Some of your favorite Drug and Device Law bloggers will be presenting at Reed Smith’s Philadelphia Life Sciences CLE Day on Thursday, November 10 at Reed Smith’s Philadelphia office.

Blogger Eric Alexander starts the day off with a discussion of the major drug and device decisions of 2016.  For our loyal readers who look forward to our annual “Top 10 Best and Worst Decisions,” here’s your chance for a potential sneak peek.

Then Bloggers Bexis and Rachel Weil wrap the day up with a presentation on implied preemption – as well as an update on off-label promotion since the FDA will have just held its meeting on the subject.

In between, some of our other Reed Smith colleagues will cover the post-Escobar landscape for False Claims Act claims, provide a primer on the biologics-biosimilars landscape, offer perspectives on the current best and worst product liability jurisdictions, and discuss the role of the Federal Communication Commission in regulating wireless medical devices.

We’ll even give you breakfast and lunch.

The sessions are presumptively approved for 6 CLE credits in New Jersey and 5 CLE credits in Pennsylvania. An application for Delaware credit is pending and, for lawyers licensed in New York, the day is eligible for 6 credits under New York’s Approved Jurisdiction Policy.

Interested?  You can learn more about the event here and you can register here.  Please note that the program is geared toward in-house counsel (who will be given preference), and space is limited.

Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving.  The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super. Law. Div. Oct. 12, 2016), and In re Accutane Litigation, 2016 WL 5958375 (New Jersey Super. Law. Div. Oct. 12, 2016).  Between these two orders, practically every permutation of causation under the learned intermediary rule is addressed, and the end result is the grant of summary judgment against an impressive 160 of 162 plaintiffs.

For obvious reasons, we’ll call the first (#374) “Accutane I” and the second (#375) “Accutane II” to tell them apart.

Eighty-six plaintiffs’ cases failed in Accutane I because they couldn’t even begin to satisfy their usual burden of proof.  That was because, by the time they got around to bringing their lawsuits, their prescribing physicians had either died (44 plaintiffs) or else simply could not be located (42 plaintiffs).  2016 WL 5958374, at *1-2.  As we’ve discussed before, in one of our “little lists” posts, there’s now quite a bit of law enforcing the burden of proof in dead/missing prescriber cases.  We even feel somewhat paternal feelings in this area, because several of your merry bloggers (Eric A, Steve M, and Bexis), litigated this issue extensively a decade ago in Diet Drug cases at a time when there was practically no directly on-point precedent.  In doing so, we increased the number of favorable decisions from one to seven.

Accutane I represents another giant step forward. The court held that, under the law of no fewer than 35 jurisdictions, a plaintiff who could not obtain any prescriber testimony at all could not meet his/her burden under the learned intermediary rule (now the law, as we’ve pointed out, of all fifty states) of establishing that the absent prescriber would have changed the relevant prescription had s/he received a supposedly “adequate” warning.  The defendant’s causation argument was rather basic:

Defendants argue that without the testimony of the deceased or missing physicians, Plaintiffs cannot establish that [the drug] would not have been prescribed given a different warning and thus they cannot satisfy proximate cause. Absent physicians’ testimony, Defendants argue that the causal link to injury is broken.  Even if the proximate cause standard were as Plaintiffs claim – that their prescriber might hypothetically have altered their risk discussion somehow if only [the manufacturer] had warned differently – Defendants assert that physician testimony is still needed.

2016 WL 5958374, at *3 (citation omitted). Plaintiffs fell back on that old canard, the “heeding presumption.” Id. at *4.  The court, however, was having none of it.

[T]he Court is persuaded by Defendants’ arguments that the heeding presumption within a learned intermediary context does not equate with a decision by the physician to not prescribe the drug.  If it did, medications would never be prescribed when accompanied by warnings because of the various risks associated with their use.

. . .Plaintiffs concede that their physicians are deceased or otherwise unavailable, and they have offered nothing by way of individual opposition papers. . . . Accordingly, the case-specific facts presented by Defendants are undisputed.

Plaintiffs’ reasoning is flawed, especially when one considers the slew of risks associated with and heeded by [prescription drug] users and prescribing physicians. Notably, application of the heeding presumption in the context of a pharmaceutical learned intermediary case where a manufacturer provided a warning and its adequacy remains in issue is not reflected within any of the cited case law.

Id. at 10-11 (citation omitted) (emphasis added).  Regardless of any presumption, all plaintiffs “still have the burden of proof for every element of their claim.”

Not only that, the heeding presumption is “rebuttable,” id. at 11, and even in the absence of prescriber testimony, the defendants did so:

This Court does not find it reasonable to believe that a prescribing physician would cease to prescribe [this drug] when (1) the medical community issued statements urging continued use, (2) there is evidence that the learned intermediaries were otherwise aware of the risk [in question], and (3) no evidence has been provided supporting the notion that one additional risk factor would lead the prescribing physicians to avoid this drug.

Id. That settled the issue under New Jersey law.  Id. at *12.  In addition, the court pointed out that the following states have:

  • Never applied a heeding presumption at all – Idaho, Kentucky, Minnesota, New Mexico, Texas, Wisconsin.
  • Never applied a heeding presumption in a learned intermediary case – Arkansas, Maryland, Missouri, North Dakota, Utah.
  • Never applied a heeding presumption in a learned intermediary case where a warning (albeit allegedly inadequate) was given – Illinois, Indiana, Kansas, Louisiana, Massachusetts, New York, Ohio.

Id. at *12-16.  Finally, the Accutane plaintiffs “fail[ed] to proffer any case law for the remaining sixteen jurisdictions on proximate cause or the heeding presumption.”  Id. at *16 (mentioning Alabama, Arizona, California, Connecticut, Colorado, Florida, Georgia, Mississippi, Nevada, North Carolina, Oregon, Pennsylvania, South Carolina, Tennessee, Virginia, and Washington).

Accutane II dispatched another 74 plaintiffs with a panoply of learned intermediary causation-defeating – and presumption-rebutting − testimony from their prescribing physicians.  In those situations, the prescribers’ conduct was the dispositive issue under the learned intermediary rule:

[W]here the LID applies, the testimony of Plaintiffs or their medical decision makers is not a part of the proximate cause determination.  If it were, the LID would be rendered useless because a proximate cause determination would ultimately come down to what the patient would have done in response to a drug manufacturer’s warning, the precise situation which the [doctrine] sought to avoid.

2016 WL 5958375, at *5 (applying New Jersey law).  Plaintiffs’ claim that dictum in a recent, unpublished New Jersey decision made “revolutionary” changes to the rule was rejected.  Id. “[C]onflat[ing] the LID with the informed consent doctrine” is “simply not the law.”  Id.  “When a prescribing physician comprehends the fact that a given medicine is associated with certain potential risks, and exercises his/her medical judgment in deciding whether and how to address those risks with his/her patient, the manufacturer cannot be held responsible for the prescriber’s decision.”  Id.

To make the multiple rulings meaningful for counsel in future cases, first, we’ll break down the rulings by state, and then we’ll organize the dispositive physician causation testimony in Accutane II by the categories that Bexis uses in his book.  See Beck & Vale, “Drug & Medical Device Product Liability Deskbook” §2.05[1].  Those are:  (1) prescriber already knew; (2) prescriber did not read; (3) prescriber did not think risk severe enough; (4) prescriber decided not to warn; and (5) prescriber would not change anything.  Most states involved multiple plaintiffs, so we’ll also indicate the number of different plaintiffs who lost by each type of testimony (some prescribers gave more than one type of testimony).

