[Drug and Device Law] Is This A Crack In The Bellwether?
We wrote recently on Lone Pine orders and the role they might play in today’s world of inventory litigation. You know what we are referring to – the mass litigation that occupies much of our time, where some people would say that the number of cases involving similar products is more important than whether any particular case has arguable merit. We are not among the people who subscribe to that view, but it got us to thinking about resolution, and particularly about trials, and particularly about bellwether trials, which have become common in multidistrict litigation and other coordinated pretrial proceedings. Bellwether trials are supposed to result in bellwether verdicts, which are intended to provide benchmarks against which to measure the resolution value of similar cases.
It is an imperfect concept, which we have noted multiple times (including here and here ). But it is the system that we have, and it has gained both legitimacy and traction. Following a number of trials in the Vioxx MDL – an MDL that saw the resolution of a great many cases – Judge Fallon and his clerks published an article in the Tulane Law Review (available here) providing very thoughtful commentary on the entire process. For our part, we have participated in the selection and trial of bellwether cases, and sometimes multiple claims get resolved in the aftermath, and sometimes they do not.
Which leads to our question for today: Has the bellwether trial process lost its luster? We have not yet formed a strong opinion one way or another, but we raise the issue now because of an order entered earlier this month in the Cook Medical pelvic repair system MDL in the Southern District of West Virginia. See Pretrial Order #59, In re Cook Medical, Inc. Pelvic RepairSystem Prods. Liab. Litig., MDL No. 2440, 2015 WL 3385719 (S.D. W. Va. May 19, 2015). There, the district court set up a bellwether trial process that largely followed the approach that Judge Fallon and his co-authors set forth in their article. The court first selected a pool of 30 cases to be worked up in discovery, with each side selecting 15 cases. That was about 20 percent of the then-pending cases, which is a significant number, and from that group the district court selected four “bellwether cases” that would be tried to verdict and provide the benchmarks that the bellwether process aims to provide. (Id. at pp. 1-2)
The proceedings, however, did not go as the court expected. Before trial, the plaintiffs voluntarily dismissed all four bellwether cases with prejudice. Returning to the bucolic metaphor from which the “bellwether” tag originates, that left no neutered ram wearing a bell to lead the flock. To make matters more frustrating for this district court, the plaintiffs dismissed 20 other cases in the original discovery pool, leaving just six cases. And in four of those remaining six cases, plaintiffs’ counsel moved to withdraw rather than oppose the defendants’ motions for summary judgment based on lack of causation. (Id.)
Thus, from the initial pool of 30 cases, due to the plaintiffs’ machinations, the court was left with just two, leading the court to conclude that “I am once again finding that the bellwether process is not effective. . . . While I had hoped that representative cases had been chosen in the bellwether process, without a trial of those cases because of their dismissal with prejudice by plaintiffs before trial, the parties have no opportunity to confirm that they were representative or determine potential values of these cases and the true cost of working them up for trial.” (Id.. at p. 2) The court’s solution was to order upward of 250 cases into discovery in preparation for remanding the cases to the transferor districts for trial. (Id.) That is a strident reaction, and we can’t help but wonder whether the court pulled the plug on the bellwether process too soon.
This is a thought-provoking order for a couple of reasons. First, whether the bellwether selection process was succeeding in this particular instance depends on how you define success. Sure, the process did not result in any verdicts. But merely by putting 30 cases into the process and shining the light on their case-specific facts, the court got rid of all but two of them. If resolution is the goal, that is a 93 percent “success” rate. Remember our reference to Lone Pine at the outset? Maybe if such an order were in place at the beginning for all the cases, the culling effect would have been comparable. We do not know why 24 plaintiffs dismissed their cases, but we suspect that the 28 dismissed/abandoned cases should not have been filed in the first place. Remember also that 15 of the cases were plaintiffs’ picks.
Second, the court had hoped that the bellwether trials would have confirmed the “representative” nature of the selected cases. We do not overestimate the ability of a bellwether selection process to select “representative” cases, and we doubt that the district court did either. The fact is that even when dealing with similar products, no two cases are alike, and resolution of one does not necessarily signal the value of another. This is the core reason why personal injury class actions no longer exist, and if what we have in their place is inventory litigation led by bellwether trials, the best we can expect are approximations. Helpful approximations in many cases, but approximations nonetheless. Here, the approximation is that 93 percent of the Cook cases have zero value, in the estimation of plaintiffs’ counsel themselves. That should tell everyone something.
We again have no strong opinion on how this particular MDL should go forth, but the district court’s order touches on two cracks in the bellwether process. Plaintiffs hold a card up their sleeves—the ability to dismiss voluntarily, which is a matter of right in many states and is rarely denied in federal court. As a result, every bellwether case presents the risk that the plaintiffs will pull the plug if they do not like what they see as they proceed toward trial. There are measures a court can take to avoid this “gaming” of the system, such as allowing the defendants to unilaterally select a replacement for every case that plaintiffs dismiss from the pool. The district court here did not enact that solution or anything comparable. In addition, even when cases are tried to verdict, there is always a way to distinguish them. Just the other day, plaintiffs in a prescription drug case responded to a defense verdict with a statement that the defendant had “gotten away with one” because of evidence unique to that case. The upshot is that courts will continue to set bellwether trials because, after all, cases have to be tried. How to make the process work best, however, will vary from case to case, and the level of success will depend on how the process is implemented.
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Posted By Steven Boranian to Drug and Device Law at 5/29/2015 02:06:00 PM --
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[DK GreenRoots] Climate Action Hub: Farming First Toolkit Prioritizes Agriculture In Climate Change Treaty
Climate Action Hub:
Farming First Toolkit Prioritizes Agriculture In Climate Change Treaty
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[Drug and Device Law] Is This The End of RICO?
The short answer is “no.” We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it at all. (Or from here.) The titular character in that flick was known as “Rico.” RICO (Racketeer Influenced and Corrupt Organizations Act), on the other hand, was an anti-gangster law, enacted in 1970 as part of the Organized Crime Control Act. In a number of posts (like here), we have decried the gangster tactics used by plaintiffs—particularly quasi-public plaintiffs—to use the threat of RICO’s treble damages and cost-shifting provisions to extort settlements from drug and device manufacturers. Particularly for prescription medical products, RICO seems like an inappropriate vehicle for addressing alleged harms allegedly caused by such standard product liability allegations as inadequate disclosure of risks or off-label promotion. A small blow to curtail the expansion of RICO was struck in Short v. Janssen Pharms., Inc., No. 1:14-CV-1025, 2015 U.S. Dist. LEXIS 61123 (W.D. Mich. May 11, 2015).
