The Pain Pump Litigation Pumps Out another Good Decision

To us, sometimes plaintiffs’ lawyers sound like Cary Grant.  You know, “Duty, Duty, Duty.”  (By the way, “Judy, Judy, Judy” is a famous misquote.  Cary Grant never once said it in a movie.  But he did say it here – at the 0:50 and 1:30 marks.)  Plaintiffs’ lawyers are often looking for new duties and how companies failed to satisfy them.  When a traditional duty, such as failure to warn of a risk, doesn’t work, new alleged duties seem to crop up.  Susan Burnett of Bowman & Brooke kindly sent us a recent pain pump decision that’s a good example of this – Todd v. Stryker Corp., 2012 U.S. Dist. LEXIS 60953 (E.D. Cal. May 1, 2012).  And the court was having none of it.

In Todd, the traditional claim that the defendant company failed to warn of a risk of which it knew or should have known didn’t work.  The state of the science at the time that the pain pump was used in the plaintiff didn’t support the risk.  There had only been a tiny number of adverse events, a discussion of them at a medical conference, and a fairly weak set of medical literature.  Id. at *13-15 & *20-12.  And, worse for plaintiff, the company seemed to react responsibly to that information, conducting investigations of its files and the medical literature, reporting events to the FDA and seeking advice from outside experts.  Id. at *15-16.

So what’s a plaintiff to do?  Well . . . create a new duty.  While the FDA had cleared the pain pump’s 510(k) application and thereby allowed it to be marketed, it had denied another 510(k) application (apparently more than once) that sought to market it for the particular indication for which the pain pump was used in plaintiff.  Aha!  While maybe there was insufficient scientific evidence of an actual risk, the company should have warned doctors about this regulatory history.  Then maybe doctors would have some basis to speculate about a risk.

This is just what it sounds like: an attempt to sidestep the science.  But in a failure to warn case the science is not something to be worked around.  It defines the very duty that the defendant is supposed to satisfy.  Regulatory history adds nothing.  There’s a reason that labels include sections for indications, warnings, precautions, and adverse events, and not for regulatory history.  As the Todd court put it, regulatory history is simply not a risk about which a warning should be given:

There is no duty to warn the patient’s physician of a prescription product’s regulatory history, because the history is not a "dangerous propensity" about which an adequate warning must be given . . . . .

Id. at *9-10. 

That makes sense.  As we all know, the FDA denies clearance of 510(k) applications for many reasons.  Maybe the FDA decided that there was no substantially equivalent predicate device on the market, or that additional information was needed to clear the new indication. 

Putting regulatory history in a label would simply invite doctors to speculate on what it means.  That’s the opposite of what labels are for.  Doctors are experts in medicine, not regulation.  And, so, labels are places for scientific and medical information, not regulatory dockets.  (For this reason, the rule in informed-consent cases is that doctors need only inform patients of a drug's benefits and risks, not regulatory status.  See our post on this here.)  If the particular regulatory history in which plaintiff was interested was the result of science that supported the presence of a risk (which apparently was not the case), the science, not the regulatory history, should have been put in the label.  The court properly rejected this new duty. 

Plaintiff didn’t abandon regulatory history so easily, though.  She also argued that the mere fact that the FDA denied clearance for the indication signaled the need to warn of a risk.  But this thinking has the same deficiency as plaintiff’s “regulatory history” argument.  The FDA denies clearance for many reasons.  The denial isn’t what matters.  It’s the science.  And, the science didn’t support the risk. 

Undaunted, the plaintiff tried yet another new duty, one that we've seen tried before: the duty to test.  We already deconstructed here plaintiffs’ past attempts to create a claim out of the amorphous and open-ended concept of duty to test.  We even created a cheat sheet of plaintiffs’ many failed attempts.  Suffice it to say that the Todd court wasn’t buying it either.  It found, as have many other courts, that there is no such thing as an independent tort for failure to test:

When the warnings accompanying a prescription product adequately inform the prescribing physician of dangers inherent in its use, the manufacturer's alleged failure to test that product cannot, by itself, either cause injury or be a source of liability for the manufacturer.

Id. at *10.

