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This post is a follow-up of sorts to our “Stupid Expert Tricks” post.  That post dealt with dodgy games that our opponents’ experts play.  This post is about adding injury to insult, that is, when the plaintiffs try to make us pay for the privilege of dealing with those tricks.

Now both our side and the plaintiffs are essentially free to pay their experts whatever the market will bear – subject to the usual cross-examination that “you’ve been paid X million dollars by the other side for your testimony about this product.”  But disputes arise when we subpoena the other side’s experts to testify.  Often the fees that they attempt to charge are exorbitant, and when the opposition is paying, no incentive at all exists to charge anything but top dollar.

That’s where the courts come in.

Our first preliminary observation is that we are not dealing here with the involuntary taxation of expert fees as “costs” to a prevailing party in litigation.  Taxation of costs is governed by statute, not by the Federal Rules of Civil Procedure.

[The general “costs” statute] create[s] a default rule and establish[es] a clear baseline against which Congress may legislate . . . .  Rule 54(d) authorizes an award of “costs” but does not expressly refer to expert witness fees.  In defining what expenses qualify as “costs,” [the statute] likewise do[es] not include expert witness fees. . . .  “When a prevailing party seeks reimbursement for fees paid to its own expert witnesses, a federal court is bound by the limit of [the general costs statute] absent contract or explicit statutory authority to the contrary.”

Rimini Street, Inc. v. Oracle USA, Inc., 139 S. Ct. 873, 877-78 (2019) (quoting Crawford Fitting Co. v. J.T. Gibbons, Inc., 482 U.S. 437, 442 (1987)).  We thus caution that pre-Rimini precedent purporting to tax “costs” under the Federal Rules that exceed those permitted by the general “costs” statute, codified at 28 U.S.C. §§1820-21, should be regarded as suspect.  See Stanley v. Cottrell, Inc., 784 F.3d 454, 464-65 (8th Cir. 2015); Halasa v. ITT Educational Services, Inc., 690 F.3d 844, 852 (7th Cir. 2012).  In Rimini, the Supreme Court just said “no” to all that.

Our next preliminary observation is that no basis exists under the Federal Rules of Civil Procedure for anyone to demand prepayment of expert fees.  An expert is entitled to be paid for his/her time, Fed. R. Civ. P. 26(b)(4)(C), but not in advance, unless the parties agree.

The rule does not state, however, that the expert’s fees must be paid in advance of the deposition absent agreement to do so.  To the contrary, unlike ordinary witness fees, no rule requires that an opposing expert’s deposition fees be tendered to the witness in advance. . . .  Because there is no rule allowing a party to terminate a deposition for the failure to pay opposing expert witness fees in advance, Plaintiff’s counsel was wrong in doing so in the instant case.

Harris v. Costco Wholesale Corp., 226 F.R.D. 675, 676 (S.D. Cal. 2005) (citations omitted) (emphasis original).

[Plaintiff] does not provide any authority to support its position that an expert witness may condition his or her appearance for deposition upon a payment in advance.  In contrast, the weight of authority is to the contrary.  Permitting an expert to condition his appearance upon prepayment of fees would undoubtedly hamper an opposing party’s ability to conduct relevant discovery.  Moreover, numerous courts have found that Rule 26(b)(4)(E) does not require the payment of expert fees in advance, and have required experts to appear for deposition without being paid in advance.

PC Anything, Inc. v. Lexington Insurance Co., 2019 WL 2515001, at *1 (S.D. Fla. June 18, 2019) (string citation omitted).  See also, e.g., PC Anything, Inc. v. Lexington Insurance Co., 2019 WL 2515001, at *1 (S.D. Fla. June 18, 2019); Smith v. Bradley Pizza, Inc., 2018 WL 5920626, at *7 n.7 (Mag. D. Minn. Nov. 13, 2018), objections overruled, 2019 WL 2448575 (D. Minn. June 12, 2019).

Our third preliminary observation is that some courts hold that experts are not entitled to be paid for time “spent reviewing or correcting his or her deposition transcript” or for “the time an expert spent preparing for his or her deposition.”  Rock River Communications, Inc. v. Universal Music Group, 276 F.R.D. 633, 635 (C.D. Cal. 2011).  Accord M.T. McBrian, Inc. v. Liebert Corp., 173 F.R.D. 491, 493 (N.D. Ill. 1997) (Rule 26 “does not require the party deposing an expert witness to bear the expense of that expert’s deposition preparation time.”).  Other courts allow subpoenaed experts to charge for preparation time, which encourages experts to run up excessive numbers of “preparation” hours.  See Cohen v. Jaffe, Raitt, Heuer, & Weiss, P.C., 322 F.R.D. 298, 301-02 (E.D. Mich. 2017) (multiple experts’ preparation time reduced as excessive, including all time consulting with counsel); Windsor Securities, LLC v. Arent Fox LLP, 2018 WL 4360769, at *2-3 (S.D.N.Y. Aug. 7, 2018) (58 hours of preparation time for 4-hour deposition cut to 20); Conte v. Newsday, Inc., 2012 WL 37545, at *4 (E.D.N.Y. Jan. 9, 2012) (65 hours of preparation time for 7-hour deposition chopped to 10 hours).

As for the amount of the fee itself, under the “manifest injustice” standard of Rule 26(b)(4)(E), “[t]he party seeking reimbursement of their expert witness fees has the burden of demonstrating to the court that the expert’s rate and fee are reasonable.”  Se-Kure Controls, Inc. v. Vanguard Products Group, Inc., 873 F. Supp.2d 939, 955 (N.D. Ill. 2012).  “The caselaw also ‘reflects widespread judicial criticism of blatant attempts to gouge opposing parties with steep fees, and an activist approach in reducing fees deemed to be exorbitant.’”  Fell v. United States, 2017 WL 2819040, at *3 (Mag. N.D. Fla. June 9, 2017) (quoting Brunarski v. Miami University, 2017 WL 713691, at *1 (S.D. Ohio Feb. 23, 2017)), adopted, 2017 WL 2817881 (N.D. Fla. June 29, 2017).  “A guiding principle is that the expert’s fee should not be so high as to impair a party’s access to necessary discovery or result in a windfall to the expert.”  In re American Medical Systems, Inc. Pelvic Repair Systems Products Liability Litigation, 2017 WL 1090029, at *2 (S.D.W. Va. March 21, 2017) (quoting Maxwell v. Stryker Corp., 2012 WL 2319092, at *2 (D. Colo. June 19, 2012)).  A multi-factor test has been used for years.  Here’s a typical list of those factors:

(1) the witness’ area of expertise; (2) the education and training required to provide the expert insight that is sought; (3) the prevailing rates of other comparably respected available experts; (4) the nature, quality and complexity of the discovery responses provided; (5) the fee actually being charged to the party who retained the expert; (6) fees traditionally charged by the expert on related matters; and (6) any other factor likely to be of assistance to the court in balancing the interests implicated by Rule 26.

Grady v. Jefferson County Board of Commissioners, 249 F.R.D. 657, 659 (D. Colo. 2008) (citations and quotation marks omitted).  This list apparently originated in Jochims v. Isuzu Motors, Ltd., 141 F.R.D. 493, 4995-96 (S.D. Iowa 1992), and has been widely followed in recent cases.

In the AMS case, in our sandbox, a plaintiffs’ expert demanded a $3500 per hour fee.  2017 WL 1090029, at *3.  The court knocked this stratospheric demand down to $500 per hour.

While [the expert] claims that other individuals have been willing to pay him $3,500 per hour, that fact, alone, does not establish the reasonableness of his deposition rate.  On the other hand, [defendant] has provided evidence that the customary hourly fee being charged in this MDL is $500.  Moreover, a review of the relevant case law indicates that $500 per hour is within the range of reasonable payment for a treating physician’s testimony.

Id. (citing Korabik v. Arcelormittal Plate LLC, 310 F.R.D. 205, 208 (E.D.N.Y. 2015) ($400 an hour was reasonable fee for expert orthopedic surgeon; rejecting $2500 per day demand); Roca Labs, Inc. v. Consumer Opinion Corp., 2015 WL 12844308, at *2 (M.D. Fla. July 23, 2015) ($500 an hour was reasonable fee for expert internist; rejecting $3000 per half day demand); Patterson v. Avis Rent A Car Systems, Inc., 48 F. Supp.3d 534, 534-35 (S.D.N.Y. 2014) ($650 an hour was reasonable for treating physician designated as an expert); Clossin v. Norfolk Southern Railway Co., 2014 WL 3339588, at *2 (W.D. Pa. July 8, 2014) ($500 an hour for the first three hours was reasonable for expert orthopod; rejecting $4000 for first hour demand); Duke v. Performance Food Group, Inc., 2014 WL 370442, at *7 (N.D. Miss. Feb. 3, 2014) (treater’s $300.00 an hour fee was reasonable); Burgess v. Fischer, 283 F.R.D. 372, 373 (S.D. Ohio 2012) ($360 an hour was reasonable for physician with unstated specialty; rejecting $2,000 per day demand); Maxwell v. Stryker Corp., 2012 WL 2319092, at *3 (no more than $750 an hour was reasonable for expert orthopod; rejecting $2000 an hour demand); Cartrette v. T & J Transport, Inc., 2011 WL 899523, at *2 (M.D. Fla. March 15, 2011) ($400 an hour was reasonable for treaters; rejecting demands for $1500 an hour).

We looked a little further for additional examples of excessive expert fees.  In the Grady case cited above, the court “f[ound] that the deposition hourly rate of $2,000 per hour as set forth in [an expert orthopod’s] fee schedule is grossly excessive and comes near to being extortionate.”  249 F.R.D. at 662.  The court set the fee at $600 per hour.  Id.  In another, more recent, American Medical case, the plaintiff’s expert pelvic surgeon sought the handsome sum of $18,000 per day for his testimony.  In re American Medical Systems, Inc. Pelvic Repair Systems Products Liability Litigation, 2019 WL 2520593, at *1 (S.D.W. Va. June 17, 2019).  He didn’t get close to that.  The Court rejected flat fees altogether:

[A] flat fee does not comply with the intent of Rule 26(b)(4)(E)(i), which requires some reasonable relationship between the services rendered and the remuneration to which an expert is entitled.”  By its nature, a flat fee runs counter to this principle.

Id. (citations and quotation marks omitted).  Plaintiffs had pointed to other flat fees charged in similar MDLs before the same judge.  Id. at *3.  Bad move, since all the flat fees cited are presumably now subject to being held invalid.  Based on all the factors, the expert received a his “regular hourly review rate” of $900 per hour, which “while on the high side, [was] reasonable.”  Id.  See also Fint v. Brayman Construction Corp., 2019 WL 124835, at *2 (S.D.W. Va. Jan. 7, 2019) (collecting cases holding “that a flat fee does not comply with the intent of” Rule 26); AP Links, LLC v. Russ, 2015 WL 9050298, at *1 (E.D.N.Y. Dec. 15, 2015) (collecting cases holding “that flat fees for expert appearances are ‘disfavored’ and are generally considered unreasonable”).

We’ve also seen “sauce for the goose” arguments in this area.  By that we mean, that what a moving party pays its own experts is cited as justification for requiring that party to pay the same rate to opposing experts that it has subpoenaed to testify.  In Dominguez v. Syntex Laboratories, Inc., 149 F.R.D. 166 (S.D. Ind. 1993), the plaintiff’s expert demanded $860 an hour.  The court rejected that amount, comparing it to, among other things, the fees paid by the other side to its experts:

To put it bluntly, no doctor with similar expertise charges as much as [plaintiff’s expert].  In fact, no similar doctor comes close.  Plaintiff makes only vague reference to unnamed doctors of unnamed specialty who are alleged to regularly earn $500 to $1,000 per hour for deposition testimony.  This is not enough to overcome defendant’s evidence that another [its expert] in the same field . . . earns only $300 per hour − or some evidence unnamed doctors may earn $350 per hour.  Other experts in fields relevant to this case earn even less: $120 to $250 per hour.

Id. at 169.  See also, e.g., Nelson v. LeBlanc, 2019 WL 1930744, at *4 (E.D. La. April 30, 2019) (expert could only recover from opponent what he charged his client); Fell, 2017 WL 2819040, at *4 (expert’s fee to opponent limited to the rate he charged his client).

