We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when the one-hundredth judicial opinion on this topic was decided.  Well, not too long ago the Fourth Circuit, in McNair v. Johnson & Johnson, ___ F. Appx. ___, 2017 WL 2333843 (4th Cir. May 30, 2017), did what no court of appeals had done since the innovator liability first reared its ugly head in 1994 – it certified the question to the relevant state high court – in this case, the West Virginia Supreme Court of Appeals:

Whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.

2017 WL 2333843, at *1.

At least a dozen federal court of appeals decisions have rejected innovator liability under the laws of some two dozen states. Ironically, the first to do so was the Fourth Circuit itself, in Foster v. American Home Products Corp., 29 F.3d 165, 168, 171 (4th Cir. 1994), under Maryland law.  Plaintiffs did not begin resorting to the delaying tactic of requesting state court certification until relatively late in the game.  Courts of appeals were not accommodating, refusing to certify what they saw as an outlier issue in Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 614-15 (5th Cir. 2014); Strayhorn v. Wyeth Pharmaceuticals, 737 F.3d 387, 406-07 (6th Cir. Dec. 2, 2013). See also In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237, at *3 (E.D. Ky. Aug. 21, 2012), aff’d, 756 F.3d 917 (6th Cir. 2014); Mosley v. Wyeth, Inc., 719 F. Supp. 2d 1340, 1351 n.9 (S.D. Ala. 2010) (district courts refusing certification motions).  But plaintiffs got lucky (for a few months) in Wyeth, Inc. v. Weeks, 159 So. 3d 649, 653 (Ala. 2014), with a certified question, and with nothing left to lose they’ve been trying it ever since.

McNair is not only an outlier procedurally, but is troubling substantively.  First, the Fourth Circuit’s certification opinion seems more concerned with preemption rather than state law – addressing preemption before even bothering with state-law causation principles, and finishing that section with the observation, “while a state law failure-to-warn claim against a generic manufacturer is preempted, such claims are not preempted as to the warnings on a brand-name drug distributed by a brand-name manufacturer.”  2017 WL 2333843, at *3 (emphasis original).  Ordinarily, the existence of a recognized state law claim precedes any decision on whether that claim is preempted.  We always find it troubling when a federal court views principles of state law more through the lens of a preemption dodge than on their merits.

Although pointing out (as could hardly be denied) that even in the current preemption environment, “overwhelming” precedent rejects innovator liability, McNair, 2017 WL 2333843, at *4, the certification order makes it appear as if there is no prior West Virginia law on this subject.  That is simply not so.  As we state in our Innovator Liability at 100 post:

In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), the Sixth Circuit concluded that West Virginia “has rejected claims attempting to impose liability on brand manufacturers where plaintiffs ingested only generic drugs.”  Id. at 953.  Darvocet relied upon Meade v. Parsley, 2009 WL 3806716 (S.D.W. Va. Nov. 13, 2009).

[Innovator defendants] are not responsible for the damage resulting from a product that they did not manufacture, distribute or sell. . . .  Product liability law in West Virginia allows for recovery when the plaintiff can prove that “a product was defective when it left the manufacturer and the defective product was the proximate cause of the plaintiff’s injuries.”  Because neither [innovator defendant] manufactured the product that injured plaintiffs, there is no proximate cause.

Id. at *2-3 (quoting Dunn v. Kanawha County Board of Education, 459 S.E.2d 151, 157 (W. Va. 1995)).

That the Fourth Circuit would decide to omit all of the most directly on-point West Virginia law-based precedent – including a published court of appeals decision − from its certification order is simply inexplicable.  Certainly, ignorance cannot be claimed, as both the Darvocet and Meade decisions were relied upon by the district court in McNair itself.  McNair v. Johnson & Johnson, 2015 WL 3935787, at *6 (S.D.W. Va. June 26, 2015).  We can only hope that the West Virginia high court (docket available here) will not be misled by these omissions.

 

We recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.”  This article consists largely of the interviews with two avatars of the other side of the “v.”:  fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues.  Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.

Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do).  Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.

The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.”  We don’t think that’s grounds for “more liability.”  First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense.  The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question.  There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design.  So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion.  Most branded drug warnings don’t have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label.  The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use.  21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA).  That’s important because, as we discussed in more detail here, only the FDA can do this.  Drug companies are not allowed to discuss off-label uses in their labels whenever they want.  Without the FDA telling them to, that is a form of misbranding.

Continue Reading What If We Win? Off-Label Promotion & Product Liability

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.

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.

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

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

Today we have a guest post (her second – she’s a glutton for punishment) from fellow Reed Smith associate Danielle Devens.  This one brings together recent precedent recognizing post-Levine preemption in cases involving non-generic prescription drugs (there are a couple our readers may not have seen before).  As always with our guest posts, the author gets all the credit, and any blame, for the contents of his/her work.

***************

As this blog has been explaining for a while, the rationale in Mensing – that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it” –  could apply to innovator (brand-name) pharmaceutical manufacturers and not just to generics.  131 S. Ct. 2567, 2579 (2013).  About a year ago, this blog reported on cases in which defendants argued for the application of the impossibility preemption doctrine outside of the context of generic drugs.  Since that time, there have been several new decisions involving innovator pharmaceutical manufacturers arguing for the application of impossibility preemption principles.  It makes sense at this point to condense the available information into one post and assess the question “where are we now?”

