New Jersey

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Without pulling back the curtain all the way on how we find out about new decisions worth a pithy post, we occasionally re-learn about decisions when they are published or added to an electronic reporting service a few months later. When there is a slow week, this dynamic may prompt us to talk about an older decision, even if has already been the subject of a breaking news post. The summary judgment decision in In re Accutane Litigation, No. 271 (MCL), 2015 N.J. Super. Unpub. LEXIS 1216 (N.J. Super. Law Div. Apr. 2, 2015) was the subject of a breaking news post two months ago, but deserves another look, more for the story it tells about drug litigation than for its direct precedential value.

We have posted through the years about the tortured course of Accutane litigation over the risk of inflammatory bowel disease (“IBD”). (There have also been cases about birth defect and suicidality, but we are not focusing on those here.) In general, the news out of the MDL proceeding has been good for years, both on expert issues and the substance of plaintiffs’ claims.   For years, the news from the coordinated proceeding in New Jersey has been very bad, including a few large plaintiff verdicts. Issues with the judge who had overseen the New Jersey proceedings were highly publicized (but not by us), and it is easy to say that her assignment to a new post explained the sea change.

We can guess that the new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. There has also, though, been development in the case law on the New Jersey Product Liability Act (NJPLA) that undercut the legal basis for old (bad) decisions. The persistence of the defendant and willingness of the new judge to consider broad issues late in the life of the litigation bring us to the decision finding the IBD warnings since April 2002 to be adequate as a matter of law under the NJPLA, which sets up a potential adoption for cases where other state law may control.

The history of Accutane’s IBD warnings from the approval of the drug in 1984 through the discontinuation of its sale in 2009 is so extensive that we wonder how warnings claims—the only claims we think should be typically available for a prescription drug—ever could have had legs. As discussed below, we also wonder about other reasons why warnings claims should not have been viable. The court provides detailed findings of fact about the warnings for IBD, which included mechanisms for providing warnings not seen with most prescription drugs. Id. at **15-26. We assume the extra measures were driven by concerns about suicidality in teenage patients and birth defects in their offspring, but IBD was also described in the warnings accompanying blister packs (the only means of distribution since 1990), a guide that physicians had to acknowledge receiving in order to prescribe the drug, a guide that pharmacists had to provide to patients while filling their prescriptions, and brochure that physicians were encouraged to give to patients. Combined with a paragraph in the Warnings section of the package insert, the information provided to physicians warned them up, down, and side to side about the risk of IBD. That sounds a lot like an adequate IBD warning as a matter of law under any state’s law on prescription drug warnings.
Continue Reading Deeper Dive on New Jersey Accutane Summary Judgment Decision

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It wasn’t too long ago that, down the shore, New Jersey hosted one of the most notorious litigation hellholes in the country.  That’s not the case anymore, as the current (2014-15) ATRA Judicial Hellholes report explains in a suitably defense-oriented way.  That’s good news because so many of our clients are headquartered in New Jersey.

But the substantive law, as well, played a part in Joisey gaining a reputation as an unusually pro-plaintiff forum.  That’s been changing too – for some time, as we pointed out here.  Earlier this month we reported that the Accutane mass tort in New Jersey finally went to ground (or to the dogs), as the state court belatedly recognized what federal judges applying Daubert had known for years – allegations that the drug caused intestinal injuries were scientifically bogus from beginning to end, and at all points in between.  See In re Accutane Products Liability, 511 F. Supp.2d 1288 (M.D. Fla. 2007).

Last week, the New Jersey Supreme Court took another step in the right direction on the expert front in Townsend v. Pierre, ___ A.3d ___, 2015 WL 1058036 (N.J. March 12, 2015), by reaffirming and strengthening the state’s “net opinion rule” for expert witnesses.

The what you say?Continue Reading New Jersey Casts a Broader Net (Opinion Rule)

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A couple of weeks ago, we talked about Westminster Kennel Club Dog Show.  We were eagerly anticipating the Best in Show competition, which was slated to feature a Standard Poodle – the breed of our heart – along with a Portuguese Water Dog whose record of wins was unprecedented in dog show history.  Based on this past record, the “PWD” was heavily favored to “take the Garden.” The Best in Show judge (few assignments in dogdom carry more prestige) built the tension in the sold-out stadium to a fever pitch.  The dogs submitted to painstaking “hands on” examinations, they “free-stacked,” they gaited.   And they gaited again.  Finally, the judge, flanked by AKC officials, strode purposefully to the table to “sign the book,” then returned to the center of the ring, microphone turned on, purple and gold rosette and trophy in hand.   He made a moving speech about the history of the event, and he praised the lineup of seven gorgeous group winners.   Pausing one more time for effect, he announced, “Best in Show at the 139th Westminster Kennel Club Dog Show is . . .  the Beagle!”  The Beagle? Make no mistake – “Miss P” is a spectacular show dog, with many Best in Show wins to her credit.  She is a striking example of her breed.  And she is very, very cute.   But it just wasn’t what we expected.

We also thought we knew what to expect when we began reading the recent decision of the Superior Court of New Jersey – Atlantic County — in the Accutane Multicounty Litigation. This litigation, in which plaintiffs allege that Isotretinoin (Accutane’s chemical name) causes Inflammatory Bowel Disease (“IBD”) and Crohn’s Disease (“CD”), has been pending since 2003, and we have been troubled, at times, about an apparent plaintiff bias. Appellate courts have agreed with us, overturning a number of plaintiffs’ verdicts. (See here and here, for example.)  But we were most pleasantly surprised this time.