In other cases, a professor of some sort sought a $1500 an hour fee in Brunarski, 2017 WL 713691, at *1.  The court cut the fee in half.  Id. at *2.  Similarly, the court in Goins v. Royal Caribbean Cruises, Ltd., 2017 WL 5891475, at *2 (S.D. Fla. Oct. 24, 2017), rejected an expert’s attempt to double his $800 an hour fee for “after hours” testimony.  In Cohen, that plaintiffs had agreed to pay their expert’s $715 an hour did not prevent reduction to $295 when the other side was paying, since the court was “not bound to force what may have been one party’s foolish bargain upon its adversary.”  322 F.R.D. at 302.  In Massasoit v. Carter, 227 F.R.D. 264 (W.D.N.C. 2005), the court held that a defense expert’s demand of a $2000 flat fee of $2,000 was excessive and allowed only $250 an hour.  Id. at 267.  In Scheinholtz v. Bridgestone/Firestone, Inc., 187 F.R.D. 221, 221 (E.D. Pa. 1999), two of the plaintiff’s medical experts, demanded flat fees of $2,900 and $5,000.  That was “patently unreasonable,” and the court “reluctantly approved a $600 an hour fee – only because the defendants had “agreed to it.”  Id. at 222.  See Fint, 2019 WL 124835, at *3-4 (expert’s $5000 flat fee held unreasonable, but his $385 hourly rate was OK).

What about Daubert?  Expert fees for Daubert hearings are not recoverable under Rule 26(b)(4)(E).  “A Daubert hearing is not a discovery proceeding but an evidentiary hearing designed to screen expert testimony.”  Knight v. Kirby Inland Marine Inc., 482 F.3d 347, 356 (5th Cir. 2007).  There is also precedent that a party need not pay any fees associated with the deposition of an expert where the expert was later excluded from testifying following a Daubert hearing.  “To require a party to pay for the costs of a witness who was not even called, and against whom the court had sustained a Daubert challenge is manifestly unjust.”  Rogers v. Penland, 232 F.R.D. 581, 583 (E.D. Tex. 2005).  Accord GWTP Investments, L.P. v. SES Americom, Inc., 2007 WL 9712172, at *5 (Mag. N.D. Tex. Jan. 30, 2007) (plaintiff “may not recover for . . .  fees as a testifying expert because this Court sustained a Daubert challenge against his testimony.”), adopted, 2007 WL 9712173 (N.D. Tex. Feb. 14, 2007) (mathematical errors corrected).  Thus, defendants with meritorious Daubert challenges should seek to have expert fee determinations postponed until after the relevant hearings, or at least to be reimbursed  for any payments “in the event any Daubert challenge is successful.”  Durkin v. Paccar, Inc., 2012 WL 12887769, at *5 (Mag. D.N.J. Dec. 28, 2012), aff’d, 2013 WL 5466930 (D.N.J. Sept. 30, 2013).

Finally, it’s a little old, but back during the DES mass tort, as “key” plaintiff side expert, had his rate cut from $420 an hour to $250.  Anthony v. Abbott Laboratories, 106 F.R.D. 461, 464-65 (D.R.I. 1985).  Anthony is a reminder of how the advent of the current MDL-dominated mass tort environment has – contrary to Congressional purpose − caused the cost of just about everything involved in such litigation to skyrocket, which includes expert fees.

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Did you ever read something and think – I couldn’t have said it better myself.  Sometimes we read opinions that give us just that feeling.  A decision that ticks all of the boxes and leaves us wondering why everybody doesn’t see how easy it is to reach the right conclusion.  Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sep. 23, 2019) is such a case.

The case involved two plaintiffs suing for injuries allegedly caused by silicone breast implants which are PMA (Pre-Market Approved), Class III devices.  Id. at *1-2.  Plaintiffs brought failure to warn and manufacturing defect claims.  The court’s decision is straight forward, logical, and concise to boot.  We’ll try to be equally so in our summary.

Failure to warn:  Plaintiffs argued three bases for their claims.  First, that defendant had a duty to warn plaintiffs directly.  Applying Kansas and Missouri law (one for each plaintiff), the learned intermediary doctrine “easily” disposed of this argument.  Id. at *5. Second, defendant had a duty to warn the FDA.  Plaintiffs warn-the-FDA claim was based on allegations that defendant failed to properly conduct FDA-mandated testing and failed to report negative test results.  This the court dismissed as impliedly preempted:

Plaintiffs have not identified a state law that required Mentor to conduct follow-up studies in accordance with FDA regulations, nor have plaintiffs identified a state law that required Mentor to report findings to the FDA. Therefore, plaintiffs are not enforcing state law, but attempting to enforce FDA regulations. The MDA impliedly preempts this type of action.

Id. No private enforcement of the MDA.  Check.

Plaintiffs’ third failure to warn argument was that defendant not only had a duty to warn physicians directly, but also indirectly by reporting to the FDA.  Neither survive preemption.  As for direct warning, plaintiffs argued that defendant was required to update its label with information it learned during post-marketing studies.  Even if state law so required, to avoid preemption such a claim would have to parallel a federal requirement and it does not. “Therefore, any state law claim that would have required Mentor to make label updates would necessarily impose a requirement beyond those imposed by federal law.”  Id. at *6.  No parallel federal requirement.  Check.

Plaintiffs also argued that defendant could have changed its label through the CBE (Changes Being Effected) procedure. The court correctly focused on the word “could.”  “The CBE procedure is permissive, not mandatory.”  Id.  Therefore, state law, which would require a change, is different from and in addition to federal law which does not require a change.  Differing state law.  Check.

As for the indirect warning to physicians, plaintiffs argued that had defendant reported adverse events to the FDA the FDA would have made that information publicly available, something they are not required to do, which physicians may have then accessed, relied on, and altered their treatment of plaintiffs.  First, the allegations are “far too speculative” to survive TwIqbalId.  Second, there is no state tort law that requires defendant to report adverse events to the FDA.  So, this is another attempt to enforce the MDA.  Not grounded in traditional state law tort.  Check.  With that, all of plaintiffs’ failure to warn claims are dismissed.

Manufacturing Defect:  Plaintiffs base their manufacturing defect claims on eight allegations.  Four were preempted because they relied solely on violations of federal law:  failure to comply with FDA specifications; failure to use FDA approved materials; failure to comply with federal regulations and manufacturing protocols; and selling implants in violation of federal law.  Id. at *7.  Because “these claims would not exist without the FDCA, including the MDA,” id., they are preempted.  We’ve already checked the no state law claim box, but we don’t mind doing it again.  Check.

Plaintiffs’ counter to this was that the federal regulations provide the standard of care for the state law claim.  To which the court responded:

In other words, to conjure up a parallel state claim that survives implied preemption, plaintiffs argue that Mentor violated state law because it violated federal law. This is a roundabout way of asserting a negligence per se claim based on a violation of the FDCA.

Id.  Which is something you can’t do under Kansas or Missouri law.  In both states, negligence per se “is limited to violations of a statute where the legislature intended to create an individual right of action for injury arising out of a statutory violation.”  Id. at *8n.5 (citations omitted).  And, we know the FDCA does not have a private cause of action.  The court dismissed plaintiffs’ negligence per se claims.  No negligence per se where no private cause of action.  Check.

That left four allegations as potential bases for a manufacturing defect claim.  While they sounded in traditional tort law – failure to follow good manufacturing practices, failure to use proper materials, failure to properly inspect/test, failure to use proper quality control procedures – they offered nothing more than conclusory assertions.  They didn’t satisfy TwIqbal.  Id. With that, all of plaintiffs’ manufacturing defect claims are dismissed.

The claims were straightforward.  The defendants’ arguments equally so.  The court’s opinion perhaps even more so.  Think outside the box may be a commonly used metaphor to inspire people to be innovative and creative but it can’t be used to overcome clear cut legal precedent.  And when you check all the preemption boxes, this should be the result.

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Speaking of iffy propositions, we’re reminded of the hypothetical, hindsight-oriented questions that plaintiffs so often ask prescribing physicians:  “What if you had known X?”  “Would you have liked to know X?”  “Wouldn’t you have wanted to know Y?”  The (usually) unspoken premise of these questions is the more knowledge is always better than less – no matter how questionable propositions “X” and/or “Y” might be.

This, we like the Texas Supreme Court’s response to such arguments in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) (which we also discussed here).

Moreover, [plaintiffs] failed to show that the warning’s alleged inadequacies . . . would have changed [the] prescribing physicians’ decision to prescribe [the drug] in light of her complicated medical history and serious ailments. . . .  [The prescriber] stated that he would want to know if [defendant] was aware of more cases of patients contracting [condition]. . . .  Even if the additional reports . . . constituted valid and reliable evidence of an elevated risk of [the condition] beyond that of a “rare” . . . side effect, the fact that [the prescriber] would have considered such information, if included in the package insert, does not prove that the presence of such information would have changed his decision to prescribe [the drug] to [plaintiff] − a critical element of [these] claims.

Id. at 172.  So much for speculative hindsight.  “Want to know” prescriber testimony, alone, is not a valid basis for establishing the warning causation element in a learned intermediary rule case.

Similarly, in Gaghan v. Hoffman-La Roche Inc., 2014 WL 37983386 (N.J. Super. App. Div. Aug. 4, 2014) (applying California law), the court ordered entry of judgment n.o.v. where all the plaintiff had was the prescriber’s affirmative answers to “would you want to know about” questions.  Plaintiff “could not get [the prescriber] to testify that he would have warned [plaintiff] . . .  if the [defendant’s]warnings had been as plaintiffs’ evidence and argument would have required.”  Id. at *16. Then,

On cross-examination, [the prescriber]testified that the stronger warnings would not have dissuaded him from recommending and prescribing [the drug] because the side effects were rare, the drug was highly effective, and a patient . . . who had tried other medications would benefit greatly by its use.

Id. at *17.  That did it.  “Want to know” was not enough.  “[E]ven if California law did focus on the decision of the patient rather than the decision of the doctor, there was insufficient evidence in the record from which the jury could rationally conclude that stronger warnings would have altered [the prescriber’s] treatment . . . .  [Plaintiff] did not establish that stronger warnings would have changed [the prescriber’s] conduct.”  Id.

Essentially the same thing happened in Sager v. Hoffman-La Roche, Inc., 2012 WL 3166630 (N.J. Super. App. Div. Aug. 7, 2012), another New Jersey litigation tourist case involving the same drug, but this time under Florida law.  “Want to know” prescriber testimony was not enough to establish causation under the learned intermediary rule:

[The prescriber], who continued to prescribe [the drug] to other patients . . ., testified that if she saw [plaintiff] . . . in the same condition, she still would have strongly considered prescribing [the drug]. . . .  [The prescriber] did note that she would have wanted to know if [defendant] had found a causal relationship . . . and that if the drug was a probable or highly likely cause of [the condition], she would have informed a patient of the relationship.  Even so, her testimony was unambiguous when asked about whether, if the product warning had been stronger, she would have made the same prescribing decision as to [plaintiff].

Id. at *17.  Under Florida law, “the inescapable conclusion is that the trial proofs failed in this case to establish proximate causation.”  Id. at *18.

In Hanson v. Boston Scientific Corp., 2016 WL 1448868, at *5 (S.D.W. Va. April 12, 2016) (applying Wisconsin law), the court held that, regardless of the learned intermediary rule, unstated implanter testimony that “at most” her “risk/benefit analysis would have been impacted” led to summary judgment in a vaginal mesh case.  Such threadbare testimony “requires a reasonable juror to speculate, based only on mere possibility, that [the implanting surgeon] would have altered her decision to prescribe the product simply because she would have considered an additional factor in her risk/benefit calculus.”  Id. at *5 (emphasis original).

Similarly abstract implanter testimony that allegedly omitted information would be a “cause for concern” likewise failed in another mesh case, Hoffman v. Boston Scientific Corp., 2015 WL 5842785, at *5 (S.D.W. Va. Oct. 6, 2015) (applying Utah law).  Such testimony:

D[id] not show that . . . the implanting physician, would have altered his decision to prescribe the product had he known of additional warnings. . . .  [Plaintiff’s] evidence is insufficient.  Indeed, such evidence requires a reasonable juror to speculate, based only on mere possibility, that [the implanter]  would have altered his decision to prescribe the product simply because of “cause for concern.”  Accordingly, a reasonable juror cannot infer that allegedly inadequate warnings proximately caused [plaintiff’s] injuries.

Id. (citations omitted) (emphasis original).

The same result obtains in prescription drug litigation.  “Would like to have known” prescriber testimony, never linked to the plaintiff’s treatment, failed in Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294 (D. Kan. 2008).  Such abstract testimony was no big whoop given other patient-specific testimony the disproved causation:

The above testimony establishes that [the prescriber] may not have used [the drug] “in a certain individual,” but it does not explain what type of individual or why [the prescriber] may not have given [the drug] to that type of individual.  The reference has no apparent relation to [plaintiff’s decedent].  [The prescriber] clearly testified that even today, he would still prescribe [the drug] for [plaintiff’s decedent].  The speculative argument that [he] “may not” have used [the drug] “in a certain individual” does not raise a genuine issue of material fact.