Short is yet another case stemming from pediatric use of Risperdal. We have posted many times on various Risperdal cases with various theories of recovery, usually tied to the idea that the drug was improperly promoted for off-label use without disclosing the true risk of gynecomastia and other prolactin disorders, like here, here, here and here. In Short, the plaintiff allegedly took Risperdal as a minor, developed gynecomastia, and sued in his own behalf under RICO and state consumer protection and product liability acts. His problems were that he never paid a cent for the drug and that he was from Michigan. We suspect the latter may be why RICO was at issue at all.
Statutory standing under RICO requires that the plaintiff have been “injured in his business or property” by the racketeering of the defendant(s). The Short plaintiff, as makes sense for a minor taking a prescription drug, alleged that his insurance company paid for the drug and his mother maybe paid a co-pay. The insurer and mother may have had standing, but they were not plaintiffs. Drawing on Sixth Circuit authority that RICO had “evolved into something quite different from the original conception of its enactors,” the court was comfortable finding no standing where plaintiff did not “actually pay[] anything himself” and merely asserted personal injuries. Id. at **7-8. Plaintiff “must, at a minimum, show some direct, pecuniary injury to his own pocket that is unrelated to the claimed personal injury.” Id. at *8. Plaintiff offered two creative arguments for why he did allege a pecuniary injury sufficient for standing without spending any of his own money. First, he argued that he “incurred the expense” of the drug, even though someone else paid it. “This is no different than ordering lunch in a restaurant: ordering lunch may obligate you to pay for it, but if your friend picks up the tab, you haven’t suffered any pecuniary injury at all.” Id. at *9 (contraction and smack down in the original). Second, he argued that he had subrogation rights from his insurer paying for the drug, but Michigan law is clear that the insurer is “the only real party in interest.” Id. at *12. So, RICO liability does not extend to a plaintiff who used a product paid for entirely by others. That is good. On plaintiff’s state law claims, the Michigan legislature has seen fit to enact fairly pro-manufacturer legislation. Our readers know that this includes immunity from product liability claims for FDA approved drugs absent the application of a narrow exception. The exception urged here, intentional withholding of key information in connection with the drug’s approval, has been held by the Sixth Circuit and most courts to consider the issue have found this exception to be preempted—unless the FDA had concluded that such a fraud had occurred. Id. at *15. Plaintiff argued that allegations of off-label use change the way the immunity and exception work, but that argument had already been rejected by the Sixth Circuit and various other courts. Id. at *16. Michigan’s legislature also put in a provision in its consumer protection act that exempted “transactions[s] . . . specifically authorized under laws administered by a . . . officer acting under the statutory authority of this state or the United States.” Plaintiff argued that FDA approval did not authorize off-label promotion, but the Michigan Supreme Court had already construed this statutory language to make the inquiry “whether the general transaction is specifically authorized by law, regardless of whether the specific misconduct alleged is prohibited.” Id. at **13-14. We can add Short to our collection of cases applying consumer protection safe harbors to FDA actions. So, plaintiff’s state law claims were also dismissed. Because all of this was not a matter of mere pleading, it looks like the dismissals of all of plaintiff’s claims were with prejudice. Thus, even if this is not the end of RICO, it should be the end of Short.
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Posted By Eric Alexander to Drug and Device Law at 5/28/2015 09:02:00 AM --
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[Drug and Device Law] Insurer Declaratory Action: To Stay or Not to Stay?
This month’s edition of For the Defense magazine focuses on insurance law. That makes sense. It is difficult to do much defending without bumping against insurance issues. Our torts professor constantly emphasized the relevance, sometimes even the primacy, of insurance considerations. But law school being law school, we learned precious little of the mechanics of insurance. Some companies self-insure, some use captive insurers, and some have some/several/many complicated insurance policies where the scope of coverage becomes a question of theoretical majesty. A colleague of ours, Rick Berkman, probably knows as much as about settling cases and dealing with insurers as anyone on the planet. He once told us that insurance policies seem to contain a clause written in invisible ink: “Void upon claim.” There are lawyers who devote their careers to representing insurers. There are lawyers who devote their careers to harassing insurers -- come to think of it, quite a few of these folks have offices quite close to us. And then there are lawyers (we count ourselves among them) who often do a delicate dance of collaboration and conflict with insurers. Whether there is insurance overage, or what is the extent of such coverage, plays a huge role in case disposition. Think of the simplest auto accident case and how the policy limits drive the settlement numbers.
We have not represented an insurer for a good long while. As a summer associate, we had a case where the issue was whether an auto insurance policy covered the death of a man who, after experiencing car trouble, entered a phone booth (remember those?) to call for road service and was then shot by a street criminal. We do not remember how that one turned out. You name a bizarre fact pattern, and there is probably an insurance case that comes close to it. Insurers naturally would rather pay less or not at all, but they are in a sticky spot, particularly when the insured seeks litigation defense. If the insurer denies coverage, including denial of a defense, and then turns out to be wrong, that insurer is in a heap of trouble. After all, when someone buys insurance, what they are really buying is peace of mind. Otherwise, just based on the actuarial numbers, it is a dodgy investment. But if the insurer wrongly denies coverage, there is a betrayal of that peace of mind. It is one of the areas of the law (along with mishandling of corpses) where psychic injury damages cropped up relatively early in our jurisprudence and did not seem entirely nonsensical. The rational thing for an insurer to do – and insurers are nothing if not rational – is to tender a defense whilst reserving rights. In the meantime that defense can turn out to be terribly expensive. Consequently, there is something else an insurer can do: file a declaratory judgment action seeking a ruling that the underlying case is outside coverage. One wonders whether that fairly typical maneuver by the insurer might exhaust a penurious insured, at least giving the insurer some leverage in the coverage dispute. But we hate to indulge our cynical side.
