Friday, October 02, 2015

Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

            We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 115601 (N.D. Ga. Aug. 31, 2015), as a bit of penance.  This act may be appropriate given the recent Day of Atonement and, much like long Yom Kippur services during a fast, the decision drags on, repeats itself, has some highs and lows, and maybe induces some confusion and a touch of a headache.  While we are not looking for a scapegoat, some of the reasoning for why the issues were presented how they were presented and why they were decided is lost on the reader, at least this reader.  (Much like the original meaning of Azazel, to where/whom the original scapegoat was to be sent by Aaron.  Or maybe not at all like that.)  As a combination Daubert and summary judgment order on a bellwether case from an MDL for a product, a metal-on-metal hip implant, for which there is considerable litigation on similar products made by other manufacturers, there will likely to attempts to extend various parts of this decision to other cases.  So, we will resort to the dreaded use of subheadings in discussing it.

            Plaintiff had a left hip replacement in 1995 with a device that used a ceramic femoral ball, a polyethylene liner, and a metal acetabular shell.  In 2006, plaintiff had her right hip replaced with the defendant’s product, which utilized a ball and cup each made of cobalt-chromium with no liner.  In 2012, plaintiff started experiencing pain in her right hip and, within a week, had a revision surgery where the defendant’s product was explanted (and presumably something else was implanted).  All three surgeries were done by Dr. Lynn Rasmussen, who happened to have been consulting with defendant on designing hip implants in between the second and third surgeries.  In doing the third surgery, Dr. Rasmussen observed what he called “metallosis” (sometimes “metalosis” in the records and briefs), but did not send any explanted tissue or material for pathological evaluation.  Plaintiff sued under a range of product liability theories based on the risk of “metallosis.”  Thereafter, plaintiff named at least ten experts to weigh in on causation and defect in some form or other, most of whom relied to some degree on Dr. Rasmussen’s characterization of what he saw—and defendant filed a bunch of Daubert motions.  Plaintiff filed a “motion for partial summary judgment” that preemption and the learned intermediary doctrine did not apply to her claims and, at the court’s request, the defendant filed a motion for summary judgment on all the claims that plaintiff did not drop.  An affiliated defendant also filed for summary judgment on different grounds.  There were some other motions we are ignoring, but everything was addressed in one big decision.

            One of the motions that defendant filed asked that none of the retained experts be allowed to rely on what Dr. Rasmussen said he saw in his third surgery because there was no pathology or test evidence from that surgery to show how the tissue had reacted to the implant.  When we saw that there was a separate “Metallosis Motion,” we expected it would be a challenge to whether there is a defined clinical entity called “metallosis” that can be diagnosed just be looking at it, no matter how experienced the surgeon making the diagnosis is.  That is not what the defendant did, though.  It did not challenge whether there is something called metallosis or even that Dr. Rasmussen observed signs of metallosis in the tissue and fluid he encountered during the third surgery.  Instead, at least as the court interpreted it, the defendant made a Rule 703 challenge to attempts to rely on what Dr. Rasmussen said he saw when no “corroborating information” was available in the medical records.  Given Dr. Rasmussen’s experience and testimony that he had seen metallosis enough to know it when he saw it—perhaps channeling Justice Stewart on obscenity—for the court to brush aside the challenge.

Rasmussen’s observations, conclusions, and opinions are the kind of medically reliable evidence that medical experts would consider in reaching a conclusion about the medical condition or complications.  That is, medical professionals and researchers often rely on the observations of treating physicians to reach diagnostic conclusions, decide on courses of treatment and opine on the commonality of disease and injury among patients to determine if there is a common course of disease or injury.  The observations of an experience treating physician are especially reliable because they serve to record a patient’s medical history and often form the basis for a person’s treatment and health issues throughout the person’s life.
Id. at **25-26.  This may seem pretty straightforward, but there should be a distinction between observations of something already described in medical literature as representing a known clinical entity and conclusions that a novel clinical entity has been observed based on the untestable ipse dixit of the physician.  We see some danger in how this ruling may be extended, as we do for the court’s related conclusion that “Rasmussen’s observations, conclusions and opinions were not required to be corroborated by laboratory or other corroborating testing before other experts could reasonably rely upon them.”  Id. at *31.

