California and Idaho share some similarities, but also many differences.  Both are sprawling Western states.  Both are year-round meccas for outdoor activities of all types, whether it be hiking, skiing, rafting, mountain biking, or just gazing idly at some of the most stunning scenery you will ever hope to see.  Both California and Idaho have areas in their far northern reaches that are sparsely populated and where some people go just to be left alone.  Idaho is one of the largest producers of potatoes; California is one of the largest producers of tomatoes.  (As the old song goes, let’s call the whole thing off.)

But oh, the differences.  Idaho is landlocked, while California has endless miles of beautiful coastline.  California’s population dwarfs Idaho’s—its largest city (Boise) would barely break the Golden State’s top fifteen.  Idaho’s state slogan Esto perpetua (which means “let it go on forever”) denotes a certain slow and steady mood, while California’s “Eureka!” is unmistakably sudden, even manic.  And let’s not forget politics—California reigns blue, and Idaho is currently the farthest western outpost for those who go red.

There are significant legal differences too, and we at the DDL Blog give Idaho props for breaking the right way on one of our favorite issues—innovator liability.  Presented with facts very similar to the California Supreme Court’s wrongly decided opinion in T.H. v. Novartis, a trial court in Idaho declined to hold an innovator drug manufacturer to answer for injuries allegedly caused by a generic version of a drug that the innovator no longer made or sold.

Here is what happened.  The innovator defendant in Stirling v. Novartis Pharmaceuticals Corp., No. CV01-18-4880 (Idaho Dist. Ct. Sept. 25, 2019), owned the New Drug Application for an asthma drug called Brethine until December 2001, when it sold the NDA to another manufacturer.  Slip op. at 2.  A pregnant woman was later given a generic version of the drug to treat premature labor contractions, allegedly resulting in harm to her child.  Id. at 2-3.  In her lawsuit claiming damages, the mother sued the innovator drug manufacturer, even though the manufacturer had sold its rights to the drug years before she used it and even though the mother neither claimed nor alleged that she used the innovator’s product.  Id. at 2.  The reason, of course, is that federal law preempted tort claims against the generic manufacturer, assuming that it could  be identified.

Does this sound familiar?  It should, because this is what happened in T.H. v. Novartis—a plaintiff suing an innovator manufacturer over the same product, which the plaintiff did not use and which the innovator had neither owned nor sold for a very long time.  Yet, the outcome in Stirling was both different and correct.  The Idaho court dismissed the complaint.  The plaintiffs admitted that Idaho had not recognized innovator liability, but argued that “the theory is consistent with Idaho law, does not impose a burden upon brand-name manufacturers and promotes critical public policies.”  Id. at 6.

The court disagreed, and it framed the issue as one of duty, i.e., “does Idaho law require the manufacturer of a product, in this case a drug, to warn the consumer of a similar product manufactured by another.”  This is exactly the correct question, and it is where the California Supreme Court got it wrong in T.H., when it created a new duty to warn and deviated from bedrock legal principles.

As the Idaho court ruled, “It has long been the general law in Idaho that a company is not liable for the injuries caused by another company’s products.”  Id. at 8 (citing Idaho authorities).  The Idaho court further declined to deviate from this rule and quoted the reasoning from a similar Iowa case.  The quote is kind of long, but definitely worthwhile:

            We are unwilling to make brand manufacturers the de facto insurers for competing generic manufacturers.  (Deep pocket jurisprudence is law without principle.)  It may well be foreseeable that competitors will mimic a product design or label.  But we decline [the plaintiff’s] invitation to step onto the slippery slope of imposing a form of innovator liability on manufacturers from harm caused by a competitor’s product.  Where would such liability stop?

. . . .

We will continue to apply the same long-standing causation rule . . . which required [the plaintiff] to prove the defendant manufactured or supplied the product that caused her injury, and we decline to extend the duty of product manufacturers to those injury by use of a competitor’s product.

