A Couple Of Interesting New Cases Forwarded By Our Readers

We like it when our readers contact us, even when it’s only to tell us that we made a mistake.  At least they’re paying attention.  But we like it most when our readers send us new opinions of interest − especially good ones.  The rapid exchange of information helpful to the defense of prescription drug and medical device product liability litigation is what the DDLaw blog is all about.

But once we receive good new cases, it becomes our responsibility to get the word out, and that’s what we’re doing today, even if we feel we’ve been a mite slow about it.

Eckhardt v. Qualitest

Two readers (Quinton Urquhart of Irwin, Fritchie, and Rachel Passaretti-Wu of Skadden) both sent us, in response to our “Conte Rejected Again” post, Eckhardt v. Qualitest Pharmaceuticals, Inc., C.A. No. M-11-235, slip op. (S.D. Tex. Aug. 9, 2012).  Eckhardt − guess what? − also rejected the notorious Conte theory that brand-name manufacturers could be liable for allegedly inadequate warnings accompanying competing generic drug products that they never sold.

Eckhardt is the latest of a number of cases to reject brand-name liability under Texas law.  As indicated in our Branded/Generic liability scorecard, Eckhardt builds on Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. 2010); Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009); Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. Mar. 29, 2010); Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009); Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008), aff’d on other grounds, 623 F.3d 271 (5th Cir. 2010); Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003) and Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, slip op. at 1-2 (Tex. Dist. Dallas Co. May 7, 2010), in hewing to the traditional product liability axiom that manufacturers are the only ones that can be liable for their products.

We make that point because we were somewhat disturbed to read the Eckhardt court expressing “disappointment” with the quality of the briefing on both sides.  Slip op. at 2-3.  While we expect the other side to do things like throw in “two several-hundred-page depositions” without page citations, id., we’re not accustomed to seeing our side criticized for citing “cases that have no nexus with” relevant law.  Id.

That’s precisely what we try to avoid with our branded/generic scorecard.  If as is the case in Eckhardt, the jurisdiction in question has a statutory product liability scheme (like Texas, or Tennessee, Kentucky, and New Jersey to name a few), we try to note in our case summary.  That way we try to make it easy for defense counsel everywhere to cite to the most relevant cases, whether inside or outside any particular jurisdiction.

Anyway, the rest of Eckhardt is good.  It’s a “one-two punch” case − by that we mean (as is apparent from our Generic Preemption scorecard) that the generic defendants have also been dismissed on preemption grounds.  Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 1511817 (S.D. Tex. April 30, 2012).  Thus, the one-two punch of preemption and product identification has effectively ended the case.

Eckhardt makes the following holdings that might be useful in future cases:

• The tenuous relationship of branded products to generic labeling was not sufficient to justify liability under any Texas product liability theory.  Slip op. at 4-5.
• Fraud and similar claims satisfy the statutory definition of “products liability” claims.  Id. at 6-7.
• Breach of warranty and consumer protection claims fail where the defendant did not make the product.  Id. at 8-9.
• Negligence and negligent misrepresentation fail because a non-manufacturer owes no recognized duty to persons using competing products.  Id. at 10-11.

Baker v. APP Pharmaceuticals

We thank old colleague Will Sachse of Dechert for sending along Baker v. APP Pharmaceuticals LLP, C.A. No. 09-05725 (JAP), slip op. (D.N.J. Aug. 21, 2012).  Baker contains an excellent description of the New Jersey presumption of adequacy of FDA-approved warnings:

In failure to warn cases involving prescription drugs, “[i]f the warning or instruction given in connection with a drug . . . has been approved or prescribed by the federal Food and Drug Administration under the ‘Federal Food, Drug, and Cosmetic Act,’” there is a rebuttable presumption that the warning is adequate.  This is no ordinary rebuttable presumption.  “Compliance with FDA regulations” gives rise to “what can be denominated as a super-presumption[.]”  “[C]ompliance with FDA standards should be virtually dispositive of such claims.”  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced in [New Jersey Rule of Evidence] 301.”

 
Baker, slip op. at 12-13 (citations, but not quotation marks, omitted).

The New Jersey presumption suffers from ill-advised, judicially-created exceptions to the broad legislative mandate, but Baker held that neither of those applied.  There can’t be “deliberate concealment” of information that’s “publicly available in published scientific and medical literature.”  Slip op. at 9-10.  Moreover, the plaintiffs weren’t being honest with the court.  The information in question was, in fact, disclosed to the FDA.  Id. at 10-11.  (The concealment claim was also a preempted fraud on the FDA claim, but the court didn’t have to discuss that.)  Also, for case-specific reasons (after-the-fact timing, and the information involving a different drug), the court found no manipulation, “intentional” or otherwise, of FDA post-marketing regulatory processes.  Id. at 12-14.  Thus the FDA-approved warning was as a matter of law.

Of equal interest, the court in Baker held that, even if the warning had been inadequate, it couldn’t have caused any injury.  This is important, because there hasn’t been all that much New Jersey law on warning causation.  There’s Strumph v. Schering Corp., 606 A.2d 1140, 1148-49 (N.J. Super. App. Div. 1993) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (adopting dissenting opinion below), which establishes the warning causation principle in New Jersey.  There’s also Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005).  These are both cases where the prescribing physician already knew the information and didn’t read the warning.  Two favorable opinions for a jurisdiction with as much learned intermediary rule litigation as New Jersey strikes us as a little thin.

Baker’s now a third case in that category.  First of all the court took out the lamentable “heeding presumption.”  “The heeding presumption is rebutted, however, if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted.”  Slip op. at 14-15 (citation and quotation marks omitted):

Moreover, a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and considered the risk in prescribing the product.  In that case, the physician’s conduct is the superseding or intervening cause that breaks the chain of liability between the manufacturer and the plaintiff.

 
Id. at 15 (citations, quotation marks, and footnote omitted).  That happened in Baker.  Not only did the prescriber know of the alleged heparin-related risk, but he “stood by his decision to administer heparin” under the facts of the case.  Id. at 15-16.  Further blocking any causal inference was the physician’s failure to read labels for “frequently” prescribed drugs with which he was familiar:

[The prescriber] testified in his deposition that he does not read the label of drugs he prescribes often, which includes heparin.  Moreover, Plaintiffs concede that [the prescriber] never testified that he would have consulted a black box warning or “Dear Doctor” letter, or that he ever reviewed the Physician’s Desk Reference when prescribing heparin.  Therefore, a different warning would not have made a difference in [plaintiff’s] treatment or outcome because [the prescriber] would not have reviewed it.

 
Baker, slip op. at 16 (citation omitted).

There was also a case-specific superseding cause − the “fail[ure]” of the nursing staff “to follow its own heparin treatment protocol” and monitor the drug level in the plaintiff’s blood.  Id. at 16-17.

Therefore, Plaintiffs have failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the failure of the hospital to follow its treatment protocol, that was a substantial factor in causing or exacerbating [plaintiff’s] injuries.

 
Baker, slip op. at 17.

Thus, Baker is a nice causation triple play (prior knowledge, failure to read, and third-party superseding cause) in a jurisdiction where such precedent is most welcome.

Thanks to everyone who sends us cases − and keep them coming.

Conte Rejected Again

Remember right after Mensing when the refrain from the other side of the "v." was that the "immunity" conferred upon generics meant that branded drugs were "safer"?  But once the other side realized that generic preemption was for real, that line was quickly airbrushed from their playbook (ATLA pulled down that press release within a week - although we may have preserved it, we're too lazy to look right now).  Now what we hear from them is "all Conte all the time," that is how it's really the nefarious branded manufacturers who should be liable for each and every purported failing in generic labeling.

Fortunately, the courts haven't been buying that twisted logic, as our Conte scorecard demonstrates.  The other day Conte failed to impress the judge presiding over Reglan/metoclopramide litigation in Tennessee (or at least the Western District).  See Strayhorn v. Wyeth Pharmaceuticals, Inc., No. 11-2058-STA-cgc, slip op. (W.D. Tenn. Aug. 8, 2012).  In the first place, the Tennessee Product Liability Act subsumed all former common-law claims and required use of the defendant's products.  Slip op. at 15-16.  Even aside from the TPLA, however,   Conte was expressly rejected as “an extreme outlier” and a "minority" position.  Id. at 12, 17-18.

Plaintiffs' (there were seven cases) secondary theories also failed.  Restatement (Second) of Torts §552 does not apply to product liability and is not a fraud claim.  Slip op. at 18-19.  Warranty claim require a sale of a product.  Id. at 19-20.

Finally, the court invoked our favorite federalism principle:

[W]ithout guidance from a state’s highest court, a federal court sitting in diversity should be reluctant to expand the substantive law of that state . . . because federal courts sitting in a diversity case are in a particularly poor position to endorse a fundamental policy innovation.

Slip op. at 20 (citations and quotation marks omitted).
Thanks to Kurt Karst at Hyman Phelps for passing along Strayhorn.

Interesting Application of State of the Art Principles

There’s a lot going on in Wendell v. Johnson & Johnson, 2012 WL 3042302 (C.D. Cal. July 25, 2012), but much of it depends on very case-specific facts about a particular prescriber’s knowledge, and some of the rest was put off essentially as premature.  There is one aspect of the Wendell decision that merits our attention, however, and that’s the court’s application of state of the art principles in the context of a defendant’s sale of its proprietary rights to a drug.


That’s significant because, while the opinion doesn’t mention it, the identities of some of the defendants suggest that Wendell involves (at least partially) generic drugs and thus generic preemption.  With generic plaintiffs looking for other defendants after PLIVA v. Mensing, 131 S. Ct. 2567 (2011), this situation might come up again for our branded clients.