An insurer filed such a declaratory judgment action in Ironshore Specialty Ins. Co. v. 23andMe, Inc., 2015 U.S. Dist. LEXIS 64145 (N.D. Cal. May 14, 2015). The defendant in that case provided a Personal Genome Service (“PGS”) directly to consumers who want to know about their personal genetic information. The results consisted of raw genetic data obtained by saliva testing (“DNA Data”), information regarding ancestry (“Ancestry Component”), and information regarding personal health (“Health Component”). On November 22, 2013, the FDA issued a warning letter stating that sales of the PGS without market clearance or approval violated the Food, Drug and Cosmetic Act because the Health Component of the PGS was not so accurate. The defendant stopped offering the Health Component to new consumers, but not quickly enough to avoid a couple of federal class actions, arbitrations, and a Civil Investigative Demand (“CID”) by the state of Washington. The federal actions and arbitration complaints alleged that the defendant had (1) falsely represented in advertising that the PGS would give consumers knowledge about their health conditions and their status as carriers of genetic disorders when, in fact, the results provided were inaccurate and incomplete; (2) misled consumers into believing that the PGS had received government approval; and (3) failed to disclose to consumers that their genetic information would be used to create a database that the defendant would market to physicians and pharmaceutical companies. The claims asserted various theories, including the inevitable violations of California Business & Professions Code § 17200.
Just as inevitably, the defendant tendered the defense of the federal actions and arbitration complaints to its insurer under a “Products/Completed Operations Liability and Professional Liability Policy for Life Sciences.” The insurer accepted the defense of the actions, and of the CID, but with the inevitable reservation of rights. Maybe it was not quite inevitable, but it was at least unsurprising for the insurer to file an action seeking a judicial declaration that it did not have a duty to defend or indemnify the defendant in the underlying actions because the claims were outside the scope of the insurance policy. Then, inevitably, the defendant moved to stay the declaratory relief action pending resolution of the underlying litigation. The court’s resolution of this dispute was not exactly inevitable, but neither was it crazy.
Whether or not to stay an insurer’s declaratory action largely turns on whether the declaratory action poses the risk of inconsistent factual determinations that could prejudice the insured. More concretely, the court examines whether: (1) the insurer might “join forces with the plaintiffs in the underlying actions as a means to defeat coverage”; (2) the insured might be “compelled to fight a two-front war, doing battle with the plaintiffs in the third party litigation while at the same time devoting its money and its human resources to litigating coverage issues within its carriers”; and (3) “the insured may be collaterally estopped from re-litigating any adverse factual findings in the third party action, notwithstanding that any fact found in the insured’s favor could not be used to its advantage.” A stay is required in the first and third type of prejudice involving factual overlap. Otherwise, whether to grant a stay or fashion some other remedy is left to the discretion of the trial court. In Ironshore, the court ended up staying parts of the insurer’s declaratory actions and not staying other parts, depending on which arguments for non-coverage were asserted by the insurer.
First, the insurer argued that all of the claims in the underlying action sought either equitable relief or restitution, which are not recoverable under the terms of the policy, or disgorgement of profits, which is not insurable under California law. But it was by no means apparent from the pleadings that the underlying plaintiffs were limiting the damages sought in the way characterized by the insurer. The insurer tried to bolster its position by submitting the mediation statement submitted by the plaintiffs in the underlying actions. No fair, said the court, because that statement is protected by California’s mediation privilege. Accordingly, the insured succeeded in staying that portion of the declaratory action with respect to the insurer’s contention that the underlying actions did not seek covered or insurable damages.
Second, the insurer denied coverage on the grounds of the policy’s exclusion for any liability or obligation assumed by the insured via a contract or agreement. The insurer argued that all of the underlying claims were barred by the exclusion because each plaintiff and class member entered into a contract with the defendant, and thus their claims sought damages arising out of the defendant’s “assumption of liability or obligations in a contract or agreement.” The court did not indicate whether it bought the insurer’s argument (to us it seems to make coverage illusory in a situation involving the sale of anything), but it acknowledged that the parties’ dispute regarding applicability of the defense turned largely upon construction of the language used in the policy exclusion. The lawyer for the insurer did a very smart thing at oral argument by representing that the insurer could demonstrate a complete absence of coverage under the policy exclusion in a limited early motion for summary judgment, without the necessity for discovery. Such a potential resolution seemed easy, potentially dispositive, and, therefore, appetizing to the court, so it denied the stay request on that coverage issue. The insurer would get its shot at getting out of the case based on the policy exclusion.
Third, the insurer argued that the underlying claims were barred by the policy’s Off-Label Promotion exclusion, which barred coverage for damages or expenses “based upon[,] arising out of, directly or indirectly resulting from or in any way involving” the defendant’s “promotion of off-label or unapproved uses for drugs or medical devices approved by the Food and Drug Administration for other uses.” We must admit that we did not know that such a thing as off-label exclusions even existed. We wonder whether most plaintiff lawyers know about that. If so, maybe they should start laying off the allegations of off-label promotion because such allegations are mostly irrelevant and might even take insurance money off the table. The Ironshore court reasoned that the insurer’s argument would require a factual determination that the defendant had promoted “off-label or unapproved uses for drugs or medical devices” that were FDA-approved for other uses, and then would have to conclude that the underlying claims are based upon that promotion. If the court ultimately found that there was off-label promotion, that would not only be a win for the insurer, but it would be a big, big loss for the insured, both in the insurance dispute and in the underlying actions. It would be an incredible gift to the plaintiffs in the underlying actions. For that very reason, the Ironshore court granted the insured’s motion to stay the declaratory judgment action as to the off-label promotion exclusion.
Fourth, the insurer sought a declaration that it need not cover intentional acts. The policy provided coverage for “Damages that the Insured becomes legally obligated to pay because of a Claim alleging a Wrongful Act by the Insured.” “Wrongful Act” means any actual or alleged negligent act, error or omission. A “Wrongful Act” would not include intentional misconduct. The insured admitted as much. But the insured argued that no purpose would be served in the court’s fashioning a determination that the policy applied only to negligent acts, errors, and omissions, because such a determination could not possibly eliminate the insurer’s duty to defend. It is not as if the plaintiffs in the underlying actions limited their claims to intentional acts. Some of the claims were a bit unclear. For example, false advertising and unfair competition might look like excluded intentional acts. But maybe not. And there were other acts alleged that did not appear to be necessarily intentional. Thus, even if the insurer were successful on that defense it would still have a duty to defend in the underlying actions. The Ironshore court concluded that the burden to the insurer in fighting a two-front war outweighed the insurer’s interest in obtaining an immediate partial coverage determination that would not eliminate its duty to defend. That part of the declaratory action was stayed.
