April 2015

[Drug and Device Law] Freehand Line-Drawing in Affirmance of Huge Verdict in Children's Motrin/TEN Case

Posted by Law

A couple of days ago, we watched the lovely “St. Vincent.” The film stars a spot-on Bill Murray as Vincent, an unemployed curmudgeon living alone in an otherwise tidy residential neighborhood. Disrepair has turned Vincent’s house into an eyesore. Vincent is eluding his threatening bookie, who is seeking repayment for money Vincent has lost on the horses. Vincent is unkempt and rude, and we are led to believe that his only “soft spot” is reserved for his white Persian cat. Enter a subdued and quietly effective Melissa McCarthy (compare “Bridesmaids”), as a newly-single mother moving next-door to Vincent with her (flat-out adorable) young son in tow. We’ve recently been the victims of spoilers ourselves (see McDreamy), so we won’t reveal more except to note that Vincent is not quite the unredeemed ne’er-do-well he seems to be. The movie reminds us to reserve judgment and not to allow initial impressions to obscure nuance. Sometimes, there is good buried among the bad.

Such is not the case for Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015). There are few, if any, silver linings in this Massachusetts Supreme Court decision affirming an eye-popping jury award of $50 million in compensatory damages to a child whose devastating toxic epidermal necrolysis ("TEN") was allegedly caused by Children’s Motrin. The Court also affirmed loss-of-consortium awards of $6.5 million to each of the child’s parents.

As one would expect, the facts of the case are horrific. After developing fever and congestion, the then-7-year-old plaintiff was given several doses of Children’s Motrin over the course of a day. She developed a sore throat and a rash, and her parents took her to her pediatrician, who diagnosed measles and instructed the parents to continue treating the child with Motrin. By the next day, the child was covered in blisters, her lips were bleeding, she could not open her eyes or mouth, and she was diagnosed with TEN. Reckis, 471 Mass. at 274-75. Against the odds, she survived, but remained hospitalized for six months, a month of it in a medically-induced coma to control her pain. The top layer of her skin sloughed off, she lost the ability to eat without a feeding tube, and she suffered heart failure, liver failure, and a stroke, underwent brain surgery, and lost most of her lung capacity. While some of these conditions resolved or improved, she was left with significant, permanent cognitive and physical impairment, including the inability to ever carry a child. Id. 275-76.

After trial, defendants filed motions for JNOV, for a new trial, and for remittitur. Defendants argued that (1) they were entitled to judgment as a matter of law because plaintiffs’ warnings claim was preempted, under principles of implied conflict preemption; and 2) plaintiffs failed to prove causation because their causation expert was unqualified to render his causation opinions. The trial court denied all of the post-trial motions, which were reviewed on appeal by the Massachusetts Supreme Judicial Court. Id. at 274.

Preemption

At the time Children’s Motrin was administered to the plaintiff, the warnings section of its label did not mention TEN or its symptoms, though it warned consumers to stop using the product if an allergic reaction occurred. Id. at 280. A little over a year later, a group including physicians and the pharmacologist who was plaintiff’s medical causation expert (more on him later) submitted a citizens’ petition to FDA requesting alterations to the Children’s Motrin label warning of the possibility of “serious skin reactions that may begin as rashes and blisters on the skin and in the areas of the eyes, mouth and genitalia [and] may progress to more serious and potentially life-threatening diseases including . . . [TEN].” Id. (emphasis added).

After conducting “a comprehensive review of the risks and benefits” of Children’s Motrin, the FDA “agreed with the petitioners that the labeling of . . . Children’s Motrin should be improved to warn consumers about the risks of severe skin reactions. . .” Id. at 281 (internal punctuation omitted). However, the agency “took the position that it was not useful for OTC ibuprofen labels to include the specific terms . . . TEN or toxic epidermal necrolysis because most consumers are unfamiliar with these terms.” Id. (internal punctuation omitted). Nor did the FDA approve the fallback position urged in the petition, which was to add the adjective “life threatening.” Id. The FDA was content with “severe skin reactions.”

Plaintiff’s failure-to-warn claim argued that the Children’s Motrin label should have warned that redness, rash and blisters might be the pathway to a “life-threatening” disease – the very same adjective that the citizens’ petition had requested and that the FDA had declined to require. Plaintiff’s father testified that he would not have given the plaintiff further doses of Motrin once these symptoms developed if the label had contained this warning. Id. at 284.