            The various experts who relied on what Dr. Rasmussen said he saw and diagnosed mostly got to offer their causation opinions, but not necessarily other opinions that were challenged.  Reconciling the various parts of this would require more effort than we have offered here. 

·                     First, a pathologist was allowed to offer a case-specific opinion on the pathological processes without having pathology slides.  This was permitted because she relied on photographs of the explant, along with what Dr. Rasmussen and plaintiff said.  Id. at **38-40.

·                     Second, a medical toxicologist, who had also personally evaluated the explant, was not allowed to give a causation opinion because he was viewed as just parroting Dr. Rasmussen’s opinion.  Id. at **44-46.

·                     Third, a biomedical engineer was allowed to opine on causation because his inspection of the explant “articulated evidence that supported Rasmussen’s conclusion.”  Id. at **49-50.

·                     Fourth, a metallurgist, who reviewed case-specific information but did not offer case-specific opinions, was allowed to refer to “tissue discoloration” as “staining.”

·                     Fifth, a mechanical engineer was allowed to opine on cause because he also relied on the biomedical engineer’s report.

·                     Sixth, our old pal Dr. Parisian was not allowed make it sound like she had reached a causation opinion in the midst of offering her regulatory opinions—which is one of her little trial tricks—but no other aspect of her opinions was challenged.

·                     Seventh, an orthopedic surgeon was allowed opine on cause without blood test results on plaintiff like he typically uses to diagnose metallosis.

·                     An eighth expert, a master’s level materials science and biomedical engineer, used a novel method to estimate the “simulated wear volume” of femoral heads and compare it to the measure of wear on the explanted femoral heads from plaintiff and other patients.  The expert’s method for estimating what cannot be measured was apparently part of his master’s thesis and, as such, his opinion had been peer reviewed to some extent.  The court saw that other Daubert factors were not met, though—as they are often not for similar guesses made by experts in medical device cases who talk about what happens with implanted medical devices that do not get explanted.  The expert could not compare actual “immeasurable wear” to his estimation and, as such, could not test his method or establish its error rate.  Id. at *69.

·                     A ninth expert, another metallurgist, was allowed to opine that plaintiff was injured because the metals selected for product were purportedly a poor choice for a prosthetic hip.  Defendant’s challenge focused on the expert’s failure to do any evaluation of plaintiff’s explant or any tests to evaluate any aspect of his theory about how the metals behave in the body.  He also relied on material data sheets—yes, those somewhat notorious documents about worker safety when handling raw materials—in forming his opinions.  Specifically, he relied on the handling instructions in the data sheets for cobalt and chromium powder in opining that metals “must also be dangerous when used in metal alloy form in a medical device.”  Id. at *77.  Rather than directly address the silly use of the data sheets or the utter lack of testing, the court concluded that the totality of the information that the expert considered, including the other plaintiff expert reports (the excluded ones among them), provided a reliable basis for the opinion.  Like we said, we would need to try hard to reconcile some of these rulings.

·                     A tenth expert—why stop at nine?—was a biostatistician who tried to opine that studies showed that the revision rate was higher than a company report stated in 2010.  In what some courts might have said was a matter for cross-examination, the court excluded these opinions (but apparently allowed others about the conduct of clinical trials) because the studies he chose as comparisons were inappropriate in considering other products and other end points and in cherry-picking lesser quality surveys over randomized controlled trials.  These “fundamental shortcomings in Waller’s comparison analysis [] discredit[] the reliability of the opinion, and to admit it would risk confusing, and likely misleading, the jury.”  Id. at *92. 