Finally, the insurer asserted that the CID issued by the Washington Attorney General did not qualify as a covered “claim” under the policy. “Claim” means a “written demand for Damages, services or other non-monetary relief.” The CID was issued at the outset of the state’s investigation and it merely consisted of document requests and interrogatories. There was not yet a written demand for damages, services, or other non-monetary relief. There was no lawsuit yet. Note those “yets.” The insured quite sensibly argued that the Washington Attorney General might not have initiated legal proceedings against it, but it was only a matter of time. The court disagreed. It held that the balance of prejudice favored permitting the insurer to demonstrate the application of the defense in a limited early motion for summary judgment. The stay motion was denied on this issue.
Essentially, it looks as if the Ironshore court was willing to allow the insurer to make its case for noncoverage only if the issues raised were straightforward and could not wreck the insured’s position in the underlying cases. That result seems reasonable enough.
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Posted By Steve McConnell to Drug and Device Law at 5/27/2015 10:00:00 AM --
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[Drug and Device Law] What Does Pharmacogenomics Have To Do With Product Liability? - Potentially Everything
Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On that same day, co-blogger Steve Boranian alerted Bexis to a new defense argument in asbestos/mesothelioma cases that also utilizes genomics – certain mutations in a gene called “BAP1” – to identify persons at greater risk of idiopathic (that is, not related to asbestos) mesothelioma. Here’s a link to that article. A verifiable alternative cause could be a game-changer for asbestos litigation. The statement we quoted back in 2009, uttered by the first person ever to have his genome individually sequenced, that “individual genes are just not very informative,” appears in the process of being disproven by ongoing scientific events.
Both items, as informative as they were on scientific facts, were rather short on the law. That’s where we come in. We thought we’d take a look at what law exists concerning the intersection of pharmacogenomics, personalized medicine, and prescription medical product liability litigation. We’ve touched on these issues back in 2011, when we blogged about Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), one of the first cases in which the plaintiff made allegations about pharmacogenomically-based risks. Back then we said:
The plaintiff is claiming that a drug is defective, not because of anything inherent in the drug itself, but solely because it is less effective (and therefore has a different risk-benefit profile) due to the plaintiff’s peculiar genetic makeup. Essentially, the allegations seek to impose a non-FDA-approved contraindication, using state law, based upon human genetic variability. With advances in computer technology making genetic testing exponentially cheaper and more detailed as times passes (see Moore’s law), more and more genetic variability in the efficacy of prescription drugs is bound to be discovered. Eventually - certainly within some of our lifetimes - we'll be able to carry our entire individual genetic code around with us on a chip, should we so choose….
The complaint in Mills is a bare genetic susceptibility claim, frankly based on an allegation of “variant” genetic characteristics shared by only a minority of the population. In our view, unless and until – and only to the extent that – the FDA decides to assess drug approvals and contraindications on the basis of genetic subgrouping, this type of tort claim should not be recognized, because it is flatly contrary to the criteria by which the intended uses of drugs are currently determined. Claims such as in Mills, which are at loggerheads with FDA criteria for drug development, are precisely those with the most potential for making pharmaceutical manufacturers into “sitting ducks” for litigation, in this instance litigation based on extraneous genetic factors.
It may well be that the coming (and to some extent existing) revolution in genetically individualized medical therapy will require changes in how drugs are evaluated, labeled, etc., but this is a singularity-driven issue that needs to be addressed by the policy branches of our government, and not haphazardly in product liability litigation.
(Emphasis added).
FDA Regulation of Pharmacogenomic Information
We still feel the same way, but now with the caveat that the FDA is starting to lay the regulatory foundation for drug warnings in the coming age of personalized medicine. Way back in 2005, the FDA allowed voluntary addition of pharmacogenomic information in drug labeling:
The pharmacogenomic data and resulting test or tests may be intended to be included in the drug labeling to choose a dose and dose schedule, to identify patients at risk, or to identify patient responders. Inclusion of a pharmacogenomic test in the labeling would be contingent upon its performance characteristics.
FDA, Guidance for Industry, Pharmacogenomic Data Submissions, at 5 (March 2005) (available here). Under the heading “Clinical Pharmacology,” drug labeling can now contain a subsection specifically devoted to pharmacogenomics. As of last year, over 100 drugs contained such information, according to the FDA.
Since our post in 2011, the FDA has released several additional guidance documents in this field. This one, the most basic, simply defines the relevant terminology, particularly in the area of clinical investigations. This one addresses how to incorporate genetic variation into the design and implementation of clinical investigations. This one concerns inventing tools to identify biomarkers in the course of drug development. This one concerns how to report pharmacogenomic data to the Agency. The FDA’s online pharmacogenomics resources offer links to scads of other stuff. We don’t purport to be either scientists or regulatory lawyers, so now we’ll turn to the underlying purpose of this post, which is the legal precedent involving pharmacogenomics and product liability.
Pharmacogenomic Product Liability Claims
Pharmacogenomics is a double-edged sword. There will be some cases in which the results of genetic testing might assist plaintiffs (for example, in the absence of an adequate warning) and others in which the results of genetic testing will indisputably aid defendants – such as the mesothelioma alternative cause scenario mentioned above:
In the ideal plaintiff’s case, a person with an allele that made him or her specifically susceptible to the action of some toxin would be exposed to that toxin, which would cause a unique and detectable biochemical change, which in turn would be shown to cause an extremely high likelihood of contracting the plaintiff's disease. The ideal defendant’s case might occur in several ways: similar biomarker evidence would point a finger at a purely genetic cause or at some other (perhaps voluntary or non-anthropogenic) exposure; or, a person exposed to a toxin known to cause the person's disease in susceptible people might have a gene that completely neutralized the toxic effect and also might lack a biomarker that is uniformly found in people whose disease was caused by exposure.
