A Better Look at Preemption in New Jersey

Those of us who practice New Jersey products liability law know McDarby v. Merck, 401 N.J. Super. 10 (App. Div. 2008).  It addressed a provision of New Jersey’s Product Liability Act that both granted manufacturers immunity from punitive damages if their product was approved by the FDA and tried to take that immunity away if the manufacturer made knowing misrepresentations to the FDA. Here’s the language of the statute:

Punitive damages shall not be awarded if a drug or device . . . which caused the claimant's harm was subject to premarket approval . . . by the federal Food and Drug Administration . . . and was approved . . . . However, where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency's regulations, which information was material and relevant to the harm in question, punitive damages may be awarded.

N.J.S.A. 2A:58C-5c (emphasis added).  We know what you’re thinking: “Wouldn’t that be preempted under Buckman?”  Yup.  And that’s what McDarby held. 

And, since this decision in 2008, courts applying New Jersey law on this topic generally cite McDarby and apply its holding.  But, last week, the court in Zimmerman v. Novartis Pharm. Corp., 2012 U.S. Dist. LEXIS 126002 (D. Md. Sep. 5, 2012), did something better.  It offered a well-reasoned, thoughtful explanation of the law on preemption and Buckman, along with an effective criticism of decisions that (we believe) get Buckman wrong.  It’s good stuff, and it provides good quotes for future briefing.  In fact, you might want to consider citing McDarby but quoting Zimmerman. 

Now, Buckman, even read narrowly, held that tort claims based on a manufacturer withholding information from or misleading the FDA are impliedly preempted because the FDCA grants the power to enforce its provisions to the United States, not private citizens.  When a federal law such as this creates an inherently federal relationship and exclusive enforcement mechanism, the presumption against implied preemption that ordinarily attaches goes away.  As the Zimmerman court wrote: 

[I]n Buckman, the Court held that there is no presumption against preemption where a jury is asked to decide whether there has been a material fraud on the FDA during the regulatory process.  This is because federal law dictated the Defendant’s interactions with and representations to the FDA. Thus, unlike circumstances that implicate “federalism concerns and the historic primacy of state regulation of matters of health and safety,” the relationship between a regulated entity and the FDA is “inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”

Id. at *37 (citations omitted).

The Zimmerman court rejected the reasoning of courts that upheld other state statutes that allowed failure to warn claims to go forward if there was a showing of fraud on the FDA.  One such court reasoned that such statutes “cannot reasonably be characterized as a state’s attempt to police fraud on the FDA” but rather they are a state’s attempt to limit tort claims.  Id. at *38 (quoting Desiano v. Warner-Lambert & Co., 467 F.3d 85, 94 (2d Cir. 2006)).  But the Zimmerman court didn’t lose track of the most important point – it’s different when a state tort claim requires determinations about fraud on the FDA:

Although this Court agrees that the presumption against preemption applies to state tort claims implicating health and safety generally, the Court concludes that such a presumption does not apply to that part of Plaintiff’s claim, which by virtue of New Jersey law, conditions any recovery of punitive damages on a showing that a defendant-drug manufacturer “knowingly withheld or misrepresented information required to be submitted under the [FDA’s] regulations, which information was material and relevant to the harm in question.” [Quoting the N.J. statute]. This conclusion is confirmed by the Court’s analysis in Buckman. There, the Court found that the presumption against preemption did not apply to a specific type of tort claim--a fraud on the FDA claim--even though the presumption against preemption applies to traditional tort claims implicating health and safety matters.

Id. at *39-40 (citation omitted).

This is because the key question is not whether the state tort claim seeks to “police” fraud-on-the-FDA, but whether it is an obstacle to FDA regulation.  Id. at *42.  A state statute that hinges compensatory or, more so, punitive damages on a jury’s – more likely, multiple juries’ – determinations of whether the FDA was defrauded raises obstacle after obstacle.  Companies concerned that juries will see fraud where the FDA doesn’t will understandably respond by providing the FDA with the kitchen sink, causing nothing but greater delay and inefficiency. 

The Zimmerman court went further, holding that even if a presumption against preemption applied, it is rebutted because the statute requires a jury determine something exclusively left to the FDA.  Id. at *41-52.  The court rejected (what we believe is wrong-headed) reasoning by some courts that Buckman preemption applies only to pure fraud-on-the-FDA claims, not claims in which such fraud is an element of, or gateway to, a broader claim:

This distinction is meaningless because it is simply not entirely accurate. In Buckman, the plaintiffs not only had to prove the device maker’s non-compliance with FDCA disclosure requirements, which served as the predicate false representation in a common law fraudulent misrepresentation action, but also other common law elements of a fraudulent misrepresentation action such as injury and proximate cause.  Put another way, the preemption analysis does not change simply because, under New Jersey law, this Plaintiff must prove something in addition to non-compliance with a FDCA disclosure requirement to recover punitive damages.

Id. at *54 (citations omitted). 

The Zimmerman  court was not moved by the argument that the New Jersey statute does not create a fraud-on-the-FDA claim, like in Buckman, but rather only gives plaintiffs the opportunity to rebut a presumption and thereby bring a tort claim under New Jersey common law:

Once New Jersey passed the statutory immunity provision for punitive damages, the traditional cause of action is no more rooted in common law doctrine than the stand-alone claim in Buckman. This is because, in the post-statutory immunity world, a plaintiff’s punitive damages claim hinges on whether the defendant-drug maker made adequate disclosures to the agency and whether, in the face of these inadequate disclosures, the agency would have approved the drug. In this way, New Jersey’s statutory immunity provision makes fraud on the FDA a “critical element” of every punitive damages claim.

Id. at *55-56 (citation omitted).

It really is a simple analysis.  The statute authorizes juries to dig into the details of regulations and New Drug Applications and make independent determinations of what the FDA should have done or would have done, but didn’t do.  In other words, precisely what juries can’t do under federal law:

Simply put, Plaintiff’s claim for punitive damages requires a state fact finder to determine what was required to be submitted to the FDA, whether it was submitted to the FDA and, whether the FDA would have made a different approval decision had it been provided with the correct or missing information. Plaintiff’s claim thus requires a fact finder to make these types of determinations as a matter of state law even though federal law makes such determinations the exclusive province of the FDA. Accordingly, Plaintiff’s claim for punitive damages poses an obstacle to the objectives and purpose of the FDCA, and is therefore preempted by the FDCA.

