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Last month we told you about two great preemption victories for St. Jude Medical in implantable cardioverter defibrillator (“ICD”) lead litigation (see post).  In one of those cases, plaintiffs decided they wanted to sing a different song – “Don’t Let Me Be Misunderstood.”  But, once again the court said “Na Na Hey Hey . . . Goodbye.”

In Pinsonneault v. St. Jude Medical, Inc., 2014 U.S. Dist. LEXIS 104994 (D. Minn. Jul. 30, 2014), plaintiffs sought leave to file a motion for reconsideration of the summary judgment ruling that tossed out almost all of their claims.   Their sole basis for reconsideration was that the court misunderstood one of their claims.  There are lots of misunderstandings in life.  What time were we supposed to meet?  I thought you were picking up something for dinner?  And, of course, keeping with our musical theme – there are a whole host of misunderstood or misheard lyrics.  For instance, Elton John’s “Tiny Dancer” isn’t a love song to Tony Danza and Credence Clearwater Revival isn’t offering directions to the restroom in “Bad Moon Rising.”  In Pinsonneault, the court makes it abundantly clear that it heard what plaintiffs were saying and that it wasn’t very happy with plaintiffs’ attempt at revisionist history.

Continue Reading Hey Jude! Reprise – Still a Sad Song for Plaintiffs

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The court in Turner v. DePuy Orthopedics, Inc., 2014 U.S. Dist. LEXIS (C.D. Calif. July 29, 2014), ordered the remand of a removed case after rejecting the defense’s argument that Mensing preemption (or at least its reasoning) should be extended to failure to warn claims brought against a doctor involved in the design of a medical device.  The defense’s argument was aggressive, even inventive, but it wasn’t bad.  Its argument was that the doctor-designer, much like a generic drug manufacturer, had no control over the warning label.  Rather, the manufacturer controls the ultimate content of the label, just as the brand manufacturer, not the generic manufacturer, controls the ultimate content of generic drug’s label.  The court saw things differently, though.  Taking plaintiff’s allegations as true, the court found a “possib[ility]” that the doctor “had a substantial ability to influence the manufacturing or distribution” of the device.  Id. at *10.

Maybe, but we’re not sure that any of that gave the doctor the power to control or influence the content of the label.  Nor did we find such support in plaintiff’s allegations.  According to the court, plaintiff alleged that the doctor “designed the hip implant,” received royalties (millions) from it, and participated in its marketing. Id. at *8-9.  We agree that, from these allegations, it’s “possible” that the doctor-designer could have influenced labeling of the device.  But did plaintiff allege enough to make it “plausible”?  It doesn’t seem so.  Only guesswork allows one to conclude that this particular individual had that type of influence.  Drugs and devices are generally developed and designed by multiple doctors and scientists.  This is reflected in the defense’s opposition, which included a declaration from the doctor-designer stating that he was only one of “eight physicians who acted as consultants in the design process.”  Id. at *9.  One of eight consultants certainly doesn’t sound like someone with influence over final labeling.  There needed to be more factual allegations suggesting, plausibly, that this doctor could have exerted such control or influence.

Continue Reading Court Holds that Claim Against a Doctor Who Served as a Designer (or Possibly Just a Consultant) Can Defeat Diversity

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We like the U.S. Supreme Court’s opinion in Daimler AG v. Bauman, 134 S. Ct. 746 (2014), because reining in general personal jurisdiction is a sound and welcome development.  General jurisdiction means jurisdiction over any and all disputes, and such a broad prerogative should be reserved to states where the defendant is “at home,” which is basically what the Supreme Court held.

Of course, because several generations of lawyers and judges have grown accustomed to very broad concepts of personal jurisdiction when it comes to large corporations, Bauman was bound to generate some pushback, and our home state of California has just fired one of the first salvos.  In Bristol-Myers Squibb Co. v. Superior Court, No. A140035, 2014 WL 3747250 (Cal. Ct. App. July 30, 2014), the California Court of Appeal acknowledged Bauman, but held nonetheless that California’s courts have jurisdiction over claims against non-resident defendants brought by non-resident plaintiffs alleging injuries that occurred outside California and involving products designed, manufactured, and sold outside California.  In other words, neither the parties nor the particular products consumed by these plaintiffs ever reached the shores of the Golden State, yet the defendant manufacturer will be held to answer.

