We know that headline is boring: “Accutane: McCarrell Remanded For New Trial.”

But give us a break.

Levine comes down. We’re duty-bound to blog about it. The press calls for reactions to it. We’re writing about the case in print media. We’re being asked to speak about the case.

And then there’s our real jobs: Our long-dormant drug cases bust loose because all those stays pending Levine are now lifted.

And that same week — that same week — the !**@!! New Jersey Appellate Division hands down a 113-page appellate decision in McCarrell v. Hoffman-LaRoche, No. A-3280-07T1 (N.J. App. Div. Mar. 12, 2009) (link here). What’s a blogger to do?

Here’s what we’ll do: We’ll give you the shortest little description of McCarrell, tell you very briefly why it matters, and then call it quits. We apologize for giving you the bum’s rush, but life’s pretty hectic here.

Andrew McCarrell took Accutane for acne and then developed inflammatory bowel disease, which led to, among other things, surgical removal of his colon. He sued Hoffman-LaRoche, the manufacturer of the drug, in New Jersey state court for product liability and consumer fraud. After a 15-day trial, the jury returned a verdict (of $119,000 for past medical expenses and $2.5 million in compensatory damages) in favor of McCarrell on the product liability claim, and a verdict in favor of Roche on the consumer fraud claim.

The first issue on appeal was the admissibility of plaintiff’s expert testimony purportedly linking Accutane to IBD. (The federal MDL judge excluded similar expert testimony under Daubert, in a decision that was upheld by the Eleventh Circuit.) The New Jersey Appellate Division trotted through (at a length that’s really not acceptable when we’re this busy) the scientific evidence supporting plaintiff’s expert’s opinion. The court then concluded that (1) different experts testified in the MDL and in New Jersey state court, (2) the standards for admissibility are different in federal court and New Jersey state court, and (3) the evidentiary record in New Jersey was more developed, because it followed a trial. The court thus affirmed the decision to admit the expert’s testimony on causation. Id. at 82.

The second issue on appeal was whether the trial court erred by letting plaintiff’s witness refer to the number of adverse incidents reported about Accutane while excluding Roche’s testimony about the large number of people who had ingested the drug and “the comparative significance of those figures.” Id. at 92. The appellate division held “that the trial court erred in unduly restricting Roche’s effort to provide relevant background statistics and other related proofs about Accutane usage to the jury.” Id. at 104.

That’s a holding that matters. Judge Higbee made similar evidentiary rulings in other Accutane cases that have been tried before her, so it’s quite likely that other plaintiffs’ verdicts will now be reversed on the same ground. And, needless to say, that holding protects defendants who manufacture other drugs from being forced into a similar evidentiary bind at trial.

Finally, the Appellate Division briefly addressed Roche’s remaining arguments. The court affirmed the trial court’s application of the New Jersey statute of limitations to this Alabama plaintiff and found that equitable tolling of the statute rendered plaintiff’s lawsuit timely. Id. at 106. The court found “reasonable factual support” for the jury’s conclusion that the warning label on Accutane was inadequate. Id. at 107. And the court remanded for the trial court to consider Roche’s preemption defense in light of the holding in Wyeth v. Levine. In particular, the trial court is to address whether “Roche can show by ‘clear evidence’ that the FDA would not have approved a change to the Accutane label.” Id. at 112. We don’t know enough about the administrative record surrounding Accutane to speculate on how that issue will ultimately play out.

That’s not a home run for Roche, but it’s a hit of some kind: Score it a single, with the batter taking second on an error.

When we say “bananas,” today’s case is actually about bananas, that herb people tend to call a fruit.  It is also quite unusual and complicated.  Because it also involves some tragic underlying events, our quips are done.  A bit of etymology is warranted, though.  We used the term “judge-made law” in the title and that can have a negative connotation sometimes.  Many of the substantive due process rights recognized by the United States Supreme Court in the roughly seventy years before the current term could be called “judge-made.”  Critics of those decisions might even label the justices who authored them as “activist judges,” which we find to be an over-used appellation.  When referring to common law, which still forms a large chunk of the law we feature on this Blog, there is typically no dig about its origin.  Was Judge Pigot an activist judge when he wrote the decision in the “Case of Thorns” (Hulle v. Orynge)?  Are the early state cases recognizing the learned intermediary doctrine for cases about prescription medical products more “judge-made” than those that followed that carved out exceptions?  We suppose this is one of those “eye of the beholder,” or perhaps “mouth of the advocate,” situations.

In Garcia v. Chiquita Brands Int’l, Inc., __ F.4th __, 2022 WL 4100393 (11th Cir. Sept. 8, 2022), the application by a federal court sitting in diversity of the Colombian statute of limitations for personal injury actions turns in large part on the class action tolling rule being “judge-made law.”  We will try to unpack this mad tangle of Erie R.R. Co. v. Tomkins, choice of law, and class action law.  Usually when we talk about Erie here, we are talking about the need for federal courts sitting in diversity to exercise restraint when they predict state law.  For instance, in a case about a class III medical device, the court should be very hesitant to create some new state cause of action as a way to create a path to avoid preemption.  The judges on a state’s highest court can make new law, but the federal judge sitting in diversity really should not.  Garcia adds the wrinkle of what happens when the “state” is another country.  The short answer is that there should be similar restraint, but the steps to get there are not simple.

Our recounting of the underlying facts and procedural posture, however, has been simplified.  The defendant apparently utilized the services of AUC, a well-known paramilitary/terrorist group—see Narcos and other depictions of the cocaine trade—to intimidate banana workers through acts of violence.  We say “apparently” instead of “allegedly” because the defendant pleaded guilty to violating a presidential order relating to national security under 50 U.S.C. § 1705(b).  2022 WL 4100393, *2.  (We note that Garcia says this plea happened in the “District Court for the District of Colombia [sic]” and that 1705(b) is the civil penalties subsection, but we will treat it like Garcia did—as a violation of U.S. criminal law.)  In 2007, those allegedly affected by these acts brought a class action called Cardona in the District of New Jersey under the Alien Tort Statute, the Torture Victims Protection Act, New Jersey law, and Colombian law.  Cardona was sent with other actions to a new MDL down in the Southern District of Florida in 2008.  Eventually, after some claims had been culled, in March 2017, the Cardona plaintiffs sought to amend to add “several hundred additional plaintiffs.”  That was denied and, in May 2019, so was class certification.  Then those additional plaintiffs—presumably all Colombian citizens—brought a new (non-class) suit in the District of New Jersey—the defendant is incorporated in NJ—asserting a range of claims under New Jersey and Colombia (but not federal) law.  The new case was sent back to the same aged MDL in the Southern District of Florida.  Then, the Colombian claims were dismissed with prejudice as time-barred and the New Jersey claims were dismissed on extraterritoriality.  After the denial of a Rule 59 motion, an appeal followed on the Colombian claims only.

As different as the facts and case history above are from what we normally cover, there are several common issues.  Most of them are more on the procedural side, but class action tolling popularized in the U.S. Supreme Court’s American Pipe decision can have a major impact in serial product liability litigation.  We can remember many exchanges where we describe our core practice to a non-lawyer and have been met with a version of “oh, you do class actions.”  Our response, time and patience permitting, may explain why class actions tend not to work for these sorts of cases except for settlement classes.  Our elevator explanation notwithstanding, persistent plaintiff lawyers do bring class actions that have broad proposed class definitions that would make many future plaintiffs “putative class members.”  Because the nature of modern advertising-driven litigation means that a chunk of all claims will be brought after the statutes of limitation have expired absent some sort of tolling, the pendency of a class action—and they do tend to pend—can save a bunch of cases that would otherwise be S.O.L. on S.O.L.  This is particular problematic where the class action was pending in a different jurisdiction than where the otherwise time-barred cases were brought.  Indeed, if Garcia had involved two states, rather than a state and a sovereign nation, then we would have included it on our cross-jurisdictional class action tolling scorecard.

Colombia has a ten-year statute of limitations for the individual claims asserted in Garcia and the conduct at issue all occurred before 2005.  Garcia was filed in March 2020, so even if the 2017 request to amend in Cardona counted as initiation of the claims in Garcia, significant tolling would be required to save every claim from the Colombia statute of limitations, if it applied.  Twelve years of class action tolling, if it applied, would do the trick.  But how do you get American Pipe to apply to claims brought under Colombia law in a case filed directly in the District of New Jersey?  Here, at least, the answer was that you cannot mix and match like that.

Based on Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3 (1975), the analysis for determining whether to apply the substantive law of a foreign country is the same as for substantive state law.  2022 WL 4100393, **3-4.  The Eleventh Circuit developed a “four-step process” for deciding which law should apply under ErieId. at *4 (citing Esfeld v. Costa Crociere, 289 F.3d 1300 (11th Cir. 2002)).  Garcia was filed in a federal court New Jersey, so its choice-of-law rules apply despite the transfer.  Being a state with lots of out-of-state plaintiffs in its courts, New Jersey had specific guidance on determining choice-of-law for statute of limitations.  Id. at *5 (citing one of the many McCarrell decisions from Accutane litigation).  Choice of law analyses always start with determining a conflict.  New Jersey has class action tolling and, according to Garcia, Colombia does not.  The latter determination involved a deep dive into Colombia’s law, which we will skip.  The tenor, though, was one of restraint, rather than projecting the court’s view of what the law should be:

In short, Colombian law has not spoken on class tolling.  And that silence speaks volumes because, as a civil law country, Colombia establishes its laws almost exclusively through criminal and civil statutes – not from the decisions of its courts.

Id. at *6.  Because the application of class action tolling vel non would be outcome determinative, the next steps under McCarrell were to determine if maintaining an action “would serve no substantial interest” of New Jersey and if Colombia had a “more significant relationship to the parties and the occurrence.”  Id. at *8.  Both clearly weighed in favor of applying Colombia’s statute of limitation law, which would bar the claims.

The next inquiry under Erie/Esfeld was “whether a congressional statute or Federal Rule of Civil Procedure covers the disputed issue.”  Id. at *9 (citation omitted).  The inquiry was not whether “federal law covers the disputed issue.”  Class action tolling under American Pipe may be federal law, but it came from judges and has not been incorporated into the Federal Rules of Civil Procedure.  In this sense, the law established by a clear Supreme Court decision did not count.  Id.  If it did, then the result of the New Jersey choice-of-law analysis would have been reversed.  We can dispense with the last two Erie/Esfeld inquiries fairly quickly.  Failure to apply Colombia’s law would lead to different outcomes in state and federal court, which is contrary to one of the purposes of Erie.  Id.  In addition, federal interests did not weigh in favor of applying federal law over Colombia’s laws.  Id. at **10-12.  While Garcia did not expressly address the issue of whether cross-jurisdictional class action tolling is ever appropriate, we note that it did cite a few cases that did reject this particular species of tolling.  Compare id. at *12 with this post.  It did recognize that New Jersey’s interest in having its class action tolling apply was limited because the prior Cardona class on which potential tolling would be based was filed in New Jersey state court.  2022 WL 4100393, *9.  In the end, of course, an attempt at cross-jurisdictional class action tolling was rejected.

All of that analysis came across as thorough and well-reasoned.  While we certainly have no dog in the fight, Garcia’s decision to reverse of dismissal with prejudice and remand with instructions that plaintiffs should be permitted to amend did not.  For one thing, it was analyzed under Fed. R. Civ. P. 15, which is the right rule for addressing a motion to amend a pleading.  But plaintiffs filed a motion to alter or amend the judgment under Fed. R. Civ. P. 59(e).  Although Garcia referred to this loosely as an “application to amend” and a “request to amend,” it is not the same thing as a motion to amend a pleading.  Id. at *3.  Second, given the long history here, relying on a pre-TwIqbal case that a plaintiff should get a second shot to state a claim with a “more carefully drafted complaint” is not terribly persuasive.  Id. at *13 (citation omitted).  Third, the rejection of the district court’s ruling that plaintiffs had waived an alternative tolling argument—that some of them were minors before March 2010—because “dismissal with prejudice” was a “hefty sanction” seemed off.  Id. at *14.  Dismissal here was based on the determination, after full briefing, that the case was time-barred, not as a sanction.  We are used to the old saw that appellate courts like to find waiver.  Maybe that is just judge-made, so it did not count here.

A relatively short post about Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law.

The plaintiff received a vena cava filter manufactured by the defendant. Surgically implanted in the vena cava vein, the filter is designed to reduce the risk of pulmonary embolism, a potentially dangerous condition caused by blood clots. According to the plaintiff, he suffered bodily injury when filter shifted after implantation. He sued, alleging that the manufacture had not adequately warned of that danger.

The district court dismissed the failure-to-warn claim under New Jersey law and the Third Circuit affirmed on that basis in a brief per curiam decision.

The court explained that under New Jersey law, “‘[i]f the warning’” at issue was “‘given in connection with a [device] has been approved or prescribed by the [FDA],’” then there is “‘a rebuttable presumption … that the warning or instruction is adequate.’” 2022 WL 1261318, at *1 (quoting N.J. Stat. Ann. § 2A:58C-4). The court further explained that, “[t]o overcome this presumption,” which has been called the “compliance presumption, “a plaintiff must plead specific facts alleging ‘deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process[.]’” Id. (quoting Cornett v. Johnson & Johnson, 48 A.3d 1041, 1056 (N.J. 2012), abrogated on other grounds by McCarrell v. Hoffmann-La Roche, Inc., 153 A.3d 207 (N.J. 2017)).

