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

A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations. Monk v. Wyeth Pharmaceuticals, Inc., 2017 U.S. Dist. LEXIS 72477, *21-23 (W.D. Tex May 11, 2017). That seems pretty straightforward to us. Plaintiffs typically use negligence per se to try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim.  State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman.  That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that. Monk doesn’t say all of that explicitly, but it relies on cases that do. That’s good enough for us.

Plaintiff based her negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions.  The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at *3, *6 (citing 21 C.F.R. § 208.24(b)).

And this is where things get confusing, because while the court dismissed plaintiff’s negligence per se claim based on violation of this regulation, the court reached the opposite conclusion regarding plaintiff’s negligent failure to warn claim based on exactly the same thing.  A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the court concluded that this very federal-sounding claim was actually a parallel state law failure to warn claim. But wait. Isn’t plaintiff suing because the defendant allegedly violated the FDCA.  That’s Buckman implied preemption. As many courts have noted, plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging they are suing for conduct that violated the FDCA, but not because the conduct violated the FDCA. But the only allegation here is that defendants did not provide the medication guides as required by federal regulations.

The court’s reasoning is based entirely on dicta in the Fifth Circuit’s decision in Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 679 (5th Cir. 2014) that “failing to provide FDA-approved warnings would be a violation of both state and federal law, this is a parallel claim that is not preempted.” Id. But the claim that defendants provided no warnings was not alleged in the complaint and so was not allowed by the court. There is no information in Eckhardt regarding the basis for plaintiff’s claim that defendant failed to provide any warnings and so it is unknown if it was “because” defendant’s violated a federal regulation.

In Monk, the court knew precisely the basis for plaintiff’s failure to warn claim – 21 C.F.R. § 208.24(b); the same basis as plaintiff’s negligence per se claim. That the result is different on both claims is really difficult to reconcile. So we won’t try. We’ll instead reiterate – no negligence per se based on FDCA in Texas.

 

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice things about Dr. Gottlieb before his confirmation.

Not so now.

Given what Dr. Gottlieb has said – and is saying – we doubt that the FDA’s absolutist ban on truthful industry speech about off-label uses (pejoratively called “promotion”) will continue much longer in its current form.  For instance, on the FDA’s website, Dr. Gottlieb is quoted here as giving a speech saying:

The question we need to ask ourselves is this: Should a patient receive one or even two-year-old care just because the wheels of my government institution and its meticulous work may take longer to turn than the wheels of clinical science?  Some people believe that patients should be treated only according to the clinical evidence included in a drug’s approved indications.  Yet this evidence may be two or maybe three years old, especially in a fast-changing field like cancer, where off label use of medicines provide important opportunities for patients to get access to the latest clinical practice and for doctors to tailor their patients’ treatment plans based on medical need and personal preferences.

*          *          *          *

Efforts to limit prescription and scientific exchange to indications only specified on a label could retard the most important advances in 21st century medicine.  The development and deployment of drugs is becoming more and more closely linked to understanding of mechanism of action, which means that physicians can use drugs in more sophisticated ways that cannot all be anticipated on a label, or easily or quickly studied in prospective studies. . . .  More important, medicine is becoming more personalized as tools like genomics make it possible to tailor treatments on an individual basis. Physicians will not be able to always wait for FDA to approve a new label for every one of their patients, and drug companies will not be able to conduct a trial to explore every possible contingency.  In the future, personalization of care could mean that we will have much more off-label use of new medicines, guided by the latest literature, at least until our regulatory approaches are able to fully adapt to a different paradigm where treatment is highly specific to individual patients.  Yet policy forces are tugging in exactly the opposite direction by placing restrictions on the exchange of some of the most pertinent information.

(Emphasis added).  Defendants in cases involving off-label-use-related allegations should consider having their FDA experts review and, if appropriate, rely upon the current FDA Commissioner’s positions – particularly to rebut contrary views offered by former FDA officials.

Dr. Gottlieb’s non-FDA writings show similar solicitude for scientific speech – whether or not that speech originates with FDA-regulated manufacturers.  In an article for the American Enterprise Institute, Dr. Gottlieb criticized FDA policies that “prohibited” a manufacturer with a drug undergoing supplemental FDA approval for a new use from “distributing the findings or educating doctors on the new use through sponsored medical education.”  “[A] more measured approach to the regulation of promotion” would allow “sharing of useful information that falls within the bounds of appropriate clinical care.”

Those who pursue a rigid adherence to restrictions on the exchange of off-label information, and who fail to recognize that the sharing of scientific evidence can sometimes have important public health benefits, are guilty of pursuing a rigid standard that does not take measure of the consequences. . . .  [E]stablishing the FDA label as the only determinant for acceptable scientific speech loses sight of the fact that these labels are slow to incorporate important medical results about the effectiveness of medical products. They are not the sole basis for medical practice.

In another AEI article a few years later – shortly after the government lost United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) − Dr. Gottlieb’s criticism of the FDA’s prohibition of truthful speech about off-label uses was even more pointed.

When this [off-label] speech is truthful, nonmisleading, and promulgated in an educational context, it is quite possible that the speech would be deemed constitutionally protected by the courts under doctrines that recognize commercial speech as being subject to First Amendment considerations.

(Footnote omitted).  Basically, Dr. Gottlieb took issue with whether scientific speech concerning off-label uses could ever be considered illegal “promotion”:

A core principle of America’s constitutional speech protections is that the government should not establish what is orthodox, especially when it comes to politics, the arts, religion, and science.  The founders recognized that these matters are by their nature iterative, and that it would be dangerous in a democratic society for the government to use its resources to pick a side in these debates.  Matters that are subject to their own evolution − a core feature of how new science unfolds − are better addressed by adding voices to the debate, not suppressing them.

Dr. Gottlieb even urged FDA regulated manufacturers to stand up and challenge the constitutionality of off-label informational restrictions promulgated by the FDA – the agency he now leads:

[T]he drug industry needs to be willing to take the prerogative to challenge the facts in some of these cases and have that day in court. When investigations turn on the sharing of truthful, nonmisleading information about widely accepted uses of drugs, in fast moving fields like cancer, there is a legitimate question about whether public health is being served by suppressing this sort of information.  However, until these cases are challenged in court, there will remain ambiguity around where the appropriate lines rest, what speech is constitutionally protected commercial speech or clearly violative, and how public health is best served.

(Emphasis added).  Not long after that, a company took up Dr. Gottlieb’s challenge, and the result was Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).

To some extent, where one stands depends upon where one sits, but Dr. Gottlieb has enough of a track record on truthful manufacturer speech about off-label uses of drugs and medical devices, and the constitutional and medical implications of suppressing it, that we are more hopeful now than we have ever been that the FDA will see reason, respect the First Amendment, trust physicians, and change its science-suppressing ways.

With that in mind, we examine the newest First Amendment precedent rejecting governmental prohibition of a manufacturer’s truthful speech about its product, Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017).  Ocheesee is a food (skim milk) case, but doesn’t involve the FDA – it doesn’t even involve the federal government.  Instead, Ocheesee is a demonstration that, when given the chance, state regulators are still equally capable of behaving just as badly towards the First Amendment as the feds, albeit on a smaller scale.

It may be that Ocheesee doesn’t involve interstate commerce, see 851 F.3d at 1231 n.1, or it may be that there is something peculiar about milk regulation that we don’t know, but the State of Florida (not the FDA or any other federal entity) came down on the plaintiff, described as “a small dairy creamery located on its owners’ farm” that “sells all-natural dairy items,” like a ton of bricks.  Id.  Apparently, the process of “skimming” the cream from whole milk “depletes almost all the vitamin A naturally present in whole milk because vitamin A is fat-soluble and is thus removed with the cream.”  Id.  Thus Florida agricultural regulations require vitamin A to be added to skim milk before it can be sold as “skim milk.” Id.

That was a problem for the plaintiff because, as a matter of philosophy, this business “prides itself on selling only all-natural, additive-free products.”  Id.  It therefore “refuse[d] to replace the lost vitamin A in its skim milk” with a vitamin A additive as Florida law required.  Id.  The State of Florida thus prevented the plaintiff from calling its product “skim milk,” even though that “product contains no ingredients other than skim milk.”  Id.  Instead (and ironically) the state sought to require the plaintiff to call its product “imitation milk.”  Id. at 1232.  Not surprisingly, the plaintiff refused and sued instead.

Readers attuned to the First Amendment no doubt see the problem already.  Calling such a product “skim milk” is truthful.  The State of Florida – like the FDA with truthful off-label speech – sought to suppress the plaintiff’s truthful speech in a commercial context, using the public health (vitamin A is not just good for you, but essential to health) as its reason for doing so.  Who wins – the First Amendment right to engage in truthful commercial speech, or the state’s public-health-based rationale for suppressing such speech?

In Ocheesee, freedom of speech prevailed.  851 F.3d at 1233 (“The sole issue on appeal is whether the State’s actions prohibiting . . . truthful use of the term ‘skim milk’ violate the First Amendment.  We hold that they do.”).

First, the lay of the constitutional land.  Ocheesee applied the now-venerable “Central Hudson” intermediate scrutiny test for constitutionality of governmental restrictions of commercial speech.  851 F.3d at 1233 (citing Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557, 563-64 (1980)).  Thus, Ocheesee did not apply the more speech protective tests enunciated in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (“heightened scrutiny”) (see our discussions here, here, here, and here); and Reed v. Town of Gilbert, 135 S.Ct. 2218 (2015) (“strict scrutiny”) (see our discussion here).  That doesn’t mean that the Eleventh Circuit was unaware of these cases – quite the contrary:

There is some question as to whether under the Supreme Court’s decisions in Sorrell and Reed an analysis to determine if the restriction is content based or speaker focused must precede any evaluation of the regulation based on traditional commercial speech jurisprudence, and if so, whether this would alter the Central Hudson framework.  In Sorrell, the Supreme Court found the restriction at issue to be content based but nevertheless cited, articulated, and applied the Central Hudson test.  And in Reed, the Court arguably broadened the test for determining whether a law is content based. . . .  We need not wade into these troubled waters, however, because the State cannot survive Central Hudson scrutiny, and in any event the [plaintiff] does not argue the State’s restriction was content based or speaker focused.