How can this be?  The answer is that BMS v. Superior Court is a symptom of the condition that we call “litigation tourism,” where hundreds or thousands of unrelated plaintiffs group their claims together in one forum without the slightest consideration for whether that forum is appropriate for each one.  The product at issue in BMS is Plavix, and of the 659 individual plaintiffs at issue, only 84 reside in California.  That means that the other 575 have imported their claims into California for no reason other than the preference of counsel looking for a hospitable place to park their inventories.

So what happened in BMS?  The defendant manufacturer moved to quash service of the summons with regard to the non-resident plaintiffs only, urging that the court lacked personal jurisdiction in connection with those claims.  Id. at *2.  The trial court denied the motion and found that it had general jurisdiction over the defendant because of the defendant’s “wide-ranging, systematic, and continuous contacts” with the forum state.  The Court of Appeal rejected the defendant’s petition for interlocutory review, but Bauman came out the same day, so the California Supreme Court ordered the Court of Appeal to reconsider.  Id. at *3.

The resulting opinion is reasoned, but could be fairly characterized as an end run.  The Court of Appeal followed Bauman and held that California’s court lacked general jurisdiction over the manufacturer, which was neither incorporated in California nor had a principal place of business in California.  Id. at **8-9.  As an alternative, however, the Court of Appeal reached out, decided an issue that the trial court did not reach, and found specific jurisdiction based on the defendant’s “substantial, continuous economic activity” in the forum state.  Id. at *1.

If you ask us, “substantial, continuous economic activity” sounds an awful lot like the “systematic and continuous” forum contacts upon which the trial court found general jurisdiction in the first place.  A reader therefore could conclude that this court’s “specific jurisdiction” is nothing more than “general jurisdiction” dressed in sheep’s clothing. That hypothetical reader might be right, but it would be oversimplifying the opinion, which is long and includes diligent discussion of personal jurisdiction.  At bottom, the Court of Appeal found specific jurisdiction in California over any claim related to Plavix, no matter who brought it, because the defendant sold a lot of Plavix in California.  There were other California contacts—various offices and facilities that the Court did not describe in detail—but the clincher was Plavix sales in California exceeding $1 billion over several years, which the court cited over and over again.  Id. at *3.

Because of sales in California, the court concluded (1) that the defendant had sufficient minimum contacts with California and (2) that the defendant’s “substantial, purposeful activities in California” were related to the non-resident plaintiffs’ claims.  According to the court, sales of Plavix in California allegedly resulted in injury to at least 84 Californians bearing similar burdens of proof.  Moreover, “the interstate character of [the defendant’s] business . . . is also significant,” and the “injuries are alleged to have occurred in the course of a common effort.”  Id. at **16-17.  Finally, the court reasoned that “a defendant’s contacts with California and their relatedness to the claims at hand are inversely related.”  Id. at *17.  This is a sort of sliding scale under which the more substantial the contacts are, the less they need to “relate” to the claims to support specific jurisdiction.

We can understand finding that the defendant had “minimum contacts” with California, but the conclusion that the relevant contacts were related to the non-resident plaintiff’s claims seems strained.  For one thing, we do not see how the California residents’ claims are relevant to jurisdiction over the non-resident plaintiffs’ claims.  The mere procedural event of joinder should not change the underlying substantive law.  The Court of Appeal asserted vigorously, even defensively, that the Californians are relevant “actors in this drama,” but justifying jurisdiction over one person’s claims by reference to a defendant’s contacts with another is difficult to reconcile with specific jurisdiction.  We suppose that could be called “joinder jurisdiction” or “piggyback jurisdiction,” but we doubt the constitution supports jurisdiction just because you join up with another plaintiff who happens to live where the defendant sold a significant volume of the product at issue.  We also doubt the U.S. Supreme Court had that in mind when it decided Bauman.

We also do not appreciate how the “interstate character” of the defendant’s business makes any difference. The relevant facts were undisputed: Plavix was neither designed nor manufactured in California; no parties at issue resided in California; no product was sold to them in California; and none of them sustained injuries in California, let alone as a result of conduct directed at California.  On these facts, specific jurisdiction as we understand it bears no bias against companies doing business of an “interstate character.” We also would like to take a harder look at the court’s sliding scale.  In applying such a scale, the Court of Appeal relied mainly on a case that neither side cited in its briefs.

