When we have given talks on preemption, whether to law firm personnel, attendees of professional conferences, or new FDA employees, we have tended to start with the Supremacy Clause and then break up the types of preemption and the issues related to them into different buckets. We have not had to name those buckets or
Georgia
Stretching Specific Personal Jurisdiction And Shrinking Preemption At The Pleadings Stage

When we started seeing a smattering of cases over long-term contraceptive devices used in connection with tubal ligation surgery, we were not surprised. Plaintiff lawyers have targeted a wide range of contraceptive drugs and devices for decades. Commentators beyond this Blog have described how this bent affects contraceptive choice and public health. When we saw…
Generic Drugs Remain Generic Drugs Even When Brand Name Drugs Leave the Market

That seems like it should be an obvious statement. FDA regulations draw important distinctions between brand drugs and generic drugs. A manufacturer seeking FDA approval of a new drug must prove safety and efficacy involving expensive and lengthy clinical trials. Once approved, that drug becomes the reference list drug. If a manufacture wants to market…
Georgia Supreme Court does not Adopt the Apex Doctrine, but comes Fairly Close

Even a meritless lawsuit can impose an enormous burden on a company. There is the ridiculous expense, of course. Legal fees and other costs of defending a lawsuit can easily add up to more money than most juries award to plaintiffs. Some of those costs can be indirect but profound. Employees who would prefer to…
Georgia Dismisses Supplement Case on Primary Jurisdiction Grounds

Today’s case – Smith v. Hi-Tech Pharmaceuticals, Inc., — S.E.2d –, 2022 WL 2285920 (Ga. Ct. App. Jun. 24, 2022 — does not break new ground. But it is a published decision by a state appellate court and for that reason, it deserves some attention.
Plaintiff, a resident of Washington, DC, brought a single…
Another Reason MDL Defendants Should Not Waive Their Lexecon Rights

This post is from the non-Dechert side of the blog.
From the first time that we discussed Lexecon, Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998), and the related MDL concept of Lexecon waivers, we’ve been plenty leery of defendants in cases transferred into multidistrict litigation waiving their retransfer rights…
Georgia Statute of Repose Knocks Out Failure to Warn Case
Georgia Somewhat Reluctantly Allows General Jurisdiction by Consent

Sooner or later we knew it would happen. The law on general jurisdiction by consent has been developing very favorably – maybe even too favorably. Since Daimler AG v. Bauman, 571 U. S. 117 (2014), almost every appellate decision (including every state court of last resort and federal circuit court) has rejected general jurisdiction…
A Most Disappointing Declaration from Georgia

This post is from the non-Reed Smith side of the blog.
Dear Readers,
The tone of today’s missive may be slightly more formal than most. For you see, as a result of binge watching Bridgerton on Netflix, the written word is being narrated in our head by the incomparable Julie Andrews. We so greatly esteem…
A New Year And An Old Issue: Warnings Claims Based On A Known Acceptable Risk Fail

In very general terms, posts on specific court opinions fall into three categories: 1) ones we think are correct, 2) ones we think are incorrect, and 3) ones we think are mixed bags. Not terribly profound. Digging a bit deeper, we sometimes pick cases to discuss because we feel the need to vent about the…