The district court’s order dismissing claims in Ebrahimi v. Mentor Worldwide LLC, No. CV 16-7316, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), is a good antidote to the Ninth Circuit’s wrongly decided opinion in Stengel v. Medtronic. Stengel is where the Ninth Circuit held that the plaintiff avoided express preemption by alleging that a pre-market approved medical device manufacturer failed to report adverse events to the FDA, thus violating FDCA regulations and a “parallel” state-law duty to warn.  We have criticized Stengel any number of times, but you can read this and this to get the gist. The most obviously questionable aspect of Stengel is its application of a California state-law duty to warn the FDA, which we are not convinced exists in the first place.

Another befuddling aspect of Stengel is causation:  How can a plaintiff plead and prove that an alleged failure to report events to the FDA actually affected his or her physician’s treating decisions or the treatment outcome?  The district court’s order in Ebrahimi v. Mentor dismissing claims against a breast implant manufacturer shows that most plaintiffs can’t do it.

Here is what happened. When the FDA approved the defendant’s silicone-gel breast implants through the pre-market approval process, it required six-post approval studies “to further assess the safety and effectiveness” of the implants.  This presumably was because of the ultimately unfounded concerns about silicone-gel breast implants that led to their absence from the U.S. market for a period of years.  The plaintiff in Ebrahimi was treated with the defendant’s silicone-gel implants and later experienced complications leading to the implants being removed.

Her lawsuit alleged failure to warn, strict liability manufacturing defect (presumably because California does not recognize strict liability for design defect), and negligence per se—all of which failed. On failure to warn, the district court distilled two theories from the complaint:  “a claim based on [the manufacturer’s] failure to report to the FDA ‘adverse events’ regarding certain dangers with the Implants’ use, and (2) a claim based on [the manufacturer’s] failure to issue sufficient warnings to consumers and doctors.” Id.

There are a number of issues here—express and implied preemption paramount among them—but the failure-to-warn claim failed at this juncture because of causation. The plaintiff opposed the manufacturer’s motion to dismiss by arguing that the manufacturer knew about “reported systemic ailments which can only be attributed to gel bleed . . . but failed to report that to the FDA.”  (emphasis supplied by court).  Those failure-to-report allegations were impossibly vague and failed to allege causation.  The following quote is kind of long, but it’s the core of the order:

The problem with Ebrahimi’s allegations concerning the flawed post-approval studies is that she has not sufficiently alleged facts to support her assertion that the unreported “systemic ailments” or negative health effects that patients experienced during the post-approval studies “can only be attributed to gel bleed” or some other actual “adverse event.” . . . . Ebrahimi fails to sufficiently allege what the “systemic ailments” are that the post-approval studies revealed and merely surmises, in conclusory fashion, that they “can only be attributed to gel bleed.”

Furthermore, Ebrahimi has not sufficiently alleged a causal nexus between her injuries and [the manufacturer’s] failure to report adverse events to the FDA.  She does not allege, for instance, how any “gel bleed” issue would have caused the FDA to require different labeling, especially given the FDA—and Ebrahmi herself for that matter—was aware of the risk of gel bleeding.  Ebrahimi states she suffered injuries “[a]s a direct and proximate results of [the manufacturer’s] foregoing acts and omissions.”  . . .  .  Yet, she fails to allege how any reporting by Mentor to the FDA would have caused her surgeon to stop using Implants or her to refrain from having the breast-implant surgery with the devices at issues, considering the potential health consequences of which she was already aware.

Id.  Let’s unpack that a little bit.  The plaintiff’s theory was the alleged failure to report events from post-approval studies caused her complications.  But in trying to get from point A to point B, the allegations fall apart.  It is awfully easy to allege “unreported systemic ailments,” but which ones?  What other actual “adverse events” did the defendant allegedly fail to report?  And how do any of them have anything to do with what the plaintiff allegedly experienced.  It is similarly easy to write on paper that such “ailments” can “only be attributed to gel bleed,” but how?  If there could be link, what else could cause the “ailments” and how can we exclude them?  We don’t know, and neither did the plaintiff, who “merely surmised” these facts, in conclusory fashion.

All that is before we even get directly to proximate causation. Sure, the plaintiff alleged injuries “as a direct and proximate result” of the defendant’s alleged conduct, as all plaintiffs do.  But when the FDA already knew about gel bleed, and the plaintiff’s doctor already knew about gel bleed, and the plaintiff herself already knew about gel bleed, how could the alleged failure to report adverse events (whatever those events were) possibly have made any difference.  Would the FDA have required a different warning?  Would the physician have reviewed the adverse reports?  If so, would anything have added to the physician’s knowledge, or to the plaintiff’s own knowledge?  Would it have changed anything?  Again we don’t know—and, again, neither did the plaintiff.

Recall what we said about Stengel at the outset.  That opinion’s Achilles heel is causation, owing to the Ninth Circuit’s result-oriented acrobatics to find a claim that avoided express preemption.  It purported to find one, but one that requires a causal chain that is extraordinarily attenuated.  We offer kudos to the district judge in Ebrahimi for recognizing the plaintiff’s burden to plead causation as part of her “parallel claim” and correctly finding that the plaintiff had not met it.  Of course, we would have preferred an order finding the failure-to-warn claims preempted, but this is not bad.

The district court also dismissed the strict liability manufacturing defect claim and the negligence per se claim.  The former was implied preempted under Buckman because “it hinges entirely on conduct [the plaintiff] claims violates the FDCA as well as the FDA’s Current Good Manufacturing Practices.” Id. In other words, she was suing because the alleged conduct violated the FDCA, which is the sine qua non of implied preemption.  The negligence per se claim fell because negligence per se is not a separate cause of action under California law. Id.

Alas, the district court granted leave to amend. But given that this plaintiff alleged a known and warned-of complication of a pre-market approved medical device, she has a tough row to hoe.

We’re quite familiar with people who say one thing, when they think that’s in their interest, and later when circumstances change, say something quite different.  For example, as the late, great Molly Ivins pointed out in “Molly Ivins Can’t Say That, Can She?”,  back during the energy crisis of the mid-to-late 1970s, folks down in Texas “did put bumper stickers on their pickups . . . that said, ‘Let the Yankee Bastards Freeze in the Dark.’” Id. at 43.  As others have pointed out, Hurricane Sandy brought out similar sentiments.  These days, not so much….

But what about in prescription medical product liability litigation?  Say, for example, one of our defense colleagues absolutely nailed it at a deposition.  The result is rock-solid deposition testimony that the prescribing physician never read that allegedly inadequate warning.  Or else it’s the plaintiff admitting that s/he only took the version of the drug manufactured by a different company.  Summary judgment should be a lock. . . .

The motion is filed. The plaintiff’s response, however, includes an affidavit from the same witness already deposed at length – and the affidavit directly contradicts the witness’ prior testimony on which the motion was based.  Plaintiff claims that, now, at minimum, the contradictory testimony creates a “fact issue” and the “credibility” of the two irreconcilable versions of for the jury to decide.

What now?

First of all, it’s happened before – many times.   Almost 20 years ago, the United States Supreme Court addressed the same situation where a plaintiff, having filed for disability (requiring her to swear she was “totally disabled”), and then later filed an age discrimination suit (the matter before the Court), in which she had to prove she was a “qualified person.”  Cleveland v. Policy Management Systems Corp., 526 U.S. 795, 805-06 (1999).  Plaintiffs, the Court held, “cannot simply ignore the apparent contradiction that arises” from taking apparently irreconcilable positions.  Instead, they “must proffer a sufficient explanation” of such discrepancies.  Id. at 806.  The Court endorsed the analogous doctrine that:

[A] party cannot create a genuine issue of fact sufficient to survive summary judgment simply by contradicting his or her own previous sworn statement (by, say, filing a later affidavit that flatly contradicts that party’s earlier sworn deposition) without explaining the contradiction or attempting to resolve the disparity.

Id. (string citation omitted).  See generally, e.g., Perma Research & Development Co. v. Singer Co., 410 F.2d 572, 578 (2d Cir.1969) (generally viewed as the seminal case on sham affidavits) (applying New York law); Shelcusky v. Garjulio, 797 A.2d 138, 144-45 (N.J. 2002) (excellent general citator for sham affidavit decisions).

Enter the sham affidavit doctrine (sometimes elevated to the status of a “rule”), now with Supreme Court imprimatur, precluding creation of “genuine” factual issues by a plaintiff (or some other essential witness) simply contradicting his or her own previous sworn testimony.  The oldest decision we’ve found applying the sham affidavit doctrine in a prescription medical product liability litigation is Miller v. A.H. Robins Co., 766 F.2d 1102 (7th Cir. 1985) (applying Indiana law), where the plaintiff, after testifying that several of her treaters told her that her injuries were caused by the product, submitted an affidavit denying everything once hit with a summary judgment motion raising the statute of limitations.  As one of the opinions that created the sham affidavit doctrine, Miller began with the proposition that “[p]arties cannot thwart the purpose of Rule 56 by creating issues of fact through affidavits that contradict their own depositions.”  Id. at 1104.  The plaintiff was not “confused” while testifying, and “made no corrections to her statements” when the transcript of her deposition was made available.  Id. at 1105.  “Consequently this affidavit did not create a genuine issue of fact and the district court could grant summary judgment.”  Id.

In another relatively old decision – pre-Cleveland, so the sham affidavit doctrine did not yet have the Supreme Court’s endorsement − a plaintiff-affiliated fact witness (the plaintiff’s mother) had her testimony excluded in Martin v. Merrell Dow Pharmaceuticals, Inc., 851 F.2d 703 (3d Cir. 1988) (applying Pennsylvania law, we think).  The witness tried to change her testimony about when she ingested a purportedly teratogenic drug.  The sham affidavit doctrine stopped this attempt:

The numerous other courts of appeals that have considered the situation in which a party contradicts, without satisfactory explanation, his or her prior testimony, have reached the same decision.  Each court has concluded that the objectives of summary judgment would be seriously impaired if the district court were not free to disregard the conflicting affidavit.

Id. at 706 (citations omitted).  “When, as in the present case, the affiant was carefully questioned on the issue, had access to the relevant information at that time, and provided no satisfactory explanation for the later contradiction, the courts of appeals are in agreement that the subsequent affidavit does not create a genuine issue of material fact.”  Id.

According to Westlaw, 128 cases cite Martin for this proposition, but as far as we can tell, only one of those involved prescription medical product liability litigation.  The exception is Rohrbough. Wyeth Laboratories, Inc., 719 F. Supp. 470 (N.D.W. Va. 1989), aff’d, 916 F.2d 970 (4th Cir. 1990), where the court entered summary judgment after excluding an expert witness’ medical causation affidavit because it contradicted prior sworn deposition testimony.  “[I]f a statement in an affidavit that contradicts earlier deposition testimony constitutes an attempt by the nonmoving party to create a sham issue of fact, it may be disregarded.”  Id. at 474. Miller was cited as Seventh Circuit precedent, along with pre-Cleveland decisions from eight circuits (with only one circuit going the other way).  Id.  In stark contrast to the expert’s deposition testimony, which “reveal[ed] a cautious, circumlocutory doctor,” the contrary affidavit was “concise” and “unhesitant.”   “[T]here is no explanation in the affidavit for why [the expert] is suddenly so willing to offer his unqualified opinion . . . when he had earlier only been willing to defer to experts in the relevant field in his deposition.”  Id. at 475.  On appeal, the Fourth Circuit affirmed, also invoking the sham affidavit doctrine:

Given the conflicts between [the expert’s] affidavit and his deposition testimony, the district court was left not with a genuine issue of material fact, but with trying to determine which of several conflicting versions of [the expert’s] testimony was correct.  We hold that the district court was justified in disregarding the affidavit.  We agree with the district court that it may not represent the considered opinion of the doctor himself, but rather an effort on the part of the plaintiffs to create an issue of fact.

