Aredia/Zometa Motions in Limine

One of the remand courts in the Aredia/Zometa litigation recently issued a decision on various motions in limine.  See Brown v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 104985 (E.D.N.C. July 27, 2012).  Here’s the rundown of the “good,” the “not-so-good,” and the “it depends.”

The good:

·                     Post-injury label changes: The court excluded evidence of the defendant’s changes to the label of Zometa in 2007 and Aredia in 2008.  Id. at *38-40. Plaintiff’s injury was diagnosed in 2005, and the court held that these years-later label changes qualified as subsequent remedial measures. Of course they do.  This has long been the view of the majority of circuit courts, and getting this type of ruling has become easier with amended FRE 407, which now reads in part:  "When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove . . . . . a need for a warning or instruction."

·                     Emails by members of an Advisory Board to the defendant:  The court excluded these as hearsay.  Id. at *34-37.  Defendant appears to have had an advisory board of outside doctors who gave the defendant advice on its draft of a white paper.  Plaintiffs sought to admit emails from two of the advisors, arguing that the emails weren’t hearsay because the doctors were somehow agents of the defendant.  But agreeing to participate in an advisory board is far different from being an agent.  There was no evidence that the defendant controlled the two outside doctors or that the doctors acted on the defendant’s behalf.  They just gave advice.  Plaintiffs also argued that the emails were business records, but the court saw no evidence that serving on these advisory boards was regularly conducted business activity or that, even if it were, the emails were a regular part of that business activity. 

The not-so-good:

·                     Adverse Event Reports (AEs):  The court allowed plaintiffs to use AEs as evidence of causation and for notice.  Id. at *25-30.  We’ve blogged many times – because it’s right – that AEs should not be used as evidence of causation.  They’re hearsay, anecdotal, incomplete, and unreliable.  Unfortunately, this court will allow plaintiffs to do it here, so long as a plaintiffs’ expert testifies that he relied upon AEs to form a causation opinion.  We don’t think that finding an expert to offer such an opinion changes the deficiencies of AEs.  For those interested, we’ve compiled a cheat sheet of AE decisions that we believe got it right.  Additionally, by the way, the court allowed plaintiffs to use AEs for notice to the defendant, a much less controversial ruling. 

·                     Failure to warn non-prescribers.  The court recognized that under North Carolina law a defendant is not liable in a failure to warn case if the defendant gave an adequate warning to the plaintiff’s prescriber.  Id. at *33.  That’s good.  But plaintiffs also wanted to show evidence of a failure to warn non-prescribers.  That seems wholly irrelevant.  The prescribers were either warned or not.  Now, while the court did not issue a final ruling, it did hold open the possibility of allowing non-prescriber failure-to-warn evidence if plaintiffs showed that the actual prescribers were not warned.  Id. at *33-34.  This seems like an invitation to mischief.  Failure to warn does not occur in the air.  It must involve the relevant learned intermediaries – the prescribers. 

The "it depends":

·                     Choice-of-law on punitive damages.  It depends because all lawyers approach this issue by first determining which state’s law they would prefer applied.  Here, New Jersey law, the home of the manufacturer, allows no punitive damages because the FDA approved the drugs, while North Carolina law, where the plaintiff purchased, used and allegedly was injured by the drug, would allow punitive damages.  The court applied Restatement (Second) of Conflict of Law and chose New Jersey.  In short, the court held that, while North Carolina law properly applied to the underlying claim because it was aimed at protecting the plaintiff, New Jersey law should apply to the punitive claim because it was aimed at deterring any wrongful conduct of the defendant, a New Jersey company.  Id. at *10-24.  No matter how you look at this, though, it was a nice victory for the defendant. 

Cross-Fertilization

With our focus on prescription drug and medical device product liability litigation, we sometimes overlook developments that occur outside the boundaries of our own little sandbox.  While that’s necessary to restrict the blog’s scope to something manageable, nonetheless it’s somewhat artificial.  Drug and device law doesn’t exist in some kind of vacuum, cut off from the rest of tort law.  What we do here sometimes affects other types of cases, and what goes on in other types of cases certainly can have significant impact on our clients.


