Last week, the Drug and Device Law Lifelong BFF asked us if we were interested in a quick trip to New York to use tickets for an early morning taping of “Live with Kelly.” Sure, we said – sounds like fun.  And so, after nearly two hours in line and significant drama over whether we were in front of or behind the “make it into the studio” line we were told would be drawn, we  were seated.   And we had a great time.  Kelly is as adorable and effervescent as she appears on television.  Her guest co-host interjected continuous comments from the “intelligent and engaged host” playbook.  And the guests were bona fide celebrities whom it was fun to observe at a distance of a scant ten feet.   But what was most impressive about the whole exercise was the opportunity to see what goes into the daily illusion that the hosts and the guests are responsible for the “workings” of an interview show.  Because, in fact, the stage was swarming with people who kept the machine operating, and the familiar faces were a tiny nucleus at the center of it all.  There were stylists and producers and directors and cameramen everywhere – so much so that they often blocked our view and we resorted to watching on monitors or on the screens mounted on the huge cameras.  And we realized that there would be no final product without every piece of this puzzle.

In today’s case, the absence of a requisite puzzle piece – a qualified specific causation expert – doomed the plaintiff’s case. In In re Zoloft Litigation, 2016 WL 5958372 (W. Va. Cir. Ct. Oct. 5, 2016), the court considered the defendants’ motion to exclude the plaintiff’s (general and specific) causation expert, who was a research scientist and not a medical doctor..  The expert had designated the expert to render the opinions that the defendants’ product could cause “deleterious effects both in developmental autonomy, neuroautonomy, and neurological function including the development of autism and other neurodevelopmental disorders,” 2016 WL 5958372 at *1 (emphasis in original), and that the plaintiff’s mother’s ingestion of the product while she was pregnant caused a seizure disorder and “cognitive and neurobehavioral disorder” in the plaintiff. Id.

The expert was deposed, on successive days, in four pending cases including this one. After the first day of his deposition, when he testified on behalf of two other plaintiffs, he met with plaintiffs’ counsel for several hours and drafted an updated disclosure in this case, omitting all references to autism and deleting the opinion that the defendants’ product caused the plaintiff’s seizures.   Instead, the new disclosure stated that the expert would testify that the plaintiff’s mother’s use of the product during pregnancy was a cause of the plaintiff’s developmental delays. *2.   Asked to explain why he revised his disclosure, the expert testified that, after “going back over the [plaintiff’s] records in preparation for” his deposition, he “felt it was prudent to focus on the developmental delay” and to delete the opinions that the defendants’ product caused autism and epilepsy. Id. Why?  Because the plaintiff had not been clinically diagnosed with autism, and because there was not a “good differential diagnosis” concluding that the plaintiff’s seizures “occurred at the right time to be related to his mother’s use” of the defendants’ product.” Id.

In his deposition, the expert admitted that, because he was not a medical doctor, he was not qualified to diagnose medical conditions. He had not performed any tests to support his causation opinions   He was unable to identify a diagnosis of “developmental delay” in DSM IV and conceded that there is no such diagnosis.   And, in an earlier case, he agreed that he has no methodology for determining the cause of a particular child’s birth defect.   We know – slam dunk.  We itch to write briefs in cases like these.

And it got better.   The expert testified that he relied, for his specific causation opinion, on two neuropsychiatric evaluations conducted on the plaintiff by a neurologist.  But the records of those evaluations identified no fewer than ten possible causes of the plaintiff’s developmental delays.  In his deposition, the expert agreed that nine of these were potential causes. Id. at *4.

The defendants moved to exclude the expert and for summary judgment. While the court conceded that, under West Virginia law, an expert need not be a medical doctor to offer medical causation opinions, it emphasized that there needed to be a “match” between the expert’s experience and his opinions, and that an expert’s opinion is properly excluded when it is not based on his professional training and experience.   Id. at *5-6 (citations omitted).  Because the plaintiff’s expert admitted that he lacked the experience to perform the differential diagnosis he claimed to have performed, his specific causation opinion was properly excluded.

There was also the matter of the “sham affidavit doctrine.” In response to the defendants’ summary judgment motion, the expert submitted an affidavit stating that he had “ruled out all alternatives” other than defendants’ drug as a cause of the plaintiff’s developmental delays, which contradicted his sworn deposition testimony.  Under the sham affidavit doctrine, an affidavit that directly contradicts a witness’s prior deposition testimony is “generally insufficient to create an issue of fact” to defeat summary judgment unless the contradiction is adequately explained. Id. at *8 (citations omitted).  Under West Virginia law, to determine whether there is an “adequate explanation” for the inconsistency, the court should examine “1) whether the deposition afforded the opportunity of direct and cross-examination of the witness; 2) whether the witness had access to pertinent evidence of information prior to or at the time of his or her deposition; and 3) whether the earlier deposition testimony reflects confusion, lack of recollection or other legitimate lack of clarity that the affidavit justifiably tries to explain.”   Id. at *8 (citations omitted).

In this case, the expert’s affidavit, stating that he excluded all causes other than the defendant’s drug for the plaintiff’s developmental delays, was inconsistent with his earlier testimony that he was not qualified to perform a differential diagnosis and with answers he gave about specific alternative causes, id., and none of the three possible “explanations” was adequate to justify the inconsistency.   As such, the court excluded the expert’s specific causation testimony.  Because the plaintiff had no other specific causation expert, the court granted summary judgment to the defendants.

While we applaud the integrity of any expert who admits that he is not qualified to render his opinions and that he arrived at them with no methodology, an expert prepared to make these admissions obviously should not have offered those opinions in the first place. And if the plaintiff’s deficient expert testimony cost him his case, this is no more than what courts are supposed to do (and too often do not).   In this case, with a key piece of the puzzle missing, the show, quite properly, did not go on.   We would love to see more of the same.

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.”

Continue Reading Warning Causation Potpourri in New Jersey Mass Tort

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.

Continue Reading S.D. Cal. Shows No Love for Aphrodisiac Class Certification

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.

Continue Reading TCPA Health Care Exceptions Properly Applied In California

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).

Continue Reading Bootstrapped Claim Against the FDA Gets the Boot

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.

Continue Reading Update on Prosecution for Truthful Off-Label Promotion

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.

Continue Reading Another Champion for Proportionality in Discovery