Given this history, one can see why the defendants argued that this was “a classic case of conflict preemption, in that the warning the plaintiffs [said] would have made a difference . . . [was] one that the FDA had expressly rejected.” Id. at 283. The Court disagreed, citing SCOTUS’s Wyeth v. Levine, 555 U.S. 555 (2009), decision for its holding that there was no “impossibility preemption” – preemption because it was impossible to comply with both state and federal requirements – in the absence of “clear evidence that the FDA would not have approved” the label change the plaintiffs sought. Id. at 286 (citations to Levine omitted).

“Clear evidence” is as clear as mud. The same regulatory facts supported a preemption holding barring a Motrin-related claim in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 873 (7th Cir. 2010). Noting that Levine had not defined “clear evidence,” the Reckis Court commented that application of the standard was necessarily “fact-specific.” Id. at 286. Apparently, the facts were not “specific” enough. With respect to the Children’s Motrin label, the Court held that, although the citizens’ petition had requested the inclusion of rash/blister language, specific mention of TEN, and allusion to “life-threatening illness,” and the FDA ultimately ordered only the symptom language added to the label, there was no “clear evidence” that the agency would not have approved “life-threatening illness” language had the manufacturer sought to add it. Even though the same language was in the petition, and even though the agency declined to require it to be added to the label. This is the Court’s attempted distinction:

The proposed language, “potentially life-threatening diseases,” was part of the same sentence as, and immediately followed by, the names of the . . . diseases or conditions that the FDA specified it did not think proper for an OTC ibuprofen label. Accordingly, the FDA’s decision not to request that the manufacturers add a warning about life-threatening diseases could well have been merely a byproduct of its rejection of these requested warnings on the basis that they mentioned [diseases] by name. Whether the FDA also would consider a mention of life-threatening diseases, by itself, to be inappropriate and off limits on the OTC label is anybody’s guess; certainly the reason specified by the FDA for rejecting use of the disease names – consumer unfamiliarity – does not apply to use of such a phrase.

Id. at 289.

This exercise in wavy line-drawing is but one more illustration of the folly that Levine permits in the name of “clear evidence.” The FDA had considered a request that the Motrin label be modified to add three things: rash/blister symptom language, language about “life-threatening illness,” and specific mention of specific diseases, including TEN. It permitted only the first. But, merely because it did not discuss at length its reasons for not requiring the “life-threatening illness” language, there is purportedly no “clear evidence” that it would decline to approve this language. Though it just had. We submit that the “evidence” was pretty “clear.” But “fact-specific” application of the standard continues to mean that conflict preemption bows to the whims of courts, especially where the injuries are sufficiently compelling.

The result in Reckis is ironic indeed. Levine only required “clear evidence that the FDA would not have approved a change” in labeling. 555 U.S. at 571 (emphasis added). The FDA regulatory history in Reckis went one step beyond even what Levine had required, with evidence that the FDA in fact did not approve use of the plaintiffs’ “life-threatening” adjective, even though that language was actually put before the Agency a year after this injury. While Levine moved the preemption goalposts, Reckis essentially demolishes them. Forget about Levine’s “would not have” standard – even “actually did not” wasn’t “clear” enough here. If the Supreme Court meant what it said in Levine, evidently it will have to say so again.

Qualifications of Causation Expert

Defendants also argued that they were entitled to judgment as a matter of law because plaintiff’s medical causation expert (Randall Tackett) offered his causation opinions without proper qualifications or foundation.