Id. at *51-52.

It doesn’t, and shouldn’t, matter whether this improper determination is an element of a claim, a gateway to a broader claim, or the entirety of the claim.  Jury after jury deciding what the FDA should have gotten and done about it gets in the way of the FDA doing its job.  The Zimmerman court gave a good quotation for this too:

Allowing state fact finders to second-guess the very decisions that federal law leaves entirely to the agency presents “the same inter-branch-meddling concerns that animated Buckman.” As in Buckman, allowing punitive damages liability here would require applicants to submit a “deluge” of unnecessary information during the approval process, which in turn, delays the approval of new drugs.  In seeking to comply with various statutory immunity provisions, drug manufacturers would “exert an extraneous pull on the scheme established by Congress.”

Id. at *57. 

We told you that the court's discussion was much better than just, "see McDarby."  Keep it handy for future briefs. 

A Couple Of Interesting New Cases Forwarded By Our Readers

We like it when our readers contact us, even when it’s only to tell us that we made a mistake.  At least they’re paying attention.  But we like it most when our readers send us new opinions of interest − especially good ones.  The rapid exchange of information helpful to the defense of prescription drug and medical device product liability litigation is what the DDLaw blog is all about.

But once we receive good new cases, it becomes our responsibility to get the word out, and that’s what we’re doing today, even if we feel we’ve been a mite slow about it.

Eckhardt v. Qualitest

Two readers (Quinton Urquhart of Irwin, Fritchie, and Rachel Passaretti-Wu of Skadden) both sent us, in response to our “Conte Rejected Again” post, Eckhardt v. Qualitest Pharmaceuticals, Inc., C.A. No. M-11-235, slip op. (S.D. Tex. Aug. 9, 2012).  Eckhardt − guess what? − also rejected the notorious Conte theory that brand-name manufacturers could be liable for allegedly inadequate warnings accompanying competing generic drug products that they never sold.

Eckhardt is the latest of a number of cases to reject brand-name liability under Texas law.  As indicated in our Branded/Generic liability scorecard, Eckhardt builds on Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. 2010); Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009); Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. Mar. 29, 2010); Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009); Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008), aff’d on other grounds, 623 F.3d 271 (5th Cir. 2010); Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003) and Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, slip op. at 1-2 (Tex. Dist. Dallas Co. May 7, 2010), in hewing to the traditional product liability axiom that manufacturers are the only ones that can be liable for their products.

We make that point because we were somewhat disturbed to read the Eckhardt court expressing “disappointment” with the quality of the briefing on both sides.  Slip op. at 2-3.  While we expect the other side to do things like throw in “two several-hundred-page depositions” without page citations, id., we’re not accustomed to seeing our side criticized for citing “cases that have no nexus with” relevant law.  Id.

That’s precisely what we try to avoid with our branded/generic scorecard.  If as is the case in Eckhardt, the jurisdiction in question has a statutory product liability scheme (like Texas, or Tennessee, Kentucky, and New Jersey to name a few), we try to note in our case summary.  That way we try to make it easy for defense counsel everywhere to cite to the most relevant cases, whether inside or outside any particular jurisdiction.

Anyway, the rest of Eckhardt is good.  It’s a “one-two punch” case − by that we mean (as is apparent from our Generic Preemption scorecard) that the generic defendants have also been dismissed on preemption grounds.  Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 1511817 (S.D. Tex. April 30, 2012).  Thus, the one-two punch of preemption and product identification has effectively ended the case.

Eckhardt makes the following holdings that might be useful in future cases:

• The tenuous relationship of branded products to generic labeling was not sufficient to justify liability under any Texas product liability theory.  Slip op. at 4-5.
• Fraud and similar claims satisfy the statutory definition of “products liability” claims.  Id. at 6-7.
• Breach of warranty and consumer protection claims fail where the defendant did not make the product.  Id. at 8-9.
• Negligence and negligent misrepresentation fail because a non-manufacturer owes no recognized duty to persons using competing products.  Id. at 10-11.

Baker v. APP Pharmaceuticals

We thank old colleague Will Sachse of Dechert for sending along Baker v. APP Pharmaceuticals LLP, C.A. No. 09-05725 (JAP), slip op. (D.N.J. Aug. 21, 2012).  Baker contains an excellent description of the New Jersey presumption of adequacy of FDA-approved warnings:

In failure to warn cases involving prescription drugs, “[i]f the warning or instruction given in connection with a drug . . . has been approved or prescribed by the federal Food and Drug Administration under the ‘Federal Food, Drug, and Cosmetic Act,’” there is a rebuttable presumption that the warning is adequate.  This is no ordinary rebuttable presumption.  “Compliance with FDA regulations” gives rise to “what can be denominated as a super-presumption[.]”  “[C]ompliance with FDA standards should be virtually dispositive of such claims.”  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced in [New Jersey Rule of Evidence] 301.”

 
Baker, slip op. at 12-13 (citations, but not quotation marks, omitted).

The New Jersey presumption suffers from ill-advised, judicially-created exceptions to the broad legislative mandate, but Baker held that neither of those applied.  There can’t be “deliberate concealment” of information that’s “publicly available in published scientific and medical literature.”  Slip op. at 9-10.  Moreover, the plaintiffs weren’t being honest with the court.  The information in question was, in fact, disclosed to the FDA.  Id. at 10-11.  (The concealment claim was also a preempted fraud on the FDA claim, but the court didn’t have to discuss that.)  Also, for case-specific reasons (after-the-fact timing, and the information involving a different drug), the court found no manipulation, “intentional” or otherwise, of FDA post-marketing regulatory processes.  Id. at 12-14.  Thus the FDA-approved warning was as a matter of law.

Of equal interest, the court in Baker held that, even if the warning had been inadequate, it couldn’t have caused any injury.  This is important, because there hasn’t been all that much New Jersey law on warning causation.  There’s Strumph v. Schering Corp., 606 A.2d 1140, 1148-49 (N.J. Super. App. Div. 1993) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (adopting dissenting opinion below), which establishes the warning causation principle in New Jersey.  There’s also Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005).  These are both cases where the prescribing physician already knew the information and didn’t read the warning.  Two favorable opinions for a jurisdiction with as much learned intermediary rule litigation as New Jersey strikes us as a little thin.

