This blogger took last week off. Not just from blogging, but from the confines of home and office – which are still one and the same. During those five days of much needed sun and sea, we had a friend stay at the house to watch the dog. Our dog/house sitter cleared out before we
This time out of Massachusetts. And in an opinion authored by a female judge. This isn’t something we would normally take the time to point out, but as we embark on the 39th Women’s History Month, the combination of Massachusetts and a female judge stood out to us. After all, Massachusetts was home to
Make no mistake about it – the result of Dunn v. Genzyme Corp., 2021 Mass LEXIS 84 (Mass. SJC Jan. 29, 2021) – is what we want. Dismissal of all of plaintiff’s claims for failure to plead them with the necessary factual support. But sometimes results need context and sometimes that context is not
The Pelvic Mesh MDLs are now all but over, with all but a few stragglers either settled or remanded. But the specious logic used in that litigation to overturn decades of precedent that had recognized compliance with FDA regulatory actions as relevant and admissible evidence, is still afoot to haunt medical device manufacturers. As we’ve
We are rounding the final curve of the Fall academic calendar, so now come the sessions in the litigation class we teach at Penn Law when we discuss story-telling. It is not as if we have anything novel to say. The best (most attention-getting, understandable, memorable, and persuasive) stories are ones we have already heard
The last baseball player to reach a .400 batting average for a season was Ted Williams in 1941. In a sport that probably keeps more stats than any other, baseball sees records broken and milestones reached all the time. Some marks, however, appear to be set in stone. One of these is Ted Williams’s 1941
We are going to take today’s decision a little out of order because we think the outcome is fairly easily surmised from our title – plaintiff couldn’t sustain his claim because he didn’t have admissible expert testimony. But before we get to the substance of the opinion, at the end the court was called on
Stephen Hawking may have been the smartest guy in the world, even though he believed that “People who boast about their I.Q. are losers.” Hawking is best known for his work on black holes. As used in physics, a black hole describes a point-sized mass (called a “singularity”) so dense that its escape velocity exceeds
We’ve often thought that tort reform should be a major goal of those interested in preserving women’s reproductive choice. Every prescription medicine has risks, which is why the FDA requires a prescription in the first place, and prescription contraceptives are no exception. But ever since the very first birth control pills, back in the 1960s, the other side of the “v.” has consistently attacked every innovation in contraceptive technology and attempted to drive it off the market. It’s happened over and over again – with IUDs, Norplant, OrthoEvra, Yasmin, NuvaRing, Mirena, Essure. Except for the Dalkon Shield IUD forty years ago (and occasional idiosyncratic manufacturing errors), all these products were (or are being) ultimately vindicated, and the FDA continues to consider their designs to be both safe and effective. Unfortunately their users have had to pay a significant tort tax in order to continue exercising their personal choice of contraceptive method.
Niedner v. Ortho-McNeil Pharmaceutical, Inc., ___ N.E.3d ___, 2016 WL 5106479 (Mass. App. Sept. 21, 2016), is both an example of the plaintiff’s bar’s ongoing attempt to deprive women of reproductive choice and an exemplar of how to beat such efforts. Niedner involved a time-release contraceptive patch:
The patch prevents pregnancy by transferring synthetic forms of the hormones estrogen and progestin through the skin. Unlike oral birth control pills, which must be taken at the same time each day, the patch is applied to the skin once per week for three weeks, followed by a fourth patch-free week.
Id. at *1. The decedent decided to use this product in preference to both condoms and daily birth control pills. Id.
Risks.
It is a well-known scientific fact that any hormonal contraceptive places its user at an increased risk of stroke, myocardial infarction, and blood clots generally. This product was no exception:
[The prescribing physician] informed [the decedent minor and her mother] of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of suffering blood clots. When the prescription was filled by [the] pharmacy, the package included an insert prepared by . . . the manufacturer[], as well as a leaflet from the pharmacy, both of which set forth the risks associated with use of the patch, including the risks of stroke, heart attack, and blood clots.
Id. Unfortunately, after three months use the decedent suffered a fatal “massive bilateral pulmonary embolus.” Id.
Continue Reading Massachusetts Rebuffs Latest Plaintiff Attack on Reproductive Choice
This post is from the non-Reed Smith side of the blog.
It’s been a bit of a slow news week in the drug and device litigation world. We are coming off a short work week and like the rest of us, judges may be looking to enjoy a few extra hours outdoors during these late spring days. We don’t blame them. While we prefer bringing you hot of the presses news or interesting new takes on old standards, sometimes all we have to report is that good law continues to be good law.
That’s today’s case – another blow to innovator liability. As you’ll see from our innovator liability scorecard, Rafferty v. Merck & Co., 2016 Mass. Super. Lexis 48 (Mass. Super. May 23, 2016) isn’t the first time a Massachusetts court has rejected this concept. But now that it has done so twice, we hope Massachusetts can be added to the list of states where innovator liability is now dead (we won’t say “and buried” since there is no state supreme court ruling yet). The case contains a thoughtful analysis of the issue and is certainly worthy of including if you are briefing this topic.
Plaintiff ingested finasteride, the generic version of Merck’s Proscar. After experiencing complications, plaintiff brought suit against his prescribing physician and Merck. Id. at 1. Plaintiff alleges that even though he didn’t ingest Merck’s product, as the brand manufacturer, Merck “had a duty to maintain the accuracy of the labels for those individuals who would rely on those labels,” including individuals who would ingest generic product. Id. at *8.
The court starts its analysis with the framework for how a generic drug gets FDA approval and following approval how the labeling requirements for brand and generic manufacturers differ. Id. at *3-6. This regulatory framework serves as the cornerstone for the Supreme Court’s Mensing and Bartlett decisions which largely insulate generic drug manufacturers from product liability lawsuits. The Rafferty court, like most others to have considered the issue, recognized the “unfortunate” result of barring generic users from recovery but also like most other courts, it was unwilling to bend or expand existing law to extend product liability to a company that did not manufacture the product at issue.Continue Reading Another Rejection of Innovator Liability