This blog has discussed Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), and its progeny on multiple occasions. We provided a quick take when Albrecht was issued; discussed the decision’s possible ramifications here and here; expressed consternation at certain parts of the decision; reported here and here on how
Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent: Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998). This article came to be cited twice by the United States…
We recently came across the law review article, E. Lindenfeld, “Clear Evidence Clarified,” 75 Food & Drug L.J. 346 (2020). Since it cited and critiqued a number of our blogposts, we thought it was appropriate to reply.
Our initial impression is that the Lindenfeld article is comparatively reasonable – that is, compared to some prior…
For the better part of a decade, Bexis has participated in the Food & Drug Law Institute’s (“FDLI”) annual Top Food and Drug Cases project. For 2019, he wrote about (surprise!) Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019). These haven’t been discussed previously on the Blog because, due…
How many of us entered law school dreaming of following the paths of Brandeis, Marshall, etc. in the field of constitutional law? How many of us now can go weeks, or even months, without reading a Supreme Court case? Paying off student loans led many of us to work for law firms where there was…
That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof. Twerski’s Wikipedia page is the fifth result when we just Googled that phrase). Prof. Twerski, one of the ALI’s reporters for the Restatement (Third) of Torts: Products Liability, has…
We recently read an interesting new empirical study that confirms what we’ve long suspected − that so-called “no-injury” class actions, those that allege that a product was “worth less” than it should have been due to some inchoate, unmanifested defect, are a litigation boondoggle, benefiting nobody but the lawyers who bring them.
The study is Joanna M. Shepherd, “An Empirical Survey of No-Injury Class Actions,” available through the Social Science Research Network, here. Ms. Shepherd, a professor at the Emory University School of Law, started with all class action settlements between 2005 and 2015 that could be located on Lexis or Westlaw – 2158 cases. She applied four criteria for identifying “no-injury” classes:
- the plaintiffs suffered no actual or imminent concrete harm giving rise to an injury in fact;
- the only harm alleged was a technical statutory violation (primarily of the Fair Debt Collection Practices Act, the Telephone Consumer Protection Act, the Fair Credit Reporting Act, and the Electronic Funds Transfer Act);
- if any out-of-pocket economic loss was negligible or infinitesimal; or
- the recovery sought was unrelated to compensating plaintiffs for economic or other harm.
Shepherd Empirical Study at 1. After applying those criteria, Professor Shepherd included only cases about which information existed on both attorneys’ fees and settlement funds. Id. This culling produced 432 class actions that could be studied.
When we examined Restatement (Second) of Torts §402A, comment k (1965), in our 2011 research post “Comment K, Some of the Way,” we remarked about how it said “a lot of things,” including: (1) that one can’t design away unavoidable risks, (2) that unavoidably unsafe products aren’t considered “unreasonably dangerous” for purposes of strict liability, and (3) that such products are “especially common” in the prescription medical product area. The first proposition suggests that design defect liability is incompatible with unavoidably unsafe product characteristics. The second indicates that unavoidably unsafe products shouldn’t be subject to strict liability. The third raises the issue of whether all prescription medical products should be considered unavoidably unsafe products – since their inherent risks are why they require a prescription in the first place.
We pointed out that some states, like California and Utah, prohibit design defect liability altogether, following that aspect of comment k. Others, like Pennsylvania, reject strict liability in the context of prescription medical products. Often, as is the case in Massachusetts, the status of negligent design liability is uncertain.
However, the most striking divide has always been between those states following a case-by case approach to determining whether a given product was “unreasonably dangerous” and those states that followed an “across-the-board” approach to comment k in the prescription medical product area. After adding everything up, we had to conclude in our blogpost that, despite its inherent inefficiency and tendency to second-guess the FDA, the case-by-case approach to comment k remained the majority rule.
We have been riding the Philly subway for years, but only recently realized how much the ads on the car walls have changed. Not so long ago there were lots of ads for vocational schools, inducing today’s un- or underemployed to become tomorrow’s truck drivers and beauticians. But nowadays at least three quarters of the ads are from plaintiff lawyers hawking their ability to wring cash out of slip-and-falls or the latest mass tort. Mass transit advertising space that formerly advised riders to get skills is now dedicated to pleas to get paid. The same is true for daytime television advertising. Perhaps we are not alone in seeing this evolution as further proof, along with Keeping up with the Kardashians and the ascendancy of kale salad, that our culture is headed to Hell in a handbasket.
You won’t be surprised to hear defendants and their lawyers bemoan plaintiff lawyer advertising. But we are not alone. Recently, we heard a MDL judge express frustration about how plaintiff lawyer advertising was a blatant attempt to extend the tail of an over-mature mass tort. Some plaintiff lawyer advertising is naked poaching of other plaintiff lawyer inventories – e.g., why pay a 40% contingency fee if you can pay only 20%? But the most obvious aim and effect of such advertising is stirring up litigation. What might not be so obvious is the extent to which plaintiff lawyer adverting causes adverse health outcomes. A recent law review article looks into this issue and it is well worth reading. The article is by Elizabeth Tippett, a professor at the University of Oregon School of Law. The title is “Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits,” 41 Am. J. L. & Med. 7 (2015).
We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes for scientific journals – and what can be done about it. Dr. Frank has just written a law review article about this problem. F. Woodside & M. Gray, “Researchers’ Privilege: Full Disclosure,” 32 Cooley L.R 1 (2015), which is available online here. Here’s the abstract:
An ever-growing chorus of academicians report that with the expanding number of academic journals there is a concomitant increase in the number of articles based on questionable methodology. Many published studies contain improper statistical conclusions, flawed methodology, and results that cannot be replicated. The recent controversy concerning the failure of parents to vaccinate their children because of the recommendations of flawed research exemplifies this crisis. This epidemic of faulty research has been exacerbated recently by the spread of low-quality academic journals and “pay-to-publish” journals, which will publish virtually anything for a fee. This Article provides an analysis of a growing crisis of reliability in scientific research and how the so-called “researchers’ privilege” allows faulty research to go undetected. This Article delineates the reasons why it is difficult, if not impossible, to evaluate published research findings without access to the underlying information that researchers have in their possession. The Article then analyzes the state of the law regarding the ability of researchers to withhold records and data based on the so-called “researchers’ privilege.” Finally, the Article explains why courts should favor the disclosure of research data and that confidentiality concerns should be addressed by a confidentiality order.
Id. at 1-2. Here are the articles subheadings, which describe the material in it in more detail:
- Misunderstanding and Misuse of Statistics and Research Methods
- An Ever-Growing Number of Journals and “Pay to Play”
- Fraud and Questionable Research Practices
- Pre- and Post-Publication Peer Review Does Not Work