One of the other things that Bexis does around here to make himself useful is to prepare monthly memoranda that summarize newly decided cases involving Pennsylvania tort and product liability law generally (he's a glutton for punishment).  In that capacity, he came across Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 3740472 (E.D. Pa. Aug. 25, 2011), which on its face has nothing to do with prescription drugs or devices.  Instead, it has to do with injury allegedly suffered from a child car seat.

The accident apparently happened when, for unknown reasons, the child’s mother plowed her minivan headlong into a tree.  The father originally brought the suit, but also for unknown reasons – possibly due to the parents’ questionable actions – a bank ended up as guardian ad litem.  See Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 2789336 (E.D. Pa. July 18, 2011) (parents sanctioned for recklessly spoliating the product); Waltman v. Dorel Juvenile Group, Inc., 2009 WL 2877153 (E.D. Pa. Aug. 28, 2009) (parents entered into secret release, and then hid it during discovery).

The Dorel opinion at No. 3740472 addressed with a plethora of "in limine" (that means evidentiary matters presented before trial) motions.  We're old enough to remember when in limine motions were thought of as unusual; but they've propagated faster than rabbits since we've been practicing - but back to the point.

In deciding these in limine motions the interconnectedness of the law becomes blatantly apparent in Dorel.  First off, in an extremely odd decision, the court threw the case into suspense, and refused to decide a large number of the motions.  We’ve blogged before about the uncertainty now at the heart of Pennsylvania product liability law, as to whether the Commonwealth will continue its peculiar brand of strict liability or else move to the more negligence-friendly Restatement Third of Torts.

As lauded in our most recent post on that subject, the Third Circuit reaffirmed its prediction that Pennsylvania would move to the Restatement Third approach.  Covell v. Bell Sports, Inc., ___ F.3d ___, 2011 WL 2690396 (3d Cir. July 12, 2011).  Well, the court in Dorel decided to stage the judicial equivalent of a sit-down strike, placing the case in “suspense pending resolution of this conflict”:

A petition for review en banc is currently pending in Covell.  Meanwhile, the Pennsylvania Supreme Court has indicated that it may take up the question again.  See Lance v. Wyeth, 15 A.3d 429 (Pa. 2011).

2011 WL 3740472, at *1.  We presume that counsel in the case have already informed the court that the Third Circuit, without dissent, denied en banc rehearing on August 8 – more than two weeks before the suspense order in Dorel.

The other (Lance) citation demonstrates the interrelatedness of tort law.  Lance is a prescription drug case.  We know it well; some of us even worked on the current appeal.  What we don’t understand is how the court in Dorel thought that, in Lance, the Pennsylvania Supreme Court somehow had before it anything relating to the Covel/Restatement Third issue.  The issues that the Supreme Court agreed to hear in Lance are available both on this blog and on the Supreme Court’s website, and they have nothing whatever to do with the future of strict liability in Pennsylvania.

So right off the bat, neither of the excuses given for putting the Dorel case into suspense hold water – and they’re both subjects already covered on this blog.  Dorel could be in suspense for a long time.

But there’s more to the seamless web of tort law at work in Dorel than an inexplicable suspense decision.  Despite that order, the court went on to decide quite a few of the motions in limine.  Some of them, we think the court got wrong; some we think the court got right.

One of the defense experts wanted to testify that the product in Dorel complied with a federal automobile regulation (called an “FMVSS”).  The plaintiff claimed that “such testimony would constitute an impermissible legal conclusion.”  2011 WL 3740472, at *4.  Shocking as it may sound, we agree with the plaintiff on that one.  We don’t see any conceptual difference between that proffered testimony, and an expert testifying that a product complied – or didn’t comply – with an FDA regulation.  In a series of posts, here, we’ve argued until we’re blue in the face that the ultimate conclusion that a product complied or didn’t comply with a statute or regulation is a legal conclusion that an expert witness should not be allowed to give.  The proper way to go about it is to have the expert testify that the product had X, Y, and Z features (all of which were in compliance with the law), and then ask the judge to instruct the jury that the product in fact complied.  The judge is where the jury should look for legal conclusions during trial, not either sides’ paid experts.