So here is our summary of all the summary judgment rulings in Accutane II:

Alabama:  Not change anything (x6).  2016 WL 5958375, at *8-11.

Arizona:  Already knew; risk not severe enough, not change anything (x3).  Id. at *11-13.

Colorado:  Already knew (x2), did not read, not change anything (x4).  Id. at *14-17.

Georgia:  Already knew, risk not severe enough, not change anything (x4).  Id. at *17-20.

Illinois:  Already knew (x2), not change anything (x3).  Id. at *21-22.

Mississippi:  Already knew (x2), not change anything (x3).  Id. at *23-24.

Missouri:  Already knew (x2), decided not to warn, not change anything (x5).  Id. at *25-28.

Nebraska:  Already knew, risk not severe enough (x2), not change anything (x4).  Id. at *28-31.

New York:  Already knew (x5), risk not severe enough, not change anything (x6).  Id. at *32-35.

North Dakota:  Already knew (x2), not change anything (x6).  Id. at *36-39.

Ohio:  Already knew (x3), did not read, not change anything (x6).  Id. at *40-43.

Oklahoma:  Already knew, not change anything (x2).  Id. at *44.

South Carolina:  Already knew (x2), not change anything (x2).  Id. at *45-46.

Virginia:  Not change anything.  Id. at *46.

Wisconsin:  Already knew, risk not severe enough, not change anything (x3).  Id. at *47-48.

As mentioned at the outset, only two of the plaintiffs in Accutane II survived summary judgment on grounds of warning causation.  One was under Colorado law, where the court found the prescriber’s testimony “demonstrate[d] substantial uncertainty” about what the prescriber would have done with a different warning.  Id. at *14.  The other denial was under Indiana law, where the doctor repeatedly testified that he was “not sure” what he would have done with a different warning.  Id. at *23.  That was it.  As to the other 74 plaintiffs, diligent defense questioning during prescriber depositions removed any possibility of causation.

While the learned intermediary rule is not as “strong” a defense as preemption or Daubert, because causation must be examined on a plaintiff-by-plaintiff basis, Accutane I and II demonstrate why the rule matters, even in a mass tort setting.  Any way one looks at it, 160 out of 162 is a great batting average.

We found a hidden (at least from us) Georgia federal court decision that we want to discuss because it hits on many of the effective defenses sometimes available to defendants on motions to dismiss. It’s two years old and, for whatever reason, we’re just now finding it. But better late than never.  In Connolly v. Sandoz Pharma. Corp., 2014 U.S. Dist. LEXIS 190163 (N.D. Ga. 2014), the court dismissed with prejudice a generic-drug complaint by invoking Mensing, Buckman and the learned intermediary doctrine. That’s a pretty good line-up.

It all turned on the plaintiffs’ decision to assert failure-to-warn claims. With generic drugs, that triggers Mensing preemption. Federal regulations do not allow generic drug manufactures to unilaterally change the content of the warnings in their labels, so a state-law claim seeking to impose liability for insufficient content in a label is preempted.

Plaintiffs tried to juke their way around this problem, however, by arguing that their claims were not about label content but instead defendants’ failure to follow federal regulations that would ensure that medication guides reached patients. Id. at *11-12.

But, setting aside that that’s not exactly what federal regulations require, that claim raises new problems. First, Buckman preemption. This revised claim alleges a failure to follow federal regulations. Yet there is no private right of action under the FDCA, meaning that only the FDA, not private litigants, can enforce the FDA’s regulations.  Any attempt by private litigants to do so, like this one, is preempted:

To the extent plaintiffs’ allegations are premised on Defendants’ alleged breach of federal regulations, they are preempted in accordance with Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001), in which the Supreme Court, citing 21 U.S.C. § 337(a), held that “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with the [law].” . . . Plaintiffs’ claim for noncompliance with the federal regulation is preempted pursuant to Buckman.

Id. at *14-15.

Next, Georgia law follows the learned intermediary doctrine, which says that a manufacturer’s duty to warn is to the prescribing doctor, not the patient. So plaintiffs’ claims that the defendants didn’t ensure that patients received medication guides is irrelevant.

Within the context of prescription drugs … Georgia employs the learned intermediary doctrine. Under the learned intermediary doctrine, the manufacturer of a prescription drug or medical device does not have a duty to warn the patient of the dangers involved with the product but, instead, has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer.” . . . . As such, Defendants did not have a duty to provide the Medication Guide or warn plaintiffs. . . . Accordingly, plaintiffs’ claims against Defendants based upon the allegation that plaintiffs did not receive the Medication Guide fail as a matter of law.

Id. at *15-16.

Finally, plaintiffs claimed that defendants engaged in inaccurate off-label promotion and that such an off-label-promotion claim is not preempted. Not so. It’s just a failure to warn claim in different clothing. The court understood this and dismissed the claim as preempted:

In essence, these allegations claim that Defendants’ alleged promotion resulted in failure to properly warn and hence are preempted by federal law.  Accordingly, plaintiffs’ allegations fail to set forth any viable claims against Defendants and must be dismissed.

Id. at *18.

Oh, and the court also saw the futility of these claims and denied plaintiffs’ request to amend its complaint. That was another nice touch. So, while we certainly wish we had found this decision earlier, we’re glad we finally did.

A class action claiming that a diet supplement was falsely advertised as being an aphrodisiac cries out for bad jokes and silly puns. Are we above all that?  Er… sure.  The supplement is called IntenseX.   (Get it?  Why don’t we ever see such clever marketing in law firm websites?) The case is called Sandoval  v. Pharmacare US, Inc., 2016 U.S. Dist. LEXIS 140717 (S.D. Cal. June 10, 2016).  The lead plaintiffs were from California and Florida.  Both alleged breaches of express and implied warranty, violations of California’s Unfair Competition Law, False Advertising Law, and Consumer Legal Remedies Act, and violation of the federal Magnuson-Moss Warranty Act.  The plaintiffs sought certification of a nationwide class of disappointed IntenseX users.  The plaintiffs also grumbled that they would accept California and Florida classes as alternatives.  The court denied class certification, so there was a happy ending.  The court did so after marching through the Rule 23 analysis in a logical, straightforward fashion, so the bits leading up to the climactic noncertification were also happiness-inducing, if not intense.


As usual, the plaintiffs could establish numerosity and (more controversially) ascertainability.  Just as usual, the plaintiffs could not establish that common issues predominated over individual ones.  The plaintiffs asserted that common to all claims for all class members was whether the representations about aphrodisiac effects were likely to deceive a “reasonable consumer.”  But an inference of reliance was not available in this case because there was no evidence that consumers had been exposed to a widespread, long-term marketing campaign.  (The court drew a contrast to advertising for tobacco, a product we wanted to use immediately after reading this case.)  What’s more, there was no evidence of any shared understanding among consumers as to the promised effects of IntenseX.  Even if there was a way to characterize the promise of IntenseX marketing in some general way, the court ruled that the plaintiffs “did not present sufficient evidence that IntenseX is incapable of producing the promised effects.”   What would such evidence look like?  Even if there were declarations by some disappointed users recounting their sad experiences with IntenseX (think of a bizarro-world version of Dear Penthouse Forum letters), would they truly establish a causal nexus?  Consider all the comorbidities that might account for why consumers couldn’t get any satisfaction.  Maybe they misplaced their Lionel Richie records, or showed up on date-night wearing socks with sandals. 