Now, the Todd plaintiff’s claims had other, more ordinary deficiencies, including a proximate cause problem because the treating doctor decided to use the pain pump and medication on the basis of his own training and judgment, not any alleged influence by the company.  Todd, 2012 U.S. Dist. LEXIS 60953, at *23-25.  But what makes Todd most interesting, at least to us, was the court’s treatment of plaintiff’s less ordinary claims – the new duties, duties, duties.  The court wasn’t having any of it.

Ear Candle Suit Snuffed

Not quite a year ago we had a little fun commenting on the Daubert dismissal of a suit involving something called an “ear candle.”  As we said back then:

[W]e never thought about lighting a candle in our ear.  That seems a little strange.  Maybe even a little risky.  We can’t think of a good reason to plant a candle in an ear, and we can think of a pretty good reason not to: hot wax.  That might hurt.

Apparently the FDA had similar qualms.  We’ve just learned from reading Holistic Candlers & Consumers Ass’n v. FDA, ___ F.3d ___, 2012 WL 5831 (D.C. Cir. Jan. 3, 2012), that:  (1) those who make candles for people to shove in their ears (at least 15 different entities) and set on fire actually have their own lobbying group (that’s scary – are UFO believers next?); (2) some people actually believe shoving a lit candle in your ear is a healthy thing to do (that’s scarier); and (3) the FDA is on the case (that’s probably good, although one might wonder about the Agency’s enforcement priorities).

So why do we care about people who stick lit candles in their ears?

Because – aside from keeping a straight face – the Court of Appeals makes a point about FDA warning letters that needs to be kept in mind whenever such things surface in product liability litigation.  Such letters, including the 15 issued in this case, don’t mean squat as supposed statements of FDA regulatory positions:

FDA’s warning letters . . . neither mark the consummation of the agency’s decisionmaking process nor determine the appellants’ legal rights or obligations.  The letters plainly do not mark the consummation of FDA's decisionmaking. . . .  FDA warning letters . . . giv[e] firms an opportunity to take voluntary and prompt corrective action before [the FDA] initiates an enforcement action. . . .  Nor do the letters represent a decision determining rights or obligations, or one from which legal consequences flow. . . .  [A] Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].  Although a warning letter communicates the agency’s position on a matter, it is only informal and advisory and does not commit FDA to taking enforcement action. . . .  In short, an FDA warning letter compels action by neither the recipient nor the agency.

Holistic Candlers, 2012 WL 5831, at *2-3 (citation to the FDA’s regulatory procedures manual and quotation marks omitted).

This discussion of FDA warning letters was important in Holistic Candlers because, due to their preliminary nature, “FDA warning letters do not represent final agency action subject to judicial review.”  Id. at *4.  Thus, the litigation was snuffed.

To us it’s important because FDA warning letters don’t even rise to the level of a criminal indictment, let alone a conviction.  An indictment is at least the “initiation of an enforcement action,” whereas an FDA warning letter isn’t even that.  It might even be less than a DOJ target letter (we say "might" because we're not criminal lawyers, and don't claim to know all the implications of a target letter).  If mere criminal charges not leading to conviction are not admissible evidence, then a fortiori an FDA warning letter should not be admissible in similar circumstances.  This isn’t the first time we’ve made this point about FDA warning letters, but it’s a point that bears repeating.

The Ignominous End Of The Digitek Mass Tort

Bexis gave blood last weekend at the Red Cross – not just any old donation, either, but pheresis, a procedure that takes a couple of hours to complete.  Because pheresis takes that long, the Red Cross supplies donors with movies to watch.  This time it was the 2006 James Bond remake, “Casino Royale,” the type of movie that Bexis waits for the Red Cross rather than actually spends money to see.  In “Casino Royale” a delectable baddie poisons 007’s martini with digitalis, nearly causing him to die from a v-fib.


Bexis being Bexis, James Bond’s digitalis overdose got him wondering about whatever happened to the Digitek MDL, which involved an FDA-approved form of digitalis, called Digoxin.  We hadn’t posted anything about it in well over a year, since the court blew out some meritless economic loss class actions.  Before that, we were impressed by the MDL court's Rule 11-based order requiring the plaintiffs’ counsel to demonstrate that they’d done a bare minimum of investigation of their clients’ supposed "cases" before filing suit.