Baker’s now a third case in that category.  First of all the court took out the lamentable “heeding presumption.”  “The heeding presumption is rebutted, however, if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted.”  Slip op. at 14-15 (citation and quotation marks omitted):

Moreover, a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and considered the risk in prescribing the product.  In that case, the physician’s conduct is the superseding or intervening cause that breaks the chain of liability between the manufacturer and the plaintiff.

 
Id. at 15 (citations, quotation marks, and footnote omitted).  That happened in Baker.  Not only did the prescriber know of the alleged heparin-related risk, but he “stood by his decision to administer heparin” under the facts of the case.  Id. at 15-16.  Further blocking any causal inference was the physician’s failure to read labels for “frequently” prescribed drugs with which he was familiar:

[The prescriber] testified in his deposition that he does not read the label of drugs he prescribes often, which includes heparin.  Moreover, Plaintiffs concede that [the prescriber] never testified that he would have consulted a black box warning or “Dear Doctor” letter, or that he ever reviewed the Physician’s Desk Reference when prescribing heparin.  Therefore, a different warning would not have made a difference in [plaintiff’s] treatment or outcome because [the prescriber] would not have reviewed it.

 
Baker, slip op. at 16 (citation omitted).

There was also a case-specific superseding cause − the “fail[ure]” of the nursing staff “to follow its own heparin treatment protocol” and monitor the drug level in the plaintiff’s blood.  Id. at 16-17.

Therefore, Plaintiffs have failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the failure of the hospital to follow its treatment protocol, that was a substantial factor in causing or exacerbating [plaintiff’s] injuries.

 
Baker, slip op. at 17.

Thus, Baker is a nice causation triple play (prior knowledge, failure to read, and third-party superseding cause) in a jurisdiction where such precedent is most welcome.

Thanks to everyone who sends us cases − and keep them coming.

Preemption in the Garden State

As we flagged for you on Friday, the New Jersey Supreme Court recently issued an opinion addressing preemption and the statute of limitations in a medical device claim.  Cornett v. Johnson & Johnson, 2012 N.J. LEXIS 831 (Aug. 9, 2012).  To say the least, it had interesting rulings and raised a number of issues to discuss. 

The case involved a drug-eluting stent that was implanted in the plaintiff for an off-label indication, and the plaintiff later suffered a thrombosis and died.  Id. at *9-11.  The plaintiff’s estate made a number of state law claims alleging improper warnings, manufacturing and design defects, improper off-label promotion and the like.  Id.  The statute of limitations and preemption issues eventually made their way to the New Jersey Supreme Court. 

Statute of Limitations

On the statute of limitations defense, the Court held that the plaintiff’s claims were barred by Kentucky’s one-year statute of limitations.  The opinion has a detailed choice of law analysis (between Kentucky and New Jersey law) that we won’t address here.  What was more interesting to us was the Court’s ruling that a plaintiff exercising due diligence should have known by December 2006 that the stent may have caused Mr. Cornett’s thrombosis.  December 2006 is when an Advisory Committee assembled by the FDA made findings related to plaintiffs’ claims, including that thrombosis from drug-eluting stents (like the defendants’) was a problem, the problem was greater when the stent was used off-label (as with the plaintiff), and drug therapy after the device is implanted should last for an extended period of time.  Id. at *28. 

With this ruling, the New Jersey Supreme Court has placed significant importance on Advisory Committee findings when considering when the statute of limitations starts to run in a product liability case.  Often the devices and drugs involved in product liability litigation have been the subject of FDA Advisory Committee meetings, and often those meetings address issues related to plaintiffs’ claims.  Now, in New Jersey, their findings may be a significant tool for weeding out time-barred claims. 

Preemption

The Cornett complaint was a consolidated complaint with over 40 other plaintiffs whose claims were not time barred.  So the Court was able to go beyond the statute of limitations to address preemption under the Medical Device Act (“MDA”) amendments to the FDCA. 

First, some general propositions about medical device preemption: Section 360k(a) of the MDA states that it preempts state law claims that address the safety and efficacy of a device and impose requirements that are “different from or in addition to” FDA regulation.  In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the US Supreme Court held that §360k(a) preemption does not apply if the FDA cleared the device under §510k.  (You may recall that we just recommended some light summer reading that reexamines whether Lohr’s reasoning should still apply.)  In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Court held that §360k(a) preemption does apply if the device was approved under the FDA’s more rigorous Premarket Approval (PMA) process.  Finally, in Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the Court held that – in situations in which §360k(a) express preemption doesn’t apply, such as with a device cleared under §510k – FDA regulations nonetheless implicitly preempt state law claims, in particular fraud-on-the-FDA claims, that improperly impact the balance struck by the FDA’s regulatory scheme. 

As for the Cornett case, it does not involve a device cleared under §510k.  The drug-eluting stent was approved under the PMA process.  This implicates §360k(a)’s express preemption under Riegel.  Lohr is irrelevant, as likely is Buckman and its implied preemption given that express preemption is already in play.

In its preemption analysis, the Cornett Court considered two claims, failure to warn and breach of an express warranty.  While the Court found significant portions of each of these claims preempted, it allowed limited parts to go forward. 

Plaintiffs’ Failure to Warn Claim

On the failure to warn claim, the Court held as preempted plaintiffs’ claim that the label lacked necessary information on the fact that comparative studies were not conducted on the stent and that drug therapy should be used for an extended period of time after the stent is implanted.  This was an easy one.  The claim goes to the heart of the FDA’s approval process and the Court saw through it:

This claim is nothing more than a challenge to the adequacy of the information required by the FDA during the PMA process and the label approved by the agency.  This failure to warn claim falls within the PLA rebuttable presumption [we’ll get back to this] and the Riegel express preemption rule.  We affirm its dismissal.

Id. at *45. 

The Court also properly dismissed plaintiffs’ failure to warn claim based on an allegation that “defendants obtained FDA approval for the device only after submitting fraudulent representations to or withholding material information from the FDA,” citing Buckman.  We agree that this claim is properly preempted.  But we also note that this isn’t a 510k case in which §360k(a) express preemption doesn’t apply.  It’s a PMA case, and §360k(a) express preemption does apply under Riegel.  That is likely all that’s necessary, not implied preemption under Buckman. 

Our real concern, though, is the Court’s decision not to preempt plaintiffs’ claim that the defendants (1) withheld from doctors and the public the fact that the label’s instructions for post-implementation drug therapy were not part of the PMA process and (2) made misrepresentations to doctors and the public that the stent was not pro-thrombotic.  Id. at *47-48.  The Court reasoned that this claim was not preempted because it “overcomes the PLA’s rebuttable presumption of adequacy.”  Id. at *48.  In other words, the complaint’s allegations, for pleading purposes, were enough to overcome the NJ Product Liability Act’s presumption that an FDA-approved label was adequate. 