With physicians aplenty at their disposal, Plaintiff couldn’t get a single one to opine on causation here. The problem is that so many things supposedly cause TEN and/or the related condition “Stevens-Johnson Syndrome,” that nothing does. We took an abbreviated look at the caselaw – only the top 25 separate pieces of litigation in the over 300 cases that mention the disease. We found causation claims levelled against everything from pain relievers, to oral contraceptives, to antibiotics. Bartlett v. Mut. Pharm. Co., 133 S. Ct. 2466 (2013) (suldinac); Ball v. Takeda Pharm. Am., Inc., 587 F. Appx. 78 (4th Cir. 2014) (Dexilant); Brown v. Roche Labs., Inc., 567 F. Appx. 860, (11th Cir. 2014) (Rocephin); Lofton v. McNeil Consumer & Specialty Pharm., 672 F.3d 372 (5th Cir. 2012) (ibuprofen); Crisostomo v. Stanley, 857 F.2d 1146 (7th Cir. 1988) (Zyloprim); Vitatoe v. Mylan Pharm., Inc., 696 F. Supp.2d 599 (N.D.W. Va. 2010) (phenytoin); Gomez v. Pfizer, Inc., 675 F. Supp. 2d 1159 (S.D. Fla. 2009) (multiple, including Zoloft); Taylor v. Merck & Co., 2009 WL 3429685 (W.D. Tenn. Oct. 16, 2009) (Indocin); Hall v. Merck, Sharp & Dohme, 774 F. Supp. 604 (D. Kan. 1991) (Dolobid); Shinn v. St. James Mercy Hosp., 675 F. Supp. 94 (W.D.N.Y. 1987), aff'd, 1988 WL 49763 (2d Cir. 1988) (multiple, including Phenobarbital); Fusco v. Shannon, 89 A.3d 1156 (Md. 2014) (Amifostine); Jones v. Detroit Med. Ctr., 806 N.W.2d 304 (Mich. 2011) (carbamazepine); Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky. 2004) (Zithromax ); Griggs v. Combe, Inc., 456 So. 2d 790 (Ala. 1984) Vagisil); Chamblin v. K-Mart Corp., 612 S.E.2d 25 (Ga. App. 2005) (Daypro); Kurer v. Parke, Davis & Co., 679 N.W.2d 867 (Wis. App. 2004) (loestrin); Parker v. Harper, 803 So. 2d 76 (La. App. 2001) (Dilantin); Jordan v. Ryan, 684 So. 2d 1030 (La. App. 1996) (erythromycin). Given the rampant uncertainty concerning the etiology of TEN, it’s no wonder that no doctor that actually specialized in treating this condition testified on causation.

Instead of a real doctor, plaintiff’s medical causation expert was a pharmacologist. He had never treated a TEN patient and had never published an article on TEN. However, he “taught courses that focus[ed] on the interactions of drugs with the human body,” and also “taught courses on NSAIDs.” He was “experienced in reviewing medical records to determine the effects of a drug because doing so [was] a component of pharmacology and toxicology” and he had “served as a peer-reviewer of papers written by physicians.” Id. at 292.

The Court commented that “the judge was entitled to credit [the expert’s] testimony that he [had] considerable experience in reviewing patient medical records in order to determine the effects of a drug on the body,” and found “no error in the judge’s ruling” that the expert was qualified to render a medical causation opinion “despite the fact that he was not a physician treating TEN patients.” Id. at 294. And so, in a trial resulting in a $50 million verdict, a “medical expert” who was not a doctor was allowed to render a medical causation opinion. In our view, another jaw-dropping example of line-drawing, reminding us of decisions admitting testimony of “regulatory experts” with the barest of credentials and no relevant experience. Only worse.

Sometimes, “bad” is just a smokescreen, and the good within is revealed when the smoke clears. And sometimes “bad” is just “bad.”

--
Posted By Rachel B. Weil to Drug and Device Law at 4/30/2015 02:57:00 PM

--
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
---
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.

[DK GreenRoots] The first post by this person on Daily Kos - Give her a boost!

Posted by Law

This person is just getting their feet wet and was very pensive about writing a diary. Give her some love. Thanks!

April filled with Rallies in Seattle

--
You received this message because you are subscribed to the Google Groups "DK GreenRoots" group.
To unsubscribe from this group and stop receiving emails from it, send an email to dk-greenroots+unsubscribe@googlegroups.com.
To post to this group, send email to dk-greenroots@googlegroups.com.
Visit this group at http://groups.google.com/group/dk-greenroots.
For more options, visit https://groups.google.com/d/optout.

[Drug and Device Law] Alabama Legislature Abolishes Weeks Innovator Liability Theory

Posted by Law

That didn’t take long. Yesterday the Alabama House of Representatives passed SB-80, which abolishes the innovator liability theory created in the execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014) (discussed here and here, and named #1 worst decision of 2014 here). Here is a copy of the enrolled bill. The online legislative history indicates that SB-80 passed the Alabama Senate 32-0 and the House 86-14.