Id. at 1312.

Ditto in Nix v. SmithKline Beecham Corp., 2007 WL 2526402 (D. Ariz. Sept. 5, 2007) (applying California law).  Abstract prescriber “would have liked to have known” testimony could not establish a genuine issue of fact on proximate causation in a learned intermediary case.

But merely raising the possibility that [the prescriber] might have acted differently is not enough to satisfy Plaintiffs’ burden of proof on causation.  As noted above, Plaintiff must provide affirmative evidence that “an adequate warning to the prescribing physician would have altered the physician’s conduct. . . .  Plaintiffs must come forward with evidence from which a reasonable jury could return a verdict for the nonmoving party.  Plaintiffs have provided no such evidence on the issue of causation.

Id. at *3 (citations and quotation marks omitted).

“Would have liked to have known” testimony from a prescriber also failed to create a triable causation case in Cross v. Forest Laboratories, 102 F. Supp.3d 896 (N.D. Miss. 2015).  The line of questioning was based on a false predicate – the claimed information did not, in fact, exist at the pertinent time.

This data was published in 2006 and was not available to [the prescriber] at the time he made the prescription, so the court fails to see how data published in 2006 could have affected [the prescriber] in 2004.  Further, even if, in 2004, [the prescriber] had had the data and had done further research, he might have still prescribed [the drug].  There is no affirmative and specific evidence provided by plaintiffs that suggest an adequate warning would have changed [the prescriber’s] conduct in a way to prevent [the claimed injuries].

Id. at 904.  Absent plaintiff-specific prescriber testimony that some change in prescriber conduct would have prevented injury, the defendant was entitled to summary judgment on causation.  Id. at 905 (“Plaintiffs have failed to show an adequate warning would have altered [the prescriber’s] conduct in any way.”).

Now, the caveats.  If the plaintiff successfully uses “would have liked to have known” questions as a springboard for more substantive questions concerning whether the prescriber would not have recommended a drug or implanted a device, then causation is likely established on the basis of affirmative answers to the latter questions.  Defendants should be prepared to distinguish those types of decisions in a situations where, as above, the prescriber’s testimony is hypothetical or abstract and is not  tied to his or her treatment of that specific plaintiff.  In such cases, it is the latter testimony – about possible alteration of a plaintiff’s treatment – that matters, not any “would have liked to know” statements.

Finally, we would also like to caution that plaintiffs might get away pure “like to know” tactics in states that allow a “heeding presumption” in prescription medical product liability litigation.  Such a presumption – which we consider invalid − effectively flips the burden of proof.  Thus, a holding that prescriber “would want to know” testimony defeated summary judgment did so because “[a]t no point” did the prescriber” suggest that he would have disregarded” such information.  Anderson v. Sandoz Pharmaceuticals Corp., 77 F. Supp. 2d 804, 809 n.7 (S.D. Tex. 1999).  However, Anderson was expressly abrogated in Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, n.16 (5th Cir. 2008), which held that Texas did not recognize a heeding presumption.

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The defense has done a good job of preventing class certification of drug and device mass torts. Individual issues of usage, causation, reliance, injury, etc. predominate over alleged common issues. It has gotten to the point where it is hard for drug and device hacks to find an interesting class cert decision. For that, we must turn to other issue areas, as in the recent case of Jones v. Brg Sports, 2019 U.S. Dist. LEXIS 128493 (N.D. Ill. Aug. 2, 2019), in which plaintiffs attempted to certify classes of high school and college football players from 18 states who alleged that they were injured while wearing Riddell helmets. (This litigation is different from the NFL concussion lawsuit taking place in Philly a few blocks east of us on Market Street.) The defendant in Jones filed a motion to strike the class allegations because they did not satisfy the requirements of Fed. R. Civ. P. 23(b)(3). The defendant angled for a categorical ruling — i.e., that no personal injury mass tort could support class certification. The court would not go that far, but the judge wrote a very strong, clear opinion denying class certification. (This is the same judge who oversaw the testosterone MDL. He does not mind deciding things. He also does not mind being quite clear and, er, strong, about what he is deciding.)

The plaintiffs argued that the predominant and common issue in the case was whether the helmets had been badly designed. End of story. But that is not the end of the story. It is not the beginning of the end. It is not even the end of the beginning, The court saw that the “core of this case” rests on individual issues such as injury and causation, and each plaintiff used the helmet “for different lengths of time, at various levels of play and in different positions on the field, sustaining different numbers of concussions and other injuries, and receiving varying medical care.” (This judge writes like he knows football. Hmmm. A Chicago judge writing about football concussions – must be a Bears fan.).

The Jones judge was also swayed by the variations in governing law. There are very real tort law differences among the 18 states. Consequently, “the complexity of the individualized factual issues bears [aha! We knew he was a Bears fan] a synergistic relationship with the state-by-state variations in the legal schemes, resulting in innumerable individualized inquiries that destroy both predominance and superiority and thus preclude certification under Rule 23(b)(3).” This concussion class action has been sacked, and the trial judge is like Khalil Mack. (Or, for those of you who have orbited the Sun a few more times, think of the great Deacon Jones. If you want to have a laugh, go on YouTube and look for Deacon’s discussion of his head-slap technique. You will encounter one of the all-time great intersections between the violence of football and the inanity of political correctness. Go ahead. We’ll wait. You owe it to yourself.) (Oddly, this is not the first time this blog has linked to an Deacon Jones video. In this 2013 post, we hearkened back to an old Parkay commercial.)

The plaintiffs tried to save their class action(s) in the usual way, first, by asking for more discovery, and second, by asking for “issue certification” under Rule 23(b)(3). Nope and nope. The court concluded that “no amount of discovery or further narrowing of class definitions will ameliorate these problems.” As for issue certification, the Jones court followed one of our favorite cases, In re Rhone-Poulenc Rorer Inc., 51 F.3d 1293 (7th Cir. 1995), and held that the proposed bifurcation would unduly up the stakes, and would artificially amalgamate the laws of different jurisdictions, run roughshod over individual issues, and quite possibly violate the defendant’s Seventh Amendment right, “because later juries would necessarily have to reassess duty and breach when assessing issues including comparative negligence and proximate causation.”

The plaintiffs sought class certification purely as a pressure device, and the judge was having none of it. If you want to see brutal pressure, go to Soldier Field and watch the Monsters of the Midway. But such pressure has no place in a courtroom. Still, we’d like to think that the Jones court delivered a nice head-slap to the plaintiffs.

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Today’s guest post is by Reed Smith‘s Jenn Eppensteiner.  In it she discusses a recurring theme on the Blog – claimed product “defects” arising from nothing more than the failure of an implanted medical device.  Case after case has recognized that the human body is a hostile environment for implants, surrounded by the equivalent of salt water that corrodes metal and plays havoc with electronics (like dropping a cell phone or a watch in a tide pool, only worse), and in the case of weight-bearing implants, producing constant stress cycles that eventually overcome the strongest metals.  Still, plaintiffs persist in bringing cases with nothing more than the allegation, “it broke.”  Jenn discusses another decision dismissing such a claim.  As always, our guest posters deserve 100% of the credit (and any blame) for the contents of their posts.

**********

Things I’ve said to my toddlers today:

  • Stop that!
  • You’ll break it!
  • Someone is going to get hurt!
  • You are entitled to a reasonable product—not a perfect, unbreakable one!

Okay maybe not that last one.  But if I was the betting kind, and I am, I’d wager that the plaintiff’s doctors in Miller v. Depuy Synthes Sales, Inc., 2019 WL 4016207 (D. Nev. Aug. 26, 2019), likely said some version of the first three to plaintiff, and maybe even the last one.  The United States District Court for the District of the Nevada did, at least.  Id. at *5.

But let me back up.  In Miller, the Court granted summary judgment in a broken device case.  The device in question was a prescription medical orthopedic implant.  Id. at *1.  The plaintiff had it surgically installed after fracturing two bones in his lower right leg.  Id.  The defendant device manufacturer included a package insert that warned that the device could fail if a patient bears weight on it, if the healing process is delayed, or if it is subjected to muscular forces from movement or repeated stresses.  Id. at *1-2.  Prior to implanting the device in the plaintiff, his surgeon provided the plaintiff with a page of instructions consistent with that warning.  Id. at *2.

The plaintiff’s implant surgery took place in 2013.  Id. at *1.  About ten weeks later, the plaintiff returned to his surgeon complaining of pain.  Id.  The doctor found that “there was a delayed union of the bones and that the device was broken, because the Plaintiff was weight bearing.”  Id. (emphasis added).  The plaintiff contested this fact.  Id.

Over the next year, the plaintiff’s injury worsened.  Id.  His implanting surgeon transferred the plaintiff’s care to an associate.  Id.  This second surgeon replaced the original implant with another similar, which had a more robust plate.  Id.  Presumably the plaintiff understands the need to take it easy now, right?  Stop that, I hear myself saying, you’ll break it.  Someone is going to get hurt.  The second device broke four months later.  Id.

The plaintiff filed suit against the manufacturer alleging five causes of action, including: strict products liability; negligent products liability; breach of an implied warranty of merchantability; breach of implied warranty of fitness for a particular purpose; and breach of an express warranty.  Because the plaintiff could not show that the device failed to function as expected—a fatal flaw for all his claims—the Court granted summary judgment in the defendant’s favor.  Id.

Before taking up the issue of summary judgment, though, the Court addressed the plaintiff’s motion in limine wherein he asked the Court to exclude his treating physicians’ testimony as to the cause of the device’s failure.  Id. at *2.  The plaintiff argued that such exclusion was proper because his physicians were retained experts without the necessary Rule 26 disclosures.  Id.  The Court disagreed.  The physicians were experts, yes, because of their degrees, training, experience, and expertise with the product, but they were non-retained experts, and accordingly were not required to submit detailed reports.  Id.; see also Fed. R. Civ. Pro. 26(a)(2)(c).

The Court also noted that the defendant had not retained the physicians, and also that both physicians formed their opinions while actually treating the plaintiff.  Id. at *3.  As noted above, when the break was first identified, the initial surgeon noted in his records that the break was “secondary to weight bearing.”  Id.  Likewise, the second surgeon’s records contemporaneous with time of treatment indicated his opinion was that the device broke because the plaintiff “had walked on [his leg] against recommendations.”  Id.  The deposition testimony was consistent with this belief.  Id.   This kind of motion in limine—to exclude one’s own treaters’ testimony—means the plaintiff is in big trouble.

The Court then turned to the issue of summary judgment, devoting the bulk to the discussion to the strict products liability claim.  To prevail under Nevada law, a plaintiff alleging strict products liability must prove that (1) the defendant placed a defective product in the market and (2) the plaintiff suffered an injury which was caused by the defect.  Id. (citing Allison v. Merck & Co., Inc., 878 P.2d 948, 952 (Nev. 1994)).  The defendant argued that (1) the plaintiff failed to show a defect; (2) the plaintiff’s misuse caused his injuries; (3) the plaintiff failed to produce a medical expert for causation; and (4) the learned intermediary doctrines shields the defendant from liability.  Id. at *4.  The Court agreed with the defendant as to their first argument—the plaintiff failed to prove the device was defective.

For design and manufacturing defects, what the plaintiff alleged, Nevada applies the consumer expectation test, which states that a product is defective when it “fail[s] to perform in the manner reasonably to be expected in light of its nature and intended function and was more dangerous than would be contemplated by the ordinary user.” Id. (quoting Ford Motor Co. v. Trejo, 402 P.3d 649, 650 (Nev. 2017) (additional citations omitted)).  The reasonable expectation may be influenced by warnings that accompany a product.  Id. 

Here, the defendant had provided a warning insert to the plaintiff’s implanters.  The plaintiff did not challenge the contents of the warning, but the Court pointed out that such an argument would have failed anyway:

The warning stated, in bold and underlined font, that the device can break when the bones fail to unionize.  The warning continued, in regular font, that “If healing is delayed … the implant will eventually break due to metal fatigue.”  Additionally, the warning unambiguously cautioned:  “In the absence of solid bony union, the weight of the limb alone, muscular forces associated with moving a limb, or repeated stresses of apparent relatively small magnitude, can result in failure of the implant.”  Furthermore, the warning listed the injuries that could result under an enlarged, bold, and underlined heading: breakage of the implant, nonunion of the bone, and pain.

