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”
We have written quite a few posts about litigation over inferior vena cava filters made by various companies. Most of those posts focused on decisions in cases pending in or remanded after a stint in one of two MDLs. Broadly speaking, those decisions involved filters intended to remain in place permanently and alleged injuries from
Maybe we have been doing this too long. Or maybe, like the prequels, spinoffs, and reboots that are so prevalent among streaming entertainment options, there is just a lot of repetition. In serial product liability cases, we hope that repetition leads to consistency of results or at least predictable rules of the game. Consider the
We came across something the other day that we don’t see very often, or really ever. The plaintiff in a medical device case served a request to inspect the two defendants’ manufacturing facilities, claiming that he was entitled to observe the premises where the device was made. Not so fast, said the defendants. And with
We have written a number of posts about pelvic mesh cases over the years. Some of us have also worked on a number of cases. At this point, many cases have gone from MDL to local district court to judgment to appeal. Over time, the tide seems to have turned. That could be because the
An explanted medical device is an interesting thing. It was designed and made to reside within the human body, and it was implanted for the purpose of saving or improving life, even if only cosmetically. Sometimes it has to be removed, often by design and under the applicable standards of care. Take for example retrievable
We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.
The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” 21 C.F.R. §801.109(c). That requirement comes
We had occasion recently to reread Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims:
[The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light
Here are some things you probably will not hear very often, if at all: 1) a fervent supporter of a defeated political candidate agreeing that the winning elected official has done a good job, regardless of economic growth, infrastructure projects, public health progress, or some other measure of good government; 2) a fervent supporter of