The plaintiffs also attempted to establish commonality and predominance via a federal regulation governing drug products offered over the counter for use as an aphrodisiac.  But IntenseX is a supplement, not a drug.  Different regulatory schemes apply.  Once again, the plaintiffs were frustrated.  (By the way, we discussed the applicable regulatory regimes in this litigation here, where we argued that the claims should have been preempted.) 


As one might expect, the depositions of class members in a case of this nature ended up weakening, rather than strengthening, the plaintiffs’ claims and their request for class certification.  Our idea of the perfect deposition is one where the deponent has a personal incentive to answer the questions the way we, as the interrogator, want.  That must have happened here.  There were plaintiffs who “testified at their depositions that they did not suffer from the sexual-health problems they claim IntenseX falsely claimed to improve.”  The plaintiffs varied in terms of what materials they relied upon in deciding to purchase the product.  Some plaintiffs were clearly time-barred.  If nothing else, these variations from the complaint undermined the typicality requirement, and the court was not about to rewrite the complaint to solve that problem, assuming there was any solution in sight.


Moreover, the “substantial mismatch between Plaintiffs and the classes they propose to represent” means that there are plaintiffs raising claims and theories they have no standing to raise.  Some consumers have no cognizable injury.  Some already obtained full refunds.  After the SCOTUS opinion in Spokeo, it looks as if both class representatives and many absent members would have a problem with standing.  (And, after all, isn’t lack of standing really the key issue in this case?)


The court also questioned the plaintiffs’ effort to apply California law to a nationwide class.  The transactions took place all over the country, and there was no good reason for California law to cover all of them.  Even if you do not have a case involving class certification (or aphrodisiacs), the Sandoval case is worth reading if you are trying to fend off extraterritorial application of California laws. The plaintiffs wheeled out some cases that certified nationwide classes under California law, but the Sandoval court observed that “those cases did not apply Rule 23” and “they gave too little consideration to federalism and other states’ interests.”


Finally, the plaintiffs also sought certification under Rule 23(b)(2), which applies when the primary relief sought is an injunction or declaratory relief.  And yet the primary relief sought in this case was a full refund of the purchase price.  Given that the plaintiffs “can no longer be deceived by the alleged false labeling, monetary relief is necessarily their primary concern.” 


The court denied class certification.  Across the board.  We do not know if the author of the Sandoval opinion made it out to the Desert Trip concerts either of the last two weekends.  Indio and the Coachella Valley are not so far from San Diego.  We know, since we made that drive last week.  With a lineup of Dylan (Nobel Prize winner!), the Rolling Stones, Neil Young, Sir Paul McCartney, The Who, and Roger Waters, it is no wonder that the show was nicknamed Old-chella.  Given the subject matter and resolution of the Sandoval case, it is hard not to think of two Stones’ classics (both of which were played at the Desert Trip): “Can’t Get No Satisfaction” and “You Can’t Always Get what You Want.”





The Telephone Consumer Protection Act (“TCPA”) potentially touches just about every kind of business, including the business of selling prescription drugs. That is what the Northern District of California grappled with (correctly) in Jackson v. Safeway, Inc., No. 15-cv-04419, 2016 U.S. Dist. LEXIS 140763 (N.D. Cal. Oct. 11, 2016).  In Jackson, the plaintiff received a telephone reminder from her pharmacy that she was due for an annual flu shot, which prompted her to go in the next day to receive her shot. Id. at **5-6.  Of course, what do you do after you receive disease-preventing medical treatment?  You file a class action lawsuit dissing the pharmacy for bothering to call.  What is the old saying about no good deed?

For the uninitiated, the TCPA is the federal statute passed in the early 1990s that regulates “telemarketing.” We place that word in quotes for two separate reasons.  First, we use quotes to demarcate a term of art—the FCC uses the term “telemarketing” to define significant obligations under the Act.  Second, we use quotes to indicate irony (picture us making the familiar “air quotes” gesture as you read this post).  Although Congress passed the TCPA to cut down on intrusive “telemarketing” calls, many say that the FCC’s regulations do not target “telemarketers” narrowly enough.  That makes other businesses who are reaching out to their customers (like our pharmacy) potential targets for abusive litigation.  The stakes are high.  The statute imposes penalties of up to $1,500 per violation, and in a society where telephones increasingly serve as our windows to commerce and human relations, those penalties can multiple to large numbers quickly.

A particular target for critics of the regulations is a 2012 FCC order that could have, for example, strengthened an exception for calls made within existing business relationships. But the 2012 order instead abolished that exception, among other provisions.  A follow-up order issued in 2015 clarified matters, but that also fell short of expectations for many.  One example is the FCC’s definition of an “automated telephone dialing system,” which some say is now broad enough to include our iPhones.  We are not so sure, but the ambiguity in the rules is most unwelcome.  (You can read Reed Smith’s alert on the 2015 order here.)

We are writing about this here because the district court in Jackson invoked two TCPA exceptions that apply to healthcare:  (1) The “exigent healthcare treatment exception,” which creates a safe harbor for “exigent” calls that have a “healthcare treatment purpose” and “are not charged to the calling party”; and (2) the “telemarketing health care exception,” which permits automated calls that deliver “health care” messages from HIPAA covered entities and their business associates.

Applying both exceptions, the district court granted summary judgment. A lynchpin of the TCPA, as applied in the FCC’s 2012 order, is that “prior written consent” is required for most automated telemarketing calls.  That can be an exacting requirement.  But the pharmacy complied with the statute regardless because its calls to the plaintiff were “exigent healthcare treatment” calls within the safe harbor.  The safe harbor covers routine health care messages, including reminders for “wellness checkups” and “prescription notifications.” Id. at *11.  There are specific requirements for what numbers can be called, the content of the messages, the length of the messages, the number of messages, etc.  The pharmacy clearly worked with capable TCPA counsel in devising its flu shot reminder program because its reminder calls met every requirement. Id. at **14-19.  The pharmacy also limited its calls to existing patients (1) who had provided their telephone numbers, (2) who the pharmacy believed had received a flu shot at the pharmacy during the immediately preceding flu season, and (3) who had not yet received a flu shot for the current flu season. Id. at **4-5.  And, because the plaintiff in this case had an unlimited talk, text, and data plan, she did not incur charges for the call. Id. at **14-15.  Under these facts, the pharmacy dropped its anchor firmly within the safe harbor.

The district court also applied the “telemarketing health care exception” to reach the same result.  Even if the calls constituted “telemarketing,” the pharmacy needed only the plaintiff’s “prior express consent”—as opposed to “prior express written consent.”  The plaintiff had provided her express consent when she gave the pharmacy her mobile number when she received her last flu shot. Id. at **30-31.  This is one of the most important parts of TCPA law:  Providing your phone number constitutes your consent to receiving calls.  The issue becomes the scope of the consent, and because the plaintiff provided her phone number in connection with receiving flu shots in prior years, the scope clearly included consent to telephone flu shot reminders. Id. at **31-32.  We are surprised that the plaintiff attempted to argue otherwise.

Other than consent, the calls were “health care” messages because they concerned “care, services, or supplies related to the health of an individual.” Id. at **23-26.  Again, we are surprised the plaintiff argued otherwise.  In addition, the reminder calls were “in accordance with a prescription,” a separate basis for invoking the health care exception. Id. at **26-27.  Flu shots are prescription drugs.  Pharmacists can administer flu shots under a California law that allows vaccinations without patient-specific prescriptions, but they are prescription drugs nonetheless.