Turns out, we didn’t have long to wait.  Yesterday, Madeleine McDonough over at Shook Hardy was good enough to tip us off to the ignominous end of that MDL.  Yesterday, the MDL court filed three orders (documents 70, 149, and 608) that, frankly, all look pretty much the same to us.  They all go under the general description of PTO (that’s “pre-trial order” for you laypeople) 87, so we’re only attaching the one that’s actually called that.

Our first reaction:  My God!  Has there ever been a more meritless MDL?  We thought Bone Screw was bad, since the plaintiffs never in ten years of litigation were able to find a practicing orthopedic surgeon who would opine on defect.  But at least in (some of) those cases there were broken screws.  In Digitek, the plaintiffs couldn’t even prove exposure to the allegedly defective product!  The alleged "defect" was that some Digitek tablets were manufactured bigger than they were supposed to be and thus contain too much of the active ingredient (see James Bond).  But it turns out that, after years of litigation, no plaintiff ever proved that a single one of the supposedly defectively too large Digitek tablets was ever sold to any consumer.

Don’t take our word for it; we’ll let the Court describe it.  Keep in mind that the product recall that prompted the massive attorney solicitation that gave rise to the Digitek litigation took place in April 2008 and involved pills made in January 2008.  PTO 87 at 4-5:

The plaintiffs’ experts’ opinions rely on the one and only verified instance of an extra thick Digitek® tablet making it to market in 2004.  A pharmacist found and returned the tablet to [defendant].  A manufacturing investigation was conducted and the situation was reported to the FDA. After reviewing the investigation, the FDA said:

No additional complaints or reports ofthick tablets have been received for this high volume product.  The event was considered an isolated incident and corrective actions were put in place to prevent its reoccurrence.  Corrective actions (procedural enhancements and review of complaint files) were verified during the inspection.

(Def. Ex.71 at 6).

This is the only verified report of a thick tablet leaving [defendant’s] facilities. The tablet was made in 2003. All recalled Digitek® was produced in 2006 or later. Since 2003, over one billion Digitek® tablets have been made and distributed to the marketplace.  This single 2003-produced tablet is the only Digitek® tablet in the marketplace found and confirmed to be out of specification.

PTO 87, at 10-11.

Not one of the over 1000 Digitek MDL plaintiffs, id. at 11 – all claiming injury from taking supposedly too-large Digitek tablets – ever produced a single purportedly too big Digitek tablet at any time during the litigation.  Id. at 2 (“Thousands of plaintiffs alleged that double-thick tablets hit the market and injured consumers.  Not one of them produced a double-thick tablet.”).  Indeed, some Digitek plaintiffs affirmatively avoided having pills in their possession tested for conformity to specification.  Id. at 19 (“Plaintiffs possess, but have refused to test (or reveal any testing of), an ample supply of unused Digitek® tablets”).

The mind boggles.  So our first reaction is “good riddance.”  What a collossal and utter waste of time, energy, and money on completely bogus cases.  No wonder the court ordered a Rule 11-based inquiry.  Digitek should be the “hot coffee” moment of drug and device litigation, a poster child that demonstrates to everyone that litigation is entirely out of control and that legislation or a rules change - we'd suggest a more muscular Rule 11 applicable to any solicited case - is necessary to reign it in.

So what do plaintiffs do when they can’t even prove that the supposedly defective product ever actually existed?  They use a lot of scary words – like things that go “boo!” on Halloween.  There are a lot of good things in PTO 87 (including Daubert rulings on some very questionable experts), but to us the best part of it is the court’s blowing to smithereens the plaintiff’s misuse of the term “adulterated.”

“Adulterated” is an FDA regulatory term of art.  It means only that some FDA regulation wasn’t 100% complied with.  “Adulterated” doesn’t mean “unsafe” – not even close.  The discussion of the plaintiffs' "adulteration" bogie man in PTO 87 is as good an exercise in refuting a plaintiffs’ misuse of a “scary” regulatory term ("experimental," "investigational," and "misbranded" also come to mind) as anything we’ve ever read:

When a manufacturing process falls short of a cGMP [that’s FDA-speak for “current good manufacturing practice”] requirement, the product is referred to as “adulterated.”  This term has a specific meaning:

A drug or device shall be deemed to be adulterated ... if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter....

