Listen to your gut. Follow your instincts. Trust your intuition. Great advice in many situations. Like deciding whether to buy skinny jeans or whether to buy your forever home. Or, when things seem “off” or feel “dangerous.” Or, when your body is trying to tell you something about your health. These are all times to
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
We have lost track of how many times we have written on pelvic mesh cases as they have gone through a number of district courts on remand and occasionally up on appeal to circuit courts. One theme we have seen play out over and over is that plaintiff lawyers who took on more cases than
Florida courts are handling a lot of lawsuits. Lots and lots of lawsuits, and for a convergence of reasons. Backlogs from pandemic-related closures and delays. The highest per capita rate of federal court personal injury cases in the country by some measures. Claims over last year’s Category 4 Hurricane Ian. Recent tort law changes
As evidenced by our PMA Preemption Score Card, on which today’s case became the 651st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions. But plaintiffs keep filing PMA medical device complaints, so we’ll keep posting about them.
Which brings us to today’s case, Arnold v.
It’s unusual when the same defendant wins two unrelated cases involving the same product in the same week – and on the same issue. But it does happen, and recently, in both Benn v. Medtronic, Inc., 2023 WL 3966000 (D.N.J. June 13, 2023), and Warmoth v. Medtronic, Inc., 2023 WL 3938464 (W.D. Okla. June 9, 2023), express medical device preemption carried the day, in decisions issued only four days apart.
That’s worth a blogpost – and two cheers. Hip hip!Continue Reading A Preemption Two-Fer
For much of the sixteen and a half years of this Blog, we have been tracking the acceptance and rejection of the learned intermediary doctrine. The first year that we compiled a worst decisions of the year list it was topped by a case that still holds the title for worst, most thinly veiled legislation
Duh. We apologize for the depth of our profundity, but there are some legal principles we think are really obvious. So obvious, in fact, that we might respond to question about these principles with this most dismissive of (clean) interjections. (We were somewhat surprised to learn from the interwebs that duh was supposedly first used
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
Recently, in describing a decision granting summary judgment in an IVC filter case, we identified some additional analyses we would have liked to have seen:
[W]hile interrelated, we think the concepts of a “compensable injury” and causation are separate. For instance, an exposure might cause a risk of future injury, but state law may hold that such a risk without present injury is not compensable. Or a subclinical injury like pleural thickening may not be compensable, in part because of the inconsistency with the principles of accrual of claims for statute of limitations purposes. Is a medical procedure not required by specific symptoms—regardless of what caused them—itself a compensable injury? We think not. A surgery may be part of the damages allegedly related to an injury allegedly caused by the drug/device/exposure, but is not an injury in and of itself. Gomez did not delve into this either.
That same day—but well after we had set our prescient post to publish—the court in Fuss v. Boston Sci. Corp., No. 2019-02348, 2022 Mass. Super. LEXIS 251 (Mass. Super. Ct. Oct. 20, 2022), did those same analyses in another IVC filter case. Rather than fall prey to the post hoc ergo propter hoc fallacy that plagues plaintiffs’ causation theories in so many drug and device product liability cases, we will admit this is mere coincidence. After all, compensable injury seems like an obvious threshold issue in an IVC filter case where perforation of the inferior vena cava (IVC) is the only claimed injury.
Given the facts of Fuss, we will go a step further and say that it would be better if there were a way to get rid of cases without compensable injuries without the time and expense of going through fact and expert discovery and briefing an all-issues summary judgment motion with accompanying Daubert motion. After a pulmonary embolism, plaintiff had his IVC filter implanted by an experienced vascular surgeon in 2007. It has remained in place, without embolism or any symptoms tied a complication, for the fifteen years since. Then plaintiff saw a lawyer advertisement, was sent by lawyers to get a CT scan ordered by a doctor he did not know and never met, and brought a lawsuit over an alleged perforation. After suing, plaintiff conferred with his implanting surgeon, who, with the benefit of an x-ray, concluded the filter was doing its job and required no treatment or intervention. In deposition, plaintiff admitted that he had been asymptomatic. After the parties completed discovery and teed up motions for both summary judgment and exclusion Massachusetts’s version of a Daubert motion on plaintiff’s catchall expert, plaintiff still had never received any treatment or intervention.Continue Reading No Muss, No Fuss In Disposing Of Litigation-Driven “Injury”