Steve C. Gold, “The More We Know, the Less Intelligent We Are? − How Genomic Information Should, and Should Not, Change Toxic Tort Causation Doctrine,” 34 Harv. Envtl. L. Rev. 369, 392 (2010) (footnote omitted).
The plaintiffs’ side has sporadically argued that genetic markers should be warned about or, in some cases designed around, although we doubt the latter is even possible. So far many plaintiffs have had trouble coming up with factual support to back such allegations – and sometimes we’re not even sure why they’re making them. In the latter category we place Newman v. McNeil Consumer Healthcare, 2013 WL 9936293 (N.D. Ill. March 29, 2013), a case we blogged about a couple of years ago. Newman involved SJS/TEN, the autoimmune diseases (or different forms of the same disease) Stevens Johnson Syndrome and Toxic Epidural Necrosis. SJS/TEN is somewhat analogous in our sandbox to mesothelioma in asbestos cases, since plaintiffs often work backwards from the diagnosis to look for some drug company to sue. We mentioned in a recent post the wide variety of drugs that plaintiffs have claimed to cause these conditions. Perhaps to bolster the often weak SJS/TEN causation testimony, in Newman the plaintiff’s expert sought to discuss pharmacogenomics. However, the testimony about purported genetic predisposition to the disease was rejected as speculative, because no genetic link to SJS/TEN has yet been discovered:
Defendants are correct that [the expert] testimony on the subject would be speculative and irrelevant. First of all, Plaintiffs’ argument admits that the relevance and helpfulness of the information is conditioned on the discovery of a genetic link, which may not happen. Secondly, even if such a link were discovered, Plaintiffs fail to explain how it rebuts Defendants claim that SJS/TEN was unpredictable during the relevant time frame.
Id. at *8. As of the time of trial, the state of the art did not include a genetic marker for SJS/TEN. “That SJS/TEN may be more predictable in the future if a particular discovery is made says nothing about Defendants’ negligence.” Id. While the genetic testimony in Newman was offered by the plaintiff, should an SJS/TEN marker be discovered, we believe that overall such a development would help defendants far more than plaintiffs by exonerating most, and maybe all – if the marker is not drug related – of the plethora of drugs that plaintiffs have alleged as causitive agents.
Then there’s the Mills case itself. Mills was similar to Newman in that the plaintiff once again made baseless allegations about possibly carrying a genetic marker. In Mills, the plaintiff claimed that, due to a variant gene (“CYP”), she could not metabolize the defendant’s drug as well as most other people. The presence of this adverse genetic marker purportedly supported a design defect theory:
Plaintiff alleges that the chemical structure of [the drug] is defective because it carries a higher risk of adverse events for patients who carry the genetic variant CYP, who are poor metabolizers of the drug. Plaintiff contends that [the drug] is the proximate cause of her injuries because, “[u]pon information and belief,” she is a CYP carrier.
Mills, 2011 WL 4708850, at *2. As in Newman, the court in Mills did not let the plaintiff get away with this subterfuge. A plaintiff’s own genetic markers, and genome generally, is something the plaintiff is uniquely in possession of. “Plaintiff’s genetic makeup is a fact solely within her control. Tests are available that can reveal whether plaintiff in fact possesses CYP.” Id. Where the plaintiff is asserting a claim based on pharmacogenomics, s/he is responsible for producing the evidence to prove it. Id.
Similar – and similarly unsupported – allegations of “genetic predisposition” to being a “poor metabolizer” of a drug contributed to the rejection of the plaintiff’s expert report in Rimbert v. Eli Lilly & Co., 2009 WL 2208570 (D.N.M. July 21, 2009), aff’d, 647 F.3d 1247 (10th Cir. 2011) (which we blogged about here).
Ultimately, almost everything in [the expert’s] specific causation opinion is hypothetical and speculative, except for her conclusion. She wrote that “it is unknown” whether [the plaintiff’s decedent] may have been among the small percentage of Caucasians who are poor metabolizers of [the drug], [and] that he “may have” been vulnerable to a rise in blood and brain levels of [the drug].
Id. at *19. See also Tamraz v. Lincoln Electric Co., 620 F.3d 665, 670-71 (6th Cir. 2010) (expert opinion founded on speculation about undiagnosed “genetic predisposition” to injury from product exposure was not admissible); In re TMI Litigation, 193 F.3d 613, 622 (3d Cir. 1999) (recognizing use of genetic markers as “an accepted method” of evaluating radiation exposure, but rejecting as unreliable a sample taken 15 years after the event in question); Munro v. Regents of University of California, 263 Cal. Rptr. 878, 882-83 (Cal. App. 1989) (summary judgment affirmed against claim that “certain rare and isolated groups” were genetically at higher risk of a disease due to lack of expert testimony); Easter v. Aventis Pasteur, Inc., 358 F. Supp.2d 574, 575 (E.D. Tex. 2005) (precluding expert testimony that “some children are genetically susceptible to mercury poisoning” in vaccine case where the minor-plaintiff “not meet th[at] genetic profile”); Agee v. Purdue Pharmaceuticals, Inc., 2004 WL 5352989, at *3 (W.D. Okla. Nov. 22, 2004) (plaintiff’s expert “did not have any basis for concluding that [plaintiff] was a ‘slow metabolizer’”), aff’d, 242 F. Appx. 512 (10th Cir. 2007); Trainer v. Sec’y of HHS, 2013 WL 4505803, at *7 (Fed. Cl. July 24, 2013) (“[p]etitioner, however, fails to present any evidence indicating that he has a mitochondrial DNA mutation that would make him more susceptible”); Kolakowski v. Sec’y of HHS, 2010 WL 5672753, at *43 (Fed. Cl. Nov. 23, 2010) (absent any testing showing “genetic predisposition,” plaintiff could not prove claim).
These cases are all well and good, but with continuing advances in genetic screening, sooner or later at least some plaintiffs should be able to support claims of pharmacogenomic injury with the necessary evidence. When that happens, defendants must be on the lookout to prevent warning claims about genetic markers and pharmacogenomic susceptabilities from becoming so detailed that they seek to tell physicians how to practice medicine. We’ve discussed those principles (outside the genetic context) here.
