Breaking News - Another Aredia Win

Another remanded Aredia/Zometa case has apparently bitten the dust.  See Ingram v. Novartis Pharmaceuticals Corp., No Civ-05-913-L, slip op. (W.D. Okla. July 18, 2012).  Ingram threw out all of the plaintiff's on warning causation grounds, a strong defense in this litigation, which involves a drug used to treat cancer.  A basic problem that plaintiffs face in such situations is that, when the alternative is likely death by cancer, most prescribing oncologists aren't going to be swayed by the possibility of a much lesser injury (with bisphosphonates, osteonecrosis of the jaw).  So an allegedly defective warning about the lesser injury won't deter anything.

The law, in Oklahoma as elsewhere, requires warning causation - some material change in prescriber conduct:
Slip op. at 6.

Even if the plaintiff establishes a duty to warn and a breach of that duty, she must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.

Slip op. at 4. Oklahoma is one of those unfortunate jurisdictions that applies a heeding presumption even in pharmaceutical cases, but for the reasons we discussed above, it was easily rebutted in Ingram.

[The prescriber] testified that had he known of [the drug's] potential complication of osteonecrosis of the jaw, he would have prescribed it for [plaintiff's decedent] anyway.  This testimony establishes that although the prescribing physician . . . would have read and heeded the warnings regarding [the drug] and ONJ, this would not have changed [the prescriber's] decision to prescribe it to [the decedent].

As is also common in these cases, plaintiff tried to salvage the case with lesser causation evidence - that the prescriber, while still using the drug, now gives various advice about dental issues.  Slip op. at 6-7.  That didn't work in Ingram because even the plaintiff's own expert (a Dr. Marx - is that Harpo, Groucho, Chico, or Zeppo?) admitted that the decedent already had ONJ. Slip op. at 8:

When this finding [pre-existing ONJ] is kept in mind, it is clear that plaintiff’s arguments regarding [the prescriber's] changed prescribing practices are insufficient to discharge her burden of proof on proximate causation.  As demonstrated above, [the prescriber] has unequivocally testified that had he known in January of 1999 that [the drug] had the potential complication of ONJ, he would have prescribed it for [the decedent] anyway.

Slip op. at 8.

The court also throws out plaintiff’s wrongful death claim, because it wasn't supported by any expert testimony.  We've commented previously about the weakness of many of the cases we're seeing after remand from the A/Z MDL, and judging by the expert testimony here, Ingram looks like another.

In any event put another one in the "W" column for the Hollingsworth Aredia team.

Twice Nice?

Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues.  Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses.  We also felt that way while we were involved in the Fagan v. AmsourceBergen litigation involving the then novel concept of liability of non-counterfeitors for injuries caused by counterfeit drugs.

We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way.  We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.

Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field.  The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling.  2011 WL 4470701, at *3.  Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use:  the reprocessing and reuse of products whose labeling is limited to single use.  Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices).  After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart.  Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own).  Plaintiff sued both the aftermarket and original equipment manufacturers.

The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.

Futile Dear Doctor letters:  In a claim analogous to what we’ve been seeing post-Mensing against generic drug manufacturers (indeed, the court references generic drugs explicitly, 2011 WL 4470701, at *24), the plaintiff claimed that the original manufacturer should have issued a Dear Doctor letter warning against use of reprocessed products.

The court assumed a duty and then assumed that such a letter was permissible under FDA regulations – but still blew out the claim.  There was no possible causal effect in warning heart surgeons to be especially careful during heart surgery:

[I]f a plaintiff's proposed warning would not have changed anyone’s behavior, a product cannot be defective for lacking that warning.  Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”?  Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart.

2011 WL 4470701, at *24.  Whoop!  Whoop!  Common sense alert!

There was also “not a shred of evidence” that this kind of content-free advice would have changed the result, id., particularly since, after learning the hard way the very information the Dear Doctor letter would have provided, the surgeons in question hadn’t changed their behavior in any way.  Id. at *25.