Here’s what went on in Wendell:  At various times the plaintiff’s decedent (who was chronically ill with inflammatory bowel disease) underwent treatment with different combinations of three drugs.  The decedent allegedly died from an adverse effect of one or all of these drugs.  2012 WL 3042302, at *1.  In Wendell the alleged injury was a type of cancer, but for purposes of this post, it could have been any newly discovered risk.

It’s not explicit, but the relevant defendant appears to be the original branded manufacturer of one of the drugs, but who left the market in July, 2003, after the onset of generic competition.  Id.  Plaintiff may well have used the branded drug at some point, since he started taking that product in 1999 (we’re not sure exactly when generics entered the market).  Id. at *2.  However, the first case report of the type of injury at issue in the litigation, in connection with the type of combination treatment the decedent received, was not published until February, 2005.  Id. at *3.  This risk led to the addition of a black box warning in May, 2006.  Id. at *4.

The branded manufacturer successfully raised the state of the art defense.  The risk for which it was being sued was not discovered until a year and a half after it left the market.  Wendell was decided under California law − meaning that the branded manufacturer was at least potentially subject to liability under Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008) − although as we have noted, Conte itself has probably been impliedly overruled by the California Supreme Court.  However, Conte aside, the law in almost every state is the same (at least as to prescription medical products) concerning the sort of after-discovered risk at issue in Wendell − “Drug manufacturers need only warn of risks that are actually known or reasonably scientifically knowable.”  2012 WL 3042302, at *12 (quoting Carlin v. Superior Court, 920 P.2d 1347, 1354 (Cal. 1996)) (emphasis original). Here’s another nice excerpt from Carlin on state of the art:

We reiterate that strict liability for failure to warn is not absolute liability. . . .  [D]drug manufacturers are not strictly liable for a risk that was not known or reasonably scientifically knowable.  In this context, it is significant that the FDA precludes drug manufacturers from warning about every conceivable adverse reaction; they may warn only if there exists significant medical evidence of a possible health hazard.

920 P.2d at 1352.

Apparently, the first known incidence of the risk in question actually occurred before the defendant’s withdrawal from the market, but critically nothing was either been published or reported to the manufacturer or to the FDA until the 2005 article appeared in the literature.  Wendell, 2012 WL 3042302, at *12.  Why it took so long to surface, we don’t know, but not even the plaintiff argued that this delay was the defendant’s fault.  So, as a practical matter, the risk was “unknowable” at the point when the defendant left the market.  Thus, summary judgment was appropriate:

Plaintiffs have not presented evidence that the risk was actually known or should have been known by the scientific or medical communities of which [defendant] is a part. . . .  [I]nformation concerning the occurrence of [the risk] in connection with [the defendant’s drug] was not reported to AERS or discussed in the medical literature until after [defendant] ceased to distribute the drug.  Furthermore, drug manufacturers are not required to warn of every conceivable adverse reaction.  Thus, [defendant] cannot be held strictly liable for failure to warn. . . .

Likewise, Plaintiffs’ negligence claim requires them to prove that [defendant] did not warn of a particular risk for reasons that fell below the acceptable standard of care; i.e., what a reasonably prudent manufacturer would have known and warned about.  Plaintiffs have presented no evidence, expert or otherwise, indicating that a reasonable manufacturer would have been in a position to discover the case that [was] reported, prior to [the date defendant left the market].  Thus, Plaintiffs cannot prevail on their negligence claim.

Id. at *12-13.

The situation in Wendell is not at all uncommon.  Branded manufacturers frequently sell their rights to drugs and exit the market after generic competition begins − and generic drugs enjoy the Mensing preemption defense.  So plaintiffs are going to be looking around for other entities to sue.  Conte liability is one example of that, and one of the many problems with that theory is its lack of any temporal limit.  So Conte claims are likely to arise well after branded defendants have left the market.  Besides Conte, branded manufacturers are likely to be sued no matter how remote actual use of their products is from onset of injury, as was the case in Wendell.  The state of the art defense is one weapon we have to defeat allegations of remotely related liability, and Wendell shows what the defense can do where the cut-off date is the defendant’s ceasing manufacture.

Lyman: Branded Out; Generic Waist Deep In Big Muddy

We’ve just read Lyman v. Pfizer, Inc., 2012 WL 2970627 (D. Vt. July 20, 2012).  Frankly, we expected it to be worse than it was.  Regular readers are no doubt familiar with Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt.  2010), in which the same court (we would say in violation of Erie principles of federalism) predicted that Vermont would follow the controversial holding of Conte v. Wyeth, Inc., 85 Cal.Rptr.3d 299 (Cal. App. 2008), in the absence of any Vermont precedent for doing so.  We were steeling ourselves in Lyman for more of the same.


Didn’t happen.

The court used remote causation to clip Conte’s wings significantly.  We were muttering about the same concept well before we got to the court’s holding.  The facts delved well back into the product liability equivalent of deep time − while the plaintiff only started using the product (metoclopramide) in 2003, the discussion of the branded manufacturer’s conduct went back at least to 1980, when the FDA approved the original Reglan branded version of the product.  Lyman, 2012 WL 2970627, at *4.  Predictably, plaintiff alleged fraud on the FDA with respect to the 1980 approval.  Id. at *5.  The fact that the opinion saw fit to mention these ancient, and blatantly-preempted allegations filled us with foreboding.

Other facts, thankfully, turned out to have more relevance.  These were:  (1) the drug was only approved for gastrointestinal reflux, (2) it was never approved for long-term use; (3) after losing its patent protection, the branded manufacturer sold all of its rights to the drug to an unaffiliated company in 2001; and (4) plaintiff never used the branded version.  Lyman, 2012 WL 2970627, at *2, 4-5.

The branded defendants − the original manufacturer and its 2001 purchaser − sought summary judgment, arguing that even under a Conte rationale, plaintiff didn’t have a case.

They were right.

The most important reason that the Conte theory of causation failed was that it relied upon events that occurred decades before plaintiff’s alleged injury.  The causal chain was simply too remote.  Activity that occurred years, even decades, before the plaintiff ever began taking (a different manufacturer’s version of) the product “ha[d] so far spent itself as to be too small for the law’s notice.”  Lyman, 2012 WL 2970627, at *17. As to warnings:

[Defendant’s] alleged negligent actions are too remote to constitute a proximate cause of [plaintiff’s] injury.  [The] development, testing, labeling and promotional activity had ceased entirely by the end of 2001, long before [plaintiff’s] first consumption of a dose of [the drug].  In fact, much of the misconduct attributed to [defendant’s predecessor] occurred in the 1980s.

Id.  Similar reasoning was also fatal to the plaintiff’s fraud claim − reliance on anything the original branded manufacturer had done years ago, before the labeling had been changed, was simply not justifiable:

[Plaintiff’s prescribers] derived their impressions from a variety of sources.  Those sources could conceivably be traceable back to statements made by [defendant], but from a time well before [plaintiff] began taking [the drug].  [Defendant] stopped manufacturing [the drug] and ceased having responsibility for its label in December 2001, and there is no evidence that it made any statements regarding [the drug] after that time. . . .  [T]he new NDA holder . . . had revised the label three times, and an inquiry into the current information . . . would have revealed . . . that therapy should not exceed twelve weeks. . . .  [A]ny prescriber’s reliance on [earlier] statements . . . was not justifiable.

Id. at *18.  Lyman thus cut off the perpetual tail of liability that Conte (which was willing to look at what a doctor had reviewed while still in training) had permitted.  Thus, the only court ever to follow Conte ultimately couldn’t stomach the temporally-infinite cause of action that Conte had described.  That’s a big deal − especially since Conte involved the same drug and thus identical hisorical facts.  Lyman demonstrates, once again, how radical Conte’s departure from established law actually was.

Legal cause as to the branded defendants in Lyman also failed for another reason − the defendant’s alleged negligence related to another condition, not the off-label use for which the plaintiff was taking the drug:

[Plaintiff] received [the drug] for the off-label use of controlling migraine-related nausea.  [The branded defendants’] development, testing and promotional efforts were directed toward treatment of gastrointestinal conditions, not [plaintiff’s] condition. . . .  Under these circumstances the negligent conduct alleged bears no causal connection to the injury suffered.

Lyman, 2012 WL 2970627, at *17.  This rationale also has potentially broad application to other cases involving disparate off-label uses.

The generic manufacturer in Lyman stayed in the case, notwithstanding preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  This ruling (which was on the pleadings; not on summary judgment) had two bases, only one of which we find particularly objectionable.  The relatively unobjectionable ground is that the generic defendant didn’t update its labeling after the FDA approved a labeling change.  Lyman, 2012 WL 2970627, at *9.  Assuming that happened, and assuming it was causal (two big ifs), we don’t have a preemption-based beef with that result.  Mensing was based on impossibility, and it was not impossible (indeed it was probably mandatory) to make that particular change.

The preemption ruling in Lyman that we don’t like tried to split warning hairs that we don’t think are splittable under Mensing.  The opinion allows some sort of claim based on an failure to communicate warnings retroactively, instead of on the inadequacy of the existing warnings:

[T]he amended complaint states that the FDA required the addition of the black box warning [in 2009] as a result of the inadequate warnings provided to consumers and the medical community, indicating that it is the failure to communicate the updated warnings adequately or at all, rather than the inadequacy of the updated warnings themselves, that is at the heart of this failure-to-warn claim against the generic manufacturing defendants.

Lyman, 2012 WL 2970627, at *10.  Sorry, we don’t see the distinction.  This claim is still an attack on the adequacy of the generic drug’s FDA-required warnings, which is preempted under Mensing.  Look at it this way − if those pre-2009 warnings hadn’t been inadequate, there wouldn’t have been any need to communicate later warnings.  Plaintiffs are simply using the 2009 warning change (which should be an inadmissible subsequent remedial measure) to impugn the adequacy of the prior warnings, and Mensing says you can’t do that.  The whole warning swamp is off-limits as preempted; plaintiffs should not be allowed into it.

