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Reed Smith won two separate decisions in New Jersey yesterday. One of them, In re NuvaRing Litigation, No. Ber-L-3081-09, slip op. (N.J. Super. L.D. April 19, 2013), we’re not at liberty to discuss, but if you’re on our side, you won’t be disappointed reading it – in all its 91-page splendor.

The other, decision,

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In a pair of cases, the Maryland Court of Appeals (the state’s highest court) rumbled through more than $1 billion in verdicts in a gasoline spill case, reducing them to nothing (although one plaintiff managed a new trial on one issue unrelated to this post).  See Exxon Mobil Corp. v. Albright, ___ A.3d ___, 2013 WL 673738 (Md. Feb. 26, 2013); Exxon Mobil Corp. v. Ford, ___ A.3d ___, 2013 WL 673710 (Md. Feb. 26, 2013).  While a lot of the analysis in these opinions is devoted to property damage issues (purportedly from groundwater contamination) that we don’t see much in our drug/device sandbox, they also dealt with a couple of issues that are near and dear to our hearts – medical monitoring and fraud on the FDA.

A Tough Medical Monitoring Standard

First, we’re sorry to report, Albright (the lead opinion) did recognize a cause of action for medical monitoring by presently uninjured plaintiffs.  2013 WL
673738, at *26, 31.  That being said, we’re pleased to report that the court attached rigorous requirements to the monitoring cause of action – a “proven necessary medical costs” requirement as tough as any state we’ve seen.

What do we mean?  Well, first, medical monitoring is a “remedy”; thus plaintiffs must first prove some underlying cause of action.  Albright, 2013 WL 673738, at *26-27.  Second, medical monitoring costs must be both “necessary and reasonable.”  Id. at *27 (emphasis original).  “Necessity for medical monitoring . . . must be reasonably certain, rather than merely possible.”  Id. Third, a plaintiff must “experience[] direct and hence discrete exposure.”  Id. at *28 (emphasis original).  Fourth, the condition for which monitoring is allegedly needed must be “related specifically and tangibly to that exposure.”  Id.  Fifth and finally, the risk must be “a direct and proximate result of th[at] exposure.”  Id. (emphasis original).

The court in Albright was determined that medical monitoring not become an excuse for crappy, unsupported claims:

[W]e are wary of damages for speculative claims resting on tenuous proof of risk of disease attributable to the type of exposure. . . . [W]e believe that . . . recovery for a latent disease due to toxic exposure involves necessarily somewhat nebulous forecasts of a potential risk to develop a disease in the future. . . .  Requiring quantifiable and reliable proof, however, will assist courts in determining whether causation and significant risk are present in a plaintiff’s prima facie case.

Id. at *28 (emphasis original).  The medical monitoring standards that the court adopted are expressly intended to “inhibit[] damages awards for speculative, and thus unreliable, opinions as to a plaintiff’s potential risk of developing a future disease.”  Id. at *29.Continue Reading Maryland Allows Medical Monitoring (Sort Of); Rejects Fraud On The FDA

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The following is a guest post by Laura Mastrangelo at Reed Smith, who gets all the credit, and takes all the blame, for its contents.  Take it away Laura….
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There was a fair amount of preemption action on punitive damage statutes last week, at least with respect to those states that limit punitive damages for FDA approved drugs and devices.  John Sullivan provided excellent coverage of Zimmerman v. Novartis Pharmaceutical Corp., ___ F. Supp. 2d ___, 2012 WL 3848545 (D. Md. Sept. 5, 2012), yesterday here, so I won’t belabor that discussion further.  Flying more under the radar, though, the Sixth Circuit issued an opinion in Marsh v. Genentech, Inc., ___ F.3d ___, 2012 WL 3854780 (6th Cir. Sept. 6, 2012), which dovetails nicely with the District of Maryland’s analysis in Zimmerman.  In Marsh, the Sixth Circuit affirmed its previous holding in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), that the fraud exception to Michigan’s bar on products liability suits against drug manufacturers is preempted, even where Plaintiffs haven’t alleged fraud-on-the-FDA in the classical sense.
Plaintiffs brought consolidated products-liability actions against drug manufacturers Genentech, Inc. and Xoma (U.S.) LLC (collectively, “Genentech”) to recover for injuries allegedly sustained from use of the psoriasis medication Raptiva, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud.  Id. at *1.  The action consolidated four different plaintiffs, but apart from their dates of use and alleged injuries, the allegations for the four were identical.  Id., n.2.Continue Reading More Punitive Damages Preemption, Sixth Circuit Reaffirms Garcia

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The scope of Mensing is one of the hotter issues in drug and device law these days. (The Bartlett appeal is one example.) To our defense-hack eyes, Mensing seems perfectly straightforward: a claim is preempted to the extent it alleges that the risks of a generic drug were not adequately disclosed. But the doctrinal landscape