In a ruling we agree with, the Dorel court ordered the exclusion of “foreign regulatory actions and labeling.”  2011 WL 3740472, at *9.  This issue also arises frequently in drug and medical device litigation, and we’ve blogged on it a number of times, most recently here.  The court held, citing drug/device precedent, that foreign standards are irrelevant and prejudicial:

Evidence of foreign labeling requirements is inherently prejudicial and presents a substantial risk of jury confusion.  See In re Trasylol Products Liability Litigation, 709 F. Supp.2d 1323, 1336 (S.D. Fla. 2010) (citing In re Seroquel Products Liability Litigation, 601 F.Supp.2d 1313, 1318 (M.D. Fla. 2009)); see also In re Baycol Products Liability Litigation, 532 F. Supp.2d 1029, 1054 (D. Minn. 2007) (collecting cases).  Plaintiff has also failed to show that [defendant’s] obligations under Canadian law are relevant here.  As Plaintiff observes, [defendant] “simply placed whatever labels conformed to the location where the [products] were sold.”  Standing alone, this difference in American and Canadian labeling requirements does not speak to the wisdom or safety of the product’s design.

2011 WL 3740472, at *10.  Again, a recurrent issue where drug/device law and other types of product liability cross-fertilize.

The same thing occurred in the next motion, where the plaintiff was trying to have the jury hear about product risks in other types of accidents (roll-overs) that didn’t happen to this particular plaintiff.  The court granted the motion because:  (1) such accidents were of little relevance, and (2) it was “cumulative” in light of studies done concerning the same type of crash.  2011 WL 3740472, *10.  Once agaain we see this sort of thing in our neck of the woods, as we discussed at some length here.  Indeed, not too long ago a Pennsylvania court rejected the contention that plaintiffs could claim that a drug maker’s failure to warn of a much less serious condition could possibly be causal where the product’s warnings contained adequate warnings of a much more serious risk (the one the plaintiff actually had).  Cochran v. Wyeth, Inc., 3 A.3d 673, 679-81 (Pa. Super. 2010) (see our post about Cochran here).

Finally, the last motion in limine that the court granted excluded the defendant’s ultimate decision to cease production of the product – taken after the accident in question – as a subsequent remedial measure.  Dorel, 2011 WL 3740472, at *16 (not proper impeachment where evidence intended to establish that the product “was in fact unreasonably dangerous and unsafe for its intended use”).  Again, we see plaintiffs in our cases try to do the same thing with subsequent drug recalls.  A subsequent drug recall (or labeling change) is equally a subsequent remedial measure, as we’ve argued here, among other places.

That’s five, count ‘em, five ways that rulings in the Dorel case – involving an infant car seat – can have impact on issues pertinent to prescription drug/medical device litigation, or vice versa.  We here at the Drug and Device Law Blog try not to wear the blinders too tightly for precisely this reason.  We recommend that our readers keep their eyes and ears open as well.  It may not be drug/device decision that helps us win our next case.

Getting Better

We included "Getting Better" among our allusions to Beatles songs in one of last week's posts. It's a light ditty from the Sergeant Pepper album and is an interesting example of a Lennon-McCartney song (on some early albums -- er, LPs, er CDs -- the writing credit for their songs was listed as "McCartney-Lennon") because the optimistic McCartney-esque "it's getting better" is counterbalanced by Lennon's murmuring of "it couldn't get much worse." We side with McCartney on this issue and, indeed, on most issues. In the movie Vanilla Sky, the Kurt Russell character describes himself as a guy whose favorite Beatle used to be Lennon but, now that he's the father of kids and has seen a few things, his favorite Beatle was now McCartney. We agree. Life is tough enough, and we need silly love songs more than primal screams.

One doesn't have to believe in the myth of human perfectability to have a healthy respect for progress. In this society, in this culture, at this time, things mostly are getting better. One might not have said that in Europe in 1100 or 1939. We hear a lot of grousing now about how our kids might grow up in a tougher world than ours. But improvements are all around us. Just look at dentistry. And American beer. Probably not preemption law.

Anyway, we should all support efforts to improve on things. Which brings us to the rule against admitting evidence of subsequent remedial measures. In one sense, it's easy to see why subsequent remedial measures might be relevant to a claim of product defect. If the issue is whether a product should have been safer, does the manufacturer admit as much by making the product safer? A reflexive affirmative answer to that question is facile and foolish. The competitive marketplace is reason enough for manufacturers to try to improve their products. Further, at any given time, there is a state of the art. It's simply unfair to suggest that a subsequent improvement proves that the earlier version was defective.