Otherwise, Lyman isn’t bad for the generics either.  The court wasn’t snowed by plaintiff’s novel (meaning desperate) attempt to repackage preempted warning claims as defective packaging claims.  Allegations that the generic defendants “failed to incorporate . . . package designs that would discourage long-term use” were simply a “nonverbal failure-to-warn claim.”  Lyman, 2012 WL 2970627, at *11; see id. (“unit of use packaging” claim preempted because it was a form of “stronger warning” against long term use) . The packaging allegations also failed under TwIqbal:

Subtracting the legal conclusions, it amounts to a suggestion that certain unspecified types of packaging designs might have discouraged long-term use of the drug, which might have prevented the harm to [plaintiff].  This is an example of an allegation that does not permit the court to infer more than the mere possibility of misconduct.

Id.

The plaintiff’s “design” claim was also preempted as a disguised warning claim.  After all, the only thing plaintiff claimed was wrong with the design was unsuitability for long term use − exactly what the challenged warning was about:

The only “defect” that arguably can be gleaned from the pleading is that the drug is unsafe for long-term use. This is simply another way of presenting a failure-to-warn claim.

Lyman, 2012 WL 2970627, at *12.

Plaintiff’s warranty claims also failed.  Off-label use of the product − intended to treat gastrointestinal conditions − for “headache-induced nausea” simply couldn’t be considered an “ordinary use” of the product as required by the Vermont UCC.  Id. at *15.  The lack of any communication between plaintiff’s prescriber and the defendant about plaintiff’s treatment similarly doomed a claim for breach of the implied warranty for a particular purpose.  Id. at *16.

Finally, one of the two generic manufacturers was dismissed on medical causation grounds.  Apparently, there is no support for causation where use of the drug is “intermittent.”  The manufacturer, whose product was only consumed intermittently, thus got out.  Id. at *14.

All in all, a much better result than we had anticipated when we first learned of the decision.

New Stuff

Miscellaneous day today, just before Memorial Day (remember to raise a glass to the common foot soldier this holiday) and the official start of summer − courtesy of our readers.


Number one:

A tip of the cyber-cap to Mike Imbroscio at Covington and Bart Sullivan at Fox Galvin for sending us Aranda v. Walgreen Co., No. 12-cv-337-DRH, slip op. (S.D. Ill. May 23, 2012).  Aranda demonstrates that, after the Seventh Circuit’s Walton decision finding fraudulent joinder of pharmacies under Illinois law, plaintiffs in the southern Illinois hellholes (St. Clair, this time) still haven’t given up.  After getting caught falsely alleging the diversity of another party (slip op. at 3-4), the plaintiffs (71 of them) argued in Aranda that despite Walton, a pharmacy could be liable.

The plaintiffs in Aranda correctly observed that there is an exception to pharmacy non-liability in Illinois where the pharmacist has actual, subjective knowledge of a reason why a particular drug is contraindicated in a particular patient.  Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118 (Ill. 2002) (actual knowledge of synergistic adverse effect of two drugs).  See slip op. at 8-10 (discussing Happel).

But so what?

None of the 71 blatantly misjoined plaintiffs in Aranda alleged any facts suggesting that the actual knowledge exception in Happel had anything whatsoever to do with their purported claims.  To the contrary, the only allegations were the usual “knew or should have known” failure-to-warn boilerplate.  Slip op. at 11-12. Thus, the Aranda plaintiffs had nothing to take their cases outside of the Seventh Circuit’s controlling Walton opinion:

Despite plaintiffs’ arguments to the contrary, the Court finds that this is the Walton case all over again.  Plaintiffs allege that the manufacturing defendants and [the pharmacist] did not provide adequate warnings; they do not allege that [the pharmacist] had specific knowledge of each individual plaintiffs’ susceptibility to the adverse side effects of [the drug].  Clearly it is possible to allege for each plaintiff individually his or her medical susceptibility and how [the pharmacist] knew of that condition.  While this may seem like a daunting task with so many plaintiffs in one complaint, it is perhaps not as daunting as preparing a different complaint for each plaintiff or paying a filing fee for each plaintiff.  Nonetheless, this is what Walton requires, and the allegations in this case come nowhere near the situation in Happel where the Illinois Supreme Court found a narrow duty existed. Accordingly, the motion to remand is denied.

Aranda, slip op. at 12 (emphasis added).  Boilerplate pleaded on behalf of a large number of improperly joined plaintiffs − hence the dig about failing to pay filing fees − doesn’t cut it.  And so these 71 plaintiffs will stay in federal court, where they will almost certainly be severed and required to pay the proper filing fee.

Good job.

Number two:

There’s also this hearing transcript in Lukas-Werner v. Novo Nordisk, A/S, No. 1009-13177 (Or. Cir. Multnomah Co. May 11, 2012), rejecting Conte and the entire concept of brand-name liability in generic drug consumer cases.  Here’s the decisive part of the hearing:

THE COURT:   Well, this is really interesting.  I think plaintiff’s argument has a lot of appeal, but that's not my job here today.  I am required to attempt to predict -- and I need a much bigger crystal ball than I am using -- what the Oregon Supreme Court would do with this theory.  And my best prediction is that the Oregon Supreme Court would not recognize the innovator liability theory in these circumstances.

Frankly, I was thinking I don’t really care about defendant’s arguments about what causes of action the plaintiffs might have still brought against [other parties].  That's not the question before me.  The question is does this particular pleading state a cause of action under the Oregon common law, regardless of what other things might have been there and weren't there.

The only reason I think there is any place for that argument in this motion, actually, is thinking that the Oregon Supreme Court, when it takes this issue up, will look at Article I, Section 10 of the Oregon Constitution and look at the Mensing case and say where that provision in our constitution says every man (sic) shall have a remedy by due course of law for injury done him (sic), and his person, property or reputation, would they say that in light of the U.S. Supreme Court's ruling in Mensing there has to be innovator liability for that remedies clause to be given effect and meaning?  And they would look and say, “Well, even if it’s not that particular remedy, are there others and so on.”  So, you know, I’m not ignoring that argument completely, but I think it's really tangential to the core issue here.

And I do not think the Oregon Supreme Court would conclude that the innovator, the original manufacturer of a drug responsible for its labeling, has a duty arising out of the FDA regulations to the consumers or prescribers of all generic versions of its drug.

And the plaintiffs acknowledge that foreseeability alone won’t get them there.  That really is kind of what it amounts to, because the regs don’t permit the manufacturer of a generic that doesn’t want to go through the labeling process to do anything other than use the innovator’s labeling. That makes the harm foreseeable to the innovator.

I don’t think we can get there from here.  So I’m granting the defendant's motion.  I do it reluctantly, but I’m granting it.

Transcript at 25:2-26:21.

Reading the rest of the transcript, we’re pleased (but not at all surprised) to see that defendants have picked up on the fact (which we discussed here) that Conte itself is an endangered species in California since the California Supreme Court’s rejection of pure foreseeability as a basis for product liability in O’Neil v. Crane Co., 266 P.3d 987 (Cal. 2012).  See Transcript at 4:15-21 (“the O’Neil decision . . . swallows Conte up and spits it out”).  Nice metaphor.  There follows (pp. 4-5) admitted “speculation” about why the California Supreme Court didn’t accept an appeal in Conte itself.  Since Bexis briefed the Conte petition for PLAC, he has his own speculation on that front to pass along.  At the time, Bexis heard from long-time members of the California bar that the justices largely didn’t come from civil litigation backgrounds, and weren’t all that interested in the area.  Only really “big” products cases − such as the asbestos-related issue in O’Neal can get their attention − despite Bexis letter brief in Conte laying out the parade of horribles.  Anyway, it’s all speculation.

On the merits, this particular Conte win is particularly gratifying because:  (1) it rejects a new plaintiff’s argument that we can expect to see elsewhere;  (2) it’s in state, rather than federal court;  (3) Oregon is not a particularly conservative jurisdiction, and (4) Oregon borders California, indicating that Conte isn’t having the kind of reach that earlier California product liability craziness (can you say "market share liability"?) did.

Thanks to Angela Higgins at Baker Sterchi for passing the transcript along.

Darvocet Plaintiffs' Hail Mary Batted Away

We’ve posted before about MDLs – and the Darvocet MDL in particular – being the new “heavyweight” division for the one-two punch of product identification (can’t sue non-manufacturers) and generic preemption (can't sue generic manufacturers) to dispose of meritless claims involving generic drugs on a large scale.


At the risk of mixing our sports metaphors, we can now report that the Darvocet plaintiffs’ attempted Hail Mary pass (if we were sticking to boxing, we might have gone with a head butt) to state court has been batted down.

After concluding that a positive product identification is required by the settled law of just about every state in the union, the MDL judge in Darvocet rejected plaintiffs’ attempt to tilt at that windmill through certification of the issue to no less than six state supreme courts simultaneously:  those being Arizona, Kentucky, Maryland, Oklahoma, South Carolina, and West Virginia.  We note that the original Darvocet order (we’ll call it “Darvocet I” to avoid confusion) involved far more than just those six states.  Darvocet I at 5 (citing precedent from Georgia, Indiana, Louisiana, Minnesota, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Texas, in addition to the six states).

We assume that plaintiffs cherry-picked those courts that they thought would be best for them (we’d do the same; lawyers are supposed to press such procedural edges).  We doubt it’s an availability issue, because the one state that we’re instantly familiar with – Pennsylvania – also has a certification procedure.  But why these six particular states, we don’t know.  None of the six has ever adopted market share liability in any context (the Oklahoma Supreme Court expressly rejected it in a DES case), so product identification is not in any sense an open question in any of them.