Id. at 8 (quoting Huck v. Wyeth, Inc., 850 N.W.2d 353 (Iowa 2014)).  This quote states the majority position that “product liability” means a “product” made or sold by the defendant, which should carry the day in most every case.  We would add that, contrary to the plaintiffs’ argument that innovator liability “does not impose a burden,” the burden on innovator manufacturers is actually quite significant.  In Stirling, the innovator did not sell the product that the plaintiff used, and it sold its rights under the NDA several years earlier, i.e., it had not sold the product for anyone’s use for some time.  Liability under this scenario is not only unfair, it potentially goes on forever, leaving the manufacturer unable to take any further action to limit, spread, or cutoff its exposure.

From there, it was a downhill run for the court to dismiss the plaintiffs’ other claims.  The plaintiffs did not allege the elements of fraud with any particularity, and the other product liability claims (negligence per se, implied warranty, and emotional distress) fell under “traditional product liability law” holding that a manufacturer cannot be responsible for a product that it neither made nor sold.  Id. at 8-10.  Ultimately, the court followed “the traditional notion that a manufacturer of a product cannot be held liable where its product did not cause harm.”  Id. at 11.  You can quote that.

In our How Not To Create an “Exception” to the Learned Intermediary Rule post two years ago, we criticized a couple of Texas trial court cases for attempting to create a company compensation exception to the learned intermediary rule, that prior decisions had almost universally rejected.  That post includes a comprehensive discussion of nationwide precedent that has considered the effects (mostly negligible) of a treating physician receiving financial payments (royalties, consulting fees, clinical trial recruitment fees, etc.) from the defendant in a prescription medical product liability case.  We won’t repeat that here.

We are pleased to add Salinero v. Johnson & Johnson, ___ F. Supp.3d ___, 2019 WL 4316163 (S.D. Fla. Sept. 10, 2019), to that discussion.  In one of the most thorough treatments of the issue to date, Salinero rejected an argument that the learned intermediary rule did not apply in a pelvic mesh case because the prescribing physician was allegedly “‘biased’ by his status as ‘Defendants’ long-time paid expert witness, consultant, corporate committee member, and . . . sales force lecturer, who happens to also have been [plaintiff’s] treating physician.”  Id. at *7.

As the plaintiff’s argument suggests, her treating surgeon was a longtime user of the product and thoroughly familiar with its risks.  As we’ve discussed in too many posts to mention, prior prescriber knowledge is fatal to warning claims because a claimed failure to warn somebody of what s/he already knows cannot be causal.  To get around the learned intermediary rule, plaintiff attacked, not the prescriber’s knowledge or treatment, but his having been (well) compensated by the defendants.

Fail.

Predictably, plaintiffs relied on the two Texas cases that we had criticized in our prior post.  Salinero, 2019 WL 4316163, at *8 (citing and discussing In re Depuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016), and Murthy v. Abbott Laboratories, 847 F. Supp.2d 958 (S.D. Tex. 2012)).  Defendants, however, argued that the result was “wrongly decided” and “point[ed] to a litany of other cases where courts granted summary judgment on the grounds of the learned intermediary defense, despite the alleged bias of a learned intermediary who had been compensated by the defendant.”  2019 WL 4316163, at *9.  We compared Salinero’s discussion of the defendant’s (id. at *9-10) cases with those in our post, and are pleased to report that we had them all.

The court rejected any purported exception to the learned intermediary rule for financial payments, and instead imposed on the plaintiff the obligation to come forward with actual evidence that the defendant should have expected its financial payments to influence the prescriber’s medical treatment, and thus should not have relied upon this particular physician, as the learned intermediary rule would otherwise permit:

The Court predicts that the Florida Supreme Court would side with the weight of authority cited by Defendants . . . above.  These cases do not stand for the proposition that these states’ learned intermediary doctrines always apply in suits against manufacturers of drugs or medical devices.  Rather, the cases suggest that the learned intermediary doctrine may not apply if the manufacturer knew or reasonably should have known that the intermediary-physician would not be exercising his independent medical judgment, such that the manufacturer could not rely on the intermediary-physician to duly consider the provided warnings when prescribing treatment.