Summary Judgment
            Holding Company’s Motion

            We have posted many times about attempts by plaintiffs to bring product liability claims against individuals or entities other than the company that designed, manufactured, and marketed the product.  State law formulations of product liability theories overwhelmingly limit liability to the company we typically call “the manufacturer,” absent an unusual fact pattern.  At first blush, one of the defendants here, Wright Medical Group (“WMG”), which called itself a “holding company,” would seem like the kind of defendant that should get out of the case.  There were two reasons why that was not the case here.  First, maybe because of the MDL dynamic of how claims and motions to dismiss are raised and maybe because Bauman came down after the defendants had answered initially but before the current amended complaint had been answered, lack of personal jurisdiction over the WMG had not been raised as a defense.  That was waiver and serves as a reminder to re-evaluate template answer and answering practice periodically.  It is unclear whether any of the complaints alleged enough to satisfy current standards for personal jurisdiction over WMG.

            Second, as the court framed it, WMG based its summary judgment motion on the lack of evidence that it “committed the wrongful conduct that Plaintiff alleges cause her injury.”   Id. at *99.  It did not contend that Utah law—which applied here—imposed no duties on it that could give rise to product liability.  As such, the analysis does not discuss the requirements of Utah law at all.  Instead, it focuses on the competency of the affidavit claiming that WMG was not involved in the design, manufacture, sale and marketing of the product at issue.  The affiant was deposed and admitted relying on outside counsel and the main defendant’s tax director rather than her own personal knowledge.  This made the affidavit insufficient to shift the burden to plaintiff under Rule 56 to establish genuine issues of material fact—and provides additional reminders on the importance of selecting the right affiant and the corresponding risk of deposition.  To top it off, general statements in SEC filings could be read as suggesting that WMG was involved in the medical device business directly as opposed to just through its subsidiaries.  These statements, along with billing and inventory records, “facially support that WMG may have been involved in the manufacture, sale, or marketing of the Conserve hip replacement components.”  Id. at *104 (emphasis added).  If the burden had shifted through sufficient evidence with the motion, then this “may have been” evidence from plaintiff might not have been enough, but the burden had never shifted.  So, motion denied.

            Defendant’s contention on preemption was that express preemption wiped out plaintiff’s design-based claims, not because the actual product had been approved through a PMA, but because the plaintiff’s theory implicated other PMA approvals.  As the court recounted it, no type of preemption besides express was asserted and Riegel makes it clear that the express preemption provisions in the Medical Device Amendment to the FDCA require a PMA approval of the specific device.  The actual language of 21 U.S.C. § 360k imposes preemption when the state law claim imposes a requirement that is “different from, or in addition to, any requirement applicable under this chapter to the device,” which is not the same as limiting preemption to requirements coming from the PMA approval of the specific device.  Whether the PMA approval of the defendant’s related device could impose a “requirement applicable under this chapter to the device” at issue was not really analyzed.  That may have been because the court considered the lack of the PMA submission for the device at issue to have “denied the FDA the opportunity” to evaluate the device, its safety, and its efficacy.  Id. at *121 n.50.  That sounds an awful lot like a Buckman issue, but, again, implied preemption was not addressed.  As for the idea that the plaintiff’s theory that all metal-on-metal hip implants were defective created preemption because FDA had approved other metal-on-metal implants, the court read the complaint as being about the product at issue rather than the class of products.  The court did not, however, look back at the opinions of plaintiff’s experts—the ones analyzed in the Daubert part of the decision—to see that their view of defect was often not product-specific.  It can certainly be the case that evidence and argument offered in support of a broader claim should be precluded based on preemption.  This has come up in various contexts—for instance, a plaintiff expert saying that the drug should have had a black box label—but it would logically apply to the basic choice of a material or broad design too.  The court, however, did not go that deep here in denying the express preemption motion.