We guess that’s why the MDL court ruled the way it did.  Certification of an issue that’s not really open to serious question – as the court had already found the product identification requirement to be, Darvocet I at 9 (“many states have expressly rejected”), 12 (“overwhelming majority of courts” reject plaintiff’s position) – is a waste of time and effort.  On the other hand, where a court may be inclined to allow a novel theory of liability in a case that would otherwise be over without it, certification makes a lot of sense.  That’s why, as we’ve mentioned before, the same issue is currently teed up in the Alabama Supreme Court in a case we can’t say much about due to Dechert’s involvement.

Anyway, the latest Darvocet order doesn’t take away plaintiffs’ ordinary appeal rights in the federal system – denying only an extraordinary form of federal-to-state review.  What it does mean is that, having filed in federal court, plaintiffs cannot avoid the consequences of diversity jurisdiction, including the Erie principle (expressly referenced in Darvocet I, at 13 ) that federal courts are not supposed to predict radical changes in state law.  Plaintiffs can, of course, file a new certification motion in the Court of Appeals.  As to that, we can only point out that the Sixth Circuit had no trouble predicting on its own that Kentucky would follow established law.  Smith v. Wyeth, 657 F.3d 420, 423 (6th Cir. 2011).

Remembrance of Bad Cases Past

Someone (we don't remember who) once said that the mark of a cultured person is the ability to discuss the work of Marcel Proust without ever having read a word of it. Okay, here goes.

Proust wrote A la Recherche du Temps Perdu, which properly translates into In Search of Lost Time, though it traditionally has been called Remembrance of Things Past. Proust offered a theory of voluntary and involuntary memory. (Proust's father, by the way, was an epidemiologist). A voluntary memory is retrieved via conscious effort. Quick: who was your third-grade teacher? By contrast, an involuntary memory hits us unexpectedly. The most famous example of the latter is Proust's recollection of childhood after sniffing some fresh-baked Madeleines. That reminds us of our Evidence professor who said you could refresh a witness's recollection with anything, including a plate of spaghetti.

As we get older, we are getting way worse at voluntary memory, and way more susceptible to involuntary memory.

The other day we saw a very short opinion out of New York called Gianvito v. Premo Laboratories, (N.Y. App. Div., 1st Dept. March 20, 2012). The plaintiffs "allege that they suffered injury due to in utero exposure to the estrogen drug Diethylstilbrenol (DES), and they urge application of the 'market share' theory of liability." In about a page and a half, the Gianvito court decided that New Jersey law applies, that "New Jersey has not formally adopted a market share theory of liability in DES or similar cases," that "such a theory cannot be found based on dicta" from New Jersey cases, and that "to the extent New Jersey law is unsettled on this issue, we decline to expand the law therein to allow plaintiffs to allege a market share theory." It is the right result.

It also brought back memories of our Torts class in law school. These are not necessarily happy memories. Suspicion is provoked when we hear somebody look back with fondness at first year in law school. Still, we learned a couple of things that are worth holding onto besides the lyrics to "Rock the Casbah". For instance, we will always remember how the case of Sindell v. Abbott Laboratories, 26 Cal. 3d 588 (1980), introduced us to the fact that the law, especially in California, could be utterly crazy. It was not quite a loss of innocence, but it helped prepare us for a couple of decades of batty rulings.

The plaintiff in Sindell was a woman who had developed cancer as a result of her mother's use of DES during pregnancy. Because approximately 200 different companies had manufactured DES, and because so much time had passed, the plaintiff could not identify the manufacturer of the particular DES her mother had taken. She sued the five biggest DES manufacturers, which sold 90% of the DES during the relevant time. What to do? In a 4-3 opinion authored by Justice Mosk, the California Supreme Court held that the plaintiff could proceed on a market share theory of liability. The rule was that if all the defendants are potential tortfeasors, the product is fungible, the plaintiff is legitimately unable to identify the product that harmed her, and a substantial share of the manufacturers who produced the product during the relevant time period are named as defendants, then a rebuttable presumption arises in favor of the plaintiff and she can collect from each defendant a percentage of her damages equal to that defendant's market share at the time the product was used. A manufacturer may rebut the presumption by showing that its product could not possibly have injured the plaintiff.

The Sindell opinion was considered a Very Big Deal in the 1980s. It continued a trend in California law of treating the tort system as a form of social insurance. The plaintiff was absolutely innocent, whereas the defendants had made and sold a dangerous drug. The manufacturers were in a better position than the plaintiff to bear the costs and guard against future harm. Arguably, deterrence would be undermined if all manufacturers of a dangerous product eluded liability. Sindell was judicial policy-making plain and simple. You could debate whether it was good or bad policy, but you could not pretend it was not policy.

Sindell was also a pretty long walk down the road of collective responsibility. Sure, there have been other cases involving joint tortfeasors where it was hard to discern the specific culprit, such as a pair of quail hunters negligently discharging their shotguns toward a fellow hunter (Summers v. Tice, 33 Cal. 2d 80 (1948)) or one member of a hospital operating room screwing up (Ybarra v. Spangard, 25 Cal. 2d 486 (1944)), but the Sindell opinion puts a defendant on the hook merely for being in the marketplace. The opinion repeatedly cites a Fordham Law Review article, and in an oral memoir Justice Mosk stated that the article is what gave him the idea. Let that serve as proof of the pernicious influence of law review articles. Surely, we cannot be the only practitioner who regards law review articles as being somewhat useful to the extent they collect and categorize cases, but invariably useless when they go on to propose some new 'solution'.

The question back in the 1980s was whether Sindell was blazing a new trail or whether it was an aberration, a dead-end. We think it was mostly the latter. Gianvito is the latest example of a court refusing to buy the Sindell burden-and-cost-shifting theory. And courts have usually refused to extend Sindell beyond DES. True, the resolution of asbestos and Agent Orange litigation had some Sindell-stink. But they are isolated, regrettable exceptions. Most products are not perfectly fungible. Not all manufacturers act in the same way. Thus, in Skipworth v. Lead Industries Ass'n, 690 A.2d 169 (Pa. 1997), the court declined to apply market share liability to manufacturers of lead-based paint. Lead-based paint is not fungible. Plus, the house in question had been around for a century.

We are not comfortable with collective responsibility. We want evidence that a particular defendant did something wrong and harmed this particular plaintiff. If we remember correctly, in A Civil Action (the book, not the movie) there is a discussion of a hypothetical involving a plaintiff who was hit by a school bus. The plaintiff could not identify the particular school bus. There were two school bus companies in town -- call them A and B. Assume that A has 80 percent of the buses in town, and 80 percent of the business. Is that 80 percent share enough to prove by a preponderance of the evidence that A was liable? Or should the plaintiff recover 80 percent of her damages from A and 20 percent from B? Don't these approaches, while making sense on some sort of macro-epidemiological-social-insurance level, offend one's sense of justice?

On the whole, it seems to us that the judiciary has retreated from activism. Most judges are content to interpret law rather than engage in social engineering. Judicial activism is perilous. If you are going to act like a policy maker, then you will be treated like one. That is why SCOTUS confirmation hearings turned so ugly. If judges will make policy, they need to answer questions about their policy predilections. So the logic goes, anyway. Mind you, we write this hot on the heels of the Affordable Care Act oral arguments. It's heady stuff when we are thrust back on thoughts of Wickard and Lochner.

This is not to say that we are completely out of the woods. Sindell has mostly been relegated to the ash-heap of legal history. But its notion of assigning liability to defendants that did not manufacture the product in question has not completely vanished. Not surprisingly, it was a California court that issued the execrable Conte opinion, permitting a brand manufacturer to be held liable to a plaintiff who took the generic product. As we explained here, Conte is even worse than Sindell because the allegedly limiting factors in Sindell were absent in Conte. In Conte, the manufacturer of the peoduct at issue was known, and there was no long-delayed injury. We look forward to the day when the Conte doctrine is only a bad memory.

The New One-Two - Heavyweight Division

We’ve mentioned before how preemption is the strongest defense because (unlike Daubert or the learned intermediary rule) it bars claims without regard to their substantive merit.  When preemption applies in mass torts, such dismissals may occur on a wholesale basis.  In our prior post, “The New One-Two,” we described how potent preemption can be in generic drug cases when teamed with the traditional requirement of product identification as applicable to branded manufacturers.

The other day this "new one-two" scored a knockout in the heavyweight division, that is to say a federal multi-district litigation (“MDL”) – specifically the Darvon/ Propoxyphene MDL.  In two simultaneously issued opinions, the court disposed of what are likely to be the great bulk of the claims in the MDL.  Darvon is a drug that’s been around for decades, and which the FDA eventually decided to take off the market because newer drugs were, the agency believed, both safer and more effective.  That doesn't mean that Darvon was any less safe than before, but anytime there’s a recall, it seems somebody takes a shot at a mass tort.

No longer - at least for Darvon.

First, preemption. In In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL No. 2226, slip op. (E.D. Ky. Feb. 5, 2012), the court dismissed a comprehensive set of claims against generic makers of propoxyphene (the generic equivalent of Darvon), finding that all of the claims are either preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), or inadequately pleaded. Specifically:

• “Wrongful marketing” – that is, claims that the generic defendants should be liable for not removing their products from the markets altogether – are preempted because such allegations prove too much: “the idea that [defendants] should have simply stopped selling [the generic drug] is an oversimplified solution that could apply anytime the issue of impossibility preemption arises: avoid a conflict between state and federal law by withdrawing from the regulated conduct altogether.”  Slip op. at 7-8.
• Failure to warn claims based upon alleged “failure to timely change the labeling” after the FDA ordered it strengthened were barred because plaintiffs had no facts to support “purely conjectural” “information and belief” pleading.  Slip op. at 8-10.
• Likewise, no facts were alleged to support “Dear Doctor” letter-based claims.  In any event, such letters would involve new information, and thus labeling that was no longer the “same” as required by federal law.  Slip op. at 10 & n.9.
• That certain defendants were designated by the FDA as “reference listed drug” holders did not prevent preemption, because “the FDA, not the RLD holder, controls label changes” once such a designation is made.  Slip op. at 10-11.
• Claims for misrepresentation, fraud, consumer protection, and express warranty, were all preempted because they demanded labeling changes that were impossible under the federal “sameness” requirement.  Slip op. at 11-12.
• Plaintiff’s “statutory negligence” claims were based solely on allegations of FDCA violations (“mostly relating to labeling or ‘misbranding’”) and were thus preempted under Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), because there is no private FDCA right of action.  Slip op. at 12.