In short, Jackson came to the right result for the right reasons.  It is difficult to disagree with the purpose behind the TCPA, which is to address “the proliferation of intrusive, nuisance [telemarketing] calls to [consumers’] homes.” Id. at *8.  But the exceptions for healthcare messages are reasoned and fair; they promote public health; and courts should apply them vigilantly, as this district court did.  If the plaintiff makes it through this flu season unscathed, she has her pharmacy to thank for it.  Of course, if her attorneys had their way, she may not have received a flu shot at all.

We’re pleased to report the demise of a plaintiff’s firm’s attempt to punish the FDA for rejecting the firm’s attempt to force the agency to create evidence helpful to plaintiffs in litigation. The ploy began in 2012, when “a law firm that represents hundreds” of plaintiffs in prescription drug mass tort litigation “on a contingency fee basis” “filed a citizen petition with the [FDA].”  Sheller, P.C. v. U.S. Dep’t of HHS, 119 F. Supp.3d 364, 368 (E.D. Pa. 2015). Plaintiff sought agency action that it could, in turn, parade before juries in the underlying mass tort, specifically: “that the FDA immediately revoke the [relevant] indication for the . . . [d]rugs” at issue or alternatively “require that labeling for those drugs include a black box warning based on the lack of sufficient data to prove their safety.”  Id.  In addition, the plaintiff law firm sought to enlist the FDA in evading a confidentiality order (originally agreed to by the law firm) that protected discovery which the defendant in the underlying litigation had provided.  Id.

So far, so what?  While annoying, attempts of this nature to embroil the FDA in mass tort prescription medical product litigation are part of the other side’s play book.  (((Bexis))) recalls similar machinations during the Bone Screw litigation whereby the plaintiffs did everything they could (ultimately unsuccessfully) to prevent the Agency from adding to those products’ labeling previously off-label uses that had become the medical standard of care – because the Bone Screw plaintiffs’ litigation strategy was based on the procedures in question being off label.

The Bone Screw plaintiffs failed, 63 Fed. Reg. 40025-41 (FDA Jul. 27, 1998) – as did the law firm plaintiff in Sheller (119 F. Supp.3d at 368) – since the FDA normally has little patience for the junk science that the other side routinely peddles in mass tort litigation.  The plaintiff law firm in Sheller would have been off not filing the petition at all, since according to plaintiff, “the FDA decision to deny its petition “has been used as the basis to assert federal preemption and other [defense] arguments against [plaintiff’s] clients in [mass-tort] litigation.”  Id.

No kidding.  That’s the down side this sort of litigation strategy.  Attempts to involve the FDA in litigation have the risk that, if one loses, the FDA’s actions can create a positive narrative for the other side.

But plaintiffs believe in the doctrine of “heads I win; tails you lose.”

So in Sheller the plaintiff law firm attempted to gin up, from their failed strategy, a tort cause of action – not an administrative claim – against the FDA.  Talk about a bootstrap.  The plaintiff law firm was the one that involved the FDA in the first place.  The bizarre theory of liability postulated that, if the FDA wouldn’t cooperate in creating pro-plaintiff evidence/themes in the underlying litigation, that required the plaintiff law firm to work harder and spend more money to come up with something that juries might believe.  So the law firm sued the FDA to recover its purportedly increased litigation costs:

Plaintiff [claims] . . . that the FDA denial of [its] citizen petition increased [its] costs in litigating [because] . . . the defendant . . . has argued that the FDA’s denial of the Petition proves, as a matter of law, that the [drug’s] label is adequate. . . . Plaintiff argues that it must continue to expend resources in defending against that argument, and it faces the risk that a Court will accept it, lowering [plaintiff’s] contingent fee recovery.

Sheller, 119 F. Supp.3d at 369-70 (quotation marks omitted).

The district court held that this purported “injury” was too remote and tangential to create standing to sue as government agency for not doing what a law firm wanted.  Even if lost profits from contingent fees could be an “injury,” it wasn’t the FDA’s fault that mass tort defendants took advantage of the law firm’s failed citizen-petition-based litigation strategy:

Plaintiff asserts that it has satisfied the causation requirement because by wrongfully denying the Petition based on a biased and incomplete factual record, the FDA created an incorrect legal argument that [the firm] is required to defend against in other litigation. But as [FDA] highlight[s], even Plaintiff’s own formulation of this “causal chain” belies its position that the FDA and not an outside party caused its injury. . . . [A]lthough [the mass-tort defendant’s] argument may rely on the FDA’s actions, Plaintiff does not allege that the FDA directly influenced [defense] litigation strategy. [The mass-tort defendant’s] independent litigation decisions therefore constitute an intervening cause of Plaintiff’s purported injury. . . . Plaintiff’s adversaries would vigorously litigate the [underlying] matters with other arguments, even if not with the particular strategy based on the FDA decision that Plaintiff labels “incorrect” and “without legal merit.” Plaintiff’s “causal chain” is too attenuated to show that Defendants caused Plaintiff’s contingent fee injury.

Id. at 371-72 (citations and quotation marks omitted).

Nor can the FDA (or anyone) be charged with responsibility for additional expenses caused by a law firm’s (in this case, unavailing) choice of litigation strategies for its clients. Otherwise, its choice of a “certain fee structure” – contingent fees – would “set[] the stage for economic injury whenever it expends additional resources in litigation, regardless of the causes for the expenditure.”  Id. at 372.  The court was not about to start down that slippery slope of assessing “damages” every time a contingent fee lawyer lost some issue that potentially lessened that lawyer’s take.  Even if arguments made by a defendant were “incorrect” and “meritless,” no relief against the FDA is going to stop mass tort defendants from pursuing them.  Id.

Nor did plaintiff’s complaining about supposed “procedural violations” by the FDA during consideration of the citizen petition create standing to sue the Agency in tort:

[I]t is well-settled that procedural violations in agency proceedings do not themselves inflict injury for which a party would have Article III standing to bring suit, absent concrete injury. . . . [T]he nature of Plaintiff’s asserted contingency fee injury does not justify the lower bar for which Plaintiff advocates.  Plaintiff does not assert an injury based on any concrete right that the FDA’s procedures are intended to protect. Instead, the cognizable injury that Plaintiff alleges is several steps attenuated from the decision on the petition itself, much less the procedures governing the agency consideration of the petition.

Id. at 372-73 (citation omitted).

The FDA’s refusal to interfere with the confidentiality of discovery in the underlying litigation likewise provided no basis for standing.  Insofar as “advocacy” was concerned, the plaintiff law firm agreed to the confidentiality arrangements it later attempted to enlist the FDA to evade:

Plaintiff was bound by the confidentiality agreement to which it refers prior to the citizen petition; presumably, the limitation that Plaintiff would call an injury occurred at that time. That the FDA did not remove this apparent burden − an action which it does not obviously have the authority to take − did not injure Plaintiff, as it did not change the status quo. To the extent that the confidentiality agreement impairs Plaintiff’s interests, the injury is the agreement itself, not [the FDA’s] decision declining to direct private entities . . . to release Plaintiff from the agreement.

Id. at 373 (citation omitted).

Finally, the plaintiff law firm had no business asserting any harm “to the general population of potential victims.”  Id.  A “risk to parties with a generalized professional interest” in a subject was “too probabilistic to be sufficient as an injury for the basis of standing.” Id.

