If you have been following along for a while, then you have surely run across our posts making some combination of the following points:  1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture).  One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted.   That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.

The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted.  The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged.  Several months later, the drug’s label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection.  Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis.  When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds.  We will address only some of them.

Part of our point here is that the order can matter.  We do not have the briefs, so all we can go off of here is the opinion.  After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this:  “The defendants argue that Young’s claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.” Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:

If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.

Id. at *8.  This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary.  Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.

Continue Reading Another Court Tackles Prescription Drug Design Defect

This post comes from the Cozen O’Connor side of the blog.

We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial of particularly curious and prejudicial evidence being presented to the jury. Given that evidence, we expected a plaintiffs’ victory, an expectation that was borne out with a whopping $498 million verdict. It raised an immediate question: “What will the Fifth Circuit do?”

Well, we’re on our way to finding out. The defense recently filed their opening appellate brief. While it features the controversial evidentiary rulings, much more is in play. If you would like to take a look for yourself, here is the brief.  Below are some of the key issues, along with a quick description of the defense’s arguments:

Design Defect Claim against DePuy (Brief at 20-29): Claim that all metal-on-metal hip implants are defective is not viable under Texas law because a wholly different product cannot serve as a safer design; design claim is preempted because the FDA approved metal-on-metal hip implants; and design claim fails under Restatement (Second) of Torts 402A comment k (adopted in Texas), which recognizes that products like implantable devices are unavoidably unsafe and therefore not defective if properly made and warned about.

Continue Reading Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL

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

As the calendar turns from August to September, it is time once again to concede the strength of the Southeastern Conference.  You probably think we are referring to college football or basketball, in which teams from Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, Missouri, South Carolina, Tennessee, and Texas prevail with grinding monotony.  [We have a feeling that OJ’s old college squad, USC, will have an ugly time of it against Alabama in the ostensibly neutral site of Jerry World this weekend.]  But, no, we are talking about product liability law.  [For the moment, we are pretending that the Weeks innovator liability abomination in Alabama never happened.  Moreover, the Alabama legislature eventually cleaned up that mess.]  Today we are focusing on the safer alternative requirement in design defect cases.  It occurs to us that some very good cases on this issue come out of the SEC.  In the beginning of the year, we discussed a Mississippi case, Mealer v. 3M, where the court dismissed a case on the ground that an elastomeric respirator was not a safer alternative to a cheap paper respirator mask.  They were two entirely different products, fundamentally different in terms of operation, longevity, and expense.   Consumers might have all sorts of important reasons, aside from safety, to choose one over the other.

[Readers who are especially nerdy or possess especially good memories might point out that in July we bemoaned a Louisiana opinion permitting a plaintiff to suggest that other drugs could constitute a safer alternative to the drug at issue.  To our mind, different drugs, which consist of different molecules with entirely different risk-benefit profiles, are separate products and cannot be treated as a safer alternative that can shame other drugs out of existence.  Under the plaintiff’s (and, unfortunately, the Louisiana court’s) theory, jury verdicts might drive all drugs that treat, say, diabetes, out of the market except one.  And even that one would not be safe from attack.  Or, to veer away from drugs and devices, we might as well shut down Harley-Davidson, since motorcycles are less safe than other modes of motorized transportation.   Live to ride, ride to live?  Not anymore.  But don’t worry too much.  You can still sing “Born to be Wild” on your Hydra Glide.  The recent Louisiana error stands as an aberration.  As Bexis pointed out in a magnum opus blogpost that strolled down bone screw memory lane back in 2013, Louisiana has quite a lot of good safer alternative decisions.]

Today’s case, Hosford v. BRK Brands, Inc., 2016 Ala. LEXIS 91 (Ala. August 19, 2016), sees the Alabama Supreme Court apply an even stricter test in pouring out a plaintiffs’ case on the ground that the proposed safer alternative was a separate product altogether.  The facts of Hosford are grim.  A four-year-old girl died in a fire that destroyed her family’s mobile home in May 2011.  The fire began in a faulty electrical outlet in the girl’s bedroom.  Her family sued the manufacturer of the smoke alarms in their mobile home.  The theory was that the smoke alarms were defectively designed because they relied solely on ionization technology which, the plaintiffs alleged, failed to give adequate warning to allow an escape in the event of a slow smoldering fire.  There are dual sensor smoke alarms on the market that employ both ionization and photoelectric technology.  According to the plaintiffs, such alarms would have roused the family in time to save the little girl.  After the plaintiffs presented their case at trial, the defendant moved for judgment as a matter of law.  The trial court mostly granted that motion, and only one claim went to the jury.  The jury ultimately returned a verdict in favor of the defendant.

Continue Reading Alabama Supreme Court Imposes Tough Standard on Safer Alternative Design