Regulatory informed consent asserted against a manufacturer. Say what?  We've seen plaintiffs sue doctors claiming that they wouldn’t have consented to a treatment if they knew it was off-label.  That’s one of the claims we killed in Bone Screw.  In Kapps, however, the plaintiff tried to turn the same argument on a manufacturer, claiming that since the prescriber testified he wouldn’t have used the product had he known there was no FDA approval (this argument assumes that minor modifications = unapproved), then the learned intermediary rule gives him a cause of action against the manufacturer.  2011 WL 4470701, at *20.

Umm....  No it doesn't.

First we find a ringing endorsement of the learned intermediary rule as a shield, not a sword:

The learned-intermediary doctrine is a defensive doctrine, not an offensive one.  It is raised by makers of drugs or medical devices who are accused of failing to warn about the dangers associated with their products.

2011 WL 4470701, at *20.  The court follows with equally good language about the limits of the duty to warn under the rule:

A manufacturer does not have a duty to communicate any and all information that might affect a customer’s decision to use one of its products.  For example, a manufacturer does not have to communicate that the product was made with child labor or that the manufacturer’s president has been convicted of fraud, even though such “warnings” might induce customers not to use the product.  The duty to warn is much narrower . . . .:  (1) The duty to give adequate instructions for safe use; and (2) the duty to warn of dangers inherent in improper usage.  [Defendant’s] alleged failure to warn that its reprocessing techniques had not been approved by the FDA breached neither of these duties.

Id. (citation and quotation marks omitted) (emphasis added).  We love it when FDA-regulatory-status claims get dismissed.

Buckman-FDCA private right of action.  In a unique setting, plaintiffs challenged the reprocessor’s decision to “extend” its line of reprocessed products to include the catheter in question by means of a “minor modification” procedure (it wasn't one of the 68 that the FDA actually approved for reprocessing).  We’ve always had some liability worries about the minor modification process, where the device manufacturer decides to act, essentially unilaterally, by means of its own memo to file.  The court refused to allow the claim, first finding that approval-related violations couldn’t possibly prove a tort:

Whether [defendant’s] reprocessing procedures damaged the failed catheter is an entirely separate question from whether [it] sought FDA approval for those procedures through the proper route.  That is, even if [defendant] had received 510(k) approval for reprocessing [the] catheters, [it] could still be liable for selling a defective . . . catheter if, in reprocessing a particular catheter, [defendant] damaged the catheter and rendered it defective.  And, conversely, if [defendant] did not damage a catheter during reprocessing, then even if [it] should have sought 510(k) approval for its reprocessing procedures, [its] failure to seek such approval would not render an undamaged catheter defective.

2011 WL 4470701, at *19. This is an important point, since practically any claim founded on a “you didn’t get the right FDA approval” argument will fail under the same analysis.  The court went on to hold that allegations of misuse of the minor modification procedure were nothing more than an improper attempt to enforce the FDCA despite its lack of a private right of action.  Id.

Meeting a similar fate is an alleged duty to warn doctors about the purported FDA lack of approval.  Such a warning has nothing to do with a state-law tort claim, but rather is “superfluous,” since if the product was defective, no FDA regulatory status warning could save the manufacturer, and if it’s not defective, then the FDA regulatory status couldn't create liability.  2011 WL 4470701, at *21.

Negligence per se. You can’t have negligence per se under the FDCA unless there’s an analogous state law claim.  We’ve harped on this, so we’re always pleased to encounter additional supportive precedent.

In a negligence per se case, the plaintiff seeks to hold the defendant liable because the defendant violated a statute.  And that is why a claim of negligence per se cannot be based on a violation of the FDCA . . . .  [T]o avoid preemption under Buckman, a state-law tort claim must be premised on the type of conduct that would traditionally give rise to liability under state law – and that would give rise to liability under state law even if the FDCA had never been enacted.  A negligence-per-se claim that is predicated on an alleged violation of the FDCA is, by definition, a claim that would give rise to liability under Minnesota law only because of the FDCA’s enactment.  Such a claim is preempted under Buckman.