Plaintiff’s assertion that it suffers an injury based on its inability to publicly disclose information is similarly speculative.  In essence, Plaintiff’s argument relies on individuals suffering harm because they lack certain information apparently in Plaintiff’s possession. . . .  Plaintiff offers no indication that an injury to these individuals works an injury on Plaintiff itself.

Id. at 374.  Indeed, preventing injury altogether is not in the interest of a plaintiff law firm, since such firms exist to seek damages, not to prevent them:

Plaintiff’s professional interest in those [uninjured] individuals evaporates, as the would-be victims would lack a claim on which Plaintiff might represent them. Thus, Plaintiff’s asserted injury based on the general population of potential victims is self-defeating.

Id.  None of the plaintiff law firm’s arguments established standing to sue the FDA for denying its citizen petition, so the action was dismissed.

In another unwise litigation decision, the law firm appealed.

And lost.

Last week a unanimous Third Circuit panel affirmed.  See Sheller, P.C. v. U.S. Dep’t of HHS, ___ F. Appx. ___, 2016 WL 5846219 (3d Cir. Oct. 6, 2016).

First, there was no injury.  Plaintiff chose to file the citizen petition, lost, and thus handed mass tort litigation defendants a weapon the they were entitled to use in their own defense:

[The mass tort defendant’s] litigation strategy would not be illegal in the absence of the Petition’s denial; [it] is entitled to defend itself against [plaintiff’s] lawsuits regardless of whether the FDA grants or denies the Petition. Thus, the government action (denial of the Petition) does not authorize third-party conduct ([the mass tort defendants’ arguments in the [underlying] Litigation) that would otherwise be illegal in the absence of such action, and [plaintiff] cannot maintain standing on these grounds.

Id. at *4.  Litigation strategy isn’t heads I win, tails you lose.

Second, the panel agreed with the district court on the causation aspect of standing:

[T]here is no “substantial evidence of a causal relationship between the government policy and the third-party conduct, leaving little doubt as to causation and likelihood of redress. . . . [The mass tort defendant] could not defend such claims without arguing that [the drug’s] labeling is adequate, and its use of the FDA’s Petition denial as support for its argument does not transform [the defense] argument into a harm caused by the FDA.

Id. (footnotes and quotation marks omitted) (emphasis original).

Third, the relief sought against the FDA would not “redress” the plaintiff law firm’s purported injury:

[Plaintiff’s] injury − increased . . . [l]itigation costs − depends heavily on the actions of both [opposing litigants], not the FDA, and granting the Petition produces only a chain of contingencies which amounts to mere speculation about how [the litigants] will conduct the [underlying] Litigation and accrue associated litigation costs. There is simply no basis to say that a favorable decision in this case is “likely” to redress [plaintiff law firm’s] injury.

Id. (footnote and quotation marks omitted).

Good riddance.

Thus, another abusive lawsuit comes to an end, and rightfully so.  If the FDA is to maintain its status as a neutral third party in prescription medical product liability litigation, then it cannot be subject to lawsuits seeking “damages” for increased litigation costs based on use of contingent fee arrangements.  That’s a classic “one-way” argument available to plaintiffs but not defendants.  As the District Court recognized, lawyers litigating “on an hourly fee basis . . . would presumably benefit from, not be injured by, the additional effort.”  119 F. Supp.3d at 372. Thus, only contingent fee lawyers would be able to threaten the FDA in this fashion. This litigation was really an elaborate attempt by the other side to put a thumb on the scale of FDA regulatory actions beyond the ability of their junk science to influence.



We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time.  (Like here, here, and here, among many posts.)  The court battles that have garnered so much attention recently can be traced back to at least the 1990s, with the famed decision in Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81, 85 (D.D.C. 1999), vacated as moot by 202 F.3d 331 (D.C. Cir. 2000).  There can be lots of talk about what FDA’s policy is on what a manufacturer can and cannot say about unapproved uses for its drug or device.  Discussions about changing 21 C.F.R. § 201.128 (drugs) & 801.4 (devices) have dragged on for a while, even with the Amarin settlement and with other FDA statements suggesting that the regs do not reflect current policy.  FDA policy, of course, involves more than just a few sentences in a regulation or guidance document.  Particularly for a prohibition that has long been the crux of FDA enforcement—like warning letters and prosecutions—and has spawned or played a major role in subsidiary FCA, RICO, and product liability litigation, a decision to stop prohibiting truthful, non-misleading statements about unapproved uses for drugs and devices is not exactly the end of the story.  For one thing, criminal prosecutions that are based at least in part on manufacturer statements about unapproved uses are always on-going and U.S. cannot just hit the reset button in those cases.

We do not often post about decisions from, let alone briefs filed in, criminal cases brought pursuant to the FDCA.  That FDA enforcement sometimes results in prosecutions is something that comes up in our cases and posts, often in the context of preemption and primary jurisdiction—the FDA does not just have the authority to root out misbranded and adulterated medical products and fraud in connection with approval or post-approval reporting, but companies and individuals get prosecuted, so you should be comfortable respecting FDA’s authority, Your Honor.  It also comes up sometimes when there has been a prosecution that resulted in an indictment, plea, conviction, or sentencing memorandum that the plaintiffs want to use as evidence of something—or for issue preclusion—in a separate case.  When it comes to prosecutions based at least in part on manufacturers or their representative making statements about unapproved uses, we have an opportunity to see what FDA’s policy on off-label promotion really is these days and how it might affect behavior.  While we generally think manufacturers and their representatives try to follow applicable guidance documents, they definitely want to avoid being convicted.

Today, we take a look at two criminal prosecutions involving off-label promotion allegations, each of which has now been tried to a jury verdict.  In the first, the court denied all of the defendants’ motions in limine before the case proceeded to a defense verdict at trial. See U.S. v. Vascular Solutions, Inc., No. SA-14-CR-926-RCL, 2016 U.S. Dist. LEXIS 133717 (W.D. Tex. Jan. 27, 2016).  That opinion showed up in our searches recently, well after the acquittal of the device manufacturer and its CEO produced its own fall out, including a letter from Senator Grassley—hardly a known industry champion—to DOJ about prosecutorial misconduct.  The Vascular Solutions defendants were charged with misbranding (and conspiracy to misbrand) of its Vari-Lase device.  This device was cleared—the opinion says “approved”—for treatment of varicose veins, specifically, per the indictment’s allegations, superficial veins and not deeper perforator veins.  The U.S. contended that the company failed to seek an expanded indication and failed to provide revised labeling to account for the use of the device to treat perforator veins. Id. at *3.  Defendants filed various motions in limine based on the First Amendment and the definition of “intended use” in § 801.4.  We will discuss only two of them, particularly the government’s position.  The government announced that it would not “use promotional speech to doctors to prove the intended use of the devices for perforator vein ablation” to avoid the “possibility that the misbranding offenses criminalize promotional speech.” Id. at **6-7.  It planned, however, to use such promotional speech as an overt act in furtherance of a conspiracy.  The court agreed with the government that a lawful act, including constitutionally protected truthful commercial speech, could be used as an overt act. Id. at **7-8.