21 U.S.C. §351 (a)(2)(B).  If a drug is “adulterated” it may still be safe for consumption and as represented on the label.  The question is only whether the manufacturing process satisfied the FDA’s regulations.  A drug will be rendered “adulterated” if any aspect of the manufacturing process did not fully comply with any cGMP.  That could be something as mundane as inadequate lighting or the lack of hot and cold running water in the building.

PTO 87 at 7-8.  See Id. at 9 (“a pharmaceutically perfect drug could be manufactured, sealed, and packaged, and yet still be rendered ‘adulterated’ because the label on the drug is upside-down”).

Thus, FDCA-based claims of “adulteration” have no bearing on whether a prescription medical product is “defective” for product liability purposes because the FDA’s adulteration standard is based upon “a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standards used to assess tort liability.”  PTO 87 at 21.  The Court took judicial notice of the FDA’s statement:

If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law.  This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP.  It does not mean that there is necessarily something wrong with the drug. . . .  A drug manufactured in violation of cGMP may still meet its labeled specifications, and the risk that the drug is unsafe or ineffective could be minimal.

Id. (quoting FDA “Facts About Current Good Manufacturing Practices”) (emphasis added).

So in the end, all the smoke and mirrors in the world couldn’t help the Digitek plaintiffs in a litigation where there was ultimately no evidence that the purported defective product ever made it to the marketplace – period.  In the future, whenever we encounter a plaintiff screaming “adulteration,” Digitek PTO 87 is where we’ll go first to try to restore calm.

Heading for the Light: Something for Everyone in Recent Pain Pump In Limine Rulings

Last week, the court in a pain pump case, Musgrave v. Breg, Inc., 2011 U.S. Dist. LEXIS 113661 (S.D. Ohio Oct. 3, 2011), denied ten plaintiff motions in limine. That, in itself, is good news. The rulings aren't especially intricate. You might even call them easy. Some of the language employed by the court to explain why the rulings were so easy might give some of us defense hacks reason to pause. We'll get to that in a moment.

We're not saying the Musgrave case isn't interesting -- it is. But we have to admit that it's not nearly as interesting as the Martin Scorsese documentary on George Harrison that aired on HBO last week: Living in the Material World. Harrison is the Drug and Device Daughter's favorite Beatle, and it's easy to respect that choice. The Quiet Beatle was spiritual and cool. It was inevitable that he would be overshadowed by the Lennon/McCartney songwriting juggernaut, but Harrison did pretty well in his own write. "Don't Bother Me" was a great early Beatles song, and "Something" was a great late one. Moreover, Harrison's post Beatles career suggests that he was a better collaborator than the others. George worked successfully with Clapton, Dylan, Petty, and Orbison. By contrast, John worked with Yoko. Paul worked with Linda. Ringo has worked with assemblies of All Stars, but only to redo old hits, not to create something new. And Harrison single-handedly saved Monty Python's Life of Brian.

So as a silly way of honoring Harrison and keeping ourselves amused, we're going to 'cite' some Harrison songs while discussing the Musgrave rulings.

It Don't Come Easy - Yes, it's a Ringo song, and Harrison isn't credited, but Harrison actually co-wrote it and a demo exists of George performing it with a guide vocal for Ringo. Before the Musgrave court issued its rulings, it spent time - way too much time - emphasizing how tough it is to preclude evidence via in limine motions: "To obtain the exclusion of evidence under such a motion, a party must prove that the evidence is clearly inadmissible on all potential grounds." 2011 U.S. Dist. LEXIS 113661 at *5. The court expressed a strong preference not to issue in limine rulings but, rather, to wait for trial proceedings to supply "proper context." Id. at *6. It almost sounds like a presumption against in limine rulings. But waiting for "context" isn't always necessary. It can make trial preparation and/or settlement more difficult, and that "context" might mean that the inadmissible, prejudicial material has already been paraded in front of the jury. So while we like this court's rulings, we aren't fans of the prologue.