Because the MDL complaints had already been amended, and plaintiffs were not entitled to speculative discovery under TwIqbal, all of the generic complaints were dismissed with prejudice and without leave to amend.  Slip op. at 12-13.

That's one.

The second blow fell on the claims against the branded manufacturers of Darvon/Darvocet.  With the original manufacturer having sold all its NDA rights for these drugs in 2002 – seven years before the FDA ordered it off the market, it’s unlikely (given the timing) that many plaintiffs ever consumed a product actually produced by the branded manufacturer.  Failure to plead use of the branded defendant's product, the court held, was fatal to all every claim that the plaintiffs pleaded.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL No. 2226, slip op. at 5-14 (E.D. Ky. Feb. 5, 2012):

In every state implicated by [the branded] motions, it is well-settled law that a threshold requirement of any products-liability claim is that the plaintiff assert that the defendant’s product caused the plaintiff’s injury.  There is no theory of product liability under which a defendant can be held liable for an injury caused by a product that it did not sell, manufacture, or otherwise supply to the plaintiff.

Id. at 5 (citatons, quotation marks and footnote omitted). So far, so good.

But are “misrepresentation theories” subject to the same limitation?  The court held that they were:

[C]ourts in many states have expressly rejected the argument that misrepresentation claims are distinct from product liability or failure-to-warn claims [page-long string citation omitted]. [A]ll claims arising from the use of a product are properly characterized as “product liability claims.” Therefore, plaintiffs must properly identify the entity responsible for the product at issue in order to proceed.

Slip op. at 9-10.

Not only that, the court held that product manufacturers do not owe any duties to persons who never used their products:

[T]o hold [the branded defendant] liable for misrepresentation in cases that do not allege the ingestion of [its] product, plaintiffs must establish that [it] owed them (or their prescribing physician) a legal duty. [discussion of Conte and Kellogg omitted]. Conte and Kellogg represent a minority position, with the overwhelming majority of courts instead adopting a rule that rejects the contention that a name brand manufacturer’s statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer’s drug [second page-long string citation omitted].

Slip op. at 10-13.

And finally, crowning blow – principles of federalism preclude the MDL court from adopting the expansive, minority view “in the absence of binding authority” to the contrary.  Id. at 14.  Neither Conte (an intermediate appellate decision not even binding on other California appellate courts) nor Kellogg (by a federal district court) warrant the description "binding."

A federal court should hesitate to expand the scope of state law without guidance from that state’s highest court. Instead, “‘given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.

Slip op. at 13-14 (citations and quotation marks omitted).

YESSSSSSSSS!

This federalist principle is something we’ve been pounding on since the beginning of the blog, and we’re pleased to see it invoked in this context.

Thus the Darvocet/Darvon/Propoxyphene litigation is listed in both our generic preemption and branded/generic scorecards.  Out of curiosity, we took a look to see what other cases might also have achieved this distinction. We found five other 1-2 knockouts so far.

Of course, there is Mensing itself, with generic preemption recognized by the Supreme Court, 131 S. Ct. 2567, and branded non-liability in Mensing v. Wyeth, Inc., 588 F.3d 603, 612-14 (8th Cir. 2009), reaffirmed after remand, 658 F.3d 867 (8th Cir. 2011).

Also there’s Smith v. Wyeth, Inc., 657 F.3d. 420 (6th Cir. 2011) (applying Kentucky law), which affirmed generic preemption and branded product identification dismissals in the same opinion.

Then there’s the peripatetic Moretti case.  First, in Moretti v. Wyeth, Inc., 2009 WL 749532 (D. Nev. March 20, 2009), a Nevada court dismissed the claims against the branded defendant on product identification grounds.  Later, after Mensing, a different court, in Minnesota, held the same plaintiff’s claims were preempted as against the generic manufacturer.  Moretti v. Mutual Pharmaceutical Co., 2012 WL 465867 (D. Minn. Feb. 13, 2012).

In Morris v. Wyeth, the court first granted the branded manufacturer’s product identification motion.  2009 WL 4064103 (W.D. La. Nov. 23, 2009).  Then, after the Supreme Court decided Mensing, the court granted the generic defendant’s preemption motion.  2011 WL 4973839 (W.D. La. Oct. 19, 2011).  At the same time, the court declined to reconsider its dismissal of the branded defendant.  2011 WL 4975317 (W.D. La. Oct. 19, 2011).

The Bell litigation was a lot like Morris – only more recent.  First the branded manufacturer was dismissed. Bell v. Pfizer, Inc., 2011 WL 904161 (E.D. Ark. March 6, 2011).  Later, after Mensing, the generic manufacturer got out as well.  Bell v. PLIVA, Inc., 2012 WL 640742 (E.D. Ark. Feb. 16, 2012).

All these cases share the same attribute – they're "win-win" for the defendants.  And that's just about as good as it gets.

The State-of-the-Art Conte Defense

Because of Dechert's involvement in Reglan litigation, we can't say as much as we'd like to (or used to) about so-called "Conte" liability - that is theories by which plaintiffs who only took generic drugs attempt to impose liability on the manufacturer of a branded bioequivalent that they neither bought nor consumed.  As we mentioned previously, that issue is currently pending in the Alabama Supreme Court in Wyeth v. Weeks, its first appearance in a state high court.

We're willing to bet that the defense briefing in Weeks represents the current state of the art in defending/arguing against Conte-style liability.  For the benefit of everyone out there who is arguing against Conte, we're therefore providing four publicly filed briefs from the Weeks case:  those filed by defendant/appellant Wyeth (be patient, this one takes a while to download), amicus Product Liability Advisory Council, amicus Defense Research Institute, and amicus Pharmaceutical Research & Manufacturers of America.

Thanks to Kevin Newsom at Bradley Arent for the Wyeth brief, to Chilton Varner, at King & Spalding for the PLAC brief, and to Paul Schmidt and Mike Imbroscio at Covington & Burling for the PhRMA brief.  We grabbed the DRI brief from its website.

Foreseeability Gets Its Wings Clipped In California

Late last night we received this message from a correspondent (who will remain anonymous since we lack permission):

Hopefully the groundwork for getting Conte thrown-out has been laid.  Only a matter of time.  And with any luck we’ll have an opportunity some day soon.

Getting a message like that makes us sit up a little straighter.  So we took a look at the attached case, O’Neil v. Crane Co., S177401, slip op. (Cal. Jan. 12, 2011), and we can see what she’s talking about.

As readers may recall from our original rants about Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), we think that decision is just flat wrong.  The California Supreme Court’s unanimous decision in O’Neil only reinforces that view.

O’Neil involved asbestos.  The plaintiff worked on an aircraft carrier.  Decades before the plaintiff was aboard ship, one class of defendants made the carrier’s propulsion system.  Those defendants supplied products that had no asbestos at all, but were manufactured to specifications that required addition of asbestos insulation from other sources.  Slip op. at 2. They were sued because it was “foreseeable” that asbestos would be used in conjunction with their products.

A second group of defendants made the asbestos-containing gaskets that were components of the ship’s engines.  These gaskets wore out and were replaced by similar products made by others well before plaintiff was aboard ship.  Id.  They were sued because it was “foreseeable” that their products would wear out and be replaced by other asbestos-containing products.

In neither case did plaintiff allege that he was exposed to asbestos from any products actually sold by the defendants.  Slip op. at 6.

In O’Neil the court unanimously held that “foreseeability” did not trump the other policies animating product liability – and did so for both strict liability and negligence.

As to strict liability the court stated:

We have never held that strict liability extends to harm from entirely distinct products. . . . Instead, we have consistently adhered to the Greenman formulation requiring proof that the plaintiff suffered injury caused by a defect in the defendant’s own product.

Slip op. at 10.

There is no duty to warn in California about defects in another supplier’s product, even though the defendant also failed to warn about similar risks in its own product:

[Defendants] gave no warning about the dangers of asbestos . . . in their products.  However, [plaintiff] never encountered these original parts. His exposure to asbestos came from replacement gaskets and packing and external insulation added to defendants’ products long after their installation. . . .  There is no dispute that these [other] products were made by other manufacturers.  No case law supports the idea that a manufacturer, after selling a completed product to a purchaser, remains under a duty to warn the purchaser of potentially defective additional pieces of equipment that the purchaser may or may not use to complement the product bought from the manufacturer.

Slip op. at 15 (citation, quotation marks, and footnote omitted).  Substitute a prescribing physician for the navy in O’Neil and you’ve got Conte.

Imposition of warning duties relating solely to other manufacturers’ products goes “too far”:

An interpretation of [the law] that would require a manufacturer to warn about all potentially hazardous conditions surrounding the use of a product, even when those hazards arise entirely from the product of another manufacturer, reaches too far.  There is no precedent in California law for such a broad expansion of a product manufacturer’s duty.

Slip op. at 25-26.

Where the exposure comes solely from subsequent exposure to other manufacturer’s products, there is no warning liability based on “foreseeability.”  “California law does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together.”  Slip op. at 27.  “[T]he foreseeability of harm, standing alone, is not a sufficient basis for imposing strict liability on the manufacturer of a nondefective product, or one whose arguably defective product does not actually cause harm.”  Id. at 28.

We reaffirm that a product manufacturer generally may not be held strictly liable for harm caused by another manufacturer’s product.  The only exceptions to this rule arise when the defendant bears some direct responsibility for the harm, either because the defendant’s own product contributed substantially to the harm, or because the defendant participated substantially in creating a harmful combined use of the products.