Rohrbough v. Wyeth Laboratories, Inc., 916 F.2d 970, 976 (4th Cir. 1990) (citation omitted) (applying West Virginia law).

On the blog, we’ve previously discussed several cases that involved the sham affidavit doctrine, but we’ve never reviewed it more comprehensively.  Most recently, in Redd v. DePuy Orthopedics, Inc., ___ F. Appx. ___, 2017 WL 2859536 (8th Cir. June 6, 2017) (applying Missouri law), the plaintiff’s marginally qualified (if that) design expert changed his tune in an affidavit “submitted after [defendant] moved for summary judgment.”  Id. at *2.  Recognizing that “[a] party may not avoid summary judgment by submitting an affidavit that contradicts rather than clarifies previous sworn testimony,” the court of appeals examined several issues on which the expert’s affidavit changed his testimony.  Id.

Given such differences between the testimony [the expert] provided during discovery and his affidavit, we conclude that the district court did not abuse its discretion by excluding the affidavit from consideration at summary judgment.

Id.  The standard of review is important in sham affidavit cases – exclusion of evidence is governed by abuse of discretion.

Another recent appellate decision reaching the same result is In re Avandia Marketing, Sales Practices & Products Liability Litigation, 639 F. Appx. 874 (3d Cir. 2016) (applying Pennsylvania law), only this time the plaintiff had suborned her prescribing physician to recant his prior testimony under oath.  In deposition, the prescriber had “testified that even if [defendant]  had warned of the risks . . . associated with [the drug], he would still have prescribed the drug to [plaintiff].”  Id. at 876.  After the defendant sought summary judgment, plaintiff offered the prescriber’s affidavit stating that with “a different and more thorough warning . . . he never would have prescribed the drug.”  Id. at 876 n.3.  The district court, and then the Third Circuit, were having none of it.  Again, “[i]t was also within the District Court’s discretion to strike . . . the [prescriber’s] Affidavit, which contradicted [his] deposition testimony.”  Id. at 877.  “This Court defines a ‘sham affidavit’ as a contradictory affidavit that indicates only that the affiant cannot maintain a consistent story or is willing to offer a statement solely for the purpose of defeating summary judgment.  Id. at 877 n.5 (citation and quotation marks omitted).

When a deponent’s post-deposition affidavit conflicts with his prior testimony, a district court may disregard the affidavit to prevent a party from creating a material issue of fact to defeat summary judgment by filing an affidavit disputing his or her own sworn testimony without demonstrating a plausible explanation for the conflict.  A district court may strike such an affidavit based upon the timing of the affidavit, whether any other record evidence supports the affidavit, and whether there is a plausible explanation for the contradiction.  Each of these considerations supports striking the [prescriber’s] Affidavit.

Id. at 877 (footnote, citations and quotation marks omitted).  Needless to say, exclusion of the sham affidavit and summary judgment on causation grounds was affirmed.  Id. at 879.

Ditto in In re Fosamax Products Liability Litigation, 707 F.3d 189 (2d Cir. 2013) (applying Florida law), where yet again the plaintiff induced her prescribing physician to change his deposition testimony and offer conflicting “expert” testimony on causation-related issues “central to [plaintiff’s] failure-to-warn claim” in a subsequent deposition taken after summary judgment was filed.  Id. at 195.  This stratagem was unsuccessful, as the Second Circuit held that the sham affidavit doctrine was nonetheless applicable to preclude plaintiff from relying on the witnesses second, “diametrically different story” in another deposition:

[W]e hold that the District Court was entitled to disregard [this] new testimony relating to his knowledge based on the “sham issue of fact” doctrine, which prohibits a party from defeating summary judgment simply by submitting an affidavit that contradicts the party’s previous sworn testimony.  Although we have typically applied the sham issue of fact doctrine where a party submits an affidavit that contradicts the party’s own prior statements, it may also apply when a party attempts to use evidence from an expert witness to defeat summary judgment.  In particular, the doctrine applies to stop [plaintiff] from manufacturing a factual dispute by submitting testimony from an expert whom she tendered, where the relevant contradictions between the first and second depositions are unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and are central to the claim at issue. . . .  We cannot reconcile his new testimony with his prior testimony.

Id. at 194 (citations and footnote omitted).  See Hickman v. Laboratory Corp., 460 F. Supp.2d 693, 699 (W.D. Va. 2006) (sham affidavit doctrine applied to treating physician’s “affidavit, which was filed only three days prior to the Motion for Summary Judgment hearing, was simply an attempt to add information that [he] failed to provide in his sworn deposition”).

In Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 973 (10th Cir. 2001) (applying Kansas law), the plaintiff’s expert changed his testimony in an attempt to support the sole remaining warning-related cause of action, after having given different testimony when the case seemed focused on design-related issues.  The subsequent “declarations” were disregarded as attempts to create “sham facts”:

[C]ourts will disregard a contrary affidavit when they conclude that it constitutes an attempt to create a sham fact issue. . . .  [Under] the[] circumstances, it is not an abuse of discretion to conclude − as the district court did − that these subsequent affidavits, which directly contradicted certain positions previously taken by [plaintiff’s expert] and which were detrimental to [plaintiff’s] sole remaining cause of action, constituted those kinds of affidavits which fall within the ambit of creating a “sham fact issue.”   Consequently, the district court was entitled to rely on [his] deposition testimony without regard to his later declarations in rendering its summary judgment ruling.

Id. at 973-74.

Another plaintiff expert bit the dust in Kline v. Zimmer Holdings, 2015 WL 4077495 (W.D. Pa. July 6, 2015), a case we discussed here.  Essentially, the expert bailed in her deposition on design defect opinions, and then later tried to resuscitate design issues in an affidavit filed in response to the defendant’s summary judgment motion.  Id. at *4.  After “consistently, carefully, and clearly set forth her opinion that the product, as designed, was not defective” at the deposition,” her contrary “affidavit cannot be considered” to “proffer expert testimony about the design defect claim.” Id.

It is appropriate to disregard her affidavit pursuant to the sham affidavit doctrine.  “A sham affidavit is a contradictory affidavit that indicates only that the affiant cannot maintain a consistent story or is willing to offer a statement solely for the purpose of defeating summary judgment.”  “[I]f it is clear that an affidavit is offered solely for the purpose of defeating summary judgment, it is proper for the trial judge to conclude that no reasonable jury could accord that affidavit evidentiary weight and that summary judgment is appropriate.”

Id. (quoting and following Jiminez v. All American Rathskeller, Inc., 503 F.3d 247, 253 (3d Cir.2007)).  See also Id. at *20 (magistrate’s opinion on same issue).

Still another plaintiff expert, after admitting that there was “no alternative” to the plaintiff undergoing certain medical procedure in his deposition, then tried to deny that same fact after the defendant sought summary judgment.   Zimmerman v. Novartis Pharmaceuticals Corp., 287 F.R.D. 357, 362 (D. Md. 2012) (discussed here).  Following Cleveland, the court invoked the sham affidavit doctrine and held that the “belatedly submitted new affidavit, being flatly contradictory to [the expert’s] deposition testimony, will not be considered.”  Id.

In state court, we encountered the same principle in In re Zoloft Litigation, 2016 WL 5958372 (W. Va. Cir. Oct. 5, 2016), again involving shenanigans by a plaintiff expert.  After being essentially destroyed in deposition, the expert signed an affidavit attempting to repair the damage.  After “not identify[ing] any means by which he was able to exclude other likely causal factors” in his deposition, in his affidavit, the expert professed “that he has excluded all causes other than [the drug].”  Id. at *7-8.  West Virginia’s version of the sham affidavit doctrine asks three questions:

(1) Whether the deposition afforded the opportunity for direct and cross-examination of the witness; (2) whether the witness had access to pertinent evidence or information prior to or at the time of his or her deposition, or whether the affidavit was based upon newly discovered evidence not known or available at the time of the deposition; and (3) whether the earlier deposition testimony reflects confusion, lack of recollection or other legitimate lack of clarity that the affidavit justifiably attempts to explain.

Id. at *8 (quoting Kiser v. Caudill, 599 S.E.2d 826, 828 (W. Va. 2004)).  Answering all these questions “yes,” finding that, since the expert “fail[ed] to offer any explanation for the inconsistency between his deposition testimony and his affidavit,” the affidavit therefore “failed to cure the admissions made during his deposition.”  Id. at *9.  As we discussed at greater length in the other post, exclusion required summary judgment.  Id. at at *10. See also Tortorelli v. Mercy Health Center, Inc., 242 P.3d 549, 561 (Okla. App. 2010) (plaintiff’s expert’s affidavit “directly contradicting prior deposition testimony” on standard of care issues disregarded); Dickenson v. EBI, LLC, 2009 WL 10672211, at *3 (W.D. Mo. July 30, 2009) (affidavit by plaintiff’s expert on design defect disregarded as sham).

Plaintiffs do it too – a lot.  They were caught twice in 2015, in Sparks v. Oxy-Health, LLC, 134 F. Supp.3d 961 (E.D.N.C. 2015), and Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226 (N.D.W. Va. Jan. 16, 2015).  In Sparks the plaintiff unsuccessfully attempted to improve upon deposition testimony involving reliance:

Plaintiff[‘s] affidavit will be struck.  The affidavit provides a number of cursory statements that . . . [she] relied on certain misrepresentations at the time she purchased the [product].  However, at her . . . deposition, plaintiff . . . stated that she relied on her conversations with [a third party] . . . and the tangible benefits [of the product]. . . .  Defense counsel pointedly asked plaintiff if she relied on anything else.  She replied “no.”  There is a “bona fide inconsistency” between the two versions of plaintiff’s testimony.  The affidavit is a sham and accordingly is struck from the record.

134 F. Supp.3d at 998-99.

In Muzichuck, the plaintiff in a wrongful death action admitted in her deposition that the decedent had actually read the product’s package insert.  2015 WL 235226, at *12.  When that admission came back to haunt her, she swore out a contrary “declaration” denying that precise fact.  Id.  The court said, “No way, Jose”:

This attempt by [plaintiff] to create a contested issue of fact by disputing her own earlier deposition testimony is unconvincing. . . .  [She] cannot create a dispute about a fact that is contained in deposition testimony by referring to a subsequent affidavit or declaration of the deponent contradicting the deponent’s prior testimony, for it is well established that a genuine issue of fact is not created where the only issue of fact is to determine which of the two conflicting versions of a party’s testimony is correct.  Therefore, the Court concludes that there is no material question of fact in dispute.