            Comment K
            The analysis of the Comment K defense did try to predict how Utah courts would apply the defense to medical device cases given the Utah Supreme Court’s adoption for prescription drugs and a Utah federal court’s refusal to apply it to medical devices.  (We discussed the Utah federal court decision here.)  Relying heavily on the old Oklahoma Supreme Court case-by-case decision in Tansy v.Dacomen Corp., 890 P.2d 881 (Okla. 1994), the court predicted a case-by-case application of Comment K for medical devices.  It also adopted Tansy’s language that Comments K should only apply where the device is designed to be “as safe as the best available research and testing permits.”  2015 U.S. Dist. LEXIS 115601, *118.  Because unspecified “record evidence establishes a genuine issue of material fact regarding whether the Conserve implant was made as safe as it could be made,” Comment K did not apply.  This does not seem like the right analysis, as Comment K is typically asserted in the face of design and manufacturing defect allegations.  The court also looked to the presence of allegations about “whether the product was properly marketed in light of the alleged misrepresentations Defendants’ representative made to Rasmussen” in connection with the well-known statement from Comment K about the need for a “proper warning.”  Id. at **118-19.  This statement, however, is about how Comment K does not prevent liability for failure to warn, as opposed to requiring proof of an adequate warning before design claims can be kicked.

            Proximate Cause for Failure to Warn
            Speaking of failure to warn, the defendant won that claim based on the basic reason that the implanter did not read the product’s label.  Faced with clear record evidence that Dr. Rasmussen did not rely on anything in writing from the manufacturer and made up his own mind on risks and benefits, the court did an appropriate Erie analysis in predicting that Utah would follow the vast majority of jurisdictions that the learned intermediary’s failure to read the allegedly inadequate warning breaks the causal chain.  A straightforward analysis and good result.  Somewhat strangely, though, the court did not consider what Dr. Rasmussen was allegedly told by representatives as going to the failure to warn claims, which it implied had to be based solely on the written warnings.  “Any allegedly false information provided by Defendants’ representatives to Rasmussen is relevant only to Plaintiff’s fraudulent and negligent misrepresentation claims, not Plaintiff’s failure to warn claim.”  Id. at *127.

            On those misrepresentation claims, which also included the concealment variant, there was no allegation that plaintiff herself received any information from the defendant directly or should have.  Instead, the allegation was that Dr. Rasmussen received and relied on various oral representations—so much for how he “prefers to ‘educate himself’ on the product and review the studies and what went into the design,” id. at *125—about the low risk of metallosis, long lifespan, and good range of motion, which made it good for patients who were young and active.  These representations were allegedly part of why Dr. Rasmussen recommended this product for plaintiff, which plaintiff accepted.  Relying on Kansas device law and Utah drug law, the court determined that all versions of the misrepresentation claims could be based on what was and was not told to Dr. Rasmussen.  While we generally agree that the learned intermediary doctrine should apply to all informational claims for a prescription medical product, however framed, the lines between failure to warn and misrepresentation claims appear to have been blurred here.  The misrepresentation claims here were about affirmative representations on safety, efficacy, suitability, and lifespan and about nondisclosure of risks, which swallows up the failure to warn claims that plaintiff lost.  The difference is that the misrepresentation claims sound in fraud and fraud . . .

            Punitive Damages
            . . . is a basis for punitive damages under Utah law.  While Utah has a statutory prohibition on punitive damages for FDA-approved drugs absent proof of fraud on the FDA, it has nothing like that for devices.  As such, the court did not see how public policy would preclude punitive damages for a 510(k) device with adequate written warnings but allegations that the manufacturer “defectively designed the device and misrepresented or concealed the risks involved in using the device.”  Id. at *8140-41.  So, the blurred lines on warnings and misrepresentation did affect the availability of punitive damages.  That is it for this decision, but we expect that we will see some parts of it cited again.