Employing a two-step analysis, the court “agree[d] with the District Court that [the plaintiff failed to state a claim because the warnings provided by [the manufacturer] in connection with the [device] were adequate as a matter of law.” 2022 WL 1261318, at *2. First, finding it “undisputed that the [device at issue] is subject to FDA oversight,” the court held that the manufacturer’s warnings were “subject to the ‘super-presumption’ in [N.J. Stat. Ann.] § 2A:58C-4.” Id. Second, the court “concluded that [the plaintiff] failed to plead facts sufficient to rebut the presumption” because he did “not allege that [the manufacturer] deliberately concealed or withheld known harmful effects associated with the [device], or that [the manufacturer] manipulated the post-market regulatory process.” Id. Because the plaintiff failed to overcome the presumption, the court held that he had failed to state a failure-to-warn claim under New Jersey law.

That is clearly the correct outcome under New Jersey law. We have no complaints as to the result.

We do, however, have reservations about N.J. Stat. Ann. § 2A:58C-4, the statute that yielded the result.

Do not misunderstand, the presumption established by the statute is not only appropriate but also helpful. As we observed before, the presumption makes it much harder for medical-device and prescription-drug plaintiffs to plead and ultimately prove a failure-to-warn claims in New Jersey. No complaints on that score. Anything to reduce the burden of typically meritless claims is welcome.

But consider how the presumption is rebutted—by pleading, and ultimately presenting evidence of, “deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process.” N.J. Stat. Ann. § 2A:58C-4. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability. But state-law claims that rest on alleged fraud on the FDA are contrary to Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), which concluded that fraud-on-the-FDA claims are impliedly preempted because they “inevitably conflict” with the FDA’s regulatory discretion under. 21 U.S.C. § 337(a).

The Fifth and Sixth Circuits have some understanding of this, having respectively held in Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012), and Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), that provisions allowing the rebuttal of a compliance presumption based on alleged fraud on the FDA are preempted unless the FDA itself finds fraud. We don’t think that goes far enough, but at least those courts recognize that Buckman preempts rebuttal provisions in at least some circumstances. The same cannot be said of the Second Circuit, which reached the contrary—and erroneous—conclusion in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by an equally divided court sub nom. Warner-Lambert Co., LLC v. Kent, 552 U.S. 440 (2008)).

We’ll take what we can get, but we are entitled to more when it comes to the preemption of rebuttal provisions.

It’s been a long road.  Well after product liability litigation over Accutane and inflammatory bowel disease (“IBD”) had been thoroughly debunked everywhere else in the nation, such litigation lived on in New Jersey – for year after interminable year.  First, a number of trials occurred, but literally every verdict for the plaintiffs was reversed on appeal.  Here are some of our posts on that phase of the litigation.  Then, once the trial court had had enough and began dismissing large numbers of cases, the intermediate appellate court reversed those decisions, too.  Here are some of our posts on that phase of the litigation.

Ultimately, it was up to the New Jersey Supreme Court to step in and figure everything out.  We blogged recently about it reversing the Appellate Division and entering a landmark decision on the admissibility of expert testimony in New Jersey.  See In re Accutane Litigation, ___ A.3d ___, 2018 WL 3636867 (N.J. Aug. 1, 2018).  Well, the defendant went back to the well on the adequacy of the drug’s warnings, and yesterday it rang the bell again.  In In re Accutane Litigation, ___ A.3d ___, 2018 WL 4761403, slip op. (N.J. Oct. 3, 2018), the court unanimously reversed the Appellate Division and affirmed the grant of summary judgment against another 532 cases brought mostly by litigation tourists.  “Of the 532 plaintiffs, 18 are New Jersey residents and 514 are residents of 44 other jurisdictions.”  Id. at *5.

The trial court had told the tourist plaintiffs that they were stuck with the consequences of choosing to descend on New Jersey like a plague of locusts – New Jersey law applied, including the presumption of adequacy that the state’s Product Liability Act (“PLA”) gives to FDA-approved warnings.  The warnings were adequate as a matter of law because “plaintiffs failed to overcome the presumption of adequacy.”  2018 WL 4761403 at *5.  The Appellate Division held that the law of each of the plaintiffs’ home states, 45 states altogether, governed, and reversed summary judgment under the laws of most of those states (all but eight).  Id.

Choice of Law

The New Jersey Supreme Court first said “you’ve got to be kidding” to the Appellate Division’s multifarious choice of law result.  The plaintiffs made their bed and thus had to sleep in it:

[W]e hold that New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL [multi-county litigation] purposes. . . .  The aggregation of hundreds of cases under MCL allows the resolution of common issues of law.   A trial judge cannot be expected to gain a mastery of the law of forty-five different jurisdictions.  Construing New Jersey’s PLA is challenging enough.  New Jersey’s interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact.

Accutane, 2018 WL 4761403 at *6 (summarizing ruling).  See Id. at *15-20 (lengthy discussion of rationale for applying New Jersey law to all cases).

The court “proceed[ed] under the assumption” that true conflicts existed – that “application of New Jersey’s PLA may lead to an outcome different from the application of the laws of those other jurisdictions.”  Id. at *17 (citation and quotation marks omitted).  Even so, the most “significant relationship” for choice of law purposes in all cases was New Jersey.  First, as to alleged failures to warn, the corporation’s principal place of business “is where the alleged conduct causing the injury occurred − the manufacturing and labeling of [the product].”  Id. at *18 (citation and quotation marks omitted).

Second, in mass torts, “ordinary choice-of-law practices should yield in suits consolidating large numbers of claims and that courts should apply a single law in such cases.”  Id. at *17 (citation and quotation marks omitted).

The two most significant Restatement factors in this MCL matter are . . . “certainty, predictability and uniformity of result” and . . . “ease in the determination and application of the law to be applied”.  Applying a single standard to govern the adequacy of the label warnings in the 532 individual cases will ensure predictable and uniform results − rather than disparate outcomes among similarly situated plaintiffs.

Id. at *20 (discussing factors under Restatement (Second) of Conflict of Laws §6 (1971)).  Litigants cannot expect “[a] single judge . . . to gain a mastery of the laws of forty-five jurisdictions.”  Id.  If mass tort plaintiffs don’t want New Jersey law to apply they should “bring suit in the state where they reside.”  Id.  Under this new, mass-tort-specific application of choice of law, the plaintiffs in Accutane were stuck with New Jersey substantive law, which “is not as beneficial to their cause as the laws of other jurisdictions.”  Id.

We recommend that defense counsel study the court’s choice of law rationale.  It is no accident that, in its discussion of choice of law, the court cited Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).  Accutane, 2018 WL 4761403 at *20.  Save for Delaware, more major pharmaceutical manufacturers are probably “at home” in New Jersey than anywhere else.  Thus, if the other side in the future chooses to congregate in New Jersey, they’ll have to put up with New Jersey substantive law, at least if the defendant makes motions in the aggregate.  Query, however, if the practicality rationale still applies in a single “bellwether” case where the alternative is application of one other state’s law, rather than the multi-state muddle the court faced in Accutane.  We think defendants have another opportunity to exercise some strategic discretion here.

Presumption of Adequacy

On the merits, the Supreme Court agreed with the trial court, that the defendant’s warnings were adequate as a matter of law under the PLA’s presumption of adequacy of FDA-approved labeling.  Initially, we get another shout out for the learned intermediary rule from the court:

[T]he PLA codifies what is commonly referred to as the learned intermediary doctrine – . . . that the physician acts as the intermediary between the manufacturer and the patient.  The prescribing physician − as a learned intermediary − generally is in the best position to advise the patient of the benefits and risks of taking a particular drug to treat a medical condition.  Under the learned intermediary doctrine, a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug’s dangerous propensities.

Accutane, 2018 WL 4761403 at *21 (citations and quotation marks omitted).  We’re always on the lookout for high court reaffirmations of the learned intermediary rule.

As to the statutory presumption of the adequacy of FDA warnings, the court reached the right result, but not before a lengthy detour based on a questionable source (a law review article written by plaintiff-side professional expert David Kessler) and the infamous decision in Wyeth v. Levine, 555 U.S. 555 (2009).  2018 WL 4761403 at *21-24.  The upshot is a ruling on how the PLA’s “rebuttable” presumption of adequacy can be rebutted:

[T]he rebuttable presumption of adequacy attaching to an FDA-approved drug label is overcome when a plaintiff presents clear and convincing evidence that a manufacturer knew or should have known, based on newly acquired information, of a causal association between the use of the drug and “a clinically significant hazard” and that the manufacturer failed to update the label accordingly.

Id. at 26.  Notably, the substantive aspects of this rebuttal standard are based on federal regulations, including the notorious Levine “CBE regulation,” 21 C.F.R. §314.70.  This result leaves little daylight between the PLA presumption and implied preemption under Levine, except for the burden of proof.  Preemption is also based on “newly acquired information” – specifically the lack of it.  So any claim that would be preempted in other jurisdictions because plaintiffs can’t point to anything new that the FDA hadn’t already considered is independently barred in New Jersey by the PLA presumption.  However, while defendants bear the burden of proving preemption, in New Jersey the PLA presumption means that plaintiffs bear the burden of proving the presence of the necessary “new” information, and must do with clear and convincing evidence, which Accutane defined as “evidence so clear, direct, weighty in terms of quality, and convincing as to cause one to come to a clear conviction of the truth of the precise facts in issue.”  Id. at *26 (citation and quotation marks omitted).

The Accutane court added “one caveat” – regardless of anything else:

A manufacturer that acts in a reasonable and timely way to update its label warnings with the FDA, in accordance with its federal regulatory responsibilities, will receive the protection of the rebuttable presumption.

Id.

The Accutane court acknowledged that this “is a standard protective of responsible drug manufacturers.”  Id.

The PLA’s rebuttable presumption of adequacy that attaches to label warnings gives pharmaceutical companies the protection necessary to research and develop the drugs that will improve and extend the lives of people around the world.  The presumption of adequacy protects manufacturers from unmeritorious lawsuits.

Id.

Plaintiffs’ Failure of Proof

Finally, Accutane applied the law to the facts, and found that none of the 532 plaintiffs came close to overcoming the statutory presumption of adequate warnings.  “[M]ultiple warning tools,” the package insert, the patient package insert, the medication guide and “blister packaging,” all warned about the possibility of IBD.  Id. at *27.  “Association” was the proper description of the drug’s relationship to the plaintiffs’ injuries; “cause” would have been too strong.  Defendant “had reports that some patients, after taking [the drug], developed symptoms of IBD.  That one followed the other does not prove cause and effect.”  Id. (citing Accutane, 2018 WL 3636867, at *8-10).  Plaintiffs offered only “isolated examples” that had been “culled from the voluminous discovery.”  Id. at *27-28.  “To be sure,” that evidence “is not clear and convincing evidence that [defendant] knew or should have known that the use of the word ‘associated’ was inadequate.”  Id. at *28.

Nor is there any evidence that [defendant] avoided necessary label changes for economic reasons.  [Defendant’s] marketing personnel certainly expressed an interest in Accutane’s financial success; it would have been surprising if it were otherwise.  However, there is no evidence that [defendant’s] financial interest in Accutane’s success led it to withhold necessary IBD-related warnings.

Id.

*          *          *          *

This latest Accutane decision is a great result and should finally drive a stake through this vampire of a litigation.  Still, a couple aspects of this ruling give us pause.  As for choice of law, the application of multiple states’ laws was one means of defending against class actions, since doing so defeated both proportionality and manageability.  Many other reasons for rejecting class actions in personal injury litigation remain, but like practically everything else about choice of law, this could be a two-edged sword.  Second, the continued willingness of New Jersey courts to craft extra-statutory “exceptions” to the New Jersey legislature’s presumption of adequacy of FDA warnings bothers us doctrinally.  The statute says what it says, and we think that – as with all other statutory provisions (including preemption clauses) – courts should enforce statutes as written, and not use subsequent developments to change what the legislature did.  Short of a constitutional issue, courts should not encroach on the legislature’s prerogative to draft legislation.

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog.  Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions by intermediate courts of appeals.  As always, our guest posters are 100% responsible for what they write – due 100% of the credit, as well as any blame.  Take it away Kevin.

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SCOTUS Calls For Solicitor General’s Views In Third Circuit Fosamax Case

Friday December 8 was a day with two items that are particularly noteworthy because of their potentially momentous implications. Remember the Blog’s previous lambasting of the Third Circuit’s unprecedented Fosamax preemption decision and the haymaker that court unleashed on the drug and device industry, in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017)?  Now, there is positive news to report. The Supreme Court has invited the Solicitor General “to file a brief in this case expressing the views of the United States.” Merck, Sharp & Dohme Corp. v. Albrecht, et al., No. 14-1900 (Order, Dec. 8, 2017).