Id.  Although it was only material that the plaintiff’s first implanter was adequately warned, both doctors showed a strong command of these dangers.  Both testified to understanding that the device could fail from weight bearing, delayed bony union, or from normal stresses and forces.  Id. at *5.  And even though he was given a copy of the warnings, whether the plaintiff saw, read, or understood the warning was irrelevant.  Id.  Stop that.  You’ll break it.  The warning was adequate as a matter of law, and the reasonable expectation must accompany the warning.  Id.

Moreover, the plaintiff had no commercially feasible alternative, and adequate warnings negate liability absent such a showing.  Id.  The Court discounted the plaintiff’s two additional arguments, first that mere evidence of a malfunction is sufficient evidence of a defect, and also that the device was not sufficiently strong, since it should never break absent abuse.  A reasonable consumer, the Court stated, could not expect the plaintiff’s “idealized product”.  Id.  The warning alerted consumers that the device could, in fact, break.  Id.  The plaintiff was entitled to a reasonable product—not a perfect, unbreakable one.  Id.  Without evidence of a defect, all of the plaintiff’s claims necessarily failed.  Id. at *5-7.

The Court did briefly address the defendant’s product misuse argument, finding the defendant’s case “compelling.”  Id. at *5.  The defense presented Facebook pictures, medical records, and the physicians’ testimony to evidence the plaintiff’s noncompliance.  Id.  [Ed. note: see our cheat sheet on discovery of plaintiffs’ social media, here]  However, because the plaintiff contested these facts, supporting his position with an affidavit from his supervisor that he relied on a knee scooter during the time in question, the Court found there was a genuine dispute sufficient to defeat summary judgment.  Id.

With regards to the defendant’s additional arguments, neither was a sufficient basis on which to grant summary judgment, but neither was necessary, either.   The Court held that the plaintiff could rely on his treating physicians for the necessary causation testimony.  Id. at *6.  Regardless of the plaintiff’s noncompliance, his physicians do not dispute that the device failed and this caused him harm.  Id.  Someone is going to get hurt.  Finally, the Court declined to speculate as to whether Nevada would apply the learned intermediary doctrine outside of failure to warn cases, especially when the Court had another adequate basis for granting summary judgment.  Id.

The Court then briefly addressed the plaintiff’s remaining claims.  All failed for lack of defect.  Id. at *6-7.

That’s the law.  Time and time again the Blog has reported on cases holding that a broken implant alone is not sufficient to establish a defect.

My toddlers do not have reasonable expectations.  Apparently, in this case, neither did the plaintiff.  Stop that.  You’re going to break it.  Someone’s going to get hurt.

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Recently, Bexis was contacted by a reporter who had read the blog’s post on ghostwriting.  Bexis explained that people at the top of any profession – medical, legal, engineering, whatever – have more reasons opportunities to publish than they could possibly have time to write from scratch on their own.  Judges have law clerks, law firm partners have associates, law professors have students, and medical doctors have. . . .  Nobody in the same capacity (medical residents are notoriously overworked), really, but if they’re conducting studies, the sponsors of the studies, to get things done in a timely fashion, are quite happy to provide for medical publication services to get things finished.

As long as:  (1) the data are accurately portrayed, (2) the methods of analysis used are scientifically appropriate, and (3) the existence and extent of sponsor support are fully disclosed, the fact of ghostwriting is of no consequence.  It’s a way to get properly conducted studies with results of interest to the medical/scientific community completed and into print as quickly as possible.  That’s called “progress.”

Still, the reporter’s skepticism was not surprising.  The other side likes to jump up and down and scream “fraud” whenever it can, even when the science being criticized is rock solid.  Bendectin is perhaps the most thoroughly debunked mass tort in United States litigation history – it produced Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), among much else − but even there the purveyors of junk science were able to hoodwink an otherwise pretty solid justice of the Pennsylvania Supreme Court:

[B]oth the majority and the Superior Court overlook . . . the record fact that the “scientific” orthodoxy on Bendectin held up to silence the appellants’ experts was in many instances bought and paid for by [defendant] to further their litigation needs. . . .  [W]ith untold millions of dollars at its disposal, and untold millions more at stake, [defendant] was able to create and influence a scientific subdiscipline devoted to result-driven studies that [it] could then cite to defeat lawsuits.

Blum v. Merrell Dow Pharmaceuticals, Inc., 764 A.2d 1, 14 (Pa. 2000) (Castille, J., dissenting).  Fortunately, this was a lone dissent.  The real science about Bendectin was such that the FDA never found any reason to take Bendectin – then the only effective treatment for morning sickness available – off the market.  Id. at 4 n.5 (majority opinion); Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d 706, 708 (Tex. 1997) (“FDA approval of Bendectin has never been revoked”).  Only the exorbitant costs of defending scientifically baseless lawsuits like Blum did that.

But what about when the shoe is on the other foot?  Plaintiffs love to take a holier-than-thou approach to scientific research, but sometimes they purport to do their own . . . science, that is.  We took a look, and the academic misconduct we found on the other side makes any theoretical problems with practices such as ghostwriting pale by comparison.  We’ll start with the aforementioned Bendectin litigation.  It was too late to save that drug from destructive (albeit scientifically baseless) litigation, but ultimately it was revealed that the primary plaintiff’s expert was a fraud:

Moreover, by the late 1980s it was becoming increasingly obvious that Dr. McBride, who “occupied a central place in the Bendectin debate” as a frequent plaintiffs’ expert, had deliberately falsified his research so as to link the active ingredient in Bendectin to limb birth defects.  Indeed, the same year that the Supreme Court’s Daubert v. Merrill Dow decision unofficially closed out the Bendectin litigation with the introduction of judicial gate-keeping, Dr. McBride was discharged from the practice of medicine for having falsified Bendectin research.

James M. Sabovich, “Petition Without Prejudice:  Against the Fraud Exception to NoerrPennington Immunity from the Toxic Tort Perspective,” 17 Penn St. Envtl. L. Rev. 1, 30-31 (2008) (footnotes omitted).  As we’ve already discussed, the same thing happened to Andrew Wakefield, a defrocked doctor who lost his licence to practice medicine for having falsified “research” – paid for by UK plaintiff lawyers – concerning vaccines and autism.

Remember the Mirena MDL litigation?  As we discussed several times before, the plaintiffs’ causation evidence was exposed as junk science, the entire MDL was ultimately dismissed for lack of valid scientific basis, and the dismissal upheld on appeal.  One of the reasons was the dodgy nature of “science” purportedly created by one of the plaintiffs’ experts.  As pointed out by the court in In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II), 341 F. Supp.3d 213 (S.D.N.Y. 2018), “no medical organization, regulatory agency, article in peer-reviewed scientific literature, or other research has found that use of [that drug] is a cause of [the claimed injuries].”  Id. at 226.  So one of plaintiffs’ experts did his own study – while concealing his litigation ties from any and all readers:

At the time that he published the study, Dr. Etminan was serving as a retained expert for plaintiffs in the pre-MDL Mirena/IIH litigation.  The Etminan study did not disclose this relationship. The study declared in its “conflict of interest statement” that the authors did not have any conflict of interest to declare.

Id. at 229.  Predictably, it was junk science.

In 2016, the Etminan study came under attack.  [An] author of various studies relating to IIH, published, in the same journal as the Etminan study, a letter critiquing on multiple grounds the Etminan study’s methodology.  Centrally, she noted that Etminan’s disproportionality analysis − the part of his study that had pointed to an increased [disease] risk for Mirena use − had failed to adjust for age and gender, thus comparing Mirena patients (reproductive-age females) to populations like older men who almost never get [the condition at issue].  [The author] termed the Etminan study’s conclusions “erroneous and misleading.”

Id. at 230.  After some further back and forth, plaintiffs’ expert surrendered.

Later in 2016, Dr. Etminan changed course.  He repudiated much of his study’s analysis.  On December 17, 2016, after being served with a notice of a deposition in a lawsuit against [defendant] that is now part of this MDL, Dr. Etminan furnished . . . a sworn affidavit retracting many of his study’s findings.

Id. at 232.  We devoted an entire post to this contretemps at the time, and provided a copy of the affidavit later mentioned in the Mirena opinion.  The opinion quoted the the conclusion of this expert’s extended mea culpa:

Based on the above, as the lead author of this article, I acknowledge that neither of the analyses in the article provide evidence that Mirena use increases the risk for [the condition at issue].  Therefore, there is no basis to say, based on these analyses, that the risk of [this condition] with Mirena use outweighs the risk of unplanned pregnancies.

Id. at 222-23.

Don’t think for a moment that Dr. Etminan folded of his own free will.  The deposition (and other discovery) in the other lawsuit mentioned in the Mirena opinion was fiercely opposed by the plaintiffs – who lost.  “[T]here is no blanket prohibition set forth in the discovery rules against discovery directed to third-party academics, and plaintiff has not cited to any cases binding on this court stating that there is any recognized privilege of an academic or scholar to avoid discovery.”  Kellington v. Bayer Healthcare Pharmaceuticals, Inc., 2016 WL 5349801, at *2 (W.D. Va. Sept. 23, 2016).

There being no privilege or prohibition against disclosure, the discovery sought is governed by the general discovery rules, which the court concludes allow the discovery, particularly under the unique facts of this case.  Those facts include that Etminan was previously identified and deposed as an expert, but then withdrew before all of his deposition testimony could be completed.  The court also finds it significant that plaintiff’s other causation experts all rely on the Etminan Article. . . .  As such, the Etminan Article is important and central to the crucial and disputed issue of causation in the case.

Id.  The Etminan Mirena affidavit appears to have been prepared to forestall a wider deposition.  Who knows what additional facts a full deposition would have discovered?  Would it have had McBride/Wakefield-level consequences?  We’ll never know.

Indeed, Dr. Etiminan could be a repeat player at this sort of thing.  Other “research” of his recently squeezed by a Daubert challenge in In re Abilify (Aripiprazole) Products Liability Litigation, 299 F. Supp.3d 1291 (N.D. Fla. 2018), including arguments that it was “compromised by bias.”  Id. at 1325.  The “facts” were as follows:

This argument is based on the fact that Dr. Etminan contacted Plaintiffs’ counsel shortly after learning about this litigation on AboutLawsuits.com, before he developed the research protocol for the Study.  The implication, of course, is that Dr. Etminan was predisposed towards results that would support Plaintiffs’ theory of general causation in this case. . . .  According to Dr. Etminan, the conversation lasted only two minutes, during which he advised Plaintiffs’ counsel that he intended to conduct a study on Abilify, gambling, and impulse control disorders.

Id.  Thus, the Abilify study at issue appears to have been an entrepreneurial initiative – a proposal made by an expert seeking additional business, to an attorney who could (and ultimately did) provide such business.

This particular study survived because “Plaintiffs’ counsel immediately ended the conversation,” had no “further discussions about the study with Dr. Etminan until after it was published,” and “did not fund the Etminan Study.”  Id.  Thus, “[w]hile contacting Plaintiffs’ counsel may have been a strange thing to do,” the court held that, “without more, it does not invalidate” the results.  Id. at 1325-26.  As in the Mirena litigation, the court in Abilify had to force plaintiffs to allow discovery into academic bias.  “Defendants should be allowed to inquire of Dr. Etminan whether his communications with any plaintiffs’ counsel influenced the study in some way.”  In re Abilify (Aripiprazole) Products Liability Litigation, 2017 WL 2225614, at *3 (N.D. Fla. May 15, 2017).

Another doozy of a plaintiff-side expert engaging in questionable academic conduct occurred in McClellan v. I-Flow Corp., 710 F. Supp.2d 1092 (D. Or. 2010), involving allegations that certain medical devices caused shoulder injuries (called “chondrolysis”).  We ran across McClellan in preparing a recent post on differential diagnosis, but it’s even more relevant to the topic of this post.  Testimony from an expert (named Matsen) based on an “ever-changing and unfinished study” was barred due to bias and related litigation misconduct.  Id. at 1119.  The unfinished study had its genesis in an earlier study by the same expert that could not be published due to pervasive litigation bias – specifically:

The idea for the study originated with [plaintiffs’ counsel], who provided [the expert] with patient records he had obtained from [another doctor] during the course of a state court pain pump litigation.  [The expert] presented the 67-[patient] study for publication in a peer-reviewed journal, but it was repeatedly rejected because of selection and litigation bias.  Journal reviewers were concerned that [the expert] provided no information about the population from which the 67 patients were selected and that the patient data had been obtained from a law firm.

Id. (record citations omitted).  The 67-patient study was the “father” of the larger, 396-patient study that was excluded in McClellanId. at 1120.