Id. (quoting In re Family Dollar FLSA Litigation, 637 F.3d 508, 512 (4th Cir. 2011)).  For other instances of subsequent statements by plaintiffs being excluded under the sham affidavit rule in prescription medical product liability litigation, see Joseph v. Costco Wholesale Corp., 2015 WL 12745803, at *6 (C.D. Cal. Aug. 27, 2015) (“conclusory, self-serving declaration” regarding reading drug label at time of purchase excluded); Finnicum v. Actavis-Elizabeth, L.L.C., 2011 WL 13193350, at *5-6 (E.D. Tex. Jan. 6, 2011) (affidavit concerning causation knowledge disergarded; controlling law “does not allow a party to defeat a motion for summary judgment using an affidavit that impeaches, without explanation, sworn testimony”); Vitolo v. Mentor H/S, Inc., 426 F. Supp.2d 28, 37 (E.D.N.Y. 2006) (contradictory affidavit about imiportance of certain manufacturer representations about medical device held a sham), aff’d, 213 F. Appx. 16 (2d Cir. 2007); Reetz v. Jackson, 176 F.R.D. 412, 414-15 (D.D.C. 1997) (contradictory affidavit denying knowledge of FDA held a sham in Bone Screw case); In re A.H. Robins Co., 197 B.R. 495, 498 (E.D. Va. 1995) (excluding, for “egregious inconsistency” affidavit regarding product identification in bankruptcy proceeding); Gehring v. Showa Denko, K.K., 1994 WL 597584, at *3 (E.D. Pa. Nov. 2, 1994) (contradictory product identification affidavit held a sham); Baker v. A.H. Robins Co., 613 F. Supp. 994, 996 n.3 (D.D.C. 1985) (contradictory plaintiff knowledge afficavit not considered).

There are literally hundreds of sham affidavit decisions out there, but nowhere else, to our knowledge, have those only involving prescription medical product liability litigation been collected. Until now.

Several of your Reed Smith bloggers are busily making travel plans to be in New York December 4-6th. Are we planning major holiday shopping sprees? Are we off to do some picturesque ice skating around a large tree? Did we finally score Hamilton tickets?

Even better: We’re heading to ACI’s Drug and Medical Device Litigation conference, one of those rare “can’t miss” industry events that consistently provides great content and great networking opportunities – including the chance to catch up with our loyal readers.

(Bexis will be in his usual front and center seat if you want to chat. Eric Alexander will be presenting on a panel on the opioid crisis, the latest developments in the litigation, and enforcement trends. Others in our blogging lineup plan to be running in and out of sessions as well.)

Since we hope to see you at ACI, we wanted to share two pieces of helpful news:

  • First, the early bird discount for ACI ends this Friday, making this week an excellent one in which to register if you haven’t already.
  • Second, the good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-999-DD18 when you register. You’ll save 10 percent.

If you want to register, you can do so here. We’ll look forward to seeing you in New York!

Hope springs eternal. At least that is what the optimists say, and while we would like to see the bright side of the Missouri Supreme Court’s split opinion on venue in Barron v. Abbott Laboratories, Inc., No. SC 96151, 2017 WL 4001487 (Mo. Sept. 12, 2017), we are having trouble this morning finding our rose-colored glasses.  The court’s ruling that a black box warning on the exact condition at issue is “irrelevant” does not help either.

Faithful readers will recognize Barron v. Abbott Laboratories from our list of worst opinions of 2016.  The Missouri Court of Appeals’ opinion in Barron affirming a $38 million verdict came in at #3 on that list.  What did that opinion do to warrant such distinction?  You might call it a twofer:  The court upheld an unfair application of Missouri’s unique and unexplainable venue rules, plus held that a black box warning that warned of the exact risk at issue was sufficiently inadequate to sustain a failure-to-warn verdict and punitive damages.  We discussed that opinion here.

The Missouri Supreme Court has now affirmed this result, and it is still unfair on multiple levels. Let’s start with venue.  The only claims at issue in this trial were those brought by a Minnesota plaintiff against an Illinois defendant under Minnesota law.  Of course, the Minnesota plaintiff found her way to the City of St. Louis by filing a complaint there with 24 plaintiffs from 13 different states, including four from Missouri. Barron, 2017 WL 4001487, at *1.  This is a tactic we often see and to which we object.  But the angle that seems to be unique under Missouri procedure is that venue is proper in the county where any plaintiff “was first injured.” Id. at *5 (concurring opinion).  That means that any plaintiff—including the Minnesotan who got her claims to trial—can piggyback his or her way into any Missouri county where any co-plaintiff “was first injured,” even though neither her claims nor the defendant have any identifiable relationship to that forum.

Even the Missouri Supreme Court in Barron could not defend this rule, but instead affirmed the plaintiff’s verdict on the basis that the trial court’s refusal to transfer venue caused the defendant no prejudice. Id. at *2.  Query how a verdict this size on these facts would not demonstrate prejudice.  Regardless, we find it interesting that a four-judge majority of the Missouri Supreme Court dodged the merits.

Which leads to a ray of hope. Three judges filed a concurring opinion stating that once the trial court determined that each Plaintiff’s claims should be tried separately, it was error for the court not to sever and transfer claims for which venue was no longer proper. Id. at *7.  In other words, venue is not a static inquiry.  When the trial court determined that the claims should be tried separately, it “necessarily decided there are no further gains in efficiency of expeditiousness to be had from the joinder.” Id. at *6.  At that point, “the trial court has discretion to deny a subsequent or renewed motion to sever only in the rarest of circumstances” and “an abuse of discretion in denying such a motion will be patently prejudicial.” Id. The concurring opinion further faulted the majority for applying a “no prejudice” standard because a defendant

will never obtain relief without showing the elusive, undefined, and likely unprovable prejudice that the principal opinion demands. I am unwilling to countenance such an immediate, improper, and easily avoided outcome.

Id. at *7. Sure, it’s a concurring opinion, but it calls out the unworkable situation that Barron has reinforced.  We will take this four-to-three decision as endorsing efforts for reform.

Missouri-based defendants should take particular interest. The United States Supreme Court’s BMS opinion clamping down on personal jurisdiction should reduce the number of out-of-state plaintiffs suing non-Missouri defendants in Missouri.  But the joinder problem remains where personal jurisdiction is not an issue.  As the concurring opinion noted, “Even though the use of a Rule 52.05(a) joinder to combine multiple in-state and out-of-state plaintiffs in a single action largely will be prevented in the future by Bristol-Myers Squibb Co. v. Superior Court, [137 S. Ct. 1773 (2017)], . . . the use of Rule 52.05(a) to join the claims of multiple Missouri plaintiffs in a single petition will (and should) still occur.” Barron, at *4.  Missouri’s joinder rules therefore discriminate against Missouri defendants, who will remain subject to Missouri’s joinder rules while out-of-state defendants will less often be around.  This is another reason why reform should finally occur.

Now, how about the warnings? When a boxed warning—the strongest warning permitted under the FDCA—warns of the complication about which the plaintiff is complaining, it should be adequate as a matter of law.  Period.  You can read more on this here.  In Bannon, the Supreme Court did not set forth what the black box warning said, so we will:  “[THE DRUG] CAN PRODUCE TERTOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA).  ACCORDINGLY, THE USE OF [THE DRUG] IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS.”  The plaintiff in Barron alleges she was born with spina bifida, which is right there in the warning—in all caps, and boldface, and surrounded by box.  To make matters worse, the Missouri Supreme Court held that the black box warning was “not relevant” to punitive damage. Id. at *4.  Quibble if you will over whether a black box warning is adequate as a matter of law.  But where the basis for liability is an alleged failure to warn, there is no way to explain how a clear and prominent warning on the exact complication at issue can be “not relevant.”  We will leave it at that.

So is there room for hope? As we observed in connection with another Missouri case a few weeks ago, time will tell.  Whatever the future holds, we are betting that Barron v. Abbott Laboratories will be in the running for the worst opinions of 2017.  Time (and Bexis) will tell.

Like many of you, on Friday mornings we turn to the “Legal Lions and Lambs” section of Law360.  It is not only voyeurism.  We are constantly working on things in media res (the middle of things), building slowly and gradually to a climax that  hardly ever arrives.  Ninety percent of cases settle, and that is seldom the stuff of Lions or Lambs. Nope: the Lions vs Lambs dichotomy is about winning and losing.  Not in any subtle sense, either.  The Law360 column focuses on trial verdicts or dispositive motions.  Those outcomes furnish teaching moments, points of inspiration, object lessons, or cautionary tales.  We have never personally shown up on either side of the list as far as we know, mirabile dictu (wonder to say – surely mastery of Latin is a mark of a Legal Lion, no?), given that we played a minor role in that vast stain on Anglo-American jurisprudence not-so-fondly remembered as the Engle tobacco litigation in Miami).
We know this much: we’d rather be a Lion than a Lamb. The Lion is king of the jungle. MGM pictures start majestically with a roaring lion.  King Richard was lion-hearted.  The hero in the best Disney animated movie was a lion. So was Barry Sanders.  By contrast, Lambs get led to the slaughter.  We count them as we try to fall asleep.  Their silence is the central image to the creepiest movie we have ever seen.  Worst of all, we garnish lamb chops with mint jelly.
Over the last couple of weeks, we saw some entries in the “Lambs” section that caught our attention because they involved lawyers we know and respect.  These lawyers defended drug or device companies that got tagged by juries with eye-popping verdicts.  These defense lawyers are, to put it plainly, great lawyers.  We co-tried, and won, a case with one of them, and counted two others as colleagues in the US Attorney’s office a long time ago.  Their skills are extraordinary.  They possess exquisite judgment, work hard, and give their clients the best possible representation.
And they lost the cases that landed them in Law360.  (One of them, by the way, had won a similar case a couple of months before – the first defense lawyer to do so.  Before he was a Lamb, this lawyer was a Lion). Suddenly, we decided that we disliked the “Lambs” label.  Law360 surely does not mean to insult anyone in the Friday column, but there is something undeniably negative about the “Lambs” term, and undeniably unfair.  We bet those lawyers on the losing end went down, not meekly, but swinging.
The fact is that great lawyers occasionally lose cases.  Why?  To begin with, great lawyers are given the hardest and most important cases.  We know a very smart in-house lawyer (in fact his company was involved with one of the cases that caught our attention in the Lions and Lambs column) who likes to ask lawyers begging for business from him to name their worst loss.  Too many lawyers pretend they have never lost, or immediately show their insecurity by ladling on the excuses. But think of the two or three best trial lawyers you have ever encountered.  Maybe there is a plaintiff lawyer in Houston with a photographic memory and unsurpassable eloquence. Maybe there is a corporate defense lawyer in Chicago who possesses laser-like focus and terrifying tenacity.  They have both been brutalized by juries. That is true for just about every other trial lawyer who has earned a glistening national reputation. Some cases are simply too hard. Some judges are simply too biased.  Or, most often, some juries are simply too batty.
When we consider our worst loss, we usually reflect on a near miss. (Right – we are cheating.)  We tried a case against one of the most unpleasant lawyers we have ever met.  You couldn’t trust his word.  He said things in open court that the Judge had explicitly ruled out of bounds.  But before violating the ruling, this lawyer would keep challenging it.  Again and again.  Every day was a new day.  (The rotten thing was that half the time the judge would give him something, as if that mollification would buy peace instead of inviting additional rounds of revisitations and defiance). He wasn’t a Lion or a Lamb.  He was a Weasel. The case was hard-fought, but we were sure we gave a bit better than we got, and our closing argument echoed Pericles (so we thought) while our villainous opponent cribbed his best lines from one of his competitor Texas plaintiff lawyers. His appeals to prejudice were utterly unoriginal. And plagiarism was the least of this scoundrel’s sins.  Be that as it may, it was now time to wait for the jury.  Our client, who was doubtless the smartest person in the room, took the plaintiff lawyer aside. They huddled and talked intently. One or two perplexing questions came from the jury.  Those questions were so unsettling as to provoke settlement. The in-house lawyer struck a deal with our adversary.  It seemed to us like a lot of money.   But there it was.