Thursday, October 01, 2015

Walking the Regulatory Compliance Path Defeats Punitive Damages

The Pope came to Philadelphia this past weekend.  That’s not the first time this has happened (JPII stopped by in 1979), but the level of paranoia this time around led to four days of street shutdowns, parking prohibitions, and all-around dystopian security that closed roads all the way from Conshohocken to City Line Avenue to the Ben Franklin Bridge.  Commercial strangulation by the unprecedented security caused Bexis’ firm shut down its Philly office for two days.

Bexis, not being a Catholic, decided that the better part of valor was simply to get out of Dodge.  So he went to New York where instead he could follow the Devil’s Path instead.  It was good, very good – some parts considerably more perpendicular than horizontal.  The Devil’s Path and nearby areas beat the literal “hell” out of anything in Pennsylvania.  The only downside is the New York State Thruway, which in its southerly direction is prone to traffic jams for no discernable reason (of course, so is the Schuylkill Expressway in Philly, except when closed entirely for Papal visits).

While walking the Devil’s Path has its benefits, so does walking the path of compliance.  In an early blogpost on the subject of punitive damages, we collected all of the caselaw we could find where compliance with government regulatory standards precluded punitive damages.  Of all the cases we found, only a couple were from state supreme courts.  Now we have another one.  While the Pope was visiting Washington, DC, the Kentucky Supreme Court reversed a multi-million dollar punitive damages award in Nissan Motor Co., Ltd v. Maddox, ___ S.W.3d ___, 2015 WL 5626432 (Ky. Sept. 24, 2015), holding that the defendant’s undisputed compliance with (and in some ways exceeding) federal regulatory standards for automobiles precluded a finding of “gross negligence” or “reckless disregard,” which is the Kentucky standard, id. at *2, to support punitive damages.  That compliance precluded punitive damages as a matter of law even under a “slight care”/gross negligence standard is particularly notable, since many states set the bar higher for punitive damages than merely gross negligence.

As we’ve already indicated, Maddox involves cars rather than prescription medical products, but the court drew from compliance cases generally:

Successful completion of regulatory product testing weighs against a finding of gross negligence.  Accordingly, exceeding mandatory requirements by successfully completing more rigorous testing strongly weighs against such a finding.  The logic is clear.  Meeting and then exceeding base safety requirements is, at the very least, facial evidence of exercising slight care. . . .  This approach has also been adopted by several of our sister states.

The undisputed evidence demonstrates that [defendant] designed [the vehicle] to withstand the most rigorous frontal crash testing offered by the Federal government at that time.  While those tests may have been performed using body weight metrics that no longer reflect our increasingly portly population, [defendant] nevertheless satisfied and exceeded the regulatory duty imposed upon it.

Maddox, 2015 WL 5626432, at *5 (citations omitted).  Thus, “there is typically no breach under the common law for failure to exercise slight care where the undisputed evidence indicates that relevant regulatory duties have been satisfied.”  Id. (emphasis original) (citation omitted).

As the quoted passage indicates, Maddox involved a rather portly plaintiff, to put it mildly – her weight exceeding that of the so-called “95 percentile male dummy” that was the largest crash dummy available – so heavy its use was not required by federal crash testing.  Id. at *2.  Maybe, with all inferences going to the plaintiff,  it was negligence not to do more, but it could not be the kind of “grossly negligent” conduct necessary for punitive damages in Kentucky.  Id. at *5-6.

Even so, compliance “does not automatically foreclose a punitive damages jury instruction” in all factual contexts.  Id. at *5.  The court discussed some cases that could tip the balance the other way:  (1) a “complete” lack of documented testing, id. at *6; (2) failure to investigate prior incidents, id.; actual “awareness” of a potentially fatal design deficiency, id.; and (4) “kn[owing] that the regulatory testing was invalid.”  Id.  However, there was no such evidence in Maddox.  Plaintiff “failed to introduce any evidence that should have put [defendant] on notice that either its seatbelt or seat system was unsound, or that the requisite regulatory testing was irrelevant or invalid.”  Id.

