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.
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.
A couple of days ago, we watched the lovely “St. Vincent.” The film stars a spot-on Bill Murray as Vincent, an unemployed curmudgeon living alone in an otherwise tidy residential neighborhood. Disrepair has turned Vincent’s house into an eyesore.
Vincent is eluding his threatening bookie, who is seeking repayment for money Vincent has lost on the horses. Vincent is unkempt and rude, and we are led to believe that his only “soft spot” is reserved for his white Persian cat.
Enter a subdued and quietly effective Melissa McCarthy (compare “Bridesmaids”), as a newly-single mother moving next-door to Vincent with her (flat-out adorable) young son in tow. We’ve recently been the victims of spoilers ourselves (see McDreamy), so we won’t reveal more except to note that Vincent is not quite the unredeemed ne’er-do-well he seems to be. The movie reminds us to reserve judgment and not to allow initial impressions to obscure nuance. Sometimes, there is good buried among the bad.
Last week, the District of Massachusetts issued its decision on Round 3 of the battle between Zogenix, Inc. and the Commonwealth of Massachusetts over Zohydro ER, an extended release hydrocodone drug product that was approved by the FDA in 2013. See Zogenix, Inc. v. Baker, 2015 U.S. Dist. LEXIS (D. Mass. Mar. 17, 2015). This is a year-long battle in which Massachusetts has tried to regulate the use of Zohydro, first banning it entirely and later implementing a series of regulations intended to restrict its use.
First, a history of the earlier rounds: In Round 1, the Massachusetts governor declared opioid abuse and overdosing to be a public health emergency and authorized the department of health to issue an emergency order that banned prescribing, ordering, dispensing or administering Zohydro (it didn’t mention Zohydro specifically, but described a category of drugs that included only Zohydro). Zogenix moved for a preliminary injunction and won. The FDA had already approved Zohydro for marketing. And so Massachusetts’s ban failed, as we put it, the “you can’t do that” test. The emergence order was preempted.
In Round 2, with the department of health licking its wounds, various Massachusetts boards of registration stepped into the battle. Two boards, the Board of Registration in Medicine and the Board of Registration of Physicians Assistants, promulgated emergency regulations that required prescribers, before they could prescribe Zohydro, to provide a Letter of Necessity stating that all other pain management treatments had “failed.” Also, Massachusetts’s Board of Registration of Pharmacy created certain “handling” requirements, including prohibiting anyone at a pharmacy who wasn’t the actual pharmacist from handling Zohydro. Zogenix once again sought injunctive relief, arguing that these regulations were preempted. It won a partial victory. The court agreed to enjoin the regulation requiring the Letter of Necessity from prescribers. Its requirement that other pain-management options have “failed” differed from the treatment indication for which the FDA had already approved Zohydro. And so it was preempted. The pharmacy regulations restricting the handling of Zohydro stood. The court did suggest, however, that Zogenix’s challenge to those regulations could be successful if Zogenix were later able to develop facts proving that the regulations would alter pharmacies’ willingness to carry Zohydro. We blogged about Round 2 here.
We again post the day after a holiday, when stores are flooded with shoppers—this time exchanging gifts purchased last time. We discuss a case involving discussions of “consumer value” and “fair market value.” So, you might think we would go back to that shopping well. No. We have decided to zag. To us, the opinion on class certifications in Saavedra v. Eli Lilly & Co., No. 2:12-cv-9366-SVW (MANx) (C.D. Cal. Dec. 18, 2014), slip op., evokes another seasonal activity, playoff football. Depending on how you count the requirements, plaintiffs in a purported class action need to clear three or four hurdles to get the certification they want. Class certification tends to be a vehicle to settlement, which is what the lawyers who drive class action litigation really want, particularly in the consumer protection context. Tripping over one of the hurdles typically means the journey was a waste. In the NFL, four of the twelve playoff teams each need to win three straight games to hoist the Lombardi Trophy; the other eight each need to win four straight. Teams that lose in the Conference Championship or Super Bowl tend to view the season as a failure, not a success. The teams and players do profit from incomplete playoff runs, but we are not shaken from our view of the parallel here.
In the top division of college football, there is now a playoff of four teams. The winner will have to win two straight games. This would be on top of the conference championship game and “rivalry week” game that each had to win over the preceding weeks. (Again, three or four hurdles, depending on how you view it.) We can assume that the three teams that lose in the playoffs will not be “happy to have been here.” The four universities will have profited quite a bit from the playoffs—and the players not all (which is a different discussion entirely)—but only one will have succeeded once it is done. Still, once the playoffs start, the champion will be measured objectively: which team won two playoff games? In the past, before there was a playoff, the crowning of a champion or champions of this division of college football was a matter of subjectivity: based on the individual view of the voters of the various groups that might anoint a champion, which team had the best season? That subjectivity irked fans. Even with mounds of statistics to measure performance, the lack of the definitive measurable—the results of playoff games—was unsatisfying. (Yes, we know that the four playoff teams are selected with a large measure of subjectivity, but work with us.)