What is that? Here is SCOTUSBlog’s description:

“CVSG” stands for “call for the views of the Solicitor General.”  In most cases in which someone is seeking review of the lower courts’ decision, the Court will issue a straightforward grant or denial.  But sometimes the Court will want the government’s views on what it should do in a case in which the government isn’t a party but may still have an interest — for example, because the interpretation of a federal statute is involved.  So the Court will issue an order in which it “invites the Solicitor General to file a brief expressing the views of the United States.”  It isn’t an “invitation” in the sense that the federal government gets to decide whether it wants to file a brief at all, because the Court expects the government to file.  There is no deadline by which the government is required to file the brief, however.  And the government’s recommendation, although not dispositive, will carry significant weight with the Court.

In Fosamax, this development is important because it signals that the case stands out from the general certiorari pool, meaning that review is more likely to be granted.  Statistics are surprisingly hard to come by, but a law review article, Thompson & Wachtell, “An Empirical Analysis of Supreme Court Certiorari Petition Procedures:  The Call for Response and the Call for the Views of the Solicitor General,” 16:2 G. Mason L.R. 237 (2009), analyzed ten years of Supreme Court cases (1994-2004) and concluded:

The overall grant rate increases from 0.9% to 34% following a CVSG from the Court; in other words, the Court is 37 times more likely to grant a petition following a CVSG.  For petitions on the paid docket, the grant rate increases even more, to 42%; a paid petition is 47 times more likely to be granted following a CVSG.

Id. at 245 (emphasis added).  If those somewhat dated statistics are even close to currently accurate, the Fosamax CVSG is a big deal.

Recall that the Third Circuit grossly misinterpreted the “clear evidence” preemption test from Wyeth v. Levine, which held that without clear evidence that the FDA would not have approved the label change, a court cannot rule a manufacturer’s compliance with federal and state law is impossible, and thereby preempted, already an exacting defense.  As the Blog explained in praising the petition for certiorari, the Third Circuit distorted Levine, applied an unprecedented standard, and ruled that a manufacturer could not invoke preemption without “clear and convincing” evidence that the FDA would have rejected a proposed warning.  Thus, not only did the Third Circuit reverse summary judgment for the manufacturer in more than 1000 cases, it rendered impossibility preemption even more difficult than the anti-preemption justices in Levine intended.  The Blog also discussed the Product Liability Advisory Council’s amicus brief in support of the petition here, which explained that the Third Circuit’s decision invites further lower court confusion, obliterates the district court’s ruling that was supported by undisputed evidence, encourages pharmaceutical manufacturers to flood the FDA with proposed label changes, and threatens to stifle the innovation necessary to develop new, potentially life-saving drugs.

This latest development raises defense hopes that SCOTUS will grant the petition, and finally reverse one of the worst decisions of 2017, which would be a huge win for the manufacturer in particular, and of greater significance for the big picture for pharmaceutical companies and consumers in general. Stay tuned.

New Jersey Supreme Court Grants Review of Accutane Cases

Also on December 8, the New Jersey Supreme Court granted the appeals in all of the Accutane cases that the appellate court revived back in July. The Blog has monitored the Accutane litigation through many of the twists and turns of its tortuous existence for more than a decade, first with the Accutane MDL, and then with the New Jersey cases.  As a resident of the San Francisco Bay Area, when I think of the Accutane litigation, I automatically picture Lombard Street, often touted “The Crookedest Street In The World,” with its eight hairpin turns and switchbacks that span the 600 feet of the street’s natural 27° grade.  In fact, Lombard Street is not even the most crooked street in San Francisco, because Vermont Street, has a greater sinuosity at 1.56 versus 1.2 for Lombard, though Vermont at seven turns, has one fewer than its more famous cousin.   Lombard Street and its adornment of brick red and beautiful flowers attracts thousands of tourists per year.  This meandering avenue is difficult to traverse, requires careful navigation, has been around a long time, and produced extreme frustration for those who occupy it: if it sounds familiar, bear in mind that the Accutane litigation likewise has a lengthy history, ongoing since 2003, has zigged and zagged, and neither side is particularly thrilled with the results.  The Blog has discussed many of the good aspects here, (vacating plaintiff verdicts) here, (dismissals based on learned intermediary doctrine) here, (MSJ granted) and here (warnings adequate as a matter of law), as well as the very bad Appellate Division decisions earlier this summer, when the court reinstated more than 2000 causation based dismissals.

With that in mind, here is a very brief summary of the mind-bending history of the Accutane saga and the battle over the proper expert testimony that has hopefully neared its dénouement.  As already discussed at length, the Appellate Division reversed the trial court’s decision that excluded plaintiffs’ expert causation testimony, reviving more than 2000 lawsuits.  Not surprisingly, the manufacturer appealed, supported by amicus briefs from 21 of New Jersey’s largest employers, including many Roche competitors, the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, the American Medical Association, and eight scholars and professors of law.  When it comes to expert testimony, New Jersey unfortunately travels The Road Not Taken, applying a “relaxed” standard of expert testimony in toxic tort cases, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), rather than the more rigorous federal Daubert standard.  Under Rubanick, expert testimony may be admitted “even though it is controversial and its acceptance is not widespread,” only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  In Kemp v. State, 174 N.J. 412, 425-426 (2002), the court ruled that the inquiry was not based on reasonableness, but instead examines “whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 426 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued the state’s unique application of scientific expert testimony with an approach distinct from the more exacting federal standard, resulting in inconsistency, confusion, and the morass of the Accutane litigation.

As the Blog discussed, and the amici explained, the Accutane trial judge applied a standard similar to Daubert, but the Appellate Division reversed the decision based on Rubanick. In so doing, the appellate court essentially ignored the gold standard of scientific evidence, epidemiological studies all but one which failed to “demonstrate[] a statistically significant increased risk of developing Crohn’s disease.”  In re Accutane Litigation, 451 N.J. Super. 153, 168  (App. Div. July 28, 2017).  Nonetheless, the Appellate Division allowed the plaintiffs’ experts to rely on evidence that should have been excluded as unreliable, such as animal studies, anecdotal case reports, and analogous medicines – in other words, scientifically unsound data.  Id. at 165-166.  Similarly to the Fosamax decision, this represents not only bad law and bad precedent, but also has far-reaching implications.  Pharmaceutical manufacturers and health professionals resoundingly decried the Accutane decision as one that will stifle research and development, and the practice of medicine out of the uncertainty of scientific evidence, and fear of legal reprisals.  The amici implored the New Jersey Supreme Court to adopt Daubert’s methodology to reaffirm the trial court’s role as a gatekeeper to ensure that only reliable scientific evidence informs the jury’s decision.  Again, the industry can take heart in the court’s order granting review of the Appellate Division’s abysmal decision, and hope that the New Jersey Supreme Court will allow modern scientific principles, rather than the unreliable and questionable methods, to govern expert testimony.  If that occurs, no doubt will the New Jersey high court reinstate the trial court’s ruling, and order dismissal of the more than 2000 cases for lack of  causation evidence.

No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious.  The rub is that the parties have very little to show for the effort.  The latest shoe dropped last week when the New Jersey Appellate Division vacated (again) a jury verdict in favor of an Accutane plaintiff.  The unpublished opinion in McCarrell v. Hoffmann-La Roche, Inc., No. A-4481-12T1, 2017 WL 1683187 (N.J. App. Div. May 2, 2017), is interesting, both in its treatment of expert opinion and evidence on causation under Alabama law.

But before we get to that, let’s review very briefly what has come before. When plaintiffs first started suing in earnest over Accutane, they alleged a variety of injuries, including psychiatric conditions, birth defects, kidney disorders, vision problems, and musculoskeletal problems.  There has been some litigation on these issues, but the proceedings in New Jersey and elsewhere have focused largely on gastrointestinal disease, including inflammatory bowel disease.  IBD can be every bit as bad as the name makes it sound, and we can see why patients who experience IBD can garner substantial sympathy.  But the warnings on gastrointestinal disorders are robust, and a federal court in Florida ruled in 2012 and 2013 that the Accutane warnings as to IBD were adequate as a matter of law.

But not in New Jersey, where several cases have proceeded to trial. We have not surveyed the New Jersey verdicts lately, but the last time we did, we counted about half a dozen verdicts—all of which were vacated, with others pending on appeal.  There certainly are others that we are not counting here, but the trend is unmistakable:  Multiple trials presided over by a New Jersey mass tort judge who was championed by some as a hard-working jurist and vilified by others for placing a thumb firmly on one side of the scale.  Substantial verdicts in favor of the plaintiffs.  All of them vacated.  In the mass tort context, vacated verdicts represent a massive waste of both sides’ time and money.

Which is what happened again last week in McCarrell.  The case was first tried to a jury in 2007, resulting in a verdict for the plaintiff.  But the Appellate Division vacated that award and remanded for a new trial because of erroneous evidentiary rulings. McCarrell, 2017 WL 1683187, at *1.  The parties therefore tried the case again in 2010, which resulted in a larger verdict for the plaintiff.  On appeal from the second verdict, the Appellate Division reversed again and held that the claims were time barred.  But the New Jersey Supreme Court disagreed and remanded the case back to the Appellate Division to address the remaining issues on appeal. Id. at **1-2

That remand resulted in last week’s opinion, and the Appellate Division reversed again.  First, the trial judge ordered that it would not allow duplicate expert testimony.  As a result, the defense had its expert gastroenterologist address certain studies, but was prohibited from having an epidemiologist corroborate that testimony. Id. at *2.  The rubber hit the road in closing argument when plaintiff’s counsel emphasized to the jury that the defense gastroenterologist’s opinion stood alone.  That was a problem, particularly once the Appellate Division ruled in 2013 that “trial courts should not prohibit overlapping expert testimony in complex matters on a ‘central issue of liability.’” Id. at *2 (citing McLean v. Liberty Health System, 430 N.J. Super. 156 (App. Div. 2013)).  Under that ruling, the trial judge’s decision to disallow overlapping expert testimony about scientific studies was error. Id. at *3.  And in light of counsel’s emphasis in closing on the defendants’ expert as a “lone outlier,” the error was prejudicial.

Second, the court held that the plaintiff had not met his burden of proving causation. This was a failure-to-warn case, but no one asked the prescribing physician whether her decision to prescribe Accutane would have been different if the drug had come with a stronger warning. Id. at *4.  Regular readers of the blog know this is warnings causation 101, and because the plaintiff bears the burden of proof under the applicable law (Alabama in this case), the absence of this essential evidence caused his warnings-based claims to fail as a matter of law. Id. We agree wholeheartedly with this ruling, although we are somewhat puzzled that the Appellate Division suggested going out and deposing the doctor again.  Sure, the doctor was deposed in 2007, but the burden of proving warning causation is not obscure now and was not obscure then.  It is not obvious to us that a second bite at the apple is warranted, nor do we know if the prescriber can even be re-deposed, after another decade has passed.

So what do we mean when we say that no one can be happy with this? The opinion gives parties on both sides more leeway in presenting expert testimony, and we have guidance on proving failure to warn under Alabama law.  But in the larger scheme, this case is apparently heading for a third trial, having first b een tried ten years ago.  Other verdicts from New Jersey have met the same fate.  Plaintiffs are left empty handed, and the defendants continue to bear the burden of vigorous litigation in New Jersey, whereas the federal MDL wrapped up in the defendants’ favor years ago.  In the end, McCarrell is a defense win, but the cost has been high.

We thought we understood statutes of limitations and choice-of-law rules in New Jersey.  Until yesterday.  That was when we read the New Jersey Supreme Court’s opinion in McCarrell v. Hoffmann-La Roche, Inc., No. 076524, 2017 WL 344449 (N.J. Jan. 24, 2017), which unhinged that state’s statute of limitations and choice-of-law jurisprudence from its own precedent and placed statutes of limitations in a special class without much explanation.  And the court did all of this for the stated purpose of preserving plaintiffs’ claims and not “discriminating” against an out-of-state plaintiff’s ability to sue a New Jersey company in New Jersey, after the suit would be barred in the plaintiff’s home state.

How did we get here? Well, this is a New Jersey Accutane case, which tells you that it was contentious, as most things seem to be in that multi-county proceeding.  Other than that, the facts in McCarrell are fairly typical—an out-of-state plaintiff (in this case a fellow from Alabama) who was prescribed a drug in his home state, used the drug in his home state, experienced alleged complications in his home state, and received medical treatment in his home state sued the drug’s manufacturer where the company is incorporated—in this case, New Jersey. McCarrell, at *3.

The rub in McCarrell was that the plaintiff’s claim was time barred under Alabama’s statute of limitations, but not under New Jersey’s statute of limitations, which includes a discovery rule.  The choice of law therefore determined the outcome, which led the parties to contest the issue hotly in the trial court, the intermediate appellate court, and eventually the New Jersey Supreme Court.

Each court applied different rules, which is why this case is so interesting and why the Supreme Court’s opinion is so odd. We have long understood that the choice of forum does not determine the applicable substantive law.  Sure, the forum’s procedural law applies, but the substantive law is determined by applying the forum state’s choice-of-law rules.