2011 WL 4470701, at *19.  The context may be new, but the principle isn’t.  Approval-based claims can’t be negligence per se because they’re a form of licensing claim, and tort law has nothing to do with licensing.

Warning claims in a reprocessing situation:  The opinion offers some interesting dictum that, since the reprocessor had removed the original manufacturer’s warnings and substituted its own, the reprocessor had “usurped” the manufacturer’s “function” and any prior failure to warn would be non-causal:

[I]f [plaintiff’s] claim depended on an argument that [defendant] negligently failed to include certain warnings in its instructions for use, [that] warning-defect claim against [defendant] would fail for lack of causation:  [Plaintiff’s] damages could not have been caused by the omission of a warning from [defendant’s] instructions for use, because [the reprocessor] replaced [the manufacturer’s] instructions with its own, and thus [the original] instructions did not accompany the catheter that injured [Plaintiff].

2011 WL 4470701, at *23.

Nor was the original manufacturer obliged to warn that reprocessing was dangerous.  The label already explicitly stated that the devices were intended for single use only:

Even if it is true that reprocessing renders [defendant’s] catheters unsafe, the Court finds, as a matter of law, that in light of the fact that [defendant] warned doctors not to use reprocessed catheters at all, [it] had no duty to emphasize that it was serious about its warning or to elaborate on the reasons for its warning.

2011 WL 4470701, at *25.  More common sense.

Can someone become a manufacturer by estoppel?  The reprocessor gave its own manufacturer’s warranty and had marketing materials in which it stated “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.”  2011 WL 4470701, at *4.  Even though the reprocessor claimed that it only provided a service, and had contracts to that effect, the court held that it could be considered a manufacturer for purposes of strict liability:

[S]everal aspects of [the reprocessor’s] business strongly suggest that it should be treated as a manufacturer.  First, [it] removed [the manufacturer’s] instructions for using the . . . catheter and substituted its own instructions. . . .  Second, [the reprocessor] removed [the manufacturer’s] lot number from the catheter, thus preventing subsequent users from learning about the catheter’s manufacturing history.  Third, [the reprocessor’s] entire marketing strategy depended on convincing customers that devices reprocessed by [it] were exactly equivalent to, and perfect substitutes for, devices made by original equipment manufacturers. . . .  Fourth (relatedly), [the reprocessor] warranted the functionality of the catheter. And finally, [the reprocessor] tells doctors that “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.”

Id. at *30. If it quacks like a duck, it’s a duck.  We don't begrudge the plaintiff this one.

The expert who didn’t do his homework.  The court blew out most of a really horrible expert report.  The expert invented some pretty wild hypotheses about a smear of polyurethane glue on the recovered part of the product, but didn’t bother to learn anything about polyurethane or how it interacted with the chemicals useds in reprocessing.  There’s nice “ipse dixit” language.  2011 WL 4470701, at *16.  Ultimately some of the expert’s testimony was allowed in support of a res ipsa manufacturing defect theory – which, since oftentimes an expert’s testimony isn’t needed at all – is just about the lowest and worst use of an expert.  Id. at *18.

Punitive damages:  Reprocessing a single use medical device isn’t enough to support a punitive damages claim, since the FDA allows this to be done:

Given that the FDA regulates the medical-device-reprocessing industry and [finds benefit to reprocessing], the fact that [defendant] reprocesses catheters that [the original manufacturer] markets for a single use cannot be a basis for awarding punitive damages.

2011 WL 4470701, at *33.  We like decisions that find FDA regulatory approval preclusive of punitive damages.  Nor was a mere “regulatory mistake” (plaintiff’s attack on the minor modification process) anything suggesting “deliberate disregard” for patient rights.  Id. We like that even better.