If and when plaintiffs are able support claims based on peculiar genetic susceptibility to injury, they will seek to convert pharmacogenomic claims into the 21st Century version of the “eggshell” plaintiff rule – that a tortfeasor is liable for aggravated injuries due to a “preexisting physical or mental condition.” See Restatement (Third) of Torts, Liability for Physical & Emotional Harm §31 (2010); Restatement (Second) of Torts §461 (1965). This principle has already cropped up in some cases involving genetic conditions. Most recently, in Vanslembrouck v. Halperin, 2014 WL 5462596 (Mich. App. Oct. 28, 2014) (unpublished), the defendants asserted a “genetic abnormality” as an alternative cause. Id. at *2. The plaintiffs sought, and received, an “eggshell” plaintiff charge, which the court held appropriate under the loose “clear error” standard, because the defendant made no objection. Id. at *58-59. The same sort of unobjected-to instruction about genetic susceptability was given in Rite Aid Corp. v. Levy-Gray, 876 A.2d 115, 140 (Md. App. 2005), aff’d, 894 A.2d 563 (Md. 2006).
The Vaccine Court has applied “eggshell” plaintiff principles to reject allegations that genetic predispositions were a superseding cause of vaccine-related injuries, but only “[s]o long as the [product] was a substantial factor” cause. Zeller v. Sec’y of HHS, 2008 WL 3845155, at *26 (Fed. Cl. July 30, 2008).
Respondent proffered evidence and arguments that [plaintiff’s] genetic predisposition was a superseding cause of her injury, rendering irrelevant the vaccine as a substantial cause. . . . [I]f the administration of the vaccine(s) to [plaintiff] creates or increases the foreseeable risk of harm that preexisted and coexisted in her genetic predisposition . . ., and the vaccine is found to be a substantial factor in causing her injury, then the genetic predisposition cannot constitute a superseding cause. . . . Applying the general rule from the common law of torts, compensation is appropriate even when the vaccine operates upon a concealed physical condition, such as a latent disease, or susceptibility to disease, to produce consequences incapable of reasonable anticipation. . . . As every aspiring attorney learns, a defendant takes a plaintiff as he finds him.
Sucher v. Sec’y of HHS, 2010 WL 1370627, at *43 (Fed. Cl. Mar. 15, 2010) (citations and quotation marks omitted); accord Byers v. Sec’y of HHS, 2010 WL 5663019, at *26 (Fed. Cl. Nov. 30, 2010) (same rationale). The possibility of a latent or otherwise unknown genetic condition is only a damages principle, however, and does not affect either the standard of care or the causation requirement. Garcia v. United States, 2010 WL 2977611, at *20 n.10 (D.N.M. June 15, 2010) (discussing example of the “genetic disorder” of osteogenesis imperfecta).
Pharmacogenomic Claims Concerning Efficacy Rather Than Safety
Pharmacogenomics can identify not only genetic markers that increase risk of adverse drug reactions, but also those that reduce a drug’s effectiveness. This latter situation – that a drug allegedly didn’t work as well as it was supposed to due to genetic variation − has not been considered a legitimate product liability claim, since the plaintiff is not asserting that the drug caused any injury that the would not have happened anyway. Several cases from the Plavix MDL establish this principle. In the first of these, Solomon v. Bristol-Myers Squibb Co., 916 F. Supp.2d 556 (D.N.J. 2013) (blogged about here), the plaintiff claimed that he “should have been genetically tested to determine his genetic response” to the drug because it was ineffective in some people due to genetic variation. The court first found that the effectiveness evidence didn’t relate to this plaintiff’s particular facts, id. at 566-67, and went on to reject the very idea of product liability due to lack of effectiveness:
[I]t appears that Plaintiff’s efficacy arguments are not relevant in the context of a failure-to-warn analysis. . . . [A] drug manufacturer is required to provide an adequate warning of its product if it knows of any potential harm that may result from the use of its product. In other words, a proper warning should adequately alert any danger or harm that may result from ingesting the drug. Permitting Plaintiff to pursue his failure-to-warn claim on an efficacy theory would, as has been found in other jurisdictions with similar laws, impermissibly expand liability under Texas law on the adequacy of pharmaceutical warning labels.
Id. at 564 (citations omitted) (emphasis original). Other cases rejecting mere effectiveness/efficacy claims are: LaBarre v. Bristol Myers Squibb Co., 544 F. Appx. 120, 125 (3d Cir. 2013) (“efficacy is not relevant to a failure to warn claim”; a warning “duty does not extend to a warning about a drug’s efficacy”) (discussed here); Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528, 536 (6th Cir. 1993) (rejecting warning “argument . . . relat[ing] to the studies on efficacy”; efficacy only relevant to design claim); Needham v. White Laboratories, Inc., 639 F.2d 394, 402 (7th Cir. 1981) (where plaintiff alleged only that defendant “failed to warn, comment k could not apply . . ., and evidence of the efficacy, or inefficacy, of [the drug] was irrelevant”); In re Fosamax (Alendronate Sodium): Products Liability Litigation, 2014 WL 1266994, at *15 (D.N.J. March 26, 2014) (“omission of efficacy information does not constitute a failure to warn about a drug’s risks and therefore, does not raise a genuine issue of material fact”); Carr-Davis v. Bristol Myers-Squibb Co., 2013 WL 322616, at *6 (D.N.J. Jan. 28, 2013) (“studies based on the efficacy of [the drug] . . . fail to raise a genuine issue of material fact on the question of whether [its] warnings were adequate”) (discussed here); Begley v. Bristol-Myers Squibb Co., 2013 WL 144177, at *6 (D.N.J. Jan. 11, 2013) (“although the efficacy of a drug may play a role in a physician’s decision to prescribe, the failure-to-warn doctrine is not primarily concerned with a drug’s efficacy”) (discussed here), aff’d, 544 F. Appx. 120 (3d Cir. 2013); In re Fosamax Products Liability Litigation, 2010 WL 1257299, at *5 (S.D.N.Y. Mar. 26, 2010) (“[t]o allow Plaintiff to pursue a claim for the ‘failure to warn’ of the efficacy of a drug would be an expansion of liability”) (discussed here).