Continue Reading New Jersey Supreme Court Turns Back The Clock on Statute of Limitations

We posted earlier about the Appellate Division’s 113-page whopper reversing a plaintiff’s Accutane verdict in McCarrell v. Hoffman-La Roche, Inc., 2009 WL 614484 (N.J. Super. A.D. March 12, 2009).  Well, more than a year later, a second Accutane verdict meets the same fate.  Here’s a copy of the opinion, Kendall v. Hoffman-La Roche, Inc., slip op. (N.J. Super. A.D. August 5, 2010).  But most of the grounds are the same as McCarrell.

One ground that isn’t, though, is the court’s holding that the trial court did not err in holding that the discovery rule tolled statute of limitations.  Slip op. 40-61 – that’s right, 21 pages to affirm a statute of limitations denial.  We don’t like that ruling because it tells drug companies “you’re damned if you do and damned if you don’t.”  The court essentially ruled that, due to the defendant’s adequate and extensive warnings about other risks (birth defects and suicide), the plaintiff could evoke the discovery rule by saying she was distracted by those warnings from another warning about a less well-established risk (inflammatory bowel disease) that she suffered:

We agree with the trial judge that the written warnings that plaintiff received in the latter part of 2003 predominantly focused upon pregnancy, and to a lesser degree, upon suicide risks.  The materials alluded to abdominal and bowel problems in a far less conspicuous or pointed manner.  Defendant’s reliance on the two consent forms signed by plaintiff is substantially undercut by the fact that neither of those forms says a word about abdominal or bowel symptoms.

Slip op. at 58-59 (emphasis added).

To us, it’s absurd and counterproductive in terms of product safety to punish a defendant’s adequate warnings, by using them to invoke the discovery rule to toll the statute of limitations for other injuries that were warned about, simply because the other warnings weren’t as “conspicuous” because the risk was less well established – and we’d have to say, less serious.  The court seems to be saying that IBD (which isn’t fatal, and is usually treatable) should have carried as prominent a warning as birth defects and suicide.

That’s (to be polite) wrongheaded.

This ruling in Kendall is simply an invitation to dilute adequate warnings about severe risks with other warnings about less severe and (in many cases) less clearly established risks.  We hope that the New Jersey Supreme Court cleans up the mess that the lower courts seem determined to create.

Bloomberg News reported this moments ago:

“Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.”

Here’s our take: The cause of inflammatory bowel disease is unknown. There’s essentially no scientific evidence linking Accutane to that condition. (Here’s a link to our post from a couple of years ago reporting on the MDL judge’s rejection of plaintiffs’ general causation evidence supposedly linking Accutane to IBD.) Despite the absence of scientific evidence, juries have repeatedly awarded millions of dollars to folks who developed IBD after taking Accutane. (Here’s a link to one example.) So Roche Holding is now giving up the ship.

If you ever need another example of the cost of litigation driving a beneficial drug off the market, add Accutane to your list.

UPDATE:  A reader has also advised us that Accutane faces generic competition, which folks thinking about this situation should consider.

We’ve had a couple of complaints that it’s hard to locate on this blog old posts that contain information of interest. (One of those complaints was Beck complaining to Herrmann; the other was Herrmann complaining to Beck.)

To make things easier, here’s an index of all of our posts to date, with hyperlinks to the indexed materials:

Scorecard: Non-Manufacturer, Name-Brand Defendants in Generic Drug Cases (11/12/09)

Actimmune Suit Gutted (11/11/09)

More MDL Panel Empirics (11/10/09)

A Safe Harbor In Arkansas (11/09/09)

Conte’s First Anniversary (11/09/09)

On Punitive Damages (11/05/09)

Erichson On “All-Or-Nothing” Settlements (11/05/09)

Poison Pill In Healthcare Bill (11/03/09)

Cleaning Up The Accutane MDL IBD Cases (11/03/09)

Three Things Around The Web (11/02/09)

More On Mousepads (11/02/09)

Shook Hardy’s Asleep At The Wheel (11/02/09)

Friday Frivolity (10/30/09)

Two Items On The Web Worth Reading (10/30/09)

Three At Last, Three At Last! (10/30/09)

Sprint Fidelis – It’s Not Just Preemption (10/29/09

Witnesses At Today’s Iqbal/Twombly Hearing (10/27/09)

Accutane Plaintiff’s Verdict Reversed (10/27/09)

The NuvaRing Master Complaint Vanishes (10/27/09)

Why Drug Companies Should Beware Of Doing Business In West Virginia (10/26/09)

Sprint Fidelis – Strike Two (State Court Dismissal) (10/23/09)

House Judiciary Hearing On Iqbal (10/23/09)

Discount for MDL/Mini-MDL Webinar (10/23/09)

Latest On Twombly/Iqbal (10/22/09)

Questionable Plaintiff Tactics Hammered In Florida (10/22/09)

An Appellate No-No (10/21/09)

Massachusetts Sort Of Recognizes Medical Monitoring (10/20/09)

Nibble & Kuhn, Attorneys At Law (10/20/09)

Wrighting A Wrong (10/19/09)

Alabama Supreme Court Rejects Medicaid Pricing Claims (10/16/09)

Cy Pres? No Way! (10/15/09)

Interesting U.S. Supreme Court Dictum (10/14/09)

Sorting Through The Free Speech Challenges To The FDA (10/13/09)

Vaccine Preemption Update: Grant Of Cert Likely (10/12/09)

The Twombly Of Scholarship (10/12/09)

Off-Label Promotion – Scratch One Flat Suit (10/09/09)

Off-Label Use – The Times They Are A Changin’ (10/08/09)

Correction To Guest Post “Counting To Seven” (10/07/09)

Third Circuit Speaks On When An MDL Court Can Be Second-Guessed After Remand (10/07/09)

Yeah, Yeah – We Know (10/07/09)

Why Subverting Court Orders Is A Bad Idea (10/06/09)

Counting To Seven: New Federal Rules Change How Due Dates In Litigation Are Calculated (10/05/09)

Allergan’s Free Speech Attack On FDA Regulations (10/03/09)

Okay – Everybody Update Your Briefs (10/02/09)

Removal Round Up (10/01/09)

Another Third-Party Payor Class Action Bites The Dust (10/01/09)

TortsProf Mondays (9/30/09)

A Detour To Pottawattamie County, Iowa (9/29/09)

Muddled Testimony Precludes Class Action (9/29/09)

More On Moving To Dismiss MDL Master Complaints (9/28/09)

Upcoming Speaking Engagements (9/25/09)

Total Recall (9/24/09)

New Article On Free Speech And FDA “Intended Use” Regulations (9/23/09)

1000 Posts! (9/22/09)

Odd Evidentiary Ruling In Philadelphia Paxil Trial (9/21/09)

Recent Scholarship Roundup (9/21/09)

Get 40% Off – Bexis’ Book On Drug/Device Product Liability (9/18/09)

NYT On Accusations Of Ghostwriting (9/18/09)

Limits To Duty (9/17/09)

Better Late Than Never? (9/16/09)

Something Old, Something New: Recent Trials (9/16/09)

Maybe Baying At The Moon Helps (Part II) (9/15/09)

An Odd Device Preemption Tangent (9/15/09)

A Half Pint, After All (Kovach v. Caligor Midwest) (9/14/09)

The “Bisphenol A” Provision Of The Food Safety Enhancement Act of 2009 (9/14/09)

Bexis’ In Box (2009 Edition)

Discount For ACI Drug And Medical Device Conference in NYC (9/10/09)

Guidance On MDL Choice Of Law (9/08/09)

A Rat In The House . . . (Foolish Friday II) (9/04/09)

Today’s Minnesota Supreme Court Decision In Fleeger — Minnesota Is Still The Ellis Island For Old, Tired Products Liability Suits. . . But Not Forever (9/03/09)

Embedded Fraud On The FDA (9/03/09)

Fleeger Will Be Handed Down On Thursday (9/01/09)

Empirics About MDL Panel Decision-Making (9/01/09)

Pre-Service Removal, Yet Again (8/31/09)

Hot Off The Presses – Statute Of Repose Defense Win In Fen-Phen Appeal (8/28/09)

Wordless As The Flight Of Birds (8/28/09)

A Rat In The House. . . (Foolish Friday) (8/28/09)

Bausch & Lomb MoistureLoc MDL Daubert Ruling (8/27/09)

Rule 11 Discovery Allowed In Digitek MDL (8/27/09)

From Zyprexa To Aredia – Summary Judgment And Case Selection (8/27/09)

Health Care (And Tort) Reform (8/26/09)

Reaction To “The Life Expectancy Of A Legal Blog” (8/26/09)

Treating Physicians As Experts (8/25/09)

A RECAP Recap (9/24/09)

The Life Expectancy Of A Legal Blog (8/24/09)

Viagra Causation Goes Limp (8/21/09)

Reconsidering The Master Complaint (8/20/09)

Off-Label Promotion Criminal Trial Begins (8/20/09)

“Litigation Hold” Blog (8/19/09)

Another Scholarship Round-Up (8/18/09)

PACER Has Been Hacked (8/17/09)

Moving To Dismiss MDL Master Complaints (8/17/09)

FDA’s CDER Handbook – Undergoing Revision (8/14/09)

Twombly/Iqbal Requires Identifying Allegedly Violated Statute (8/14/09)

Jersey Barrier Still Stands (8/14/09)

Defense Briefs Filed In Pennsylvania Contingency Prosecution Case (8/13/09)

New Stuff Filed Under “A” (Accutane and Acetabular Hip) (8/12/09)

Epstein On Preemption In Forbes (8/11/09)

D. Utah Goes 1-1-1 (Lake-Allen v. J&J) (8/11/09)

New News On Iqbal (8/10/09)

Scientific Articles As First Amendment Protected Speech (8/07/09)

MDL Panel’s “Guide for MDL Transferee Judges” (8/07/09)

FJC On MDL (8/07/09)

Twombly/Iqbal And Product Liability, How Much Progress Is There? (8/06/09)

Preemption In The Washington Post (8/06/09)

Read The Blog, Luke! (8/04/09)

Preemption in the In Box (8/03/09)

Iqbal Saves Some Dough (8/03/09)

Compounding, Repackaging, or Manufacturing? (7/31/09)

Riegel At 1 1/2: What Do We Know Now About Parallel Violation Claims? (7/30/09)

Does Neurontin Make You Scratch Your Head? (7/30/09)

Beck and Herrmann: Settlement Gurus! (7/28/09)

Removal Based On Misjoinder Of A Treating Physician (7/27/09)

Rimbert – What Goes Around, Comes Around (7/25/09)

Friday Frivolity – Are We All Excommunicated? (7/24/09)

Iqbal And Rule 8: Will Congress Turn Back The Clock? (7/23/09)

Vague Pleading Barred Under Iqbal And/Or Twombly? (7/23/09)

New York Times On Iqbal (7/21/09)

A Trot Through Some Recent Scholarship (7/21/09)

Seroquel Expert Non-Causation Order (7/20/09)

Dr. Strangelove Redux (7/20/09)

Going Our Way? Class Actions, Punitive Damages & Due Process (7/17/09)

Contact Lens Solution – Frye Exclusion (7/16/09)

Wisconsin High Court – Inherent Chemical Characteristics Can’t Be Design Defects (7/15/09)

Fraudulent Joinder Of Sales Representatives (7/14/09)

Yet Another Off-Label Promotion Class Action Dismissed (7/14/09)

Disqualifying An Opposing Expert (7/13/09)

ADE Reports: Redaction Required (7/10/09)

Taking Stock (7/09/09)

Blogging About Blogging (7/08/09)

What’s Up With Colacicco? (7/07/09)

Daubert Gives Plaintiffs A Pain In The Pump (7/07/09)

More On Big Firm Blogging (7/06/09)

Whither The Heeding Presumption? (7/02/09)

Device Preemption Win In Louisiana (7/02/09)

An Avandia Removal Spat (6/30/09)

Another Severance Of Med Mal Claims To Preserve Diversity As To Products Defendants (6/29/09)

Wham, Bam; Thank You, Kamm! (6/29/09)

WSJ On Twombly And Iqbal (6/27/09)

Cost Of Litigation Drives Accutane Off The Market (6/26/09)

Scratch Three More Zyprexa Plaintiffs (6/26/09)

Some Thoughts On Pleading And Proving FDA Actions (6/25/09)

Strike Three; You’re Out! (6/25/09)

The State Of The Big Firm Blogosphere (6/24/09)

Going After Anyone In The Neighborhood (Adelmann-Chester v. Kent) (6/23/09)

Daubert In A Med Mal Context (6/22/09)

Addendum To Yesterday’s Off-Label Use Post (6/19/09)

Our Latest Rant On Off Label Promotion (6/18/09)

Pennsylvania News Flash: Bugosh Appeal Dismissed (6/17/09)

The Volokh Conspiracy On Our Ethics Question (6/16/09)

Calling For The Views Of The Solicitor General (6/16/09)

Taking A Run At Things (6/16/09)

Blast From The Past – A Baycol Affirmance (6/15/09)

Physician Confusion: Do Physicians “Sell” Prescription Drugs? (6/15/09)

An Accutane Appellate Win (6/11/09)

The Learned Intermediary Rule And Expert Witnesses (6/11/09)

Sharkey On “Agency-Forcing” Measures (6/09/09)

Free Webcast On Comparative Effectiveness (6/09/09)

Supreme Court Tantalizes On Vaccine Preemption (6/08/09)