The relevant statutory language, imposing a product identification requirement in all cases seeking damages caused by a product, states:

Section 1. In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product. Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury. A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer's product, even if use of the design is foreseeable.

SB-80 §1 (emphasis added). Not only does this kill Weeks innovator liability, which was the motive force for the legislation, but it also abolishes market share liability, alternative liability, conspiracy liability, and any other industry-wide theories of liability in cases involving product-related injuries. Finally, the law shields non-manufacturing designers unless they “express[ly] authoriz[e]” the particular use of their design, regardless of “foreseeability.”

Thus, Weeks does not even survive long enough to obtain a published citation. Good riddance.

The legislation is not perfect, however – probably because of constructional concerns about making the abolition retroactive, even though the liability recognized in Weeks was completely unprecedented and had no business ever existing at all. Instead, the statute only takes effect “six months” after becoming law and applies only “to civil actions filed thereafter.” SB-80 §4.

--
Posted By Bexis to Drug and Device Law at 4/29/2015 11:59:00 AM

[Drug and Device Law] Fraud In The Smoke Will Not Do

Posted by Law

This is from the non-Dechert side of the blog.

We do not write too often about tobacco decisions. While FDA has added a Center for Tobacco Products and there are still lots of cases against tobacco manufacturers, we are more likely to talk about some consumer protection or preemption issue from a food case than any issue from a tobacco case. Rather than discussing the reasons why we typically ignore the tobacco cases in our nearly never-ending search for bloggable cases, we will say what interested us in Berger v. Philip Morris USA, Inc., No. 3:09-cv-141567 (M.D. Fla. Apr. 23, 2015). First, the decision is a grant of a post-trial motion for partial judgment after essentially the same motion was denied without prejudice at the end of the plaintiff’s case. For readers who have not gone through this particular emotional roller coaster, it can be analogized to watching your playoff basketball or hockey team be up three games to two, fail to clinch the series in game six, and then take game seven. You were sure that your team would lose game seven after the earlier missed opportunity. Then, your relief at the ultimate win is somewhat tempered by the thought that you could have avoided significant progress toward an ulcer. Still, this is much better than taking the loss. Ask any Caps fan. Second, it involved a verdict of more than $20 million going away. And, third, it involved the issue of the plaintiff’s reliance on representations by the defendant—representations that the court had no trouble characterizing in the most damning ways. Going back to the basic principles of tort law—Palsgraf, anyone?—even decades of an industry-wide “disinformation campaign” does not create liability unless it can be tied to the plaintiff’s use of the product.

The last time we chimed in on the so-called Engle-progeny cases, it was to address rampant fraud by plaintiff lawyers in bringing frivolous lawsuits like personal injury cases for dead people, survivorship actions for living people, and suits for people they did not represent. Apparently, among the progeny, there are real cases on behalf of living people with tobacco-related injuries and, apparently, they proceed on claims for fraud and conspiracy to commit fraud. In the context of personal injury claims for drugs and devices, we mostly see fraud and conspiracy claims added in to complaints as a proposed route to punitive damages with little chance the actual evidence with bear out the allegations of the defendant’s conduct. The Engle-progeny cases, at least as the Berger court recounts the trial evidence, are a different animal. The industry—most of the general evidence is presented as a coordinated effort of the entire industry—“deliberately targeted persons of school and college age to begin smoking, knowing that, as a result of the addictive powers of their product, and the oft irresistible influence of peer pressure on pupils and students, they would acquire new, life-long consumers of their products,” which the industry already knew to be deadly. The “massive, multi-faceted, protracted, and effective disinformation campaign” about the risks and addictive potential of cigarettes included downplaying the 1964 Surgeon General’s Report, lying to Congress, and claiming that “light” cigarettes and/or cigarettes with filters were safer. Even with a mountain of bad evidence, plaintiff still “had to prove that she relied on what the tobacco companies were saying and doing, by both affirmation and concealment, as she began and/or continued to smoke.” Even though plaintiff began smoking in 1960, later switched to filtered Parliament Lights, was generally aware of Philip Morris’s advertising, and later developed COPD, her detrimental reliance was not a foregone conclusion.