After the 67-study was rejected for publication, [plaintiffs’ counsel] and [the expert] developed the idea for the 396-[patient] study to address the concern of selection bias.  [Counsel] offered to provide [the expert] with a more complete set of patient data and obtained patient records from . . . surgeries performed by [the same other doctor].

Id. at 1119-20.

No dice.  The court “f[ou]nd that litigation bias is ultimately what renders [the expert’s] testimony unreliable.”  Id. at 1120.  First:

[P]laintiffs retained Dr. Matsen as an expert before the 396-study’s genesis . . ., and [the expert] had no prior experience in [the surgery or the condition].  Thus, not only was [the expert] opinion developed for purposes of litigation, the study that was intended to support his opinion was designed and conducted during the course of litigation.

Id.  Second:

Plaintiffs do not dispute that [the expert] undertook his investigation in the course of litigation and his analysis has not yet been published.  That [the expert] agreed to assert a causation opinion in this and other litigation − prior to the conclusion of his study that purportedly forms the basis of his opinion − evinces a preconceived belief that is not supported by a reliable, or even identifiable, basis.

Id. at 1121 (record citation and quotation marks omitted).  Third:

[T]he circumstances under which the 396-study evolved give the court pause.  First, the idea for the 396-study originated in part with . . . counsel for plaintiffs in this and other [similar] litigation.  Second, the patient data for the study was provided by [counsel]. Third, [counsel] obtained the patient data from [the other doctor], a surgeon whose patients experienced a high incidence of [this particular injury] and who entered into settlement agreements with patients who were represented by [counsel]. . . .  Finally, [plaintiffs’ counsel] and [the expert] developed the idea for the study and compiled the data to support it after [counsel] retained Dr. Matsen as an expert witness and during the course of litigation.  These facts alone raise the disquieting specter of litigation bias.

Id. (various record citations and footnote omitted).

Once again, defense discovery into the relationship between counsel and the excluded expert was critical.  The defendant forced the disclosure of a series of damning emails (quoted at length in McClellan) that established rampant litigation bias and attorney interference:

[N]ot only did [plaintiffs’ counsel] create the idea for the 396-study, provide the raw patient data for the study, and select the nurse to perform data extraction for the study, [counsel] also compared his (or his “team’s”) findings from the data with those of [the expert] and encouraged [the expert] to do the same, identified patients who should be diagnosed with [the condition], conferred with [the expert] to “correct” diagnoses of chondrolysis, and directed [the expert] to include certain patients in the study.  Contrary to plaintiffs’ strenuous assertions, [their counsel] was more than a “mere conduit” for the delivery of raw data.

Putting to rest any doubt that these communications are not what they seem, [the expert] conceded at his deposition that he contacted [counsel] for information and in doing so disregarded protocol intended to insulate the study from ongoing litigation.

McClellan, 710 F. Supp.2d at 1123 (D. Or. 2010) (more record citations omitted).

McClellan fits the emerging pattern of plaintiff obstruction of discovery intended to unearth evidence of their experts’ litigation bias.  This expert “entitled [plaintiffs’ counsel] to access information pertinent to the 396-study, even as defense counsel was denied such information on grounds that it was ‘proprietary.’”  Id. at 1124.

[T]he e-mail communications that reflect [plaintiffs’ counsel’s] involvement were not produced by [counsel] or [the expert], even after plaintiffs were twice ordered to produce documents, including e-mail communications, relating to the subject matter of the 396-study.  Instead, [a nurse] produced the documents in response to a deposition subpoena.  Given that [counsel] eventually was advised by [the expert] “not to include [the nurse] on these e-mails,” the court is not confident the full extent of [counsel’s involvement or his communications with [the expert] have been disclosed.  In any event, I find that counsel’s withholding of e-mail communications clearly violate the court’s discovery orders. . . .

*          *          *          *

Despite clear direction from two federal judges regarding the scope of discovery, plaintiffs nonetheless withheld e-mail communications between [their counsel] and [the expert] that discuss the diagnosis of [the condition] in certain patients involved in the 396-study − communications considered [the expert] that clearly discuss, address and/or pertain to the subject matter of his opinion.

Id. at 1124-25 (quotations from various discovery orders omitted).

In view of plaintiffs’ obstruction of discovery in McClellan, the court could have “rel[ied] solely on Rule 26 to exclude Dr. Matsen’s expert testimony,” but instead did so for substantive reasons – litigation bias.  Id.

[T]he circumstances of the 396-study and its unfinished status render [the expert’s] opinion irreparably tainted by litigation bias and unreliable.  At best, [the expert] sought “clarification” from [plaintiffs’ counsel] concerning his analysis of the patient data.  At worst, [counsel] utilized [the expert] in an orchestrated attempt to design, conduct, and complete a research study for the purpose of supporting litigation in which he has a vested economic interest.  Either way, the resulting litigation bias, combined with the ever-changing and still unfinished report that is the crux of [the expert’s] opinion, render his testimony unreliable and inadmissible.

Id. (footnote omitted).

The oldest case we found discussing academic misconduct by a plaintiff’s expert in product liability/toxic tort litigation is Wade-Greaux v. Whitehall Laboratories, Inc., 874 F. Supp. 1441 (D.V.I. 1994), aff’d mem., 46 F.3d 1120 (3d Cir. 1994).  In Wade-Greaux, one plaintiff’s expert (named Gilbert), “conceived” of a rabbit study that might tie a certain drug to birth defects.  However, from there things became rather questionable:

Once the study had been completed, [the expert] prepared a manuscript that she submitted to Teratology, [a] peer-reviewed journal. . . .  Teratology rejected the manuscript and returned it with criticisms.  Thereafter, [the expert] enlisted . . . another of plaintiff’s expert witnesses, to rewrite her report of the study. . . .  [The first expert] sent [the second] two drafts of the manuscript of her study, but did not send him, and he did not see, any of the data underlying the rabbit study.  [The second expert] simply revised [the original] draft, added his own name as an author and, with [the first expert’s] approval, submitted the revised draft to a veterinary publication, Veterinary and Human Toxicology.

[The experts] did not report either in her manuscript to Teratology or in the later manuscript to Veterinary and Human Toxicology that plaintiff’s counsel contributed to the costs of the study.

Id. at 1459 (lots of record citations omitted).  In addition to concealing the plaintiffs’ financial sponsorship, the study itself (according to the court) was garbage:

  • “Plaintiff’s experts demonstrated great confusion as to the number of rabbits used in the study.
  • It was “a mere pilot study” that was “inappropriate for [the expert] or any other scientist to rely upon” for causation purposes.
  • “[N]either [expert] was familiar with the underlying data of the study.”
  • “[T]he required dose/response relationship does not exist.”
  • The study was “compromised by the fact that the protocol’s directions . . . was [sic] not followed.”
  • “[N]one of the reports of the study, especially the one rewritten by [the second expert] accurately reports the data underlying the study.”

Id. at 1459-62 (many other criticisms omitted).  Affirming, the Third Circuit “agree[d] with the district court’s conclusion and s[aw] no reason . . . to repeat what the district court exhaustively explained.”  Wade-Greaux v. Whitehall Laboratories, Inc., 1994 WL 16973481, at *1 (3d Cir. Dec. 15, 1994) (unpublished).

At the other end of the chronological spectrum, the most recent similar decision is a still ongoing saga, but (so far) looks like another doozy.  In In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2019 WL 3335967 (D. Mass. July 25, 2019), a study (see p. 19 for the expert’s “no outside involvement” conflict of interest statement) that was “a central piece of plaintiffs’ experts’ causation opinions” turned out to be extremely questionable.  Id. at *1.  Seeking to prevent discovery into the study’s provenance, “plaintiffs characterized Dr. Zambelli-Weiner as a research scientist.  They did not reveal that she was a paid consulting expert for plaintiffs.”  Id. at *2.  That effort failed, so the expert next submitted a sworn affidavit while seeking a protective order, also to thwart discovery.  Id.  This affidavit proved most unfortunate, and eventually led “counsel for Dr. Zambelli-Weiner [to] file[] an emergency motion to withdraw his appearance, notifying the Court that he had learned that ‘factual representations’ made in her affidavit were ‘inaccurate.’”  Id.  That’s what’s known as a “noisy withdrawal,” an unusual procedure that lawyers use only in extreme circumstances.

A lawyer who knows or with reason believes that her services or work product are being used or are intended to be used by a client to perpetrate a fraud must withdraw from further representation of the client, and may disaffirm documents prepared in the course of the representation that are being, or will be, used in furtherance of the fraud, even though such a “noisy” withdrawal may have the collateral effect of inferentially revealing client confidences.

ABA Formal Ethic Opinion 92-366.

According to the Zofran decision, counsel’s noisy withdrawal was justified:

As events later proved, the affidavit contained at least three false statements.  First, Dr. Zambelli-Weiner swore that she had “not been retained as an expert witness by any party in this case.”  In fact, she had been a paid consulting expert to plaintiffs since at least [date].  Second, she swore that she had “no direct factual information about the litigation.”  That, too, was false.  Her work as a consulting expert clearly was focused on this litigation. . . .  Third, she swore that none of the funds paid by the plaintiff law firms “were paid to directly fund the study”. . . .  In fact, her company was paid more than $200,000 for her work on the study.

Id. at *2.  Given these facts, the Zofran court ordered otherwise confidential “consulting expert” materials disclosed, finding “exceptional circumstance[s],” the defendant’s “‘substantial need’ for the materials,” and that “the protection of those rules has been waived by litigation misconduct.”  Id. at *5.

Plaintiffs’ counsel paid for the study, and appear to have consulted with Dr. Zambelli-Weiner during the course of the study.  It is troublesome, to say the least, for a party to engage a consulting, non-testifying expert; pay for that individual to conduct and publish a study, or otherwise affect or influence the study; engage a testifying expert who relies upon the study; and then cloak the details of the arrangement with the consulting expert in the confidentiality protections of Rule 26(b) in order to conceal it from a party opponent and the Court. . . .  Furthermore, in this case, the consulting expert made false statements to the Court as to the nature of her relationship with plaintiffs’ counsel.  The Court would not have been made aware of those falsehoods but for the fact that her attorney became aware of the issue and sought to withdraw.

Id.  Under these circumstances, “the submission of those falsehoods effectively waived whatever protections might otherwise apply.”  Id.  At minimum, the bias and concealment was fodder for cross-examination of any testifying experts relying on the study:

[P]laintiffs’ testifying experts have relied heavily on Dr. Zambelli-Weiner’s study. . . .  In order to effectively cross-examine plaintiffs’ experts . . . the documents shed additional light on the nature of the relationship between Dr. Zambelli-Weiner and plaintiffs’ counsel, and go directly to the credibility of Dr. Zambelli-Weiner and the reliability of her study results.

Id.  See also In re Bair Hugger Forced Air Warming Devices Products Liability Litigation, 2019 WL 4394812, at *10 n.13 (D. Minn. July 31, 2019) (even more recent decision noting attempt to conceal both authors’ litigation involvement; “[i]n the published study, the authors originally declared no conflicts of interest”).

Similarly, in Gerke v. Travelers Casualty Insurance Co., 289 F.R.D. 316 (D. Or. 2013), the court ordered disclosure of otherwise confidential communications between plaintiff’s counsel and an expert due to counsel’s involvement in the creation of the expert’s opinions, after legitimate discovery requests were thwarted.  Counsel had certified that no discoverable information existed without ever reviewing the expert’s file.  Id. at 320.  The expert’s testimony revealed that counsel was deeply involved in the drafting of his report:

[T]he record gives rise to the question whether Plaintiff’s counsel’s involvement in the creation of [the] expert report exceeded [permissible] limits.  First, [the expert’s] deposition testimony suggests that Plaintiff’s counsel might have authored portions of [the] final report.  [The expert] acknowledged Plaintiff’s counsel changed his preliminary report after [the expert] emailed it to him, and he could not identify the portions of his . . . final report that Plaintiff’s counsel wrote without comparing the final report to his . . . preliminary report.  Although [the expert] testified the final report’s conclusions and opinions were his, that statement does not create a barrier to further inquiry.

Id. at 328.  Relying on McClellan (discussed above), the court ordered production.  “McClellan makes clear that the expert’s adoption or ratification of a lawyer’s changes and additions . . .  does not preclude opposing counsel from learning how the lawyer’s contributions affected the expert’s final opinions.”  Id.

[A]dditional disclosure is consistent with the privilege exceptions specified in Rule 26(b)(4)(C).  [The expert’s] testimony suggests his final report contains facts, data, and assumptions provided by Plaintiff’s counsel.  If [the expert] adopted that information as his own opinion and included it in his final report, . . . the facts, data, and assumptions provided by Plaintiff’s counsel might well have become [the expert’s] opinion or have formed part of it.