Perhaps most telling is the court’s discussion of the “reasonableness” of asserting jurisdiction over the defendant.  The defendant evidently did not argue that jurisdiction would be unreasonable, focusing instead on the argument that its forum contacts vis-a-vis the non-resident plaintiffs were insufficient.  But the court went ahead and wrote a multi-page explanation of why it is reasonable to keep all the hundreds of claims in California.  The court’s discussion is too long to summarize here, but it is fair to say that much of the court’s rationale for the “reasonableness” of jurisdiction appears to endorse the “mass tort” business model and the convenience and expediency it purportedly promises.  That’s not a sliding scale, but might relate to economies of scale.  We routinely see these kinds of arguments in opposition to motion to sever and transfer and motions to dismiss for forum non conveniens, and we disagree.

With the diminished scope of general jurisdiction after Bauman, plaintiffs will push the limits of specific jurisdiction, and BMS v. Superior Court is not the last word. For our part, we take our last words from the closing stanza of the Eagles’ Hotel California, which seems strangely apropos:  “Last thing I remember, I was running for the door.  I had to find the passage back to the place I was before.  ‘Relax,’ said the night man, ‘We are programmed to receive.  You can check out any time you like.  But you can never leave.’”  Welcome to the Hotel California.

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We made no secret that we were appalled by the result in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), as soon as it came down.  We’re still appalled.  Lance remains our current front-runner for worst decision of the 2014.  But a couple of recent cases have suggested that there may be a very thin silver lining to Lance.

That has come about because, whatever its other faults (and they are many), Lance reaffirmed “this Court’s refusal to extend strict liability to prescription drug manufacturers,” 85 A.3d at 438 (citing in Hahn v. Richter, 673 A.2d 888, 889 (Pa. 1996)).  “[F]or policy reasons, this Court has declined to extend strict liability into the prescription drug arena.”  85 A.3d at 453.  Thus, what the court had previously ruled in Hahn about Restatement §402A, comment k precluding strict liability across the board remains intact:  “the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability.”  85 A.3d 434, 45 n.19 (quoting Hahn, 673 A.2d at 891)).

These statements have had the effect of stemming what had been an unfortunate trend – again among Pennsylvania federal courts applying diversity jurisdiction that should know better  − of allowing certain non-warning or warranty-based strict liability claims to survive.

Continue Reading A Silver Lining To Lance?

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The following is a guest post from Reed Smith’s Rachel Weil. As always, she takes full responsibility for the content of the post.
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Dipping our toes into the blogosphere is intimidating, given the company in which we daily find ourselves. We can claim neither Bexis’s pinpoint command of all recorded jurisprudence nor McConnell’s encyclopedic recall of cinematic and literary history.   (He knows law, too, for the record.) Plus, our life notably lacks the anecdote-generating adrenaline our colleagues’ adventures provide. (Bexis and Alexander are BOTH zip lining in exotic locales as we type this.) Our individual voiceprint is thus not self-evident, and it would be easy to wax overly precious in attempting to identify it. For the time being, we will content ourselves with reporting legal developments and will remain optimistic that a niche will fashion itself for us.

This initial foray will curry little favor, as we are charged with summarizing two recent decisions in the Pinnacle Hip Implant MDL, neither of which contains a shred of good news for defendants.   In one day, the MDL judge issued an opinion denying all five dispositive motions filed by defendants in two individual cases (In In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2014 U.S. Dist. LEXIS 97743 (N.D. Tex. July 18, 2014)) and an opinion denying all six of defendants’ Daubert motions to exclude the testimony of plaintiffs’ experts. (2014 U.S. Dist. LEXIS 97798).

The Pinnacle implant is a metal-on-metal hip implant device, marketed to younger hip replacement patients because it lasts longer than other implant devices. Plaintiffs in both individual cases alleged that the metal-on-metal design of the articulating surfaces of the Pinnacle implant produced metallic ion debris, potentially causing an inflammatory reaction leading to bone and/or tissue necrosis and resulting in the need for revision surgery. Four corporate affiliates of manufacturing defendant DePuy Orthopaedics, Inc., collectively the “Johnson & Johnson Companies,” filed a motion to dismiss, arguing that the Court lacked personal jurisdiction over them, and a summary judgment motion to be decided if the Court denied the jurisdictional motion. DePuy filed motions under Montana law addressed to plaintiffs medical monitoring/future medical damages claims, their failure to warn/misrepresentation/omission claims, and their claims for intentional infliction of emotional distress, breach of implied warranty, and res ipsa loquitur. Finally, DePuy moved for summary judgment on plaintiffs’ design defect claims, arguing that these claims were preempted under Pliva v. Mensing.  Some “lowlights” of the Court’s denials of all of these motions:

After denying the Johnson & Johnson Companies’ jurisdictional motion, the Court considered their motion for summary judgment, in which the entities argued that they couldn’t be liable to plaintiffs because none of them had ever manufactured or sold the Pinnacle device. With Conte-esque disregard for this bedrock principle, the Court denied the motion, invoking Section 876(b) of the Restatement (Second) of Torts, which “provides that a party is subject to liability for harm to a third person resulting from the tortious conduct of another if he knows the other’s conduct constitutes a breach of duty and gives substantial assistance to the other so to conduct himself.” 2014 U.S. Dist. LEXIS 97743 at *13. Pointing out that § 876 “has recently been applied to business organizations by the Montana Supreme Court, id.,  the Court held, “The summary judgment evidence in this case raises fact issues that the Johnson & Johnson  Companies knew that DePuy was engaged in the manufacture and marketing of a defective product and that they provided assistance to DePuy in marketing that product.” Id. 

DePuy’s Motions: Failure to Warn and Related Claims

Relying on Oakberg v. Zimmer, Inc. 211 Fed. Appx. 578 (9th Cir. 2006), DePuy advanced a “failure to read” argument in support of its motions addressed to plaintiffs’ warnings-related claims. DePuy argued that, because the implanting physician had not read the Instructions for Use (“IFU”) accompanying the Pinnacle device, plaintiffs could not meet their burdens of proving that he relied on the warnings and representations in the IFU or that the warnings and representations caused him to choose the Pinnacle device. The Court declined to follow Oakberg, noting that, while the doctor never read the IFU, he “had a close relationship with his DePuy salesman” and relied on him for information, and was exposed to DePuy’s statements through seminars, lectures, advertisements, and medical publications. The Court concluded “that a reasonable jury could determine that Dr. Allmacher relied upon DePuy’s misrepresentations and omissions concerning the Pinnacle device.” 2014 U.S. Dist. LEXIS 97743, at *22-23.  (As you will see below, the Court’s rejection of the “failure to read” argument returned to doom one of defendants’ Daubert motions.)

Intentional Infliction of Emotional Distress

DePuy argued that it could not be liable to the plaintiffs for intentional infliction of emotional distress because plaintiffs could not “demonstrate that DePuy engaged in intentional conduct directed at them for the purpose of causing them emotional distress.” Id. at *26. The Court insisted that “intentional” didn’t really mean “intentional,” noting that Section 46(l) of the Restatement (Second) of Torts discusses emotional distress caused by either “intentional” or “reckless” conduct. And even though no Montana decision had ever addressed “reckless” infliction of emotional distress through conduct not directed specifically at the plaintiffs, one nine-year-old Tennessee state court decision had allowed such a claim. And even if Montana did require specific conduct directed at Plaintiffs, and even if there was no proof that DePuy’s conduct “may not have been directed specifically at [the individual plaintiffs],” it was certainly directed at people like them. Id. at *28-29. And so the Court found its way to denying summary judgment on plaintiff’s intentional infliction of emotional distress claims while acknowledging that there was no evidence of intentional infliction of emotional distress.

Preemption

Finally and predictably, the Court denied DePuy’s preemption motion.   The Pinnacle device is a Class II medical device, cleared for marketing under the FDA’s 510(k) process after the agency concluded that it was “substantially equivalent” to a predicate device. DePuy argued that plaintiffs’ state law design defect claims were preempted under Pliva v. Mensing because, under 510(k), DePuy could not have changed the design of the Pinnacle without FDA approval. Bypassing Mensing entirely and muddling both preemption law and DePuy’s argument, the Court held that, because the Pinnacle was a Class II medical device, not a generic prescription drug, any express preemption argument was foreclosed by Medtronic v. Lohr.  DePuy, of course, did not advance an express preemption argument, and its impossibility preemption argument – an accurate statement of 510(k)’s constraints  – deserved consideration it did not get.