851 F.3d at 1235 n.7.  Thus, the favorable First Amendment decision in Ocheesee sets a floor for the protection of truthful commercial speech in the Eleventh Circuit that parties arguing Sorrell and Reed may exceed.

Under the Central Hudson criteria, as a “threshold question,” the government (which always has the burden of proof) had to establish that the suppressed speech either concerned “unlawful” conduct or was “false or inherently misleading.”  851 F.3d at 1235-36.  It failed because selling the plaintiff’s product was not unlawful – the state would have allowed its sale under the “imitation” description.  Id. at 1237.  Note the parallel to off-label speech – doctors are free to engage in off-label use, and products so used may be lawfully sold.  “[T]he only difference between the two courses of conduct is the speech.”  Id.

Nor could the speech be considered false or misleading.  The state could not simply “define” a product in whatever way it chose, and declare anything not meeting that definition “misleading.”  The court rejected such “self-evidently circular” reasoning:

Such a per se rule would eviscerate Central Hudson, rendering all but the threshold question superfluous.  All a state would need to do in order to regulate speech would be to redefine the pertinent language in accordance with its regulatory goals.

Id. at 1238.  Again, any resemblence to the FDA’s salami slicing of “intended uses” is entirely intentional.  Consumer “unfamiliarity is not synonymous with misinformation.”  Id. at 1239 (citation and quotation marks omitted).

Next up in Ocheesee was the three-pronged “intermediate scrutiny” Central Hudson test:  (1) was the asserted governmental interest substantial? (2) did the regulation directly advance the that substantial governmental interest? And (3) was the restriction on speech more extensive than is necessary to serve that interest?  851 F.3d at 1235-36.

As in off-label promotion cases, the “substantiality” of the government’s “interest in combating deception and in establishing nutritional” – that is to say product safety and effectiveness – “standards” was concededly “substantial.”  Id. at 1240.  Ocheesee jumped over the second prong and went right to the third, “because the measure is clearly more extensive than necessary to achieve its goals.”  Id.

In all commercial speech cases, “the preferred remedy is more disclosure, rather than less.”  Id. (Supreme Court citation omitted).  Florida’s flat ban on use of the term “skim milk” failed because a disclaimer would serve the same purpose in a “less restrictive” and “more precise” way.  Id.  “[A]llowing skim milk to be called what it is and merely requiring a disclosure that it lacks vitamin A” was sufficient “to serve [the state] interest in preventing deception and ensuring adequate nutritional standards.”  Id.

The First Amendment thus prevailed where the speech is truthful – without the court going even having to go to the trouble of relying on heightened (Sorrell) or strict (Reed) scrutiny, both of which would be argued in truthful off-label speech cases.  Visions of shattered backboards come to mind.  We don’t think Dr. Gottlieb wants the FDA to end up like Bill Robinzine, so we’re looking for a more reasonable off-label speech policy to emerge from the FDA, before a court has to do so for the agency.

We were not affected by the recent ransomware attack that disabled computers worldwide, including in multiple public hospitals in the UK. At least not yet.  For those who have never had the pleasure or who otherwise do not follow cybersecurity news closely, “ransomware” refers to an attack on a computer system that encrypts the user’s data—making it unavailable—and then informing the user where it can send payment in exchange for the encryption key.  It’s diabolical, and it preys upon users who have an immediate and urgent need for their data—such as healthcare providers in the process of providing life-saving and life-improving care.  The topic is of particular interest to us because healthcare data presents the classic data security conundrum:  Access to healthcare information improves patient care, yet the private nature of health information mandates tight control to prevent unauthorized access.

So it got us to thinking, what about the government? What are federal agencies doing to protect the enormous volumes of private information that they hold?  Regulators such as FDA, the FTC, and the Department of Homeland Security have stridently and justifiably insisted that our clients have policies in place regarding the protection of private information.  We would expect no less.  But is what’s good for the goose also good for the gander?

It just so happens that President Trump signed an executive order last week calling for federal agencies to get their cybersecurity houses in order. In its Presidential Executive Order on Strengthening the Cybersecurity of Federal Networks and Critical Infrastructure, the administration set forth three cybersecurity priorities:  (1) Cybersecurity of Federal Networks, (2) Cybersecurity of Critical Infrastructure, and (3) “Cybersecurity for the Nation.”  We put the last one in quotes because it is so broad that it could mean anything.  You can link to the executive order here.  You can also take a look at what our colleagues at Reed Smith’s Technology Law Dispatch have to say about the executive order here.

The executive order directs federal agencies to take stock of their systems and prepare reports to be submitted ultimately to the Assistant to the President for Homeland Security and Counterterrorism, a position that has existed in some form since about a month after the attacks of September 11, 2001. Lots of reports.  By our count, the executive order calls for more a dozen categories of reports prepared by federal agencies on such topics as risk mitigation, budget concerns, the transition of computer systems, and authorities and capabilities that can be deployed against cyberattack.  It’s a lot, and on an extremely aggressive time schedule—the first of the reports are due in less than 60 days.

The section on Cybersecurity of Federal Networks starts with certain findings, including this one: “The executive branch has for too long accepted antiquated and difficult-to-defend IT.”  We know from the Jason Bourne movies and any number of television shows about super-secret government agencies that the federal government has multiple windowless rooms filled with slick computer systems that know all and can do all, and look really cool in the process.  We also know from our very brief sojourns into government service that reality does not match the movies.  Technology is certainly better now than it was when we last plied government halls, but we would describe the available technology then as piecemeal, even haphazard.  It’s like when the government renovated the Pentagon years ago and found multiple antennas on the roof that no one what they did or to whom they transmitted.  The technology had outlived the people who implemented it.

The Trump administration wants to fix that. The first and maybe the most important provision is that, effectively immediately, all government agencies will use the Framework for Improving Critical Infrastructure Cybersecurity developed by the National Institute of Standards and Technology.  The NIST Framework is a published framework for computer security that is highly regarded and widely referenced in private industry.  It dates back to 2014, and its hallmark is proactive risk management.  As we reported here, the FDA has recommended that medical device manufacturers adopt parts of the Framework in designing their own cybersecurity programs.

It therefore came as a surprise that the government has not already itself widely adopted the NIST Framework. Nor will all federal agencies be able to do so “immediately.”  The NIST published its draft Implementation Guidance for Federal Agencies just the other day, and the comment period remains open through June 30, 2017.

Timing aside, adoption of the NIST Framework is a welcome development. It addition, each agency head (including presumably the FDA head) has to prepare a risk management report within 90 days that sets forth the agency’s direction and its plan to implement the Framework.  Then within another 60 days, the President wants an overall plan.  Again, these are very aggressive time frames, and we will see if they permit any real analysis or viable plans of action.

The executive order also makes it’s the policy of the executive branch to build and maintain a “modern, secure, and more resilient executive branch IT structure.” Agency heads “shall show preference” to shared IT services, and a committee of officials will prepare a report, again within 90 days, on transitioning federal agencies to shared IT services.  This provision seeks to make the government technology bureaucracy reasoned and consistent.  Reality may get in the way.  We are not sure that every agency head will even be capable of surveying and describing his or her agency’s systems within 90 days, but it is nice that they now have to try.

The section on Cybersecurity of Critical Infrastructure pledges the government’s support for the cybersecurity risk management of the owners and operators of the nation’s critical infrastructure, and it calls for additional assessment, reporting, and plans. The deadlines given for these efforts are characteristically short—ranging from 90 to 240 days.  The seemingly all-encompassing section on “Cybersecurity for the Nation” is really about one thing:  Promoting an open, interoperable, reliable, and secure Internet for all.  The Internet is at the center of everyday business and living, and it will only get more pervasive.  We heard on this morning’s news that Google is developing “ambient” networking technology, under which the Internet will be all around us.  A device in your home will, for example, monitor your schedule and tell you when you take your meds, whether your flight is delayed, or whether you need to leave extra time to pick up your spouse at the train station.  The potential for inconvenient attacks, or worse, clearly exists.

The executive branch aims to secure the Internet from cyber threats through protection against adversaries, cooperation with international allies and other partners, and development of a domestic workforce trained and equipped to promote these ends. Of course, there will be more reports, and we will be interested to see what the various agency heads will have to say.

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the Spanish Riding School in Vienna, as we had wished for this since we were very small. And in the phrase “hold tickets” lies the rub.  Though our companion warned us, as we locked the door and departed for the airport, to be sure we had the tickets, we somehow arrived in Europe without them and descended into panic.  For, unlike virtually every other admission credential we had used in the past five years, these were not e-tickets or pdfs but were actual, cardboard tickets, mailed to us in a postal envelope.  And they were missing.  Luckily, in this age of e-mailed confirmations and of people everywhere speaking perfect English, we were able to secure duplicate tickets and to see the stunning white horses of our dreams.  But we were warned, so we would have had no one to blame if the outcome had been different.