Of even greater interest to our side, the Kentucky Supreme Court also discussed what kinds of evidence were unable as a matter of law to overcome the “weight” accorded to compliance evidence.  First, evidence that other manufacturers had arguably safer designs does not establish “that an inferior design was recklessly or wantonly dangerous.”  Maddox, 2015 WL 5626432, at *7.  Second, evidence that the defendant could have done more or better testing can’t establish a right to punitive damages where the defendant performed the governmentally required tests.  Those tests “demonstrate[] that there was at least some effort to test the safety of [the product].  Id.  “Based on this additional sled testing, no reasonable juror could determine that [defendant’s] conduct demonstrated a reckless or wanton disregard for occupants weighing at or near the 95th percentile.”  Id.  Third, destruction of documents in accordance with corporate record retention practices doesn’t get a plaintiff to punitive damages.  “The mere absence of these documents does not permit a reasonable inference that [defendant] intentionally disregarded relevant materials, or that those materials demonstrated that the seatbelt system was deficient.”  Id.

Thus, while not an absolute bar (such bans are usually statutory) to punitive damages, compliance with relevant government safety regulations “typically” precludes punitive damages, even under Kentucky’s relatively generous “gross negligence” standard for punitive damages.  We would argue that, a fortiori, regulatory compliance should preclude punitive damages in states (like Pennsylvania) that follow the tougher scienter requirements of Restatement (Second) of Torts §500 (1965), which rule out punitive damages based on any form of negligence, however “gross.”  See, e.g., Hutchison v. Luddy, 870 A.2d 766, 771-72 (Pa. 2005); Takes v. Metropolitan Edison Co., 695 A.2d 397, 399 n.4 (Pa. 1997).

Wednesday, September 30, 2015

M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case

Today’s case gives us a lesson and a laugh.  The lesson is that a court can be persuaded to prevent enterprising plaintiff lawyers from turning warning adequacy and the learned intermediary rule into not-so-funny jokes.  The laugh comes from watching plaintiff lawyers invoke preemption [!] to keep frail claims alive.  The case is Small v. Amgen, Inc., et al., Case No. 2:12-cv-476 (M.D. Florida Sept. 25, 2015).  You can read the slip opinion here.  The plaintiff claimed that Enbrel, which she was taking to treat her rheumatoid arthritis, eventually caused her to suffer from a diverticulitis infection.  Before we get to the matters at hand in this opinion, we learn that the court had earlier dismissed claims for negligence per se and negligent failure to test or inspect.  That’s a nice start.  [These earlier decisions in the Small case were mentioned here and here.]  Now the defendants moved for summary judgment on the remaining claims, arguing that they were barred by the learned intermediary doctrine. 

The Small case looks like it should be a big problem for the plaintiff, since the Enbrel package insert identified infections as a primary risk.  The defendants also distributed an FDA-approved medication guide that warned patients of the risk of serious infection.  Moreover, before starting her Enbrel treatment, the plaintiff was given a consent form that warned of “life-threatening infections.”  The plaintiff attempted to vault past these inconvenient facts by pointing out that there were no warnings that Enbrel could cause “asymptomatic serious infections,” and that the defendants failed to school doctors and patients “on how to mitigate and manage the risks associates with the use of Enbrel.”  None of that should matter, because the treating doctor was very knowledgeable and testified that any of this new information would not have changed her mind about prescribing Enbrel.  Under the learned intermediary rule (Florida is not one of those screwy states that abrogated the learned intermediary rule or cobbled together a silly exception), the failure to warn claims should fail.    