But, if the Amarin settlement memorialized FDA’s policy on off-label use, then was the use of this promotional speech to prove conspiracy consistent with FDA’s policy?  If it was not, then that would be a problem.  The settlement’s language included that “truthful and non-misleading speech promoting the off-label use of [the product] may not form the basis of a prosecution for misbranding.”  It is true that it does not say “may not form the basis of a prosecution for conspiracy to misbrand,” but that seems like a bogus distinction.  The U.S. position on how it would use a truthful, non-misleading statement about an off-label use—that is, commercial speech protected by the First Amendment—seems to be that it can make such a statement a central part of its prosecution for misbranding as long as there is also a conspiracy count and the jury is informed that the statement is not to be taken as proof that the product was intended to be used for the off-label use.  This sort of nod-and-a-wink approach is like telling a civil jury that there is no count for punitive damages to punish the defendant for its egregiously bad conduct.  Just as this would be an improper incitement to award inflated actual damages, the government’s approach in Vascular Solutions seems to invite punishing protected speech through a different route.

The second motion that caught our eye relates to the interplay between the first and last sentences of § 801.4:

The words “intended uses” or words of similar import . . . refer to the objective intent of the persons legally responsible for the labeling of the devices.

* * *

But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

As discussed in many prior posts, this “knowledge” sentence is problematic because off-label use of drugs and devices is prevalent and often standard of care, the scope of approved indications cannot be changed unilaterally or quickly, there is no obligation to discourage off-label use per se, and there is a distinction that even FDA has recognized between knowledge of off-label use and promotion of it (truthful and non-misleading or otherwise). Defendants moved to preclude evidence concerning “knowledge of how the Vari-Lase device would be used,” which they contended related to “subjective intent” only.  The court rejected this, focusing generally on how internal statements can show objective intent and a twenty year old case saying the last sentence of § 801.4 imposes requirements on manufacturers. Id. at **10-12.  What is missing, though, is the government’s position.  A few months before the ruling, FDA put in the Federal Register that “the Agency does not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use,” clarified that this applied to drugs and devices too, and stated that it was amending §§201.128 and 801.4 along these lines.  Seems like a bit of a disconnect.

This disconnect has continued in our second case, U.S. v. Facteau, Crim. No. 15-10076-ADB (D. Mass.), which was tried to a jury verdict in June.  The jury convicted the two executives from a device manufacturer of ten misdemeanor counts of misbranding and acquitted them of all counts of fraud related to statements about an off-label use.  We do not have any court opinion to discuss yet, just two of the briefs filed in connection with the defendants’ post-trial motion.  For our purposes, the two important issues presented in that motion are whether protected truthful statements about off-label uses are still being criminalized and whether § 801.4 and the rest of the regulatory scheme is too vague and ambiguous to allow for a conviction consistent with due process.  Arguments on both of these, including a detailed history of the fights over what is improper off-label promotion and a cite to one of our posts—Bexis almost blushed—are set out in an excellent amicus brief from an industry group that has been a player in this area for a decade.  We will recommend it to you without repeating its content.  Instead, we will highlight a few things from the government’s brief.

The government took the position that the defendants were not convicted based on speech at all.  The court had, after all, given a long instruction on the issue, presented below as in the government’s brief:

It is not illegal in and of itself for a device manufacturer to provide truthful, not misleading information about an off-label use. The FDCA does not prohibit or criminalize truthful, not misleading off-label promotion. You may not convict a Defendant of a crime based solely on truthful, non-misleading statements promoting an FDA-cleared or approved device, even if the use being promoted is not a cleared or approved use. . . .

The indictment in this case does not charge any defendant with the crime of promoting a device off-label, because that is not itself a crime. Rather, the FDCA crimes charged are conspiring to introduce, and causing the introduction of, devices into interstate commerce that were adulterated or misbranded. Although you may not convict a Defendant of a crime based solely on truthful, non-misleading statements regarding off-label use, even truthful statements about an off-label use can be considered as evidence. To put it another way, to convict, there must be a criminal act. Truthful, non-misleading speech cannot be a criminal act in and of itself, but it can be evidence and therefore used by you to determine whether the government has proved each element of each offense beyond a reasonable doubt, including the element of intent . . .

Off-label promotional statements can constitute evidence of an intended use, although truthful, non-misleading speech alone cannot be the basis for a criminal conviction. Neither the First Amendment nor any other law, however, protects false or misleading speech.

In addition, it is permissible to respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a manufacturer to provide information on unapproved or uncleared indications or conditions of use. Under these circumstances, such responses may not be considered as evidence of a new or different “intended use.”

Gov’t brief at 3-4 (ellipses in original). We do not have a problem with most of this, which is a far cry from what FDA would have urged a few years ago.  The part that confuses us that “truthful, non-misleading speech . . . can be used by you to determine whether the government has proved each element of each offense beyond a reasonable doubt, including the element of intent . . .” Id. at 3 (ellipsis in original).  A completely accurate and enlightening statement about the risks, benefits, and off-label nature of a particular use proposed by a physician can be evidence that the defendant intended that the device be marketed for a use different than what FDA cleared?  Consistent with the First Amendment protections recognized in Caronia and Amarin?

The government’s theory in Facteau was that the indication proposed in the 510(k)—accepted by FDA according to its standards and reflected in the product’s labeling—was a sham and the defendants intended that the product would be used only for other indications.  Under this theory, even the most well-supported discussion of an off-label use in response to an unsolicited inquiry would suggest that the defendants sold the device for uses other than those for which it was cleared.  The government argued that:

Distribution of the Stratus for the intended purpose of drug delivery, without FDA clearance or approval for that use, was a crime independent of any promotional claims. Any truthful, non-misleading promotional speech was evidence of that crime, but not itself the criminal act . . . . A reasonable juror could have found Defendants guilty based on evidence showing that the Status did not work for its cleared use.

Id. at 4.  We are experiencing some cognitive dissonance over this argument.  First, and this would require a little more space than we are willing to devote to explain how it connects to the off-label promotion issues, we do not see how the government’s position could be that the device was not effective for the indication for which it was cleared.  That is, unless there was an allegation from FDA that it was defrauded in connection with the evaluation of the device, which was not made for the device in Facteau from what we can tell.  Second, we do not see how every truthful, non-misleading statement about the off-label use of drug delivery was “evidence of that crime [or misbranding].”  We can come up with promotional statements about the official indication that could suggest misbranding and we can come up with misleading statements about the off-label use that suggest misbranding, but we have a hard time seeing non-misleading statements about off-label use as showing misbranding.  In fact, the government contended that there was evidence presented of false and misleading statements about the risks and benefits of the device for both the cleared indication and off-label uses and that the acquittal on fraud claims did not prohibit the jury from relying on these statements in convicting on misbranding.

Still, the government contended that defendants were “not charged with any speech crime,” making the First Amendment irrelevant here. Id. at 13.  The manufacturer’s “conduct in putting on the market a product that was never intended for its approved use and instead intended solely for an unapproved use was unlawful and thus speech in furtherance of that crime is simply not protected.” Id. The government cited two cases as support, but each involved products without approvals/clearances.  The device in Facteau had a clearance, so the manufacturer was allowed to make truthful, non-misleading statements about it, including its off-label uses.  Taking the position that the First Amendment does not protect truthful, non-misleading promotional statements as long as the Government also contends there was misbranding does not sound consonant with the Amarin settlement.

