The Louisiana Product Liability Act (“LPLA”) was enacted way back in 1988 – almost 30 years ago – to rein in the Louisiana courts’ product liability insanity (inanity?) epitomized by Halphen v. Johns-Manville Sales Corp., 484 So.2d 110 (La. 1986), which had allowed strict liability without defect under something called “unreasonably dangerous per se.”
Back in 2013, we published a comprehensive post on the checkered Daubert history of the notorious and prolific (in equal amounts) plaintiff-side “FDA expert” (although she routinely attempts to opine way beyond FDA matters) – “Dr.” Suzanne Parisian. We use quotation marks, because although Parisian is technically an MD, she hasn’t seen a single patient
Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe. In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs. When he proposed a song for The Life of Brian, he ran into resistance. The song seemed insufficiently catchy. That song was “Always Look on the
This post is from the non-Reed Smith side of the blog, only.
Last week the Third Circuit overturned the dismissal of thousands of cases in In re: Fosamax Products Liability Litigation, — F.3d –, 2017 WL 1075047 (3rd Cir. Mar. 22, 2017), finding that the trial court had improperly granted summary judgement on
A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant’s product was not defective, the MDL judge told the jurors that perhaps they did not “fully understand” and instructed them to try again. So the jury went back into the jury room, and having been duly
Doctors warn patients and decide which warnings to give. Manufacturers warn doctors and, if a particular doctor already knows a particular risk, it doesn’t even matter—in a court room, that is—whether the manufacturer warned the doctor. That is the interplay between the learned intermediary doctrine and the proximate causation element of a failure to warn
As we’ve mentioned before, we watch state-law litigation over genetically-modified organisms (“GMOs”) because they tend to produce interesting results on federalism issues such as preemption, since anti-GMO zealots often try to interpose state law to gum up the works of federal regulatory decisions that they don’t like. Those results are applicable by analogy (at
Most of the cases we defend involve claims of inadequate warnings. What makes a warning inadequate? Falsehood is the first thing that comes to mind. But the Pontius Pilate question of “What is truth?” continues to vex. We have seen very few drug or device labels uttering an affirmative misrepresentation. More often the complaint is about what the warning did not say, not what it did say. If John Lennon sang “Gimme Some Truth,” plaintiff lawyers sing (off-key) “gimme some more truth.” To our ears, it sounds like “gimme some more money.” Whatever. Plaintiffs allege that the product label did not disclose all of the serious side effects, or did not recite them with sufficient detail and drama. There is a hierarchy of warning inadequacy. A warning can ‘fail’ for any of various reasons. You pays your money and you takes your choice. Did the warning:
The last test is a slam dunk. If the consumer heeded the warning, we wouldn’t be enjoying each other’s company in the courtroom. There would be no complaint. Probably.
The first warnings we remember seeing were on cigarette packs. The United States was the first country to require such warnings. Back in 1966, the sides of cigarette packs were adorned with the following: “Caution: Cigarette smoking may be hazardous to your health.” That warning did not include the word “warning.” Change came a couple of years later. In 1970, packs reminded us that the Surgeon General had determined that cigarettes were “dangerous.” Still later, smokers were treated to rotating warnings. Some packs warned of cancer, emphysema, heart disease, and pregnancy complications. Some stated that cigarette smoke contains carbon monoxide. Some suggested that quitting now could improve one’s health. And some warned pregnant smokers of possible fetal injury, premature birth, and low birth weight. We heard that one fellow filed a lawsuit alleging that cigarettes had caused his lung cancer, while also claiming he had not been adequately warned, because he had made a point of buying only the packs that talked about pregnancy complications. That case proved at least two things: (a) no matter what, some people will smoke, and (b) no matter what, some people will file silly lawsuits.Continue Reading Warning: Lawyers May Be Hazardous To Your Health
“The facts and data considered by the witness . . . .” That is what expert witnesses must disclose to the other side after forming their opinions, although the rule was not always this way. Before 2010, you had to disclose “the data or other information” considered by an expert. But for many that was too broad, potentially encompassing attorney thoughts or impressions. So the committee changed the rule, and we now have the “facts and data” standard. As the committee explained, “The refocus on ‘facts or data’ is meant to limit disclosure to material of a factual nature by excluding theories or mental impressions of counsel.” Rule 26(a)(2)(B)(ii) advisory committee note to 2010 amendment. We wrote on the 2010 changes to Rule 26 here.
Your work product is therefore somewhat safer from disclosure than it once was, but if an expert considered “facts and data,” those facts and data must be disclosed. That is the lesson of In re Benicar (Olmesartan) Products Liability Litigation, No. 15-2606, 2017 WL 970263 (D.N.J. Mar. 13, 2017), where an MDL judge ordered the plaintiffs to produce medical records upon which their experts had relied.
The records at issue appear to have involved patients other than the plaintiffs, which we guess is why the production of medical records was the least bit controversial. As it turned out, those other patients’ records became discoverable when two experts considered them in forming their opinions. One, for example, reviewed the charts of certain patients and relied on them in reaching his ultimate conclusions. Id. at *3. The other similarly confirmed that his review of a number of patient charts “contributed to his thinking.” Id.Continue Reading All Things “Considered”: Plaintiffs’ Experts Ordered To Produce Patient Records
We recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.” This article consists largely of the interviews with two avatars of the other side of the “v.”: fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues. Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.
Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do). Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.
The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.” We don’t think that’s grounds for “more liability.” First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense. The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question. There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design. So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion. Most branded drug warnings don’t have a preemption defense now.
Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label. The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use. 21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA). That’s important because, as we discussed in more detail here, only the FDA can do this. Drug companies are not allowed to discuss off-label uses in their labels whenever they want. Without the FDA telling them to, that is a form of misbranding.Continue Reading What If We Win? Off-Label Promotion & Product Liability