But that doesn’t seem to be the issue.  Before the PLA’s presumption should be considered, the determination first should be made as to whether PLA can even be applied – that is, whether it is preempted.  And a claim of failure to warn doctors and the public is preempted under Riegel.  While the PLA and its presumption might eventually be relevant in a prescription drug case where there generally is no express preemption, this is a medical device case – one that involves the PMA process and Riegel’s express preemption.  What is and is not involved in the PMA process, what is said about that to doctors and the public, and what is said about post-implementation drug therapy or the dangers and safety of the product (here, it allegedly being pro-thrombotic) are all in the wheelhouse of the FDA’s regulatory scheme. 

For instance, the FDA-approved label, according to the Court, already addressed post-implementation drug therapy.  Id. at *12.  Requiring further disclosure to doctors and the public about what the FDA considered or didn’t in granting that approval is something for the FDA to determine.  The fact that is has not done so does not act to allow the plaintiffs’ claim.  It only underscores that plaintiffs’ claim is preempted as imposing requirements different from or in addition to what the FDA required.

The Court next addressed plaintiffs’ failure to warn “concerning off-label uses . . . based on a failure to warn the medical community and the general public of adverse information gathered about the device and that instructions for post-implantation therapy were not part of the PMA process.”  Id. at *48.  The Court held that, “[t]o the extent [this] claim is founded on promotion by defendants of off-label uses of the device beyond the [FDA’s] safe harbor [for off-label promotion], the claim is not preempted.”  In other words, if the defendant’s off-label statements do not fall under a safe-harbor created by the FDA for off-label statements, then it is not preempted.

We also question this decision.  The FDA has had a lot to say about off-label promotion.  The Cornett decision cites some of it.  FDA regulations require manufacturers to warn about off-label uses in certain circumstances.  Id. at *35.  There is a safe-harbor for off-label promotion that was previously codified in the United States Code and has since been adopted by the FDA in a guidance document.  It  says that the Secretary of HHS won’t consider a manufacturer’s dissemination of information on unapproved uses to be off-label promotion if certain conditions are met.  Id. at *33-35.  And, as described above, the FDA convened an Advisory Committee to address off-label use and post-implementation drug therapy for the very stent at issue in this litigation.  There is no doubt that the FDA regulates off-label promotion and was actively doing so for this device.  Even the Riegel case, which established express preemption, involved off-label use.  552 U.S. at 320.

And we don’t see how the plaintiffs alleging off-label promotion “beyond the safe harbor” somehow exempts plaintiffs’ failure to warn claim from §360k(a)’s express preemption.  Falling within the safe harbor simply means that the FDA itself will not consider the statements to be evidence of off-label promotion.  It doesn’t mean that statements outside the safe harbor are off-label promotion.  It just means that the FDA considers them evidence of off-label promotion.  The ultimate determination is for the FDA, not private litigants.  And the United States, not private litigants, enforce the FDCA and FDA regulations.  (Setting that aside, it’s not clear how, in Cornett, falling outside the safe harbor matches up with a failure to warn claim.) 

Now, plaintiffs may argue that by invoking the safe harbor they are making a parallel violation claim, which is arguably permissible under Riegel.  But that doesn’t seem to work either.  The FDA hasn’t determined that the alleged off-label promotion in Cornett violated any FDA requirements.  And, failure to satisfy the safe harbor doesn’t create a violation either.  So plaintiffs aren’t really seeking to enforce an FDA requirement.  They can’t be making a parallel violation claim.  In short, they are seeking to enforce a requirement “different from or in addition to” FDA requirements. 

Plaintiffs’ Breach of Express Warranty Claim

Plaintiffs alleged that the defendants breached express warranties that were created by the labeling and packaging.  The Court quickly dismissed this claim as preempted under Riegel:

Plaintiffs contend that the MDA does not preempt an express warranty claim based on the information contained in FDA approved product labels and packaging inserts.  We disagree. . . . [I]n order to succeed on the breach of express warranty claim, plaintiffs must show that the label provides inaccurate or insufficient information in spite of FDA approval following the rigorous PMA process. Success on this state law claim would inevitably impose greater requirements than those already established by the MDA.  This claim is, therefore, preempted.

Id. at *51-53. 

The Court, however, also held that an express warranty claim based on statements voluntarily made to third parties and that “deviated from the labeling and instructions” are not preempted.  Id. at *53.  This seems, if we understand it correctly, to be an attempt to again make a parallel violation claim.  But it doesn’t seem to be a fit, at least not based on the information in the opinion.  A manufacturer can make statements that are not in the labeling.  Now, it may be that some of those would violate FDA regulations.  But that doesn’t mean that any deviation from the labeling is a violation.  And without any particulars, it’s not clear that plaintiffs properly stated a parallel violation claim for breach of express warranty. 

                              *                   *                 *                 *                             

All this said, there is still hope for preemption of the claims that remain after the Court’s decision.  The Court more than once qualified its decision by saying that it was being indulgent to plaintiffs’ allegations on a motion to dismiss [in state court, by the way, where TwIqbal doesn’t apply].  Discovery may reveal further information establishing that plaintiffs’ remaining claims are, as we discussed above, preempted.  Id. at *49-50, 53.  We think that, come summary judgment time, Defendants will have a good chance of establishing that the remaining claims are in fact preempted too.

This Just In … NJ Win on Innovator Liability

We direct your attention to Coundouris v. Wyeth, et al. No. ATL-L-1940-10, 2012 WL 2401776 (N.J. Super. Jun. 26, 2012).  It’s a Reglan decision (actually a decision that applies to 8 Reglan cases) that Dechert was directly involved in – so we can’t say much.  But we can tell it is worth a read :

·         NJ resident plaintiffs who ingested generic metoclopramide sued the manufacturers of brand name Reglan for failure to warn – what we and others have dubbed, innovator liability.

·         The Court granted the brand manufacturers’ motion to dismiss finding:

o   the claims were governed by New Jersey’s Products Liability Act, slip op. at 4;

o   under which liability is limited to “specific parties – namely the manufacturer or seller of a product,” slip op. at 6 -- hence, no brand liability without brand product usage;

o   the Supreme Court’s Mensing decision did not address or impact the issue of innovator liability under NJ law. 

