Larry Patterson and Tammy Patterson v. Covidien, Inc., et al.

Summary

The United States District Court for the District of Massachusetts ruled on Covidien’s motion to exclude the testimony of Dr. Laura Plunkett in the first bellwether case in the Covidien hernia mesh multidistrict litigation. The court allowed exclusion of her opinions concerning Covidien’s postmarket surveillance and complaint handling, but otherwise denied the motion, subject to limits barring opinions on FDA processes, legal conclusions, and Covidien’s state of mind.

Holdings

1. Dr. Plunkett's opinions concerning the resorption period of the porcine collagen barrier were sufficiently reliable for admission under Rule 702 because she reviewed the preclinical studies and applied her toxicological expertise in assessing the data.
2. Dr. Plunkett may provide background testimony concerning the applicable FDA regulatory schemes and may explain deficiencies she identifies in Covidien's preclinical testing, labeling, and marketing of Symbotex.
3. Dr. Plunkett may not offer opinions criticizing the FDA, its regulations, or the § 510(k) process because such opinions would not assist the jury.
4. Dr. Plunkett may not testify about the adequacy of Covidien's postmarket surveillance or complaint handling for Symbotex.
5. Dr. Plunkett may testify about information contained in Covidien's documents or otherwise in Covidien's possession, but she should not characterize Covidien as having 'known' or been 'aware' of the information as an opinion about the company's state of mind.
6. Dr. Plunkett may describe regulatory requirements and explain deficiencies in Covidien's testing, labeling, and marketing, but she may not testify that Covidien violated regulatory requirements.

Questions Presented

1. Whether Dr. Plunkett's weight-of-the-evidence methodology was reliably applied under Federal Rule of Evidence 702.
2. Whether Dr. Plunkett's regulatory, preclinical-testing, labeling, and marketing opinions would assist the jury.
3. Whether Dr. Plunkett could testify about information in Covidien's possession without improperly expressing opinions about Covidien's state of mind.
4. Whether Dr. Plunkett could testify about FDA regulatory requirements or characterize Covidien's conduct as violating those requirements.
5. Whether Dr. Plunkett had sufficient facts or data to offer opinions on Covidien's postmarket surveillance and complaint handling for Symbotex.

Disposition

other