Id. at *10 (emphasis original).  It agreed with us about the Texas cases, expressly “disagree[ing]” with Pinnacle Hip:

to the extent it suggests that the mere fact of [a prescriber’s] having served as an expert witness for [a defendant], or the mere fact of [a prescriber’s] having received “thousands of dollars in Honorariums, reimbursements, royalties, and payments for speaking engagements and promotional speaking events” and having been identified as a “Key . . . Surgeon,” created a genuine dispute that those surgeons acted or reasonably could have been expected to act in a non-objective manner when choosing a course of treatment for the plaintiffs in that case.

Id. at *11.

More than just money, to avoid the learned intermediary rule, a plaintiff must come forward with “proof of non-objectivity – . . . proof of [the prescriber] being ‘so closely related’ to the manufacturer ‘that he could not exercise independent professional judgment.’”  Id. (quoting Talley v. Danek Medical Inc., 179 F.3d 154, 163 (4th Cir. 1999)).  Predictably, plaintiff in Salinero had no such thing.

Plaintiffs offer no evidence to suggest that Defendants knew or reasonably should have known that [the implanting surgeon] would not be exercising his independent medical judgment when he decided to implant [the device] in [plaintiff].  Plaintiffs cannot prevent the application of the learned intermediary doctrine here simply by pointing to [the implanter’s] history as an expert witness and consultant for Defendants. . . .  [N]othing in [his] deposition ties his role as a consultant or expert witness to the . . . product specifically.  Plaintiffs have not presented any evidence to suggest it was a foregone conclusion that [he]  would prescribe [the device] to treat [plaintiff].

Id.  Calumny and innuendo are not enough.

[T]here is no evidence beyond Plaintiffs’ conjecture and speculation to cast doubt on [the implanting surgeon’s] testimony that he believed that he was fully apprised of the risks of implanting [the device] . . . and still would have chosen to implant it in [plaintiff] anyway. As [the surgeon] testified, his decision to use [the device] in [plaintiff’s] surgery had nothing to do with any consulting or expert witness work he had done for Defendants.

Id.

The end result was predictable, which is why plaintiff tried so hard to get around the learned intermediary rule in the first place.  Any surgeon experienced enough to serve as a defense expert in mass tort litigation will have a full and complete understanding of the risks of the products s/he uses – and that was true in Salinero.  Id. (discussing at length the surgeon’s non-reliance on product labeling, prior knowledge of all relevant risks, and that no revised warning would have changed his decision to use the device).

Today is John Winston Lennon’s birthday. He would have turned 79 on this date but for a truly crazed assassin. Imagine stalking someone because of Catcher in the Rye! Lennon wrote many marvelous songs (we especially like his early stuff, such as “Hard Day’s Night,” “If I Fell,” and “Help”). But since this is the Drug and Device Law blog, it feels almost obligatory to supply a list of Lennon’s top ten drug songs. Here they are (feel free to send us your own lists):

1. Dr. Robert
2. Tomorrow Never Knows
3. She Said She Said
4. Day Tripper
5. Lucy In the Sky with Diamonds
6. A Day in the Life
7. Everybody’s Got Something to Hide Except Me and My Monkey
8. Happiness is a Warm Gun
9. Cold Turkey
10. #9 Dream

(Bexis is lobbying to include “With a Little Help from My Friends.”)

And thus we have discharged our duty.

Speaking of duty and speaking of drugs, let’s take a look at Franklin v. Wal-Mart, Inc., 2019 WL 2744624 (D. Md. July 1, 2019), where the plaintiff sued a pharmacist and the pharmacist’s employers because the pharmacists failed to obtain her informed consent to the use of hydrochlorothiazide by not warning her of the risks associated with taking it and lithium at the same time. The result of this failure, according to the plaintiff, was that she ended up suffering from lithium toxicity and pancreatitis. As part of her claim against the pharmacist, the plaintiff alleged that the pharmaceutical warnings for hydrochlorothiazide include that it should not be taken in combination with lithium due to the combination causing increased lithium levels. She also alleged that the warnings indicate that patients should be closely monitored for toxicities if the two medications are administered together.

The defendants moved to dismiss the claims because pharmacists, unlike doctors, have no duty to obtain informed consent. Maryland law controlled, and Maryland law said that the defendants were right.

Specifically, the Franklin case turned on the language of the Maryland Pharmacy Act, which provides that “pharmaceutical care” “may include patient counseling and providing information to licensed and certified health care providers.” That “may” is permissive, as opposed to mandatory, language. It does not create an obligation to provide patient counseling. (Note this theme. It comes up frequently in this case.)