In consumer protection class actions premised on an alleged misrepresentation about a prescription drug, the plaintiffs should have to allege an objective harm and an objective way to measure it. When they cannot, they should not have a class (or probably even individual claims of the purported class representatives). Saavedra comes out of litigation over the risks of withdrawal from a prescription antidepressant. We have posted previously on summary judgment on warnings claims in personal injury cases with the same product and risk. Here and here.
Just how far can a state go in regulating prescription drugs? The simple answer is that states can go nowhere and that FDA is king in this field under the FDCA and the Supremacy Clause. But we all know that it is not that simple. We are reminded every day when we come to work that states regulate prescription drugs by allowing state-law tort lawsuits, although federal preemption is a mighty shield where it applies. We are also aware that states regulate the practice of medicine, as well as regulating the pharmacies that dispense prescription drugs on doctors’ orders.
Our first reaction to Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014), wasn’t related to the fact that it involved a federal court recognizing a cause of action previously unrecognized by Massachusetts state courts. Our first reaction was that the case shouldn’t be complicated. The plaintiff participated in a clinical trial involving a bilateral gene transfer, which is a new procedure intended to treat Young-Onset Parkinson’s Disease. Id. at *3. As the “bilateral” in its name implies, a bilateral gene transfer consists of two injections of genes into the brain, one into the right side and one into the left. Id. at *3-4. But (plaintiff alleged) the surgeon gave both injections to the left side. Id. at *4.
It seems fairly easy to identify the problem here. If an engineer designs a twin-engine plane, and the mechanics put both engines on the left side, you’ve got a good idea who made the mistake. If the Doublemint gum company told its casting director to hire blond twins for its commercial, and the casting director hired some guy named Roy, you can be pretty sure who made that mistake too. So whom did the Zeman plaintiffs sue over the improper procedure? The manufacturer and the Institutional Review Board (“IRB”), of course.
On the Drug and Device Law Son’s 13th birthday, back in 2008, we reflected on the contrast between his experience as a Philly sports fan versus that of a 13 year old in Boston. Our son had no idea what a sports championship looked like. Philly had not hoisted a banner since Moses Malone led the Sixers to the “Fo Five Fo” payoff run in 1983. But a 13 year old New Englander probably had come to assume championships as a birthright. The Celtics had a parade that Spring, the Patriots had won three Super Bowls (one against the Eagles), and even the Sawcks, who had dashed the hopes of the region for four score and six years, had managed to break the curse of the Babe and win the World Series in 2004 and 2007. (In the 1915 World Series, the Red Sox demolished … Philadelphia.) The Bruins had not won a championship in that 13 year period, but they would soon.
The Boston-Philly rivalry is an old one, and more one-sided than makes sense. Even a Penn professor, Digby Baltzell, acknowledged that Boston seemed to overachieve while Philly persistently underachieved. He thought that the historical Puritanism of Boston pointed the way toward public proofs of accomplishment and virtue, while the Quaker roots of Philly prompted people to tend to their own gardens and steer clear of the public sphere. The theory explained why Bostonians were braggarts and Philadelphians tended toward self-disparagement. The Puritans hanged the Quakers, and both were happy. Of course, it is hard to imagine how these old religious differences could say much about current mores. We know some Quakers here, but not that many. In our four years in the Boston-area, we never encountered a Puritan. Still, there are some odd points supporting Baltzell. Boston leaders are usually home-grown, but Philly has often chased away local high-achievers (Harvard’s main library came from a Philly-area fortune) and has frequently brought in outsiders to run things. The most consequential Philly mayor in recent times hails from NYC. We’re not sure how this fact fits in with Baltzell’s theory, but Ben Franklin fled Beantown and ended up doing fairly well in Philly.
We have no problem liking both cities a lot. Both have great history, great schools, great museums, and great bars. For many key criteria, Philly comes out ahead. Philly’s citizens get abused for their supposed hostility (throwing snowballs at Santa Claus, blah-blah-blah), but have you ever tried sharing a street with Boston drivers? Philly is much better for bike riders. Philly’s weather is okay; Boston’s is horrible.
We start June with a fabulous two-fer: yes, that is two cases discussed in the same post. But wait, there’s more. The two cases each discuss civil RICO claims against drug companies and state law claims. For an unknown, but surely exorbitant, cost to the defendants, the courts, and maybe even the third party payors