As was the case in today’s decision. Ford v. Riina, et al., 2017 N.Y. Misc. LEXIS 1649 (N.Y. Sup. Ct. May 2, 2017), is an unpublished opinion out of the Supreme Court of New York County. The facts are quite tragic.  The plaintiff was being treated for a brain aneurysm by the physician defendant when “a coil escaped” and migrated further into the plaintiff’s brain. Ford, 2017 N.Y. Misc. LEXIS 1649 at *1.  The doctor attempted to retrieve the coil using the manufacturing defendant’s device after another method failed.  “Retrieval of foreign bodies misplaced during interventional radiologic procedures in the neuro . . . vasculature” was one of the indications in the device’s Instructions for Use (“IFU”), which contained warnings about, inter alia, using the proper size of the device (available in a range of sizes) and not performing more than six retrieval attempts in the same vessel using the device.   The IFU also reported that one fracture of the retriever had occurred during clinical trials and provided instructions for reducing the risk of fracture.

The doctor first tried one size of the retriever in the plaintiff. He captured the errant coil, but the retriever fractured when he attempted to retract it.  He tried a larger retriever, which also fractured.  Ultimately, the doctor was able to capture one of the fractured retrievers with a snare but was unable to capture the second retriever or the coil.  The plaintiff was taken for an emergency craniotomy and suffered a major stroke that left him severely brain-damaged.  He sued the doctor and the device manufacturer, and stipulated that claims against the manufacturer would be limited to design defect and failure to warn, and the manufacturer moved for summary judgment on both claims.

In support of its motion, the manufacturer submitted four affidavits.   The first was the affidavit of an engineer employed by the manufacturer’s successor.  The engineer stated that he was able to determine the lot number of each device opened by the doctor and that he was able to determine that there were no reported fractures of any devices in the relevant lots except the fractures to the devices used in the plaintiff.  The second affiant was a bioengineer, who stated that the retriever was the state-of-the-art medical device for foreign body removal from the time of the plaintiff’s procedure up to the present time.  He also stated that fracture was exceptionally rare in the device in question and that the benefits of the device outweighed the risk of fracture, which is inherent in all retrieval devices. The third affiant, a neurologist, opined that the retriever’s IFU expressly warned of the risk of fracture and of vessel damage, that the warnings – including the warning of the precise event that occurred in the plaintiff – were clear an adequate, and that the risks of fracture and vessel damage were “generally known and accepted in the relevant medical community.” Id. at *13-14.  Finally, a registered professional engineer opined that “no other commercial engineering or biomedical alloy can come close” to the elasticity and shape memory of the alloy used in the defendant’s device, id. at * 15-16, that there is no other material commercially available to manufacture the device for its intended use. Id. at *17.

In opposition, the plaintiff submitted the affidavits of two witnesses. The first, a materials scientist, claimed that he tested the retrieval device under a variety of conditions, that the testing confirmed that cracks and fractures could occur with much greater ease and frequency than the IFU suggested and under conditions of which the IFU did not warn, and that, as such, the IFU did not contain adequate warnings related to the potential for fracture. The second witness, a biomedical engineer, opined, inter alia, that the IFU did not adequately warn of the potential for the device to become entangled or stuck in a vessel and of the difficulty of disengaging it once it was stuck.  He also claimed that there were feasible alternative design features that would have prevented the plaintiff’s injury.

The court held that the manufacturer had “establishe[d] prima facie that the IFU conveyed to physician-users the most current knowledge concerning the potential risk of fracture associated with the [device], which is all the law requires.” Id. at *33 (citation omitted).  In addition, the IFU “set forth various steps which the physician-user could take to reduce that risk.” Id. Finally, the manufacturer “establishe[d] its prima facie entitlement to summary dismissal of plaintiff’s design defect claim by establishing that the [device] was state of the art for removing . . . foreign bodies from the neurovasculature, that the device was properly designed and manufactured . . . and . . . incorporated changes made to the [device’s predecessor] as well as other modifications that minimized the risk of fracture.” Id. at *34 (citations omitted).

Once the manufacturer made its prima facie showing, the burden was on the plaintiff to identify a triable issue of fact. And the court held that the plaintiff did not satisfy this burden.  The court stated, “An expert’s affidavit – offered as the only evidence to defeat summary judgment – must contain sufficient allegation to demonstrate that the conclusions it contains are more than mere speculation and would, if offered alone at trial, support a verdict in the proponent’s favor.” Id. at *35 (citations omitted).  In this case, the plaintiff’s experts made “repeated reference to various tests and experiments they performed which they contend[ed] replicated the foreseeable event of the [device] being ‘fully stuck’ within a patient’s cerebral vasculature.  However, noticeably absent . . . is any description . . . of the actual tests and experiments they performed or the conditions under which they performed them . . . [including whether] the tests and experiments . . . were based on accepted industry standards. Id. at *36 (citations omitted).  The court concluded, “Simply stated, there is nothing in the experts’ affidavits from which the validity of their ultimate conclusions about the design of the [device] and the adequacy of the IFU can be inferred. . . .In the absence of any reference to a foundational scientific basis for their conclusions, [the plaintiff’s experts’] opinions lack sufficient probative value to raise a triable issue of fact” as to design defect or the adequacy of the warnings.”  Claims dismissed, summary judgment for the manufacturer.

Ford is a well-reasoned and correct decision that fits nicely into our self-styled crusade against the opinions of experts who should never darken the courthouse steps.  We will keep our eyes open for similar holdings in published, precedential opinions, and we will keep you posted.

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug (Eliquis) were preempted under the impossibility preemption reasoning in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).  However, as we noted in that post, dismissal of the non-design aspects of complaint was with “leave to amend.” See also Utts, 2016 WL 7429449, at *1.

Of course, plaintiffs amended.

Now, they probably wish they hadn’t.

In a second opinion, issued earlier this month, the Utts litigation was dismissed a second time, this time with prejudice. Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2017 WL 1906875 (S.D.N.Y. May 8, 2017) (“Utts II”).  Preemption was once again front and center, but this time an excellent preemption result was accompanied by a variety of equally pleasing common-law – California law – rulings.

Impossibility Preemption

First, preemption. Design defect claims had already been preempted under Mensing/Bartlett, as plaintiffs were reminded whenever they crossed the line into design-type claims. Id. at *1, 9, 10 n.10, 13 n.15, 16, 19.  But the major preemption issue this time around involved warnings – and whether any of the information that plaintiffs claimed required some kind of “better” warnings involved “newly acquired information” of the sort that a defendant could unilaterally add given the scope of the FDA’s “changes being effected” exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the “CBE” regulation for drugs – note, there are similar CBE regulations for devices and biologics; we’ve discussed the device regulation here).

For a more detailed discussion of the “newly acquired information” aspect of preemption, see our post here about In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), which was the first appellate decision finding preemption where plaintiffs failed to come forward with any “new” information to support their warning claims. Utts II explained that, in the preemption context, “if the plaintiff can point to the existence of ‘newly acquired information’ to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by ‘clear evidence’ that the FDA would not have approved the labeling change made on the basis of this newly acquired information.”  2017 WL 1906875, at *9.

Plaintiffs threw a lot of mud at the drug and its manufacturer, but nothing they heaved against the wall stuck – everything plaintiffs cited all old information that did not go beyond what the FDA had before it when it approved the drug in the first place.

Why is that?

Basically, Eliquis is a next-generation anticoagulant, very effective at what it does, and not requiring the kind of dietary restrictions and constant blood testing that older blood thinners such as warfarin – originally sold as rat poison – do.  Utts II, 2017 WL 1906875, at *2 & n.4.  Unfortunately, the plaintiffs’ bar has decided that anybody needing anticoagulation therapy should be should only have such older drugs available, and has launched an ongoing litigation assault at practically every next generation anticoagulant (others include Xarelto and Pradaxa) – because of risks of serious and sometimes fatal bleeding inherent in what these drugs are supposed to do.

The FDA was well aware of the risks that Eliquis, like any other anticoagulant, could cause uncontrollable bleeding when it approved it. Indeed, the “label warns about the risk of serious bleeding no less than five times.” Id. at *3.  It “specifically warns about the risk of bleeding” during concomitant therapy “in conjunction with antiplatelet agents, such as aspirin.”  Id. at *4.  The labeling also “twice warns about the fact that there is no specific antidote” should serious bleeding occur.  Id.

That’s why plaintiffs lost in Utts II.

Basically, the well-known fact that anticoagulants carry with them serious bleeding risks is why none of the information that the plaintiffs in Utts II brought forward qualified as “new.”  “New” is defined in the FDA’s CBE regulation as “studies, events, or analyses [that] reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.  21 C.F.R. §314.3(b) (quoted at 2017 WL 1906875, at *8).  In the preemption context, “

  • “The table and the description from the ISMP report do not suggest − nor do the plaintiffs allege − that the real-world signal data for [the drug] shows a greater severity or frequency of bleeding events or deaths than previously disclosed in [defendant’s] submissions to the FDA. Accordingly, the information contained in this table does not constitute newly acquired information. Utts II, 2017 WL 1906875, at *13.
  • Plaintiffs argue “that the guidance regarding concomitant use of antiplatelet agents is inadequate because the label does not advise how or when to use combination therapy . . . or how commonly bleeding events will occur. This omission . . . was evident to the FDA when it approved the label and the plaintiffs have not identified any newly acquired information.” Id. (quotation marks and footnote omitted).
  • This observation does not constitute newly acquired information, as it simply speculates whether [drug] safety could be further improved. Id. at *14 (as to “improved dosage guidance”).
  • [E]mbolic-thrombotic events are . . . not bleeding events. Nor do the plaintiffs argue that any of this data comparing the incidence of embolic-thrombotic events . . . constitutes newly acquired information. Id. (footnote omitted).
  • [T]he findings directed towards the risk of ischemic stroke for [the drug] users do not constitute newly acquired information. Id. at *15.
  • [P]laintiffs do not allege, however, that this expert guidance contains, or is founded upon, any newly acquired information regarding reversal agents or the treatment of excessive bleeding.” Id.
  • “[P]laintiffs do not allege that this statement contains newly acquired information about what constitutes a safe residual drug level.” Id. at *16.
  • “[T]his article does not refer to any new information that would have permitted the defendants to amend the [drug’s] label. And, in their opposition to this motion, the plaintiffs do not argue that it does.” Id.
  • “[P]laintiffs do not contend that any of the five remaining documents . . . contains newly acquired information regarding an undisclosed risk of bleeding. Several of these articles merely express a desire for further investigation. Id.