Using Pharmacogenomic Conditions As Alternative Cause
Pharmacogenomics can also assist the defense of prescription medical product cases by establishing alternative cause. Many of the most thoughtful cases doing so involve federal vaccine litigation. For example, an exhaustive discussion of the genetic underpinnings of autism is found in Snyder v. Sec’y of Dept. of HHS, 2009 WL 332044, at *45-50 (Fed. Cl. Feb. 12, 2009). Ultimately, the vaccine court concluded, “[t]he evidence for autism’s genetic basis and prenatal origin renders petitioners’ [vaccine-related] theory of causation improbable. Id. at *52. Similarly, in Simanski v. Sec’y of HHS, 115 Fed. Cl. 407 (Fed. Cl. 2014), aff’d, 2015 WL 795060 (Fed. Cir. Feb. 26, 2015), an inherited genetic condition was advanced as an alternative non-vaccine-related cause for the injury being alleged. The plaintiffs’ position was rejected in part because “have done very little to refute these conclusions, including allowing genetic testing” that would have confirmed or denied the alternative cause. Id. at 427. In another vaccine case, Waters v. Sec’y HHS, 2014 WL 300936 (Fed. Cl. Jan. 7, 2014), genetic testing had occurred, and it had revealed an alternative genetic cause that precluded a finding of vaccine-related causation:
Petitioners have failed to show by a preponderance of the evidence that [minor plaintiff’s] current condition constitutes a significant aggravation of his condition prior to vaccination. He had the SCN1A mutation before his vaccinations, his clinical course developed consistent with that condition, and his current condition is a result of his genetic mutation.
Id. at *23. See also Chapman v. Procter & Gamble Distributing, LLC, 766 F.3d 1296, 1310 & n.16 (11th Cir. 2014) (defendant successfully established a genetic condition as alternative cause); Kane v. Motorola, Inc., 779 N.E.2d 302, 309 (Ill. App. 2002) (plaintiff’s expert properly excluded because he “could not rule out any other cause of [plaintiff’s injury], including genetics”); Hendrix v. Evenflo Co., 255 F.R.D. 568, 598 (N.D. Fla. 2009) (plaintiff’s expert’s causation opinion excluded because he “ignore[d] the possibility of other genetic conditions as a cause”), aff’d, 609 F.3d 1183 (11th Cir. 2010); Schenk v. Novartis Pharmaceuticals Corp., 2014 WL 3656904, at *4-5 (D. Ariz. July 23, 2014) (plaintiff’s expert excluded for lack of good grounds for excluding plaintiff’s known genetic condition as causative factor); Blackmon v. American Home Products Corp., 346 F. Supp.2d 907, 919 (S.D. Tex. 2004) (plaintiff’s expert excluded for lack of good grounds for excluding “other known causes . . ., such as genetics”); Medalen v. Tiger Drylac U.S.A., Inc., 269 F. Supp.2d 1118, 1139 (D. Minn. 2003) (plaintiff’s expert testified “I didn’t really evaluate the genetic aspect of that”; Daubert motion granted).
Defense-side pharmacogenomics alternative cause evidence should be adequately supported by both known facts and expert testimony. Otherwise, a defendant’s assertion of a genetically-based alternative cause runs the risk of failing for essentially the same reasons as the plaintiffs in the cases already discussed. See In re Prempro Products Liability Litigation, 586 F.3d 547, 566 (8th Cir. 2009) (pointing out that the plaintiff “submitted to every available genetic test” without any positive result); Levy-Gray, 876 A.2d at 139-40 (no evidence of genetic marker for alternative cause). However, in Roberti v. Andy’s Termite & Pest Control, Inc., 2011 WL 635369 (Cal. App. Feb. 23, 2011) (unpublished), a defense expert was allowed to give testimony that the plaintiff could well have a “genetic abnormality” responsible for his condition that had not yet been discovered:
[The expert’s] opinion was not speculative or devoid of foundation. He merely pointed out that the current state of medical science does not allow him to confirm, or to rule out, a genetic or chromosomal abnormality as the cause of plaintiff’s condition. It was a factually accurate statement to say that often birth defects are linked to genetic abnormalities, but that relatively little is known about identifying the precise genetic defect responsible for various conditions. . . . [H]e simply said that it was possible that a genetic cause was responsible. This was not speculation; it was a statement relevant to [the expert’s] opinion regarding causation based on his scientific knowledge. In addition, we note that the opinion was offered to refute plaintiff’s counsel’s attempt to definitively confirm that plaintiff did not have a genetic disorder. . . . Merely suggesting that the injury could have another cause that cannot be verified is hardly prejudicial or likely to mislead the jury.
Id. at *13.
Using Pharmacogenomic Conditions To Defeat Medical Monitoring Claims
Genetic markers can also defeat claims for medical monitoring. In Sheridan v. NGK Metals Corp., 609 F.3d 239 (3d Cir. 2010), “exposure [to the defendant’s product] itself appears to be insufficient because only persons who have a particular genetic ‘marker’” went on to develop the medical condition at issue. Id. at 244. The evidence established that “only a small percentage of the population with the known genetic marker . . . is at risk of becoming sensitized.” Id. at 252. Since only that small percentage was therefore at risk of eventually developing the disease for which monitoring was being demanded, the class-wide monitoring claim failed as a matter of law:
[P]laintiffs did not prove they were at a significantly increased risk of developing [the disease] and thus did not present sufficient evidence to make out a prima facie cause of action for medical monitoring.
Id. Accord Pohl v. NGK Metals Corp., 936 A.2d 43, 51 (Pa. Super. 2007) (affirming summary judgment against medical monitoring claim on similar facts; “[a]ppellants cannot show they are even susceptible . . ., because [such] susceptibility cannot be determined by a test”). Although Sheridan and Pohl did not involve class certification, the same logic should apply in that context as well, since any risk dependent on the presence of genetic markers – by definition not common to the entire population – would require individualized evidence to establish for every purported class member. See Norwood v. Raytheon Co., 237 F.R.D. 581, 592 (W.D. Tex. 2006) (individual “genetic makeup” one of factors cited in denying class certification in radiation case).
