We’re serious – we’re not planning to give a flip answer like “an extortion racket.”  No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?”  (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)).  The question of “what is product liability” is of interest to us primarily, but not exclusively, because of 21 U.S.C. §379r(e), which creates an exception for “product liability law” to what is otherwise a rather broad preemption provision governing over-the-counter (also called “monograph”) drugs.

We wrote a post in the early days of the blog – 2008 – about that particular provision, entitled “Preemption Without a Prescription,” where we discussed cases that, up to that time, had addressed the scope of §379r(e)’s saving clause.  That boundary of that clause, as we explained it then, was that “suits for purely economic loss – primarily, but not exclusively, brought under state consumer protection statutes – are not ‘product liability’ actions.”

That’s still true.

We’re not repeating the 2008 post, but we will update it.  Here is a list of cases not discussed in that post, which likewise hold that preemption defeats OTC drug litigation that does not involve personal injury claims:  Wiltz v. Chattem, Inc., 2015 WL 3862368, at *1-2 (C.D. Cal. May 8, 2015); Bowling v. Johnson & Johnson, 65 F. Supp.3d 371, 376-77 (S.D.N.Y. 2014); Gisvold v. Merck & Co., 62 F. Supp.3d 1198, 1202-03 (S.D. Cal. 2014); Crozier v. Johnson & Johnson Consumer Cos., 901 F. Supp.2d 494, 503-05 (D.N.J. 2012) (discussing scope of §379r(e)); Delarosa v. Boiron, Inc., 818 F. Supp.2d 1177, 1188 n.7 (C.D. Cal. 2011) (discussing scope of §379r(e)); Eckler v. Neutrogena Corp., 189 Cal. Rptr.3d 339, 357-61 (Cal. App. 2015) (discussing scope of §379r(e)).

Thanks to this recent blogpost, however, we’ve become aware of another way that the definition of “product liability” is important.  Down in Texas, they have a unique indemnification statute, Tex. Civ. Prac. & Rem. C. §82.002(a) that provides:

A manufacturer shall indemnify and hold harmless a seller against loss arising out of a products liability action, except for any loss caused by the seller’s negligence, intentional misconduct, or other act or omission. . . .

We’d vaguely heard of this statute before, in connection with a case, Hadley v. Wyeth Laboratories, Inc., 287 S.W.3d 847, 849 (Tex. App. 2009), which we liked because it held that prescribing physicians weren’t “sellers” of the drugs they prescribed, which means they can’t be sued for strict liability.

But §82.002(a) also means that, in Texas, the ability of an intermediate seller to recover indemnity (including counsel fees) requires that the underlying action to be one for “products liability.”  That’s where the blogpost comes in.  It discussed a recent case, vRide, Inc. v. Ford Motor Co., 2017 WL 462348 (Tex. App. Feb. 2, 2017), that also addressed the definition of “product liability.” vRide involved an indemnity claim brought by a lessor of a motor vehicle from the defendant, which manufactured the vehicle.  The underlying claim had not been for strict liability, but rather for misrepresentation – that the vehicle did not have the attributes that the original defendant (the lessor) claimed that it did.

The court in vRide held that a misrepresentation claim did not fall within the meaning of “product liability”:

The [plaintiffs’ complaint] did not allege that the [product] was unreasonably dangerous, was defective by manufacture or design, was rendered defective because it lacked certain safety features, or was otherwise defective. Instead, the petition alleged that [defendant] represented [that the product] had certain safety features when in actuality [they] did not have those safety features. . . .  In short, the [complaint] did not contain allegations that the damages arose out of personal injury, death, or property damage allegedly caused by a defective product.

2017 WL 462348, at *7. We can imagine situations in which this definition could come in useful in litigation involving OTC preemption, since it excludes from “product liability” even some actions involving (as did vRide) personal injury.

The most significant hypothetical involves a situation where the plaintiff’s injuries were caused by a generic OTC drug. In that situation, given the broad scope of preemption available in generic drug cases, one could expect plaintiffs to attempt to assert innovator liability against the branded drug manufacturer.  But innovator liability is based (like vRide) on the (we believe phony) proposition that “misrepresentation” is not “product liability” and thus can extend to non-manufacturers.  But if misrepresentation is not “product liability,” then the savings clause in §379r(e) would not apply, and innovator liability claims would be expressly preempted whether or not they involved personal injury. vRide would thus be precedent in favor of preemption.

That would be a good thing.  And so is cross-fertilization – where a definition in a completely unrelated statute can be utilized in support of preemption.