Thus, although plaintiffs loaded up their amended complaint with no fewer than “34 warnings that the defendants allegedly failed to provide,” 2017 WL 1906875, at *11, there was no safety in numbers. None of their supposedly missing warnings was based on “newly acquired information” as defined and required by the FDA’s CBE regulation.

Because, plaintiffs could not point to any “newly acquired information” to support their warning-related allegations, those allegations fell outside the scope of the Levine CBE exception and were preempted, because under Mensing/Bartlett such warnings could not be added without prior FDA approval.  2017 WL 1906875, at *9.

Next, in accordance with practically all law, Utts II held that preemption could be decided on a motion to dismiss.  A “determination regarding preemption is a conclusion of law.” Id. at *19 (pointing out that Mensing had been decided on a motion to dismiss).  To the extent that the Third Circuit’s aberrant Fosamax decision was pertinent, it was distinguishable.  Fosamax was limited to “clear evidence” determinations, and in Utts II, because plaintiffs offered no “new” information, clear evidence was never at issue.  Id. at *19-20.  Finally, plaintiffs were “not entitled to discovery on preempted claims.”  Id. at *20 (discussing TwIqbal).

In a way, the new evidence requirement discussed in Utts II resembles the so called “public disclosure” requirement that is a defense to False Claims Act claims (see here for more discussion), except that the “newness” of the information in preemption of state-law warning claims is measured against the evidence presented to the FDA, as opposed to the public.

Buckman Preemption

Utts II also found fraud-on-the-FDA preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Plaintiffs ran from their blatant fraud-on-the-FDA allegations, asking that they “be read merely as evidentiary background.”  2017 WL 1906875, at *26.  The court read them as they were written (and no doubt intended), and found preemption:

Each of the statements on which the fraud claim is premised depends on statements made to and approved by the FDA. There is no newly acquired information that required or suggested that the allegedly fraudulent statements should be altered to remain truthful and non-fraudulent.  Accordingly, the fraud claims are preempted.

Id.

Other FDCA-Related Issues

On other FDCA-related issues, Utts II ends up on our Adverse Drug/Device Event cheat sheet because of its discussion of how voluntarily reported adverse events aren’t legitimate proof of causation:

Federal regulations advise that a report submitted by a manufacturer “does not necessarily reflect a conclusion by the [manufacturer] or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse effect.” 21 C.F.R. § 314.80(l).  As the FDA Website explains:

FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

The Supreme Court has similarly warned that “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.” Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44 (2011). I n sum, “the mere existence of reports of adverse events . . . says nothing in and of itself about whether the drug is causing the adverse events.” Id.

Utts II, 2017 WL 1906875, at *12.

In addition, Utts II contains an excellent discussion of the harmful effects of overwarning.  The need to prevent overwarning is the reason that the CBE regulation does not apply to all information, new or old, that could in some way “strengthen” existing warnings:

The FDA has recognized that “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it.” Indeed, “labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance.” For this reason, the CBE regulation requires that there be sufficient evidence of a causal association between the drug and the information sought to be added.

Utts II, 2017 WL 1906875, at *8 (all quotes from “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices,” 73 Fed. Reg. 2848 (FDA Jan. 16, 2008).

Another notable FDA-related aspect of Utts II has to do with so-called “comparative claims” – claims that one medication is better than another in some respect.  Plaintiffs often claim (as they did in Utts II) that there is some sort of duty to warn that ones product is less safe than its competition.  However, Utts II points out that the FDA does not permit such claims except when supported by specific types and amounts of scientific evidence.  “[A]ny claim comparing the drug to which the labeling applies with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”  2017 WL 1906875, at *7 (citing 21 C.F.R. §201.57(c)(7)(iii)).  Further, “federal regulations do not require a manufacturer to include information about a competitor’s product or progress.” Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, 201.80).

State-Law Warning Issues

Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful holdings, mostly about California law.  The decision contains an excellent discussion of the state of the art defense.  2017 WL 1906875, at *10.  It also points out that, the California Supreme Court’s holding – quite apart from preemption – that as a matter of federal/state comity, warning liability does not exist as a matter of state law where the purported duty flies in the face of FDA regulation:

Even where a risk is “known” or “knowable” at the time of distribution, under California law, a manufacturer “may not be held liable for failing to give a warning it has been expressly precluded by the FDA from giving.” Thus, if the manufacturer disclosed to the FDA “state-of-the-art scientific data concerning the alleged risk” and the FDA determined, after its review, “that the pharmaceutical manufacturer was not permitted to warn − e.g., because the data was inconclusive or the risk was too speculative to justify a warning,” then the manufacturer could not be held strictly liable for failure to warn. “[T]he FDA’s conclusion that there was, in effect, no ‘known risk’ is controlling.”

2017 WL 1906875, at *11 (all quotations from Carlin v. Superior Court, 920 P.2d 1347 (Cal. 1996)).  Thus, the same grounds that support preemption as a matter of federal law – where, as here, the FDA says “no” – also preclude liability as a matter of state law.

In tandem with preemption, Utts II also holds that the defendant’s drug labeling was adequate as a matter of California law on the bleeding issues raised by plaintiffs – just as our prior post thought it should.  In general, the label “clearly discloses that there is a risk of excessive bleeding and that there is no known antidote if that occurs.”  2017 WL 1906875, at *21.  Nor could plaintiffs prevail with any of the usual nitpicking that goes on in this type of litigation.

  • Monitoring – “The label provides, in unambiguous terms, all of the scientifically reliable information that physicians may need to determine how to monitor their patients.” Id.
  • Bleeding Reversal – A “recommendation is to discontinue [the drug] and apply ‘standard supportive treatment and other local measures’ . . . does not supply a basis for a plausible claim that the label needed to add further guidance.” Id. at *22 (quoting medical article).
  • Dosage – Plaintiffs do “not identify any research or data that undermines or contradicts the dosing guidance” and “speculation about information that the defendants may possess is insufficient to plausibly plead a claim.” Id. (citing TwIqbal).

Similarlly, plaintiffs other warning-based claims failed due to the adequacy of the warning.  Id. at *24 (implied warranty), *26-27 (fraud); *29 (consumer fraud)

Finally, here are some other California warning-related nuggets we can use:  (1) Under the learned intermediary rule, “a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably knowable dangerous side effects, regardless of whether the warning reaches the patient.”  2017 WL 1906875, at *11. (2) “[P]harmaceutical manufacturer[s] may not be required to provide warning of a risk known to the medical community.” Id. (quoting Carlin).  (3) “[W]arnings relevant to any breach of warranty claim are those directed to the physician rather than the patient.” Id. at *22 (quoting Carlin) (emphasis original).  (4) The opinion notes that the learned intermediary rule applies to California consumer fraud claims.  Id. at *28 n.32.

Looking Forward

Utts II contains by far the most detailed discussion to date of the interplay between preemption and the “newly acquired evidence” requirement of the FDA’s CBE regulation.  It would be notable for that reason alone.  However, it also finds the labeling adequate as a matter of law, which is second highly significant ruling in any prescription medical product litigation.  What’s more, since the entire Utts amended complaint is now dismissed with prejudice, not only Utts II, but also the original Utts design defect preemption ruling, is now appealable.

Any appeal would be interesting.  Every ruling in Utts II is double-breasted, in that preemption is bolstered by independent state law grounds.  That is not the case with design defect preemption in the original Utts decision, where preemption is the sole basis for dismissal.  Utts, 2016 WL 7429449, at *12.  So, if plaintiffs were to appeal, their only clean shot at preemption would involve their design claim.  In any event, the preemption rulings in both Utts (Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015)), and Utts II (Celexa, 779 F.3d 34) are supported by court of appeals decisions, as our preemption cheat sheet demonstrates.  At best, in a hypothetical appeal, we would get an affirmance and reinforcing appellate precedent supporting preemption in innovator drug cases.  At worst, there would be a circuit split, which would offer the further (double-hypothetical) possibility of additional Supreme Court review of what Utts II called the Levine “trilogy.”  2017 WL 1906875, at *9.  While we always prefer to win, whenever, however, and as quickly and as thoroughly as possible, we certainly would find another shot at innovator drug preemption in the Supreme Court an interesting proposition.

We like bright lines in the law.  They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability.  Rear-end a car and you’re liable, even if the other guy stopped short.  Leave a sponge behind in a patient’s abdomen, and you and your operative team are on the hook.  The thing speaks for itself, and the thing it speaks is very bad for your defense case.  Utter a negative statement about someone in a courtroom, and you’re immune from libel liability.  Say the same thing on the courthouse steps, and you might be in trouble.  Sell a pharmaceutical product with a federally approved label, and when someone sues you for failure to warn you’re … uh oh. Thanks to the Supreme Court’s opinion in Wyeth v. Levine, you’re still in the soup if you could have added warnings via the Changes Being Effected (CBE) provision.  You might not like that rule, but at least it’s clear, right?  Wrong.  Recent opinions have come out on opposite sides as to what would constitute “clear evidence” that the FDA would have rejected an additional warning, or even who gets to decide that ‘fact.’

