As defense attorneys who represent drug and device companies, we generally cheer when a state-law claim is held preempted by the FDCA. We are, however, not sure whether to cheer the decision we discuss today, Thogus Products Co. v. Bleep, LLC, 2023 WL 5607458 (N.D. Ohio 2023).
Thogus involved a contract dispute between a
Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation. He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” FDA, “Medical Device Reporting (MDR): How to Report Medical Device Problems,” at MDR Data Files, Alternative Summary Reports (available here). Bexis came across preemption cases mentioning ASR reporting with respect to surgical staplers, Bell v. Covidien LP, 2023 WL 3006175, at *2 (D. Mass. April 19, 2023), breast implants, e.g., Gravitt v. Mentor Worldwide, LLC, ___ F. Supp.3d ___, 2022 WL 17668486, at *3 (N.D. Ill. Dec. 14, 2022); D’Addario v. Johnson & Johnson, 2021 WL 1214896, at *3 (D.N.J. March 31, 2021), and contraceptive devices. McLaughlin v. Bayer Essure Inc., 2019 WL 3764658, at *1 (E.D. Pa. May 9, 2019). It appears that plaintiffs are attempting to turn various defendants’ use of this FDA-created and authorized program into a tort (variously described as warning defect or a variant of a misrepresentation claim).
Continue Reading Thinking About the FDA’s Alternative Summary Reporting Program
It is looking very much as if the U.S. Supreme Court will hear a case this upcoming October term that will permit it, at long last, to inter the Chevron doctrine. Under that doctrine, if there is ambiguity about the scope of rule making powers provided to an agency by Congress, courts will defer to
One key point where implied preemption differs from express preemption is that express preemption is inherently limited by the language of the particular statute that contains the pertinent preemption clause, whereas general principles of implied preemption have broad application to all similar cases. Since the preemption of agency fraud claims recognized in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was based entirely on implied preemption, Bexis has kept track of non-FDCA applications of Buckman implied preemption in his book. See § 5.02[4][c] n.294. Non-FDA-related findings that federal agency fraud claims are preempted include:
Farina v. Nokia, Inc., 625 F.3d 97, 104 (3d Cir. 2010) (FCC); Transmission Agency of Northern California v. Sierra Pacific Power Co., 295 F.3d 918, 932 n.10 (9th Cir. 2002) (FERC); Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1204-06 (9th Cir. 2002) (EPA); Murray v. Motorola, Inc., 982 A.2d 764, 770 n.6 (D.C. 2009) (FCC); McCall v. Pacificare, Inc., 21 P.3d 1189, 1199 n.9 (Cal. 2001) (Health Care Financing Administration); Timaero Ireland Ltd. v. Boeing Co., 2021 WL 963815 at *6-7 (N.D. Ill. March 15, 2021) (FAA); LCS Group v. Shire LLC, 2019 WL 1234848 at *6 (S.D.N.Y. March 8, 2019) (patent office); In re Volkswagen “Clean Diesel” Marketing, Sales Practices, & Products Liability Litigation, 264 F. Supp.3d 1040, 1054-55 (N.D. Cal. 2017) (EPA); Syngenta Crop Protectin v. Willowood, 2016 WL 6783628 at *1 (M.D.N.C. Aug. 12, 2016) (EPA); Giglio v. Monsanto Co., 2016 WL 1722859 at *3 (S.D. Cal. April 29, 2016) (EPA); Offshore Service Vessels, LLC v. Surf Subsea, Inc., 2012 WL 5183557 at *11-12 (E.D. La. Oct. 17, 2012) (Coast Guard); Ramirez v. E.I. Dupont De Nemours & Co., 2010 WL 3529509 at *2 (M.D. Fla. Sept. 3, 2010) (EPA); Lockwood v. Sheppard, Mullin, Richter & Hampton, LLP, 2009 WL 9419499 at *7 (C.D. Cal. Nov. 24, 2009) (patent office); Beck v. Koppers, Inc., 2006 WL 2228910 at *1 (N.D. Miss. April 7, 2006) (EPA); Hill v. Brush Engineered Materials, Inc., 383 F. Supp.2d 814, 822 (D. Md. 2005) (EPA, OSHA); Williams v. Dow Chemical Co., 255 F. Supp.2d 219, 232 (S.D.N.Y. 2003) (EPA); Morgan v. Brush Wellman, Inc., 165 F. Supp.2d 704, 722 (E.D. Tenn. 2001) (Dept. of Energy); Zwiercan v. General Motors Corp., 2002 WL 31053838, 58 Pa. D. & C.4th 251, 266 (Pa. Com. Pl. 2002) (NHTSA); Redelmann v. Alexander Chemical Corp., 2002 WL 34423377 (Ill. Cir. July 26, 2002) (EPA).
Now Buckman preemption is the centerpiece of In re Ford Motor Co. F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation, ___ F.4th ___, 2023 WL 3029837 (6th Cir. April 21, 2023). Indeed, at least one aspect of Ford F-150 is favorable to Buckman preemption in a way that should be useful in the drug/device field.
Continue Reading Automotive Preemption Case Has Buckman Front and Center
Earlier this year we discussed the application of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), to a variety of private litigation that sought to second-guess the FDA’s drug or medical device classification decisions. Then we followed up with what we described as a “doozy” of a case along the same lines,
Things have been weird. What was normal is not now. What has been common recently is not normal. The phrase “the new normal” has been so over-used that hearing it induces a sour look on our face. Somewhere in our brain—like our face, the bloggers have a single, first-person plural brain for stylistic purposes—there is
Truly unique cases are, well, unique. Most cases involve variations or combinations of cases we have seen before. Sometimes you get different results between two decisions on basically the same case with a single fact different. In February, we posted on an Eastern District of Pennsylvania decision on a motion to dismiss in a case
As we mentioned in our recent Preemption Teaser post, last month’s concurrence in denial of certiorari in Lipschultz v. Charter Advanced Services (MN), LLC, ___ S. Ct. ___, 2019 WL 5300908 (U.S. Oct. 21, 2019), provides an indication that, at least to some extent, Justice Thomas might have found a kindred spirit of sorts
One of the more peculiar things about Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019) (“Albrecht”), is the almost off-hand way that the majority (made up mostly of justices that have opposed preemption in closer cases) wandered away from the procedural preemption issues that the Court was
On our office bulletin board, we keep a post-it listing the states we have not yet visited. We are down to ten, and we expected to cross Oregon off after a deposition last week. But our deponent moved from Bend, Oregon to St. George, Utah. We’ve been to Utah lots of times, and were annoyed