The plaintiff also relied on the definition of “practice pharmacy,” which includes, inter alia, the following activities:

(iv) Monitoring prescriptions for prescription and nonprescription drugs or devices;
(v) Providing information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices; or
(vi) Identifying and appraising problems concerning the use or monitoring of therapy with drugs or devices.

The Franklin court reasoned that “to engage in an activity, however, does not mean that one is required to do so.”

The plaintiff also argued that “because pharmacists, like physicians, must be licensed, pass an exam, and maintain continuing education requirements, the doctrine of informed consent should apply to them.” The problem with that argument is that licensure and continuing education requirements “are common to many professions” and it seems a bit much to leap from those general requirements to the imposition of a duty on pharmacists to obtain informed consent. (Phew! For a moment there, we were wondering whether we, as mere hack attorneys who somehow passed the bar and now pay outrageous amounts for continuing legal education, are on the hook for informed consent.)

The plaintiff was still not out of arguments. Under Maryland law, pharmacists may refuse to fill a prescription based on their professional judgment. But that “authorization is inapposite to the situation here where the pharmacist did fill the patient’s prescription.” The plaintiff next referred to the section of the Maryland Pharmacy Act stating that “only a licensed pharmacist…may provide information to the public or a health care practitioner concerning prescription or nonprescription drugs or devices including information as to their therapeutic values, potential side effects, and use in the treatment and prevention of diseases.” But this is another instance where the word “may” connotes permissive authority rather than mandatory action. The court held that pharmacists “are thus not required to provide information about potential side effects pursuant to this section.”

Similarly, the Maryland Pharmacy Act, contains another may-not-must when it says that pharmacists shall offer to discuss “any matter which, in the exercise of the pharmacist’s professional judgment, the pharmacist deems significant,” and such matters “may include…[c]ommon severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur.” But as the Franklin court held, “an offer to discuss and a duty to inform are two distinct obligations. Moreover, the passive means through which pharmacists can satisfy their duty pursuant to Section 12-507(b) stand in stark contrast to what is required of physicians to obtain informed consent.”

The Franklin case was in federal court. No Maryland court had been presented with this precise same issue. There were cases discussing a physician’s duty to obtain informed consent, and even one rejecting an argument that a “pharmacist is per se unqualified to testify in an informed consent action when a physician has been sued.” But no Maryland case has ever come close to holding that pharmacists have a duty to obtain informed consent. Rather, Maryland courts have imposed such a duty on “health care providers.” Guess what? Pharmacists are not included in the statutory definition of “health care providers.” Accordingly, the federal court in Franklin held “that pharmacists are under no obligation to secure informed consent.”

The last baseball player to reach a .400 batting average for a season was Ted Williams in 1941.  In a sport that probably keeps more stats than any other, baseball sees records broken and milestones reached all the time.  Some marks, however, appear to be set in stone.  One of these is Ted Williams’s 1941 season.  Some consider it the best offensive season in baseball ever.  That the record has stood for 78 years seems to support that.  Some of the best to play the game in those 78 years have come close – Tony Gwyn’s .394 (1994), George Brett’s .390 (1990), Rod Carew’s .388 (1977), Stan Musial’s .376 (1948) – but they’ve come up shy.  It’s a monumental feat.  But what does .400 mean anywhere else outside of baseball.  It means 40%.  And 40% can mean different things in different scenarios.  In baseball, it means you’re going to the Hall of Fame.  A 40% return on investment probably means you’re going to be investigated by the SEC.  A 40% on an algebra test probably means you didn’t study.  And, if you win 40% of the motions you bring.  It’s not Cooperstown, but it’s not failing either.

That’s what Bayer won in Goodell v. Bayer Healthcare Pharmaceuticals Inc., 2019 WL 4771136 (D. Mass. Sep. 30, 2019).  It went 2 for 5 on its motion to dismiss.  Plaintiff underwent an MRI in 2010 during which he was administered a gadolinium-based contrast agent.  Risks of retained gadolinium in people with impaired kidneys was known around that time.  Several years later, scientific evidence led to the FDA to change the drug’s labeling to include warnings about gadolinium retention in patients with normal kidney function.  Id.  Plaintiff alleges he continues to have detectable levels of gadolinium in his body.