This is from the non-Reed Smith side of the blog.

Looking back at our posts on innovator liability, it’s becoming more and more difficult to title them. According to the DDL blog, innovator liability has been rejected, abolished, denied, refused, disallowed. You get the idea. With the news from earlier this summer that the California Supreme Court is going to consider the issue – which will hopefully spell the demise of Conte – we may be nearing the end of the chapter on innovator liability. In the meantime, we’ll keep bringing you the wins as they stack up.

Today’s case was actually decided right around the time the California Supreme Court decided to take on the issue. Gillette v. Boehringer Ingelheim Pharm., Inc., 2016 WL 4217758 (Mag. D. Minn. Jun. 16, 2016). The decision didn’t come to our attention, however, until the magistrate’s report and recommendation was adopted last week. See 2016 WL 4203422 (D. Minn. Aug. 9, 2016).

The Gillette decision comes out of the Mirapex MDL and involves the application of Indiana law. Indiana products liability claims are governed by the Indiana Products Liability Act (“IPLA”) which provides a single cause of action subsuming all common law strict liability and negligence claims, as well as tort based warranty claims. Gillette, 2016 WL 4217758 at *3-4, *6. So, plaintiff in this case had one cause of action based on her allegations that her use of Mirapex caused her to gamble compulsively.

But was it Mirapex that plaintiff was taking at the time she suffered her injuries? According to her pharmacy records, plaintiff was prescribed Mirapex from 2001 until 2015. Id. at *1-2. It appears that from 2001 until April 2010, plaintiff’s pharmacy filled her prescriptions with brand name Mirapex. In April 2010, when her prescribing physician increased plaintiff’s dosage, her pharmacy began filling her Mirapex prescriptions with its generic equivalent – pramipexole dihydrochloride. Id. at *1. From April 2010 until late 2015, plaintiff received the generic version of the drug manufactured by a succession of four different generic drug manufacturers. Id. at *1-2.

Continue Reading Brand Defendants Thwart Another Innovator Liability Claim

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted, under certain circumstances, non-manufacturers to be sued for failure to warn of a risk that the product they manufactured didn’t have (exposure to asbestos), where they “encourage[ed]” the use of products containing that risk with their products and thereby benefitted economically:

[A] manufacturer’s duty to warn of combined use of its product with another product depends in part on whether the manufacturer’s product can function without the other product, as it would be unfair to allow a manufacturer to avoid the minimal cost of including a warning about the perils of the joint use of the products when the manufacturer knows that the combined use is both necessary and dangerous. And, the justification for a duty to warn becomes particularly strong if the manufacturer intends that customers engage in the hazardous combined use of the products at issue.

*          *          *          *

[W]here a manufacturer creates a product that cannot be used without another product as a result of the design of the product, the mechanics of the product or the absence of economically feasible alternative means of enabling the product to function as intended, the manufacturer has a substantial, albeit indirect, role in placing the third-party product in the stream of commerce. . . .  Specifically, when the manufacturer produces a product that requires another product to function, the manufacturer naturally opens up a profitable market for that essential component, thereby encouraging the other company to make that related product and place it in the stream of commerce.

NYCAL, 2016 WL 3495191, at *__ (for some reason there is no Westlaw star paging at the moment).  This opinion is very bad news for the affected companies, who are now sucked into the maw of interminable asbestos litigation on the basis of products they didn’t even make, but it should not open the door to innovator liability type claims against our medical product manufacturer clients, and it’s good on causation, too.

Here’s why.

Continue Reading New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense.  For more important stuff, we find qualifiers like “vague” and “fuzzy” being applied more often to our own characterization of what we think we recall.  (We can only imagine how different things will be should be advance to the current age of McConnell, Bexis, or Weil.)  Buried somewhere between esoteric and important would be the question of whether we have seen a certain issue before in cases that have been the subject of past posts.  With a caveat about our memory, supplemented by a less than exhaustive search of prior posts, we thought we could present a decision addressing an issue we have never talked about before—and we have talked about a boatload of issues through the years.  (No, “boatload” was not our first choice, but we try to keep it clean here.)

The silly Conte case popularized the idea that a company that developed and brought a drug to the market could be liable for injuries allegedly caused by a generic version of the drug sold by a competitor. Conte was itself a reaction to the realization, even before Mensing and Bartlett, that most traditional product liability theories against the makers of generic drugs would be preempted.  When plaintiffs have tried to sue both the manufacturers of the generic drug they took and the company that “innovated” the drug and a single decision rejected the claims against both sets of defendants, we have called that a one-two punch.  Because plaintiff lawyers are stubborn in their pursuit of ways to pin liability on defendants with money—or get far enough along in the case to take some of that money to go away—we have described a number of varieties of these one-two punch cases. Just skimming our scoresheets on these issues should give some idea of that variety.