On Weinstein’s Reflections On Administering Complex Litigation (6/08/09)

More Boring Stuff We Need To Know (6/05/09)

Liberal/Conservative Supreme Court Graphic (6/05/09)

More On Pleading In The Wake Of Twombly And Iqbal (6/04/09)

MoistureLoc Daubert Hearing (6/03/09)

Weinstein Grants Two Motions For Summary Judgment In Zyprexa (6/02/09)

The Reviewability Of Remand Orders (6/02/09)

Severing Med Mal Claims To Perfect Federal Jurisdiction (6/01/09)

Welcome, New Readers From Academia! (5/29/09)

Tort Reform In Oklahoma And Ysbrand (5/29/09)

In Praise Of “Short And Plain” Pleadings After Twombly And Iqbal (5/28/09)

A Suggestion For Medical Malpractice Insurers (5/27/09)

On Iqbal and Twombly (5/26/09)

Defendants Aren’t Plaintiffs’ Bagmen (5/22/09)

ALI’s Principles Of The Law Of Aggregate Litigation Now Final – Sort Of (5/21/09)

Administration Takes Preemptive Action (5/21/09)

Preemption Conference in Philadelphia June 3, 2009 (5/19/09)

Off-Label Promotion And RICO (Actimmune) (5/19/09)

On Ex Parte Blogging (5/18/09)

Update On NY Learned Intermediary Bill (5/15/09)

Neurontin Class Certification Denied – Again (5/15/09)

Sprint Fidelis FOIA Spat (5/15/09)

A Device Preemption Quickie — Heisner v. Genzyme (5/14/09)

Weinstein Grants Daubert Motion in Zyprexa MDL (5/13/09)

Hearings On The Medical Device Safety Act of 2009 (5/13/09)

Finalizing ALI’s Principles Of The Law Of Aggregate Litigation (5/12/09)

Pre-Service Removals: They Keep On Coming (5/11/09)

Vioxx Class Action Goes Down to Defeat in California (5/09/09)

Product Liability-Related Medicare Secondary Payor Reporting Delayed (5/08/09)

Strike Suit Strikes Out (5/08/09)

Differential Diagnosis – Sometimes Best Isn’t So Good (5/07/09)

Device Preemption Win In Connecticut (5/07/09)

Pennsylvania Employee Benefit v. Zeneca Remanded to District Court (5/05/09)

Sole Proximate Cause Clarity (5/05/09)

The Personal Genome (5/04/09)

Boring Stuff We Need To Know (4/30/09)

Colacicco Decision On Remand! (4/28/09)

Solicitor General’s Letter In Colacicco On Remand (4/28/09)

REMS Preemption (4/28/09)

On Lexecon Waivers (4/27/09)

Change Coming To Pennsylvania? (4/22/09)

Suing Business Entrepreneurs For Fraudulently Inducing Medical Treatment (4/21/09)

Off-Label Use And Medical Malpractice (4/20/09)

From 510(k) To PMA (4/20/09)

Words We Never Thought We’d Write: “Must Watch YouTube” (4/18/09)

Preemption 2.0 – 2.0 (4/17/09)

Preemption 2.0 (4/17/09)

Medical Monitoring – Another 50-State Survey (4/15/09)

On The “Custom Device” Exemption (4/14/09)

Don’t Mess With Bexis! (4/13/09)

NYU Preemption Symposium Available Online (4/13/09)

Non-Prescribed Plaintiffs, In Pari Delicto, And Duty (4/09/09)

The Web On Wyeth v. Levine (4/07/09)

FAS 5 Update: Report On FASB Roundtable (4/07/09)

Another Levine Client Alert (4/06/09)

Civilization Comes To Canada! (Merck v. Wuttunee) (4/06/09)

Protection Of Customer Lists in Discovery (4/02/09)

Ebel – Affirmed (3/31/09)

Another Look At Some Recent Scholarship (3/31/09)

Tuna That Tastes Good: Tri-Union Seafoods (3/30/09)

Vaccine Act Preemption Affirmed in Bruesewitz (3/27/09)

“Fun” Friday: Academic Earth (3/27/09)

New Drug/Vaccine Preemption Scorecard (3/26/09)

Colacicco Briefing Slightly Postponed (3/25/09)

Calabresi On Preemption (3/24/09)

Colacicco Update – Briefs due 4/1 (3/23/09)

Riegel Redux: Delaney v. Stryker Finds PMA Preemption (3/23/09)

Preemption Still Be-Longs After Levine (3/22/09)

The State-Of-The Art Defense In Drug/Device Cases After Levine (3/20/09)

NJ Vioxx Class Certification Denial (3/18/09)

Class Action Articles Posted To SSRN (3/18/09)

Generic Drugs Meet Levine (3/17/09)

A Riegel Wrinkle: “Adjunct Clinical Trial” Preemption (3/17/09)

Your Humble Scribes On Levine In BNA Product Safety Reporter (3/16/09)

Accutane: McCarrell Remanded For New Trial (3/13/09)

How The Chief Resolved The Recusal Issue (3/13/09)

Everyone’s Talking About Levine (3/13/09)

Device Preemption Bookends (3/12/09)

Updates: Sprint Fidelis and Seroquel MDLs (3/12/09)

Herrmann on Levine in Chicago Tribune (3/12/09)

Reaction to Wyeth v. Levine (3/10/09)

Colacicco and Pennsylvania Employees Benefit Trust Fund GVR’ed (3/9/09)

Should Congress Distinguish Between Drugs and Devices? (3/9/09)

Dechert Client Alert on Wyeth v. Levine (3/6/09)

Medical Device Safety Act of 2009 (3/5/09)

Wyeth v. Levine and the End of Deregulation (3/5/09)

Not Just Colacicco (3/5/09)

Press Coverage of Levine (3/5/09)

Colacicco Set For Friday, March 6, Conference (3/4/09)

Wyeth v. Levine – First Real Thoughts (3/4/09)

Wyeth v. Levine Decided – No Preemption (3/4/09)

Unrefundable (3/3/09)

Pre-Service Removal — For The Umpteenth Time (3/3/09)

Product Liability Comes To Thailand – Drug/Device Implications (3/2/09)

Abdullah v. Pfizer and the Alien Tort Statute (3/2/09)

Subpoenaing the Enablers (2/27/09)

Class Actions and Punitive Damages – Unconstitutional Together (2/26/09)

Welcome, Lawyers Weekly Readers! (2/26/09)

Following Up On Our Conte Thought Experiment (2/25/09)

Trans-substantivism (2/24/09)

Discount For FDA Bootcamp (2/24/09)

A Thought Experiment On Conte v. Wyeth (2/23/09)

Medical Monitoring In The Air – The Guinan Parody (2/20/09)

Generic Drug Preemption – Reconsideration Denied in Morris (2/20/09)

FAS 5 Update: Roundtable Meeting On March 6 (2/19/09)

Upcoming Events Featuring . . . Us! (2/19/09)

Supplemental PMA = Preemption (2/18/09)

Appeal Allowed in De Bouse v. Bayer (2/17/09)

Good News On The Class Action Front (2/16/09)

We Finally Show Mixed Emotions: Banning DTC Ads For Two Years (2/16/09)

Recusal Follies (2/13/09)

Defeating FDCA-Based Negligence Per Se On State-Law Grounds (2/12/09)

Special Masters Reject Autism-Vaccine Link (2/12/09)

Giles, An SSRI-Suicide Defense Verdict, Affirmed (2/12/09)

Hither And Yon (2/11/09)

Waiting For Levine (2/10/09)

He Likes It — We Think (2/10/09)

The Second Shoe Drops In Seroquel (2/09/09)

Bert Rein On The Politics Of Preemption (2/09/09)

Wyeth Letter To Supreme Court Re Pfizer Acquisition (2/06/09)

The New Voice In The Blogosphere (2/06/09)

No Injury Consumer Fraud Claims (2/05/09)

One Two Medical Device Punch (2/04/09)

Seroquel MDL Summary Judgment Order (2/03/09)

Seroquel MDL: Motions In Limine Granted (2/03/09)

Refunds And Ascertainable Loss (2/03/09)

The Procedural Effect of MDL Master Complaints (2/02/09)

Government By Contingent Fee In Pennsylvania (1/29/09)

Defense Wins Summary Judgment In First Seroquel Test Cases (1/29/09)

A Grace Note To Beisner And Miller (1/28/09)

The Ethics Of Genetic Research (1/27/09)

Ideas For Voir Dire (1/26/09)

Closing The Arguments On Conte (1/22/09)

Conte v. Wyeth: Review Denied (1/21/09)

Using The Internet To Improve Class Actions (1/21/09)

Welcome to the Blogosphere, Russell Jackson! (1/21/09)

How Much Should Judges Make? (1/20/09)

Wait! Blogging Works! (1/20/09)

The Role Of Inside Counsel In Deposition Preparation (1/19/09)

Second Circuit Agrees To Review Weinstein’s Zyprexa Class Certification (1/16/09)

A Push Away From 510(k)? (1/16/09)

To Cert. Or Not To Cert. (1/16/09)

Thoughts On The New FDA Guidance On Off-Label Information (1/15/09)

A Quick Apology (1/15/09)

Welcome, . . . Blogosphere! (1/14/09)

Guest Post – In Defense Of Preemption & FDA Regulatory Authority (1/13/09)

The New Meaning of “Global Coordinating Counsel” (1/13/09)

S. Ct. Order List (1/12/09)

Blogging As A Business Development Tool (1/12/09)

What’s Not Up With Off-Label Use Economic Loss Claims (1/08/09)

Lanier on Torts at Harvard (1/07/09)

Pseudoephedrine Nuisance Claims Rejected (1/06/09)

Judicial Wisdom (1/06/09)

Sprint Fidelis Preemption Decision – Yessssss (1/06/09)

Oy, Canada! (1/05/09)

Happy New Year on the Class Action Front (12/31/08)

Top Ten Best And Worst Prescription Drug/Medical Device Decisions of 2008 – The Best (12/30/08)

Regulatory Preemption – Class II Devices and Special Controls (12/29/08)

Polar Bears Nudge The MDL Panel In A Helpful Direction (12/29/08)

Supreme Court Conference 1/9/09 (12/23/08)

Off-Label Promotion MDL Dismissed Under FDCA (12/23/08)

Top Ten Best And Worst Prescription Drug/Medical Device Decisions of 2008 – The Worst (12/23/08)

A Gripe With A Piece of Scientific Literature (12/22/08)

Preemption and Investigational Devices After Riegel (12/19/08)

Bong Water Blues (12/19/08)

Informal Physician Interviews – Where It’s Kosher; Where It’s Not (12/18/08)

Gunvalson v. PTC Therapeutics: Injunction Reversed (12/16/08)

New York, New York (Reprise) (12/16/08)

Amending FAS 5 — An Update (12/16/08)

Blog Honors (12/16/08)

On Communicating By E-Mail (12/16/08)

What Does Good Say For Levine? (12/15/08)

Altria v. Good Decided (12/15/08)

A Look At Some Recent Scholarship (12/15/08)

DoJ/FDA Take Positions On Section 337(a), “Parallel” Requirements Litigation (12/11/08)

Implied Attorney-Client Privilege Waivers: Hearn Gets Burned (12/09/08)

Avoiding Mass Torts: Pre-Litigation Counseling (12/08/08)

Irrelevance of Pending Legislation (12/05/08)

Umm . . . What He Said (12/04/08)

Defendants Oppose Certiorari in Colacicco (12/03/08)

Gunvalson v. PTC Argument Date (12/03/08)

Another Milestone: 150 Countries! (12/03/08)

DRI Drug/Device Webinar (12/02/08)

The Biomaterials Access Assurance Act of 1998 (12/02/08)

We’re In The ABA Journal Blawg 100! (12/01/08)

Not Quite Buckman Preemption (Devore v. Pfizer) (12/01/08)

Happy Preemption Thanksgiving (11/27/08)

Preemption Without A Prescription (11/25/08)

Tennessee Rejects Consumer Fraud Class Actions (Walker v. Sunrise Pontiac) (11/24/08)

How To Prepare Motions In Limine (11/20/08)

Richard Epstein In Forbes On Wyeth v. Levine (11/18/08)

Using Biomarkers To Foment, Or Resolve, Litigation (11/18/08)

Another Buckman Preemption Case (Grange v. Mylan) (11/17/08)

More On E-Discovery For Defendants (11/14/08)

Pardon Our Appearance. . . . (11/14/08)

More Thoughts On Conte v. Wyeth (11/13/08)

Hats Off To “Above The Law” (11/13/08)

Three News Items For Our Friends (11/12/08)

We’re On Twitter! (11/12/08)

Michael Hausfeld “Expelled” From Cohen Milstein (11/11/08)

A Class Action Settlement Rant (TJX Security Breach Litigation) (11/11/08)

If Not Reliance, Then Remoteness (11/10/08)

He Who Fights And Runs Away . . . (11/10/08)

Generic Drug – Pioneer Liability (11/07/08)

It’s Better To Be Lucky Than Good (11/07/08)

Our Own Analysis Of The Wyeth v. Levine Oral Argument (11/06/08)

Reading Tea Leaves: Obama’s Appointments At FDA (11/06/08)