And here is where the plaintiff’s argument took a comical turn.  According to the plaintiff, the FDA’s medication guide regulations (21 CFR sections 208 et seq.) created a duty for manufacturers to provide pertinent safety information directly to consumers where special circumstances required it.   In this through-the-looking-glass world, those regulations supersede or preempt the learned intermediary rule.   The court rejected the plaintiff’s argument for various reasons.  First, the plaintiff was essentially endeavoring to construct a private right of action out of the medication guide, a no-no pretty much everywhere, including Florida.  “Furthermore, the FDA explicitly stated that it did not intend to change or expand state tort law when it promulgated the medication guide regulations.”  The plaintiff never managed to identify “any cases supporting their theory that FDA regulations ‘inactivate’ the learned intermediary doctrine.”  Then, to cap things off and make our mirth complete, the court cited Wyeth v. Levine against the plaintiff’s argument, reasoning that the Supreme Court “concluded that neither Congress nor the FDA intended the FDA’s drug labeling requirements to occupy the field.”  When have we ever before found a reason to applaud the majesty of Wyeth v. Levine?   The Small court also observed that the plaintiff’s preemption theory seemed more than a little improbable considering that “the learned intermediary doctrine and the medication guide regulations have coexisted since 1998.”  [By the way, the Bexis drug and medical device desk book lists a couple of other cases that have rejected plaintiff-side attempts to use preemption to undermine the learned intermediary rule:  Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1287 (11th Cir. 2002); Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp.2d 1018, 1031-32 (S.D. Ill. 2001).]

The plaintiff also argued that the treating doctor could not be treated as a learned intermediary because the defendants’ pharmaceutical sales representative advised the doctor that it was safe to resume the plaintiff’s Enbrel treatment.  Whatever the sales rep said apparently rendered the doctor unlearned.  (It’s like watching a reality tv program, where the hour actually shaved points off your IQ.)  But any representations made by the defendants’ sales representative were irrelevant if the treating doctor “had independent knowledge of the possibility that Enbrel could cause the injuries sustained” by the plaintiff – which was, in fact, the case. 

After preserving the sanctity of the learned intermediary rule, the Small court then smacked down the typical plaintiff maneuver of finding something-anything that wasn’t in the warning.  Here, the plaintiff argued that even though the label clearly warned of serious infections, it was inadequate because it failed to provide guidance on resuming treatment with Enbrel after an infection.  But as the court concluded, “[t]he problem with this theory is that manufacturers are only required to warn the prescribing physician of the possibility that the drug may cause the injury alleged by the plaintiff.  There is no duty to provide guidance under Florida law.”  That is a clear-eyed view of what constitutes an adequate warning.  (We’ll even forgive that misplaced “only.”)  Maybe plaintiff lawyers can always, like Oliver Twist, ask for more.  But it does not mean they should get it.  If the risk allegedly suffered by the plaintiff is identified in the label, warning adequacy is established.  A court need not entertain a demand that the warning should be elaborated or embroidered.

The reasoning of the Small case suits us right down to the ground.  It is no small favor. 

Tuesday, September 29, 2015

Oops . . . You’ll Just Have to Wait

So, we were preparing a post for today on Sparks v. Oxy-Health, LLC, et al, Case No. 5:13-cv-649-FL, slip op. (E.D.N.C. Sept. 15, 2015) – an opinion we pulled off a national news source.  But, we just learned that the opinion was filed under seal and subject to a confidentiality order.  Unlike mainstream reporters, as officers of the court, we are not going to violate a confidentiality order.  The order calls for the parties to propose redactions to the court by today and we anticipate the decision will be unsealed shortly after that – at which time, we’ll bring you our full analysis. 

For now, all we can say is that it is a complete summary judgment win for defendants implicating several key legal concepts – such as off-label use, product misuse, failure to heed warnings, the “sham” affidavit rule, causation and foreseeability.  There’s more, but we aren’t prepared to go into any greater detail at this time.  Stay tuned.

Monday, September 28, 2015

Section 510(k) Clearance: While it Doesn't Support Preemption, Is It Relevant Evidence at Trial?