While off-label promotion allegations feature prominently in a range of cases involving prescription drugs, we have not seen them much in innovator liability or generic drug cases.  That might be because NDA holders tend not to do much promotion at all on their drug once generic drugs have entered the market and ANDA holders tend not to promote their generic drugs much at all, especially when there are multiple generics available.  This is not a matter of on-label or off-label promotion as much as it is of economics.  So, when we saw that Perdue v. Wyeth Pharms., Inc., No. 4:15-CV-208-FL, slip op. (E.D.N.C. July 20, 2016), delivered a one-two punch in a case where both the branded manufacturer and three generic manufacturers were alleged to have promoted off-label, we thought we might have a chance to talk about something novel.  We were wrong.  We wrote about another case last year.   Twice.  Involving the same drug as in Perdue.  One post even talked about elephants, known not just for their girth but for their memories.  Oh, the irony.  But that will not stop us from talking about the good result in Perdue.

Continue Reading A One-Two Punch Case With An Off-Label Twist

We’ve always hated Conte v. Wyeth, 85 Cal. Rptr.3d 299 (Cal. App. 2008), and the whole concept of innovator liability (imposing liability on the original innovator drug manufacturer for injuries allegedly caused by a generic drug equivalent).  As amicus for PLAC, Bexis tried to strangle Conte in its cradle, as discussed here, but failed, as the California Supreme Court denied review.

Good news. Others have succeeded where Bexis failed.  The California Supreme Court has just granted an appeal in T.H. v. Novartis Pharmaceuticals Corp., 199 Cal. Rptr.3d 768 (Cal. App. 2016), an even more extreme Conte follow-up that imposed innovator liability in perpetuity − for injuries occurring even after an innovator manufacturer had sold all rights and left the relevant market altogether.  For full discussion of T.H., see our post here.  The order, entered yesterday, states:

The applications to appear as counsel pro hac vice are granted. The petition for review is granted.  The issue to be briefed and argued is limited to the following:  May the brand name manufacturer of a pharmaceutical drug that divested all ownership interest in the drug be held liable for injuries caused years later by another manufacturer’s generic version of that drug?

It appears online here.  Fingers crossed folks, but this is the necessary first step towards eliminating Conte.

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 scorecardRafferty 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

We have closely followed the development (or perhaps more accurately, stagnation) of so-called “innovator liability.” It started with the wrongly reasoned and wrongly decided opinion from the California Court of Appeal in Conte v. Wyeth, 168 Cal. App. 4th 89 (2008), where the court held that an innovator drug company could be liable for injuries allegedly caused by generic products it did not make and did not sell. We rolled our collective eyes at this unmooring of tort law, where lines of cases dating back to cars with wooden wheels placed responsibility with parties who made and sold the allegedly offending product.

In the eight years since Conte, courts throughout the country in more than 100 different cases have roundly rejected innovator liability, with only a few exceptions. You can view our innovator liability scorecard here, and you can click on the “Conte” link on the side of the page to see all of our commentary on the subject. There is a lot of it. Our 50-state survey of innovator liability is here, which is as good a place to start as any. The upshot is that innovator liability should become another Sindell v. Abbott Labs, which introduced market share liability in 1980, only to become nothing more than a curious historical footnote in product liability law.

We revisit the issue now because the California Court of Appeal has gone off the rails again. In T.H. v. Novartis Pharmaceuticals Corp., No. D067839, 2016 Cal. App. LEXIS 179 (Cal Ct. App. Mar. 9, 2016), the court held that a listed drug manufacturer can be liable for injuries alleged caused by a generic version of the drug terbutaline sulfate, even though the listed manufacturer divested itself of the product six years before the plaintiff even used it. At least in Conte the plaintiff alleged that Wyeth still held the NDA. Here, the listed manufacturer had been completely out of the terbutaline business for several years.

Continue Reading Another Outlier From California On Innovator Liability

A couple of years ago the onetwo punch was all the rage in prescription drug cases.  “One-two punch” has been our moniker for decisions where plaintiffs ingested only generic drugs, but tried to hedge their bets, given the threat of generic drug preemption, by also suing branded drug manufacturers on innovator liability theories alleging that innovators’ purportedly inadequate labeling could make them liable to people who never used their products.  The new one-two held the generic drug claims preempted while at the same time ruling that the state in question (see our 50-state compilation) did not recognize inadequate warning claims against companies that neither sold nor profited from the sale of the drug that purportedly injured the plaintiff.  A one-two punch decision required us to update both our generic preemption and our innovator liability scorecards.