Addendum To Report From The Field On Levine Argument (11/05/08)

Welcome, California Lawyer Readers! (11/05/08)

Press Coverage Of The Levine Argument (11/04/08)

A Curmudgeonly Interview (11/04/08)

Transcript Of Levine Argument (11/03/08)

Other Reports On The Levine Argument (11/03/08)

Wyeth v. Levine: Our Reporter From The Field (11/03/08)

The Levine Argument: More Early Returns (11/03/08)

Wyeth v. Levine Argument – Early Returns (11/03/08)

Welcome To The Blogosphere, DRI! (11/03/08)

Carve Your On-Line Pumpkin (10/31/08)

Wyeth Letter To Supreme Court re Waxman Report (10/31/08)

Our Kingdom For A Post (On The Levine Argument) (10/31/08)

Interlocutory Appeal Granted In Knipe (10/31/08)

A Halloween Special: Bodysnatchers! And Jujyfruits! (10/31/08)

Cong. Waxman Positions For The Levine Argument (10/30/08)

Our Terrible Twos! (10/30/08)

Everything You Need To Know About Wyeth v. Levine, From A Defense Perspective (10/29/08)

Welcome, ABA Journal Readers! (10/28/08)

Learned Intermediary Doctrine In Puerto Rico (10/28/08)

Does Tort Litigation Improve Drug Safety? (10/27/08)

Federal Circuit Upholds “Reverse Payment” Patent Settlements (10/24/08)

An ER Doc’s Take On Preemption (10/24/08)

Interesting New PMA Device Preemption Case (10/24/08)

Partial SJ In One Of The “Bodysnatcher” Cases (10/23/08)

Sleeper Case, Sleeper Issue (10/23/08)

Kotler’s Alternative To Standard Preemption Analysis (10/23/08)

National Politics And Product Liability Settlements (10/22/08)

Obama Wins! (10/21/08)

Preemption In The Context Of Off-Label Uses (10/20/08)

Nailing Jell-O To A Wall (10/17/08)

Baron Receives Tysabri (10/17/08)

Bextra and Celebrex Cases Settled (10/17/08)

Fred Baron and Compassionate Use (10/16/08)

Off-Label Use – Yet Again (10/15/08)

The End Of Securities Fraud Class Actions, Part II (10/15/08)

A Final MDL Timing Issue (10/15/08)

Friend Of The Court Briefs in Gunvalson v. PTC (10/14/08)

Cert. Granted in McDarby (10/13/08)

The Brokers With Hands On Their Faces Blog (10/13/08)

Troy and Wood on Preemption (10/13/08)

Preemption Smackdown in DC – 10/29/08 (10/10/08)

Principles Of Aggravated. . . Er. . .Aggregated Litigation (10/09/08)

Updates (10/08/08)

Sebok & Zipursky on Preemption, Part II (10/08/08)

Colacicco Cert Petition Filed (10/08/08)

Welcome, ReachMD Listeners (10/08/08)

Salmon Swim To The Solicitor General (10/07/08)

Genetic Damage As Compensable Injury (10/07/08)

In The Deserts Of New Mexico (10/06/08)

Why You Need To Bookmark Point of Law (10/03/08)

Learned Intermediary Rule 201 (10/02/08)

Another Off-Topic Post: En Banc Permitted in Ohio (10/02/08)

The End Of Securities Fraud Class Actions? (10/02/08)

The Vioxx ADVANTAGE Trial (10/01/08)

A Note On Ackermann v. Wyeth, Learned Intermediaries, and the Heeding Presumption (9/30/08)

Interesting Stuff On The Web (9/29/08)

Living On The Point Of The Spear (9/25/08)

More On New FRE 502 (9/25/08)

Gunvalson v. PTC Update (9/24/08)

Sebok on Wyeth v. Levine (9/24/08)

We’re Depressed: Johnson v. GlaxoSmithKline (9/24/08)

New Federal Rule of Evidence 502 – A Modest Improvement? (9/23/08)

A Multidistrict Litigation Compendium (9/22/08)

Defense Amici – One Stop Shopping (9/18/08)

Defense Reply Brief in Levine (9/16/08)

We’re Duty-Bound To Post (Pre-Service Removal) (9/16/08)

We’re Not Heartless, Jeremy! (9/15/08)

Is The FDA Really So Weak? (9/15/08)

Holding The Line On The Duty To Warn (9/11/08)

To Arms! (9/11/08)

Okay, We’ll Play: 5 Blogs and 5 Blawgers. (9/10/08)

More Upcoming Talks (9/10/08)

How Long Does the MDL Process Take? (9/09/08)

Exciting Drug and Device TV (9/08/08)

Potential Uses of Genetic Evidence to Prove Causation and Exposure in Toxic Tort Litigation (9/08/08)

Zyprexa Third Party Payor Class Certified (9/05/08)

Preemption And Guerilla Warfare (9/04/08)

We Never Get Bored: More On Pre-Service Removals (9/03/08)

The Multidistrict Litigation Process (9/02/08)

Friday Fun (8/29/08)

Manufacturer Ordered To Provide Experimental Drug (8/28/08)

Accutane Affirmed (8/27/08)

Issue Preclusion in Mass Torts (8/27/08)

Brickman on “Litigation Screenings in Mass Torts” (8/27/08)

Exploring The New CBE Rule (8/25/08)

The New CBE Rule Is Final (8/22/08)

“The Case For Field Preemption of State Laws in Drug Cases” (8/22/08)

(New) Medical Device Preemption Scorecard (8/21/08)

Chicken Of The Sea is Sunk (8/20/08)

Random Thoughts on Randomness (8/20/08)

The MDL Panel Plays It By The Book In Denying Plaintiffs’ Motion To Centralize The Shoulder Pain Pump Litigation (8/19/08)

Accutane Appeal (8/19/08

Medtronic Defibrillator Preemption Win (8/18/08)

Yet More on Pre-Service Removals (8/18/08)

Consenting to Removal (8/18/08)

Tulane Law Review MDL Symposium Issue (8/16/08)

Even More Flattered! (8/16/08)

We’re So Flattered! (But We Flatter Easily) (8/15/08)

Our Other Recreational Writing (8/15/08)

Riegel At (Almost) Six Months (8/14/08)

Today’s WSJ on Wyeth v. Levine (8/13/08)

After Twenty Years (8/13/08)

Thoughts About The Massachusetts Marketing Law (8/13/08)

The Other Shoe Drops (8/12/08)

Pining For Lone Pine (8/11/08)

The Effect of the Proposed Amendment to FAS 5 on Mass Torts (8/08/08)

Cross-Jurisdictional Class Action Tolling Scorecard (8/07/08)

A News Roundup (8/07/08)

Put Our Service To The Test (8/07/08)

Will Congress Overrule Riegel? (8/06/08)

Why You Should Always Plead And Prove Preemption (8/6/08)

Medical Monitoring Limited in Missouri (8/05/08)

Lone Pine Order in Celebrex MDL (8/05/08)

Welcome To The Blogosphere, Reed Smith! (8/05/08)

Stop Us If You’ve Heard This Story Before (More On Pre-Service Removals) (8/04/08)

PMA Preemption Reaches Negligent Training Claims (8/01/08)

Tuckered Out (7/31/08)

Is That A Half Pint Or A Half Gallon? (7/30/08)

A Public Service Announcement (7/29/08)

A Texas 82.007 Preemption Win (7/29/08)

Colacicco Update (7/29/08)

Levine Oral Argument (7/28/08)

Mirapex Bellwether Trials Begin (7/28/08)

Do Bad Things Come In Threes? (Masquat v. DaimlerChrysler) (7/28/08)

New PhRMA Voluntary Guidelines – Will No Good Deed Go Unpunished? (7/24/08)

Review Granted in County of Santa Clara v. Superior Court (Atlantic Richfield Co.) (7/24/08)

Nice Daubert Ruling Out Of The E.D. Pa. (7/23/08)

Levine Briefing Schedule (7/22/08)

Sharkey’s “Colloquy” On Riegel Online At Northwestern (7/21/08)

Riegel Toothpaste (Adkins v. Cytyc) (7/21/08)

Ideas, Random Thoughts and Musings from ACI Preemption Conference (7/17/08)

Reverse Parlay (7/17/08)

Extra! Extra! Read all about it! (7/16/08)

What Are The Drug And Device Mass Torts? (7/16/08)

Are You “Less Protected” When Using An Overseas Litigation Vendor? (7/15/08)

The First of Many: A “Parallel Requirements” Case (7/14/08)

We Can’t Resist: McCain Can’t Be President? (7/11/08)

Welcome Good News On The HRT Front (7/11/08)

An Update On Epilepsy And Suicidality (7/11/08)

We’re Off To Philadelphia (7/11/08)

Headcount II: The Learned Intermediary Rule And Medical Devices (7/10/08)

HRT Punitive Damages Reversed – S. Parisian Testimony Inadmissible (7/09/08)

No, Bu shi, Non, lie, Nada, Nyet. . . . (7/09/08)

A Bridge To Zyprexa (7/09/08)

Shocking Ruling From The Seventh Circuit: “Less” Doesn’t Mean “More” (7/08/08)

We’re The Pennsylvania Star! (7/07/08)

FDA Proposes Black Box Suicidality Warning On Epilepsy Drugs (7/07/08)

Affirmative Defenses In Pharmaceutical Product Liability Cases (7/07/08)

No Injury Scorecard (7/03/08)

NEJM Editorial on Preemption (7/03/08)

Strike Two? (7/02/08)

4th OF JULY FIREWORKS – Big Defense Win in RI Lead Paint Nuisance Case (7/01/08)

Rhode Island Lead Paint Decision (7/01/08)

An Arkansan Atrocity (General Motors v. Bryant) (7/01/08)

Expert Opinions on Legal Issues Excluded (6/30/08)

Guest Post – Using Twombly To Fight Fraudulent Joinder (6/27/08)

More Thoughts About “Parallel” Requirements Claims and Preemption (6/26/08)

Exxon Valdez Punitive Damages Award Vacated by Supreme Court (6/25/08)

More On Taxation of Confidentiality Agreements (6/25/08)

What Do You Know? Many 9/11 Workers Not Sick (6/25/08)

Taxation of Confidentiality Provisions (6/25/08)

Dog Bites Man in Connecticut (Breen v Synthes) (6/24/08)

From The Mouth of Plaintiffs’ Counsel. . .(6/23/08)

Redish on qui tam (6/20/08)

Why Can’t We Be Friends? (Gaeta v. Perrigo Pharma) (6/15/08)

Of Pre-Service Removals, Yet Again (6/16/08)

Upcoming Panel on Legal Blogging (6/16/08)

Seen on. . . (6/16/08)

Will Technology Increasingly Favor Plaintiffs? (6/17/08)

Can We Type These Words? Generics Are On A Roll! (6/17/08)

A Helpful Decision on Protective Orders (6/18/08)

User’s Guide To Defense Amicus Briefs – Wyeth v. Levine, Part II (6/19/08)

Epilepsy drugs and suicidality (6/13/08)

Taylor v. Sturgell (on virtual representation) decided (6/13/08)

The ebb and flow of the law – New Jersey edition (6/13/08)

Scratching our heads about Ledbetter v. Merck (6/12/08)

Ledbetter v. Merck: Appeal dismissed (6/11/08)

Teamsters vs. plaintiffs’ lawyers re Vioxx (6/11/08)

Why Congress has left Lexecon alone (6/10/08)

Supreme Court news (6/9/08)

On the MDL Panel and transparency (6/9/08)

Users’ guide to defense amicus briefs – Wyeth v. Levine (6/5/08)

Government retention of contingent fee lawyers (6/5/08)

First thoughts on Sinclair v. Merck (6/4/08)

Vioxx – the hits keep on coming (6/4/08)

The Texas twins (Garza and Ernst) (6/3/08)

A reaction to McDarby (6/2/08)

A bad idea whose time has passed (5/30/08)

FDA proposed pregnancy/lactation rule discusses preemption (5/30/08)

First impressions of the defense position – Wyeth v. Levine (5/29/08)

More breaking Vioxx news – Ernst Vioxx verdict reversed (5/29/08)

Cona/McDarby – split Vioxx appellate decision (5/29/08)

Curmudgeon to Lawyer2Lawyer (5/28/08)

Small, but nice (5/28/08)

Wyeth’s Principal Brief in Levine filed (5/28/08)

A race in which we have no horse (5/27/08)

Reasonable degree of certainty – Pennsylvania stands firm (5/23/08)

Twombly comes to our neighborhood (5/22/08)

CAFA intrigue (Pew v. Cardarelli) (5/21/08)

The limits of MDL common benefit funds (5/19/08)

500 posts! (5/16/08)

Oh, to be known by the company you keep! (5/16/08)

Off-label use – is the FDA missing an opportunity? (5/15/08)

Coverage of yesterday’s preemption hearing (5/15/08)

Huge Texas Vioxx verdict reversed (5/14/08)

Video of today’s preemption hearing in Congress (5/14/08)

Congressional hearing on drug and device preemption (5/13/08)

The Pythagorean integrity of the law (5/13/08)

The profs have it! (5/12/08)

AEI program on off-label use (5/9/08)