 

We informed the Judge. The Judge then informed the jury.  We then talked to the jury.  What they told us made none of us happy.  It seems that the jury was leaning toward awarding a verdict about ten times higher than the settlement. One member of the jury had been a bit, um, stealthy.  In voir dire she had disclaimed any relevant prior history at all.  It turned out that she had a daughter who suffered from a condition pretty similar to what the plaintiff claimed.  This juror pushed hard to become foreperson, and then pushed even harder for a punishing verdict.  We (the defense) were stunned.  But perhaps we weren’t quite as stunned as the plaintiff lawyer, who had bargained away his next vacation home.
We were almost Lambs.

 

There are lots of reasons why cases are won or lost, or settled.  We hate it when judges are outcome-oriented, and we should beware of that fault in ourselves, too.  The best lawyers don’t always get the best results.  We can think of a case where one of the finest, smartest, smoothest two or three trial lawyers we ever saw lost to one of the two or three dopiest, clumsiest ones we ever saw. The jury was moved by undeniable facts and unavoidable sympathy.
Let’s have a little sympathy for those Legal Lambs.  They might very well be much better than the Lions, and they probably did a better  job than most of us would have done.  Heck, they probably don’t want our sympathy.  They are much too tough for that.  They are not Lambs at all.

 

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision.  Purporting to apply Stengel v. Medtronic Inc., 704 F.3d 1224, 1228-31 (9th Cir. 2013) (en banc) – an even worse case (#2 on the same list) – Ramirez held, basically, that allegations of off-label use/promotion eliminated preemption altogether, even for Class III pre-market approved products.

When the device is not being used in the manner the FDA pre-approved and the manufacturer is actually promoting such use, there is no law or policy basis on which to pre-empt the application of state law designed to provide that protection.

Id. at 991.

Fortunately, Ramirez has proven to be an outlier, with numerous decisions, several even in the same District of Arizona, considering and rejecting Ramirez’s meat axe approach to preemption.  See Angeles v. Medtronic, Inc., 863 N.W.2d 404, 413 (Minn. App. 2015) (“Ramirez has been rejected by most federal district courts that have reviewed this issue”); Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300, 314 (App. 2014) (“[w]e find the approach taken in Ramirez unpersuasive”), app. dismissed & opinion ordered published, 331 P.3d 178 (Cal. 2014); McCormick v. Medtronic, Inc., 101 A.3d 467, 486 n.13 (Md. App. 2014) (“Ramirez has been almost universally rejected”); Shuker v. Smith & Nephew PLC, 211 F. Supp.3d 695, 701 n.5 (E.D. Pa. 2016) (“this Court considered but declined to follow” Ramirez); Jones v. Medtronic, 89 F. Supp.3d 1035, 1051 (D. Ariz. 2015) (“this Court joins the majority of courts in rejecting Ramirez”); Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp.3d 619, 627 (W.D. Mich. 2015) (Ramirez “has been rejected by numerous district courts”); Wright v. Medtronic, Inc., 81 F. Supp.3d 600, 610-11 (W.D. Mich. 2015) (same as Thorn); Byrnes v. Small, 60 F. Supp.3d 1289, 1299 (M.D. Fla. 2015) (“the Court disagrees with the reasoning in Ramirez”); Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *10 (E.D. Pa. March 31, 2015) (“the Ramirez decision has been widely criticized by other district courts reviewing allegations of off-label promotion of PMA-approved devices”); Arvizu v. Medtronic Inc., 41 F. Supp.3d 783, 790. Ariz. 2014) (“the Court finds the reasoning of [decisions rejecting Ramirez] to be more persuasive”); Martin v. Medtronic, Inc., 32 F.Supp.3d 1026, 1036 (D. Ariz. 2014) (“join[ing] the majority of other courts which have rejected Ramirez to the extent that it holds that the preemption analysis does not apply to claims based on off-label promotion”); Beavers-Gabriel v. Medtronic, Inc., 15 F.Supp.3d 1021, 1035 (D. Haw. 2014) (“however, Ramirez has been rejected − for good reason − by numerous courts”); Schouest v. Medtronic, Inc., 13 F. Supp.3d 692, 700 (S.D. Tex. 2014) (Ramirez “read Riegel too narrowly”); Scovil v. Medtronic, Inc., 995 F.Supp.2d 1082, 1096, n.12 (D. Ariz. 2014) (“respectfully disagree[ing] with [the] ruling in Ramirez”); Arthur v. Medtronic, Inc., 2014 WL 3894365, at *5 (E.D. Mo. Aug. 11, 2014) (Ramirez’s “reasoning has been rejected by several courts”); Brady v. Medtronic, Inc., 2014 WL 1377830, at *4 (S.D. Fla. April 8, 2014) (applying “the traditional preemption analysis to [plaintiff’s] off-label marketing claims” contrary to Ramirez); Houston v. Medtronic, Inc., 2014 WL 1364455, at *5 (C.D. Cal. April 2, 2014) (“the Ramirez holding is not consistent with the text of §360k(a), the scope of federal requirements imposed on Class III devices, or Ninth Circuit precedent”); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *4 (N.D. Ala. Oct. 31, 2013) (Ramirez is “inapposite” and “of no assistance” to plaintiff).

Now the FDA has jumped into the fray, and its view of preemption and allegations of off-label use is no more favorable to Ramirez – and to plaintiffs trying to oust preemption of PMA devices – than these judicial decisions.  The sharpest-eyed of our readers may have noticed the two citations above to relatively recent district court opinions in a case called Shuker.  It so happens that Shuker is currently on appeal, and following oral argument, the Third Circuit Court of Appeals invited the FDA to provide its views on the preemption question.  Last week, the FDA did so.  You can find a copy of the FDA’s amicus brief in Shuker here.

Apparently, in Shuker the plaintiffs allege that the defendant was somehow responsible for Mr. Shuker’s surgeon creating a hybrid hip prosthesis construct that included some components of a Class III PMA system and others belonging to a Class II system cleared under the FDA’s “substantial equivalence” (“§510k”) process.  FDA amicus br. at 3-4.  This hybrid construct was an off-label use.  Id. at 4.  Exactly how the individual Class III and Class II component used in the construct are alleged to have contributed to the plaintiffs’ injuries appears totally unclear, but we do know that the Class III component was later recalled.  Id.

That causes the plaintiffs a big problem. On the one hand, they would love to smear the defendant with the recall, and wave it around like a bloody shirt.  On the other hand, the Class III component – because it was PMA approved – brings the powerful preemption defense into play.  So plaintiffs invoked off-label use to try to have their cake and eat it too.

The FDA did not agree.

Rather, the agency advised that “[t]he district court correctly held that §360k(a) applies to a component of a premarket-approved device even when the component is put to an unapproved use.”  Id. at 6.  First, the FDA clarified the status of device “components” under the FDCA::

The component of the premarket-approved device is itself a “device” under the FDCA, and FDA’s approval imposes device-specific requirements with respect to that component.  The manufacturer generally may not deviate from those requirements without prior approval from FDA, regardless of the uses to which the component may be put by third parties.  Because the component is subject to device-specific federal requirements, §360k(a) expressly preempts any state requirements “with respect to” the component that are “different from, or in addition to,” those device-specific federal requirements.

Id. (emphasis added).  Thus, all components of a pre-market approved device system are themselves PMA devices for preemption purposes, and that status doesn’t change because of off-label use.

With respect to other components, if they are “not subject to device-specific federal requirements,” then they are “outside the scope of §360k(a),” and claims limited to them “are not expressly preempted.”  Id.  To the extent those components are §510k cleared, they “generally” (but apparently not necessarily always) not entitled to preemption.  Id. at 7.

The fact that off-label use (which the FDA calls “unapproved use” in its letter) is possible for a device does not allow – let alone allow the common law to require – a manufacturer of a PMA device to change its design or labeling (read: warnings) or manufacturing processes without prior FDA approval:

As a general matter, the device-specific requirements that attach to a medical device through premarket approval apply even when the device is put to an unapproved use.  Once a device receives premarket approval, the FDCA generally prohibits the manufacturer from making, without FDA permission, changes that would affect the safety or effectiveness of the device. . . .  Those requirements apply irrespective of the use to which the device is ultimately put.  The possibility that a physician may choose to use a device for an unapproved purpose − something the FDCA contemplates, see 21 U.S.C. §396 − does not authorize a manufacturer to vary the design, the manufacture, or (with limited exceptions) the labeling of the device in anticipation of that use.  Such variation would violate federal law.

Id. (emphasis added).  Thus, the general rule that alterations that significantly affect a device’s “safety or effectiveness” require FDA preapproval exists “irrespective” of off-label use.

The FDA observed that “most” courts recognize that PMA imposes “requirements” – and therefore preemption – on medical devices “even when the device is put to an unapproved [off-label] use.”  Id. at 7-8 (citations omitted).  The agency also recognized something this Blog has repeatedly pointed out, that Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the case in which the United States Supreme Court recognized broad PMA preemption, itself involved an off-label use.  FDA amicus br. at 8 (“Riegel itself involved an off-label use of the device in question”).  The FDA advised that, “[s]imply put, once a device receives premarket approval, it remains subject to federal requirements for purposes of §360k(a) regardless of how it is used.”  Id.

Nor did it matter that the off-label use was only of a “component” rather than of an entire device system. The PMA “requirements” applicable to that component as a “device” “apply equally when third parties put the [component] to an unapproved use with components of another device” even if the other device is §510(k) cleared. Id.

Defendants generally may not deviate from the requirements imposed through premarket approval regardless of how the liner is used.  Claims touching on those requirements therefore implicate §360k(a) even when a component of an approved device is put to the type of unapproved use here at issue.

Id.

Preemption of such claims is not only the law, but is good policy:

The conclusion that §360k(a) applies in this context also makes sense as a matter of policy.  Congress entrusted FDA with determining which device designs should be approved for marketing, as well as how approved devices should be labeled to provide medical professionals with appropriate safety information.  Section 360k(a) acknowledges FDA’s judgment in this respect and prevents States from pursuing competing judgments that would impose different or additional requirements on approved devices.  That provision also protects manufacturers that have complied with detailed federal requirements from being subjected to liability under state law for doing what federal law required.  Manufacturers must generally adhere to the specifications established through premarket approval, even if healthcare practitioners subsequently exercise their judgment and employ the device for an unapproved use.

Id. at 9 (emphasis added).  The FDA recognized the precedent cited at the beginning of this post – those cases criticizing Ramirez – as being “consistent” with the Agency’s preemption analysis.  Id.