Handle with Care - This was the hit single from the first Traveling Wilburys album. Harrison sang the lead, but Dylan, Petty, Orbison, and Jeff Lynne (of ELO fame) all chimed in nicely. Great team effort. Harrison took the title from a label on a nearby box when the band was rehearsing the song. The first motion in limine in Musgrave is the most interesting. The plaintiff sought to exclude evidence that the FDA had cleared or considered the pain pumps for intra-articular use, or that the FDA had never expressed any concern regarding the pain pumps. That's a breathtakingly bold and crazy motion, and one would be thunderstruck by a court that would keep such crucial information from the jury. Talk about context! Luckily, the Musgrave court did the right thing, concluding that the probative value of FDA approval was not outweighed by whatever prejudice the plaintiff claimed. The plaintiff argued that if FDA approval and lack of concern were admissible, then also admissible should be the fact that a U.S. Attorney's office had subpoenaed documents from the defendant as part of an investigation regarding possible off-label marketing of the pain pumps. The Musgrave court correctly held that the issuance of subpoenas was simply not relevant. Id. at *9. All a subpoena means is that an agent and a prosecutor think there is something worth reviewing. There might be no there there.

In Spite of all the Danger - This is a pre-Beatles song. It was performed by the Quarrymen and is credited to McCartney/Harrison. You can hear it on Anthology, volume 1. The plaintiff in Musgrave asked "the Court to prohibit Breg from utilizing the learned intermediary doctrine." Id. at *10. Why? The plaintiff argued that "at no time did Breg fulfill its duty to warn physicians." Id. Well, plaintiffs always argue that, don't they? And defendants always dispute that. They usually have some facts to back up that dispute. That, according to the court, was the case here. Whether the warning was adequate, and whether the learned intermediary had decided to use the pain pump after receiving the adequate warning, were questions for the jury.

Isn't it a Pity - A quintessential Harrison song from All Things Must Pass. It's deep and caring, and it grows on you. Sometimes for years. In the third motion in limine, the plaintiff sought to preclude evidence that any doctor negligence in implanting the device constituted an intervening or superseding cause. It turns out that the defendant wasn't intending to make that argument, so the issue was moot. But the defendant asked the court to make clear that it would admit evidence "of plausible alternative causes" of the shoulder condition, including the shoulder injury itself. Sad to say, but, according to some experts, the surgery itself can cause cartilage damage, and there's no reason why a defendant shouldn't be able to put that testimony and evidence in front of a jury. It's "relevant to causation" and is admissible. Id. at *12.

Beware of Darkness - Another underrated song from All Things Must Pass. Clapton does a superb version of it in the 2002 Concert for George. The plaintiff requested exclusion of the defendant's experts on general and specific causation. The court denied that motion, and we are fine with that. But the court's explanation is the usual thin gruel that gets dished out in rejecting defense motions to exclude plaintiff experts: the experts are qualified, the arguments go to weight, not admissibility, you can cross-examine ... blah blah blah. The court views its role as "simply to keep unreliable and irrelevant information from the jury because of its inability to assist in factual determinations, its potential to create confusion, and its lack of probative value." Id. at 13. Again, we like the ruling here, but, like the court's discussion on motions in limine generally, it sounds a little as if the court's general predilection is to wave things by. The court doesn't appear to have done a detailed analysis of the experts' opinions. If it had, it probably would've arrived at the same result. But sometimes that sort of detailed analysis is necessary to discharge the court's gatekeeping function to keep out plaintiff experts with threadbare data and 'flexible' methodologies.

Wah Wah - Harrison wrote this during the Let it Be sessions, when the Beatles were at each other's throats. Nice guitar riff. The Musgrave plaintiff asked the court to exclude evidence of his prior injuries. Unsurprisingly, the defendant argued that the plaintiff's "medical history and any past shoulder injuries bears directly upon whether his use of the Breg pump caused his shoulder condition." Id. at *13. The court agreed with the defendant that evidence of the plaintiff's "past shoulder injuries is relevant and probative of the issue of causation." Id. Nor was such probative value outweighed by prejudice. Id. at *14. What prejudice? It's like the criminal defense lawyer who sputters, "Objection your Honor, that's prejudicial - it tends to show guilt." It's whining. (The British call it "whinging," don't they?)