Id. at 328-29.

In Nelson v. Tennessee Gas Pipeline Co., 1998 WL 1297690 (W.D. Tenn. Aug. 31, 1998), aff’d, 243 F.3d 244 (6th Cir. 2001), the plaintiffs’ expert (named Kilburn) published the first ever study purporting to link the chemical in question to the condition claimed by the plaintiffs.  Id. at *4. Every other study was contrary.  Id. at *7.  The expert’s study included “included the seven flagship plaintiffs and 91 other individuals from “the same town.”  Id. at *4.  Whether plaintiffs’ counsel was involved in recruiting the rest of the cohort isn’t discussed, however, “the fact that the study was performed in connection with litigation and funded by plaintiffs’ counsel does not militate in [the expert’s] favor.”  Id. at *8.  One would have expected such a groundbreaking result to have a high profile – but no:

[The expert’s] epidemiological study of the [town] residents has not been published or peer reviewed. . . .  [It is] particularly significant [that] the expert had developed his conclusions as a result of independent research or for purposes of litigation testimony. . . .  Where the proffered testimony did not arise from independent research, . . . the party seeking admission of the evidence [must] come forward with other objective, verifiable evidence that the testimony is based on scientifically valid principles.

Id. (citation and quotation marks omitted).

All of these cases arose in federal court, where the Daubert standard applies, and relatively broad discovery is usually available into expert testimony.  Thus, defendants in federal court at least have some opportunity to investigate and expose the kinds of lawyer-generated junk science discussed above.  Cf. Boren v. BOC Group, Inc., 895 N.E.2d 53, 61 (Ill. App. 2008) (allowing testimony by an expert who “admitted that his opinion was based in large part on information he gathered while participating in the lawyer-funded [union hall plaintiff] screenings”).  This is a major reason that defendants usually prefer to litigate in a federal forum.  Nonetheless, no post about dodgy conduct by plaintiff-side experts can be complete without some discussion of the shenanigans that went on in the Minnesota Bair Hugger litigation.  We discussed the trial court’s Frye-based exclusion of the Bair Hugger plaintiffs’ experts in detail here, so this time around we’ll simply provide you with the summary written by the affirming appellate court (which we also reviewed, here):

In 1987, Scott Augustine, an anesthesiologist and the CEO of [defendant’s predecessor], invented . . . the Bair Hugger. . . .  In 2002, Augustine was notified that he was under investigation for Medicare fraud [and] resigned. . . .

In 2003, Augustine formed [a competing company] and invented [a competing] device known as the HotDog.  In 2004, he pleaded guilty to Medicare fraud, was fined $2 million, and was prohibited from participating in federal health-care programs for five years.

During those years, he deprecated the Bair Hugger in other countries, leading the UK [regulatory agency] to reject his claim that [it] increase[d] the risk of [the condition plaintiffs sue over] and a German court to enjoin him from making false claims. . . .

In 2009, Augustine hired a law firm to promote the use of [the HotDog] and agreed to work with the law firm as a nontestifying expert for individuals who brought lawsuits against [defendant’s predecessor].  The [FDA] investigated Augustine’s claims that the Bair Hugger increased the risk of [the risk at issue] and rejected them.

In 2010, [the predecessor] was acquired by [defendant].  Augustine repeatedly and unsuccessfully attempted to induce [defendant] to purchase the HotDog system, which he claimed reduced the [relevant risk] compared to . . . the Bair Hugger.  The FDA warned Augustine that his claim lacked clinical support.

In 2013, the law firm that Augustine had hired began filing lawsuits against [defendant] claiming that the Bair Hugger was unsafe.  In 2014, Augustine funded the [a medical study], which purported to find an association between the Bair Hugger and [the risk at issue].  One of the study’s authors, a former employee of Augustine, testified that “[t]he study does not establish a causal basis” and characterized it as marketing rather than research.

In re 3M Bair Hugger Litigation, 924 N.W.2d 16, 19 (Minn. App. 2019) (footnote omitted).  So in Bair Hugger, we have the apotheosis of stupid expert tricks – a business competitor, acting as both a “consulting expert” and a litigation funder, not only financed the junk science upon which the plaintiffs’ testifying experts would base their opinions, but also hired the law firm that represented the plaintiffs.

Is Bair Hugger the Brave New World of mass torts, with litigation funders hiring would-be “experts” on a speculative basis to gin up something that passes for “research,” with the intent of using that research to create the very litigation in which they then plan to invest?  We hope not, but it’s certainly another reason that such funding can be considered suspect.

Finally, we note that in none of these cases did the proponents of questionable expert testimony suffer anything worse than additional discovery and exclusion of evidence, and possibly a discovery-related fee award (we didn’t read the cases looking for that).  Just imagine what the response would have been had a defendant expert or defense counsel engaged in such conduct.

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We write mostly about decisions in cases, with those mostly coming from judges. Occasionally, we will also comment on articles, amicus briefs, and official government pronouncements. We cannot remember the last time we explored a press release. In today’s political environment, speculation about what is contained in documents that purportedly exist but we cannot see can be time-consuming and often pointless endeavor. We will try to be brief and pointed in our discussion about an FTC press release that addresses something that can keep us busy and keep our clients up at night: plaintiff lawyer advertising. The other day, the FTC announced that it had sent out “letters to seven legal practitioners and lead generators expressing concerns that some television advertisements that solicit clients for personal injury lawsuits against drug manufacturers may be deceptive or unfair under the FTC Act,” but it was not making the letters public or saying to whom they were sent. Beyond how “lead generators” was just thrown out there like a legitimate business, why does this matter?

The short answer is that this might be another step towards curtailing some of the problematic behavior, at least from the defense perspective, that drives serial product liability and mass tort litigation. After railing for some time about practices by the plaintiff lawyers and their fellow travelers in terms of contingency fees and litigation funding, we have seen federal indictments of various players in these scheme and court rulings undercutting them (like here  and here). It has been an open secret for years that the spending on legal advertising is also often funded by third-parties and part of a “Field of Dreams” like model of “if you build (the advertising campaign), they will come (to give you enough plaintiffs to make it worth your while).” If you start with the assumption that the plaintiff lawyers, “lead generators,” and funders all want to make money, then legal advertising can add pressure in multiple ways. In addition to gathering up potential clients, including those will different injuries or products over which to sue, the ads can impact the perception of potential jurors, judges, investors, patients, prescribers, etc., on the product(s) at issue. In this sense, misleading ads can be highly effective ads. The historical problems with trying to get rid of misleading lawyer ads—even without the recent expansion into things like digital advertising, paying to alter search results, and creative ways to avoid gag orders through local pre-trial advertising—are that lawyer advertising has been the province of state law and state bars and that the First Amendment protection of commercial speech—so hotly debated over the years in the context of off-label promotion of prescription drugs, for instance—does apply to lawyer advertising. The ABA presents a good discussion of these subjects here and here.

As the advertising spend has increased, the methods have gotten more sophisticated, and the stakes have gotten higher, it does seem that the advertising has gotten more aggressive both in tone and in tendency to stray from the truth. This is not just our assessment. We previously posted on a law professor’s article that systematically analyzed the ads encouraging people to sue over drugs. The ads were not only misleading, but they influenced some patients to disregard the medical advice they had received. (We recall almost losing it when someone we know, otherwise fairly sensible, advised that he planned to discontinue a prescription medication for a chronic medical condition based on a lawyer ad’s statement about a particular study. The study, which only purported to show a very small absolute risk of a disease that occurs anyway, had already been debunked by the time we had this discussion.) This is actually a pretty scary concept. It is one thing to encourage someone to sue over a complication experienced with a drug in the past (that had not made that someone sue before); it is another thing to make some stop taking a drug that their doctor recommended and was doing what it was supposed to without any problems. And this seems to be what caught FTC’s attention.

The press release notes:

The letters state that some lawsuit ads may misrepresent the risks associated with certain pharmaceuticals and could leave consumers with the false impression that their physician-prescribed medication has been recalled. According to the letters, some of the lawsuit ads may make deceptive or unsubstantiated claims about the risks of taking blood thinners and drugs for diabetes, acid reflux, and high blood pressure, among other conditions. The letters explain that advertisers must have competent and reliable scientific evidence to substantiate their claims about these purported risks.

The letters note that the FDA’s Adverse Event Reporting System contains reports of consumers who saw lawsuit ads about the prescription drugs they were taking, discontinued those medications, and suffered adverse consequences as a result. The letters say that lawsuit ads that cause, or are likely to cause, viewers to discontinue their medications might constitute an unfair act or practice. To prevent consumer injury, the letters suggest that lawsuit ads may need to include clear and prominent audio and visual disclosures stating that consumers should not stop taking their medications without first consulting their doctors.

The suggested disclaimer on consulting with physicians before discontinuing medication would be something we have never seen in these lawyer ads. Including such a disclaimer would undercut the shock value of the ad. Similarly, the press release states:

The letters also highlight lawsuit ads that open with sensational warnings or alerts, which may initially mislead consumers into thinking they are watching a government-sanctioned medical alert or public service announcement. The letters remind the recipients that advertisements promoting goods or services should be identifiable as advertising from the beginning.

Again, making it clear that the ad comes from someone who wants to make money suing and not from the government or a neutral party would limit the impact on the same part of the brain targeted by the plaintiff lawyers at trial.

While the press release says the recipients of the letters were advised to make sure “their advertising is not unfair or deceptive” or there may “follow-up action as warranted” in the future, there is not much indication as to whether this will be an area for broad enforcement going forward. The FTC’s website does, however, include two contemporaneous blogs to aid either “consumers” or “businesses.” The consumer one emphasizes the concern about patients changing their own care without consulting doctors and offers even stronger language about the plaintiff lawyer ads than the press release:

You see the ads on TV, hear them on the radio, or read them in print and online: attorneys telling you about the dangers of certain prescription drugs. Many of these ads open with “medical alert,” “health alert” or “consumer alert” to get your attention. The ads generally say that if you or a loved one has been injured by a certain prescription medication, you may be entitled to compensation, and to contact the law firm for more information.

The FTC, the nation’s consumer protection agency, says that if you’re thinking about stopping your prescription medications for any reason, talk with your doctor first.

Some attorney ads may overstate the risks of the drugs they talk about. But even when they don’t, the benefits of the drugs at issue may outweigh the risks. In fact, the FTC is aware of reports of serious and tragic consequences — including death — that happened when people stopped taking their medications without first talking with their health care professionals.

Just because a lawyer talks about the dangers of a drug doesn’t mean you should stop taking it. In fact, it might be more dangerous if you stop taking it. Check with your doctor before you stop taking any prescription medication.

Included is a link to a more general FDA recommendation that patients take the drugs they are prescribed.

The blog for businesses may be for the ones doing the advertising to tell them how to avoid breaking the law or it may be for the ones whose products are being discussed to determine when a lawyer ad may go too far. This part stands out to us:

Ads should be clear from the start that they’re ads. Some of the ads in question begin with wording and graphics that could leave consumers with the misimpression that they’re watching a public service alert or an FDA safety warning. FTC cases clearly establish that ads and promotional messages should be identifiable as advertising from the very beginning. The FTC’s Enforcement Policy Statement on Deceptively Formatted Advertisements offers practical guidance on keeping ad formats non-deceptive. And if you refer in your ads to actions taken by government health agencies, make sure what you convey to consumers expressly or by implication is accurate.

Be careful about the impact of scare tactics. It’s a fact-specific analysis, but an ad that highlights a medicine’s risk and leads consumers to discontinue their medication could constitute an unfair act or practice. The wiser course of action is to clearly disclose that people shouldn’t stop taking medicines until they’ve talked it over with their doctor. Some of the ads in question included that information in fine-print footnotes – a no-go under FTC law. Given the significant risks of discontinuing prescription drugs without medical consultation, a disclosure to that effect should be easy to spot, should use simple unambiguous language, and should be made both audibly and visually.

Health claims must be backed by sound science. Even if you’re not advertising a health product, the bedrock advertising principle that health-related claims must be supported by sound science remains unchanged. This means that any claims about the risks or dangers of a drug or device must be supported by competent and reliable scientific evidence.