Res ipsa: You can’t bring a res ipsa claim against the original manufacturer of a reprocessed medical device, because the reprocessing and reuse, contrary to labeling, are an obvious other cause for any post-reprocessing malfunction.  2011 WL 4470701, at *22.

Heeding presumption:  Minnesota doesn’t recognize a heeding presumption, but in any event, warning someone to be careful, when they probably already are, doesn’t show any different result whether the warning is heeded or not.  2011 WL 4470701, at *25 n.22.

Some of the issues in Kapps are completely novel.  None of them have (as far as we know) been raised in the context of the reprocessing of single use devices.  For this reason, Kapps should be required reading for anyone defending a case involving a reprocessed device – whether representing the original manufacturer or the reprocessor.

Montana Takes a Flexible Approach to the Heeding Presumption

            We previously discussed the Montana Supreme Court case of Riley v. American Honda Motor Co., 856 P.2d 196 (Mont. 1993) and touted it as one of the best rejections of the heeding presumption we’ve seen – rejecting all of the most often advanced arguments in favor of the heeding presumption.  So we were a bit surprised when we learned about that same court’s decision in Patch v. Hillerich & Bradsby Co., No. 2011 MT 175, slip op. (Mont. July 21, 2011) (unpublished) – applying the heeding presumption. 

            While not a drug or medical device case, Patch is definitely a step backward by the Montana Supreme Court and one that may well have implications for our clients.  Patch involves the tragic death of an 18 year-old boy who, while pitching a baseball game, was struck in the head by a ball hit using an aluminum bat manufactured by the defendant.  Patch, slip op. at 2.  A jury returned a verdict for the plaintiff finding that the defendant failed to adequately warn about the enhanced risks associated with its bat which allegedly increased the velocity speed of a batted ball.  Id. at 3. 

            On appeal, the defendant sought review, among other things, of the lower’s court’s denial of defendant’s motion for judgment as a matter of law on the failure to warn claim.  Id. at 2 (other aspects of the appeal raised issues related to decedent’s status as a bystander, the “workability” of providing a warning, and assumption of the risk, see id. at 5-8, 12-13).  The main issue – causation.  It is here that the Montana Supreme Court seems to do an about face.

            The question in Patch was whether the trial court’s adoption of the heeding presumption violated the holding of Riley.  Id. at 9.  Clearly, it does.  In Riley, the court specifically rejected the argument that the heeding presumption – i.e. shifting the burden of causation to the defendant – is necessitated by the policy underlying strict products liability.  Riley, 856 P.2d at 200 (“[w]e are unwilling to shift the respective parties’ burdens in such a fashion. . . . A defendant certainly is in no better position to rebut a presumption which totally excuses a plaintiff from meeting the causation element than a plaintiff is in establishing the causation element as part of the prima facie case.”).   

            So, with the heeding presumption squarely rejected, how did the Patch court get around its holding in Riley?  By being flexible.  That’s right, flexible. 

The policy underlying products liability – protecting the consuming public by requiring manufacturers to bear the burden of injuries caused by defective products – requires courts to apply a flexible standard of proof.

Patch, slip op. at 9 (emphasis added) (further, “our decision in Riley was not intended to limit the flexible standard of proof in products liability cases.”  Id. at 10).  What exactly is a flexible standard of proof?  Well, that’s the rub – how is anyone supposed to know what the standard is if it’s flexible?  Unhelpfully, the court goes on to state the obvious:  “The nature and quality of evidence used in products liability cases to demonstrate causation varies.”  Id.  at 9.  Well, sure it does.  But does that mean that when the plaintiff is going to have a particularly difficult time proving causation, he no longer has to? 

