligent and warranty-based failure-to-warn under Massachusetts law)
- Garside v. Osco Drug, Inc., 976 F.2d 77 (1st Cir. 1992) (manufacturer's duty to warn satisfied by reasonable physician warning)
- Lubanski v. Coleco Indus., Inc., 929 F.2d 42 (1st Cir. 1991) (causation required for failure-to-warn claim)
- DeWolfe v. Hingham Ctr., Ltd., 464 Mass. 795 (Mass. 2013) (elements of negligent misrepresentation in Massachusetts)
- Jorgensen v. Mass. Port Auth., 905 F.2d 515 (1st Cir. 1990) (elements of negligence claim under Massachusetts law)