First up – motion to dismiss for lack of personal jurisdiction.  Plaintiff is a resident of Massachusetts, defendant is not.  In his complaint, plaintiff alleged only that defendant is authorized to do business in Massachusetts, derives income from sales of its products in Massachusetts, and in fact sells, markets and distributes the product in Massachusetts.  Id. at *3.  Plaintiff contends that is sufficient to establish specific jurisdiction – that his claim arises out of defendant’s in-state activities.  But he’s missing any allegations about the actual transaction at issue.  Plaintiff failed to allege where he was prescribed the drug, where the drug was administered, or where he suffered his alleged injuries.  Without those facts, the court concluded plaintiff had not met his burden and granted defendant’s motion.  Plaintiff is going to be given the chance to re-plead his jurisdictional allegations.  Not a homerun, but a decent infield single.

Next – preemption.  Defendant argued that plaintiff’s failure to warn claim was preempted because it could not have amended its label without FDA approval.  Plaintiff relied on the CBE regulation which allows a manufacturer to amend its label to add “newly acquired information” without prior FDA approval.  But, it’s not enough to point to the CBE regulation, plaintiff has to “provide plausible allegations of newly acquired information that manifested after the FDA’s approval of the [drug’s] label but before Plaintiff’s injury.”  Id. at *4.   Missing from plaintiff’s complaint was any allegation that there was any new information to support a CBE label change prior to plaintiff being administered gadolinium.  Id.  The court would not “merely accept Plaintiff’s conclusory allegations that such information existed.”  Id.  Therefore, the claim is preempted.  Again, plaintiff gets a chance to re-plead but we think this is at least a double that could get stretched to a triple.

Now we have to move on to the misses.  Defendant argued that plaintiff’s claims should be dismissed because he had not alleged a cognizable injury.  Retention of gadolinium is not enough in the absence of any current physical symptoms.  The court disagreed finding retained gadolinium “is a health risk and that the nature of the risk it creates is still being ascertained.”  Id. at *5.  Ultimately, the court concludes the nature of the injury is a fact question that can’t be resolved at the motion to dismiss stage.  While this motion wasn’t granted, we refer you back to an excellent Daubert win in another gadolinium case that points to this win being temporary as it’s hard to prove an injury that “is still being ascertained.”

Next was plaintiff’s claim under Massachusetts’ Consumer Protection Law (Ch. 93A).  Ch. 93A has an exemption for “transactions or actions otherwise permitted under law as administered by any regulatory board . . . acting under statutory authority of . . . the United States.”  As this provision has been interpreted, “a defendant must show that such [regulatory body] affirmatively permits the practice which is alleged to be unfair or deceptive.”  Id. Since plaintiff is alleging defendant’s warning was improper and the FDA approved that warning, the exemption seems to apply.  But the court was unwilling to find that the FDA permitted the warning given the availability of the CBE process.  This, however, seems contrary to the court’s prior conclusion that plaintiff had failed to plead facts sufficient to show defendant could have used the CBE process.  At a minimum, we think it would have been more logical to dismiss this claim on the same grounds.  Instead, the court found it was an issue for trial.  Perhaps there will another chance to take a swing at this one after the court’s sees plaintiff’s amended CBE allegations.

Finally, plaintiff’s complaint also included an allegation that he was entitled to permanently enjoin defendant from continuing its unlawful business practices. Id. at *6.  Defendant moved to dismiss the injunctive relief claim on standing grounds.  Because plaintiff hadn’t sought preliminary relief, the court considered the issue premature and denied the request to dismiss.

There was a statute of limitations motion that was also denied and that we are opting not to count in our analysis as we usually only address limitations issues when they are significant or compelling (and it would have reduced our batting average analogy to .333 which while still pretty darn good – only 25 players have ever had a higher career batting average – we liked the Ted Williams record better).

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.

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 TwIqbal.  Id.  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.

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.

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.

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 Noerr–Pennington 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 McClellan.  Id. 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.

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.