Id. (citations omitted).

Public policy requires that product liability be limited to the manufacturers of products that actually cause harm.

• “[A] manufacturer cannot be expected to exert pressure on other manufacturers to make their products safe.” Slip op. at 30.
• Non-manufacturers “will not be able to share the costs of ensuring product safety with these other manufacturers.”  Id.
• “It is also unfair to require manufacturers of nondefective products to shoulder a burden of liability when they derived no economic benefit from the sale of the products that injured the plaintiff.”  Id.
• “[I]mpos[ing] on manufacturers the responsibility and costs of becoming experts in other manufacturers’ products . . . would impose an excessive and unrealistic burden.”  Id. (citation omitted).

Now, Conte involved a “negligent misrepresentation” claim rather than strict liability, but that won't save it from O'Neil.  See 85 Cal. Rptr.3d at 310 (“this is a case involving legal principles of negligent misrepresentation, and not a products liability action”), 310 n.7 (“negligent misrepresentation will subsume intentional fraud”).

O’Neil goes on to reach the same result – holding that there is no equivalent non-manufacturer liability claim in negligence.  The California Supreme Court directly addresses “foreseeability” and its limits, applying the public policy factors that Conte refused to address.  “[I]n strict liability as in negligence, foreseeability alone is not sufficient to create an independent tort duty.” O'Neil, slip op. at 29 (citation and quotation marks omitted) (emphasis added).  “Duty” in negligence “is not an immutable fact of nature but only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection.”  Id. at 30-31.

The plaintiff in O'Neil argued foreseeability uber alles.  The court did not agree:

[F]oreseeability alone is not sufficient to create an independent tort duty. Instead, the recognition of a legal duty of care depends upon the foreseeability of the risk and a weighing of policy considerations for and against imposition of liability.

Slip op. at 31 (citations and quotation marks omitted).  Rather, “when the consequences of a negligent act must be limited to avoid an intolerable burden on society, policy considerations may dictate a cause of action should not be sanctioned no matter how foreseeable the risk.  Id. (citation and quotation marks omitted).

These “policy considerations” (the same Rowland v. Christian factors that Conte ignored, 85 Cal. Rptr.3d at 814) mandate no liability where product-related claims are being made against non-manufacturers.

• The connection between defendants’ conduct and [plaintiff’s] injury is extremely remote because defendants did not manufacture, sell, or supply any . . . product that may have caused his [injury].”  O’Neil, slip op. at 32.
• Plaintiff’s injury is “attenuated,” as it occurred decades after the allegedly negligent conduct  Id.
• “[L]ittle moral blame can attach to a failure to warn about dangerous aspects of other manufacturers’ products.”  Id.
• “There is no reason to think a product manufacturer will be able to exert any control over the safety of . . . products made by other companies.”  Id.
• “Manufacturers may also have scant ability to influence their customers’ choices about other products.”  Id.
• “[R]ecognizing a duty of care would clearly impose a significant burden on defendants and all other companies that could potentially be held liable for injuries caused by products they neither made nor sold.”  Id. at 33.
• “[R]ecognition of such a duty could lead to an overabundance of potentially conflicting product warnings.”  Id.
• “[I]t is doubtful that manufacturers could insure against the “unknowable risks and hazards” of other manufacturers’ products used decades later.  Id.

For all these reasons, the court in O’Neil unanimously held that, regardless of foreseeability, there should be no negligence liability against the manufacturer of one product for injuries caused by similar products manufactured by other companies:

[E]xpansion of the duty of care as urged here would impose an obligation to compensate on those whose products caused the plaintiffs no harm. To do so would exceed the boundaries established over decades of product liability law. [S]ocial policy must at some point intervene to delimit liability even for foreseeable injury. The same policy considerations that militate against imposing strict liability in this situation apply with equal force in the context of negligence.

Slip op. at 33 (citations and quotation marks omitted).

We hope, as did our anonymous correspondent, that O’Neil spells the beginning of the end for Conte.

Breaking News - The New One-Two

We just received from defense counsel Matt Wender at Pietragallo Gordon a copy of Moore v. Mylan, Inc., No. 11:1-CV-03037-MHS, slip op. (N.D. Ga. Jan. 5, 2012).  It's another post-Mensing case holding:  (1) that the plaintiff can only sue a maker of the drug s/he took (whatever that might turn out to be in this case), and (2) dismissing the generic on the basis of preemption.

As to product identification, Moore, applies well-settled Georgia law:

Moreover, the plaintiff needs to establish that the product that allegedly caused the injury was in fact manufactured or supplied by the defendant.  Plaintiffs allegations in her complaint fail to state a claim for strict liability under Georgia law . . . Third, setting aside the lack of specific factual information regarding [defect claims], plaintiff has not even alleged that a phenytoin product designed or manufactured by [one or the other of the defendants] proximately caused plaintiffs injuries.  It is unclear from plaintiffs complaint whether [the branded or generic defendant] manufactured, distributed, supplied, or sold the product that the decedent ingested.

Moore, slip op. at 12-14 (citations omitted); accord id. at 32 (additional causes of action).  Plaintiff's complaint was so poorly pleaded that that product identification was wholly lacking as to any defendant.  Other branded related rulings are:  (1) all warning claims other than as to the plaintiff's physician are barred by the learned intermediary rule, id. at 9-10; and (2) fraud claims were not pleaded with particularity, id. at 29-30.

As to preemption, the court held that the fact that the defendant generic was also a reference listed drug ("RLD") did not preclude preemption.  As far as we know, Moore is the first decision thoroughly discussing RLD issues.  The court holds:  (1) that being the RLD for one strength of a generic product does not give the generic manufacturer the ability to change the label unilaterally on another strength of drug.  "Thus, because 100-mg and 300-mg are two different products, plaintiff has not shown any authority that would have required [defendant] to change the label of 100-mg to conform to the 300-mg label."  Slip op. at 21-22.  (2) The RLD for the strength that the plaintiff used continued to be a branded product, therefore the Mensing rationale for preemption fully applied.  Id. at 22.  (3) There's no authority that becoming an RLD gives a generic manufacturer rights to change the label unilaterally:

[P]laintiff has not shown how [defendant] acquired all of the same rights as a brand name drug manufacturer simply by manufacturing one drug that was an RLD.  Plaintiff has not shown that [defendant's] manufacture of one RLD converted [defendant] into brand name drug manufacturer with the right to use the CBE process to change the label of any of its drugs.

Id. at 21-22.

Another notable generic preemption ruling in Moore is that any claim that the defendant should simply have stopped selling its product is preempted.  Id.  at 34 n.14.

Plaintiff was given leave to file an "amended complaint [that] should address the concerns in this order."  Id. at 37.

We'll be adding Moore to both our generic preemption and branded/generic scorecards.

New Stuff #3

We can’t say much about it because we’re involved in the metoclopramide litigation, but those of you involved in product liability suits involving generic drugs will want to review Fullington v. PLIVA, Inc., 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011), for the following propositions:


(1) Warning-related claims involving generic drugs are preempted under Mensing, no matter what a plaintiff calls them.  Fullington, 2011 WL 6153608, at *4-5.

(2) Manufacturing defect claims can’t be pleaded under TwIqbal without pleading either an act of manufacturing or defect.  Id. at *5.

(3) Design defect claims can’t be pleaded under TwIqbal without pleading either an act of designing or defect.  Id. at *5.

(4) Plaintiffs may not escape preemption by arguing that a generic drug should have been removed from the market altogether.  Id. at *6.

(5) Nothing in Mensing did (or could) change state law that product-related claims only lie against the manufacturer of the product that the plaintiff actually used.  Id. at *6.

Thanks to Kurt Karst at the FDA Law Blog for passing this decision along.

Alabama Update

Back in April, we put up a post complaining about Weeks v. Wyeth, 2011 WL 1216501 (M.D. Ala. March 31, 2011), one of the few courts anywhere not to dismiss a Conte-type non-manufacturer liability claim for failure to state a claim.  Instead, contrary to five prior Alabama decisions (and literally scores of cases nationwide, see our branded in generic case scorecard), Weeks allowed a plaintiff who solely used a generic product (and only paid generic prices) to proceed with a pure foreseeability/fraud claim against the “brand name” manufacturer of a drug that the plaintiff never used.

Anyway, after restating all our gripes about Conte-style non-manufacturer liability, we closed that post with:

We can only hope that appropriate appellate supervision - preferably by the Alabama Supreme Court - isn't long in coming.

We’re pleased to tell you that this wish, at least, has come true.  The defendant in Weeks (we’re involved, so we can’t say much) sought certification, and at the end of July the district court judge in Weeks granted the request to certify the question.  Here’s a copy of that order.

More importantly, On October 17, 2011, the Alabama Supreme Court accepted the certification.  Here’s a copy of the high court’s order. Also, here’s the language of the certified question, as the court accepted it:

Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?

As our scorecard indicates, while three federal appellate courts (Foster (4th), Mensing (8th - the part that the Supreme Court did not reverse), and Smith (6th)) have rejected expanding brand name liability along the lines that the plaintiffs seek in Weeks – no state high court has ever addressed this type of liability theory.  Weeks will be the first.

We’ll be rooting for a big D win, and we'll let you know if and when that happens.

The New One-Two

As you can tell from our old drug preemption cheat sheet (before we split off generic preemption after Mensing), the Smith/Morris/Wilson trilogy out of Kentucky has been hanging fire for quite awhile, since before Levine, actually.  No longer.  Today the Sixth Circuit ruled and delivered a one-two punch that's precisely the winning combination that we're looking for.  Smith, et al. v. Wyeth, Inc., ___ F.3d ___, slip op. (6th Cir. Sept. 22, 2011).