DEFENDANTS’ DAUBERT MOTIONS

Defendants fared no better in their Daubert motions addressed to the testimony of plaintiffs’ experts. The Court foreshadowed its holdings  in its prefatory comment that “[a] review of cases within the Fifth Circuit in which expert opinions have been deemed unreliable and inadmissible reveals extreme circumstances of unreliability that were well beyond, for example, whether the expert considered all potentially relevant literature.” 2014 U.S. Dist. LEXIS 97798 at *19. Apparently finding no such “extreme circumstances,” the Court found ways to deny all six motions. Among them:

Plaintiffs’ “Expert on the Truth of Marketing”

First, the Court considered DePuy’s motion to exclude the testimony of Dr. John Abramson, plaintiffs’ “expert on the truth of DePuy’s marketing.” DePuy sought to exclude five opinions in which Dr. Abramson argued that DePuy exaggerated the benefits and minimized the risk of Pinnacle implants in is marketing materials, as well as his opinion that DePuy “paid physician consultants millions of dollars in return for input into the design and marketing” of the Pinnacle devices.   Id. at *20-21.

The Court rejected DePuy’s arguments that: 1) Dr. Abramson, a family practitioner, was not qualified to render opinions about orthopedics; 2) his opinions were nothing more than lengthy narratives and speculation about DePuy’s state of mind; and 3) his opinions about DePuy’s marketing efforts were not relevant. The Court held that Dr. Abramson’s opinions did not require expertise in orthopedics; rather, he was “more than qualified” to compare DePuy’s marketing messages with his interpretation of “what underlying scientific research actually showed,” id. at *23, “ due to his expertise in the area of the influence of marketing on medical decision” and his expertise “in research design and the interpretation of scientific data.” Id.  The Court noted that Abramson had “written extensively about the integrity of information that doctors rely on in making clinical decisions,” and that he had left his clinical practice to conduct full-time research in this area” and had “written a book on this issue.” Id. 

Acknowledging that Dr. Abramson’s report contained “narrative summaries in addition to his opinions,” the Court shoehorned these summaries into Fed. R. Civ. P. 26, holding that they functioned to articulate the bases of Dr. Abramson’s opinion, and that “[e]xpert narrative testimony is entirely permissible where [it] would assist the trier of fact in understanding” complicated, voluminous . . . . scientific or technical” documents forming the basis of the expert’s opinion, id. at 25-26, and that “the admission of Dr. Abramson’s alleged speculation and narrative testimony . . . is not properly the subject of this Court’s gatekeeping function under Daubert.” Id. at 26.

Finally, the Court brushed aside DePuy’s argument that Dr. Abramson’s testimony was not relevant given plaintiffs’ physician’s admission that he had not relied on any of DePuy’s advertising in deciding to use the Pinnacle device.   With reasoning akin to its rejection of defendants “failure to read” summary judgment argument, the Court held that the physician had other sources of the information in DePuy’s materials – presentations by key opinion leaders, surgeon dinners, medical education seminars, and medical journals – so DePuy’s marketing messages “were conveyed” even if the physician never saw any of DePuy’s marketing materials.

We confess to puzzlement over this decision, even against the backdrop of the Court’s other decisions. How is Abramson’s opinion “scientific, technical or other specialized knowledge [that] will assist the trier of fact,” as required by Fed. R. Civ. P. 702? The Court states that Abramson’s testimony is “helpful to the fact finder (even an orthopedic surgeon) [??? – how is the orthopedic surgeon a fact finder?] because he is interpreting complex scientific data to assess the truth of DePuy’s marketing claims.” Id. at 23-24. We think this is a stretch, even for this Court.

Scott Bayley, C.P.A., Plaintiffs’ Punitive Damages Expert

In denying DePuy’s motion addressed to this expert, the Court held that this “punitive damages expert” was not a “punitive damages expert” at all.   According to the Court, Bayley was not being offered “as an expert on the calculation of punitive damages,” properly the jury’s function, as defendants argued. Rather, the expert “analyze[d] the financial condition and net worth” of defendants, and calculated three different figures, by three different methods, representing “the amount that Defendants could afford to pay before being adversely affected.”  Id. at *30. Rejecting defendants’ argument that these figures simply provided the jury a range of awards within which to choose, the Court concluded, “The admissibility of Mr. Bayley’s testimony on the basis that it invades the province of the jury is more appropriately a question to be determined in this Court’s discretion over the presentation of evidence at trial and not as part of the Court’s gatekeeping function under Daubert.” Id. at *31. Finally, the Court rejected the defendants’ argument that the expert’s testimony was not reliable, notwithstanding the expert’s admission that “there is no basis in accounting for considering dividends, materiality or credit ratings for calculating the largest punitive damages award a company could sustain,” reiterating that the expert was calculating defendants’ ability to pay and was not calculating “an amount of punitive damages.” Id.          