It was one that plaintiff contended, based on intermediate Florida appellate authority, could be presumed based solely on generic evidence. The Berger court, consistent with its jury instruction, rejected that contention both because federal standards for sufficiency of evidence apply in federal courts sitting in diversity and because the court predicted that the Florida Supreme Court would not adopt such a presumption. We have been critical of other courts for blithely extending state law against Erie principles, but the court here took a reasoned approach in refusing the proposed deviation from traditional proof requirements—something we would characterize as a proposed extension of state law. The Florida Supreme Court authority emphasized that the whole point of Engle-progeny cases was to allow trials of “matters individual to each claimant individually,” including “individual questions of reliance and legal cause.” Despite the intermediate appellate decisions, the court was “persuaded that the Court would opt for requiring some proof of individual reliance on the tobacco companies’ fraudulent misconduct.” Thus, although there was some expert testimony that skirted the subject of whether the plaintiff relied on anything from the defendant or industry, plaintiff’s “claim of reliance rises or falls on her own testimony.”

That testimony was “remarkably candid and forthright” in attributing her decisions to start smoking cigarettes, keep smoking after warnings were added to cigarette packaging, and switch to a “light” filtered brand to things other than the defendant’s representations. According to the definition of reliance imported from the Restatement (2d) of Torts, reliance on the truth of a misrepresentation “must be a substantial factor in inducing [the plaintiff] to act or refrain from action.” By her own testimony, plaintiff decided to smoke based on peer pressure. She switched to a new brand because of how it tasted and kept bits of tobacco out of her mouth, not based on a belief that it was safer than other brands. She “kind of knew” that smoking was hazardous after warnings came out, “but I didn’t take it seriously enough. I knew a lot of people that smoked and they were in their 90s.” Without more, and even with reasonable inferences in her favor:

the evidence offered here simply cannot support a reasonable fair-minded inference of her detrimental reliance on either incomplete representations by PMUSA regarding the health effects and/or addictive nature of smoking cigarettes, or, on statement(s) made or act(s) done in furtherance of a conspiracy to conceal or omit material information from representations regarding the same.

With this, the fraud and conspiracy claims and the $20 million punitive award based on them were reversed. Glossing over the procedural details for the rest of the case, we will end with the dual lessons that the nexus between generic evidence and case-specific evidence should always matter and honest plaintiffs sometimes submarine their own cases.

--
Posted By Eric Alexander to Drug and Device Law at 4/29/2015 08:00:00 AM

[Drug and Device Law] InFuse State Court Appellate Win

Posted by Law

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

Last week we reveled in the Tenth Circuit affirming the Caplinger decision – a complete rejection of plaintiffs’ attempt to utilize allegations of off-label promotion to slip through the exceedingly narrow gap that remains in Pre-Market Approval device cases. Think of it like taking a shot on goal. The shot deflects off the goalie’s stick and goes wide – that’s express preemption. The shot hits the goalpost and sails over the net – that’s implied preemption. Between the puck and the net are the sticks of the opposing team – they’re pleading requirements. You don’t give the who, what, where and when – the puck’s going to be stolen. Plaintiffs have been trying to push the puck into the net with diversion. Get the courts thinking off-label use changes the rules; that it should force a penalty on the manufacturers that opens up the lane for a clean shot. Wrong. No free shot. No empty net. All the obstacles remain in place. Only, in PMA cases plaintiffs are less likely to score than Sidney Crosby facing Henrik Lundqvist (sorry Pittsburgh, and to be clear this blogger is not supporting Lundqvist in the next series. Go Capitals!).

While plaintiffs may have managed to sneak a few claims through in Angeles v. Medtronic, Inc., 2015 Minn. App. LEXIS 19 (Minn. Ct. App. Apr. 20, 2015), we ultimately believe they will be as helpful to the plaintiffs as the aforementioned Crosby’s 2 goals in the series against the Rangers were – useless.

We begin where we begin our discussion of all InFuse cases. The allegations are the same. Plaintiffs (here a consolidated group) underwent surgery in which components of the InFuse spinal fusion device were used off-label. The lower court threw out all their claims as preempted, except fraud which they tossed for failure to plead with particularity. Id. at *2. Plaintiffs argued that that decision was erroneous because it did not correctly consider that the landscape was altered by the off-label use and promotion of the device.