Thus, the FDA advised that plaintiffs can’t go after the recalled PMA component, but are limited to claims concerning the non-PMA components of the construct only.  Id. at 10 (“§360k(a) requires a court to parse a plaintiff’s claims to determine whether the state-law requirements that underlie them are indeed directed at the premarket-approved component”).  “[A] component that did not receive premarket approval and is not otherwise subject to device-specific federal requirements” is not subject to express preemption under §360k(a).  The FDA “t[oo]k[] no position” on whether such claims were actually alleged, although they conceivably could be.  Id. at 12.

As for implied preemption, the FDA noted that “defendants did not raise implied preemption in their dispositive motions below, nor . . . in their original appellate briefing.” FDA amicus br. at 13.  Assuming that implied preemption was nonetheless at issue, the Agency confirmed:

[T]he existence of an express-preemption provision such as §360k(a) does not ordinarily alter the normal operation of implied-preemption principles.  Accordingly, state-law medical-device claims that are not expressly preempted remain subject to challenge on implied preemption grounds

Id. (citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001)).

The FDA then briefly explored what many courts (but not the FDA) have called the “narrow gap” between express and implied preemption in PMA cases.  Implied preemption impacts two types of claims that are not expressly preempted:  (1) “parallel” claims; and (2) claims concerning “generally applicable federal requirements that do not trigger the operation of §360(k).”  FDA amicus br. at 14.  Purportedly parallel claims are preempted when they “have features that intrude impermissibly on the operation or enforcement of the FDCA, as where they represent an attempt to enforce the federal scheme, rather than asserting independent state-law requirements.”  Id.  As for “generally applicable” claims, “on a case-by-case basis,” “divergent state requirements may stand as an obstacle to the operation or objectives of the federal scheme and may be impliedly preempted on that basis.”  Id.  The FDA did not get any more specific than that as to implied preemption, noting instead that failure to report claims had been dismissed as inadequately pleaded, and therefore avoiding that issue.  Id. at 14 n.7.

What takeaways can we, as defense counsel, extract from the FDA’s filing? How about these:

  • Ramirez was wrongly decided. Off-label use does not affect the applicability of preemption at all. FDA amicus br. at 6-9.
  • PMA preemption applies to PMA components – period.  Id. at 7-10.
  • “[T]he FDCA generally prohibits the manufacturer from making, without FDA permission, changes that would affect the safety or effectiveness of the device.”  Id. at 7. That should help with Mensing/Bartlett preemption.
  • Implied preemption operates independently of express preemption, so that manufacturers of devices not subject express preemption under §360k(a) can still assert implied preemption “on a case-by-case basis.”  Id. at 14.  Also good for Mensing/Bartlett, particularly in the device context.
  • Ostensibly “parallel” claims are preempted where they “intrude impermissibly on the operation or enforcement of the FDCA.”  Id.  The FDA likes Buckman.
  • No state generally bans off-label promotion, only the FDCA, so “promotion” based claims involving off-label use are likely to be impliedly preempted.  In fact, we just saw another one of these the other day.  See Markland v. Insys Therapeutics, Inc., 2017 WL 4102300, at *9 (M.D. Fla. Sept. 15, 2017).
  • The FDA twice carefully qualified its discussion of §510(k) devices, recognizing that express preemption could exist where such a device was “otherwise subject to device-specific federal requirements.”  FDA Amicus br. at 6, 12. Good for limiting Lohr “on a case-by-case” basis.

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

Search for Medtronic on this blog and you’re going to find preemption cases. Lots of preemption cases. Mostly preemption victories for the defense. An overwhelming body of preemption law has been made by Medtronic. They’ve certainly led the charge. So, if we say today’s post is a Medtronic case about a spinal implant, you’re likely thinking more preemption. While that wouldn’t be a bad thing, even here at the DDL blog we can get a little tired of beating the preemption drum (don’t let Bexis know). Everyone once and a while we like to sing a different tune.

After all, if you never flipped over to the B-side, you may have missed some really good music. We’ll now pause to explain B-sides to the iPod generation who may be completely unfamiliar with the old 45-rpm single. The single was meant to showcase an album’s prospective hit on its A-side with an additional song on the B-side. The B-sides were typically throw away tracks. But sometimes, an equally good, and some may argue better, song could be found by flipping the single over. For example, ‘I Am the Walrus’ was on the B-side of the Beatles ‘Hello Goodbye’ (that was a John v. Paul thing). Pearl Jam’s ‘Yellow Ledbetter’ was the B-side of ‘Jeremy’ until radio DJs made it a hit on its own. U2 originally only released ‘The Sweetest Thing’ as the B-side to ‘Where the Streets Have No Name.’ And, perhaps one of the best songs of all time (says this blogger and Sir Paul McCartney) – ‘God Only Knows’ was a B-side. To be fair it was the B-side to the Beach Boys ‘Wouldn’t It Be Nice?’ so isn’t that really like two A-sides?

In the case we’re bringing you today, Medtronic had previously won a motion to dismiss plaintiff’s fraud and consumer protection claims on the grounds of preemption (among other reasons). See our post here.  So, you’ve already heard the A-side.  But following that decision, plaintiff’s design defect and manufacturing defect claims under the Louisiana Products Liability Act (LPLA) remained. So Medtronic moved for summary judgement. As to design defect, plaintiff had to concede that it had no evidence of an alternative design, so that claim was dismissed with prejudice. See Lyles v. Medtronic Sofamor Danek, USA, 2016 U.S. Dist. LEXIS 38550, at *15 (W.D.La. Mar. 23, 2016). On manufacturing defect, plaintiff alleged res ipsa loquitur — welcome to the B-side of this record.  The district court granted summary judgment. See id. at *21-23. Plaintiff appealed. But the Fifth Circuit said the district court got it right.  Like the Stones got it right with ‘You Can’t Always Get What You Want’ on the flip side of ‘Honky Tonk Women’.

Plaintiff had multiple medical device components implanted in his spine to treat his spinal stenosis and cervical cord compression. Lyles v. Medtronic Sofamor Danek, USA, 2017 U.S. App. LEXIS 17534, at *3 (5th Cir. Sept. 11, 2017). X-rays taken within the first day of surgery showed something amiss with one of the implanted plates (experts disagree regarding whether the plate was broken or just misaligned). Id. at *3-4. Plaintiff sought additional treatment and underwent a second surgery, but the plate was not explanted and remains in plaintiff’s spine. Id. at *4-5.

To maintain a manufacturing defect claim under the LPLA, plaintiff has to prove that at the time the medical device left the manufacturer’s control, it materially deviated from its specifications or from other identical products from the same manufacturer. Id. at *9. Plaintiff offered no proof of either the device’s specifications or how the device used in his surgery deviated from those specifications. He relied instead on res ipsa loquitur – arguing that the only reasonable inference that would explain the device breaking was that there was a defect in how it was made. Id. at *10.

The Fifth Circuit does a nice job of explaining both how the doctrine is to be applied sparingly and then discussing those rare situations in which a plaintiff has been allowed and not allowed to use it in the products liability context. See id. at *10-13. In sum, “where there are other potential causes of injury, a plaintiff’s inability to exclude all known potential causes other than a manufacturing defect preclude his reliance on the doctrine.” Id. at *13.

In his opposition to defendant’s motion for summary judgment, plaintiff relied exclusively on two things – the short time between implant and breakage and his expert’s conclusion that he had no other reason for the breakage other than a defect. Id. at *13-15. What plaintiff failed to do was address any of the “multiple potential explanations,” offered by the defendant. Id. at *14. Putting aside for a minute that plaintiff can’t make an argument on appeal that he didn’t make below, his new argument to the Fifth Circuit was that there was no evidence for defendant’s alternative explanations. But plaintiff lost sight of his burden of proof:

[T]o succeed on the theory of res ipsa loquitur, [plaintiff] has the burden of producing evidence excluding other reasonable explanations. Though [plaintiff] argues that there is no evidence for any other cause for the [device’s] breakage, there is no evidence for a manufacturing defect either, which is why he is invoking res ipsa loquitur. The other reasonable explanations for the [device’s] breakage posited by [defendant] are equally as likely as a manufacturing defect. It is [plaintiff] who has the burden to adduce evidence excluding them.

Id. at *15-16. The issue isn’t whether there is evidence to support the other reasonable explanations, but rather what evidence plaintiff has adduced to exclude the other reasonable explanations. Id. at *18.

Further, plaintiff didn’t offer any evidence that any alleged defect existed when the device left the manufacturer’s control. Prior to plaintiff’s surgery, the device was stored at the hospital and any number of people had access to it. Id. at *16-17. The Fifth Circuit concluded that even if the district court had been wrong in not applying res ipsa loquitur, which it wasn’t, plaintiff’s manufacturing defect failed on this ground as well. Id. at *17.

Res ipsa loquitur is definitely a B-side to preemption but don’t overlook the B-sides or you might miss out on a winner.

We previously addressed the in pari delicto doctrine, whereby a plaintiff injured in the course of his or her criminal conduct cannot recover for those injuries.  We specifically examined this doctrine’s most common application in prescription medical product liability litigation – where the plaintiff is injured as a consequence of his or her illegal use of prescription drugs, particularly those prescribed for somebody else.

In what other situations, besides criminal activity, is plaintiff conduct going to matter to liability issues (a great variety of conduct can be relevant to damages, especially that affecting lifespan and employability) involving prescription medical products?  We recognize that, given the learned intermediary rule, the conduct of prescribing (and in some jurisdictions, treating) physicians is ordinarily going to have considerably more impact on causation issues than what plaintiffs themselves did, or didn’t do, but that said, there are situations in particular cases in which plaintiff conduct becomes especially relevant.

Plaintiff’s Comparative Fault & Contributory Negligence

In general, nothing inherent in prescription medical product liability litigation makes a plaintiff’s comparative, or where relevant contributory, negligence irrelevant.  As long as “more than a scintilla of evidence” as to comparative fault exists, the defense goes to the jury. In re C.R. Bard, Inc., 2013 WL 2431975, at *9 (S.D.W. Va. June 4, 2013) (applying Wisconsin law). See Barraza v. C.R. Bard Inc., ___ F.R.D. ___, 2017 WL 3976720, at *8 (D. Ariz. Sept. 11, 2017) (recognizing potential applicability of “assumption of the risk, or comparative or contributory negligence, as defenses” in eleven states; discussing plaintiffs who failed to comply with medical instructions).

of Judge Posner, in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) (applying Virginia law), affirmed a defense verdict on contributory negligence where the plaintiff “didn’t sue [her doctor] for malpractice, and she doesn’t argue that it was reasonable for her (and therefore not contributorily negligent) to rely on the doctor’s failure to warn her.”  Id. at 870.  In Craft v. Peebles, 893 P.2d 138 (Haw. 1995), the defendant was entitled to assert the plaintiff’s failure to stop smoking as contributory negligence.

However, the contributory negligence instruction was appropriate with respect to [the defendant manufacturer] because the evidence presented at trial raised a bona fide issue with respect to [plaintiff’s] alleged contributory negligence.  The record indicates that . . . she smoked a pack of cigarettes a day and that she had been smoking for seventeen years.  [Plaintiff’s] expert . . . testified that [her symptoms] could have resulted from the cigarettes.