Other Daubert Motions

The Court also denied DePuy’s motions addressed to: 1) Plaintiffs’ expert on metal corrosion (rejecting arguments that the expert was not qualified to testify about design or defect issues and used unreliable methodology to reach his conclusions. Id. at *33.);   2) Plaintiffs’ expert on the injuries allegedly caused by cobalt nanoparticles in the metal-on-metal wear debris produced by the Pinnacle (“DePuy’s criticism of Dr. Colvin is merely a battle of the experts and goes to the weight rather than the admissibility of her testimony. A difference of opinion in interpreting the literature is not grounds for a Daubert challenge. Id. at *39-40.); 3) Plaintiffs’ biostatistics expert (rejecting DePuy’s argument that the expert based his conclusion on the wrong data, holding that “the factual basis for an expert’s findings goes to the weight of his testimony, not the admissibility.” Id. at *42 ) (citations omitted); and 4) Plaintiff’s expert in “measuring manufactured components” (“DePuy’s disagreement about how Dr. Ziegert executed the steps in the process for measuring wear volume goes to the weight not the admissibility of this testimony.” Id. at *44.)

Apparently, the “gatekeeper” was on hiatus. All in all, a bad day for defendants, and for the application of law to facts, in the Northern District of Texas. We hope that we have better news to report next time.

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

These wins are becoming routine – but we’re not taking them for granted.  In fact, we’ve given them their own label on the blog and we highly recommend you peruse this collection if you are facing off-label promotion allegations.  It is an overwhelming body of precedent establishing that almost all claims in pre-market approved (“PMA”) medical devices are preempted and that off-label use does not change the analysis or the conclusion.   And one of the great benefits of tallying up all of these favorable decisions from courts across the country is citing them to courts considering the issue.  Both of the recent InFuse wins demonstrate that the vast authority supporting preemption is quite compelling.

A quick reminder of the core issue in the InFuse litigation.  The InFuse bone graft device is a Class III, PMA device.  The Supreme Court has determined that the PMA process imposes federal requirements that preempt state law tort claims.  That express preemption combined with the implied preemption of claims that seek private enforcement of the FDCA leave only a “narrow gap” through which a claim must fit to survive.  Plaintiffs most often used method for threading that needle is to allege a parallel claim – a violation of a state law duty that is genuinely equivalent to federal requirements.  Since so few claims even come close to being parallel claims, the InFuse plaintiffs allege that because their surgeons implanted the device in an off-label manner, the standard preemption analysis shouldn’t apply.  First, they argue that the PMA requirements for InFuse should be inapplicable to off-label uses and without specific requirements, the first prong of the express preemption analysis isn’t met.  Alternatively, even if the requirements apply, plaintiffs allege their claims are parallel claims because the FDA prohibits off-label promotion.

Continue Reading Two More InFuse Victories

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This post is from Bexis:

In a decision reflective of how attorney solicitation dredges up bad cases that should never have been filed, a New Jersey appellate court has handed the defense three wins in its Accutane litigation involving inflammatory bowel disease (“IBD”).  Gaghan v. Hoffman-La Roche, Inc.,Nos. A-2717-11T2, et al., slip op. (New Jersey Super. A.D. Aug. 4, 2014).  Gaghan involved three appeals, two from defense verdicts and one from a plaintiff’s verdict, affirming the defense wins and reversing the one adverse verdict.  The trial had been something of a circus – three unrelated Accutane plaintiffs’ cases tried together.  All three plaintiffs were litigation tourists from California, so that state’s law applied, which is probably why the decision is unpublished.  It certainly is detailed enough to be published, had it not been one state’s courts opining on the law of another state.

Continue Reading Accutane Triple Win in Jersey

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As Bexis demonstrated yesterday, we can have strongly held views.  When we do, we are not always subtle about letting our readers know what those views are.  When a rant builds, it can pour like an avalanche coming down a mountain—with more vinegar than cinnamon or sugar.  When we read In re Actiq Sales and Marketing Practices Litigation, No. 07-4492, 2014 U.S. Dist. LEXIS 984411 (E.D. Pa. July 21, 2014), we felt the rant coming on.  The case involves Daubert in a case with outsourced
representation and collective causation evidence related to alleged off-label promotion of a prescription drug, so a few things we care about were brewing.