The analysis in Angeles isn’t all that different from what we’ve seen before either. But, it’s an appellate decision and that’s significant. The court started with express preemption and plaintiffs’ argument that it shouldn’t apply at all because the specific FDA requirements for the InFuse device do not apply when a component of the device is used alone. Id. at *8. In the battle of device v. use – device emerges victorious again. The FDA approves devices. PMA requirements are device specific. The FDA does not and cannot regulate how devices are used by surgeons, but the FDA is well aware that devices will be put to off-label uses. Put all that together, and you conclude, as the court did here, that “the FDA established specific federal requirements for the Infuse Device, even when [an InFuse component] is used alone.” Id. at *13-14. A variation on plaintiffs’ argument is that the PMA requirements should only apply when the device is put to its “intended use” as stated in its labeling. The corollary to that argument is that when a surgeon opts to use the device in a different manner, the PMA requirements somehow disappear. Not so said the court, acknowledging that plaintiffs support for this argument, the Ramirez case, has been rejected by almost every other court to consider the issue. Id. at *14-17.

Not successful in dodging express preemption in its entirety, plaintiffs move to step two in the usual InFuse case – their claims aren’t preempted because they are parallel violation claims. The court looks at each claim in turn – failure to warn, design defect, breach of express warranty. On failure to warn, plaintiffs, in short, allege that Medtronic should have warned of risks of off-label use. In other words, plaintiffs “allege that, while promoting off-label use of the Infuse Device, Medtronic should have given warnings that were different or additional to those required by the FDA.” Id. at *21. To succeed on this claim, the jury would have to find that Medtronic was required “to provide directions and warnings for off-label uses in addition to the FDA-required warnings.” Id. at *25. This is the exact opposite of a parallel claim. And, the icing on the cake is the court’s recognition that there is “no state-law duty to abstain from off-label promotion.” Id. at *24.

Unfortunately, the court didn’t extend that “no state-law duty” analysis far enough in our opinion. The court decided to divide failure to warn into failure to warn doctors and patients (the above claim) which is preempted and failure to warn the FDA which it concluded was not preempted. Stengel rears its ugly head again. Relying on the reasoning of the Ninth Circuit, the Angeles court found that Medtronic was required by the FDCA to report adverse events to the FDA. Therefore, the court determined that failure to warn the FDA was not expressly preempted because it paralleled federal law. So the court had to move on to implied preemption, where the question is whether the claim is “based in traditional state tort law.” Id. at *32. We haven’t done a review of Minnesota law, but we don’t think we are reaching too far to suggest you are unlikely to find a state law claim for failure to warn the FDA. But the court didn’t look that closely. Rather, it cited to a manufacturer’s general duty “to give warning.” Id. at *33. We don’t think that’s nearly enough to “moor” this claim in traditional state tort law. But the court did.

On the upside, the opinion expresses some real concern for the viability of this claim outside the preemption arena. First, the court acknowledged that plaintiffs barely pleaded the claim. Id. at *34 n.2 (one reference in one sentence in a 90 page complaint). Second, the court emphasized that upon remand the lower court was tasked with deciding whether the claim was sufficiently pleaded and to meet that burden, plaintiffs “must show how Medtronic’s alleged failure to warn the FDA about adverse events concerning the Infuse Device contributed to their injuries.” Id. at *33. Without the necessary details, the court was skeptical it could “determine whether timely reporting would have affected the off-label use” of the device in plaintiffs’ surgeries. We are fairly confident plaintiffs will have a difficult time pleading, let alone proving, this causation element.

Next the court quickly dismissed plaintiffs’ design defect claims as expressly preempted because to prevail, they “would need to show that the Infuse Device should have been designed in a way that is different than the FDA-approved design.” Id. at *36. Different equals preemption.

And, then the court lets another one by – express warranty. The reasoning isn’t unfamiliar in the InFuse cases. The court found that the basis for the express warranty claim is allegations that Medtronic voluntarily made misleading statements outside the confines of the product label (in its marketing and promotion) and that that is prohibited by state law (breach of warranty) and by federal law (FDCA prohibitions on false and misleading statements). Therefore, it survives as a parallel claim. Id. at *37-40.