Using Pharmacogenomic Conditions To Defeat Failure-To-Recall Claims
Another way that pharmacogenomics can help defendants is in those relatively rare cases where the plaintiff claims that the drug should have been recalled. These claims have mostly been preempted, but Lance v. Wyeth, 85 A.3d 434 (Pa. 2014) (discussed on several occasions, most notably here), remains. Lance, however was based in significant part on Restatement (Third) of Torts, Products Liability §6(c) (1998), which Lance indicated “at the very least overlaps or intersects” with Pennsylvania negligence law. 85 A.3d at 459 n. 37. This section, however, is only applicable where the risk/benefit ratio is such that “reasonable” physicians, aware of such risks, “would not prescribe the drug or medical device for any class of patients.” Id. (emphasis added). Advances in genomics and individualized genetic markers should narrow this already small exception concerning prescription drug design even further, since such markers will create precisely those “classes of patients” so benefitted. In Mills, for example, the court rejected a §6(c) claim because “nowhere does plaintiff allege that [the drug] would not be prescribed for any class of patients” besides those allegedly carrying the adverse genetic marker. 2011 WL 4708850, at *3.
Using Pharmacogenomic Conditions To Support the Statute of Limitations
Genetic testing has also proven relevant to the operation of the discovery rule where the timeliness of the suit under the applicable statute of limitations is at issue. See D.D. v. Idant Laboratories, 374 F. Appx. 319, 322-23 (3d Cir. 2010) (plaintiff deciding to undergo genetic testing showed sufficient awareness of possible external cause to satisfy discovery rule).
Pharmacogenomic Discovery
Finally, discovery. As mentioned in Mills, plaintiffs are in sole possession of their genome. Along the same lines, we have often seen plaintiff’s experts get away with blowing off the entire subject of genomics with the flippant statement that the plaintiff has “no known history” of genetic issues, without any affirmative investigation. E.g., Junk v. Terminix International Co., 577 F. Supp.2d 1086, 1096 (S.D. Iowa 2008); Colville v. Pharmacia & Upjohn Co. LLC, 565 F. Supp.2d 1314, 1319 (N.D. Fla. 2008). That should stop, and if the plaintiffs won’t do genetic testing themselves, it’s increasingly feasible for defendants to fill that gap with court-ordered discovery. Each year, more genomic research identifies more genetic markers for drug (and other) reactions that were previously considered idiopathic. Thus, going forward, pharmacogenomics and identification of genetic markers will become increasingly relevant to product liability (and other) litigation. Simultaneously, the cost of genetic sequencing and testing continues to drop dramatically.
For all these reasons the discovery of genetic information should become, for plaintiffs, what ediscovery has been for defendants – only without the exorbitant cost. In ten years it is likely that the submission of genetic samples by plaintiffs will be as commonplace in MDLs as the completion of a preliminary questionnaire is today. Cf. In re Welding Fume Products Liability Litigation, 2006 WL 2505891, at *1 (N.D. Ohio Aug. 28, 2006) (MDL discovery order requiring plaintiff’s counsel to search medical records for “known genetic or familial susceptibility” to the conditions at issue).
Back in 2008, we had a guest post that addressed discovery of genetic information. That post cited Cruz v. Superior Court, 17 Cal. Rptr. 3d 368, 369 (Cal. App. 2004), affirming compelled genetic testing of the plaintiff mother in a birth defect case to determine if the injury was, in fact, a pre-existing genetic condition unrelated to the defendant; and Bowen v. E.I. DuPont de Nemours & Co., 2005 WL 1952859, at *5 (Del. Super. June 23, 2005), aff’d, 906 A.2d 787 (Del. 2006), relying upon compelled genetic testing to exclude as unreliable the plaintiff’s expert witnesses testimony as to non-genetic cause. See also Harris v. Mercy Hospital, 596 N.E.2d 160, 163 (Ill. App. 1992) (although “the blood test may not conclusively determine whether [plaintiff] has a genetic disorder, we conclude that the trial court did not abuse its discretion in ordering . . . the blood test since the probative value of this evidence is outweighed by the potential risk”); Bennett v. Fieser, 1994 WL 542089, at *2 (D. Kan. Feb. 25, 1994) (plaintiff ordered to provide blood sample under Fed. R. Civ. P. 35 for genetic testing); Dodd-Anderson v. Stevens, 1993 WL 273373, at *1 (D. Kan. May 4, 1993) (same).
Looking at the issue anew, we’ve found more cases in which the court has ordered recalcitrant plaintiffs to undergo genetic testing. See Vanslembrouck, 2014 WL 5462596, at *37 (noting trial court order requiring genetic testing); Cutting v. United States, 2008 WL 5064267, at *1 (D. Colo. Nov. 24, 2008) (court ordered genetic testing of plaintiff, but held that Rule 35 did not apply to non-party relatives); see also Kirk v. Schaeffler Group USA, Inc., 2014 WL 2807681, at *3 (W.D. Mo. June 20, 2014) (requiring plaintiff seeking recovery for auto-immune condition to identify “medical providers who provided treatment . . . for autoimmune illnesses or disorders”).
To those, we would also add Johnson v. Superior Court, 95 Cal. Rptr. 2d 864 (Cal. App. 2000), which ordered considerable genetic-related discovery against a non-party witness – albeit not outright testing − an anonymous sperm donor. The rationale in Johnson was:
There may be instances under which a child conceived by artificial insemination may need his or her family’s genetic and medical history for important medical decisions. For example, such genetic and medical history can lead to an early detection of certain diseases and an increased chance of curing them. . . . While in most situations the donor’s genetic and medical information may be furnished without the need of disclosing the donor’s identity, there may be other situations that require disclosure of the donor's identity in order to obtain the needed information.
Id. at 875 (citations omitted). If genetic discovery can be demanded from an third-party who had been promised anonymity, then a fortiori it can be ordered from a plaintiff that initiated the very litigation to which that person’s genetic information is relevant.
Given privacy rights, the question of court-ordered genetic testing of third parties is a dicey one, however, with respect to plaintiffs themselves, we believe that any such interests were surrendered when they chose to file suit – at least insofar as the particular test results are relevant to a claim or defense in the case. For plaintiffs, privacy concerns are addressable by protective orders, and “fishing expedition” arguments manageable by only looking for genetic markers already identified by science as pertinent to the claim to alternative causes. If extraneous results are generated, plaintiffs’ counsel can decide, on a client-by-client basis, whether the client wants to/should know those results. Compared to ediscovery, discovery concerning pharmacogenomics will be much easier, cheaper, and (most importantly) relevant.
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Posted By Bexis to Drug and Device Law at 5/26/2015 10:42:00 AM --
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