First, the relevant statutes in a nutshell:  to obtain FDA approval for a new drug, an innovator manufacturer must prove the safety and efficacy of its product through lengthy clinical testing, while generic drugs can gain FDA approval by showing that the product is equivalent to a brand-name drug that has already been approved by the FDA.  21 U.S.C. §355(j)(2)(A).  (One caveat – there may be drugs legally marketed today that were not subject to these requirements, such as drugs evaluated prior to 1962 which were instead subject to the FDA’s Drug Efficacy Study Implementation program). This, of course, is not a complete description of the requirements, but you get the gist.  The generic drug application must also show that the safety and efficacy labeling proposed is the same as the labeling approved for the innovator drug.  21 U.S.C. §355(j)(2)(A)(v).

Continue Reading Guest Post – Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

This is a quick-hit post as we head into the Independence Day holiday weekend.  The Southern District of West Virginia’s order this week in McNair v. Johnson & Johnson, No. 2:14-17463, 2015 WL 3935787 (S.D. W. Va. June 26, 2015), dismissed claims against the seller of an innovator drug for precisely the right reason: The defendant neither made nor sold the generic drug that the plaintiff ingested.  That is to say, there is no Conte-style “innovator liability” in West Virginia.

It seems obvious, doesn’t it?  It has been seven years since the California Court of Appeal issued its wrongly reasoned and wrongly decided opinion in Conte v. Wyeth, where the court held that a plaintiff who used a generic drug could sue the manufacturer of the listed version.  As we like to say, the 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.  The late Roger Traynor and his colleagues on the California Supreme Court, who presaged strict product liability way back in 1944 in Escola v. Coca-Cola Bottling Co., must have rolled in their graves.

The Conte opinion has predictably become an outlier, and courts have rejected the opinion and its reasoning many times over, often expressly. (Check out our Innovator Liability Scorecard here and our survey of innovator liability here.)  As we reported here, the Alabama legislature abolished innovator liability just a few months ago, and we believe the California Supreme Court overruled Conte in Crane v. O’Neill, 53 Cal. 4th 335 (2011), where it held that a manufacturer has no duty to warn of hazards in another manufacturer’s product due to “foreseeability.”

Continue Reading No Innovator Liability: National Drug Code Saves the Day

This will be an odd post for us – a research-heavy discussion that doesn’t cite to drug/medical device case law.  However, the nonsensical “innovator liability” is a clear and present danger.  Generic drug plaintiffs, refugees from generic preemption, are looking for any deep pocket to sue, no matter how contrary to existing law and the economic justifications for product liability.  Thus they continue to peddle this jurisprudential snake oil.  Defense counsel need every available arrow in their quivers to combat its possible spread.

Today we discuss asbestos “bare metal” cases.  In asbestos-land widespread bankruptcy of asbestos manufacturers has had much the same effect as preemption is having in generic drug product liability litigation.  Thus, most major manufacturers of asbestos-containing products can’t be sued.  In addition to searching for minor actual manufacturers, asbestos plaintiffs have also turned to suing manufacturers of products that don’t contain asbestos at all.  These defendants made turbines, boilers, engines, pumps, valves – you name it.  None of these products contained asbestos when sold.  They were simply “bare metal.”  However, purchasers of these products attached various asbestos-containing products to them, such as insulation or gaskets, which helped the products run better and/or longer.

While those parts were made by others (usually harder to identify), the asbestos plaintiffs claim it was “foreseeable” to the bare metal equipment manufacturers that these other products would be added.  Some products, plaintiffs claim, couldn’t be operated at all without the addition of asbestos-containing components.  Because third-party addition of asbestos-containing components was “foreseeable,” these asbestos plaintiffs allege that bare metal defendants had a duty to warn about that risks from addition of other products that those defendants never made.

Continue Reading More Support in the Fight Against Innovator Liability

We were walking through San Francisco’s Chinatown the other day, and above an otherwise nondescript storefront we saw a sign that said “Fortune Teller.  Tells Past Present and Future.”  We are not sure what is worse:  Someone who claims the clairvoyant power of telling the “past” and “present,” or the poor sap who pays for the privilege of learning where he is and what has already happened to him.  It seems that telling the present would get somewhat tedious and repetitive:  “You are sitting in a second floor apartment in Chinatown across from a woman who looks like Professor Sybill Trelawney from Harry Potter and the Prisoner of Azkaban.  That will be $100 please.”

Now, telling the future — that’s a keen trick, one that we would pay to see, and one that we attempt from time to time here at the Drug and Device Law Blog, such as when we predict (or encourage) the demise of judicial opinions that are particularly wrong headed and/or wrongly decided.  You might have already guessed that we are leading up to yet another post on Conte v. Wyeth, 158 Cal. App. 4th 89 (2008), the wrongly reasoned and wrongly decided opinion from the California Court of Appeal that took the “product” out of “product liability.”  For those not keeping score, Conte held that a drug innovator can be liable for inadequate warnings in connection with a competitor’s generic version of the drug.  That is to say, a drug manufacturer can be liable for injuries alleged caused by a product it did not make and did not sell.  Holy tarot cards!  The fortune teller nearly fell off her chair when she saw that in our past.

Fortunately, Conte appears to have a future no brighter than another notorious California opinion that bent product liability and expanded liability for questionable reasons — Sindell v. Abbott Laboratories, 26 Cal. 3d 588 (1980).  Sindell and its innovation known as market share liability was big news when it came out in 1980, and it was still making waves when we took Torts in law school in the early 1990s.  Today, 33 years after Sindell hit the books, we think it is safe to say that the opinion has had little lasting impact on the product liability landscape, and we doubt that it occupies any space in law school curricula other than as an interesting historical novelty. Continue Reading New York Rejects “Innovator Liability”: The Future Of Conte Looks Dim