 
But at least we know that the CBE provision is available only in certain circumstances, right?  Thanks to the recent case of Blackburn v. Shire US, Inc., 2017 WL 1833524 (May 8, 2017), even that inquiry is muddy.  The plaintiff in Blackburn alleged that he contracted kidney diseases from a drug known as LIALDA.  Please forgive us for thinking that the failure to warn claim is a straight loser, since the LIALDA warned of precisely the injuries suffered by the plaintiff.  That would be a nice example of a bright line rule.  The defendant filed a motion to dismiss the entire First Amended Complaint.  That motion to dismiss was strongly supported by the Wyeth v. Levine “clear evidence” standard.  Or at least it should have been.  The motion to dismiss was also strongly supported by the Pliva/Bartlett independence/impossibility principle.  Or at least it should have been.  The Blackburn court granted the motion to dismiss only in part, and it is hard to characterize the court’s reasoning as anything but disappointing.
 
The plaintiff argued that the label was defective because it merely recommended “periodic” evaluations for possible kidney damage.  The plaintiff argued that “periodic” was too vague.  According to the plaintiff, “periodic” might mean semi-monthly or annual.  According to the plaintiff, the LIALDA label should have suggested evaluations every month for the first three months after therapy, then on a quarterly basis for at least one year.  The court bought the plaintiff’s argument, which amounts to a duty to tell doctors how to practice medicine.  Technicality and a belief in the vicissitudes of juror deliberations triumph over common sense. This ruling is further proof that no matter what a warning label says, a clever plaintiff lawyer and a cautious court can always conjure up an ‘improvement’ to a product label and thereby keep a weak case on the docket.
 
Even assuming that “every month for a while, then quarterly” would be an improvement, or even a distinction with a difference vs. “periodic,” the defendant had a pretty good argument in support of preemption. The CBE supplementation process applies only when “newly acquired information” becomes available and would support the label change that the plaintiff wants.  Prior to the LIALDA label, there was already information regarding the sort of testing protocol argued for by the plaintiff.  That’s not just how we defense hacks parse the record.  The plaintiff admitted “that evidence of the renal toxicity of LIALDA and his proposed testing regimen existed prior to LIALDA’s FDA approval.”  Blackburn, 2017 WL 1833524 at *4. That pre-existing information environment should support preemption.  Shouldn’t it?  No, said the court, because there was additional evidence about testing after the label went into effect.  Such incremental evidence could have had a cumulative effect, and that effect could constitute “newly acquired information.”  Ugh.  How much more is enough to make a difference?  Is mere repetition enough?  Who knows?  So we have a label that warned of the injury suffered, advised periodic testing, and even if it didn’t specify the period as much as the plaintiff would like, there was already pre-label information about such testing.  Maybe the only bright line the court favors is one against preemption.
 
The plaintiff’s proposed change faced another preemption barrier.  The change would seem to apply both to the “Full Prescribing Information” section in the label and the “Highlights” section.  The regulations (21 C.F.R. §314.70(b)(2)(v)(C), to be specific) do not permit a drug manufacturer to change the Highlights section without FDA approval.  That would be a “major change.”  The plaintiff argued that the FDA might have approved a change in the Highlights section, but that sort of speculation is foreclosed by the Pliva/Bartlett independence/impossibility principle.  If a manufacturer cannot take unilateral action, a lawsuit insisting on such action is preempted, and even this cautious court agreed that any change to the Highlights section would be preempted.  The “periodic” language criticized by the plaintiff appeared in both the Highlights section as well as the body of the label.  Is it possible to demand change in one without demanding the same for the other?  The Blackburn court was not sure, but gave the plaintiff the benefit of the doubt.  The plaintiff might be going forward on “shaky ground” (2017 WL 1833524 at *7), but the court permitted the plaintiff to proceed under the highly fictional notion that the term “periodic” in the Highlight section is okay so long as the body of the label supplies a “mere clarification” of what “periodic” means.  So the elaboration of “periodic” to mean a particular testing regimen manages to be both crucial and perfunctory at the same time.  
 
Even aside from preemption, the learned intermediary doctrine should have barred the plaintiff’s failure to warn claim.  There was no allegation that the treating doctor would have prescribed a different treatment.  It is not even clear that there was a specific, plausible allegation that the doctor would have done anything different.  If preemption is Scylla and the learned intermediary doctrine is Charybdis, how did the plaintiff evade both?  The court thought it sufficient that the plaintiff alleged that the treating doctor was a gastroenterologist, and that he probably missed the nephrology literature that expounded on the preferred testing regimen.  Thus, the First Amended Complaint offered sheer speculation that the treating doctor would have implemented a different testing regimen if only the label had informed him of as much.  But, did the treater read beyond the Highlights?  That treating doctor’s deposition will turn out to be quite important, though the court’s roadmap promises a bumpy trip, filled with blind alleys and detours.
 
Not everything the Blackburn court did was dismal.  The court dismissed the express warranty claim because the LIALDA label cannot be construed as “an express warranty of safeness.”  Id. at *9.  What the label did say was that LIALDA was safe to treat the illness at issue, and that the medicine presented a risk of precisely the injury suffered.   How can there be a breach of warranty?  At this point, we are nodding our head in agreement, quickly followed by shaking it in puzzlement over how this rationale does not equally apply to the failure to warn claim.  The court also dismissed the fraud claims because there was no misstatement of a material fact.  Rather, the plaintiff alleged only deficiencies with the label’s recommendation for testing.  We certainly agree that the alleged deficiency is not material, but then wonder how that same immateriality permitted the plaintiff to circumvent both preemption and the learned intermediary doctrine.   

One of the issues that the federal Civil Rules Committee’s discovery subcommittee considered, but that eventually fell by the wayside, on the way to the 2015 discovery rules amendments, were proposals to convert to a “requestor pays” discovery system.  That would be a very significant change, and one of the criticisms that the other side leveled at such a system was that only rich people (or at least only rich plaintiff lawyers) could afford to bring suit, given the prospect of having to pay for expensive discovery that current system now gives plaintiffs for free.

Well, not for free.  Nothing is free.  The current “producer pays” discovery system gives plaintiffs a windfall by allowing them to demand production of millions of dollars’ worth of documents – and as importantly, electronically stored information (“ESI”) − and to impose those costs almost entirely on defendants.  As any economist will tell you, any system that provides access to something for free or at greatly below-market cost, be it health care, “dumped” imports, or discovery, creates greater demand for whatever the below-cost item is than would exist otherwise.

It’s worse in the legal system, because the other side’s heightened demand for “free” discovery has the concomitant effect of increasing the nuisance (that is to say, settlement) value of all litigation in which such demands are made – since one’s opponent is stuck with the bill.

All our side got out of the 2015 rules amendments cycle on requestor pays is a provision more clearly recognizing the authority of courts to shift discovery requests.  See Fed. R. Civ. P. 26(c)(1)(B).  As we’ve mentioned, a couple of courts have done this during prescription drug/device MDL litigation.  See In re Bard IVC Filters Products Liability Litigation, 317 F.R.D. 562 (D. Ariz. 2016); In re Benicar (Olmesartan) Products Liability Litigation, 2016 WL 5817262 (D.N.J. Oct. 4, 2016).  Both of those cases involved what the courts viewed as excessive and unnecessary MDL discovery targeted at the defendants’ overseas activities.

Now we’ve found a third case – it took a little longer because it didn’t involve prescription medical products – that also invoked the new cost-shifting provisions in a very familiar (and frustrating) situation.  McClurg v. Mallinckrodt, Inc., 2016 WL 7178745 (E.D. Mo. Dec. 9, 2016), wasn’t an MDL, but it could have been, except for a limited geographic scope.  Many hundreds of plaintiffs were all seeking recovery for alleged radiation-induced injuries from the same two defendants.

A situation depressingly familiar to any defense counsel in mass tort litigation developed.  Although plaintiffs are nominally responsible under the rules for collecting (and paying for the collection of) their own medical and related records in response to discovery requests, they botched the job so badly that the defendants – in whose interests it was to have these records – had to step in and do it themselves on their own dime.  Plaintiffs did produce “a list of known health care providers and a signed authorization for the release of medical records.”  Id. at *1.  “Because Plaintiffs did not timely and fully produce all of their records, Defendants contracted with a third-party vendor . . . to collect records directly from Plaintiffs’ health care providers and employers.”  Id.  Also, “the parties in this matter could not agree to a reasonable scope of record collection and allocation of costs.”  Id. at *4.

So things stood until bellwether plaintiffs were selected (interestingly, by random selection, id. at *2).  All of a sudden the plaintiffs became very interested in the additional records that the defendants had been collecting at their own expense.  So they served discovery requests seeking those records – only for the bellwether plaintiffs – for free.  Id. (“Plaintiffs served document requests seeking ‘all documents and records’ that Defendants had collected regarding each of the 16 Bellwether Plaintiffs”).  Somewhat ironically, they also claimed that the defendants had engaged in excessive records gathering, and therefore also demanded access to the defendant’s records database (also set up at defendants’ sole cost) so they could select which records they wanted.  Id. (“Plaintiffs assert that they, too, wish to access [defendants’] secure portal free of charge, in order to decide which records they want”).

The two McClurg defendants’ response was “hell, no; not without you sharing the cost equally – that is shouldering one-third of the expense along with the defendants each sharing a third.  Id. (subject to a credit for whatever records plaintiffs had actually collected and turned over).