Id. at 154.  In the same vein, in Rosa v. Medtronic MiniMed, Inc., 2008 WL 1990892 (D.P.R. May 6, 2008), the plaintiff’s “failure to adequately monitor his glucose levels and take the necessary measures in response,” presented a jury question, notwithstanding plaintiff’s blaming his actions on bad advice from his treating physician. Id. at *7-8.  Conversely, because the defendant failed to develop the necessary expert testimony to support causation-based defenses of comparative negligence, plaintiff misconduct, apportionment of liability, and superseding/intervening cause – but only because of that failure – in Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 184, 188-191 (D.N.H. 2010), the plaintiff was successful in removing those defenses from the case.  So, where supported by sufficient evidence defenses based on plaintiff conduct are available in pharmaceutical product liability litigation.

Plaintiff’s Failure To Read Relevant Warnings

The most common way to defeat causation in a prescription medical product case with plaintiff-specific evidence is when that evidence establishes that the plaintiff did not read available information about serious risks.  We’ve discussed at length how this argument works when the prescribing physician fails to read warnings, and the principle is the same when the plaintiffs themselves are at fault.  Several state appellate courts have so held.  Most of these cases involve situations where, for one reason or  another, the learned intermediary rule is inapplicable.  In an OTC drug case, the California Supreme Court held:

Plaintiff’s mother, who administered the [product] to plaintiff, neither read nor obtained translation of the product labeling.  Thus, there is no conceivable causal connection between the representations or omissions that accompanied the product and plaintiff’s injury.

Ramirez v. Plough, Inc., 863 P.2d 167, 177 (Cal. 1993).  Along the same lines is E.R. Squibb & Sons, Inc. v. Cox, 477 So. 2d 963, 971 (Ala. 1985), holding:

The evidence is undisputed that plaintiff did not read any of the instructions or warnings [defendant] provided on and with its [product]. . . .  Even if the warning accompanying this [product] had read, [extremely graphic warning omitted], it would not have altered this plaintiff’s course of action and prevented his injury, because he would not have read it.  [Defendant’s] inadequate warning, therefore, did not cause plaintiff’s injury.

Id. at 971.  Accord Moore v. Vanderloo, 386 N.W.2d 108, 112 (Iowa 1986) (summary judgment affirmed where “[t]here is no evidence under this record that [plaintiff] read or relied on any of [defendant’s] informational material”); Prince v. B.F. Ascher Co., 90 P.3d 1020, 1027 (Okla. Civ. App. 2004) (“[m]anufacturers, however, are not required to foresee that consumers will fail to read the product’s warnings and then use the product in a manner that the instructions expressly warn against”); Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y. App. Div. 2007) (summary judgment affirmed; plaintiff testified that she “chose not to read the consent forms warning against the risks [in question] and even death, and signed them nonetheless”); Sosna v. American Home Products, 748 N.Y.S.2d 548, 549-50 (N.Y. App. Div. 2002) (summary judgment affirmed where “plaintiff’s deposition testimony was clear that he had not read defendant manufacturer’s warnings until after he had stopped using its product and sustained the complained-of injury”).

In another OTC drug case, the aforementioned, Robinson v. McNeil decision also relied on the plaintiff’s failure to read warnings in affirming a defense verdict:

[Plaintiff] didn’t read or remember the warnings before taking the [drug], so it wouldn’t matter what the label had said unless it had contained truly terrifying warnings that the state of medical knowledge would not have justified.

615 F.3d at 870.  Accord Boruski v. United States, 803 F.2d 1421, 1426, 1429 (7th Cir. 1986) (“had [plaintiff] read what the form says about risks and the particular disease she claims to have contracted, she would have found the form clearly sufficient in its warning”) (applying Illinois law).

In Sparks v. Oxy-Health, LLC, 134 F. Supp.3d 961 (E.D.N.C. 2015), plaintiffs bought a action about a home-use medical device, but none of them “ever read the instruction manual that came with the [device] when it was purchased.  Id. at 994.  Plaintiffs’ conduct required summary judgment against their warning claims:

because the [plaintiff] family did not read the Reference Manual or follow existing warnings, and because there is no credible evidence to suggest an on-[product] warning would have changed [their] behavior, plaintiffs cannot establish causation as a matter of law. . . .  Of particular importance is the [plaintiff] family’s collective failure to read the Reference Manual provided with the [device].

Id. at 995.  Similarly, the court in Walker v. Merck & Co., 648 F. Supp. 931, 935-36 (M.D. Ga. 1986), held:

Manufacturers are not insurers, and a manufacturer cannot be held liable for a consumer’s failure to read or to listen to understandable warnings.  Even taking as true [plaintiff’s] allegation that she does not remember being asked about the [risk], the fact remains that [she] and her mother were provided with a form delineating the risks inherent in [the product] while they were waiting in line for [her] to be vaccinated.  [Defendant] used all reasonable care required by law to warn of potential injury.

Id. at 935-36.

Not all the cases are when the learned intermediary rule is inapplicable.  Some involve supplemental patient-directed information.  For example, “[a]s Defendants point out, there is no evidence the alleged inadequate warning was the proximate cause of [plaintiff’s] injury.  The record is clear Plaintiffs failed to read the detailed patient labeling, which explicitly warned of the precise injury that resulted.”  Canady v. Ortho-McNeil Pharmaceutical, Inc., 2014 WL 4930675, at *3 (N.D. Ohio Oct. 1, 2014) (applying Oregon law).  Accord Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *9 (N.D. Ill. May 26, 2015) (summary judgment granted where “there is absolutely no evidence that [plaintiff] ever read the [disputed] Brochure”); Scharff v. Wyeth, 2011 WL 3320501, at *14 (M.D. Ala. Aug. 2, 2011) (plaintiff “testified that though she might have glanced at the . . . Patient Information Insert, she did not read it”); Crayton v. Rochester Medical Corp., 2011 WL 475009, at *13 (E.D. Cal. Feb. 4, 2011) (“[n]o matter what the “Instruction for Use Sheet” would have said, based on Plaintiff’s representations, he would never have seen it”), aff’d, 548 F. Appx. 483 (9th Cir. 2013); McSwain v. Sunrise Medical, Inc., 689 F. Supp.2d 835, 844 (S.D. Miss. 2010) (plaintiff “cannot prove that the manual’s inadequate warnings proximately caused his injury because [he] voluntarily made the decision to not read the manual”); Gibson v. Sanofi-Aventis U.S., LLC, 2009 WL 3490454, at *5 (W.D. Ky. Oct. 27, 2009) (plaintiff “testified that she did not read any product materials which accompanied her [drug] prescription”); Dyson v. Winfield, 113 F. Supp.2d 35, 41 n.3 (D.D.C. 2000) (“by plaintiff’s uncontradicted testimony, she did not read the warning”; “an unread warning cannot serve as a basis for a claim that the warning affected one’s behavior”), aff’d mem. 21 Fed. Appx. 2 (D.C. Cir. 2001); Cornelison v. Tambrands, Inc., 710 F. Supp. 706, 711 (D. Minn. 1989) (plaintiff “fail[ed] to show the existence of a material factual dispute because there is no evidence that [she] used [product] from boxes which contained the labels”); Ortolano v. BDI Marketing, 2005 WL 4889720 (La. Dist. April 21, 2005) (plaintiff “admitted . . . that he did not read the entire label”; his “failure to warn claim must fail because it could not have possibly been the proximate cause”).

For awhile, West Virginia rejected the learned intermediary rule.  That ruling didn’t actually help plaintiffs all that much, since most of them actually did engage in the conduct on which the rule is predicated – they in fact relied on their prescribers (as the rule posits) and thus didn’t read the allegedly defective drug warnings themselves.  That failure meant West Virginia plaintiffs still lost on the issue of causation.  See Meade v. Parsley, 2010 WL 4909435, at *9 (S.D.W. Va. Nov. 24, 2010) (plaintiff “testified that she never read [defendant’s] package insert or any other documents accompanying her . . . prescription); In re Zyprexa Products Liability Litigation, 2009 WL 1514628, at *12 (E.D.N.Y. June 1, 2009) (“no evidence that [plaintiff] ever read any of defendant’s warnings”) (applying West Virginia law).

The heeding presumption can also be defeated by plaintiff failure to read.  Precisely that supported a defense verdict in Gaghan v. Hoffman-La Roche, Inc., 2014 WL 3798338, at *7 (New Jersey Super. App. Div. Aug. 4, 2014), where neither plaintiff nor her mother “read the warning material that was provided to them, thus suggesting that a more strongly-worded warning would not have been heeded.” Id. at *7.  Likewise, in In re Prempro Products Liability Litigation, 514 F.3d 825, 829 (8th Cir. 2008) (applying Arkansas law), it was proper to instruct the jury under Arkansas law that the defendant was justified in assuming that the plaintiff would read an available warning where plaintiff “admi[tted] that she never read the warnings [defendant] included.”  See Seley v. G.D. Searle & Co., 423 N.E.2d 831, 839 (Ohio 1981) (plaintiff’s failure to inform prescriber of prior medical history defeated heeding presumption).

Plaintiff’s failure to read – or lack of exposure to – direct to consumer information has also been successful in defeating warning claims, whether or not (mostly “not”) courts have allowed this purported exception to the learned intermediary rule. See Ramirez, 863 P.3d at 177 (“plaintiff’s mother could not have relied upon defendant’s advertising because she admittedly did not see or hear it”); In re Norplant Contraceptive Products Liability Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (no evidence that plaintiffs “actually saw, let alone relied, on any marketing materials issued” by defendant) (applying Texas law); Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp. 2d 222, 230 (D.P.R. 2008) (“none indicate that decedent was privy to this informational material prior” to use).

Plaintiff’s Failure To Follow Relevant Warnings

Another recurring way to defeat causation is to establish that the plaintiff in fact received an adequate warning about the risk(s) in question and nevertheless used the product and suffered from the warned-of risks. The Texas Supreme Court considered this type of evidence in holding in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), that plaintiffs had failed to establish causation:

[The prescriber] specifically warned [plaintiff] that she might have [the adverse event at issue], but despite this warning, [plaintiff] chose to continue receiving [the drug] and [the prescriber] continued prescribing them to her.  [Plaintiff’s] actions indicate that, even if [defendant] provided a different warning to her doctors, she would likely have continued [the drug] for her serious medical condition despite the risk. . . .  [Plaintiff] was also aware of other potentially serious, yet rare, side effects from [the drug], such as cancer, but chose to take the drug anyway.

Id. at 172-73.

A plaintiff’s outright disregard of relevant warnings is, of course, the most persuasive form that this type of evidence can take. Thus, in Broussard v. Procter & Gamble Co., 517 F.3d 767 (5th Cir. 2008), the plaintiff “violated extensive warnings when she used” the medical device at issue.  Id. at 770.  Under Louisiana law “plaintiffs who used a product in a manner that violates clear and express warnings can show that their use was reasonably anticipated only by presenting evidence that the manufacturer had reason to know that these warnings were ineffectual,” as to which she suffered summary judgment by “fail[ing] to present even one scintilla of evidence.” Id.

Likewise, in Bock v. Novartis Pharmaceuticals Corp., 661 Fed. Appx. 227 (3d Cir. 2016) (applying Pennsylvania law), summary judgment was affirmed where,

the evidence mustered paints the opposite picture [from what plaintiff needed], particularly the fact that [plaintiff], though informed by [his prescriber] of the risks of dental procedures and the concomitant need to inform his doctor of the need for any dental work, scheduled tooth extractions without consulting [his doctor].