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Does Buckman v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), apply any time that a plaintiff raises a fraud on the FDA allegation in litigation, or is it limited to causes of action denominated “fraud on the FDA?  Most courts have agreed with the Sixth Circuit that Buckman applies across the board.  See , 385 F.3d 961 (6th Cir. 2004).  A persistent minority, however, has limited Buckman to complete “fraud on the FDA” causes of action.  See Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).  The Supreme Court attempted, but failed, to close the split in Desiano, but failed – splitting 4-4.  See Warner Lambert LLC v. Kent, 552 U.S. 440 (2008). Garcia v. Wyeth-Ayerst Laboratories
Both Garcia and Desiano involved the “fraud on the FDA” exception to a Michigan tort reform statute that imposes a presumption of adequacy on warnings that are FDA approved – that is, just about every warning.  The Michigan statute was essentially dispositive.
Then Texas passed a similar presumption statute that is almost as dispositive in the ordinary case as Michigan’s.  It was only a matter of time before the Fifth Circuit would be called upon to decide the same question as in Garcia/Desiano.
Also in the mix is the Supreme Court’s later, extremely anti-preemption, decision in Wyeth v. Levine, 555 U.S 555 (2008).Continue Reading Fifth Circuit Breaks Buckman Tie

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In our rather terse (due to firm involvement) post on Monday concerning Merck & Co. v. Ratliff, ___ S.W.3d ___, 2012 WL 413522 (Ky. App. Feb. 10, 2012) – beating both BNA and 360 by two days, BTW – we mentioned the “interesting” aspects of that case.  Having noodled it a bit more, we’ve

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            We could have gone with “if at first you don’t succeed, try, try again.”  Or, Dory’s famous “Just keep swimming” from Disney’s Finding Nemo.  But, when talking about plaintiffs, slinging mud just feels more appropriate (to us).  And, I guess somewhere in here is a backhanded compliment about being persistent, but really we would

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A friend of ours, we’ll call him “Anonymous,” let us know about the recent decision in Forman v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2011 WL 2559386 (E.D.N.Y. June 27, 2011).  We reviewed it, and were somewhat taken aback that – after the court in Desiano v. Warner–Lambert & Co., 467 F.3d 85 (2d Cir. 2007), presumed to know more about Michigan law than either the Michigan courts (Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003)) or the Sixth Circuit (Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004)), with jurisdiction over Michigan – yet another court out of New York now presumes to know New Jersey law better than the New Jersey courts (McDarby v. Merck & Co., 949 A.2d 223 (N.J. App. Div.2008)), and the New Jersey federal courts, which have followed McDarbySee Stanger v. APP Pharmaceuticals, LLC, 2010 WL 4941451, at *4 (D.N.J. Nov. 30, 2010); Baker v. APP Pharmaceuticals, LLC, 2010 WL 4941454, at *4 (D.N.J. Nov. 30, 2010); Haggerty v. Novartis Pharmaceuticals Corp., 2009 WL 5064779, at *4 n.4 (D.N.J. Dec. 15, 2009).
We made that point to our friend.
His response?
“Hey, its New York!  You’re looking for humility?”
We wouldn’t dream of going that far.  After all, we know more than a few Yankees fans.
We’d just like to see a little comity every now and then.
That would preferable to the current, absurd situation where, in a prescription drug case in Michigan, or in a punitive damages case involving drugs in New Jersey, the plaintiffs lose under those states’ application of the fraud-on-the-FDA preemption rule of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), to their own law.  But if plaintiffs can somehow wheedle their way into court in New York, then the same claims survive.
We made this last point in our initial discussion of Desiano way back in 2006, where we urged federal courts to “remember federalism” and not construe state causes of action differently from the courts of those states.  With New York courts continuing to boldly go where no courts have gone before (or since), and forum-shopping plaintiffs following them, we think it’s time to review this issue.
First, Buckman (with the caveat that Bexis’ role in that case gives us more than the usual defense interest in its correct application).Continue Reading No Stand Up Comity In New York

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We’ve blogged before about the split among Utah courts about whether Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), preempts the fraud on the FDA exception to Utah’s statutory bar (Utah Code Ann. §78B-8-203) against punitive damages where the product complies with FDA standards.
The first case, Grange v. Mylan Laboratories, 2008 WL 4813311 (D. Utah Oct. 31, 2008), got it rightBuckman‘s rationale extends to any state-law assertion of fraud on the FDA that could bring about submission to the FDA of unnecessary and unwanted information due to fear of later tort liability.
Indeed, since punitive damages can (and often do) exceed compensatory damages in their amounts, allowing punitive damages based on fraud on the FDA is even more likely to bring about the prophylactic conduct that Buckman decried than the claim in Buckman itself – particularly since punitive damages are frankly intended to “deter” the conduct they punish – and thus create precisely what Buckman held was unacceptable.
The next case, Lake-Allen v. Johnson & Johnson, 2009 WL 2252189 (D. Utah July 27, 2009), botched the issue, for some reason asserting that Buckman involved express preemption.  We criticized this patently wrong result here.Continue Reading Utah Preemption Split Deepens