Enjoy!

Bessemer Process Yields Stainless Steel

Id. at *1.

We mentioned last Friday that the defense win in the Bessemer Aredia case had been affirmed.  We didn’t have time to gloat then, but we do now − at least a little.  The affirmance, which won’t be published, is now online here:  Bessemer v. Novartis Pharmaceuticals Corp., 2012 WL 2120777 (N.J. Super .A.D. June 13, 2012) (per curiam).  There isn’t much to this opinion; it’s basically an appellate endorsement of two of the trial court’s (Judge Jessica Mayer) opinions:

[W]e affirm substantially on the basis of the well-considered and thorough opinions of Judge Mayer, which are well supported by the evidence and legal precedent.

The two prior opinions in question are:  Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6052544 (N.J. Super. L.D. Nov. 12, 2010) (denying post trial motions), and Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6257855 (N.J. Super. L.D. April 30, 2010) (granting partial summary judgment).  Now that they’ve been confirmed as "well-considered and thorough," what we’d most like to see is these two opinions (particularly the summary judgment order) get published in the A.2d reporter − so Westlaw would give them page numbers, for one thing.

So what exactly did the Appellate Division endorse last week? Here’s a synopsis:

The post-trial motion decision (2010 WL 6052544) in Bessemer held:

• The testimony by plaintiff’s prescribing oncologist at trial that called causation into question was in response to plaintiff’s own question, and plaintiff, having asked the question, had to live with the answer.


• Plaintiff failed to place other objections to videotape deposition testimony on the record, and thus waived them.


• If plaintiff did not like the prescriber’s videotape testimony, she could have called him as a live witness, but failed to do so.


• The jury was told that the defendant paid the travel expenses for the treating physician who testified that plaintiff likely didn’t have the disease condition she claimed she did.


• The court acted properly in letting both sides speak informally to plaintiff’s treating physicians.


• The total number of patients with similar conditions (at least to what plaintiff claimed she had) was properly excluded as irrelevant and prejudicial, and in any event the jury never reached causation, having found for the defendant on defect.

If we had page numbers, we’d use them, but we don’t so we can’t.

Except for the informal interviews point − to which the Appellate Division spoke in its recent decision in the mesh litigation − these issues are very case specific and, frankly, seem rather makeweight.

The more important of the two Bessemer trial court decisions was its summary judgment decision (2010 WL 6257855). That opinion held:

• Plaintiff presented enough evidence of her warning theory to survive summary judgment (that’s why there was a trial).


• Defendant was under no obligation to warn a non-prescribing physician in a different field (dentistry) of the risks of what was a drug prescribed in the treatment of cancer.


• Plaintiff presented enough evidence of causation for her warning theory to survive summary judgment.


• Aredia was FDA approved, so punitive damages could not be assessed.


• Plaintiff failed to establish a design defect claim.


• There is no independent cause of action for implied warranty.

Of these rulings, the most important concern warnings to non-prescribing physicians in other fields and punitive damages. While we don’t like everything in this opinion, we think it deserves to be published.

Defense Aredia/Zometa Appellate Win in New Jersey

We just found out, and we're under the gun, but we thought you'd like to know that the Appellate Division of the NJ Superior Court just affirmed the defense trial win in Bessemer v. Novartis, No. A-2069-10T1, slip op. (N.J. Super. App. Div. June 13, 2012).  The Appellate Division basically affirmed for all the reasons stated in the trial court's two opinions, here (learned intermediary and other) and here (summary judgment).

Sorry we can't gloat more, but we don't have the time.

Enjoy reading - we will.

News Flash: Mass Tort Defendants in New Jersey Entitled to Level Playing Field

Because Bexis’s firm is involved in the Pelvic Mesh litigation, he is not involved in this post about yesterday’s opinion of the New Jersey Appellate Division in In Re Pelvic Mesh/Gynecare Litig., No. A-5685-10T4, slip op. (N.J. Super. App. Div. June 1, 2012). 

We wish it wasn’t so newsworthy, but defendants in New Jersey have had a devil of a time getting the same opportunity as plaintiffs in mass torts to obtain certain important evidence.  And now, so sayeth the Appellate Division.

Here’s what happened.  The Pelvic Mesh mass tort involves several hundred plaintiffs.  After first precluding defendants from informally contacting plaintiffs’ treating physicians – ordinarily allowed under Stempler v. Speidell, 495 A.2d 857 (N.J. 1985) – the court entered an order precluding any defendant from using as an expert witness any physician who had ever treated or consulted with any plaintiff, even though that plaintiff was not the subject of the expert testimony.  As described by the Appellate Division:

[T]he [trial] court issued an order and written decision dated May 26, 2011, barring defendants from consulting with or retaining any physician who had at any time treated any plaintiff in the pelvic mesh litigation. . . .  At the time of the court’s order, the number of plaintiffs had risen to more than 220.  Defendants estimated that more than 1,000 physicians were thus disqualified as potential defense experts.

Pelvic Mesh, slip op. at 8-9. 

The result was predictable.  The plaintiffs in that litigation had the opportunity to try to retain as an expert any physician in the relevant specialties.  The defense, on the other hand, was prevented from retaining a significant number of the available experts, disproportionately including the most active specialists with the largest practices.

Not only that, but the exclusion order was retroactive, disqualifying already-retained defense experts because that physician happened to treat (even a single consultation was enough) a plaintiff in a newly-filed case:

Although the trial court’s order made reference only to treating physicians, its ruling disqualifying [an already-retained defense expert] indicates that even a single consultation with a plaintiff will prevent the defense from consulting with or engaging a physician as an expert against the claims of other plaintiffs.

Pelvic Mesh, slip op. at 14.

Fortunately, the Appellate Division set this ruling aside.  First, the Appellate Division rejected the rationale that the plaintiffs’ physician/patient confidences were threatened.  Those confidences pretty much no longer exist, since plaintiffs waive them when they file suit:

[T]he physician-patient privilege has limited significance in this dispute.  Because plaintiffs have filed suit, they have waived a claim of privilege with respect to any medical condition relevant to their claims.  A plaintiff in these cases cannot claim the privilege as to the diagnosis and treatment of her medical condition that is the subject of the lawsuit. . . .  Here, the treating physicians that defendants seek as experts are [specialists].  The treatment and consultations provided by those specialists most likely involved only medical conditions that are relevant to plaintiffs’ claims of injuries in this litigation, including the medical history that was provided to the specialists.  If treating physicians have knowledge of a plaintiff’s medical history or condition that is irrelevant to this litigation, the privilege can be protected by defendants’ proposed protocol.