            The Montana Supreme Court, clinging now to the dissent in Riley, has answered that question affirmatively – at least where plaintiff is deceased  -- “the death or inability of the plaintiff to testify is one of the factors influencing the requisite standard of proof.”  Id.   But, as the majority in Riley reasoned, the burden of establishing causation “is not qualitatively different than other testimony given by a party in support of her or his prima facie case.”  Riley, 856 P.2d at 200.  The facts in Patch are a horrible tragedy; a young man died and we don’t make light of the situation.  But, by the court’s reasoning, it would seem wrongful death plaintiffs should be relieved of all their burdens of proof in products liability actions simply because they are deceased (Does this likewise extend to other plaintiffs who are unable to testify for whatever reason?). 

            Finally, the Patch court found it would be “unfair and unjust” to require the plaintiff to prove causation because he had died – “it [would] be virtually impossible to prove what the decedent would have done had he been warned.”  Patch, slip op. at 11.  If it would be “virtually impossible” for the plaintiff to prove – what chance does a defendant have?  The defendant is left with an even more difficult burden of rebutting the presumption with the same lack of testimony.

            Unfortunately, the Montana Supreme Court has flexed enough to allow the heeding presumption in cases where the plaintiff is unable to testify.  It remains to be seen just how supple that court is.

Defense Verdict in Hogan

We have recently highlighted a few decisions coming out of Hogan v. Novartis Pharmaceuticals Corp., No. 06-Civ-260 (BMC) (EDNY), and we’ve got some good news to report. After a week and a half long liability-only trial in the EDNY Brooklyn division, a six-member jury returned a defense verdict after about five hours of deliberation on Wednesday. Plaintiff Karlene Hogan alleged that her late husband developed ONJ after using the Novartis drug Zometa® to treat his widespread and aggressive multiple myeloma.

As we reported previously, the defense was able to exclude testimony from ubiquitous plaintiff expert and – as the Court put it – “superlawyer” Dr. Suzanne Parisian before trial. The Court also shut down plaintiff’s efforts to get in irrelevant and prejudicial “corporate conduct” evidence from other experts and through corporate documents. We didn't necessarily agree with the Court that the FDA was a "sideshow" in a prescription drug product liability case, but at least the Court excluded the plaintiff's effort to introduce what truly would have been a "sideshow."

Among her witnesses at trial, plaintiff called oral surgery expert Dr. Robert Marx, who claims to have discovered ONJ and has testified in several cases in the bisphosphonate litigation. Dr. Marx testified that a pathologist who analyzed samples from Mr. Hogan’s jaw incorrectly concluded that the specimen showed cancer. The defense case was headlined by a local oncology expert and their national expert on bisphosphonates and bone. The jury answered “no” to the first question on the verdict form: “Did plaintiff prove by a preponderance of the evidence that the Zometa® used by Mr. Hogan medically caused his jaw condition?” That is what we in the business call a resounding defense win.

The Court made some noteworthy rulings on the elements of plaintiff's causes of action along the way. For example, when the Court denied defendant’s motion for judgment as a matter of law (while making clear that it would revisit defendant’s argument should the jury return a plaintiff verdict), it made two important, good rulings. First, the Court concluded that Rhode Island would apply the learned intermediary doctrine and held that Novartis had no duty to warn Mr. Hogan directly. Here is what the Court said:

I see nothing in Rhode Island case law, including the Castrugnano case, to suggest that Rhode Island would require direct patient warning in pharmaceutical drug cases.  Just because 4024 A of the second restatement says nothing about the learned intermediary doctrine doesn't bother me.  There are a lot of states that adopted both.

If Rhode Island doesn't accept the doctrine in the way that most courts have, then it's likely it's going to look to the third restatement, which requires direct warnings when the manufacturer has reason to know that the health care provider will not be in a position to reduce the risk to the patient.  Unlike the mass inoculation vaccine scenario that the restatement mention in one of its comments, Zometa is a very serious therapy that is commenced after consultation with doctors.