But it is now the first day of August and a tropical vacation is looming.  School for the kids and other rituals signaling the transition from summer to fall will be here soon.  Thus, we resolved to keep this post somewhat calm despite a bad result, questionable analysis, and a fundamental misunderstanding of the relationship between FDA regulation of drug companies and what doctors do with their own patients.  Rest assured, though, that we would have many more snarky comments about the opinion if not for our resolve to stay “chill,” as much as we ever do.

Continue Reading Assuming What You Are Trying to Prove in A Third-Party Payor Case

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A bit of a rant today.

We’ve just read Gibson v. American Cyanamid Co., ___ F.3d ___, 2014 WL 3643353 (7th Cir. July 24, 2014), and we have to say that it’s one of the most constitutionally arrogant decisions we’ve ever read.  Stripped to its essentials, Gibson is the judicial branch thumbing its nose at the supposedly co-equal legislative branch and saying “we can do it but you can’t.”

Gibson involves one of these seemingly one-way legal doctrines that only protects plaintiffs, but for some reason never defendants, the concept of so-called “vested rights.”  Here’s the back-story.

Thirty years ago, the Wisconsin Supreme Court, in a judicial exercise of social policymaking, decided to adopt a peculiar form of an already peculiar doctrine – market share liability.  See Collins v. Eli Lilly Co., 342 N.W.2d 37 (1984).  The court breached a hitherto (mostly) sacrosanct defense – product identification − that a defendant can’t be liable unless the plaintiff first proves that s/he actually used the defendant’s product.  The reason was … well, the usual fuzzy-headed logic that the common law can change and we think it’s better that the plaintiff wins.  Id. at 45 (we can change the common law), 49 (we’re gonna change the law and let the plaintiffs win because of “interests of justice and fundamental fairness”).  Despite the fact that the product was off the market and plaintiffs had taken it many years earlier, the court in Collins had no compunction in extending this new theory of liability retroactively to defendants whose conduct had previously been protected by the product identification defense.

Collins, as most of our readers probably already know, was a DES case.  DES was, for all intents and purposes, the world’s first generic drug.  Its patent had expired, so anybody who wanted to go to the time and effort to do so (this was the pre-1962 FDA, before NDA requirements were made a lot tougher) could set up shop and make the drug.  Scores of companies did, and “DES” became the reference of choice for most doctors and pharmacists.  Given the peculiarly long latency period for the peculiar injury – suffered in utero − in DES cases, product identification was a mess.  Collins decided to let the plaintiffs win anyway by shifting the burden of proof, contrary to decades (at least) of precedent.

At least in Collins there was a real product identification problem.  In the next case (the one ultimately at issue in Gibson), a bunch of class action lawyers decided to gin up a product identification problem.  They wanted to sue on behalf of everybody theoretically injured by lead paint, which had been off the market for a quite a while by the time suit was brought.  Since causation was an individualized issue that could defeat aggregated litigation, they created an impossible ID problem by skipping over the manufacturers of lead paint (some of whom might have been identifiable in building maintenance records) and sued only the bulk suppliers of lead paint pigment.

Continue Reading Court: It’s Only Unconstitutional If You, Not We, Do It

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The other day ESPN’s Sportscenter ran a teaser entitled “Less of Maya Moore.”  WNBA player Maya Moore had what was for her a less than stellar night, but her teammates on the Minnesota Lynx picked up the slack and they won anyway.  Maya Moore is a fantastically gifted basketball player with the resume to prove it.  She has won team championships and MVP trophies on the collegiate and professional levels.  A scientist has measured Moore’s reflexes to approximate those of a striking rattlesnake.  Moore has also donned makeup to look like an old lady and, along with Kyrie Irving dressed up as Uncle Drew, scammed some recreational ballers on a neighborhood hoops court.  The video is here.

Maya Moore is very, very good at what she does.

By contrast, the Maya litigation in our fair city is very, very bad.  First, there was the trial here in the Philly Court of Common Pleas, where the plaintiff won a $10 million verdict when a jury found that the defendant failed to warn that over-the-counter Motrin could cause SJS/TEN (a rare but life-threatening disease that causes severe blistering and sloughing off of skin, together with serious damage to the mouth, eyes, throat and esophagus).

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Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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