Id. at 232-33.  The Sparks case, cited above, also involved the plaintiffs “fail[ing] to follow a pre-existing on-chamber warning.”  134 F. Supp.3d at 994.  So did Kelley v. Unico Holdings, Inc., 2009 WL 6316398 (Mag. S.D. Ohio July 16, 2009), adopted, 2010 WL 1267375 (S.D. Ohio March 29, 2010), since the plaintiff took “twice the daily dose” in the face of label warnings that “exceeding the recommended dose . . . can be harmful.”  Id. at *6.  Accord Crayton, 2011 WL 475009, at *13 (“Plaintiff was aware there was [a condition] in the [product] that could be painful for him to use [it], but he continued to use”); In re NuvaRing Litigation, 2013 WL 1874321, at *24 (N.J. Super. Law Div. April 18, 2013) (plaintiff “should have consulted her doctor as advised by the label”).

On similar evidence, a heeding presumption-based claim was defeated in D’Agnese v. Novartis Pharmaceuticals Corp., 952 F. Supp.2d 880 (D. Ariz. 2013):

Moreover, even after being warned of the possible risk . . ., [plaintiff] continued to take [the drug]. This would permit reasonable minds to conclude that [plaintiff’s] original prescribing doctor would have nonetheless prescribed [the drug] to [plaintiff] and/or that [his risk] would not have been averted.

Id. at 892-93 (footnote omitted).  Likewise, the plaintiff lost in In re Zyprexa Products Liability Litigation, 2009 WL 5216930 (E.D.N.Y. Dec. 21, 2009) (applying Minnesota law), where his prescriber “herself provided comprehensive warnings to the patient about [the drug’s]  association with” relevant risks. Id. at *12.  Thereafter, the plaintiff “elected to continue treatment with [the drug] for nearly three years after being diagnosed with [the risk], despite having been counseled that [these risks] are potential side effects of the medication.”  Id.  See In re Zyprexa Products Liability Litigation, 2009 WL 5062114, at *14 (E.D.N.Y. Dec. 10, 2009) (prescriber “counselled plaintiff on the need for close monitoring”), aff’d, 394 F. Appx. 814 (2d Cir. 2010) (applying California law); Harrington v. Biomet, Inc., 2008 WL 2329132, at *6 (W.D. Okla. June 3, 2008) (“Plaintiff was advised both before and after surgery and repeatedly thereafter of the risk . . . and what precautions to take”); In re Accutane Litigation, 2016 WL 5958375, at *16 (New Jersey Super. Law. Div. Oct. 12, 2016) (granting summary judgment where plaintiff testified “that he would have taken [the drug] regardless of his receiving [risk] warnings”) (applying Colorado law); id. at *30 (same where plaintiff admitted she “would have allowed” the drug where “the doctor felt that the benefits outweighed the risks”) (applying Nebraska law); In re Alloderm Litigation, 2015 WL 5022599, at *10 (New Jersey Super. Law Div. Aug. 14, 2015) (admitting testimony that plaintiff’s injury stemmed from activity that plaintiff “was advised repeatedly by medical professionals to limit or reduce”).

In Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226, at *13 (N.D.W. Va. Jan. 16, 2015), summary judgment was granted where the warning in question came directly from the defendant, not the plaintiff’s prescriber.  The warning was “adequate,” and “uncontroverted facts establish that [plaintiff’s decedent] actually read the warning from the package insert.” Id. at *13.  Similarly, Niedner v. Ortho-McNeil Pharmaceutical, Inc., 58 N.E.3d 1080, 1086 (Mass. App. 2016), involved an exception to the learned intermediary rule, with the same result, since the warning was adequate as a matter of law:

As a matter of law, the insert adequately warned [plaintiff] of the increased risk . . . that could result in death, as compared to the risks associated with the [alternative], in terms understandable to a lay person. . . .  Here, the insert was abundant in its warning of the possibility [the risk] that could lead to death.

Id. at 1086 (citations omitted).

Note: there is another subset of cases of this type, involving off-label use where no manufacturer promotion occurred, that could fit here, but those cases have somewhat different implications, and since this post is getting long already, we will leave them for another day.

Plaintiff’s Informed Consent Forms as a Source of Risk Knowledge

Evidence of what a plaintiff “was told regarding the risk . . . and what [the] response was to that knowledge” is admissible concerning causation, E.R.G. v. Abbott Laboratories, Inc., 2017 WL 2126837, at *2 (S.D. Ill. May 16, 2017) (applying California law); see Newman v. McNeil Consumer Healthcare, 2013 WL 7217197, at *17 (N.D. Ill. Mar. 29, 2013) (contents of OTC drug label that plaintiffs read sufficient to create jury question as to assumption of the risk).   Besides the label itself, one good place to look for such evidence are informed consent forms signed by plaintiff or a relevant guardian.  Such forms can controvert a plaintiff’s denials of being warned (defeat plaintiff’s burden) or even constitute assumption of the risk (meet defendant’s burden).  As mentioned above, the evidence that defeated the heeding presumption in D’Agnese came from an informed consent form.  952 F. Supp.2d at 892 n.10.

In In re C.R. Bard, Inc., 2013 WL 5591948, at *8 (S.D.W. Va. June 4, 2013) (applying Mississippi law), and C.R. Bard, 2013 WL 2431975, at *9 (applying Wisconsin law), information from plaintiff informed consent forms were held relevant and admissible “to whether [the plaintiff] understood and assumed the risk of having the defective . . . product implanted in her.”

[Defendant] has provided some evidence that [plaintiff] was advised of the risks and consented to the implantation of the . . . products anyway.  Accordingly, even if the court or jury found that the . . . product was, in fact, defective, there would be a genuine issue of material fact as to whether . . . knew and understood of the defects and nonetheless consented.

2013 WL 5591948, at *8; accord 2013 WL 2431975, at *9.  See Taylor v. Pharmacia-Upjohn Co., 2005 WL 3502052, at *5 & n.9 (S.D. Miss. Dec. 19, 2005) (informed consent form established that plaintiffs had in fact received warnings); McMurdie v. Wyeth, 71 Pa. D. & C.4th 225, 230-35 (Pa. C.P. 2005) (extensive “on record” informed consent discussions established that plaintiff “knowingly and voluntarily assumed these risks”) (applying Utah law).

Plaintiff’s Failure To Offer Affirmative Testimony

We’ve already discussed how the burden of proof in a learned intermediary case mandates summary judgment where the plaintiff fails to obtain testimony from the prescribing physician(s) that a different warning would have changed the outcome in some relevant way.  Well, the same result can occur when a plaintiff does not provide his or her own affirmative causation testimony – which, believe it or not, does happen sometimes.  The plaintiff’s testimony in Georges v. Novartis Pharmaceuticals Corp., 988 F. Supp.2d 1152, 1157-1158 (C.D. Cal. 2013), failed to establish causation on a theory that she “would have ignored [her prescriber’s] advice and declined the Treatment Drugs after being warned of the risk when she was first offered them.”  Id. at 1158.  All plaintiff established was “that she would have stopped taking them after [her] symptoms . . . first arose.”  Id.  Likewise, in Hanson v. Boston Scientific Corp., 2016 WL 1448868 (S.D.W. Va. April 12, 2016) (applying Wisconsin law), the plaintiff tried to have it both ways on the learned intermediary rule, but instead lost both.  As to the plaintiff, Hanson held:

[T]he plaintiff still has not provided evidence of causation.  In fact, despite arguing against the application of the learned intermediary doctrine in her response, [plaintiff] provides no evidence that she − instead of [her prescriber] − would have rejected implantation had she known of the warning’s alleged insufficiency.

Id. at *5.  See In re Accutane Litigation, 2016 WL 5958375, at *42 (New Jersey Super. Law. Div. Oct. 12, 2016) (“Summary Judgment must be granted even under Plaintiff’s own standard where Plaintiff’s decision maker did not testify that she would not have allowed her daughter to take [the drug] in the face of an allegedly stronger warning) (applying Ohio law); id. at 48 (similar ruling under Wisconsin law).

Plaintiff’s Failure To Disclose Critical Medical Information

Another way in which plaintiff conduct can defeat causation is when the plaintiff fails to inform his or her prescriber of critical medical history necessary to an accurate assessment of medical risk.  Way back in 1975 the Oregon Supreme Court ruled in Vaughn v G.D. Searle & Co., 536 P.2d 1247 (Or. 1975), that the plaintiff’s failure to inform her treating physicians of “premonitory symptoms of a stroke prior to or at the time she saw” them defeated causation. Id. at 1249.

We find that plaintiff has offered no evidence, either direct or indirect, that she ever advised her treating physicians of symptoms which would have alerted them to the possibility of a stroke.  Without such knowledge there was no way the physician could have related any warning (that there is a cause-and-effect relationship between the ingestion of the drug and a stroke) to plaintiff’s particular case.  Thus, there was no evidence that even a properly warned physician would have treated plaintiff differently or removed her from defendant’s [product] prior to her stroke.

Id. at 1249-50.  Therefore, “there was no evidence that any failure to warn plaintiff’s physicians was a substantial factor in producing plaintiff’s injuries and that defendant’s motion for a directed verdict should have been granted.”  Id. at 1251.

The Ohio Supreme Court came to the same conclusion in Seley, 423 N.E.2d at 838-39, where the plaintiff asserted that the defendant “failed to warn that women with a prior history” of a particular condition “were subject to a higher risk” when using the drug.  Id. at 838.  Plaintiff, however, had “failed to disclose to [her prescriber] that she had experienced” that condition.  Id.  Thus, even “an adequate warning would have made no difference” to the prescriber, misled by the plaintiff’s non-disclosure.  Id. See  Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 878-79 (Wis. App. 2004) (summary judgment affirmed; “when [plaintiff] suffered her symptoms, her patient insert advised her to call her doctor,” but “she did not call her doctor as the patient insert instructed”); Brown v. Glaxo, Inc., 790 So.2d 35, 42 (La. App. 2000) (plaintiff did “not report[] the increasingly severe side effects” from the drug to her prescriber and was therefore “negligent”); Dyer v. Best Pharmacal, 577 P.2d 1084, 1088 (Ariz. App. 1978) (“Just as a drug manufacturer cannot be required to foresee a physician’s negligence, neither can it be required to foresee that a patient might mislead a physician about her physical condition in order to obtain a prescription drug”); Parkinson v. Novartis Pharmaceuticals Corp., 5 F. Supp.3d 1265, 1275 (D. Or. 2014) (following Vaughn; summary judgment granted where “Plaintiff failed to advise any of her dental-treatment providers until after both of her teeth had been extracted” about her use of defendant’s drug); Davids v. Novartis Pharmaceuticals Corp., 857 F. Supp.2d 267, 287 (E.D.N.Y. 2012) (granting summary judgment where treater “testified that the Plaintiff did not disclose that she was taking [the drug], or any other [similar] drug, until after she allegedly developed” the complained of condition); Dyson, 113 F. Supp.2d at 41 (summary judgment granted; where plaintiff did not inform prescriber of pregnancy, no better birth defect warning would make any difference).