Pelvic Mesh, slip op. at 12-13 (citations and footnote omitted).

Doctors are smart enough to “understand they are subject to ethical constraints against disclosure of confidential patient information.”  Id. at 13.  The defendants were quite willing to remind doctors of this fact through their proposed protocols.  Id.  There was no need for restrictive court-imposed prophylaxis. 

Instead, the Appellate Division held that courts cannot exalt a plaintiff’s “litigation interests” over that of the other side:

We conclude that the court’s ruling was a mistaken exercise of authority to manage this litigation.  It inappropriately equated a plaintiff’s “litigation interests” with a patient’s “medical interests,” and it elevated those “litigation interests” to a preemptive level not previously recognized by binding authority.  It imposed sweeping restrictions upon physicians that allow litigation instituted by a current or former patient to interfere with the physician’s professional judgment about the medical interests of all the physician’s patients. Moreover, it deprived defendants of fair access to physicians who could be among the best-qualified experts in these cases.

Pelvic Mesh, slip op. at 15.  The “litigation interests” excuse really bothered the Appellate Division.  It returned to that point several times:

We disavow any suggestion that a physician, or any witness for that matter, has a duty to support substantively a litigant’s claims or defenses.  The duty of a witness is to tell the truth when testifying and to provide information accurately in anticipation of testimony.  No physician or other witness has a duty to support the “litigation interests” of a party to a lawsuit in the sense of supporting the party’s claims or defenses.

Id. at 26-27. And still more:

Although the “medical interests” of a patient may be consistent or overlap with the patient’s “litigation interests,” such a determination should be made as a matter of professional judgment by the treating physician, not by the patient’s lawyers, or by the courts applying wholesale rules of prohibition and disqualification.

Id. at 31.  Such a “duty of loyalty” is “beyond the scope of judicial authority to impose.” Id. at 35-36. 

The Appellate Court also addressed the trial court’s concern that “a physician is ethically or legally obligated to ensure the continuing trust of a patient who has brought a lawsuit.”  Id. at 15.  In the first place, those concerns “do not apply to a physician whose treatment of or consultation with a patient plaintiff has ended.”  Id.  More important, doctors serving as experts in litigation likely give opinions adverse to “litigation interests” of some of their patients.  But it is their experience with those and other patients that qualifies them to be experts:

[I]n many types of personal injury cases, physicians who testify for the defense or consult with defense counsel provide those services contrary to the interests in litigation of other patients they have treated or continue to treat. . . .  Our system of civil justice does not bar a physician from expressing a position in litigation of one plaintiff that is contrary to the “litigation interests” of a current or past patient in another case.  In fact, it is the physician’s experience with similar injuries or conditions that qualifies him or her to provide expert opinion for the defense in a personal injury case.

Pelvic Mesh, slip op. at 16-17. 

Furthermore, although not before the Appellate Division, its opinion powerful ammunition for defendants to try to eliminate the exception to Stempler that New Jersey trial courts have made in the past in mass torts.  The Appellate Division explained the ruling by the New Jersey Supreme Court in Stempler:

The Court rejected the argument of the plaintiff that a patient’s rights to confidentiality and the loyalty of his physician should be paramount.  It confirmed the right of defense counsel to interview treating physicians informally and outside the presence of plaintiffs or their attorneys if the treating physician consents.  In addition to recognizing the right of access to the doctor’s relevant information, the Court noted that historically the physician-patient privilege has not been broadly applied, and that patients have only a “qualified” right of confidentiality in the physician’s information.

Pelvic Mesh, slip op. at 23 (Stempler cites omitted). 

Subsequently, however, a number of trial courts created a mass-torts exception to Stempler, barring defendants from conducting such ex-parte interviews of plaintiffs’ doctors.  We’ve posted before about these rulings and how they undercut defendants’ rights as recognized by Stempler. 

But the Appellate Division’s Pelvic Mesh opinion now provides strong language and reasoning to wipe away once and for all that exception.  The existence of a mass tort – that is, the mere fact that plaintiffs chose to invoke a procedural rule to consolidate cases – doesn’t justify imposing unequal restrictions on defense rights to gather information from treating physicians:

[O]ur mass tort procedures for managing coordinated litigation will unfairly hinder defendants’ right to defend lawsuits such as these if plaintiffs as a group may engage as experts any qualified physicians with knowledge and experience but defendants may not.  The fact that plaintiffs have filed suit in this State and taken advantage of our Rule 4:38A for joint case management should not affect the availability of relevant evidence to both sides. It should not preemptively limit defense access to the same pool of qualified witnesses and consultants knowledgeable about defendants’ products as available to plaintiffs.

Id. at 25 (emphasis added) (footnote omitted).  Everything said in Pelvic Mesh about expert witnesses is equally applicable to Stempler informal interviews. 

Litigation plaintiffs don’t own their treating physicians:

Here, the treating physicians are not confidential expert consultants whose services were engaged by plaintiffs’ counsel for purposes of preparing litigation.  The identity of treating physicians and the fact that they possess relevant knowledge will be known to both sides as they are identified by plaintiffs and their medical records.  As previously stated, the relatively insignificant risk in these cases that treating or consulting specialists may reveal privileged information if consulted or retained by the defense can be addressed through appropriate protective measures.

Pelvic Mesh, slip op. at 22. 

In light of this new Pelvic Mesh precedent, we look forward to defendants in New Jersey challenging the mass-torts exception to Stempler and getting back the right to obtain information from treating physicians via interviews, just as do plaintiffs.  As the Appellate Division said in Pelvic Mesh in reversing the trial court, it should be a level playing field:

Both sides in this litigation should have the opportunity to present evidence from the most qualified physicians who can serve as experts.  The trial court’s order unfairly impeded defendants’ access to many of those physicians, and so, must be reversed.

Pelvic Mesh, slip op. at 40-41.

