Yesterday we did our annual best of/worst of CLE, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device and Vaccine Decisions of 2025”. It was good fun for us presenters and hopefully at least mildly educational and entertaining for the audience. (If you missed it, the video replay will be available
There is a special kind of optimism—some might call it magical thinking—that animates the modern failure-to-warn claim against prescription drug manufacturers. It goes something like this: Yes, the FDA-approved label warned about the exact risk that happened to me, but the manufacturer still failed to warn.
Which is a pretty accurate summary of plaintiff’s argument
We’ve been defending drug and device litigation for a long time, and we’ve seen many plaintiffs who experienced real injuries. Those of us at the blog, our colleagues at other defense firms, and our clients are genuinely sympathetic to injuries a plaintiff actually experienced. Many plaintiffs we’ve encountered also endured terrible circumstances earlier in their lives. Some of those can be heartbreaking. Defending cases on the basis that our clients’ products did not cause the injury or that the injury was a known and warned of risk doesn’t mean the defense bar looks askance at plaintiffs and their experiences. But, when we see a case involving a syringe needle purportedly propelled into a plaintiff’s derrière, some of us might exhibit a moment of minor moral weakness and include the above title in a blog post. Mea culpa.
Today’s case, Rudzinskas v. Retractable Techs., Inc., 2025 U.S. Dist. LEXIS 191860 (S.D. Ga. Sept. 29, 2025), involves a type of syringe that automatically retracts once the plunger handle is fully depressed. Plaintiff’s husband regularly administered vitamin B-12 shots to her and had been doing so for six or seven years. Plaintiff claimed that, on one of those occasions, the needle from defendant’s syringe “shot into [her] like a slingshot.” Id. at *4. Plaintiff went to the hospital and an ultrasound suggested the needle was embedded in the plaintiff’s buttock. Plaintiff underwent surgery to have the needle removed, but the surgeon was not able to extract it. Continue Reading A Real Pain in the . . .
If you’re a frequent visitor to the DDL blog, you’ll know all about products liability claims premised on defendants’ alleged failure to report adverse events to the FDA. You’ll also be acutely aware of what we think of such claims—they are flat-out preempted. Much to our dismay, not every court agrees with us. But recently
When we read the word “Georgia”, we hear it in our heads sung in the voice of the great Ray Charles. Actually, we hear the entirety of the opening lyrics to Georgia on My Mind. Is that just us? Ok, well, anyhoo.
We have been reading a lot about Georgia of late because of
The plaintiff in Pachecho v. Johnson & Johnson, 2024 WL 3260883 (M.D. Ga. Jul. 1, 2024), both over-pleaded her causes of action and under-pleaded their factual support (at least as to manufacturing defect). Both errors led the court do a little pruning. And while the cases continues, we hope in its uncluttered state, the
How is the Georgia General Assembly like Dr. Seuss’s kind-hearted Horton the Elephant? They both meant what they said and said what they meant. Horton was talking about an elephant’s faithfulness (being 100%). The Georgia General Assembly was talking about requiring that product liability claims be initiated within ten years from “the first sale
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
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
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