It's All Too Much - This one's from The Yellow Submarine LP. Probably one of the better songs on the group's worst effort. The plaintiff objected to introduction of "any evidence to compare the number of times pain pumps have been used with the number of patients who have developed chondrolysis." Id. at *14. It's hard to blame the plaintiff, because the evidence he was trying to exclude is so powerful. Plaintiffs like to focus on the numerator: the case at hand, plus, maybe, other instances of injury, perhaps in the form of adverse event reports. But how is it fair to look at the numerator without looking at the denominator -- all those times when nothing bad happened? We know this is powerful evidence because jurors have repeatedly told us so. For example, twenty adverse events don't look so bad, and the company doesn't look so negligent, when there are millions of successful uses of the product. Anyway, we think it's a no-brainer that the plaintiff's effort to exclude the denominator should fail. The court comes out the right way on this important issue, but adds an interesting reason for its ruling: the plaintiff experts "considered the nonoccurrence of cases of chondrolysis following discontinuation of intra-articular pump use" and made much of the temporal relationship. Id. Apparently the court is saying that if the plaintiff experts want to exploit non-occurrence of injuries, so should the defense experts. That's all well and good, but the denominator needs to be admitted no matter what the plaintiff experts' approach was.

The Answer's At the End - From Extra Texture (Read All About It) (1975). The plaintiff anticipated that the defendant would attempt to "suggest to the jury that it is a 'good corporate citizen' that benefits society by making products that are life-saving or improve the quality of peoples' lives." Id. at *15. The defendant argued that it was premature to rule on this issue. Not surprisingly (given some of the other things the court says in its opinion), the court agreed. This time we have to agree with the court. What most courts end up saying is that the defendant can bring in its good conduct evidence, including wonderful things it has done in general, but then the plaintiff might get more latitude in introducing some not-so-wonderful things. It can be a tough choice for the defendant in terms of how many doors it want to open, or how wide. But in any event the decision does not need to be made before the trial begins.

Sue Me, Sue You Blues - The thing about Harrison is that he mostly seemed like a sweet, gentle guy, but he could also be incredibly cranky. By all accounts, he didn't suffer fools gladly. That comes across in the film A Hard Day's Night, where Harrison gets off many of the snarkiest lines. It also came across with the first song on the great Revolver LP, Harrison's angry masterpiece, "Taxman." And Harrison had his fill of the legal system. He lost a lawsuit where it was claimed that his "My Sweet Lord" was cribbed from "He's So Fine." Harrison later wrote yet another angry song, "This Song," as a commentary on how the legal system had hosed him. All of which is to say that we think Harrison would have liked us and would have agreed with everything we've ever written in this blog. We're just saying. We also think that George would have been amused by the final three motions in limine in the Musgrave case, where the plaintiff asked the court to prohibit the defendant from referencing the results in other pain pump cases (mostly defense wins), or referencing "lawyer-made" lawsuits, or in painting plainjtiff lawyers in a negative light. Id. at * 16. Those motions in limine were deemed moot because the defendant said it did not intend to make any such references. We suspect that George might not have been so charitable to plaintiff attorneys.

Recent HT Wins Worth Knowing About

As much as we like blogging, first and foremost we’re lawyers who represent clients in court.  Our clients tell us how much we can say about litigation we’re involved in, and when they say “not much,” that’s what we do.  If that has the odd effect that we’re sometimes more effusive about other lawyer’s wins than our own – well, that comes with the territory.  This blog has never been primarily about self-promotion, and never will be.


This firm is involved in the HT litigation.  A couple of significant defense wins have occurred in that litigation lately that our readers should at least know about.

The first of these (technically two cases) was in New Jersey.  After a lengthy appellate process, last week the New Jersey court with jurisdiction over the HT mass tort affirmed summary judgment in two HT cases.  Here’s a copy of the opinion:  DeBoard v. Wyeth, Inc., Nos. A-6230-07T1, A-6251-07T1 slip op. (N.J. Super. App. Div. Sept. 29, 2011).  The court essentially adopted the reasoning of the trial court’s (“Law Division” in New Jersey parlance) opinion:

[W]e affirm substantially on the basis of the well-considered and exhaustive opinion of Judge Happas in the Bailey matter, which we have determined to be well supported by the evidence and legally unassailable.

DeBoard, slip op. at 4.