Lawyer ads about drugs and devices without scare tactics and “sound science” to back up “health-related claims” would have to look pretty different than most of the stuff in current rotation on TV. The referenced FTC Enforcement Policy has many of the principles already discussed here, but we will highlight two more that seem to apply to the internet advertising in particular. First, ads should not masquerade as actual news. Those ads are out there, offered up under the names of sponsors and authors that might easily pass for legitimate without some digging. Second, it needs to be “fully disclosed. . . . clearly and conspicuously” when what appear to be “user-generated social media, personal blogs, online comment forums, or television talk show interviews” are actually paid advertisements. Among other things, there are many online “victim forums” that seem to be used to route potential drug and device plaintiffs to lawyers.

While it remains to be seen where FTC enforcement will go—and how the plaintiff lawyers and “lead generators” will adapt—it does seem that shedding some light on these practices might be a step toward making litigation be more about testing the merits than testing the defendant’s capacity for withstanding pressure.

 

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One of the more peculiar things about Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019) (“Albrecht”), is the almost off-hand way that the majority (made up mostly of justices that have opposed preemption in closer cases) wandered away from the procedural preemption issues that the Court was actually deciding (whether the jury has any role in preemption decisions and whether a “clear and convincing” evidence standard applied), to redefine what had been known (after Wyeth v. Levine, 555 U.S. 555 (2009) (“Levine”)) as the “clear evidence” standard.  They did so even after expressly cautioning up front that “The question of disapproval ‘method’ is not now before us.”  Albrecht, 139 S. Ct. at 1679.  So we now have this:

[I]n [Levine], we confronted that question in the context of a particular set of circumstances. . . .  In a case like [Levine], showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.

Id. at 1687 (to avoid confusion, the Blog’s naming conventions use plaintiff names for important cases when the defendant’s name is common; the Supreme Court uses whichever is first in the caption).  At the same time, the Court also described the relevant test much more simply − whether “the relevant federal and state laws ‘irreconcilably conflic[t].’”  Id. at 1679

There are quite a few issues with Albrecht’s longer “definition” – if that’s what it is.  First, in light of the Court’s reminder about Levine’s “particular set of circumstances,” what is a case “like” Levine?  Plaintiffs trying to say that every fact pattern is “like” Levine have failed in the early going.  As previously mentioned, the Tenth Circuit in Cerveny v. Aventis, Inc., ___ F. Appx. ___, 2019 WL 3763441 (10th Cir. Aug. 9, 2019), rejected the plaintiffs’ argument that only a “manufacturer’s” actions could be considered under this definition with the retort that a case involving a third-party citizen petition inducing FDA action was not “like” Levine.

[Plaintiffs] contend that Albrecht “dictates that only labeling changes sought by the manufacturer can lead to preemption  . . .  But we note that Albrecht prefaced its requirement that “[the drug manufacturer] fully informed the FDA . . .” as applying “[i]n a case like [Levine], and noted that “in [Levine, [the Court] confronted [preemption] in the context of a particular set of circumstances.”  And here, [plaintiffs’] case involves a particular set of circumstances with a key difference. . . .  Here, [defendant] argues a different ground . . . − the FDA’s unequivocally having rejected [a] citizen petition advocating for the warning that [plaintiffs]now assert.  We see nothing in [Levine] or excluding [defendant] from justifying preemption on this basis.

Id. at *3 n.9 (citations omitted).

A second court, in North Dakota, recently rejected similar plaintiff-side arguments as “nonsensical” for similar reasons:[Plaintiff’s]

[Plaintiff] argues that, under [Albrecht], the FDA’s decision not to change a medication’s labeling triggers [Levine] preemption only if the manufacturer itself proposed the change. . . .  This Court does not read [Albrecht] so narrowly.  [Plaintiff’s] argument ignores [Albrecht’s] explicit warning that “[t]he question of disapproval ‘method’ is not now before us.”  . . .  [Albrecht] did not involve agency “actions” or “methods” similar to this case. . . .  [Albrecht] certainly did not decide whether other agency actions, such as the denial of a Citizen Petition, would be sufficient. . . .  Where the FDA has already rejected a proposed label or warning change, as it did in this case, there is no reason why the “impossibility” of a subsequent change would depend on whether the earlier change was proposed by the manufacturer as opposed to a third party or the FDA itself.  Regardless of who submitted the proposed warning or labeling change, the FDA has already decided that the relevant evidence and policies do not meet the standard to justify a change.

State v. Purdue Pharma L.P., 2019 WL 3776653, at *2-3 (N.D. Dist. July 22, 2019).

Another issue (among several) stemming from Albrecht’s definitional dictum, as to which no subsequent precedent yet exists, is what does it mean for “the drug manufacturer to show that it fully informed the FDA of the justifications” for not using the warning that the plaintiff now wants.  The rest of this post is devoted to that question.

In light of the Albrecht Court’s longer definition – as opposed to its basic “irreconcilable conflict” statement – we expect plaintiffs to make arguments that squarely implicate the Court’s prior decision in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Buckman employed conflict preemption to bar agency fraud claims against FDA-regulated products, largely for institutional reasons:  (1) the FDCA explicitly prohibits private parties from enforcing the FDCA, id. at 349 n.4; (2) states have not “traditionally” been in the business of “policing” the adequacy of regulated entities’ submissions to the FDCA, id. at 347; and (3) FDA is “empowered to require additional necessary information,” id. at 349; and (4) state-law second-guessing the sufficiency of submissions to the FDA:

would also cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.  Applicants would then have an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA’s evaluation of an application.

Id. at 351.

Allegations based on “counterfactual” claims involving what the FDA might have done with different, supposedly better, information have always (except for the Third Circuit decision reversed in Albrecht) been recognized as preempted:

Effectively, actions for fraud on the FDA would allow individual juries to undertake a counterfactual FDA review, and conclude that the FDA would not have approved the [product].  However, Congress allocated the FDA responsibility to design and manage a process which would result in approval of the safest and most effective medical devices possible.  Congress also assigned the FDA the responsibility to approve or disapprove of applications to market medical devices.  Furthermore, we agree that permitting the “searching inquiry” of FDA internal procedures and personnel runs counter to both congressional intent and sound policy.  Hence, we hold that to allow common-law suits for fraud on the FDA to go forward would permit juries to reach a different conclusion than the FDA did in approving the device in question, thereby imposing a different requirement than that required by the federal requirements.

Kemp v. Medtronic, Inc., 231 F.3d 216, 235-36 (6th Cir. 2000) (pre-Buckman decision reaching same result).  See Lefaivre v. KV Pharmaceutical Co., 636 F.3d 935, 943 (8th Cir. 2011) (claims that “depend upon speculation as to the FDA’s behavior in a counterfactual situation” “second-guess[] the FDA’s decisionmaking [and] overburden[] its personnel”) (quoting Buckman, 531 U.S. at 354 (concurring opinion)).  There is “no support for the theory that it is appropriate for a court . . . to determine preemptively how a federal administrative agency will interpret and enforce its own regulations.”  Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990).

“Allowing juries to perform their own risk-utility analysis and second-guess the [agency’s] conclusion would disrupt the expert balancing underlying the federal scheme.”  Farina v. Nokia Inc., 625 F.3d 97, 126 (3d Cir. 2010) (applying Buckman outside FDCA context).  As a result, Buckman in particular, and the FDCA scheme in general, have almost universally been held to preclude state-law plaintiffs from looking behind FDA actions and making claims that the FDA’s basis for acting was, for one reason or another, insufficient.  Surprisingly, neither the majority nor any of the concurring opinions in Albrecht even mention Buckman – another sign that Albrecht’s dictum was not well thought out.

For example, in Riley v. Cordis Corp., 625 F. Supp.2d 769 (D. Minn. 2009), the plaintiff contended that “preemption only applies when the FDA has regulated a device with full knowledge of that device’s safety and efficacy.”  Id. at 779.  After pointing out that not a word in the Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), express preemption case supported such a contention, the court held that preemption does not “turn[] on the nature or extent of the information made available to the FDA at the time it approved a device,” and relied on Buckman:

[Plaintiff’s] argument that his claims are not preempted because the FDA was fraudulently deprived of the knowledge it needed to make an informed decision about the [product] is just a thinly veiled way of claiming that the FDA would not have approved the [product] in the absence of fraud − a claim that is squarely foreclosed by Buckman.

Id. (citation omitted).  See In re Baycol Products Litigation, 532 F. Supp.2d 1029, 1053 (D. Minn. 2007) (evidence “offered only to show that the FDA was misled, or that information was intentionally concealed from the FDA . . . must be excluded” under Buckman).

A prescription drug plaintiff’s claim that “if [defendant] had funded or conducted studies that generated subsequently published data, those studies would have generated the same data sooner,” and the FDA would not have rejected the warning they sought, was dismissed as both “speculative” and preempted in Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749 (S.D. Ohio 2015), aff’d, 680 F. Appx. 369 (6th Cir. 2017).

Plaintiffs support their position with proffered expert testimony of four experts who have reviewed and opined on allegedly misleading information in Abbott’s [various] . . . correspondences with the FDA.  Plaintiffs’ argument . . . appears to be a fraud-on-the-FDA theory, which is preempted. . . .  Regardless, an expert’s opinion that the FDA would have reacted differently if the submissions to the FDA . . . had been supported by different evidence is speculative. . . .  Testimony about what [defendant] could have and should have researched or stated to the FDA in its applications is speculative, and does not serve as the basis for a genuine issue of material fact.  Thus . . ., the Court finds that Plaintiffs’ fraud-on-the-FDA theory is either preempted or based on speculation.

Id. at 767-68 (citations omitted).

On appeal, the Sixth Circuit determined that “[t]he district court’s preemption analysis was correct.”  Rheinfrank v. Abbott Laboratories, Inc., 680 F. Appx. 369, 371 (6th Cir. 2017).

[Plaintiff] nevertheless contends that, even if the FDA signaled that it would not have approved a stronger . . . warning on [the product’s] label, a finding of “clear evidence” would still be precluded, either because [defendant] misrepresented the state of the evidence to the FDA in its communications about its proposed labeling changes, or because there was evidence about [the product’s] effects . . . that [defendant] should have known but failed to obtain.  Each of these arguments, however, is unavailing.  First, even if the evidence that [defendant] submitted was as misleading or incomplete . . ., the evidence in the record establishes that the FDA undertook its own review of the relevant empirical literature. . . .  Thus, whatever may have been [defendant’s] omissions or misrepresentations in its communications with the agency, the FDA clearly explained that, in its own view of the data, the . . .  warning . . . was not yet warranted. . . .  [F]urther . . . refus[al] to fund or conduct studies . . . is too conjectural to defeat preemption. . . .  [Plaintiff] asks this court to accept[] a series of speculations as to what the FDA could have done with different evidence that [defendant] might have collected if it had run its own studies.

Id. at 387-88 (citations omitted).  See Willis v. Abbott Laboratories, 2017 WL 5988215, at *8 (W.D. Ky. Dec. 1, 2017) (following Rheinfrank; “any speculation as to what the FDA may have done had [defendant] performed certain testing remains just that: speculation.  Therefore, the Court rejects this argument.”); In re Depakote, 87 F. Supp.3d 916, 922 (S.D. Ill. 2015) (claim that defendant “deliberately omitted” information from FDA submissions was “unavailing” to prevent preemption).

Rheinfrank relied on In re Fosamax (Alendronate Sodium) Products Liability Litigation, 2014 WL 1266994 (D.N.J. March 26, 2014), which just happens to be the same decision reversed by the Third Circuit decision that was in turn unanimously overturned by the Supreme Court in Albrecht.  While Buckman issues fell out of the Fosamax litigation by the time it reached the Supreme Court (because the plaintiffs did not appeal that issue), their claim attacking the sufficiency of the defendant’s FDA submissions about the warning in question was held preempted:

[W]hile Plaintiffs were able to find an expert to agree with their contention that [defendant] should have acted differently . . ., they did not set forth any evidence which suggests that the FDA thought the same. . . .  Moreover, to the extent that Plaintiffs claim that [defendant] withheld information from the FDA and clear evidence does not exist as to whether the FDA, if fully informed, would have rejected a stronger label, this does not defeat Defendant’s showing that it is entitled to judgment . . . on preemption grounds. . . .  Plaintiffs’ contention appears to be a fraud-on-the-FDA theory which was rejected by the Supreme Court in Buckman.

Id. at *16-17, vacated, 852 F.3d 268 (3d Cir. 2017), reversed, 139 S. Ct. 1668 (2019).  See Id. at *9 (“what [defendant] could have or should have done is immaterial because we know what [it] did”).

In Perez v. Nidek Co., 657 F. Supp.2d 1156 (S.D. Cal. 2009), the plaintiffs attacked the off-label use of certain devices as “adulteration.”  The court held such claims preempted because they “require the Court to make determinations regarding” the product that “should be decided by the FDA in the first instance.”  Id. at 1166.  The Ninth Circuit affirmed because such claims “conflict[ed] with the FDCA’s enforcement scheme.”  Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013).  “Although citizens may petition the FDA to take administrative action . . ., private enforcement of the statute is barred.”  Id.