But again, the court took no position on whether those claims were adequately pleaded. Id. at *41. We won’t be surprised to see a challenge on that basis after remand. And, we suspect that that challenge will look somewhat like Medtronic’s successful challenge on plaintiffs’ fraud claims. Here the court upheld the trial court’s decision that the “amended complaints do not identify who made the alleged false representations to the treating physicians, which medical journal articles were read and relied on by the physicians, or what false statements were contained therein.”

So, plaintiffs are left with a failure to warn the FDA claim that we already know is insufficient because it contains no causation allegations and an express warranty claim that we surmise suffers from the same deficiencies as plaintiffs’ fraud claims. A couple of shots snuck through, but we don’t see this case advancing in round two.

--
Posted By Michelle Yeary to Drug and Device Law at 4/28/2015 03:01:00 PM

[MMIT Want to learn how to create a miracle?

Posted by Law

Share:

Greetings Dear One...

My friend and colleague Allyson Chavez has discovered how to reverse engineer miracles!

Say what? What does that even mean?

Reverse engineering is when you take something apart, look at its parts, and then put it back together again in order to duplicate it or enhance it. And Allyson has discovered that you can do this with miracles, too!

We're both so fired up about it, we wanted to share the secrets of miracle making with you. Allyson is hosting a FREE 60 minute webinar, where you're going to spend that time learning exactly how to create miracles.

You'll walk away with:
--knowing every part of the miracle making process, and how to use each part correctly

--confidence knowing that you can take this knowledge and apply it to anything you want to create

--feeling the certainty that comes with having a plan and knowing how to work that plan

You have more to do with creating miracles than you might think. It's worth it to hop on this webinar to see just exactly how simple it is, and how powerful you are!

---->Sounds fascinating!
bit.ly/MiracleAC Sign me up! <-------

Creating miracles is a simple, fun process. There are limited phone lines available for this webinar, so be sure to register now and be there early so you'll have a seat.

----> Got it! bit.ly/MiracleAC I'm there! <------

Love & Blessings
DaKara

P.S. You will LOVE Allyson's energy! Register now to make sure you receive all the details and get a seat to the Miracles the Universe has in store for you! bit.ly/MiracleAC

.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:.
DaKara Kies, Master Energy Healer, Miracle Rainmaker,
HPT Master. Certified Inspiration, Money & Relationship
Coach. Intuitive Reader, Feng Shui Consultant & Artist
www.DaKara.com
www.HPTHealing.com
www.FengShuiMind.info
www.RelinquishSeries.com
www.NewMoonCheck.com
www.DaKaraEssences.com
DaKara's Flower Essences for Petswww.Pet-Calm.com www.Pet-Ease.com

Share:

P.O. Box 4338
Everett, WA 98204, USA

[Drug and Device Law] Yes, There Is Still Vioxx Litigation

Posted by Law

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

The Vioxx MDL is still alive. But not really kicking. The master settlement agreement ended the mass tort portion of this litigation, leaving behind a vastly smaller number of cases filed by plaintiffs who chose not to “opt in” to the settlement. The MDL court is still managing some of those cases. But, if Levitt v. Merck Sharp & Dohme Corp., 2015 U.S. Dist. LEXIS 52756 (E.D. La. Apr. 21, 2015), is any indication, it won’t be for much longer.

In Levitt, the MDL court denied Merck’s motion for summary judgment, instead ordering that discovery be reopened. While that might not sound like the decision of a court looking to end its involvement in the Vioxx litigation, remanding the case to the original transferor court for further proceedings sure does. And the MDL court did that too. Id. at * 30.