This post comes from the non-Reed Smith side of this blog.

With some courts, the § 510(k) clearance of a medical device is not only insufficient to support preemption.  It’s not probative enough to be discussed at trial.  The MDL court in the Boston Scientific Pelvic Repair System Products Liability Litigation is one such court, consistently excluding from trial evidence of 510(k) clearance of the pelvic mesh device.  According to a recent decision by one of the courts overseeing a trial on remand from the MDL, the MDL court read Medtronic v. Lohr to hold that § 510(k) clearance addresses only the device’s equivalence with an already marketed device, not safety.  Winebarger v. Boston Scientific Corp., 2015 U.S. Dist. LEXIS 126616, at *13-14 (W.D.N.C. Sept. 22, 20150) (describing the basis for the MDL court’s decision).  

We’re not so convinced.  The 510(k) process is not a complete abandonment of safety considerations.  And it certainly provides evidence of whether the manufacturer behaved reasonably.  Congress enacted the 510(k) process, in part, to enable quicker clearance for new devices that are equivalent to devices that have already been on the market and have accumulated some sort of safety and efficacy record.  Moreover, the 510(k) process is an inescapable reality for device manufacturers.  A discussion of the process, how it was followed, and the safety information that was provided or available through the marketing of equivalent devices is relevant to assessing the reasonableness of the manufacturer’s actions.  If plaintiffs want to minimize its importance, establish that it says nothing about safety, or show what the manufacturer failed to do, they are free to present such evidence.  The jury can then decide the relevance of this evidence. 

Fortunately, the remand court, applying North Carolina law, got this right – sort of.  In North Carolina, a jury may consider the “extent to which the design or formulation [of the device] conformed to any applicable government standard.”  Winebarger, 2015 U.S. Dist. LEXIS, at *19 (quoting North Carolina’s Product Liability Act).  And so, unlike the MDL court, the remand court determined that evidence of § 510(k) clearance is admissible.  But introduction of that evidence will likely come with a fairly severe limiting instruction:

The fact that BSC followed the requisite 510(k) protocol – limited as it is – prior to marketing its Uphold device has minimal probative value regarding BSC's efforts to adhere to FDA processes and procedure generally. . . .  Admissibility might depend upon a limiting instruction that 510(k) clearance is not to be considered as evidence that the FDA authorized the Uphold as safe and approved its intended use as such; that 510(k) clearance is not evidence that BSC satisfied any standard of care in designing the Uphold device.  For these reasons, the Court's preliminary ruling on Plaintiff's motion is that the 510(k) clearance process is admissible subject to a limiting instruction consistent with the terms of the instant Order.

Id. at *22-23.  

In other words, the Boston Scientific will be able to present evidence that it followed the 510(k) process and received clearance to market the product.  But the court may then instruct the jury that such clearance is not evidence of the manufacturer satisfying a standard of care. 

That presents a tricky decision for Boston Scientific.  Should it present this evidence to the jury knowing that it will be met with this severe limiting instruction?  It seems to us that this evidence is probative, even if not determinative, of whether Boston Scientific satisfied its standard of care.  It’s certainly probative of whether Boston Scientific acted reasonably.  North Carolina’s Product Liability Act makes that clear.  It authorizes juries to consider whether a manufacturer met any governmental standard when determining the reasonableness of its actions.  N.C. Gen. Stat. § 99B-6(a) & (b). 

Frankly, this seems like a decision that Boston Scientific should not be forced to make.  If the plaintiffs want to undermine the significance of 510(k) clearance, they can do so by presenting their own evidence and experts, and by cross-examining Boston Scientific’s witnesses.  It’s a whole other ballgame, though, for the court to interject and describe the evidence, telling the jury that it is not probative of whether Boston Scientific met its standard of care.  That seems to verge on undermining the mandate of the statute, which leaves that determination to the jury. 

It will be interesting to see how this plays out at trial.