The McClurg court shifted costs, not 33% but 18%, to plaintiffs under Rule 26(c)(1)(B).  2016 WL 7178745, at *3.  Cost-shifting was necessary so that the plaintiffs did not become free riders:

The Court finds . . . that good cause exists to order some amount of cost-sharing before Plaintiffs may obtain the records collected by Defendants here.  Plaintiffs would ordinarily have been, and pursuant to the Court’s order were, responsible for gathering and producing their own records.  But while Plaintiffs appear to have produced some records as new complaints were filed, they did not do so in a complete and timely manner.  Indeed, Plaintiffs apparently produced records for a few of the Bellwether Plaintiffs just one or two days before their scheduled depositions.

Id.  That “Plaintiffs [were] seek[ing] access to the portal establish and maintained at Defendants’ expense” further justified a cost allocation order.  Id.

Although it was “unfortunate” that the parties never sought court intervention after failing to reach a records production protocol, id. at *4, giving plaintiffs free access to records collected and maintained at the defendants’ expense was unfair.  Id. (“it would be unfair to allow Plaintiffs to gain the benefit of Defendants’ early record collection and creation of the portal, which helped move the case forward, without contributing a fair share of the overall costs of such collection”).  Crediting plaintiffs’ complaints about excessive collection, McClurg reduced the percentage to 18%.  Id. (eliminating records collected concerning plaintiffs that the defendants knew could not be in the bellwether pool).  Plaintiffs also received a credit for the comparatively small amount of timely produced records they had collected.  Id.

Since the same failure by plaintiffs to collect their own records competently is endemic to prescription medical product MDLs, the cost-shifting in McClurg is of significant interest to us.

In fact, the results in all three of these cases – Bard IVC, Benicar, and McClurg – are also of interest to us because they provide pointers to where the requestor pays debate might reasonably go.  We certainly don’t agree with the other side’s largely bogus argument that across-the-board requestor pays discovery might shut the courthouse doors on the “poor” plaintiffs in the litigation-funded, advertising-driven mass tort industry.  In such litigation, there “does not appear to be a significant financial disparity in the parties’ ability to finance these putative litigations.  Thus, what this Court and other courts similarly situated are faced with is ‘Goliath versus Goliath.’”  Arch v. American Tobacco Co., 175 F.R.D. 469, 496 (E.D. Pa. 1997).

However, since the federal rules are supposed to be transubstantive, we will accept for the sake of argument that some deserving plaintiffs in some types of litigation might be excluded by a blanket requestor pays regime.  As an alternative, we think that the rules should include a presumption that the requestor pays for certain types of unduly burdensome, or otherwise unfair, discovery.  While such discovery might nonetheless be “proportionate,” were it to uncover something significant, these types of discovery are expensive and not particularly likely to produce evidence usable at trial.

Here are some examples of discovery that we have encountered that we think deserve to be presumptively discoverable only at the requestor’s expense – there are undoubtedly more:

  • Discovery into a defendant’s overseas activities, particularly if the documents are not in English (Bard IVC and Benicar both involved this kind of discovery);
  • Discovery into information independently gathered by the defendant for purposes of the litigation, excepting witness statements, and other items specified by the rules as peculiarly relevant (that’s McClurg);
  • Discovery into products manufactured by defendants other than those used by plaintiffs;
  • Discovery into product risks other than those suffered by plaintiffs;
  • Discovery into information in the possession of third parties, including government agencies;
  • Discovery into time periods where recovery is barred by relevant statutes of limitations;
  • Discovery into post-litigation information, after the alleged conduct has ceased;
  • Subjects of Rule 30(b)(6) depositions where the entity faced with deposition has no available percipient witnesses, and any witness would only have reviewed the same documents available to the deposing party;
  • ESI discovery into information located on inactive legacy/obsolete computer systems; and
  • Other similarly burdensome discovery, not of a type likely to produce significant evidentiary benefit, as determined by research commissioned by the Federal Judicial Center.

None of this kind of information is ordinarily essential to the hypothetical impecunious plaintiffs who would otherwise be shut out of court by having to pay for what are almost always expensive wild goose chases.

And if one of these categories turns out to be of particular importance in a given lawsuit, the requestor pays directive is only presumptive.  The party requesting the discovery would be able to go to the judge – either before or after the discovery takes place − and explain why a category of discovery, presumptively disfavored under the new regime, should be exempted from the requestor pays rule on the facts of the case in question.  Likewise, if the requestor is able to overcome the presumption beforehand, and the supposedly important discovery turns out to be a wild goose chase anyway, then the producer should be entitled to file a motion to shift those costs back to the requestor.

Implementing across-the-board requestor pays is a long shot right now, and such a dramatic change in the system could well have unintended and unforeseeable litigation consequences.  We think our proposal is not only a way to discourage types of discovery that are peculiarly prone to abuse, but might also be a way of trying out requestor pays on a smaller scale to see whether it is indeed a desirable change to the system generally.

If anybody out there is interested in this idea, have at it. Unlike discovery, our blogging is free to all readers.

This post comes from the Cozen O’Connor side of the blog.

Plaintiffs and defendants have now completed briefing before the Fifth Circuit on defendants’ appeal of the $498 million verdict in the second bellwether trial of the Pinnacle hip implant MDL. Obviously, there is a lot riding on this appeal. In March, we laid out for you the manner in which defendants’ opening brief addressed certain key issues. Below, we discuss the defendants’ responses, in their reply brief, to the arguments that plaintiffs make on those key issues in their opening brief:

Design Defect Verdict: While defendants have offered a number of reasons to overturn the verdict on design defect, the survival of that portion of the verdict could very well turn on whether plaintiffs can convince the Fifth Circuit that an allegedly safer alternative design for DePuy’s metal-on-metal hip implant, a necessary element of a design defect claim, can be an entirely different product—a metal-on-polyethylene hip implant—one that is already marketed by DePuy. In our experience, an entirely different product cannot serve as an alternative design. Here is a portion of defendants’ discussion of this failing in their reply brief:

To prevail on their design-defect claims, plaintiffs were required to prove that a safer alternative design existed for the Pinnacle Ultamet. Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384 (Tex. 1995). Yet plaintiffs do not argue that the Ultamet should have been shaped differently, secured differently, made of a different metal alloy, or altered in some other way. Instead, plaintiffs argue that the safer alternative design is the Pinnacle AltrX, an existing metal-on-polyethylene hip implant. The question here is whether that metal-on-polyethylene hip implant—which already exists and, indeed, is manufactured and sold by DePuy—is an “alternative design” for the Pinnacle Ultamet, or is instead an “entirely different product.” Brockert v. Wyeth Pharm., Inc., 287 S.W.3d 760, 770 (Tex. App.—Houston [14th Dist.] 2009).

Brockert provides the answer. In Brockert, the plaintiff argued that an “alternative design” for a drug combining estrogen with progestin was a drug containing only estrogen. Id. at 769. There, like here, that proposed alternative already existed and, again like here, was manufactured by the defendant. Id. The Fourteenth Court of Appeals held that plaintiff’s claim failed because she did not show how the defendant’s drug “could have been modified or improved”; she instead argued that the drug should be an entirely different product—i.e., the one defendants already made. Id. at 770-71. . . .

Plaintiffs attempt to distinguish Brockert and Caterpillar by noting that the proposed alternatives in those cases “impaired the product’s utility.” But that is no distinction at all: plaintiffs’ proposed alternative design here would impair the Ultamet’s utility by eliminating precisely the feature that makes it distinctive and an arguable improvement over pre-existing products. Plaintiffs do not deny that metal is more durable than plastic, making metal-on-metal implants a more “attractive option for the younger, high-demand patient who was wearing out their plastic previously.” Nor do they dispute that metal-on-metal implants eliminate plastic debris. Texas law requires plaintiffs to propose an alternative design that replicates those benefits, not just any two benefits they can conjure up. In short, plaintiffs were required to propose a safer alternative design for a metal-on-metal hip implant, but they instead pointed to a different product altogether, which is precisely what Texas courts have held that plaintiffs may not do.

(Defendants’ Reply Br. at 3-6.)

Failure to Warn (Marketing Defect) Verdict: In their opening brief, defendants argued that their Instructions for Use sufficiently warned about the risks that form the basis of plaintiffs’ claims, while plaintiffs’ opening brief argues that those warnings needed to be more specific. While we believe that defendants have the better of that argument, they appear to have even stronger arguments as to plaintiffs’ failures to offer expert testimony on causation or prescriber testimony on how a different warning would have changed their decisions to use the Pinnacle metal-on-metal hip implant. Here are key excerpts from defendants’ reply brief on these issues:

[Lack of Expert Opinion]

Regardless, plaintiffs can prevail under Texas law only if they established with expert testimony that the warnings were inadequate, and they did not do so here. Plaintiffs do not dispute this requirement, instead contending that Dr. Matthew Morrey’s testimony satisfied their burden. But Dr. Morrey was never tendered or admitted as a warnings expert at trial. Plaintiffs attempt to dance around that problem by stating that they designated Dr. Morrey as a warnings expert before trial, but the district court never evaluated his qualifications to be a warnings expert or admitted him as a warnings expert, and his testimony therefore cannot carry plaintiffs’ burden.

[Lack of Prescriber Testimony]

Greer: Greer’s surgeon, Dr. Goletz, did not testify at trial. . . .

Peterson: Peterson’s surgeon, Dr. Schoch, also did not testify at trial. . . .

Christopher: Plaintiffs do not dispute that Christopher’s surgeon, Dr. Kearns, “never read an [IFU] on the Pinnacle Ultamet” and did not know what the IFU said “regarding risks for the implantation of these devices.” . . .