Merck had two bases for its motion. The first was deposition testimony of one of plaintiff’s prescriber, Dr. Katz. Plaintiff alleged that Dr. Katz merely continued a Vioxx prescription that had been started a few months earlier by a Dr. Hartman. Id. at *4-5. She alleged that she had asked Dr. Hartman for Vioxx after seeing Vioxx advertisements. Id. Dr. Katz testified, however, that he relied on his own medical training and experience to independently decide to prescribe Vioxx to plaintiff, not the earlier decision of Dr. Hartman or advertisements. Id. The record indicates that Dr. Katz was the first to prescribe Vioxx to plaintiff for daily use. Id. at *25-26. Dr. Katz also said, in what you’d think would be case-ending testimony, that he would still have prescribed Vioxx to plaintiff even if it carried a black box warning on cardiovascular risks. Id. at *19. This presents a massive proximate causation problem for plaintiff. But plaintiff again turned to her first prescriber, Dr. Hartman. She claimed that discovery was still needed on whether Dr. Harman continued to prescribe Vioxx to plaintiff while Dr. Katz was also prescribing and, if so, whether he would have continued to do so if there were an adequate warning. She also argued that Dr. Katz was biased because he had been a paid speaker and researcher for Merck. She apparently offered no evidence of actual bias, however, just evidence of the consulting relationship. The court decided that this was enough to deny summary judgment and, in fact, re-open discovery on Dr. Hartman’s prescription history, his position on the Vioxx warning, and the possibility of actual bias by Dr. Hartman. Id. at *26-27.

But this raises a serious question: hadn’t discovery already happened? Plaintiff has the burden of proof, not Merck. And, if after nine years of litigation there was no evidence on the extent and regularity of Dr. Hartman’s prescriptions, or whether a different warning would have changed this uncertain prescription history, or actual bias by Dr. Katz, that seems like a reason to end plaintiff’s case, not reopen it.

Anyway, the second basis for Merck’s motion was that plaintiff had at the last minute (of a multi-overtime game) changed her claimed injury to plaque build-up and heart disease from the two heart attacks that she alleged in her complaint. Id. at *7, 10-11. In fact, it’s not clear that she had a heart attack at all. The court’s discussion of her medical history seems to mention no heart attacks. Id. at *6. Plaintiff argued that, regardless of what he complaint said, her plaintiff profile form (or, fact sheet, as some of us know them) provided a detailed history of her plaque and heart disease. But she never changed her allegations. And, while plaintiff argued that she is “merely providing a more descriptive explanation of her injuries,” plaintiffs’ principal mechanism theory in the Vioxx litigation had always been that Vioxx promoted clotting and resultant heart attacks, something very different from promoting plaque and heart disease. The court, noting that plaque and heart disease “very closely related to – if not a component of –the initial alleged injury [heart attack],” nonetheless denied Merck’s motion. But, component or not, it seems to us to be a very different claim to allege that Vioxx caused plaintiffs’ plaque and heart disease rather than a heart attack (that never happened). In the finely tuned area of scientific study, those are two very distinct endpoints. Building a defense to one is quite different from building a defense to the other.

There is a ray of hope, though. Apparently plaintiff’s expert for her new damages theory will be Dr. David Egilman. We’ve written before on Dr. Egilman’s vast and controversial history as a plaintiffs’ expert. So, once reopened discovery comes to an end, Merck may have fertile grounds on which to attack plaintiff’s causation case with yet another summary judgment motion.

The court itself noted that this case had “already spanned nine years and should be put to rest.” Id. That sentiment, it seems to us, screamed for summary judgment here, not more discovery. Plaintiff had had years’ worth of opportunities to disclose her case and press it through fact and expert discovery. Unfortunately, the MDL court may have been war-weary from an admittedly long and arduous litigation and kicked the can down the road to the transferor court for further proceedings. But the MDL court did not green-light the case for trial. That’s good, and it means that this is likely not the last we hear of this case. Expect a decision on another summary judgment motion in, say, a year.

--
Posted By John J. Sullivan to Drug and Device Law at 4/27/2015 11:55:00 AM

Law

Pages

[Drug and Device Law] Freehand Line-Drawing in Affirmance of Huge Verdict in Children's Motrin/TEN Case

[DK GreenRoots] The first post by this person on Daily Kos - Give her a boost!

This person is just getting their feet wet and was very pensive about writing a diary. Give her some love. Thanks!

April filled with Rallies in Seattle

[Drug and Device Law] Alabama Legislature Abolishes Weeks Innovator Liability Theory

[Drug and Device Law] Fraud In The Smoke Will Not Do

[Drug and Device Law] InFuse State Court Appellate Win

[MMIT Want to learn how to create a miracle?

[Drug and Device Law] Yes, There Is Still Vioxx Litigation

Blog Archive