The government also offered a long defense of § 801.4’s definition of “intended use” definition as clear and justified in response to due process arguments.  This was most noteworthy to us by what it left out.  There was no mention of the pending revision of § 801.4, or public statements relating to it.  There was a long defense of broad FDA policies like requiring devices be approved/cleared, prohibiting and prosecuting misbranding, and having some definition of “intended use.”  There was no attempt, however, to justify the “knowledge” provision of § 801.4.  It was quoted once (p. 31) and there was a statement saying courts consider knowledge of an unapproved use as evidence of intended use (p. 32).  Of the cases cited with the statement that related to knowledge, the most recent was 1994.  So, it seems like the government’s position in Facteau does not reflect FDA’s current, or even recent, position.  Our look at Vascular Solutions and Facteau hardly represents a survey of the government’s position in on-going prosecutions that involve statements about off-label uses of devices, but we certainly did not see a consistent and coherent FDA policy on these issues—consistent with Amarin—being advanced by the government.  We wonder whether the government lawyers on these cases are not sufficiently in touch with FDA to understand its current policy or whether FDA does not yet have a clear policy on this issues that it can share with the government lawyers.  Neither is acceptable.


The Third Circuit just confirmed what we all knew had to be true in device litigation: pointing to the failure of another device in another patient or to a supposedly better label for a different device is not nearly enough to get to trial on design defect or failure to warn claims. That’s precisely what the Zimmer hip-implant plaintiff tried in Kline v. Zimmer Holdings, Inc., 2016 WL 5864886 (3d Cir. Oct. 7, 2016), and the Third Circuit rejected it.

To support his design defect claim, the plaintiff submitted an affidavit from his treating doctor discussing a different patient who also had a failure of a Zimmer hip implant. But the occurrence of two purported failures does not clear the way to trial. In fact, the court only had to scratch the surface of the affidavit to see its problems. The other patient’s product was a different Zimmer product. The circumstances of the other patient, the implant and its failure were different. There was no evidence as to what caused the other device’s failure. And the other patient’s implant failed after the device had already been implanted in plaintiff. These facts so solidly established the irrelevance of the affidavit that the Third Circuit held it inadmissible. The plaintiff also tried a host of design defect theories from his experts that were just that—theories—but with, as the Third Circuit held, no “record evidence showing any of these design choices were unreasonable.” It then upheld summary judgment against plaintiff’s design defect claims.

The Third Circuit was equally unimpressed with plaintiff’s failure-to-warn evidence. That evidence consisted of pointing to another product’s label, which included a contraindication for patients at a certain weight or BMI, something that the label for the Zimmer product did not have. But that was the extent of plaintiff’s evidence. He did not show that the other device was similar to the Zimmer device. He did not show that the other device’s contraindication was reasonable or why. And he did not show that the risk of fracture in the Zimmer device with patients at such a weight or BMI was high enough to warrant a contraindication. It seems that plaintiff thought that, like pointing to another patient who experienced a failure of a different device, pointing to a contraindication in a different device’s label would get him to trial. It did not. The Third Circuit upheld summary judgment against plaintiff on his failure to warn claim.

Not surprisingly, pointing to the mere existence of other products’ failures or labeling isn’t nearly enough to prove a plaintiff’s claims. We all knew that. To the extent we had any doubts, the Third Circuit just dispelled them.

For the second time within a month, an MDL court has rejected wide-ranging and potentially abusive discovery on the basis that the requests were out of proportion to the needs of the case. This is a welcome development.  We have written multiple times about the 2015 amendments to the Federal Rules of Civil Procedure, including the amendments elevating proportionality to a marquee spot in Rule 26(b) and placing the “reasonably calculated to lead to discovery of admissible evidence” standard on the ashbin of history (at least in federal court).  We have lamented (particularly here) that multiple district courts continue to apply that now-obsolete standard, relying on case authority that predates the amended Rule 26(b) by nearly 30 years.

We particularly appreciated the recent order in the Bard IVC Filter MDL, where the MDL judge also happens to chair the Advisory Committee on the Federal Rules.  That court thus took the opportunity to remind his colleagues about the applicable rules and also to emphasize that discovery requests must be proportional to their burden, even when there are hundreds or thousands of plaintiffs. See In re Bard IVC Filters Products Liability Litigation, ___ F.R.D. ___, 2016 WL 4943393 (D. Ariz. Sept. 16, 2016).

Last week, the district judge in the Benicar MDL demonstrated that he too knows the rules. In that proceeding, the plaintiffs moved to compel the depositions of employees of the defendant drug manufacturer’s European affiliate and to compel production of documents from Europe. See In re Benicar (Olmesartan) Prods. Liab. Litig., No. 15-2606, 2016 U.S. Dist. LEXIS 137839, at **196-97 (D.N.J. October 4, 2016).  The court denied both motions, and before the court explained why, it observed that “it is helpful to summarize the discovery to date.” Id. at *198.

Calling a summary of completed discovery “helpful” turns out to be a vast understatement. In fact, this district court had invested a tremendous amount of time in planning discovery in this MDL, and it gave the plaintiffs abundant leeway.  The court permitted discovery of electronically stored information from both the U.S. and Japan from “extensive custodial files” with “a long list of English and Japanese search terms”; the plaintiffs took nearly 40 company depositions in just the first phase of discovery; and the defendant had already produced 64 million pages of documents. Id. at **198-99.  The court had permitted all this after “several oral arguments and discovery conference.” Id.

In other words, this district placed a priority on managing discovery at the front end with intense involvement of the parties. Sure, it would be burdensome—discovery always is when you’re facing 1,800 plaintiffs.  But the parameters were set through a contested and deliberative process, and the parties went on their way knowing what to expect.

Until the plaintiffs asked for more. Denying the depositions of employees of the defendants’ European affiliate seems non-controversial.  The Federal Rules clearly do not allow a party to compel a non-party to appear for a deposition in the United States with a deposition notice. Id. at *205.  There are, however, two interesting notes.  First, the court rejected the plaintiffs’ argument that the two proposed deponents were within the defendants’ “control.”  People are not documents, and “control” is not the test. Id. at **208-211.

Second, and more importantly, this is where proportionality became the lynchpin of the court’s order. Even if the plaintiffs were properly to pursue the European depositions under the Hague Convention, the court was still not inclined to allow the depositions because the plaintiffs had not shown that the depositions were needed:

To date plaintiffs’ discovery directed to defendants has been extensive, lengthy and costly. Defendants have produced tens of millions of documents and thus far plaintiffs have taken thirty-eight (38) . . . fact depositions.  Give the breadth of plaintiffs’ discovery the Court is disinclined to authorize more depositions unless the new testimony is likely to be materially important and non-cumulative.  Stated differently, the requested depositions must be “proportional to the needs of the case.” Fed. R. Civ. P. 26(b)(1).  . . . [T]he Court finds that in this instance the proportionality analysis weighs in defendants’ favor.

Id. at *212 (emphasis added). There you have it.  Proportionality takes center stage, complete with a citation to the amended rule.  Significantly, the plaintiffs argued that the proposed European deponents knew information on health and regulatory issues in various regions.  This sounds to us like an argument that their depositions were reasonably calculated to lead to the discovery of admissible evidence.

The district court’s rebuke again focused on reason and proportionality:

If the Court permitted depositions to be taken to answer every conceivable question litigants raise, and fill every “gap” a party raises, discovery would never end. Moreover, the Court would be abdicating its role to efficiently manage the litigation.  See Fed. R. Civ. P. 26(b)(1) Advisory Committee Note to 2015 Amendment.  (“The parties and the court have a collective responsibility to consider the proportionality of all discovery and consider it in resolving discovery disputes.”).

Id. at *2015. Another citation to the 2015 Amendment, along with a quote on proportionality from the Advisory Committee’s notes.  Having received 64 million pages and taken nearly 40 depositions, the plaintiffs had not shown that they were seeking “materially relevant non-cumulative information” that was “not otherwise available.” Id. at **215-16.