Klusmann: Plaintiffs assert that Klusmann’s surgeon, Dr. Heinrich, testified that additional information “would have changed how he treated Klusmann.” But Heinrich did not say he would have used a different hip implant; he said only that he would have evaluated Klusmann’s post-implant symptoms differently. Dr. Heinrich never testified that he would have used anything other than the Ultamet, and in fact testified that he was aware of the risk of metal ions attacking tissue, but used the Ultamet anyway.

Aoki: The only testimony plaintiffs cite about Aoki is her statement that Dr. Heinrich told her the Ultamet could last “up to 20 years and perhaps life.” But that testimony does not prove that Dr. Heinrich would have used a different implant if DePuy provided different warnings, especially in light of his testimony that he was aware of the Ultamet’s risks. . . . .

(Defendants’ Reply Br. at 10-14.)

Verdict against J&J: Defendants’ reply brief surgically attacks plaintiffs’ arguments on why the trial court could maintain personal jurisdiction over DePuy’s parent company, J&J, as well as plaintiffs’ theories for ultimately holding J&J liable. Plaintiffs’ personal jurisdiction arguments appear to be different from those raised at trial (and therefore waived) and to rely on exhibits that, in some cases, were not even admitted at trial and acts that were not committed by J&J itself, but instead by its subsidiaries. Plaintiffs’ opening brief also struggles to support the viability of their substantive claims against J&J, including how plaintiffs can turn an affirmative defense for a non-manufacturing seller into a cause of action. Here is how defendants sum up these problems in the introduction to their reply brief:

Plaintiffs’ efforts to justify J&J’s presence in this case are no more persuasive. They abandon their previous personal-jurisdiction arguments for new ones, asking this Court to adopt a stream-of-commerce theory so expansive it would bring every parent company into any litigation involving a subsidiary. They try to buttress that argument with lengthy footnotes full of string-cites to evidence either not in the trial record or not what they claim, but super-sized footnotes are no substitute for minimum contacts, which are plainly lacking. And even if they could establish jurisdiction, plaintiffs have no viable claims against J&J. They do not point to a single Texas case holding a defendant liable in tort for a “nonmanufacturing seller” claim or an aiding-and-abetting claim, and they fail to show that J&J undertook a duty for their protection or that they relied on its performance.

(Defendants’ Reply Br. at 1.)

Highly Inflammatory, Irrelevant and Unduly Prejudicial Evidence: This is the BIG issue, the one that raised so many eyebrows as the trial moved on. In their opening brief, plaintiffs try to calm those reactions by underplaying their use of this evidence at trial and its importance to the verdict. But the defendants reply brief reacts effectively to this tactic, providing detail on plaintiffs’ repeated, not limited, used of this evidence, so much so that it formed a central component of their presentation to the jury. Here is how defendants address this issue in, once again, the introduction to their reply brief:

Plaintiffs’ defense of the inflammatory evidence they introduced at trial is to assert that each transgression was not that inflammatory. After all, they referenced Saddam Hussein in only “a handful of exchanges,” linked defendants to tobacco and asbestos companies while questioning only “one defense expert,” invoked the threat of cancer for only “three-and-a-half pages of testimony,” implied just “twice” that the Ultamet could lead to suicide, told the jury that plaintiffs considered jumping off a bridge for a mere “five lines of argument,” mentioned the thousands of other lawsuits in the MDL only “on five occasions,” and discussed transvaginal mesh lawsuits brought by “45,000 women” for only “12 lines of testimony.” The suggestion that the combined effect of all this profoundly prejudicial evidence was marginal does not pass the straight-face test; indeed, the best indication of the importance of this evidence is that fact that plaintiffs’ counsel repeated all of it in his closing statement to the jury. Inflaming the jury’s passions through irrelevant evidence was not just a happenstance but a core component of plaintiffs’ trial strategy, and the gargantuan verdict shows the success of that strategy.

(Defendants’ Reply Br. at 2.)

Next comes oral argument and then the Fifth Circuit’s decision. And that decision will, quite obviously, have a major impact on the future of an MDL that without appellate intervention appears destined to produce more and more massive verdicts.

No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious.  The rub is that the parties have very little to show for the effort.  The latest shoe dropped last week when the New Jersey Appellate Division vacated (again) a jury verdict in favor of an Accutane plaintiff.  The unpublished opinion in McCarrell v. Hoffmann-La Roche, Inc., No. A-4481-12T1, 2017 WL 1683187 (N.J. App. Div. May 2, 2017), is interesting, both in its treatment of expert opinion and evidence on causation under Alabama law.

But before we get to that, let’s review very briefly what has come before. When plaintiffs first started suing in earnest over Accutane, they alleged a variety of injuries, including psychiatric conditions, birth defects, kidney disorders, vision problems, and musculoskeletal problems.  There has been some litigation on these issues, but the proceedings in New Jersey and elsewhere have focused largely on gastrointestinal disease, including inflammatory bowel disease.  IBD can be every bit as bad as the name makes it sound, and we can see why patients who experience IBD can garner substantial sympathy.  But the warnings on gastrointestinal disorders are robust, and a federal court in Florida ruled in 2012 and 2013 that the Accutane warnings as to IBD were adequate as a matter of law.

But not in New Jersey, where several cases have proceeded to trial. We have not surveyed the New Jersey verdicts lately, but the last time we did, we counted about half a dozen verdicts—all of which were vacated, with others pending on appeal.  There certainly are others that we are not counting here, but the trend is unmistakable:  Multiple trials presided over by a New Jersey mass tort judge who was championed by some as a hard-working jurist and vilified by others for placing a thumb firmly on one side of the scale.  Substantial verdicts in favor of the plaintiffs.  All of them vacated.  In the mass tort context, vacated verdicts represent a massive waste of both sides’ time and money.

Which is what happened again last week in McCarrell.  The case was first tried to a jury in 2007, resulting in a verdict for the plaintiff.  But the Appellate Division vacated that award and remanded for a new trial because of erroneous evidentiary rulings. McCarrell, 2017 WL 1683187, at *1.  The parties therefore tried the case again in 2010, which resulted in a larger verdict for the plaintiff.  On appeal from the second verdict, the Appellate Division reversed again and held that the claims were time barred.  But the New Jersey Supreme Court disagreed and remanded the case back to the Appellate Division to address the remaining issues on appeal. Id. at **1-2

That remand resulted in last week’s opinion, and the Appellate Division reversed again.  First, the trial judge ordered that it would not allow duplicate expert testimony.  As a result, the defense had its expert gastroenterologist address certain studies, but was prohibited from having an epidemiologist corroborate that testimony. Id. at *2.  The rubber hit the road in closing argument when plaintiff’s counsel emphasized to the jury that the defense gastroenterologist’s opinion stood alone.  That was a problem, particularly once the Appellate Division ruled in 2013 that “trial courts should not prohibit overlapping expert testimony in complex matters on a ‘central issue of liability.’” Id. at *2 (citing McLean v. Liberty Health System, 430 N.J. Super. 156 (App. Div. 2013)).  Under that ruling, the trial judge’s decision to disallow overlapping expert testimony about scientific studies was error. Id. at *3.  And in light of counsel’s emphasis in closing on the defendants’ expert as a “lone outlier,” the error was prejudicial.

Second, the court held that the plaintiff had not met his burden of proving causation. This was a failure-to-warn case, but no one asked the prescribing physician whether her decision to prescribe Accutane would have been different if the drug had come with a stronger warning. Id. at *4.  Regular readers of the blog know this is warnings causation 101, and because the plaintiff bears the burden of proof under the applicable law (Alabama in this case), the absence of this essential evidence caused his warnings-based claims to fail as a matter of law. Id. We agree wholeheartedly with this ruling, although we are somewhat puzzled that the Appellate Division suggested going out and deposing the doctor again.  Sure, the doctor was deposed in 2007, but the burden of proving warning causation is not obscure now and was not obscure then.  It is not obvious to us that a second bite at the apple is warranted, nor do we know if the prescriber can even be re-deposed, after another decade has passed.

So what do we mean when we say that no one can be happy with this? The opinion gives parties on both sides more leeway in presenting expert testimony, and we have guidance on proving failure to warn under Alabama law.  But in the larger scheme, this case is apparently heading for a third trial, having first b een tried ten years ago.  Other verdicts from New Jersey have met the same fate.  Plaintiffs are left empty handed, and the defendants continue to bear the burden of vigorous litigation in New Jersey, whereas the federal MDL wrapped up in the defendants’ favor years ago.  In the end, McCarrell is a defense win, but the cost has been high.

May 10 is an important day in the history of the law.  On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit.  The case was called Nix v. Hedden, 149 U.S. 304 (1893).  The issue concerned application of the Tariff Act of 1883, which imposed a tax on vegetables, but not fruits.  The appellant was one of New York City’s biggest produce sellers.  He imported lots of tomatoes, and was looking to dodge the tax.  He cited dictionaries defining tomatoes, in a technical/botanical sense, as the “’fruit’ as the seed of plants, or that part of plants which contains the seed, and especially the juicy, pulpy products of certain plants, covering and containing the seed.”  But, alas, the High Court ruled that “[t]hese definitions have no tendency to show that tomatoes are ‘fruit,’ as distinguished from ‘vegetables,’ in common speech, or within the meaning of the tariff act.”  Science be damned, people eat tomatoes in their salads, not desserts, so they are vegetables, not fruits.  Because common parlance prevailed, the taxpayer did not.