It's a situation we've seen a lot in generic drug cases.  These plaintiffs, having taken nothing but the generic product (actually one did not fit that scenario here), claim some sort of injury and sue not only the maker of the generic drug that actually injured them, but also sue the original brand name manufacturer (who never made a penny from selling the plaintiff anything) under some woolly, attenuated reliance theory.

Well, the Sixth Circuit had none of it in Smith.  First, without any trouble at all, the court held that the warning claims against the generics were preempted:

Just as in the present case, the plaintiffs in Mensing alleged that their long-term use of generic [drug] caused [injury], and they predicated the manufacturers’ liability under state law on the failure to provide adequate warnings on the product’s label.  The Supreme Court held unequivocally, however, that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug’s label, thus barring the plaintiffs’ state-law tort claims. The plain language of the Pliva decision compels the same result here.

Smith, slip op. at 4 (6th Cir. Sept. 22, 2011).  That's the right hook to the jaw.

The Sixth Circuit also refused to have anything to do with allegations that branded manufacturers could be liable for defects in drugs they did not make or sell - but were in fact sold by their competitors.  "Just because a company is in the same business as a tortfeasor, the company is not automatically liable for the harm caused by the tortfeasor’s product."  Slip op. at 5 (quoting district court).  Kentucky law, the court held, did not allow that.  "A threshold requirement of any products-liability claim is that the plaintiff assert that the defendant’s product caused the plaintiff’s injury."  Smith, slip op. at 5 (citing Kentucky Supreme Court case).  The other, pure foreseeability, theories have been rejected almost anywhere, the court observed, and then agreed, deciding that Kentucky would not permit anything so adventurous under its product liability statute:

The plaintiffs’ argument – that the name-brand defendants’ liability stems from the fact that the regulatory structure governing name-brand and generic drugs makes it foreseeable that patients and their physicians will rely on the name-brand labels to use and prescribe generic drugs – has been rejected by all but one of the courts that have considered it. [discussing and agreeing with Foster v. AHPC, 29 F.3d 165 (4th Cir. 1994) as "the leading case"; identifying Conte as exception]  As have the majority of courts to address this question, we reject the argument that a name-brand drug manufacturer owes a duty of care to individuals who have never taken the drug actually manufactured by that company.  Moreover, and most significantly, the plaintiffs have not convinced us that the state courts of Kentucky would adopt their vicarious-liability argument under the Kentucky Products Liability Act.

Smith, slip op. at 6 (emphasis added).  That's the left cross to the temple, and plaintiffs are down for the count.

As the first court of appeals ruling post-Mensing on both issues, Smith promises to be an important case.

We'll be adding Smith to the relevant scorecards in a moment.

Thanks to Alan Klein of Duane Morris and Dave Schaefer at Dinsmore & Shohl, both for independently tipping us off within about ten minutes of each other.

We Dare Defend Established Alabama Law

We have to admit that we’re scratching out heads about a recent decision out of Alabama that – contrary to everything else we’ve seen – concluded that the manufacturer of a branded drug could be liable in a case where it never sold the generic product that was all the plaintiff every took and thereby (allegedly) suffered injury.


It’s not like this issue hasn’t been litigated before in Alabama.

The first Alabama case we know of to consider the issue was Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 WL 5787186 (S.D. Ala. April 24, 2007), a Stephens-Johnson case where the plaintiff took cephalexin, a generic form of Keflex, but nevertheless tried to sue the manufacturer of branded Keflex.  The court held that no non-manufacturer product liability cause of action existed under Restatement (Second) of Torts §402B (a strict liability form of misrepresentation), for negligent failure to warn, for negligent failure to test (which shouldn’t exist at all), for negligent design, for negligent marketing and sale, for negligent manufacturing, for negligent failure to training physicians, and breach of express and implied warranty.  The court found all of these theories “essentially nonexistent” against a non-manufacturer, and that there was no evidence that the branded defendant was somehow an licensee, agent, or co-conspirator with the generic manufacturer.  Id. at *1-2

That’s one.

Next, in Green v. Wyeth Pharmaceuticals, Inc., 2007 WL 6428717 (Ala. Cir. May 14, 2007), an Alabama state court judge reached the same conclusion in a metoclopramide/Reglan case:

The majority of courts that have considered the issues presented in this case have found that only the manufacturer of the generic drug which was sold are liable.  The cases cited by defendants are persuasive that [non-manufacturing] defendants . . . are not liable.

Id. at *1.

That’s two.

Fast forward a few years, and in Mosley v. Wyeth, Inc., 719 F. Supp.2d 1340 (S.D. Ala. 2010), another metoclopramide/Reglan case, the court threw out negligent misrepresentation, fraud, and warranty theories against manufacturers of both branded and generic products that the plaintiff admittedly never used.  In Mosley the plaintiffs claimed:  (1) that the FDCA made branded manufacturers “primarily responsible” for labeling even for drugs they didn’t sell, and (2) that the branded manufacturer “created a sense of security and safety” through dissemination of supposedly “false” information about its own drug.  Id. at 1344.

Mosley accepted that plaintiffs, having fled from product liability, “did not argue that the defendants’ product caused them harm, but rather that their dissemination of false and misleading information, which they knew would be relied upon by the generic manufacturers in generating their own labels, was a direct and proximate cause of plaintiffs' injuries.”  Id. at 1344-45. That didn’t turn out to change the bottom line in Mosley - no liability.

Rather, Mosley dismissed the misrepresentation claim because the Alabama Supreme Court had never included product manufacturers within the category of persons who could be liable for “supply[ing] information” as “part of their business or profession” for “the guidance of others in their business transactions.”  Id. at 1346 (construing Restatement (Second) of Torts §552).  Product liability plaintiffs are not suing over “business transactions,” and the Alabama Supreme Court has only applied §552 in “limited circumstances” that did not include product warnings made to non-customers.  Id.

There was also no viable fraud claim in Mosley under Alabama law where the defendant was not a manufacturer of the product that injured the plaintiff.  Alabama has rejected market share liability and similar non-manufacturer theories in cases involving alleged product-related injuries.  Id. (citing Franklin County School Board v. Lake Asbestos of Quebec, Ltd., 1986 WL 69060, at *6 (N.D. Ala. Feb. 13, 1986)).  No fraud claim had ever been permitted in Alabama to hold a manufacturer liable for injuries caused by the products of a competing manufacturer:

The plaintiffs present no evidence or argument tending to establish that a relationship existed between [plaintiffs] and the [non-manufacturer defendants].  The plaintiffs cite no binding authority for the assertion that a manufacturer of brand-name drugs owes a duty to consumers of the generic version of their products.  Nor do [they] cite any binding authority for the contention that an injury resulting from consumption of a generic version of the drug can be considered a “proximate consequence” of a manufacturer's alleged misrepresentation regarding the brand-name version of the drug.

Mosley, 719 F. Supp.2d at 1347.

Nor did the FDA’s regulatory scheme mandate that brand name manufacturers be liable for competing generic products.  Nothing in the FDCA revealed an intent to change common-law duties.  Rather “generic manufacturers bear the same burden as brand manufacturers of providing a warning that adequately describes the risks associated with the particular drug they are manufacturing.”  Id. at 1348.

Likewise express and implied UCC warranty claims fail where there isn’t any contact between the plaintiffs and the “goods” that were allegedly subject to the breached warranties:

[Plaintiff] cite no authority holding that [UCC] §7-2-318 . . ., as adopted in any other jurisdiction-provides a cause of action to plaintiffs who were neither purchases, users, or consumers of, nor in contact with, goods produced by the manufacturer against whom they claim breach of warranty resulting in personal injury.

719 F. Supp.2d at 1351.  The court in Mosley refused plaintiffs’ “invitation” to be come the first court to do so.  Id.

That’s three – and the third one was a whopper.

Next, in Simpson v. Wyeth, Inc., 2010 WL 5485812 (Mag. N.D. Ala. Dec. 9, 2010), adopted, 2011 WL 10607 (N.D. Ala. Jan. 4, 2011), yet another metoclopramide/Reglan case, the plaintiffs conceded negligence, strict liability, and warranty.  Instead they argued that, by virtue of prior branded drug sales, the non-manufacturer “entered into a relationship with plaintiffs’ prescribing physicians that required them to notify those physicians of” allegedly suppressed information, even in the absence of prescription in a particular case.  Id. at *2.  They further claimed that if the prescribers had known of the “true” risks of the branded drug, they would not have prescribed the generic either.  Id.

In Simpson plaintiffs claimed that a general fraud proposition – that fraud can pass through intermediate “third parties” – allowed a non-manufacturer claim, when tied to the learned intermediary rule.  Id.  No way, said the court.  There was no duty.  The learned intermediary rule was a product liability doctrine, and plaintiffs could not cloak themselves in a product liability doctrine while at the same time violating the fundamental tenet of product liability, which is that manufacturers are the liable parties:

“[U]nder the learned intermediary doctrine, a manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product.”  Thus, the duty to warn of risks related to the use of a drug is owed to the prescribing physician by the drug manufacturer, not some other manufacturer of the same or a similar product.  As a matter of law, the manufacturers of [a drug] have no duty to communicate any information regarding the risks of taking this product to anyone other than their own customers.

2010 WL 5485812, at *5 (quoting Walls v. Alpharma USPD, Inc., 887 So.2d 881, 883 (Ala. 2004)) (emphasis added).

That’s four.

Finally, in Overton v. Wyeth, Inc., 2011 WL 1343392 (Mag. S.D. Ala. March 15, 2011), adopted, 2011 WL 1343391 (S.D. Ala. April 7, 2011), pretty much the same result ensued, after the plaintiff was forced to amend her complaint to identify who did and did not manufacture the metoclopramide she took.  “[I]t is abundantly clear . . . that Plaintiff cannot state a claim against the Brand Name Defendants.”  Id. at *5.