One beneficial aspect of the DeBoard affirmance is that the Bailey trial court summary judgment opinion, which is every bit as long and well-reasoned as the Appellate Division (also New Jersey parlance) found it to be, is now going to be published.  We’ve complained in the past about the citation problems arising from the non-publication of Bailey, but now we expect those annoyances to be a thing of the past.  Here’s a copy of the Bailey summary judgment opinion, annotated with its clearance for publication:  Bailey v. Wyeth, Inc., Nos. L-0999-06 MT, et al., slip op. (N.J. Super. June 11, 2008).  Look for it in A.3d in the reasonably near future.  But don't wait for that.  It’s well worth a read if you haven’t done so already (it’s been around in slip for over three years).  Among the topics Bailey covers are:

• Expert opinions on questions of law.  Bailey, slip op. at 8 n.11.

• Scope of the FDA’s changes being effected (“CBE”) regulation.  Id. at 9-10.

• Off-label use.  Id. at 11-13.

• FDA regulations concerning class labeling.  Id. at 16-17.

• The various types of FDA enforcement-related correspondence (advisory letters, untitled letters, and warning letters).  Id. at 19-20.  On this issue, there's probably no better discussion anywhere.

• The New Jersey statutory presumption of the adequacy of an FDA-approved warning.  Id. at 30-34.

• The types of evidence that can, and cannot, rebut the presumption.  Id. at 34-44.

• Ghostwriting.  Id. at 39-40.

• Statutory consumer fraud in the product liability context.  Id. at 49-54 (this is New Jersey specific).

• Fraud/misrepresentation claims in the product liability context.  Id. at 54- (this is also New Jersey specific).

The other recent HT win is Scharff v. Wyeth, 2011 U.S. Dist. Lexis 107408 (M.D. Ala. Sept. 19, 2011).  The plaintiff in Scharff blew the statute of limitations as to most of the usual product liability claims available in prescription drug cases, but due to quirks of Alabama law, a separate claim for “wanton” conduct in warning/design was still timely.  Scharff, 2011 U.S. Dist. Lexis 107408, at *62.  “Wanton” conduct in Alabama is the standard for punitive damages.  Id. at *50.

The court granted summary judgment against plaintiff’s wanton conduct claims in Scharff, essentially holding as a matter of law that the evidence was insufficient to establish liability for punitive damages.  In particular, the court found persuasive the low statistical increase in breast cancer risk that these drugs have.  That increase, the court held, was insufficient to satisfy the “likely or probably result” in harm standard for wantonness in Alabama.  Id. at *54-63.  In a particularly notable footnote, the court criticized the opinion in Scroggin v. Wyeth, 586 F.3d 547 (8th Cir. 2009), for “ignor[ing]” the low risk increase in the context of similarly-phrased Arkansas statute.  Scharff, 2011 U.S. Dist. Lexis 107408, at *57-58 n.24.  Moving on, the Scharff court also found an absence of evidence of actual knowledge of the increased risk on the part of the defendant.  Id. at *63-71.  Finally, the court held that there was no genuine issue of fact as to the adequacy of the drug’s label with respect to breast cancer under Alabama’s wantonness standard.  Id. at *71-76.  Scharff is thus of interest to anyone faced with a punitive damages claim in Alabama.

Wasting Time And Money

Most of the opinion in Riley v. Medtronics [sic], Inc., C.A. No. 2:10-01071, slip op. (W.D. Pa. Aug. 8, 2011), is a fact-specific statute of limitations discussion – oddly occurring in the context of a motion to dismiss – about a less-than-diligent plaintiff who did next to nothing until the statute had almost expired and an obstreperous (or so the plaintiff alleges) hospital that refused to turn over that plaintiff’s own medical records when he (or more properly his lawyer) finally got around to requesting them.  That’s interesting in the sense that a car crash on the other side of the highway is interesting, but there's nothing in that that's really bloggable.


What interests us is the final argument where the defendant argued under Pennsylvania law (which imposes comment k “across the board” to prescription medical products) that the plaintiff’s strict liability warning claim should be dismissed for failure to state a claim.  The court denied this motion, too, not because of any uncertainty about the law, but because, from the face of the complaint, the court couldn’t tell whether the product – described in the opinion as a “pacer box” – was in fact a prescription only product:

Here, the Defendant is essentially arguing that this Court should infer, from the facts pled by Plaintiffs, that the pacer box is a prescription medical device.  However, in their briefs, the parties disagree as to whether the pacer box constitutes a medical device or medical equipment.  Neither party provides any basis for this Court to determine whether the aforementioned case law applies to the subject pacer box, as its status as a prescription medical device or medical equipment, has not been established, in the Second Amended Complaint.