Warning causation – greatest hits (5/8/08)

So big and yet so small (5/7/08)

So little time, so much to blog! (Negrete v. Allianz) (5/6/08)

What’s new on Alltop? Us! (5/6/08)

Rehearing denied in Colacicco (5/5/08)

If I could put fish in a barrel (5/5/08)

Welcome Law.com readers! (5/2/08)

New decisions raise old issues (5/1/08)

Welcome American Lawyer readers! (5/1/08)

Common ground with the plaintiffs’ bar! (5/1/08)

He’s no Grippando, but . . . (4/30/08)

Learned intermediary bill in California (4/30/08)

MDL transfer after Section 1404 denial? (4/30/08)

A far cry from drugs and devices (4/29/08)

Slow boats from Europe (4/28/08)

Colacicco rehearing petition filed (4/24/08)

Ackermann: Affirmed on learned intermediary grounds (4/24/08)

CPSC preemption (Bic Pen v. Carter) (4/24/08)

A thought on standard of review (4/23/08)

Seidel subpoena (vaccine-autism blog) quashed (4/22/08)

Hear, hear, Public Citizen! (4/21/08)

The future is now (4/21/08)

Colacicco and judicial notice (4/17/08)

Taylor v. Sturgell and virtual representation (4/17/08)

Michigan Law Review book review issue (4/16/08)

The FJC’s latest report on CAFA – The trends continue (4/16/08)

Overseas class actions come of age (4/15/08)

We’re actually worth something to you! (4/15/08)

Rehearing granted in Despain (4/14/08)

St. Jude is heavenly (4/14/08)

Schwab affects pharma (4/12/08)

They write, but can they speak? (4/11/08)

Delving into Colacicco (4/10/08)

The composition of the Third Circuit (4/9/08)

Class cert reversed again in St. Jude Medical (4/9/08)

Easy cases make good law (4/9/08)

Preemption affirmed in Colacicco (4/8/08)

All the news that’s fit to link (4/6/08)

The unfairness of consolidated trials (4/4/08)

McLaughlin (Schwab) class action snuffed out (4/3/08)

The learned intermediary rule and warning causation (4/3/08)

A tactical thought about Clark (4/2/08)

“Anticipated Life” and the statute of repose (3/31/08)

Welcome . . . World! (3/30/08)

We like Sykes again (3/28/08)

Preemption wins again (3/27/08)

Adverse event reporting – by the numbers (3/27/08)

Alaska Zyprexa consumer litigation settles (3/26/08)

A few of our favorite posts (3/26/08)

Today’s news (3/25/08)

Damned if you do . . . (3/24/08)

North to the future? (3/21/08)

Preemption in Philadelphia (3/20/08)

Taxation by litigation – A dubious proposal to expand False Claims Act liability (3/19/08)

Unequal minds think alike (Sharkey’s model to understand preemption jurisprudence) (3/19/08)

A tea leaf for Levine (3/19/08)

Off-label promotion – an indictment (3/18/08)

Dukakis and Riegel (3/17/08)

Scruggs pleads guilty (3/14/08)

More on legal questions and FDA experts (3/14/08)

That didn’t take long (3/14/08)

Riegel and “parallel” state law duties (3/12/08)

A simple twist of fate (Despain v. Bradburn) (3/11/08)

Loopholes in Riegel (3/9/08)

We grow too soon old and too late schmart (3/7/08)

California scheming (3/6/08)

There oughta be a law (an odd implication of Kent) (3/5/08)

Back to the trial courts (Ebel v. Eli Lilly) (3/4/08)

Sometimes “big law” values blogs (3/3/08)

First thoughts about Kent (3/3/08)

Kent affirmed by 4-4 tie (3/3/08)

A securities law aside (Guidant and Pfizer 10b-5 dismissals) (3/3/08)

Counting noses (predicting Kent) (3/2/08)

The value of blogging: We figured it out! (3/2/08)

Why are blogs undervalued? (2/29/08)

Pennsylvania product liability developments (2/28/08)

More on excluding FDA experts (2/28/08)

Developments in off-label promotion and the First Amendment (2/28/08)

Finding us on the web (2/28/08)

FDA e-mail alerts (2/27/08)

New Levine briefing schedule (2/27/08)

Nuisance litigation (2/26/08)

Henry Kissinger and Riegel (2/26/08)

Warner-Lambert v. Kent – transcript of oral argument (2/25/08)

Oral argument in Warner-Lambert v. Kent (2/25/08)

More from N’awlins (event jurisdiction) (2/24/08)

Welcome New York Times readers (2/22/08)

Random thoughts on comments we’ve received about Riegel (2/22/08)

Intrepid correspondent wanted (2/28/08)

Now who’s quoting Reagan? (2/21/08)

Welcome, Bloomberg News readers! (2/21/08)

Much is given, much is expected (2/21/08)

Ginsberg’s Riegel dissent: A hidden win for drug preemption? (2/20/08)

Welcome, Wall Street Journal Health Blog readers! (2/20/08)

More on Riegel (2/20/08)

Riegel decided — a win for MDA preemption (2/20/08)

More from Tulane: Judge Jack on silicosis (2/19/08)

Federal jurisdiction over Attorney General cases (Zyprexa) (2/18/08)

A report from the Tulane MDL symposium (2/17/08)

Comment on e-discovery for defendants (2/15/08)

E-discovery for defendants (2/14/08)

The proposed ALI aggregate settlement rule (2/13/08)

In California, a four-letter word beginning with “F” (2/12/08)

More on aggregate litigation in the U.K. (2/12/08)

Neither drugs nor devices, happily (farm raised salmon) (2/11/08)

The Berenson Bears (2/11/08)

Class actions in Denmark (2/10/08)

The great suicide debate (suicidality in epilepsy trials) (2/10/08)

FDA takes strong stand against regulatory expert testimony (2/9/08)

Department of corrections (2/8/08)

Welcome, Philadelphia Inquirer readers! (2/7/08)

What happens if we win? – Violation claims (2/7/08)

It wasn’t Pepper’s fault! Berenson confirms (2/6/08)

Ouch! So that’s how the NYT found out! (2/5/08)

SSRI medication guides (2/4/08)

CAFA’s revolving door? (2/4/08)

Law firm blogging (2/4/08)

Contingent fee research (2/4/08)

YOUR FIRM LOGO HERE (2/1/08)

Levine to next term? (1/31/08)

Breaking news, just in (1/31/08)

Preemption, mass torts and representing our clients (1/31/08)

Fosamax as a mass tort (1/31/08)

Congratulations! You’re our 100,000th customer! (1/30/08)

The more things change, the more they remain the same (1/30/08)

A thought on jury questionnaires (1/29/08)

First U.K. class action recovery (1/29/08)

The same old story, part II (1/28/08)

Written juror questionnaires in civil cases (1/28/08)

We should go into fortune telling (1/26/08)

More Zyprexa settlements (1/25/08)

Stop us if you’ve heard this one before (1/25/08)

Political backlash to the new CBE regulation (1/25/08)

Levine – assessing the playing field (1/25/08)

Antitrust objection to Vioxx settlement (1/23/08)

“Comments” are now unrestricted and unmoderated (1/23/08)

Tulane Law Review MDL symposium (1/22/08)

Minnesota – still on the road to recovery (1/22/08)

Upcoming Curmudgeon book talks (1/22/08)

Take our third thesis — please! (1/21/08)

Collecting our thoughts on Wyeth v. Levine (1/18/08)

Levine cert. grant order (1/18/08)

FDA cubed it is (1/18/08)

One, two punch in California (1/18/08)

Forum non conveniens ruling in blood products (1/17/08)

Drug preemption victory in Dobbs (1/17/08)

Hello, Canada! (1/17/08)

Why fixing the FDA’s CBE (“Changes Being Effected”) regulation is a big deal (1/17/08)

FDA post-argument submission in Colacicco (1/15/08)

New FDA regulatory initiative would assist preemption (1/15/08)

Canadian medical monitoring (Peter v. Medtronic) (1/15/08)

Date for cert decision in Wyeth v. Levine (1/12/08)

Proving your own thesis (“blogging lessons learned”) (1/12/08)

Medical device PMA preemption affirmed in California (1/11/08)

From Bexis’ in box – Fosamax class action denial (1/11/08)

From Bexis’ in box – medical monitoring (1/10/08)

From Bexis’ in box – punitive damages (1/10/08)

First class action threatened in Italy (1/10/08)

Webcast of Vioxx settlement panel (1/9/08)

HRT JNOV explained (Simon v. Wyeth) (1/7/08)

A plague on you, New York Times! (1/6/08)

Welcome, National Law Journal Readers! (1/5/08)

Panel discussion of Vioxx settlement (1/5/08)

The big three defenses in drug product liability cases (1/4/08)

An idiot’s guide to litigation (1/4/08)

Three docs oppose preemption: New England Journal of Medicine (1/3/08)

Welcome, Legal Marketing readers (1/3/08)

New Year’s resolutions for basic legal marketing (1/2/08)

Experts excluded in vaccine case (Blackwell v. Sigma Aldrich) (1/1/08)

Pharma stories of the year (12/31/07)

Arbino v. Johnson & Johnson: Ohio tort reform upheld (12/30/07)

TWO-OH (2.0) OR NOT TWO-OH: The proper role of statistical thresholds in toxic tort litigation (12/28/07)

Ohio Supreme Court upholds tort reform (12/27/07)

The best and worst of 2007: The best (12/27/07)

The best and worst of 2007: The worst (12/26/07)

Merry Xmas to pharma! SG’s brief in Wyeth v. Levine (12/22/07)

Warner-Lambert v. Kent set for argument (12/21/07)

Proposed changes to Vioxx settlement (12/21/07)

The “rule of construction” — clarifying or confounding the preemption debate about prescription drug warnings? (12/20/07)

ATRA’s 2007 judicial hellholes (12/18/07)

Attorney to client communications (Nationwide v. Fleming) (12/18/07)

More on removing NJ cases before the NJ defendant is served (12/17/07)

Gottlieb on prosecutions for off-label promotion; Kessler woes (12/17/07)

Stray thoughts from the ACI conference (12/16/07)

Law And More: A keen eye for talent (12/14/07)

Guided tour of defense briefs in Warner-Lambert v. Kent (12/12/07)

An MDL surprise: The Engle Progeny order (12/12/07)

Minnesota — not yet healed, and the implications for Vioxx (12/12/07)

Hormone replacement therapy news (12/11/07)

A new medical device blog (12/11/07)

Upcoming talks (12/10/07)

Colacicco: A report from the courtroom (12/10/07)

More on funding litigation in the U.K. (12/10/07)

Colacicco/McNellis argument: First report (12/10/07)

Gaming the “related case” rules (12/8/07)

The Supreme Court’s preemption trilogy (12/8/07)

Preemption cross fertilization (12/6/07)

Ackermann appellate argument (12/5/07)

Riegel – our intrepid correspondent reports (12/5/07)

Riegel oral argument – draw your own conclusion (12/4/07)

Welcome, Bloomberg readers! (12/4/07)

New York, New York! (Arons allows ex parte interviews of treaters) (12/4/07)

Alcohol, Tobacco, and Firearms (assignments to Weinstein) (12/4/07)

Thomson v. Novartis fallout: Judge Higbee reacts (11/30/07)

More storm clouds from across the pond (11/30/07)

Sweet surrender, what a week! (11/30/07)

Recent FDA/Solicitor General preemption amicus filing – Riegel (11/29/07)

Latest FDA/Solicitor General preemption amicus filing – Kent (11/29/07)

We agree with a plaintiff’s lawyer! (11/29/07)

Riegel SG/FDA amicus brief (11/28/07)

Thomson v. Novartis: More news to come (11/28/07)

SG briefs: Riegel and Kent (11/28/07)

An MDL argument cheat sheet (11/27/07)

How’d the world miss this? Thomson v. Novartis (11/25/07)

Gaming the Colacicco/McNellis panel (11/25/07)

So what happens if we lose? (11/21/07)

Colacicco/McNellis appellate panel (11/20/07)

Celebrex summarized (11/20/07)

Celebrate for Celebrex! (MDL Daubert ruling) (11/20/07)

Another MDL oddity (arguing without a client) (11/20/07)

Duh! Another Vioxx settlement thought (11/17/07)

Posting “comments” on this blog (11/16/07)

Stop calling! The ethics of the Vioxx settlement (11/16/07)

More on cross-jurisdictional class action tolling (11/15/07)

Daubert and class certification (11/13/07)

Thoughts on the Vioxx settlement (11/11/07)

Vioxx settlement (11/9/07)

Ruminations on Executive Orders and the Federal Register (11/8/07)

Product liability MDLs in 2007 (11/6/07)

Zandi — or we might reconsider removal in Minnesota (11/5/07)

Probing Statprobe (11/4/07)

Guided tour of defense briefs in Riegel v. Medtronic (11/1/07)

Welcome, Pharmaceutical Executive readers! (11/1/07)

Scary issues for this Halloween (10/31/07)

Thanks for the memories! (10/30/07)

Happy birthday to us! (10/30/07)

A med mal tangent (Harris v. Mt. Sinai) (10/28/07)

Why mediation shows the future of litigation (10/26/07)