The FDA knew about the allegations that the [product] was being used for unapproved . . .  use and took steps to address the allegations . . ., but it did not take final action against the defendants . . . .  All of these matters rest within the enforcement authority of the FDA, not this Court.

Id. at 1120 (quoting, in part, district court decision).

Also, in In re Trasylol Products Liability Litigation, 763 F. Supp.2d 1312 (S.D. Fla. 2010), the court applied Buckman to the plaintiffs’ allegations about the sufficiency of the information provided to the FDA in connection with a prescription drug:

The concerns expressed by the Supreme Court in Buckman hold true not only where there is a separate fraud-on-the-FDA claim but also where a plaintiff seeks to prove fraud on the FDA in order to bring a traditional state-law torts suit.  If the Court were to find fraud-on-the-FDA when the FDA itself has not made such a finding, the Court would be intruding upon the FDA’s right to police itself and second-guessing what the FDA would have done had it received the information that was allegedly withheld from it by the defendant-company.

Id. at 1325.

Claims are preempted under Buckman whenever they “requires a fact finder to make a determination under state law that federal law leaves exclusively to the FDA.”  Zimmerman v. Novartis Pharmaceuticals Corp., 889 F. Supp. 2d 757, 777 (D. Md. 2012).

Allowing state fact finders to second-guess the very decisions that federal law leaves entirely to the agency presents the same inter-branch-meddling concerns that animated Buckman.  As in Buckman, allowing punitive damages liability here would require applicants to submit a “deluge” of unnecessary information during the approval process, which in turn, delays the approval of new drugs.

Id.

This issue has also arisen repeatedly in medical device cases enforcing the “narrow gap” between express preemption under Riegel and implied preemption under Buckman.  Plaintiffs may not mount “attacks on the risk/benefit analysis that led the FDA to approve” a product.  In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1206 (8th Cir. 2010).  Claims that “depend on speculation that the FDA would have taken any particular regulatory action in response to violation of the regulations at issue, as in Buckman” are preempted.  Hughes v. Boston Scientific Corp., 631 F.3d 762, 775 (5th Cir. 2011).  It is “impermissibl[e to] allow the jury to question the FDA’s decision to approve the device for the market.”  Id. at 776 n.12.  “A challenge to the integrity of FDA’s premarket approval of the Product, however, is itself preempted under Buckman.”  McNeil-Williams v. DePuy Orthopaedics, Inc., 384 F. Supp.3d 570, 578 (E.D.N.C. 2019).  “[A] valid parallel claim cannot challenge the process itself or the requirements imposed by the FDA pursuant to that process.”  Raab v. Smith & Nephew, Inc., 150 F. Supp.3d 671, 687 (S.D.W. Va. 2015).

The thrust of [plaintiffs’] argument is that the FDA could not have granted premarket approval to the [product] because it did not have sufficient data to do so.  However, the sufficiency of the data submitted to the FDA . . . does not govern the scope of the [FDA’s] approval.  Whether a product is FDA-approved is determined by the language in the approval letter, not by the application documents submitted to it for review.  The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval.

Duggan v. Medtronic, Inc., 840 F. Supp.2d 466, 471-72 (D. Mass. 2012) (citing Buckman; other citations omitted).

Plaintiff’s claim of “fraudulent concealment” depends on speculation that the FDA would have taken [a] particular regulatory action in response to violation of the regulations at issue, as in Buckman.  Indeed, Plaintiff argues that “had the FDA classified [defendant’s] recall as Class 1, it would have likely imposed more stringent notice requirements, and expanded the class of recipients of the notice.” . . . Under Buckman, such a claim is preempted.

Bush v. Thoratec Corp., 837 F. Supp.2d 603, 608–09 (E.D. La. 2011) (citation and quotation marks omitted).  See Reed v. St. Jude Medical, 2018 WL 4293146, at *4 (Mag. D. Minn. July 24, 2018) (“foreclos[ing] Plaintiffs’ arguments . . . that the FDA did not adequately study [certain subgroups] as part of the PMA”), adopted, 2018 WL 4251872 (D. Minn. Sept. 6, 2018); Rand v. Smith & Nephew, Inc., 2017 WL 8229320, at *4 (C.D. Cal. April 5, 2017) (plaintiff may not challenge the adequacy of [defendant’s] effort in proving [the product’s] . . . included in the [approval] application”); Gross v. Stryker Corp., 858 F. Supp.2d 466, 487 (W.D. Pa. 2012) (“[t]he application submitted to the FDA does not facilitate this Court’s determination of what the FDA actually approved”); Lewkut v. Stryker Corp., 724 F. Supp.2d 648, 655 (S.D. Tex. 2010) (“What was submitted in the FDA application has little bearing on this Court’s assessment of what was ultimately approved.”); Webster v. Pacesetter, Inc., 259 F. Supp. 2d 27, 37 (D.D.C. 2003) (“what was told to the FDA cannot support a tort claim, and more importantly, plaintiffs’ approach would be nothing more than an invitation for the jury to speculate about what . . . the FDA . . . might do if the facts were different”); Bagumyan v. Medtronic, Inc., 2010 WL 4009891, at *11 (Cal. App. Oct. 14, 2010) (unpublished) (“There is no authority for the proposition that a court may reexamine the [approval] process to evaluate whether the FDA expressly considered the particular feature of the device that is claimed to be defective.”).

Thus Buckman bars state-law plaintiffs from any “collateral attack on the validity of [a federal agency’s] decision” because “whether federal regulatory bodies fulfilled their duties with respect to the entities they regulate is ‘inherently federal in character.’”  Bader Farms, Inc. v. Monsanto Co., 2017 WL 633815, at *3 (E.D. Mo. Feb. 16, 2017) (quoting Buckman).  Could the Supreme Court sweep all of this precedent away?  As a matter of raw power, probably (although Congress might react).  But as a matter of jurisprudence, we think that if the Court intended to effect a legal change of that magnitude, such change would be supported by a lot more legal and policy consideration than occurred in Albrecht.  The Supreme Court, no more than Congress, cannot be viewed as “hid[ing] elephants in mouseholes” – particularly when preemption is involved.  Puerto Rico v. Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1947 (2016).

So what do we think Albrecht meant by its reformulation of Levine’s “clear evidence” basis for preemption?  Well, particularly in light of what the Court actually held in Albrecht – that preemption is a legal matter to be decided by courts, not juries, including any ancillary factual issues that may arise, 139 S. Ct. at 1680  − we think that it is incumbent upon a defendant asserting that a particular common-law claim runs afoul of the FDA’s regulatory position concerning the product at issue to create a record showing that the FDA had sufficient information before it to come to that position under the relevant standards set by the FDCA.  The Court was legitimately concerned that defendants might have done the administrative equivalent of “tanking” requests for additional warnings.

Then, on the record created by the defendant, the trial court “simply” answers the preemption question, id. at 1679 − concluding yes or no based on that record.  Should a party, or the court, wish to go beyond this determination, it can ask the FDA itself, either through a citizen petition (which produces a “formal” agency decision of the sort Albrecht requires, id., see 21 U.S.C. §355(q)(1)(F); 21 C.F.R. §10.30(i)), or by inviting the FDA to present its views via an amicus curiae brief.  See Kisor v. Wilkie, 139 S. Ct. 2400, 2418 n.6 (2019) (an agency appearing as amicus is “not a party to the litigation, so “there [is] simply no reason to suspect that the interpretation [does] not reflect the agency’s fair and considered judgment”); 21 C.F.R. §10.30 (setting out formal procedures for resolution of citizen petitions, including Federal Register publication).

What we don’t think Albrecht means that plaintiffs can oppose preemption with arguments that the defendant should have done this, that, or the other thing differently in its submissions to the FDA.  That kind of second-guessing the bases for FDA decisions runs headlong into the policies that the Court enunciated in Buckman.  State common-law tort litigation is not, and should not be allowed to become, a basis for collateral attack on preemptive federal decision-making with lesser proof than applicable to legitimate administrative challenges (such as the “arbitrary and capricious” standard) under the Administrative Procedures Act.  Albrecht’s emphasis on agency action “within the scope of its congressionally delegated authority” demands no less.  139 S. Ct. at 1679.

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This post is from the Reed Smith side of the blog only.

Yesterday was National Punctuation Day; it is a good time to administer a semi-colonic to turgid prose. Today we apply an exclamation mark to our unhappiness with judges whose choice of law principles seem not so, er, principled.

Last Thursday, Bexis commented on the New Hampshire federal judge in the Atrium litigation who invariably applies New Hampshire law no matter what. We offer a few more words on In Barron v. Atrium Med. Corp., 2019 U.S. Dist. LEXIS 151042 (D. N.H. Sept. 5, 2019), in which the plaintiffs sued three related companies under various product liability and warranty theories, alleging injuries from implanted hernia mesh. The surgical procedure took place in Pennsylvania. The first named defendant, Atrium, was located in New Hampshire, where the lawsuit was pending, while the other two defendants were in New Jersey and Sweden.

The defendants filed motions to dismiss the complaint. The defendants argued that Pennsylvania law governed the claims, and that those claims flunked Pennsylvania law. The plaintiffs responded that it was too soon to decide choice of law, but that if a choice had to be made at this point, then New Hampshire law should prevail.

(A question mark popped up in a thought bubble over our head when we saw a defendant plump for product liability law. Can New Hampshire law really be that bad? And then we remembered that the Bartlett case came out of New Hampshire.)

In any case, this much is clear: New Hampshire choice of law principles govern. As with many states, the first question is whether an actual conflict exists. If there is no conflict, why burn up calories worrying over choice of law? Here, there is a very real conflict on the strict liability claim, because Pennsylvania does not smile upon strict liability design defect claims against medical devices, whereas New Hampshire apparently says Live Free and Sue. The other claims are treated similarly in the Keystone and Granite states, so the New Hampshire federal judge would apply New Hampshire law to them. So far so good. But now the New Hampshire federal judge needed to decide whether to apply New Hampshire or Pennsylvania law to the strict liability claim. Do you follow us so far? Do you have a suspicion where this is going?

New Hampshire employs a five factor test for choice of law:

1. predictability of results;
2. maintenance of reasonable orderliness and and good relationship among the states in our federal system;
3. simplification of the judicial task;
4. advancement by the court of its own state’s governmental interests rather than those of other states; and
5. The court’s preference for what it regards as the sounder rule of law.

Whenever we see a multi-part test, we prepare ourselves for an outcome-driven exercise in rationalization. Here we go. The Barron court concluded that the first three factors “have little or no relevance in this case.” Hmmm. We are skeptical. The court admits that it is more familiar with New Hampshire law, but says it could just as easily apply Pennsylvania law. Sure. But it won’t. By the way, don’t the second and fourth factors seem at least slightly in conflict? And if the court is the tiniest bit pro-plaintiff or anti-dismissal, don’t the fourth and fifth factors potentially swallow up everything else and make inevitable a preference for a local pro-plaintiff rule every time?

That is what happened here. In contrast to Pennsylvania’s nuanced approach to strict liability claims versus medical devices, the Barron judge tells us that New Hampshire believes that “if today’s products are capable of causing illness or physical injury, the risk of liability is best borne by the companies that profited from their sale, rather than by the unfortunate individual consumers.” To our graying noggin, this formulation sounds less like New Hampshire in 2019 and more like California (courtesy of Justice Traynor) in the 1950s. We would have thought that New Hampshire, home of flinty New Englanders steeped in self-reliance, might not so whole-heartedly embrace the notion of wealth redistribution and social insurance. Silly us.

The New Hampshire federal judge ends up deciding – surprise! – that New Hampshire product liability law is better (i.e., more anti-corporate) than Pennsylvania law and, therefore, New Hampshire law carries the day. The court denied the defendants’ motion to dismiss.

A New Hampshire federal judge preferred New Hampshire law. In the words of one-time New Hampshire resident Robert Frost, “and that has made all the difference.”

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As we mentioned several weeks ago, several of your Reed Smith bloggers are making plans to be in New York on December 10-11 to attend ACI’s annual Drug and Medical Device Litigation conference. We’re looking forward to great content and numerous networking opportunities – and maybe even the chance to catch up with some of our loyal readers.

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

  • If you’ve been meaning to register for the event, this would be a great week to do so, as prices increase after Friday.
  • 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 D10-710-710DX01 when you register. You’ll save 10 percent.

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