Maybe it would be possible to explain to juries that making a product better doesn't mean that the old product was bad. But one suspects that evidence of a subsequent remedial measure inevitably makes the defendant pay a judicial price for progress. That possibility might, at the margins, discourage some improvements. We don't want that. Consequently, as a policy measure, evidence of subsequent remedial measures is usually precluded. Here is what Federal Rule of Evidence 407 provides:

When, after injury or harm allegedly caused by an event, measures are taken that, if taken previously, would have made the injury or harm less likely to occur, evidence of the subsequent remedial measures is not admissible to prove negligence, culpable conduct, a defect in a product, a defect in a product's design, or a need for a warning or instruction. This rule does not require the exclusion of evidence of subsequent measures when offered for another purpose, such as proving ownership, control, or feasibility of precautionary measures, if controverted, or impeachment.

That seems clear enough. In a moment, we'll see that it's not invariably so clear. The words "subsequent" and "remedial" possess a surprising amount of elasticity.

Every now and then we encounter courts that do not take Rule 407 (or the state analogue) seriously. Those courts look for ways to admit the evidence of a subsequent remedial measure, usually by stretching the exception for "feasibility." In an individual case, the broad policy behind the evidentiary exclusion might seem to recede in importance, and some judges succumb to the temptation to let the jury sort things out. Some of those bad opinions are published. We're not naming them here, because we don't particularly feel like doing research for plaintiff lawyers. Most of the opinions are not published, and are part of the legion of bad decisions that every day evade review or correction and disappear in the mists of time.

There is an interesting application of Rule 407 in Pusey v. Becton Dickinson & Co., 2011 WL 2200144 (E.D. Pa. June 7, 2011). In early 2008, up through July 11, 2008, the plaintiff underwent a breast expansion procedure, which involved use of saline inflation of tissue expanders. The saline was in certain syringes Becton manufactured. On July 17, 2008, the plaintiff's doctor came to the belief that the plaintiff's breast became infected. Meanwhile, between July 15 and 23 of 2008, the doctor received a notice from Becton recalling syringes due to packaging issues. A key issue in the case was whether the recall of the syringes was a subsequent remedial measure that should have been excluded from the case:

[T]he plaintiffs suggest that the Rule's operation turns not on the occurrence of harm -- and not even on the event from which the harm arises -- but on the "recognition" of harm. This is a transparent attempt to stretch Rule 407 to cover the facts of this case since "[t]he recall letter is dated July 15, 2008, [and] Dr. Noone became aware of Mrs. Pusey's infection on July 17, 2008." … But the Rule is not ductile enough to withstand plaintiffs' manipulations. Plaintiffs' complaint asserts that Judith developed an infection within forty-eight hours of the procedure performed on July 11, 2008…. Because Becton's recall notice of July 15, 2008 followed the occurrence of harm to Judith, evidence of the recall is inadmissible under Rule 407.

Pusey, 2011 WL 2200144 at * 7. Three reactions to that: (1) Wow, the timing was close; (2) this was an instance where the plaintiff's furnishing pf details in the complaint amounted to a self-inflicted wound; and (3) we love the word "ductile."

But wait, there's more. The syringes recalled were from a number of lots where there was a concern that unit package seal integrity may have been compromised for some of them. The syringe used by the doctor to treat the plaintiff came from one of the recalled lots. But there was no evidence that the particular syringe was defective. That made it easy for the court to dispose of the plaintiff's claims: "because plaintiffs must show this syringe was defective in order to succeed on their strict liability or warranty claims -- which they most assuredly have not done -- we must grant Becton's motion for summary judgment as to the Puseys' claims for strict products liability, breach of warranty of merchantability, and breach of warranty of fitness." Id. at * 11 (emphasis in original).

And we're still not done with the issue of subsequent remedial measure. Before the product recall, the defendant had conducted an investigation. One would expect that. These things cannot always happen immediately. The question is whether evidence of that investigation can be introduced by the plaintiff. The court points out that the Third Circuit has "not squarely ruled on the question of whether post-injury investigations qualify as subsequent remedial measures." Id. at * 8. If the investigation led to the remedial measure, is it part of the remedial measure? It turns out not to matter in the Pusey case, because the investigation of the syringes preceded the plaintiff's injury. That is, it was not "subsequent," whether it was "remedial" or not. Thus, the court would admit evidence of the investigation, even though it would not admit evidence of the recall that resulted from the investigation.