Plaintiff has admitted in the joint pretrial order that Zometa is admitted [sic, probably should be "administered"] at infusion centers and the patient sees the package or gets any written information about it.  Plaintiff doesn't despite Zometa's successful bone manufacturer, even if it can lead to ONJ.  As intended there Zometa is a type of drug learned intermediary doctrine encourages a doctor-patient dialogue.  Zometa does not fall within the exception of the restatement and I, therefore, find a direct warning to Mr. Hogan was not required.

That is a significant ruling because, as far as we know, no other court has addressed whether Rhode Island would adopt the learned intermediary doctrine.

Second, the Court refused to instruct the jury on the heeding presumption. Rather, the Court reasoned that the heeding presumption was something a court takes into account in deciding whether to allow a claim to proceed to the jury.

We offer congratulations to the Novartis trial lawyers, Bruce Berger and Robert Johnston of Hollingsworth LLP and Jesse Graham of Rivkin Radler, and thank them for sending us the transcripts.

* * * * * *
Once again, we pause on this Memorial Day to salute those who made the ultimate sacrifice. Over the last year we have visited Normandy. We have attended a ceremony at Arlington for a departed colleague. Today in particular those and other memories overwhelm us with sadness and gratitude.

Not Swallowing the Whistle

Last week we settled a case. It was a good settlement. But we groused about it a bit, because we thought the judge should have granted us summary judgment on preemption grounds. The denial of summary judgment was truly "summary." There was no written opinion at all, and the judge's few statements at the hearing hardly qualified as any sort of legal analysis. What was going on?

Then we took a look at a recent book, Scorecasting: The Hidden Influences Behind How Sports are Played and Games are Won, by Moskowitz and Wertheim. The book, in a manner reminiscent of Moneyball or Freakonomics, uses data to unearth some surprising truths, debunk a lot of conventional wisdom, and raise interesting questions. For example, there is no valid reason to believe that a player with a "hot-hand" will continue to score at will. Or, you probably know that home teams enjoy an advantage, but do you know when and why? Or -- and this is the topic of today's intellectual frolic and detour -- when and why do sports referees "swallow the whistle?"

Sports have rules and somebody's got to enforce them: umpires in baseball, referees in football, etc. When hockey games are in their final minutes or in overtime, referees don't call as many penalties. One of the all-time great examples in football is when the Giants upset the then-unbeaten Patriots in the Super Bowl. In the closing minutes of the game, David Tyree caught a pass against his helmet that some call the single greatest play in a championship game. But what some people forget is that Eli Manning threw that pass only after escaping the clutches of a Patriots lineman. In fact, Manning was in those clutches so long that, under the rules, he could (and people in Boston will howl that he should) have been called "in the grasp" and the play would have ended. So would the Giants' chances. History would have changed. But the referee didn't blow his whistle. He let the players decide the game. Similarly, Moskowitz and Wertheim analyze statistics from baseball, comparing umpire balls-and-strikes calls against a machine. It turns out that umpires are right way more than they are wrong, but their error rate goes way, way up in failing to call ball four or strike three. That is, the rules enforcers are seemingly reluctant to be outcome-determinative.

We wondered whether something like that happens in the law. Maybe our judge thought there ought to be some sort of settlement, even if the plaintiffs' case had certain legal and factual weaknesses. Granting us summary judgment would have knocked that out. Not granting summary judgment keeps the case alive and leaves open the possibility that the parties will reach agreement. In fact, we did. Maybe the judge thinks that rough justice was done. Or maybe the judge is just happy to have the case off the docket. (And we make no bones about our belief that it is pernicious and counterproductive for judges to shape their rulings to aid docket management rather than to follow the law. It's wrong and ultimately counterproductive.) Maybe judges sometimes swallow the whistle.