Fail to warn about anything — liability for everything? (10/26/07)

Our first reader poll: Herrmann on tv (10/24/07)

Current issues in pharmaceutical litigation and policy (10/24/07)

Curmudgeon, meet Benjamin Franklin (10/24/07)

Another thought on Warner-Lambert v. Kent (10/23/07)

When litigation and science collide (Childs article) (10/20/07)

But it’s our nights and weekends . . . (10/19/07)

The FDA’s amicus curiae briefs on preemption – redux (10/18/07)

The 2007 FDCA amendments and preemption (10/18/07)

Litigation hold memos (10/16/07)

Warner-Lambert v. Kent and corporate headquarters (10/14/07)

Promoting diversity (10/12/07)

Curmudgeon book talks (10/12/07)

Scholarly work on bellwether trials (10/9/07)

“Coordinated” versus “consolidated” proceedings (10/9/07)

Thank you, blogosphere! (10/7/07)

In praise of ALI (10/7/07)

A reader’s request for help (10/7/07)

Kaye Scholer ego-surfs (10/7/07)

Tort reform works in Texas (10/5/07)

Notes from the scientific underground (10/4/07)

Preemption scorecards (10/3/07)

The vanishing trial (10/2/07)

Preemption roundup (10/2/07)

Riegel survives (10/1/07)

Warner-Lambert v. Kent around the web (9/30/07)

Entertaining ourselves: An experiment in ego-surfing (9/30/07)

Warner-Lambert v. Kent: What’s at stake (9/27/07)

Welcome, Fortune readers! (9/27/07)

Welcome, Crain’s Chicago Business readers! (9/27/07)

Device preemption scorecard (9/26/07)

Warner-Lambert v. Kent: Broader implications (9/25/07)

Desiano: Cert granted (9/25/07)

How did this headline show up on this blog? Reforming legal education (9/25/07)

Drug versus device preemption (9/25/07)

Drug preemption scorecard (9/23/07)

Riegel motions (9/21/07)

Whither Riegel? (9/21/07)

Getting the judge to notice the FDA (9/20/07)

Flipping through the Times (popular press and litigation) (9/18/07)

A plaintiff-side thought (liability for costs) (9/16/07)

Consumer class actions hit New Jersey barrier (9/13/07)

Colacicco oral argument scheduled (9/11/07)

Man bites dog (Depo-Provera MDL ruling) (9/10/07)

Yet another disappointment (legal scholarship) (9/9/07)

Mass joinder rejected in Vioxx MDL (9/7/07)

Upcoming speaking engagements (9/7/07)

Joining issue in Vaccine Act preemption – Ferrari gets a red flag (9/6/07)

Wither the privilege for in-house counsel? (9/5/07)

Herrmann makes a move (9/4/07)

An MDL irrelevancy (8/30/07)

Abigail Alliance: Tempest in a teapot? (8/28/07)

An MDL conundrum (8/27/07)

Wyoming does it right (8/24/07)

Dealing with plaintiffs who use prescription drugs illegally (8/23/07)

Third Circuit finds preemption of consumer fraud claims challenging FDA-approved labeling (8/20/07)

C.B. Fleet’s Turn (8/17/07)

Another Accutane “causality” win (8/17/07)

Informal interviews — docs for the goose, docs for the gander (8/16/07)

Untitled (as in “untitled letters”) (8/14/07)

(b)(2) Becomes (b)(3) Buynie v. Airco (8/12/07)

Abigail Alliance and the Volokh Conspiracy (8/10/07)

More on Milberg (8/10/07)

No constitutional right to compassionate use of unapproved drugs (8/9/07)

Excluding foreign regulatory activities (8/7/07)

Solving the inequality of scientific articles offered to show “notice” (8/5/07)

Seen on a t-shirt (8/4/07)

Former class members sue Milberg Weiss (8/3/07)

Preemption and pre-market approved medical devices – the hits keep on coming (8/2/07)

Why we’re proud to support off-label use (8/2/07)

A Daubert victory (Ervin v. J&J) (7/31/07)

Crediting preemption: Credit Suisse IPO case strengthens the FDA’s argument for the preemption of state law failure-to-warn claims (7/30/07)

Daubert versus Parklane Hosiery (7/29/07)

Vaccine preemption – A murder at the Bates Motel? (7/26/07)

Antidepressant-suicide trial (7/26/07)

Does the rise of the consumer fraud class action mean the decline of the learned intermediary doctrine? Nah! (7/23/07)

Daubert decision in Baycol raises interesting legal points (7/19/07)

Why the changing face of the MDL Panel won’t change the outcome of your transfer motion (7/17/07)

Reasonable degree of medical certainty redux (7/12/07)

News flash: CAFA is working (7/9/07)

In defense of the learned intermediary rule (7/6/07)

Headcount: Who’s adopted the learned intermediary rule? (7/5/07)

And then there were seven (7/3/07)

Take me home, country roads (W. Va. rejects learned intermediary doctrine) (7/1/07)

Thank you! (7/1/07)

Striking back at strike suits (6/28/07)

News from NJ HRT litigation (6/28/07)

Danger from another corner: Third party claims against pharmaceutical and medical device companies (6/26/07)

Cert granted in Riegel (6/25/07)

$3.7 million in fees for a $4000 recovery (Vioxx fee award) (6/23/07)

Congressional preemption watch – good news (6/22/07)

Informed consent and FDA regulatory status – oil and water still don’t mix (6/21/07)

The FDA bill – more on what Congress might do with preemption (6/19/07)

Minnesota — on the road to recovery (6/19/07)

The week that was — to Z (Zyprexa preemption decision) (6/16/07)

The week that was, from A — (Accutane Daubert decision) (6/16/07)

How lawyers’ ads hurt patients (6/16/07)

Preemption finally surfaces in FDA-related legislation (6/14/07)

Watson – sifting through the rubble (6/14/07)

Preemption news (Colacicco v. Apotex) – revised (6/13/07)

California dreaming – inadequate class representation (6/13/07)

Compliance with FDA regulations as a defense (6/12/07)

Of inconsistent standards and conflicting requirements (6/10/07)

Statistics and similar occurrences (6/7/07)

Clash of privilege waiver and expert disclosure rules (6/5/07)

Anatomy of a mass tort (6/2/07)

Welcome, Continental fliers! (6/1/07)

Long overdue retirement for anything goes pleading (Twombly) (5/31/07)

Proposed Fed. R. Evid. 502 – an update (5/30/07)

“Relatedness” assessments (In re Accutane) (5/28/07)

Preemption lite (5/24/07)

Riegel v. Medtronic – The Solicitor General weighs in on medical device preemption (5/23/07)

A preemption tangent (Watters v. Wachovia Bank) (5/22/07)

Preemption news (Colacicco v. Apotex) (5/21/07)

Preemption news (Levine v. Wyeth) (5/21/07)

Contingent fees and government lawyers (5/19/07)

Picking spots in preemption cases (5/17/07)

An empirical study of the value of impeaching with prior inconsistent statements (5/15/07)

Agency deference prevents “evisceration” of the FDCA regulatory scheme (5/15/07)

Welcome, DRI (and Cali drug cartel) (5/12/07)

The privilege and public relations firms (5/11/07)

Latest draft of ALI principles of aggregate litigation: Three steps forward, two steps back (5/9/07)

Million-dollar wise, and billion-dollar foolish (Kelly v. Ford) (5/8/07)

More of our space on the web (5/5/07)

Finger lickin’ good (5/4/07)

Municipal cost recovery rule restricts government tort suits (5/3/07)

FDA proposes new antidepressant suicide warnings (5/2/07)

Colacicco appellate status (5/2/07)

CAFA’s mass torts provisions: Lowery (4/30/07)

Our space on the web (4/28/07)

Preemption and FDA archaeology (4/26/07)

Reader response to “shouting credibility” (4/24/07)

Why the Texas Vioxx decision matters (4/22/07)

“If only my expert had treated me”: “Reasonable” physicians don’t prove warning causation (4/19/07)

Shouting “credibility” and praying for trial (4/17/07)

Why does preemption matter? (4/15/07)

ALI draft would abolish “reasonable degree of professional certainty” requirement (4/12/07)

A very brief add-on (4/11/07)

Filing fees due after severance for misjoinder (4/10/07)

MDL choice of law: Direct filing stipulations (4/7/07)

Restricting government by contingent fee — a welcome development (4/6/07)

“Changes being effected” labeling and novelty (4/5/07)

Have you ever sent an opinion to your client? (4/4/07)

Okay, we missed one (4/3/07)

A medical monitoring compendium (4/3/07)

We like Sykes (3/31/07)

Welcome sanity in New Jersey (3/29/07)

The jurisdictional amount under CAFA (3/27/07)

If not preemption, then regulatory compliance (3/25/07)

Cross-jurisdictional class action tolling – a bridge too far (3/22/07)

Stays pending Rule 23(f) appeals (3/20/07)

Storm clouds nearing (overseas class actions) (3/18/07)

How able is Grable to support removal? (3/15/07)

A securities case worth reading (Citizens Insurance) (3/13/07)

Should Lexecon be overruled? (3/11/07)

It’s our blog; we’re allowed! (3/11/07)

Regulatory compliance and punitive damages (3/8/07)

“Lexecon waivers”: Another prohibited MDL practice? (3/6/07)

Epstein on FDA drug preemption (3/4/07)

Implied warranty – Pennsylvania has a better idea (3/1/07)

Williams v. PM and the passing of punitive damages class actions (2/27/07)

Nagareda (implicitly) on preemption case selection (2/26/07)

The bridges from Madison county (2/25/07)

The Illinois Jensen case – a class action cautionary tale (2/22/07)

Another stray thought on Williams v. PM (2/22/07)

Proposed Fed. R. Evid. 502 (2/21/07)

Send them a message (2/20/07)

Philip Morris v. Williams decided (2/20/07)

Punitive damages make the news (2/20/07)

A note on FDA politics (2/19/07)

HIPAA does not preempt state litigation practice (2/15/07)

Chaining the muse (2/14/07)

Keeping the label out of the case (2/13/07)

Approaches to coding documents (2/11/07)

Making book on the MDL Panel (2/9/07)

31 (or more) reasons to watch ALI’s principles of the law of aggregate litigation (2/8/07)

Pediatric suicide rates (2/6/07)

(b)(1)(A) begone! (2/5/07)

Bone screws and informed consent (2/4/07)

Deconstructing the duty to test (2/1/07)

Silly MDL tricks (1/30/07)

Litigation preparedness and IT upgrades (1/29/07)

CAFA and choice of law (1/27/07)

More thoughts on pharmaceutical class actions (1/26/07)

Defenses to FDCA-based negligence per se (1/25/07)

2003 amendment to Rule 23 (1/24/07)

Plaintiffs’ counsel “hijacking” the news cycle (1/22/07)

Rule 706 experts on e-discovery (1/22/07)

Zyprexa First Amendment hearing (1/20/07)

Hearings on Hatch-Waxman settlements (1/19/07)

Ruminations on bellwether trials (1/19/07)

Guest Post – Medical monitoring, prescription products and ALI (1/19/07)

The First Amendment and off-label use (1/17/07)

Another off-topic post: Overtime wage litigation (1/17/07)

More on multiple misjoinders (1/16/07)

An off-topic post: Judicial pay (1/15/07)

Zyprexa and the First Amendment (1/15/07)

An MDL bibliography (1/12/07)

Class actions – merits review is “in” in the Second Circuit (1/12/07)

Mass torts and multiple misjoinders (1/11/07)

Law and science (1/10/07)

The apocalypse is upon us (overwarnings) (1/9/07)

Advice for the MDL Panel (1/6/07)

Mass torts in state courts (1/5/07)

Colacicco delayed (1/5/07)

Medical device preemption and forms of FDA approval (1/5/07)

Dog bites man (MDL transferee court power) (1/4/07)

.05 versus 51% (1/2/07)

Territoriality and punitive damages (12/29/06)

Amending California’s “mini MDL” statute (12/27/06)

Preemption of “Black Box” warning claims (12/20/06)

Zyprexa protective order update (12/20/06)

Reprocessing single-use medical devices (12/19/06)

Take our second thesis – please! (Protective orders) (12/18/06)

Drug preemption cases (12/15/06)

The FDA’s amicus briefs on preemption (12/14/06)

Nagareda on preemption (12/14/06)

Just to show off (a Curmudgeonly podcast) (12/14/06)

Consumer reaction to off-label use (12/12/06)

Judge Weinstein proposes amending CAFA (12/11/06)

Take our thesis – please! (Class action notice) (12/9/06)

Colacicco appellate briefs (12/8/06)

MDL Panel statistics on mass torts (12/8/06)

Heedless use of heeding preemptions (12/8/06)

Interlocutory appeals in MDLs (12/7/06)

Choice of law in class actions (St. Jude Medical) (12/2/06)

Buckman scorned (implantable defibrillators) (11/30/06)

Medical device preemption (11/30/06)

Federal courts should remember federalism (11/28/06)

A Vioxx aside: Master MDL complaints (11/25/06)

The presumption against preemption (11/15/06)

MDLs in 2006 (11/15/06)

DISCLAIMER AND TERMS OF USE (10/28/06)