In the end, all of the plaintiff's claims in Pusey were dismissed. But what would happen if that weren't so, and the defendant faced a trial where its investigation was admissible, and the defendant had the choice of admitting or excluding evidence of the recall? We're not sure how we'd feel about a case where the plaintiff introduced evidence that our client had started thinking about recalling or improving the product, but the jury did not learn of the actual recall or improvement. Who benefits from such an incomplete story? If punitive damages are at issue, and if there is a unitary as opposed to bifurcated trial -- and sometimes from the defense perspective a unitary trial is favorable -- then is the defendant better off telling the jury that it did the right thing and recalled or improved the product?

To quote our favorite Beatle: Maybe

Hogan's Heroic

Usually, when we've had occasion on this blog to touch on the Erie doctrine, it has been in the context of castigating one federal court or another for adopting an expansive view of state tort law in the absence of state court authority for that interpretation.

But there's more to Erie than that, and the recent case, Hogan v. Novartis Pharmaceuticals, Inc., 06 Civ. 0260 (BMC) (RER), slip op. (E.D.N.Y. April 6, 2011), illustrates what else Erie entails.  "Erie" is a shorthand for a famous U.S. Supreme Court case, Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938), that established the modern framework for deciding what law governs - state or federal - in case removed from federal to state court under diversity jurisdiction.

At the risk of being almost misleadingly simplistic, Erie essentially says that the substantive rules of decision for diversity cases are governed by state law (that's why expansive interpretations of state law come under the doctrine), whereas "procedural" matters - especially those encompassed by the various federal rules of this or that - are governed by federal law.

Among the items designated as "procedural" are the Federal Rules of Evidence - or so the plaintiff in Hogan found out when she tried to argue otherwise.  Like most prescription drug cases, Hogan involves failure to warn.  It's a Zometa case, and after the plaintiff stopped using the drug, the FDA changed the label to toughen the relevant warnings.

As we've discussed before, a subsequent label change is a "subsequent remedial measure" - a post accident change intended to increase the safety of, here, the product at issue.  For various reasons, chiefly not to deter defendants from making things safer, the prevailing rule is that subsequent remedial measures aren't admissible to prove that the defendant was negligent before, for not having done what it later did.  The post-1997 version of Fed. R. Evid. 407 (the relevant federal rule) explicitly states that post-accident changes to a product are not evidence that earlier versions of the product was defective.

Hogan, however, comes from Rhode Island, where at some point in the past, the plaintiffs side hijacked the state's rules committee and produced a version of Rule 407 that's diametrically opposed to the federal (and almost every other state's) version.  Rhode Island's rule expressly allows subsequent safety changes to be admissible into evidence.  R.I. R. Evid 407 ("[w]hen, after an event, measures are taken which, if taken previously, would have made the event less likely to occur, evidence of the subsequent measures is admissible").  For technological advances and other safety improvements, Rhode Island is thus something of a stalag. 

In Hogan, the plaintiff took a Sgt. Shultz attitude towards federal Erie practice - knowing nothing and seeing nothing.  Fortunately the court shot her down.  Essentially, for Erie purposes, a rule is a rule is a rule.  If it's in the federal rules, then it controls in a diversity case removed to federal court:

Plaintiffs claim that the Rhode Island Rule must govern because it is substantive rather than procedural misses the mark. The inquiry begins and ends with the federal rule; Hanna teaches that if the federal rule is valid, the Court will apply it.  To determine the rule's validity, the Court must ask what it regulates:  If it governs only the manner and the means by which the litigants' rights are enforced, it is valid; if it alters the rules of decision by which the court will adjudicate those rights, it is not.

Hogan, slip op. at 4-5 (quotation marks omitted).  Needless to say, Hogan was not about to strike down Rule 407 as unconstitutional.

Thus, Hogan stands for two important principles.  First, that subsequent label changes are excludable under Rule 407, and second, that in general in federal court a favorable federal rule will trump an unfavorable state rule on the same subject.