 

*                    *                    *                    *                    *

 

We’ll exploit this historical legal oddity and its exaltation of common understanding as a semi-ironic preface to a case where a pro se plaintiff went down in flames in a product liability case.  In Coleson v. Janssen Pharmaceutical, Inc., et al., , 2017 U.S. Dist. LEXIS 68072 (S.D.N.Y. May 3, 2017), the plaintiff filed a pro se complaint against the defendants in New York state court (the Bronx, to be specific) , which alleged that he developed gynecomastia as a result of taking Risperdal and generic risperidone. The defendants removed the suit to federal court.  Things were already heading in the right direction for the defense.  After discovery, during which the plaintiff apparently never found an expert on causation, the defendants moved for summary judgment.  The defendants won.  The plaintiff lost.  Common sense also won: the court rejected innovator liability for an alleged failure to warn by a generic competitor.  Finally, we are reminded of that most common of courts, The People’s Court, where Judge Wapner routinely blasted plaintiffs for not having the requisite paperwork to back up their claims. 

 

After the plaintiff in Coleson had been diagnosed with bipolar schizophrenia around 2009 or 2010, physicians prescribed Risperdal and risperidone. Risperdal is the brand name product and was manufactured/sold by the defendants.  Since at least 1996, Risperdal’s FDA-approved disclosures stated that Risperdal is associated with endocrine-related side-effects, including gynecomastia.   Risperidone is the generic version.  It had been available since 2008.  Medicaid paid for all of the plaintiff’s prescriptions. New York’s Medicaid program excludes coverage of brand-name drugs when there is an FDA-approved generic equivalent on the market unless one’s healthcare provider specifically requests an exemption for the patient.  So it looks as if the plaintiff was probably taking risperidone.  That is, he took risperidone until sometime in 2013-14, when he switched to an entirely different atypical antipsychotic, which was also associated with gynecomastia.  The plaintiff was diagnosed with gynecomastia in 2015. 

 

Despite his usage of generic risperidone and a different antipsychotic, the plaintiff sued only the Risperdal brand manufacturer.  As with most pro se complaints, the theories of the case were less than pellucid.  The defendants and the court construed the causes of action as failure to warn and design defect against the brand manufacturers.  The plaintiff alleged that the side-effect information in the generic risperidone was different from the FDA-approved Risperdal label.  The defendants’ summary judgment motion argued that the plaintiff’s claims failed for lack of any evidence that the plaintiff ingested name-brand Risperdal, as opposed to generic risperdone. The defendants argued that they could not be held liable for either failure to warn or design defect for an injury resulting from a product that they did not manufacture, distribute, or sell. The defendants also argued that the plaintiff could not show medical causation between Risperdal and his gynecomastia.

 

Yes, we are confronted yet again with the issue of innovator liability.  Under Erie, the federal court needed to determine the substantive law of the forum, New York.  The New York Court of Appeals has not yet addressed whether a manufacturer of a name-brand prescription drug can be held liable for injuries resulting from another company’s generic equivalent. But there is at least one federal case, Goldych v. Eli Lilly & Co., No. 04 Civ. 1477 (GLS)(GJD), 2006 WL 2038436 (N.D.N.Y. July 19, 2006), and one New York state case, Weese v. Pfizer, Inc., 2013 N.Y. Misc. LEXIS 4761, 2013 N.Y. Slip Op. 32563 (Sup. Ct., N.Y. Cty. Oct. 8, 2013), rejecting innovator liability.  Those two New York decisions are in accord with the majority of courts to consider the topic: fifty-five other state courts across twenty-one states, in addition to all six circuit courts of appeal, have ruled that innovator liability makes no sense.  See our general innovator liability posts here and here. The Conte decision in California, which applied such innovator liability, stands as an egregious, eccentric exception.   The Coleson court acknowledged that there are a couple of cases clumsily following Conte, but the Coleson court declined to join the heresy.

 

Supporting its decision, the Coleson court discussed a recent asbestos case that, at first blush (but only first blush) seemed to offer some hope for the plaintiff.   Last year, in In re N.Y. City Asbestos Litig., 27 N.Y.3d 765, 59 N.E.3d 458 (2016), the New York Court of Appeals held that manufacturers had a duty to warn of potential dangers resulting from their products’ use in conjunction with third party products. To support this interpretation, the asbestos court observed that the manufacturers had “knowledge and ability to warn of the dangers” when consumers used the product with a third party’s product. As we discussed at the time, here, that is quite a bit different from being required to warn about use of a competitor’s product, when the defendant’s own product was not being used at all.  The Coleson court reasoned that the asbestos ruling was unlikely to make “the cost of liability and litigation . . . unreasonable”  and, moreover, the manufacturers “derive[d] a benefit from the sale of the [other party’s] product.” This rationale weighed in the opposite direction in Coleson. The brand defendants “had no oversight in the manufacturing of the generic drugs. They earned no profit from the sale of the generic drugs. Given the length of time generic drugs can sell following a patent’s expiration, to find a new duty would unforeseeably expand the cost of liability on brand-name drug manufacturers.”  Coleson, 2017 U.S. Dist. LEXIS 68072 at *10.  

 

Goodbye failure to warn claim.  The plaintiff’s failure to warn claim was dismissed because he alleged a warning defect as to only risperdone, over which the defendants had no duty of care.

 

The Coleson plaintiff’s design defect claim also failed.  He could not show by a preponderance of the evidence that he ever ingested name-brand Risperdal. The plaintiff’s declaration and deposition stated that he was prescribed, amongst other drugs, “Risperdal (risperidone)” and that a hospital in 2009 or 2010 dispensed “Risperdal and/or risperidone.” The plaintiff also claimed that hospital records proving he actually received Risperdal in the hospital were likely destroyed by a fire in January 2015. [We know some especially nettlesome plaintiff lawyers who would turn this misfortune into a spoliation claim, but the pro se plaintiff lacked either the expertise or chutzpah to pursue that vexatious path.] It was true that the plaintiff’s medical records at times recorded his prescription as only for Risperdal.  But generic risperidone is regularly written as “Risperdal (risperidone),” a nomenclature even the plaintiff repeatedly adopted in his papers.  That a drug is prescribed under its brand-name does not mean that a patient receives that name-brand drug, and it is hardly justifiable to infer that it does. In the absence of real evidence, the Coleson court was unimpressed by the plaintiff’s “mere speculation or conjecture” as to Risperdal usage.  Coleson, 2017 U.S. LEXIS 68072 at *11.

 

But let’s for the moment speculate that a “fair-minded jury” could speculate that the plaintiff was prescribed brand name Risperdal somewhere in the relevant time-frame. And yet it was undisputed that by 2009, when the plaintiff was first prescribed the medicine, risperidone was a widely available generic to Risperdal. It was also undisputed that all of the plaintiff’s prescriptions were paid by Medicaid.  Aside from exceptional circumstances the plaintiff never showed, the plaintiff’s prescriptions under Medicaid needed to be filled with generic drug equivalents. Thus, from the evidence presented, no jury could draw the “justifiable inference” that the plaintiff received name-brand Risperdal for his prescriptions. There might well have been an inference of injury from ingestion of risperdone, but the Coleson plaintiff had not sued the generic manufacturer.  Id. at *12.

 

Even assuming that the plaintiff had ingested Risperdal, his design defect claim against the defendants would still fail because he could not establish that Risperdal caused his gynecomastia. The Coleson court embraced the requirement in products liability cases that, to establish causation, plaintiffs must offer admissible expert testimony regarding both general and specific causation. The requirement is particularly pertinent where a causal link is beyond the knowledge or expertise of a lay jury.  In the Coleson case, there was no such expert in sight. Id. at *13.   

 

The plaintiff suggested he did not need an expert on causation when he had something even better:  the Risperdal label.  That label contains a warning regarding gynecomastia.  The plaintiff also pointed to a  July 2015 medical report, which concluded that the plaintiff’s gynecomastia “is related to phychiatric [sic] medical ingestion.”  The court did not buy either of these arguments.  First, Risperdal’s warning label cannot establish general causation: “Product warning labels can have over-inclusive information on them, often out of ‘an abundance of causation or the avoidance of lawsuits.’  Coleson, 2017 U.S. Dist. LEXIS 68072 at *14 (quoting In re Mirena IUD Prods. Liab. Litig., , 202 F. Supp. 3d  304, 323 (S.D.N.Y. 2016)).  Unless a warning label specifically says that an alleged injury can be caused by a drug, courts have held that a drug’s product warning label alone cannot “raise a genuine issue of material fact with respect to general causation.”  Id. Risperdal’s label states merely that it “elevates prolactin levels” and that “gynecomastia . . . ha[s] been reported in patients receiving prolactin elevating compounds.” This information is not the same as an admission of “a genuine phenomenon” creating a “material fact with respect to general causation.”

 

Nor did the Coleson plaintiff’s July 2015 medical report establish proximate cause. The plaintiff claimed to have taken Risperdal around only 2009-10. Throughout 2010 to 2014, the plaintiff took risperidone. In early 2014, the plaintiff switched to a different antipsychotic, which is also associated with cases of gynecomastia. The plaintiff was diagnosed with gynecomastia only in early 2015, and the medical report to which the plaintiff points indicates the plaintiff had taken both risperidone and the other antipsychotic. This report does not state which, if any, of these drugs was responsible for the plaintiff’s injury. Without competent medical expert testimony on the issue of causation, a jury would be left only to “theorize” as to how the plaintiff came to suffer from gynecomastia. Id. Accordingly, the defendants’ motion for summary judgment was granted.

 

So what we have here is a good result from a smart court.  That decision was made a bit easier because a pro se plaintiff sued the wrong party, hired no expert who would render some frail opinion on ‘substantial causative factor,’’ and failed to assemble decent evidence of usage.  What’s that saying about someone who acts as his own lawyer?