Unlike Moskowitz/Wertheim, we don't have data to back up that allegation. But if judges do swallow the whistle at crucial moments, we don't think it's at all benign. At least in sports, swallowing the whistle affects both sides equally. In the sort of litigation we do, it's almost always the defense side that files Daubert motions and summary judgment motions. So a judicial reflex against granting dispositive motions disproportionately hurts defendants. Moreover, sports referees swallow the whistle because they know that fans pay to see players, not refs, decide the game. The last time we looked, litigation was not a spectator sport and was not being conducted for the amusement of paying fans.

Anyway, these are just musings. The case is over and we're on to the next thing. But we'd be fascinated if anybody could assemble data and do a sort of Moneyball or Freakonomics or Scorecasting-type analysis on our business.

Today we report on a case where the referee did not swallow the whistle. In Barnhill v. Teva Pharmaceuticals USA Inc., 2011 U.S. Dist. LEXIS 51222 (S.D. Ala. May 10, 2011), the court granted summary judgment to the defendant and ended the case. The plaintiff went through "a stormy course of SJS" after taking cephalexin, a generic substitute for Keflex. Barnhill, 2011 U.S. Dist. LEXIS 51222 at *4. SJS is a bad disease, SJS plaintiffs are entirely sympathetic, and SJS cases are tough. By the time the defendant moved for summary judgment, the plaintiff had three remaining claims: (1) negligent failure to warn, (2) negligent failure to conduct post-marketing surveillance; and (3) breach of the implied warranty of merchantability. Id. at * 10.

The plaintiff claimed that the warning was inadequate "because the information about SJS was listed as an 'Adverse Reaction' rather than under 'Warnings'. Id. at * 17. Even assuming such inadequacy, the claim failed for want of proximate cause. There was simply no evidence that the prescribing doctor would have done anything different if the warning had been different. In fact, at the time of her deposition, which was ten years after the treatment at issue, the doctor continued to prescribe cephalexin. The plaintiff tried to prop her claim up via the heeding presumption, but "Alabama courts have not recognized such a presumption." Id. at * 20. In any event, a heeding presumption "would not alone establish proximate cause." Id. at *21. At this point the court relies on Thomas v. Hoffman-Laroche, Inc., 949 F.2d 806 (5th Cir. 1992), where the Fifth Circuit rejected the contention that causation can be presumed from an inadequate warning. This is the first discussion of Thomas we've seen in a while and is, as far as we know, the first use of Thomas in Alabama.

The court certainly puts Thomas to good use. "Heed" means that the learned intermediary would have incorporated the additional risk into the risk-benefit calculation, but there was no evidence that didn't happen here. And it's not as if the plaintiff pointed to some bit of missing information. It was an issue of where the information resided in the label. "Stated differently, the warning label was not wrong, it simply was not forceful enough. Because there is no evidence that a more forceful warning would have changed Dr. Jaalouk's decision to prescribe cephalexin, Plaintiff has failed to establish proximate cause." Id. at * 22.

The plaintiff's claim for negligent failure to conduct post-marketing surveillance evolved. At first, the defendant read that claim the way most of us would, and responded with evidence showing that the defendant followed FDA regulations requiring the reporting of adverse events for its drug. It fulfilled whatever post-marketing surveillance duty it had. But the plaintiff argued that the defendant was negligent because it "did not track the adverse event experience of other cephalexin manufacturers." Id. at * 24 (emphasis in original). There is no such duty. So much for that claim.

Finally, the breach of implied warranty of merchantability claim turned on dicta in an Alabama Supreme Court decision. Alabama law generally does not recognize a cause of action for breach of implied warranty of merchantability for inherently dangerous products. The issue is whether there's an exception for products that affect a "significant number of persons." Id. at * 25. Well, maybe there is and maybe there isn't? (Guess which way we vote.) But it doesn't matter because it doesn't look like there have been more than two cases of SJS-from-cephalexin in the United States from 1992 to 2008. The plaintiff offered an unreliable study and some bad math to suggest a bigger number, but the court didn't buy it. Id. at * 26-27.

In short, the court blew the whistle.