More recently, these cases sort of tailed off.  We assumed this was due to a litigation version of chronic traumatic encephalopathy − the plaintiffs had grown weary (and financially wary) of losing, and had stopped suing these defendants on theories that had been so widely rejected in the courts.  Apparently, though, the plaintiff in Tsavaris v. Pfizer, Inc., ___ F. Supp.3d ___, 2016 WL 80221 (S.D. Fla. Jan. 7, 2016), didn’t get the memo.  The result is another excellent one-two punch decision.

Continue Reading The New One-Two Is Back

This past Sunday, we, as Drug and Device Law Jews, celebrated Rosh Hashanah, the Jewish New Year.  Normally, we host dinner for 20 or so members of our extended family.   This year, the entire day before the holiday was occupied by the uber-wedding of the Drug and Device Law Rich Cousin’s daughter.  Because we had no time to prepare for the holiday dinner, we opted, for the first time ever, to go out for the meal.  We, along with several dozen relatives, descended upon a local (Italian!) restaurant that was hosting hundreds for what was billed as a “traditional” Rosh Hashanah feast.  As the courses arrived, our table rang with youthful cries of “that doesn’t look like our gefilte fish/brisket/kugel” answered with a chorus of “it’s close enough.”  Such is the case with today’s decision.  It does not involve a drug or a medical device, but it is a products case with a strong holding that bolsters arguments we make in the prescription drug context.  So it is “close enough” to be relevant for readers of this blog.

Regular readers know that we have blogged many times about the issue of ‘innovator liability” – whether the innovator and manufacturer of a branded drug can be liable for injuries to a plaintiff who took the generic version of the drug, which was not manufactured or sold by the innovator company.  Seven years ago, in Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), review denied (Cal. Jan. 21, 2009), the California Court of Appeal came up with the wrong answer to this question, holding that a plaintiff who used a generic drug could sue the manufacturer of the branded  version.  As Bexis likes to say, the Conte court took the “product” out of product liability and held a company potentially liable for injuries allegedly caused by a product that it did not make and did not sell.  In the months after Conte was decided, we criticized virtually every aspect of it here, here, here, and here.

n the ensuing years, we have posted about Conte and innovator liability numerous times – you can see all of our posts collected here — as we waited and watched to see which courts would adopt this poorly-reasoned holding that flew in the face of the foundations of product liability law.  As we have been happy to report (you can see our innovator liability scorecard here and our 50-state survey of innovator liability here) Conte is now an outlier, with the majority of courts holding that an innovator drug manufacturer cannot be liable for injuries allegedly caused by a generic drug it did not manufacture or sell.

Continue Reading Solid “No Designer Liability” Decision in a Non-Pharma Case in the Eastern District of Pennsylvania

Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and superseded), and Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (en banc)—which kept alive a version of the innovator liability that had been rejected almost everywhere else.  The Alabama Supreme Court—in 2013 and again in 2014—deviated from the well-established principle of product liability that liability for an injury allegedly produced by a particular product may run to the manufacturer of that product but not to the manufacturer of some other product that did not allegedly injure the plaintiff.  Recognizing the weakness of Weeks, in 2015, the Alabama legislature re-affirmed the need for any product liability plaintiff to prove an injury from the defendant’s product, not just “a similar or equivalent product.”  Because Alabama’s law is not retroactive, there is a gap for plaintiffs in pending cases to try to impose liability on manufacturers of drugs they did not take.

Before we knew the days of Weeks were numbered, we highlighted how the Northern District of Alabama had distinguished the Weeks theory that “a brand-name-drug company may be held liable for fraud or misrepresentation . . . based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company” from the plaintiff’s theory that the innovator should be liable for “failing to ensure that [plaintiff] received the Medication Guide,” which plaintiff conceded provided adequate information on risks and indications for the drug.  Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073. *12 (N.D. Ala. Jan. 14, 2015).  Without support from Weeks, no putative breach of a duty by the innovator could give rise to liability.  Id. at *13.  We characterized the holding in another case from the same district, Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014), as “If Weeks does not allow innovators to be tagged for [run-of-the-mill product liability] claims, absent fraud allegations that will need to be pleaded in detail and eventually supported by lots of evidence, then the effect of Weeks may end up being pretty narrow.”

Continue Reading The Elephant in the Room in Alabama