NJ in Mainstream on Generic Preemption

We can't say much about it because of Dechert's involvement in the Reglan/metoclopramide litigation, but Judge Higbee has ruled on on generic preemption under Mensing.  There are two opinions.  The first, In re Reglan Litigation, No. 289, slip op. (N.J. Super. Law Div. May 4, 2012), deals with generic preemption generally.  This decision is in line with most other recent decisions.  The rulings

(1)  The 2007 FDAAA amendments made no relevant changes affecting preemption under Mensing.  Slip op. at 7.
(2)  All the plaintiffs' claims, however designated are labeling related and are preempted.  Id. at 8-9.
(3)  To the extent that a generic defendant failed to update its labeling when required to by the FDA, warning claims based on that failure do not violate the FDA "sameness" requirement and are not preempted.  Id. at 9-10.
(4)  Claims that the generic defendants should have communicated warning changes through means (such as "Dear Doctor" letters) other than timely updates to the warnings themselves are preempted.  Id. at 10-11.
(5)  Claims that generic manufacturers should have removed their product from the market altogether do not exist under state law ("go[] beyond the duties and remedies that have ever been applied in state courts") and if they did exist would be preempted ("[t]he conflict between state and federal law would be much more pronounced if the state courts upheld a decision that an FDA-approved drug should not have been on the market").  Id. at 12.

The second, shorter, opinion, In re Reglan Litigation, No. 289, slip op. (N.J. Super. Law Div. May 4, 2012) (which we'll have to call "Reglan II" because in citation form it's identical to the first), dealt with arguments that certain generic manufacturers' status as FDA-designated "reference listed drugs" (RLD) after the branded drug left the market resulted in those defendants losing their preemption defense.  The court held that the RLD designation did not alter preemption analysis under Mensing:

[T]his court does not find any support for plaintiffs' contention that once [a generic drug] is designated by the FDA as an RLD, it can simply take advantage of the CBE process to strengthen its label unilaterally. . . .  In fact, the FDA regulations are clear in putting the agency in charge when no [branded] holder is in the market.

Reglan II, slip op. at 3.

For more commentary, beyond what we are able to impart, see the FDA Law Blog.

Who Needs TwIqbal?

Don’t misunderstand us.  TwIqbal’s great.  It’s left a lot of badly pleaded carnage in its wake over the last five years.  But at times it makes sense to mix things up, to give the bench players a chance.  Take standing for instance.  Standing arguments don't make it into motions to dismiss all that often, at least not in products class action cases.  But when it makes legal and tactical sense, standing can be effective.  The defendant in Young v. Johnson & Johnson, 2012 U.S. Dist. LEXIS 55192 (D.N.J. Apr. 19, 2012), thought it was a good fit for its motion to dismiss, so it put standing in the starting line-up.  And, like so often happens, the bench player came through.  The court dismissed the complaint. 

Young was a putative class action.  The plaintiff claimed that a J&J subsidiary was able to charge a premium price for its margarine substitute, Benecol Spread, through misrepresentation.  Id. at *1.  The alleged misrepresentations included promotional claims that Benecol was a heart healthy choice, contained no trans fatty acids and could reduce cholesterol through ingredients such as plant stanol esters.  Id. at *1-2.  The plaintiff asserted that these product claims were misleading principally because Benecol did in fact contain unhealthy levels of trans fatty acids and partially hydrogenated oils.  Id. at *6-7.

The court’s standing inquiry focused on injury-in-fact, which is often determinative in a standing analysis.  Id. at *6.  Where was the injury?  Certainly, the plaintiff did not allege that he had suffered any unhealthy outcome from using the product.  Id. at *6-7.  But worse, he couldn’t meaningfully allege that he got anything less than what the defendant promoted. 

Sure, the product contained a small amount of trans fat, but less than 0.5 grams per serving.  FDA regulations require such low levels to “be expressed as zero.”  Id. at *8.  “Zero trans fat” means “no trans fact,” which is exactly what the defendant promoted.  And the defendant’s packaging wasn’t coy about any of this (the court considered the language of the packaging because the plaintiff referenced it in his complaint).  Benecol’s packaging contains a disclaimer about trans fats and partially hydrogenated oils that reads like a legal argument you’d expect to see on a motion to dismiss:

A small amount of partially hydrogenated oils are used in Benecol Spreads . . . As a result, Benecol Spreads contain an extremely low level of trans fat.  The FDA allows foods containing less than 0.5 grams of trans fat/serving to be labeled 0 grams trans fat, since this is considered an insignificant amount.

Id. at *9.  Benecol’s ingredient list also says, flat out, that it contains partially hydrogenated oil.  Id.  As to the cholesterol-reducing claims regarding plant stanol esters, the FDA authorized that too.  FDA regulations state that “scientific evidence establishes that including plant stanol esters in the diet helps to lower blood-total and LDL cholesterol levels.”  Id. at *8 n.2.

In other words, the plaintiff suffered no injury.  He got what he paid for:

[B]eyond relying on his own subjective belief as to the unhealthy nature of even small amounts of trans fats, [plaintiff] does not set forth allegations as to how he paid a premium for Benecol or received a product that did not deliver the advertised benefits. . . . [Plaintiff’s allegations] are insufficient to establish injury-in-fact, particularly in light of Plaintiff's failure to allege any adverse health consequences, the consistency of Defendant's claims with relevant FDA regulations, and the disclosures made on Benecol's packaging indicating the presence of small amounts of partially hydrogenated oils and trans fats.

Id. at *10-11.  So there was no injury and, for plaintiff, no standing.

We should note that standing did not stand alone.  Plaintiff’s claims were also preempted.  The Federal Food, Drug and Cosmetic Act (“FDCA”), as amended by the Nutrition Labeling and Education Act (“NLEA”), governs food nutritional labeling.  And the NLEA has an express preemption clause.  States can’t impose a nutritional labeling requirement “that is not identical to the requirement” imposed by the FDCA.  Id. at *13.  And since plaintiff’s claims sought to do just that, the court held that they were preempted.  Id. at *13-14. 

So the bench player – standing – got the job done – with a little help from preemption. 

By the way, if you’re wondering whether TwIqbal could also have won the day, well . . . it could have.  The court said as much in a footnote at the end of its opinion: “[T]he Court notes that Defendant's argument that Plaintiff's complaint is subject to dismissal for failure to sufficiently plead the requisite elements of his claims appears to have merit.”  Id. at *18 n.8.  But that’s for another day.  For now, let’s let standing have its moment.