Misrepresentation under Ala. Code. §6-5-101 required that a duty to disclose be owed to the particular plaintiff.  As in Mosley and Simpson, the non-product liability fraud claims foundered on lack of either duty or causation.  There is “no binding authority for the assertion that a manufacturer of brand-name drugs owes a duty to consumers of the generic version of their products.”  2011 WL 1343392, at *7.  Nor can “an injury resulting from consumption of a generic version of the drug can be considered a ‘proximate consequence’ of a manufacturer’s alleged misrepresentation regarding the brand-name version of the drug.”  Id.

Overton also rejected the FDA-created duty theory.  Id. at *7 n.9.  UCC warranty claims also failed because the statute’s anti-privity language required the plaintiff to have been “affected” by “the goods” themselves, not merely by purported “negligent misrepresentations in the warning labels.”  Id. at *7.

That’s five – including three – Mosley, Simpson, and Overton, that specifically addressed and just as specifically rejected the plaintiffs’ non-product liability theories that did not depend upon any “defect” in the generic product or its warnings.

So what just happened in Weeks v. Wyeth, Inc., 2011 WL 1216501 (M.D. Ala. March 31, 2011)?

For one thing, we’d have to say that that federalist concerns for the power of state courts to develop state tort law got mugged.

Weeks was essentially indistinguishable from, at least, Mosley, Simpson, and Overton, since plaintiffs suing over the same drug in the same situation asserted the same product liability and non-product liability theories of liability.  First, the Weeks court conceded that “a brand name manufacturer has no duty to warn a consumer about a generic manufacturer's drug.” 2011 WL 1216501, at *3, and dismissed all the product-related claims.  However, the court interpreted the plaintiff’s allegations as asserting an independent duty to warn “prescribing physicians,” including the doctor who prescribed the drug to the plaintiff, irrespective of product use.  In the words of the court:

[Plaintiffs’] claims center, however, on statements the brand name defendants made or failed to make to [the] prescribing physician. Specifically, [plaintiffs] argue that the brand name defendants had a duty to disclose information about Reglan, the product they did manufacture, to [the] physician. . . . They also claim that the brand name defendants’ failure to adequately warn prescribing physicians about Reglan’s side effects caused [the prescriber] to prescribe generic MCP for extended use.

When framed in this way, [plaintiffs] would not be required to demonstrate that the brand name manufacturers had a duty to warn about generic MCP. [Plaintiffs] would not even have to demonstrate that the brand name defendants owed a duty to [the patient] himself, only that the brand name defendants owed a duty to the prescribing physician to adequately disclose and warn about the risks associated with Reglan.

Weeks, 2011 WL 1216501, at *3 (emphasis added).

Whoa!  Let’s think about that.

That analysis isn’t a restatement of the learned intermediary rule – at least not any learned intermediary rule we’re familiar with.  Rather than a duty to warn the prescriber of the drug that injured the plaintiff, Weeks postulates that drug manufacturers have some broad, nebulous duty to warn the medical community as a whole, totally divorced from what drug any particular doctor actually prescribed to any particular patient, since this purported duty extends to situations where the defendant’s drug was not in fact prescribed to the patient.

Is that something that Alabama recognizes?  We don't think so.

Alabama has followed the learned intermediary rule since Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1305 (Ala. 1984).  In Stone, the Court was explicit that the learned intermediary rule involved “the manufacturer’s” duty involving “the use” of its “drug”.  “[T]he manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use.”  447 So.2d at 1304 (quoting Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974)) (emphasis added).

The learned intermediary rule next came up in Morguson v. 3M Co., 857 So.2d 796 (Ala. 2003), involving a device that included some tubing.  Again, the duty to warn under the learned intermediary rule was limited to the physician actually using the defendant’s product.  “[Defendant’s] duty was to warn the physicians and perfusionists at [the hospital] who used the vent tubing.”  Id. at 802 (emphasis added).

In Walls v. Alpharma USPD, Inc., 887 So.2d 881, 883 (Ala. 2004), the Court decided that the learned intermediary rule precluded liability against a pharmacist for failing to warn the plaintiff.  The Court once again stated the rule in terms of warnings about the uses of particular products:

Under the learned intermediary doctrine, a manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product.  This standard is an understandable exception to the Restatement's general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products.

Id. at 883 (quoting Toole v. Baxter Healthcare Corp., 235 F.3d 1307, 1313-14 (11th Cir. 2000) (applying Alabama law)) (emphasis added).

Finally, in Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513 (Ala. 2008), the Court provided its most recent interpretation of Alabama’s learned intermediary rule in another pharmacist situation – where a pharmacist voluntarily provided information about the same drug that the plaintiff in fact took.  The Court once again refused to expand warning duties under the learned intermediary rule beyond a manufacturer’s “customers”:

In those cases [Stone and Walls], the duty at issue was a drug manufacturer's or a drug dispenser’s duty to warn customers.  Here, the duty at issue is not a duty to warn a customer . . . of potential risks or side effects, but a duty of care, allegedly breached by [a pharmacist] when he gave [a prescriber] allegedly incomplete dosing information.

Id. at 518 (emphasis added).  The alleged warning duty – going beyond “customers” – did not exist:

In light of the foregoing, we are unpersuaded by the estate’s argument that [the pharmacist] voluntarily assumed a duty of care when he answered [the prescriber’s] question. . . .  Because we find the principles articulated in Walls and Stone applicable to this case, we hold that the learned-intermediary doctrine precludes [the pharmacist’s] liability for harm resulting from any mistakes on [the prescriber’s] part in prescribing [the drug].

Id. at 521 (emphasis added).

Thus, in all four cases in which the Alabama Supreme Court has interpreted the state’s learned intermediary rule, it has never once suggested that the scope of a manufacturer’s duty to warn extends beyond those persons actually using the drug that the manufacturer's warnings accompanied.  The quote from Toole, that the Alabama Supreme Court adopted in Walls, demonstrates that the Eleventh Circuit has likewise not expanded liability in the way envisioned in Weeks.  No Alabama law case has applied the learned intermediary rule to allow liability where the doctor in question never treated the plaintiff with products that the defendant actually made.  See also Toole v. McClintock, 999 F.2d 1430, 1433 (11th Cir. 1993) (breast implant maker owed duty to physician who implanted its product) (applying Alabama law); Southern v. Pfizer, Inc., 471 F.Supp.2d 1207, 1218 (N.D. Ala. 2006) (drug reps cannot be liable under learned intermediary rule, even where their employer’s drugs were prescribed); Bloodsworth v. Smith & Nephew, 2005 WL 3470337, at *7 (M.D. Ala. Dec. 19, 2005) (same with respect to device manufacturer’s representative); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1296 (N.D. Ala. 2003) (no liability under learned intermediary rule where doctor failed to follow manufacturer’s warnings about its own product).  In Alabama, the learned intermediary rule has never previously been construed as creating duties to the “medical profession” in the abstract.

That’s not to say that plaintiffs haven’t argued before in favor of a broad duty owed to the medical profession as a whole.  They used to, but to no avail.  For instance, in Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 91 (2d Cir. 1980), the court rejected such an argument under New York law:

It is somewhat misleading to say that defendant owed a duty to warn the “medical profession”.  We are not concerned here with whether adequate warnings were given to chiropodists in California or orthopedists in Arizona.  [Plaintiff] contends that [the defendant’s] drug was defective as to her because [defendant] did not adequately warn her doctors.  So far as these plaintiffs are concerned, if [defendant] adequately warned [plaintiff’s] doctors, the drugs were not defective.

Id. at 91.  Likewise, in Desmarais v. Dow Corning Corp., 712 F. Supp. 13 (D. Conn. 1989), the court, applying Connecticut law, held:

Warnings to the medical profession generally rather than to individual prescribing physicians would be illogical and contrary to the very policy and purpose underlying the learned intermediary doctrine and the duty to warn.  Unless the individual prescribing physician receives specific, relevant warnings, she cannot make a careful, balanced assessment of the risks and benefits to her patient, nor can the patient herself be adequately informed.  Thus, the learned intermediary doctrine does not alter the duty of a manufacturer to provide adequate warnings of risks with each product sold; rather, the doctrine simply substitutes the physician for the consumer as the person to receive those warnings.

Id. at 18.

There is thus no basis in Alabama law (or any other state’s law, save maybe the bizarre California Conte case) for expanding the learned intermediary rule to the medical profession generally, without regard to what doctor prescribed what drug to what patient.  Indeed, the court in Weeks admits that there is no “case on point.”  2011 WL 1216501, at *6.  The plaintiff's claim in Weeks was allowed to proceed only after the court imposed a burden on the defendant to come up with precedent affirmatively debunking the existence of this novel cause of action:

[T]he Court finds that neither side has provided a case on point.  The defendants' cases do not establish that a relationship between [plaintiffs] and the brand name defendants is required when the plaintiff’s claims are based on fraud perpetrated against the prescribing physician.  Therefore, the defendants have not demonstrated, based on this argument, that [plaintiffs] fail to state a claim for which relief can be granted.

Id.

Thus the root cause of this Alabama muddle is the same fundamental Erie doctrine principle upon which we have harped time and time again. The Weeks court failed to respect Alabama’s right, as a co-sovereign in our federal system, to decide when and if to expand its own tort liability.  When in doubt – and even Weeks conceded that there is doubt – a federal court sitting in diversity should refrain from expansive interpretations of state-law tort liability:

A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975); see Seaboard Surety Co. v. Garrison, Webb & Stanaland, P.A., 823 F.2d 434, 438 (11th Cir. 1987) (in a “federal forum” a plaintiff “must abide by federal determination as to the present state of [state] law”); Lee v. Hunt, 631 F.2d 1171, 1175 (5th Cir. 1980) (quoting and following Day & Zimmerman).

We can only hope that appropriate appellate supervision - preferably by the Alabama Supreme Court - isn't long in coming.