Riley, slip op. at 20

It strikes us as a huge waste of time and money to deny a motion to dismiss for lack of such a basic fact.  From the opinion, the “pacer box” sounds like some sort of pacemaker (it has leads, for one thing), and we’re pretty sure that there’s no such animal as an OTC pacemaker.  More to the point, the basis for approval of medical devices is available to the public on the FDA’s website.  This kind of purely objective, and publicly available information – prescription-only or not – seems to us tailor-made for judicial notice.  As we’ve blogged about before, FDA information of this sort (and much more) has been routinely judicially noticed in case after case.

The court in Riley never even mentions judicial notice, so we have to assume that this avenue of supplying the missing fact on a motion to dismiss was not raised.  To us, that’s a shame.  In almost every case, the point of bringing a 12(b)(6) motion is to win it, and this is a motion that was eminently winnable.  Now there will have to be discovery, which is expensive, and the cost of bringing the motion will be duplicated – all on an issue where the application of the law to the particular fact in question isn’t really in serious dispute.

If only somebody had noticed judicial notice.

Securities Suits Can Be Brought On Non-Statistically Significant Complaints

So says the unanimous Supreme Court today in Matrixx Initiatives, Inc. v, Siracuso, 09-1156, slip op. (U.S. March, 22, 2011).  We're not securities lawyers, so we're primarily concerned with how Matrixx could affect product liability litigation.

We don't think it will have all that much, since the court makes pretty sure that "materiality" for securities litigation does not mean proof of medical causation that would stand up in a court of law.  Instead it basically shies away from a "bright line" test.  Slip op. at 11-12.

We've discussed earlier how the government (especially FDA) can, and does, act on data that could not establish causation in a court of law.   The Supreme Court's decision also makes that clear:

Not only does the FDA rely on a wide range of evidence of causation, it sometimes acts on the basis of evidence that suggests, but does not prove, causation.  For example, the FDA requires manufacturers of over-the-counter drugs to revise their labeling “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”  21 CFR §201.80(e).  More generally, the FDA may make regulatory decisions against drugs based on postmarketing evidence that gives rise to only a suspicion of causation.

Slip op. at 13-14 (citation omitted).  Indeed, specifically with respect to the civil "more likely than not" civil liability standard, the court quotes the Manual on Scientific Evidence - “[R]isk assessors may pay heed to any evidence that points to a need for caution, rather than assess the likelihood that a causal relationship in a specific case is more likely than not.”  Slip op. at 14 n.9.

Frankly, we'd rather the Court not have cited expert witness cases allowing "testimony on causation based on evidence other than statistical significance," slip op. at 12, especially the pre-Daubert abomination, Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741 (11th Cir. 1986).  But the Court did go out of its way to state that "We need not consider whether the expert testimony was properly admitted in those cases, and we do not attempt to define here whatconstitutes reliable evidence of causation."  Slip op. at 12. But since we've never been able to have Daubert construed as limiting experts solely to statistically significant epidemiological proof (as opposed to the infamous "differential diagnosis"), we'd actually have been jealous if the securities defense bar had been able to pull off that result.

Basically, Matrixx comes down on the side of a case-by-case assessment of whether statistically significant adverse events are considered "material" in any particular case.  The bottom line:

Application of [the prevailing securities law] standard does not mean that pharmaceutical manufacturers must disclose all reports of adverse events.  Adverse event reports are daily events in the pharmaceutical industry. . . . The fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event. The question remains whether a reasonable investor would have viewed the nondisclosed information as having significantly altered the "total mix" of information made available.  For the reasons just stated, the mere existence of reports of adverse events - which says nothing in and of itself about whether the drug is causing the adverse events - will not satisfy this standard.  Something more is needed, but that something more is not limited to statistical significance and can come from “the source, content,and context of the reports.

Slip op. at 15-16 (various citations omitted) (our bold emphasis added, other emphasis original).

Sure, we'd rather the Court have bought into a bright line statistical significance standard - because we'd have tried to import it into Daubert - but after the oral argument, we didn't see that as in the cards, and it definitely wasn't.

One final observation:  anybody who claims that the current court is "pro-business" is just spouting plaintiff-side propaganda.