No Bracketology for Us: Chalk Up Wins for TwIqbal and Statute of Limitations

Some of our friends suggested that we honor the NCAA basketball tournament by engaging in a little bracketology. Presumably, they want us to run some legal concepts, cases, or personalities through brackets, ultimately selecting an overall champion. For those five or six of you who did not fill out March Madness sheets, bracketology is a way of deciding a winner by pairing off items, deciding winners, with winners advancing to confront other winners until there is one ultimate winner. Theoretically, bracketology can be as useful as, say, a decision-tree in evaluating alternatives or determining a course of action. Mostly, it's a harmless diversion. Our favorite recent example was a bracketology treatment of characters from the late, lamented HBO series The Wire.

Bracketology can be fun. But it doesn't really work for our purposes. Creation of an intial bracket requires a seeding of the contestants. That is, at the outset you first make an assessment of relative value or merit. The excitement of the NCAA tournament is how reality can play havoc with the seeding. (Ask anyone who picked Duke or Missouri to make it to this year's Final Four.) Injuries, sudden and surprising ineligibilities, 19 year-olds calling timeouts when all timeouts have been used up, screwy turnovers, and miracle shots can all create improbable results. But an abstract exercise is different. It lacks the fluidities and frictions of real life. Doesn't the initial assessment pretty much predetermine the outcome? How can there be any upsets? In fact, that is what happened with The Wire bracket. Everyone knew right away that Omar would likely win as best character. President Obama picked Omar. And, indeed, Omar won.

When people practice bracketology, the major issue is the extent to which one follows or departs from the "chalk." The "chalk" means picking the favorites. It is a boring strategy, but is mostly effective. For every amazing underdog success story, such as Butler, George Mason, and VCU, there are way more Kentuckys, North Carolinas, and Michigan States. Odds are that this year's Final Four will include at least three number 1's or 2's. Maybe one surprise team will sneak in. If one followed the chalk for The Wire bracket, one simply had to pick either Omar or Stringer Bell to triumph. (If you haven't seen The Wire, shame on you. It certainly makes our Final Four of the best television dramas of all time.)

All of which is to say that we won't be doing Drug and Device Law bracketology. We would simply end up going with the chalk. Plus, we're not sure how to do the graphics for the brackets. If we were to pair off legal defenses, we're fairly sure that TwIqbal, Daubert, Preemption, and Statute of Limitations would be our Final Four. A couple of posts ago we discussed how preemption is so strong because it can preclude cases that otherwise possess substantive merit. That is also true with the statute of limitations. We like TwIqbal because it gets rid of junk pleadings, and we like Daubert because it gets rid of junk science. It would be nice if courts followed the chalk and applied these doctrines to send the bad cases away, like Kentucky dispatching an inferior opponent.

Last week we saw two cases where courts followed the chalk. First, we have a straightforward application of TwIqbal in Reed v. Pfizer, Inc., 2012 WL 859729 (E.D.N.Y. March 14, 2012). The plaintiff alleged injuries from ingesting an oral contraceptive. In an early court conference, "plaintiffs acknowledged that the complaint allowed room for further factual details." Reed, 2012 WL 859729 at *1. Leave was given to file an amended complaint. That amended complaint alleged the usual claims: failure to warn, manufacturing defect, design defect, and breach of warranty. All flunked TwIqbal. The failure to warn claim did "not plead facts indicating how the provided warnings were inadequate." Id. at *3. "In contrast with their thorough recitation of Ms. Reed's claimed injuries, plaintiffs plead nothing about the content of Lybrel's warnings. This is likely because, as defendants note by reference to the FDA's website, Lybrel's FDA-approved warning labels warn of the very injuries plaintiffs have pled." Id. The manufacturing defect claim offered mere conclusions about negligent manufacturing, violations of regulations and "appropriate standards of care," and failure to test, but without an ounce of fact or a hint as to how the product differed from its design. Id. at *5. The design defect claim did "not plead facts alleging the existence of a feasible alternative design that would make the product safer, as is required to establish a design defect, under either New York or West Virginia law." Id. Finally, the warranty claim missed the mark: "Plaintiffs' unsupported conclusions that Lybrel differed in some defective manner from what was warranted lack the required factual content identifying that difference and making its existence plausible." Id. at *6.
　
All of these rulings follow TwIqbal faithfully and are predictable. Not quite as predictable was the Reed court's allowance of another opportunity to amend the complaint. We would have thought that the court's reasoning, particularly on the failure to warn claim, demonstrated that further amendment would be futile. But the plaintiffs will now get a third chance to plead a viable complaint. At least the NCAA tournament is single-elimination. Lose and go home. Maybe folks in Durham, North Carolina right now would like another chance, but there is something to be said for finality.

In the second case, Judge Mayer in New Jersey granted summary judgment for Novartis because Virginia’s two-year statute of limitations barred the case in its entirety. Irby v. Novartis Pharm. Corp., No. MID-L-1815-08 MT, slip op. (N.J. Super. Ct. Mar. 16, 2012). It was yet another Zometa case where the plaintiff alleged that the medicine caused him to develop osteonecrosis of the jaw. Judge Mayer agreed with Novartis that the limitations period begins to run on personal injury claims in Virginia "as soon as the alleged injury occurs, not at the time of diagnosis or discovery." Id. at 8 (quotation marks omitted). The plaintiff filed his complaint approximately three months too late. Id. The court rejected plaintiff’s argument that his lawsuit had been saved and was timely because of cross-jurisdictional class action tolling. Id. at 8-10 (citing Casey v. Merck & Co., 2012 Va. LEXIS 48 (Va. Mar. 2, 2012)). We discussed the Casey case here. It's nice to see it being put to such good use so soon. The court also rejected the plaintiff’s alternative argument that New Jersey law should govern the statute of limitations issue. It was more of a desperate, rather than an alternative argument, because the parties had all along acted as if they assumed that Virginia law applied: "Plaintiff cannot argue in the alternative that New Jersey’s period of limitations governs his affirmative claims, having failed to raise that issue by way of a timely choice of law motion." Id. at 10-11; see also id. at 10 (stating that "it is unfair to [Novartis] and this court for Mr. Irby to suggest at this late juncture in the litigation that a question remains as to which state’s law governed" the statute of limitations issue"). Thanks to Joe Hollingsworth and Martin Calhoun for bringing this decision to our attention.

And now, back to college basketball. All of our Final Four picks are still alive, and only one of our Elite Eight (Kansas State) is gone. We mostly followed the chalk, and our few departures have thus far paid off well. If you don't hear further bragging from us next week, you'll know that our bracket got busted.