Which brings us to the plaintiffs’ requests for European documents. Here, “control” is the test, and “clearly yes[,] Defendants are required to produce documents within their control,” even if the documents are in Europe. Id. at **216-17.  But proportionality was again the plaintiffs’ undoing.  Now, we do not necessarily agree that proportionality was the only reason for denying the motion to compel European documents.  If, for example, the plaintiffs were all or mostly from the U.S. and were treated in the U.S., experienced their alleged injuries in the U.S., etc., it is not obvious to us how documents from Europe would be relevant to any claim or defense in the first place.  We also note that the defendants did not contest that they had “control” over documents in Europe, but the devil would be in the details, especially in light of the evolving and currently unclear European rules governing the cross-border transfer of data.

But proportionality was enough for this district court to deny the motion, and we agree. As the court observed,

[O]n the whole, the Court finds that plaintiffs’ document request are overbroad and far-reaching. . . . [¶]  . . . Instead of general and overbroad requests, . . . plaintiffs’ requests must be specific, focused and narrow.  In light of the tremendous efforts already devoted to this MDL, and the fact that fact discovery regarding causation issues is virtually complete, plaintiffs must specifically identify what they want rather than making omnibus requests.

Id. at *219. If you skipped the block quote, go back and read it, because the key to the entire order is hidden in there:  “In light of the tremendous efforts already devoted to this MDL . . . .”  Enough is enough.  Defendants from time immemorial have argued that discovery is overly broad and unnecessarily repetitive to what they have already completed.  That is what the defendants argued here.  The court did not draw its all-important summary of “discovery to date” out of thin air.  We are wagering that the defendants briefed it, probably with an attorney declaration laying it all out.

Proportionality made a difference because it gave this factual background a legal referent—a pillar of support, a hook on which to hang its hat. You can choose your own analogy.  The point is that elevating proportionality makes these kinds of arguments more legally meaningful and significantly more compelling.  Put another way, when judges have invested heavily in discovery the way this judge did and feel enough is enough, the rules now more explicitly back them up.  Indeed, this judge may have been justified in cutting off discovery based on proportionality even earlier.

It may take a little while longer for judges fully to see the light, but we like what we have seen lately. With this order and the Bard IVC Filter order (which also involved foreign sources), discovery from foreign sources appears to be a good place for defendants to make vigorous proportionality arguments.

Sometimes we take routine things for granted. We don’t appreciate the taste of our morning coffee, it’s just always there. We don’t appreciate the softness of our favorite college sweatshirt, it’s just always been that way. We don’t appreciate that while watching an episode of The Walking Dead and seeing a familiar face we can IMDB and find out we recognize the actor from a 3-episode storyline on Law & Order from the late 1990s. That last one hasn’t always been available, but it’s getting harder to recall what it was like to not have that answer until it woke you from a sound sleep at three in the morning.

In the legal world we take things for granted too. We talk about things like breach, duty, causation, and on this blog, preemption, so routinely, we do start to gloss over them a bit. TwIqbal, Daubert, Buckman. Routine, routine, routine. And for sure, learned intermediary fits into this category of things we know about, we like, but maybe take a bit for granted. For many of us, it’s been part of drug and device law our whole careers given that the term was first coined in 1966 by the Eighth Circuit in Sterling Drug Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). So sometimes, it’s good to be reminded just how important it is.

That is what today’s case is all about. In Bock v. Novartis Pharmaceuticals Corp., 2016 U.S. App. LEXIS 18042 at *1 (3d Cir. Oct. 5, 2016), decedent’s family alleged that the defendant failed to adequately warn decedent’s doctors that its drugs Aredia and Zometa contribute to the risk of developing osteonecrosis of the jaw (“ONJ”), which decedent developed following multiple tooth extractions and other dental procedures. The court’s decision starts out with a recitation of the warnings that accompanied the drugs as well as additional warnings distributed by the defendant via “Dear Doctor” letters. Those warnings, which pre-dated decedent’s prescription and use of the drugs, included information such as that ONJ had been reported in patients using the drugs, mostly associated with dental procedures like tooth extractions and that invasive dental procedures should be avoided. Id. at *2-3. We know we come at this from the skewed perspective of drug and device defense counsel, but the warning seems fairly clear to us.

But, if you don’t want to take our word for it – let’s see what the learned intermediaries had to say. Decedent’s first prescriber testified that he was aware of the risk of ONJ when he prescribed for Mr. Bock and that it was his practice to discuss that risk with his patients. Id. at *5. Further, he testified that at the time he prescribed the drugs to Mr. Bock it was the standard of care to do so and that he continues to prescribe today. Id. Mr. Bock’s second prescriber continued the drugs because it was the standard of care to do so. That doctor’s records also reflect that Mr. Bock was told about the risks of dental surgery while taking Aredia/Zometa and told to advise the prescriber of any problems with his teeth right away. Id. at *5-6. The second prescriber also testified that the risk of ONJ is so small and non-life threatening that it is outweighed by the enormous benefit of treatment with Aredia/Zometa. Id. at *6. This doctor’s records also reflect that Mr. Bock had his tooth extracted without informing his office as he was advised to do. Id. at *7. Finally, there is the dentist who performed decedent’s tooth extractions. He testified that he was unfamiliar with Aredia/Zometa at the time, but per his usual practice, he would have looked them up and discussed any risks with Mr. Bock. Id. at *7-8. He also testified that regardless of the recommendation to avoid tooth extractions, he would have removed the tooth anyway because of the more serious risk of infection if left in. Id. at *8.

Sounds like the learned intermediaries also thought defendant’s warnings were adequate. They were certainly well aware of the risk of ONJ when they prescribed and even made decedent aware of the need to be careful about dental procedures. There really is little else to discuss. Could plaintiff produce an expert to opine that to a reasonable degree of certainty Mr. Bock’s use of Aredia/Zometa led to his development of ONJ? Probably. But what the learned intermediary evidence demonstrates is that there is no additional or different warning that defendant could have provided that would have altered the outcome. Under Pennsylvania law, “[p]roximate causation may be shown in learned intermediary cases through evidence that, if properly warned, the doctor either would have declined to prescribe a particular drug or would have detailed the known risks for the patient, who would then have declined the medication.” Id. at *12. The doctors in this case were clear that they would not have changed their prescribing and/or treatment decisions and while Mr. Bock is deceased, the available evidence is that he was warned on multiple occasions by different doctors about the risk and opted to both use the drug and undergo dental procedures while using the drug despite the risk.  There is also no heeding presumption in Pennsylvania, not that it should have mattered in this case anyway.

Plaintiffs attempted to avoid summary judgment by arguing that the case should have gone to the expert testimony stage, at which time their expert would have testified that the risk of ONJ is actually greater than what is “presently known” and that if decedent’s doctors knew that they would have changed their prescribing and treatment decisions. But this argument fails on two bases. Pennsylvania law does not permit a failure to warn claim to be based on “subsequent revelations.” Id. at *16. And, speculation about the possibility of what expert testimony might reveal is too little, too late at summary judgment. Summary judgment is time for the non-moving party to “put up or shut up” with facts not allegations or argument. Id. at *17.

The facts are undisputed. They are the testimony and the records of the learned intermediaries who said — we knew, we prescribed, it was the standard of care, and we’d do it again.  Learned intermediaries are important. Don’t take them for granted.