Plaintiff’s Noncompliance With Medical Instructions

A plaintiff’s non-compliance with his or her physician’s affirmative medical instructions is also fair game.  In Zyprexa, 2009 WL 5062114, defendant was entitled to summary judgment, inter alia, where the “it was well documented throughout plaintiff’s medical records that she was non-compliant with [risk] treatment and diet since the time of her diagnosis.”  Id. at *14.  In Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), the defendant successfully asserted the plaintiff’s comparative fault in “improperly caring for his incision” and not “adhering to a prescribed rehabilitation regimen” to preclude plaintiff’s reliance on res ipsa loquitur.  Id. at 499.  Previously, in the same court, comparative fault likewise applied to the plaintiff’s failure to follow his drug treatment regimen in Purnell v. United States, 1987 WL 11211, at *6 (E.D. Pa. May 21, 1987).  Similarly, in Emody v. Medtronic, Inc., 238 F. Supp.2d 1291 (N.D. Ala. 2003), the plaintiff’s failure to return for several medical appointments raised “a matter of legitimate dispute” over “[w]hether this [conduct] constituted contributory negligence” as a matter of law.  Id. at 1294.  In Barraza, 2017 WL 3976720, at *8, plaintiffs’ non-compliance, including one who “ignored no less than five letters from her implanting physician requesting clinical follow-up” were cited as examples of possible comparative fault in denying class certification.

Miscellaneous Relevant Plaintiff-Related Evidence

Plaintiff conduct has also been admitted as evidence allowed in various other contexts. In Gaghan, such testimony encouraged a jury to disbelieve the usual plaintiff “I wouldn’t have used, had I only known” testimony:

There was substantial evidence from which the jury could have found that [plaintiff] would have taken [the drug] even if [the prescriber] had received and passed on to her and her mother a stronger warning in the form recommended by plaintiffs’ expert witnesses.  [Plaintiff mother] testified that her daughter was upset and embarrassed . . ., disgusted with the way she looked, and becoming socially withdrawn.  The mother was very concerned about the detrimental physical and emotional effect [this] was having on her daughter.

2014 WL 3798338, at *7.

Plaintiffs who are also physicians in their own right lose when they don’t act like the professionals they’re supposed to be.  The plaintiff-physician in Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95 (N.Y. App. Div. 1979), aff’d, 52 N.Y.2d 768, 417 N.E.2d 1002, 436 N.Y.S.2d 614 (1980), lost because he “knew the risks of taking this particular drug whose side effects were those specifically warned against.”  Id. at 97.  In Herzog v. Arthrocare Corp., 2003 WL 1785795 (D. Me. March 21, 2003), the plaintiff, also a physician, had used the defendant’s medical device himself when performing surgery, and therefore “a jury might conclude that [plaintiff] should have known that [his surgeon] might use the” device in a particular way and “therefore, he unreasonably proceeded to encounter a danger that was known to him.”  Id. at *17.

Where the plaintiff continued using the same drug, or continued having the same symptoms after ceasing use of the drug also “undermine[s]” the causation element.  Taylor, 2005 WL 3502052, at *5 n.9 (plaintiffs’ resumed use of the product indicated no warning would have deterred them).  See Richardson v. GlaxoSmithKline, 412 F. Supp.2d 863, 867 (W.D. Tenn. 2006) (summary judgment granted where plaintiff made multiple suicide attempts before and after using drug).

In Roberts v. Albertson’s LLC, 464 F. Appx. 605 (9th Cir. 2011) (applying Nevada law), causation was not established where plaintiff “did not present any evidence that it would have been foreseeable that the defect would cause him to stop taking his medication” altogether, so that no defect could have been “a substantial factor in causing [plaintiff’s] injury.”  Id. at 608.

In Carey v. Shiley, Inc., 32 F. Supp.2d 1093, 1099-1100 (S.D. Iowa 1998), causation was not proven where plaintiff’s “physicians agreed that the [procedure] was necessary regardless of the need for the [product] explant,” so the later explant was inevitable.

Finally, plaintiff misconduct, leading to “sexually transmitted diseases” in Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1162 (D. Or. 1989), and to suicide in Rimbert v. Eli Lilly & Co., 577 F. Supp.2d 1174, 1233 (D.N.M. 2008), have also been considered relevant in particular situations, irrespective of labeling.

 

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing theory of recovery.  Just last month, we noted that it looked like the issue had been largely resolved against allowing such claims or relief.  Sometimes, the issue is whether the plaintiff sufficiently pleads the elements of a medical monitoring claim in a jurisdiction that recognizes it.   Today’s case involves a different consideration of medical monitoring, looking at whether the requirements of Fed. R. Civ. 23 are met and a medical monitoring class can be certified.  There is quite a bit to Barraza v. C.R. Bard Inc., No. CV16-01374-PHX-DGC, 2017 WL 3976720 (D. Ariz. Sept. 11, 2017), and we are only going to focus we find most interesting.

Barraza comes from an IVC Filter MDL, which has been the source of some other decisions that drew our interest, and ultimately focused on the question of whether class certification was appropriate for eleven separate classes, each for the residents of a state that has recognized medical monitoring and had a resident proposed class representative.  Each class sought medical monitoring for people with one of seven of the defendant’s IVC filter devices in-place (after being implanted at any time) who had not brought a case alleging personal injury.  In other words, these were to be classes of uninjured plaintiffs with on-going use of the allegedly defective devices.  (Note that the proposed class definition does not expressly exclude all patients claiming current complications, but the court addresses the case as though it presents a “no injury” class, so we will too.)  Keep in mind that a common reason for rejecting medical monitoring has been that the tort system is predicating on an actual injury, giving rise to accrual of claims, damages that can be determined by somewhat predictable rules, a duty to mitigate, etc., and people who have not have an actual injury do not fit well within the existing tort system.  Someone with an actual injury, however, may be entitled to compensation for on-going medical care to minimize the progression or sequelae of the injury.  With that in mind, we turn to the evaluation of whether individual considerations or common issues predominate in trying to decide the elements of medical monitoring—as identified by the plaintiffs based on an amalgam of the law of the eleven states.

We will focus on the elements that mattered to the outcome.  While plaintiffs argued that negligent design and failure to warn could be decided on common evidence, the court disagreed.  The seven devices were designed and launched over a more than ten year period and exhibited different design features, manufacturing specifications, and testing.  Similarly, the labeling for the devices differed depending on the date and product, but seemed to address the risks that plaintiffs claim required monitoring.  “Trial of a single class representative’s claim would not suffice because the representative would have received a different filter with different warnings than many members of the class.”  Similarly, the application of affirmative defenses like assumption of the risk and contributory negligence would also turn on individual evidence about what the plaintiff and her doctor knew and did.  The court noted how some of the named plaintiffs—putative class representatives—had ignored recommendations for medical follow up and removal of the device they claim subjects them to an increased risk of harm requiring monitoring.  Thus, individual considerations in evaluating liability predominated and “the classes cannot be certified simply because Plaintiffs allegedly face a common risk and need medical monitoring.”

The related issues of whether the proposed monitoring was necessary and different from the treatment the plaintiffs would otherwise receive also turned on individual considerations.

Here, the amount of monitoring a class member would require in a normal course of her treatment and illness, without the monitoring sought in this case, is an individualized inquiry into the medical needs and ongoing course of treatment for each class member.

For instance, some named plaintiffs were already undergoing monitoring of their own doctor’s devising with different levels of compliance.

Even what law would apply to classes defined by the state of residency involved individual considerations as the state where each plaintiff’s implant surgery occurred, the state where the injury occurred, and the state where the defendant designed the products and drafted labeling could affect the law that would apply.

Put it all together and plaintiff did not come particularly close to satisfying the predominance requirement and class certification under Fed. R. Civ. P. 23(a).  (The plaintiffs also tried for certification of a 23(b)(2) class, but that was pretty much a non-starter as the relief sought—paying for monitoring—is not injunctive.)  Some of the result here is likely due to the plaintiffs’ insistence on broad classes and the selection of putative class representatives with warts, but Barraza also illustrates how class treatment of medical monitoring claims should be a long shot even when state law allows monitoring for uninjured people.

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity.  That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from the Northern District of New York.  We have all suffered through opinions in which judges (or their clerks) painstakingly flog possible outcomes, arguments, and counter-arguments before finally reaching their decisions. And as (once again) McConnell recently pointed out, the result has been some spectacularly bad preemption decisions.  But Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), arising in the relatively clear jurisprudence surrounding so-called “PMA preemption,” was what we fondly call a “slam-dunk,” and the court treated it accordingly.

In Olmstead, the plaintiff was implanted with an Essure device, an implantable birth control device manufactured by the defendant.  She alleged that, after she was implanted with the device, she experienced months of pain, fatigue, and excessive bleeding culminating in a hospital visit for an episode of severe abdominal pain.  Though an initial ultrasound appeared normal, a subsequent ultrasound allegedly revealed that “one of the coils of the Essure was sticking out of the uterus by about one inch.” Olmstead, 2017 WL 3498696 at *2 (internal punctuation and citation omitted).  The plaintiff sued in state court, asserting claims for negligent misrepresentation, strict liability, failure to warn, and breaches of express and implied warranties.   The defendants removed the case to federal court and moved to dismiss it, arguing that the plaintiff’s claims were preempted by the Medical Device Act (“MDA”).

As the court explained (and as we have discussed in these pages many times before (like here, also in the context of Essure litigation), Class III medical devices like Essure must undergo FDA’s “rigorous” premarket approval (“PMA”) process before they can be marketed to the public. Id. at *1.  Under the MDA, once a Class III device obtains PMA, the manufacturer may not make changes to the device’s design, specifications, or labeling without FDA permission.

The MDA also includes an express preemption clause. Under this clause, as construed by the Supreme Court in Riegel v. Medtronic, 522 U.S. 312 (2008), state laws that impose obligations that are different from or in addition to the requirements of the MDA are expressly preempted. Id. at *3 (citations omitted).  A common-law claim challenging the safety of an FDA-approved medical device survives only if it alleges a parallel violation of federal law for which state law provides a damages remedy.  Id. (citations omitted).

As such, the Olmstead court explained, the plaintiff’s “onerous task” first required her “to identify a parallel federal law upon which she [had] based her state law claims.” Id. at *4.   In response, the plaintiff cited the Current Good Manufacturing Processes (“CGMPs”) described in 21 CFR § 820.1 et seq..  But she failed to explain how the defendants had violated the CGMPs, which, in any event, were intended “to serve only as an umbrella quality system providing general objectives medical device manufacturers must seek to achieve.” Id. (internal punctuation and citations omitted).  The court emphasized, “Since these regulations are open to a particular manufacturer’s interpretation, . . . allowing a suit to continue on the basis of the CGMPs would necessarily impose standards that are ‘different from, or in addition to’ those imposed by the MDA – precisely the result that the MDA provision seeks to prevent.”  Id. (internal punctuation and citations omitted).

Thus, the court held, because the plaintiff had “failed to identify a single parallel federal statute or regulation related to any of her claims,” the MDA expressly preempted the suit as a matter of law. Id. The court commented that it ordinarily would have allowed the plaintiff to amend her complaint to “attempt to allege a plausible claim that [was] not preempted.” Id. But, in yet another layer of certainty, the court held that New York’s three-year statute of limitations barred the plaintiff’s claims.

Nothing but net. And we are told that this is the twenty-fourth time that an Essure suit has been dismissed or narrowed on preemption grounds.  Short, sweet, and correct – hard to beat that.  We will keep you posted on further developments.