Every once in a while in this space we summarize law review articles. In the course of doing so, we typically pat ourselves on the back by announcing that we read such articles so that you don’t have to. That is not true with the article we are discussing today, Goldberg, Gramling, & O’Rourke, “A
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
This week my health care colleagues authored an industry trends report highlighting many of the major regulatory issues facing life sciences and health care companies in the coming year. The “Outlook: U.S. Health Care 2021” report includes sections on post-COVID trends and lessons learned, the future of value-based care, the intersection of health care and
This week we are pleased to report on yet another breast implant case in which a plaintiff’s effort to circumvent preemption failed. In Diodato v. Mentor Worldwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020), the plaintiff brought manufacturing defect, breach of warranty, and failure to warn claims that were typically skimpy in
Some states seem stronger on FDA preemption than SCOTUS was in the Wyeth v. Levine decision. For example, Michigan, New Jersey, and Texas prevent or limit the ability of plaintiffs to sue over an FDA-approved drug, including attacks on the FDA-approved label. See, e.g., Texas Civ. Prac. & Rem. Code Ann. § 82.007. Sometimes
In Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239 (S.D. Fla. Dec. 30, 2019), the plaintiff claimed that a breast implant leached chemicals into her tissue, causing a constellation of symptoms known as Breast Implant Illness. Her lawsuit alleged that the manufacturer knew of this danger but failed to warn the implanting surgeon who,
We like bright lines in the law. They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability. Rear-end a car and you’re liable, even if the other guy stopped short. Leave a sponge behind in a patient’s abdomen, and you and your
When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or the distinction between taking under false pretenses vs. larceny by trick – Chicago sports teams got better. Much better. The perpetually mediocre White Sox, who shared the South Side with U of C (no matter what former U of C law professor POTUS says about his glee that the Cubs are in the World Series, don’t believe him; he roots for the White Sox and any self-respecting fan of that team is miserable over the Cubbies’ success) (and if either presidential candidate dons a Cubs cap even though we know full well they root for New York’s arrogant American League franchise, we will barf like a DePaul student who shot-gunned too many cans of Old Style; we don’t care if it’s complicated), started “winning ugly” and made it to the playoffs. So did the Cubs, though when Tim Flannery’s weak little ground ball dribbled “right between [Leon Durham’s] legs!”, we knew that the Billy Goat curse was still strong and that the Padres would ultimately knock out the home town team. And so they did. Tragedy still tainted triumphs. But triumph was unalloyed in 1985, when Da Bears assembled the most fearsome defense of all time and captured the team’s only Super Bowl title. (Please do not refer to the Bears as the Monsters of the Midway. That title properly belongs to the University of Chicago Maroons, a college football team that, in the early part of the last century, brought home many wins and the very first Heisman Trophy.) Oh, we almost forgot – in 1984 the Bulls drafted a guard out of North Carolina who looked like he might be a pretty good basketball player.
Sports weren’t the only thing that improved on our law school watch. The Seventh Circuit started raiding the U of C faculty. Posner became a judge. Then Easterbrook. Then Wood. If there is an appellate court anywhere that approaches the Seventh Circuit in terms of pure intellectual wattage, we’d be frightened to hear about it. Seventh Circuit opinions come with doctrinal heft, sharp insights, brave creativity, and the occasional ounce of craziness. (Remember Posner’s drawing of an ostrich with its head in the ground?) Today’s case is more interesting than it has any right to be. The plaintiff in Wagner v. Teva Pharmaceuticals USA, Inc., — F.3d —, 2016 U.S. App. LEXIS (7th Cir. Oct. 18, 2016), was pro se, though she was also a lawyer. She had taken both brand name and generic versions of hormone therapy drugs and claimed they caused her to develop breast cancer. The complaint included causes of action under Wisconsin law for defective product and failure to warn. The generic manufacturers argued that the claims were preempted by federal law, relying primarily on the SCOTUS opinions in Mensing and Bartlett. The district judge agreed with the defendants and granted their motion for judgment on the pleadings. The plaintiff appealed to the Seventh Circuit, arguing that the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA) meant that her claims were not preempted. The plaintiff also argued that her claims are not preempted to the extent they are based upon the failure to update the generic drug labels to match the updated labels on the brand name drug.
Continue Reading Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption