Through the Past, Darkly

We’ve been reading the Keith Richards autobiography, Life, and it made us think about the past. The Rolling Stones were formed 50 years ago, in April 1962. We were Beatles fans in the 1960's. (Still are). When the Rolling Stones showed up on The Ed Sullivan Show they seemed sort of terrifying. (Still are.) Time is no longer on their side. Or ours.

The Stones have been around long enough that their songs constitute the soundtrack of the Babyboomers. Maybe that is why Martin Scorsese repeatedly uses Stones tunes in his films. "Jumping Jack Flash" was recorded in 1968, an annus horribilis (Tet offensive, assassinations, Nixon election) if ever there was one. But the song that best captures the feel of 1968 -- "Gimme Shelter" -- came out the following year. In 1971, we pilfered Sticky Fingers (an album with the scandalous zipper -- try doing that with a cd or an iTune) from our sister's room. The 1980's was not a terrific decade for the Stones, though Steel Wheels at the end was a redemption.

We were listening to Voodoo Lounge while preparing for a Ninth Circuit oral argument. The issue was whether the district court erred in admitting evidence of prior bad acts. The panel was less than happy with our prosecutorial zeal back then. ‘Mr. AUSA, what percentage of cases does your office win? More than 95%, right? So why did you need to gild the lily and parade in front of the jury another heroin deal that took place ten years earlier?’ Well, gulp, because the defendant was guilty as Hell, always followed the same playbook, probably played a role in murdering a federal agent, and needed to go away with an LWOP (life without parole). Why the sympathy for the devil? Further, Federal Rule of Evidence 404(b) permits introduction of “crimes wrongs, or other acts” to prove “motive, opportunity, intent, preparation, plan, knowledge, identity, absence of mistake, or lack of accident.” One of the judges said something like, ‘The past is not always prologue.” Yeah, but sometimes it is. Anyway, evidence of prior acts is hot stuff. Appellate courts play close attention. It can clinch a conviction or it can be the biggest mistake in a trial. For a prosecutor to introduce prior acts is to play with fire.

Nowadays we usually argue against introduction of prior acts. Does that make us hypocritical? We (naturally) demur. Most of the time, when plaintiffs seek to drag in evidence of prior injuries, accidents, etc., there is little purpose beyond prejudice. The prior acts are not really similar. Or it is not even clear that they happened at all, or that they happened the way the plaintiffs want to argue they happened. Plus, a product liability plaintiff does not have to prove liability of a corporate defendant beyond a reasonable doubt. Tell you what: if plaintiff lawyers shoulder the reasonable doubt burden, then we defense hacks won’t file so many in limine motions seeking to preclude other acts evidence. Okay? No? We didn’t think so.

A court recently did a pretty careful job of going through the other acts analysis in the product liability case of Hershberger v. Ethicon Endo Surgery, Inc., 2012 U.S. Dist. Lexis 45220 (S.D. W.Va. March 30, 2012). Some of the analysis is sound. But we view the overall outcome with mixed emotions. The defendants moved to prevent introduction of investigative reports related to Ethicon stapler performance, as well as allegations of other incidents concerning stapler performance and litigation related to Ethicon staplers. The defendants’ motion was premised on arguments that that the evidence was: (1) irrelevant under Rules 401 and 402 of the Federal Rules of Evidence and the substantial similarity test; (2) far outweighed by undue prejudice under Rule 403; and (3) inadmissible hearsay.

Rule 404 was not discussed by the Hershberger court. Now discuss among yourselves why that is so.

The plaintiff argued that the prior incidents, which came from the defendants’ adverse event files, were relevant. The plaintiff proffered a summary of forty-five incidents and offered to produce to the Court the investigative files in full. Then, following the usual path, the defendants produced a chart of their own in reply to the plaintiff’s chart, setting forth the “inherent differences” between the allegations in this case and the forty-five incident files. Hershberger, 2012 U.S. Dist. LEXIS 45220 at *3. As is the case with adverse event reports, all the information was “necessarily derived second-or third-hand from medical personnel reporting an incident directly to Ethicon or through regional sales representatives.” Id. The main issue is whether the prior events were sufficiently similar so as to prove negligence, design defect, notice of defect, or causation.

The court reasoned that substantial similarity requires a showing that “(1) the products are similar; (2) the alleged defect is similar; (3) causation related to the defect in the other incidents; and (4) exclusion of all reasonable secondary explanations for the cause of the other incidents.” Id. at *5. Crucially, “nowhere in the incident files is there any indication that reasonable secondary explanations for the other incidents were eliminated. The most obvious reasonable secondary explanation, which to the Court’s knowledge was not ruled out in any of the forty-five other incidents, is surgical team error. Put simply, the forty-five other incidents are not clearly the result of a faulty Ethicon stapler, and thus, they are not substantially similar so as to permit their admission as direct evidence of negligence or a defect.” Id. at *7. So far so good. But “the threshold for admissibility is significantly lower if the other incidents are used to prove Ethicon’s notice or knowledge of a product issue.” Id. The court then came up with different rulings for different claims:

• Negligence – The similar incidents evidence was relevant to “show that Ethicon had notice or knowledge or other staplers that reportedly malfunctioned, and Ethicon was therefore better positioned to foresee the injury that is the subject of this litigation.” Id. at *9. Yet while the similar acts are relevant to notice, they cannot constitute “direct proof negligence in this case-that is, arguing that Ethicon was negligent in marketing defective staplers in the past and it therefore was negligent in this case-is strictly prohibited in light of the Court’s above ruling regarding the (dis)similarity of the incidents.” Id.
• Product defect – “[E]vidence of similar incidents is wholly inadmissible pursuant to the Court’s similarity finding. In a strict liability cause of action, Ethicon’s knowledge or notice of a potential defect in its product is irrelevant.” Id.
• Breach of warranty – “The Court perceives no relevant use of the other incident evidence to Plaintiff’s breach of warranty claim. Presenting other incidents evidence to demonstrate that Ethicon’s stapler was not fit for its intended foreseeable uses is impermissible under the Court’s similarity ruling.” Id. at *10.
• Punitive damages – “Such evidence is directly relevant to the jury’s determination of whether Ethicon acted in a wanton, willful, or reckless manner.” Id. [Ouch.]

Thus, the court deemed the evidence of prior adverse events relevant only for notice/negligence and punitive damages. But still remaining is whether, under Rule 403, the probative value of the prior acts is substantially outweighed by the danger of prejudice or jury confusion. Once again, the court applied that analysis differently to the different claims. As to the negligence claim, the court found “that introduction of other similar incidents is likely to waste time and confuse the jury. The applicability of other incidents to the negligence claim is somewhat obscure, and there is significant danger that the jury will consider the other incidents as direct evidence of negligence. Further, the probative value of the other events is minor-these records amount to uncorroborated and incomplete customer complaints constituting approximately 0.003% of Ethicon’s sales during the relevant time period.” Id. at *11.

No surprise, but that ruling gives us satisfaction. We’ve argued in the past that it is a very unfair and dangerous thing to permit plaintiffs to argue, and juries to deduce, that adverse events show negligence or product defects. For one thing, adverse events are not probative of causation. For another, in more and more litigation the adverse event process becomes tainted by litigation. Lawyer ads (that ain’t too proud to beg) can inflate adverse event reporting. Lawsuits themselves become adverse events. Some people complain about data-mining. Data-planting is just as bad. Accordingly, to the extent the Hershberger court rules that the adverse events are irrelevant or prejudicial, it's all right by us.

But you can't always get what you want. Are the good bits in Hershberger shattered by the ruling on punitive damages? The court held that “[a]s the punitive damages claim however, the risk of confusion is diminished-Ethicon’s knowledge and notice of other product complaints is directly relevant to punitive damages.” Id. at *12. (By the way, since the adverse events are admitted for knowledge and notice, the court holds that the hearsay objection fails.) That ruling leaves us scratching our heads. If the adverse events are unduly prejudicial with respect to the negligence claim, they are probably also prejudicial on punitive damages. We do not know whether or how the punitive damages issue would be staged at trial, but if the adverse events come in during the main liability phase, and if the plaintiff can argue that knowledge of such adverse events shows that the company was wanton or reckless, isn’t the prejudice nearly complete? Would a jury instruction really solve the problem? Would a defendant even ask for such a limiting instruction? Moreover, “to the extent Plaintiff may wish to cross-examine a defense witness regarding the general subject matter of the other incidents, i.e. the existence of reports of faulty staplers, such use may well be permissible.” Id. at *13. So not only will the adverse events come in, they might come in at a particularly dramatic time, and it might look like the defense was trying to hide them.

To be sure, we’re not trying to take a mostly good ruling and paint it black. But we wonder how this ruling will play out at trial. Predicting the future is harder than replaying a past that will not fade away.

Motions In Limine In Pa. Case

Motions in limine were decided (or not) recently in Wolfe v. McNeil-PPC, Inc., 2012 U.S. Dist. Lexis 2160 (E.D. Pa. Jan. 9, 2012).  The defendant did pretty well, so here’s a brief listing of the highlights (this isn’t everything, as some were case specific, not decided, moot, or simply boring).

 

• Adverse events – These probably aren’t admissible as they are double hearsay. Some earlier ones might be admissible as to notice, assuming that’s disputed.  Experts can rely upon them, but not exclusively, and that doesn’t mean they get to talk about them to the jury (which will be decided at trial).  Id. at *6-12.
• FDA citizen’s petition – Excluded.  The petition was argumentative and didn’t show notice.  The defendant also can’t use its outcome to argue that the FDA rejected the requested warnings.  Id. at *14-16.  A different (older) FDA petition could show notice, assuming that’s disputed.  Id. at *17-19.
• Voluntary recalls unrelated to the plaintiff’s condition – Excluded as unduly prejudicial.  Id. at *19-21.
• Foreign labeling – Generally excluded subject to plaintiff making specific arguments that a particular foreign label is somehow relevant, and not hearsay.  Id. at *21-22.
• Various FDA documents – Generally excluded subject to plaintiff making specific arguments that a particular FDA document is somehow relevant, and not hearsay.  Id. at *22.
• Marketing material/information not seen by plaintiff (this is an OTC case) – Generally excluded as prejudicial and irrelevant following dismissal of negligent marketing claim.  Plaintiff may seek reconsideration as to specific items.  Id. at *22-23.
• Other lawsuits/claims, etc. – Generally excluded as irrelevant. Plaintiff may argue at trial that specific items are relevant to notice.  Id. at *24-25.
• Plaintiff continuing to use product after injury – Admissible.  That the plaintiff continues to use the product with specific knowledge of its potential risk is relevant to whether any inadequate warning could have been causal.  Id. at *31-32.
• Other drugs taken in close proximity – Admissible, as tending to prove alternative causes of the claimed injuries.  Id. at *34-35.

 

One general comment on motions in limine.  The court in Wolfe criticized both sides on a number of occasions for making overbroad and unsupported arguments.  That’s a good thing to keep in mind when drafting or responding to motions in limine.  We believe that anything worth doing is worth doing well.  If counsel is serious about filing motions in limine, such motions should be both focused and supported with everything a court would need to rule.  It’s not only a waste of time to file vague and generic motions in limine/responses, but such filings run the risk of losing credibility with the court.

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.

Of Treating Physicians And Manufacturing Defects

The new case, Williams v. Mast Biosurgery USA Inc., ___ F.3d ___, 2011 WL 2566426 (11th Cir. June 30, 2011), raises two fascinating issues, but we only offer our opinions about one of them. The facts in Williams are unfortunate, as is true with most of the cases we handle.


The plaintiff, a young lady, was being evaluated for possible infertility.  Her treating gynecologist (doctor #1) found an ovarian cyst and drained it.  During that procedure, he also found “significant dense adhesions that had resulted from a prior surgery some years before,” 2011 WL 2566426, at *1 – surgery that, oddly in our view, was not further described or discussed.

More on that later.

More significant surgery, to remove these adhesions, soon followed.  To prevent adhesions from recurring, doctor #1 inserted the medical device in question, a “bioresorbable” (that is, designed to break down and gradually be destroyed by the body’s biological processes) barrier manufactured by the defendant.

Anyway, since we’re describing a product liability suit, things necessarily went awry.  Within a month after this surgery, the plaintiff returned, in bad shape.  A colonoscopy (performed by doctor #2 in a different medical specialty) revealed “several stiff, hard and brittle pieces of plastic” perforating the plaintiff’s colon.  Id.  This required a second surgery – by a doctor #3 – which “cleaned out” the material and a significant accompanying infection.  Doctor #3 “suspected” the material was from the barrier that had been implanted in the second surgery.

A pathologist (doctor #4), also examined the material.  He echoed doctor #3's suspicions, but his testimony turned out to be incomptently based solely on a product label he had been given.

Somehow – the opinion does not describe the circumstances – these plastic pieces were never analyzed “to determine their identity or composition” before they were (we guess, the opinion is less than clear) thrown away.  Id.

Oops.  It's always a bad idea to lose the product in a product liability case.

This failure to retain the offending pieces was the first problem with the plaintiff’s case, which led directly to the second problem – the plaintiff did not retain any experts, instead attempting to make a case solely through the four treating physicians’ testimony.

The lack of any expert led to the court’s first interesting conundrum – to what extent the plaintiff’s treating physicians provided “lay” or “expert” opinion testimony. This distinction is important because expert testimony is subject to Daubert standards.  The trial court found that major parts of these physicians’ testimony was excludable as incompetent expert testimony.  The holes in the plaintiff’s case left by those exclusions defeated causation (but not in the way we were expecting), resulting in summary judgment.

The plaintiff appealed.

The distinction between “lay” and “expert” treating physician testimony is important, and there aren’t that many appellate cases discussing it in a prescription medical product context (Williams didn’t cite any).  But this isn’t a subject we’re opining about ourselves, because depending on how things work out we might find ourselves on either side of this issue in any given case.  Sometimes it’s the defense that likes the “lay” opinion testimony of the plaintiff’s treating physicians – sometimes (as in Williams) it’s the plaintiff.  So we’re not taking sides; just describing the court’s resolution of this interesting issue.

As a gross generalization, the “lay opinions” that a treating physician can testify about are those s/he acquired from things observed/done in the course of treating the particular patient.  Anything further – resulting from the application of the treating physician's medical knowledge to a broader set of facts – is “expert” testimony that must withstand the rigors of Daubert.  As the Eleventh Circuit stated the issue in Williams:

Much of the testimony proffered by treating physicians is an account of their experience in the course of providing care to their patients.  Often, however, their proffered testimony can go beyond that sphere and purport to provide explanations of scientific and technical information not grounded in their own observations and technical experience.  When such a situation presents itself, the trial court must determine whether testimony not grounded in the physician's own experience meets the standard for admission as expert testimony.

2011 WL 2566426, at *4.

There are also procedural differences in how lay opinion testimony, as opposed to expert testimony, is discoverable under the rules.  Neither the district court nor the Court of Appeals based their rulings on failure to follow the proper discovery rules.  Id. at *3 n.1.

In Williams the plaintiff argued that the testimony of all four physicians (the original gynecologist who drained the cyst and found the adhesions; the implanting surgeon, the explanting surgeon, and the pathologist) should have been admitted in full as “lay” testimony.”

The Court of Appeals disagreed, and affirmed the district court (the abuse of discretion review standard undoubtedly helped, too).  Critical parts of the treaters' testimony relating to the (now missing and never definitively identified) pieces of plastic crossed the line and were actually expert opinions.

By the way, the plaintiff did not dispute the trial court’s Daubert-based expert evidence exclusions on the appeal – so the lay/expert distinction was the whole ball of wax.  Williams, 2011 WL 2566426, at *5 n.5.

The court “focus[ed] on the physician statements that the foreign substance removed from [plaintiff’s] abdominal cavity was [the product in question].”  2011 WL 2566426, at *4.  Indisputably, foreign objects – pieces of plastic – were removed from the plaintiff. That alone, however, did not establish a defect in the defendant's product.

But not for the reason we expected.

Whenever we're in a missing product case, as defense attorneys we go first to product identification, because it’s pretty basic that unless the plaintiff can prove that the defendant’s product (as opposed to something else) that hurt him/her, that provides an easy, early end to the case.  So we were surprised that the earlier surgery was never the subject of any significant discussion.  Perhaps those pieces of plastic – never analyzed in any way – were accidentally (or intentionally, but the medical records would probably show that) left over from the first surgery.  Something made out of plastic could have broken the first time around.  Those pieces could have been benignly sitting there for years until disturbed by the later surgery to remove the adhesions.  A surgeon, not not expecting to find anything of the sort and intent on doing his job, could have moved things around without seeing small pieces of plastic and produced a perforation of the colon .

In any event, Williams did not turn on pure product identification.  One piece of admissible lay opinion testimony was doctor #1’s statement that he didn’t put anything in the patient other than the product.  2011 WL 2566426, at *6.  Nobody raised the possibility of leftovers from the prior surgery.

Instead, what doomed the plaintiff’s case was a total lack of evidence about whether and how the observed pieces of plastic established a failure of the defendant's product to act in an intended fashion:

[O]ne other piece of testimony merits our consideration.  [Doctor #1] provided the only direct testimony that [the barrier device] had failed to perform as intended and thus was defective.  We agree with the district court that such a conclusion requires some knowledge of how [the device] should have performed, a question outside the ken of a lay witness because it must be premised on scientific or other specialized knowledge.

2011 WL 2566426, at *6.  Such testimony crossed the line.  An opinion about how a bioresorbable product was supposed to perform, how long it ordinarily took to break down, and what the break down products should have been, was “based on a hypothesis, not the experience of treating the patient.”  Id. at *4.

The procedural takeaway from Williams is that experience with a product generally – beyond the individual plaintiff’s treatment – could not be admitted as the lay opinion testimony of a treating physician.  Rather, it is expert testimony that was admissible, or not, only subject to the strictures of Daubert.

There was no such Daubert-admissible expert testimony in Williams.  As a matter of substantive Georgia law, that meant, because plaintiff could not prove how the product was supposed to perform, there was no evidence that it had failed to perform as expected.

On this second point – what is necessary to establish a manufacturing defect – we have no problem stating that we fully agree with the ruling in Williams.  The entire concept of a manufacturing defect is based upon the product not meeting intended performance/specifications, and the plaintiff in Williams, by failing to offer any evidence of proper performance/specifications, flunked out.

In manufacturing defect cases, res ipsa loquitur a/k/a “malfunction theory” a/k/a “circumstantial evidence” is always the last refuge of a plaintiff without a case, and that’s precisely where the Williams plaintiff sought to hide out – thankfully unsuccessfully.  The intended behavior of a bioresorbable product during its first month in the body was not something that a lay juror could understand without the assistance of admissible expert testimony.  This situation was not obvious like a “loud rattling noise” in a brand new car.  Williams, 2011 WL 2566426, at *6 (distinguishing McDonald v. Mazda Motors, Inc., 603 S.E.2d 456 (Ga. App. 2004)).  Nor was it equivalent to pieces of an implantable medical device that reveal a “clear break.”  2011 WL 2566426, at *7 (distinguishing Williams v. American Medical Systems, 548 S.E.2d 371 (Ga. App. 2001)).

In short, Williams was hardly an “unremarkable” broken product case:

[T]he issue of whether there was a defect concerned a bioresorbable plastic product with which even the treating physicians, let alone the lay jurors, had little to no experience.  Under these circumstances, where those who had observed the patient and her condition could not assess accurately what they had observed and its significance, we do not believe that Georgia law would have permitted [plaintiff] to proceed to a jury without testimony about the nature of the product, its properties or its expected functioning when implanted in the human body.

2011 WL 2566426, at *7.  The mere fact that some foreign body injured the plaintiff did not establish that this particular product had a manufacturing defect at the time it left the manufacturer’s hands.  The plaintiff offered no evidence to exclude product mishandling, negligent implantation, contraindicated use, or “other potential causes” of the purported malfunction.  Id. at *8.

We would add that there was also no evidence that the foreign bodies even came from the product at all.  They could just as well have been artifacts from the prior surgery that – until disturbed by later surgery – had not been causing any trouble.

Bottom line in Williams was that the plaintiff failed to prove any case of manufacturing defect.  Beyond that, both sides need to be cognizant of applicable evidentiary limitations whenever relying upon lay opinion testimony of treating physicians.  This time the plaintiff stepped in it.  Next time, the shoe could be on the other foot.

Experts Offering Evidence of Corporate Intent, Ethics, And The Like

Returning from the ALI meeting, Bexis had sitting in his inbox the final hard copies of update 14 for his Drug/Device products liability book.  For those of you that use Bexis' book, that means there's more to use, but for Bexis that means that it’s time to start on update 15.  A legal author’s work is never done.  This time he’s planning to update the chapter on evidence.

It's also time for our Thursday long post - time to kill two birds with one stone.


Right now the book has a short subsection on corporate intent evidence in drug and device cases.  That section states simply that corporate motive and intent evidence (usually offered by some purported “expert”) has generally been found inadmissible by courts trying drug and medical device product liability cases.  There’s one footnote, citing four cases from three jurisdictions:  Smith v. Wyeth-Ayerst Laboratories Co., 278 F. Supp.2d 684, 700 (W.D.N.C. 2003); Figueroa v. Boston Scientific Corp., 2003 WL 21488012, at *4 (S.D.N.Y. June 27, 2003); In re Diet Drugs Products Liability Litigation, 2001 WL 454586, at *2 (E.D. Pa. Feb. 1, 2001); In re Diet Drugs Products Liability Litigation, 2000 WL 876900, at *9 (E.D. Pa. June 20, 2000).

We think Bexis can do better than that with this update – and we think we can make a blog post out of it as well.  So let’s take a look.  What have courts held about corporate motive and intent evidence lately?

Probably the best treatment of the subject, of the cases coming down since this part of the book was updated, is in In re Rezulin Products Liability Litigation, 309 F. Supp.2d 531 (S.D.N.Y. 2004). There, three purported corporate ethics “experts” were excluded for a variety of reasons.  First, their ethics opinions were “speculative” in the sense that they were based upon “subjective belief.”  Id. at 543-44.  Second, ethical matters were not relevant to product liability litigation, as it was unrelated to the alleged defects being claimed.  “While the defendants may be liable in the court of public opinion, or before a divine authority . . ., expert opinion as to the ethical character of their actions simply is not relevant to these lawsuits.”  Id. at 544.  Third, ethics evidence was argumentative and prejudicial.  Id. at 545.  Fourth, expert witnesses aren’t really qualified at divining corporate intent, which is something that lay jurors are equally competent to judge, should it be relevant to anything.  Id. at 546-47.

Other cases have also considered and rejected ethics/intent-related testimony for one or more of the reasons articulated by the Rezulin court.  In re Trasylol Products Liability Litigation, 2010 WL 1489793, at *7-9 (S.D. Fla. Feb. 24, 2010), largely followed Rezulin in excluding disguised business ethics evidence:

Despite Plaintiffs’ argument that the opinion at issue is not an ethical opinion because [the witness] does not use the word “ethical” or “unethical” in his Report . . ., this Court will consider [its] substance. . . .  Much of the testimony in dispute relates to [defendant’s] responsibilities, the studies that [it] should have done to comply with drug safety principles, and the issues that [defendant] should have addressed earlier than it did.  The Court finds that this proffered testimony is akin to the ethics testimony found to be inadmissible in Rezulin. . . .  The Court finds this testimony inadmissible because it is a reflection of [the witness’] own subjective beliefs and personal views and does not rest on knowledge as required by Rule 702.

Id. at *8; see id. at *9 (“speculation about [the defendant’s] subjective motivations . . . is not a proper subject for expert testimony”).  See also In re Trasylol Products Liability Litigation, 709 F. Supp.2d 1323, 1347 (S.D. Fla. 2010) (witness lacked expertise “to infer . . . knowledge and intent and present those inferences to the jury”); In re Trasylol Products Liability Litigation, 2010 WL 4052141, at *8 (S.D. Fla. Feb. 24, 2010) (opinion concerning defendant’s “knowledge, motive, intent, and state of mind . . . are inadmissible . . . because they have no basis in any relevant body of knowledge or expertise and lie outside the proper bounds of expert testimony”); In re Trasylol Products Liability Litigation, 2010 WL 4259332, at *8 (S.D. Fla. Feb. 24, 2010) (“[t]he question of intent or motive is a classic jury question and not one for experts”).

The court in Deutsch v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2011 WL 790702 (E.D.N.Y. Mar. 8, 2011), also found corporate intent evidence to be improper on multiple grounds, relying primarily on Rezulin:

[The witness] scatters improper personal opinions, speculation, and state of mind inferences throughout the narratives in her report.  Such opinions are inadmissible insofar as the opinions of expert witnesses on the intent, motives, or states of mind of corporations, regulatory agencies and others have no basis in any relevant body of knowledge or expertise.  In addition, “bad company” opinions that are not based on any FDA regulation or other applicable standard are similarly inadmissible.

Id. at *45.  In addition, the witness was found generally unqualified to testify about corporate ethics, and to have no basis beyond subjective personal opinion for any assertion that “ghostwriting” (preparation of scientifically accurate articles for others to claim authoship) was unethical or otherwise improper.  Id. at *46.

Essentially the same result occurred in In re Fosamax Products Liability Litigation, 645 F. Supp.2d 164 (S.D.N.Y. 2009), with vague and conclusory ethics testimony being excluded:

To the extent [defendant] challenges testimony about purported general ethical standards . . . [its] motion is GRANTED . . . .  [A]uthorities such as the 1964 Declaration of Helsinki [] providing generally accepted international standards such as “The health of my patient will be my fist consideration” . . . [and] that “[t]rust and honesty are essential virtues that permeate all aspects of human life, including the drug approval process” . . . are so vague as to be unhelpful to a fact-finder.

Id. at 194 (quoting Rezulin); see id. at 192 (“the knowledge, motivations, intent, state of mind, or purposes of [defendant and] its employees . . . is not a proper subject for expert or even lay testimony”); 195 (same).

Likewise, the court in In re Baycol Products Litigation, 532 F. Supp. 2d 1029 (D. Minn. 2007), blew out corporate ethics evidence as “only marginally relevant’ and not a proper subject for expert testimony:

Personal views on corporate ethics and morality are not expert opinions.  Further, expert testimony that is merely speculation or pure conjecture based on the expert’s impressions of the physical evidence must be excluded as not based on any reliable methodology or scientific principle.

Id. at 1053; see id. at 1054 (“testimony . . . that [] speculates as to [defendant’s] motive, intent or state of mind, or speculates as to motives of the FDA or what other drug companies would do is excluded”); 1058 (ethics opinion concerning “preclinical and clinical testing not only lacks foundation, but is also speculative and will not assist the fact-finder”); 1067 (ethics opinion “is legal argument that does not qualify as expert testimony”); 1069 (“an expert may not testify as to ethical issues or to his personal views”).

Corporate ethics testimony also bit the dust in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, 2010 WL 1727828 (M.D. Ga. Apr. 27, 2010).  An author of a general business ethics textbook was found unqualified to testify about what it was “appropriate” for a medical device company to do:

[The witness] has no expertise in the fields that would qualify a witness to testify about what scientific information should be reported to the FDA or to testify about medical device industry standards for warning physicians and patients about potential adverse effects of a medical device. Therefore, she is not qualified to offer an opinion about the appropriateness of [defendant’s] conduct.

Id. at *4.  The “code of ethics” that the witness purported to interpret was such that “anyone who reads and understands the English language can interpret and apply [its] principles.”  Id. at *4 n.3.

Corporate ethics testimony was excluded as unscientific and unduly prejudicial in Wolfe v. McNeil-PPC, Inc., 2011 WL 1673805 (E.D. Pa. May 4, 2011):

Simply because [the witness’] subjective views of ethics are informed by well-known principles does not convert them into objective, reliable, scientific knowledge. . . .  Whatever benefit could be derived from his opinions about [defendant’s] social responsibility and ethical obligations is vastly outweighed by the tendency of such testimony to encourage the jury to impose liability on an improper basis.

Id. at *8-9.

In In re Prempro Products Liability Litigation, 554 F. Supp. 2d 871 (E.D. Ark. 2008), aff’d in pertinent part, rev’d in part on other grounds, 586 F.3d 547, 571 (8th Cir. 2009), a purported expert ran amok at trial. Among other things, the witness' “editorial about pharmaceutical companies putting sales and marketing before science” should have been excluded.  Id. at 881.  Similarly, in Lopez v. I-Flow Inc., C.A. No. 08-1063, slip op. at 19-20, 2011 WL _______ (we’ve sent this to Westlaw; there will be a cite in a few days) (D. Ariz. Jan. 26, 2011), the court rejected intent testimony for lack of personal knowledge, helpfulness to the jury, and as outweighed by prejudice, confusion, etc.  See also In re Heparin Product Liability Litigation, 2011 WL 1059660, at *7 (N.D. Ohio March 21, 2011) (witness must “not express any views as to Defendants’ intent, motives, or state of mind”); In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334, at *13 (N.D. Ohio May 4, 2010) (“[n]or may [the witness testify as to [defendant’s] knowledge, motivations, intent or purposes”); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 2008 WL 4878066, at *6-7 (N.D. Tex. July 25, 2008) (opinions “regarding Defendants’ ethical obligations, motive, state of mind, asserted knowledge, and alleged conduct” excluded as “personal opinions or legal conclusions based on Defendants' alleged behavior”); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *8 (D. Minn. June 29, 2007) (witness “not allowed to testify as to [defendant’s] knowledge” or “whether Guidant's conduct was ethical”); Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 2300222 (N.J. Super. L.D. April 30, 2010) (“state of mind, intent, motive, or ethics” “are not the proper subject of expert opinion testimony” and would be “speculative”).

Rezulin also demonstrates that there are really two types of evidence at issue in most of these sorts of cases. Not only is there the kind of thing that first attracted our attention – that is, the giving of outright opinions about whether a defendant acted properly – but there’s also the broader issue of bringing in an expert to review documents s/he had nothing to do with preparing and/or knows nothing about and then, in effect, giving the lawyer’s closing argument from the witness stand, in some sort of narrative casting the defendant in the worst possible light.  So there’s really a distinction between “ethics” evidence and “conduct” evidence. Rezulin excluded this sort of “narrative” evidence as well:

[The] “history of Rezulin” is merely a narrative of the case which a juror is equally capable of constructing. . . .  Such material, to the extent it is admissible, is properly presented through percipient witnesses and documentary evidence. . . .  [T]he glosses that [the witness] interpolates into his narrative are simple inferences drawn from uncomplicated facts that serve only to buttress plaintiffs' theory of the case.  As plaintiffs’ Rezulin “historian,” therefore, [the witness] does no more than counsel for plaintiff will do in argument, i.e., propound a particular interpretation of defendant’s conduct.  Accordingly, [the witness’] testimony relating to the “history of Rezulin” is inadmissible.

309 F. Supp.2d at 551 (various citations omitted).

So one thing that will be happening is the division of the one existing paragraph in the book into two, one involving corporate ethics/intent directly and the other the sort of “narrative” held inadmissible in Rezulin.

Other cases (mostly the same cases, actually) similarly exclude narrative-type evidence in drug/device cases.  For instance, in Prempro the court reversed its own rulings at trial and held:

If an expert does nothing more than read exhibits, is there really any point in her testifying as an expert? . . .  [T]the use of the “regulatory expert” to deal with large volumes of documents is subject to abuse.  The expert did not explain the documents, provide summaries, or tie them in to her proposed regulatory testimony.  [The witness] did not provide analysis, opinion, or expertise.

554 F. Supp.2d at 886. See Heparin, 2011 WL 1059660, at *8 (witness “may not give a narrative history . . . which must be presented through direct evidence”); Deutsch, 2011 WL 790702, at *45 (excluding a “a factual narrative of events” because it lacked “analysis, opinion, or expertise” and because it included “personal opinions, speculation, and state of mind inferences throughout”); Lopez, slip op. at 18-19 (excluding “report [that] simply presents a narrative of selected regulatory and corporate events and quotations”); Gadolinium, 2010 WL 1796334, at *13) (witness “may not provide a narrative history of [the product], which must be presented through direct evidence”); Trasylol, 709 F. Supp.2d at 1346-47 (excluding “pure factual narrative regarding [the drug’s] regulatory history”); Trasylol, 2010 WL 4259332, at *8 (a “narrative . . . is lay matter that is not a permissible subject of expert testimony”); In re Viagra Products Liability Litigation, 658 F. Supp.2d 950, 967 (D. Minn. 2009) (“there is no evidence that the jury could not be presented with these same documents and draw from them the relevant regulatory history”); Fosamax, 645 F. Supp.2d at 192 (“[a]n expert cannot be presented to the jury solely for the purpose of constructing a factual narrative based upon record evidence”); Prempro, 554 F. Supp. 2d at 880 (testimony that “simply read and summarized the documents, as any layperson could have done” should have been stricken); 887 (“an expert witness simply summariz[ing] a document (which is just as easily summarized by a jury) with a tilt favoring a litigant, without more, does not amount to expert testimony”).

Whew!

Yup, we’d have to say that this part of Bexis’ book requires updating.  It will be, but blog readers just got a sneak preview.

Thinking About Compliance Presumptions

A couple of weeks ago we posted about the recently enacted Wisconsin tort reform statute, which, among a bunch of other things, included a “rebuttable” presumption that a product compliant with federal or state standards isn’t defective. Specifically, the statute provides:

Evidence that the product, at the time of sale, complied in material respects with relevant standards, conditions, or specifications adopted or approved by a federal or state law or agency shall create a rebuttable presumption that the product is not defective.

§895.047(3)(b).

One of our readers questioned whether the other side would gut this presumption by arguing it was meaningless, since what constitutes “rebuttal” is not defined.  Plaintiffs bear the burden of proving defect anyway, so might can contend that the same evidence that they have always needed to get to a jury on the defect element of the tort is also sufficient to rebut the presumption.

Will they try it?  Of course they will. They’re plaintiffs’ attorneys. Their job is to represent their clients with every bit as much vigor as we on the right side of the “v.” represent ours.

That also means it’s our job not to let them.

So we thought today we’d give the question of statutory compliance presumptions some thought.

First of all, what’s the universe of the statutes we’re talking about?  We know of 14 states, and one federal statute, that address compliance with governmental standards, and most of them create presumptions.  Some (Michigan and Texas) are stronger than others. Some are broader than others:

The federal statute, for example, applies only to vaccines, and only to warnings. It provides:

[A] vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the [FDCA and the Vaccine Act] applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows –

(A) [fraud or bribery against the FDA], or

(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance. . . .

42 U.S.C. § 300aa-22(b)(2).  Note that, unlike the Wisconsin statute, the federal law explicitly addresses the amount (we lawyers say “quantum”) of evidence necessary to overcome the presumption.

The other state statutes that we know of that address compliance in one way or another are:  Arizona:  Ariz. Rev. Stat. Ann. §12-701 (punitive damages only; mentions only “drugs”; compliance bars an award unless plaintiff proves FDA fraud/bribery by “clear and convincing” evidence); Arkansas:  Ark. Code Ann. §16-116-105(a) (compliance generally is “evidence” of non-defectiveness); Colorado:  Colo. Rev. Stat. §13-21-403(1)(b) (compliance generally creates rebuttable presumption; whenever facts exist that establish the presumption, the jury is to be charged); Florida:  Fla. Stat. Ann. §768.1256 (compliance generally creates rebuttable presumption; special exclusion for products recalled or “seized” by the FDA); Indiana:  Ind. Code §34-20-5-1 (compliance generally creates rebuttable presumption); Kansas:  Kan. Stat. Ann. §60-3304(a) (compliance generally “deems” a product non-defective “unless the claimant proves by a preponderance of the evidence that a reasonably prudent product seller could and would have taken additional precautions”); Michigan:  Mich. Comp. L. §600.2946(4-5) (compliance generally creates rebuttable presumption; FDA approved drugs are not defective unless sold after a recall or plaintiff proves FDA fraud/bribery); New Jersey:  N.J. Stat. Ann. §2A:58C-4 (FDA approval of warning creates rebuttable presumption of warning adequacy); North Carolina:  N.C. Gen. Stat. § 99B-6(b)(4) (evaluation of reasonableness  of drug manufacturer "shall" include extent of FDA compliance); North Dakota:  N.D. Cent. Code §28-01.3-09 (compliance generally creates rebuttable presumption); Tennessee:  Tenn. Code Ann. §29-28-104 (compliance generally creates rebuttable presumption); Texas:  Tex. Rev. Civ. Prac. & Rem. C. §82.007 (FDA approval of warning creates rebuttable presumption of warning adequacy; rebuttal limited to FDA fraud bribery, sales after a recall, and some off-label promotion situations); Utah: Utah Code Ann. §78-15-6 (compliance generally creates rebuttable presumption).

The question of what to do with a compliance presumption once a state has created it involves two separate but related issues.

The first issue is the amount of evidence necessary to overcome the presumption.  As is evident from the descriptions we just gave you, the Vaccine Act and Arizona specify that “clear and convincing” evidence is required, while the other states’ statutes are silent.

The second issue is what happens to the presumption once it arguably has been overcome?  Is the jury charged on it and allowed to make up its own mind?  Alternatively, does the presumption vanish once contrary evidence is introduced, so that the jury never finds out about it?

The response, as we see it, to the first issue begins with some of the most basic canons of statutory interpretation – something we expect is followed in every state – (1) that statutes are not to be read as nullities, and in the same vein, (2) that the legislature is not presumed to act futilely. Another related proposition is (3) that an act is not to be construed to product an absurd result.

By enacting what it called a “presumption,” based upon the defendant’s compliance with relevant governmental standards, the legislature had to intend to benefit the compliant defendant in some way, right?  If not, then why do anything at all?

Assuming that the legislature meant its enactment to mean something, then we have to figure out what's the most logical meaning with respect to our clients – in this context, FDA compliant drug/device companies.  In this post-Levine world, we’ve largely been relegated to the old FDA standards as “minimum standards” view of the common law.  See, e.g., Wyeth v. Rowatt, 244 P.3d 765, 780 (Nev. 2010); Dorsett v. Sandoz, Inc., 699 F. Supp.2d 1142, 1149 (C.D. Cal. 2010); In re Trasylol Products Liability Litigation, 2010 WL 4259332, at *4 (S.D. Fla. Oct. 21, 2010), and other depressing precedents.

What these compliance presumptions do after Levine is flip the common law default position regarding the effect of FDA compliance. Under Levine, compliance with FDA warning approval is presumptively not binding in a common-law case “absent clear evidence that the FDA would not have approved” a label change in the nature of what the plaintiff advocates.  Wyeth v. Levine, 129 S. Ct. 1187, 1198 (2009).  But in states where the legislature has enacted a presumption of non-defectiveness by reason of FDA (or other) compliance, the “minimum standard” analysis is upended.  Under those statutes, compliance with the FDA’s approval of a warning now is presumptively binding in a common-law case – unless the plaintiff proves whatever the statute says s/he has to prove to overcome the presumption.  So in those states, we’re dealing with Levine in reverse.

The logic of a statute creating a Levine in reverse situation (where the statutory presumption is that FDA compliance equals non-defectiveness), is that to rebut the presumption, a plaintiff should have to present the same degree of “clear evidence” as required by Levine.  This analogy, which we think is to the closest relevant presumption in an FDA compliance case, would of course only apply where the legislature is silent (unlike Arizona or the Vaccine Act) as to the quantum of proof necessary to overcome the presumption.  But again that’s closely analogous to Levine.  Just as Congress in Levine was silent as to the preemptive effect of FDA compliance, most of the state compliance statutes are equally silent as to how much rebutting it takes to rebut a rebuttable presumption (or how much wood could a wood chuck chuck).

The Levine analogy is just that – an analogy.  It’s not mandated by either statute or common-law postulate.  But neither is anything else.  So we think there are good logical reasons to apply the Levine “clear evidence” rebuttal standard to FDA compliance presumptions with respect to the quantum of evidence question.  For one thing, this standard prevents the statutory presumption from being treated as a nullity, which is precisely what would happen if a plaintiff didn’t need to meet anything more than the pre-existing burden of proof in order to rebut the presumption.  For a second thing, there’s symmetry.  Levine applied a “clear evidence” standard to rebut the presumption against preemption in an FDA compliance context where the default was that compliance wasn’t controlling.  Where a state legislature has determined that compliance is controlling, it makes sense to apply the same rebuttal standard, only in reverse.  Third, the Levine “clear evidence” standard is consistent with the legislative judgment in those two instances (Vaccine Act and Arizona) where a statute actually did address the quantum of proof issue, suggesting that, if other legislatures had bothered to think about the issue, they most likely would have come out the same way.

Now we’ll turn to the second issue.  What happens to a “rebuttable” presumption once it – arguably at least – has been rebutted by evidence of whatever it is that the legislature has provided should constitute rebuttal (which ranges from FDA fraud/bribery in a number of states, to unspecified “additional precautions” in Kansas).  Only one of the compliance statutes, Colorado’s, deals expressly with this issue.  Colorado law provides:

In a product liability action in which the court determines by a preponderance of the evidence that the necessary facts giving rise to a presumption have been established, the court shall instruct the jury concerning the presumption.

Colo. Rev. Stat. §13-21-403(1)(b)(4).  So in Colorado, once the defendant had proven compliance, then the presumption of non-defectiveness is always charged to the jury, and it is a jury question whether the plaintiff has rebutted it.

In the other states, where the legislature is silent, the question of whether the jury is charged on the presumption where some rebuttal evidence has been received will depend on how the state’s law (or possibly federal law in a diversity case, if this question is considered “procedural”) treats presumptions.

There are two theories of presumptions – the more traditional “bubble bursting” theory and the more recent persistent presumption approach.  A bubble bursting presumption vanishes when it is rebutted and the jury is not thereafter instructed on it:

[U]nder what has become known as the Thayer or “bursting bubble” theory, the only effect of a presumption is to shift the burden of producing evidence with regard to the presumed fact.  If that evidence is produced by the adversary, the presumption is spent and disappears.  In practical terms, the theory means that, although a presumption is available to permit the party relying upon it to survive a motion for directed verdict at the close of its own case, it has no other value in the trial.

McCormick on Evidence §344 (footnote omitted) (emphasis added).

The other, more modern approach declares that some rebuttable presumptions are in the nature of substantive law, and it is for the jury to determine whether or not they are rebutted:

The “bursting bubble” theory has been criticized as giving to presumptions an effect that is too “slight and evanescent” when viewed in the light of the reasons for the creation of the rules.  Presumptions, as we have seen, have been created for policy reasons that are similar to and may be just as strong as those that govern the allocation of the burdens of proof prior to the introduction of evidence.  These policy considerations may persist despite the existence of proof rebutting the presumed fact. . . . If the policy behind certain presumptions is not to be thwarted, some instruction to the jury may be needed despite any theoretical prohibition against a charge of this kind.

Id. (footnotes omitted) (emphasis ours).

In this context, the federal approach is about as clear as mud.  See McCormick §344 (“Despite the best efforts of legal scholars, instead of having one rule to govern all presumptions in all proceedings, we are left in some ways in a more confusing state than that which existed prior to the adoption of the Federal Rules.”); Hjelmaas, “Stepping Back from the Thicket:  A Proposal for the Treatment of Rebuttable Presumptions & Inferences,” 42 Drake L. Rev. 427, 447 (1993) (“The [federal] rule is unclear . . . concerning the effect of rebuttal evidence on challenges to an established presumption. . . .  The adoption of Federal Rule of Evidence 301 has not clarified this area of law”); Louisell, “Construing Rule 301:  Instructing the Jury on Presumptions in Civil Actions and Proceedings,” 63 Va. L. Rev. 281 (1977) (Fed. R. Evid. 301 adopts a traditional, bubble-bursting approach, but can be interpreted broadly enough to permit an inference instruction); Mueller, “Instructing the Jury Upon Presumptions in Civil Cases:  Comparing Federal Rule 301 with Uniform Rule 301, 12 Land & Water L. Rev. 219 (1977) (arguing against the traditional bubble bursting interpretation of Rule 301).

We think that compliance presumptions should persist – and that the jury should be charged on them – in any case where there is a jury question as to compliance.  There are two reasons for that.  First, the traditional bubble bursting approach arose, as McCormick points out in the part of the quote that we highlighted; where the presumption was created to assist a party bearing the burden of proof to avoid a “directed verdict at the end of his case.”  Legislatures have passed compliance presumptions to assist defendants, who do not bear the burden of proof (except as to compliance itself).  Thus the statutory compliance presumptions do not fit the rationale of the bubble bursting theory.

Conversely, compliance presumptions are the epitome of the “policy” based presumption, which is created for a reason other than to address a burden of proof problem.  In this respect, we recommend the analysis of the Indiana Supreme Court in a non-drug case Bexis worked on, involving what weight to give the Indiana compliance statute (which, as we've indicated, was silent):

[T]he [compliance] presumption recognized in the statute is not a conventional presumption at all.  A presumption . . . relieves the party with the burden of proof on a presumed fact from having to produce evidence of the presumed fact once that party has proved a basic fact. . . .  But under the statutory presumption at issue here, the presumed fact is the presence or absence of defect and negligence.  And the plaintiffs. . ., not the defendant. . ., have the burden to prove defect and negligence in a product liability action. . . .  Is another implication of this anomaly that, except at the summary judgment stage, there simply is no presumption to be given continuing effect. . .?  We think not. The point of giving “continuing effect” to a presumption through a jury instruction is to further the policies that give rise to the presumption in the first place.  By authorizing the instruction here, we recognize the policy embodied by the Legislature in Indiana Code §34-20-5-1, regardless of whether the provision conforms to the conventional definition of a legal “presumption.”

Schultz v. Ford Motor Co., 857 N.E.2d 977, 985-86 (Ind. 2006) (footnotes omitted).

In the case of the brand new Wisconsin compliance presumption – and, indeed, in the case of compliance presumption statutes generally – the plaintiffs’ side can be expected to seek judicial interpretations that these statutes are meaningless nullities.  They will do this by:  (1) arguing that the presumption is rebutted by the same quantum of evidence that they already have to present to meet their pre-existing burden of proof, and (2) arguing that once they have put on any evidence at all of non-compliance, the presumption “bursts” and drops from the case.

We have to offer persuasive contrary arguments that preserve what the legislature actually wanted to do when it took the affirmative step of changing the common law with respect to FDA (and other) compliance.  Lawmakers didn’t intend to enact a nullity, so the plaintiffs should have to meet the same “clear evidence” standard where state law says compliance equals lack of defect as we do when state law says otherwise.  Furthermore, because legislatures only enact presumptions to favor parties not bearing the burden of proof for substantive policy reasons (because defendants don’t otherwise need them), juries should always be charged on a statutory compliance presumption except in the unusual situation where failure to comply is undisputed.