In In re Accutane Litigation, 2015 WL 753674 (N. J. Super. Law. Feb. 20, 2015), the Court considered defendant’s motion to exclude plaintiffs’ general causation and biostatistics experts.  The Court explained that New Jersey applies a standard less stringent than Frye’s “general acceptance” standard, in determining whether expert testimony is admissible.  Under the guiding Rubanick decision of the New Jersey Supreme Court (125 N.J. 421 (1991)), “if the methodology by which the expert reached a conclusion is sound, the conclusion may be introduced into evidence.”  Accutane, 2015 WL 753674 at *4 (citation to Rubanick omitted).  Later, in Kemp v. The State of New Jersey,  174 N.J. 412 (2002), the Supreme Court held that the trial court was obligated to conduct an evidentiary hearing “any time an expert’s theory has not attained ‘general acceptance,’” and that the failure to do so is “plain error.” Accutane, 2015 WL 753674 at *6 (citations to Kemp omitted).  Hence the moniker “Kemp hearing” to describe hearings such as the one that was the subject of the Court’s decision.Continue Reading A Pleasant Surprise from the Accutane MCL

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This past week you probably heard the low monotone sound that emanates from Patriot head coach Bill Belichick’s mouth whenever he’s explaining deflate-gate and trying to muster up the energy to drool out words that ultimately reveal only that he’s not interested in saying them. His barely operating mouth doesn’t tell you what his eyes so clearly communicate: “This is stupid.  It was a blowout.  It’s stupid, stupid, stupid.  Really stupid.”  His eyes make a better point than his mouth.  It was a blowout and was always going to be.

The same is true of Becker v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 6853 (D.N.J. Jan. 20, 2015).  Like most blowouts, you knew it early on.  Before the court even began analyzing the defendant’s motion to dismiss, it said this, which we describe as foreshadowing with a mallet:

Plaintiffs did not timely respond to the motion.  On December 3, 2014, after their response to the motion was due, Plaintiffs mailed the Court a short letter asking the Court to deny the motion.  Citing no case or other authority, the letter attached what it alleged were medical records of Deborah Becker and an earlier letter from Plaintiffs’ counsel to Defendant’s counsel describing those records.  Plaintiffs later filed the letter and attachments on ECF.

Id. at *3.  Uh-oh.  This was a mismatch from the start.  On one side, we have no cases, no authority, an almost fact-less complaint, and a letter to the opponent that attaches some medical records that was later filed with the court in lieu of a brief, amended complaint or something legal sounding like that.  On the other side, we have TwIqbal and New Jersey product liability law.  If you deflated defendant’s brief by removing half the authorities, you’d still get a blowout.Continue Reading Deflate-Gate Wasn’t the Only Blowout Last Week

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A belated Happy New Year to you, and we’ll say it softly just in case your head still hurts.  That is not an issue for us, as we greeted 2015 in Kennett Square, watching a giant lit mushroom drop from a crane.  A majestically descending fungus is even better than it sounds.  The drive there and back was pretty long, so we were sober as a judge.  (Sorry to say, we have had a couple of occasions in our career that prompted us to doubt the veracity of that phrase.)  Happy birthday to Dax Shepard, who appeared in that criminally underrated film, Idiocracy.  If you have not already seen Idiocracy, rectify that situation immediately.  You’ll be glad you did … especially after reading today’s post.

January 2 is a date we associate with depression and doltishness.  The holidays are really and truly over – unless, like the Russophile Drug and Device Law Son, you’ve made the smart move to embrace the Eastern Orthodox tradition.  But January 2 is still a date that will live in infamy, if only because on this date in 1974 President Nixon signed the bill capping the speed limit at 55.  We make no apologies for siding with Sammy Hagar in screeching that we “can’t drive 55.”

All of which is to say, here’s a case that makes us think that The Law can be depressing and dumb.   In Beyerle, Jr. v. Wright Medical Technology, Inc., 2014 U.S. Dist. LEXIS 176653 (D.N.J. December 23, 2014), the plaintiff alleged that he had been injured by an orthopedic hip implant that had “inexplicably fractured.”  The plaintiff cited the New Jersey Consumer Fraud Act (CFA) in alleging that the defendant’s advertisements about product safety were lies.Continue Reading Damage to a Product vs. Damage by a Product: Why New Jersey Law Sometimes Makes Our Heads Hurt

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What is that sad, semi-clever thing bartenders have been known to say at closing time?　 “You don’t have to go home, but you can’t stay here.”　 Our days of being around at closing time are in the rear view mirror, growing tinier by the second.　 We are unlikely ever again to reenact that greatest of all Sinatra songs, “One for My Baby” (“It’s quarter to three/there’s no one in the place except you and me”).　 Odds are that at 2 am on any Saturday night, we will be deep asleep, enduring another of those dreams where we showed up late for our Contracts exam, naked and afraid.

This will be the third, and almost certainly last, post we do on the Johnson v. Draeger Safety Diagnostics, Inc. litigation, where a purported class challenged the accuracy of the Alcotest machine used in New Jersey to measure blood alcohol content for driving-while-intoxicated (DWI) arrests and prosecutions. In our first post, Three Dumb Legal Theories Walk Into a Bar, we reported how a New Jersey federal court rejected a claim brought by a pair of plaintiffs whose claim was basically that a defective Alcotest machine forced them to plead guilty to DWI. We thought the theory was wobbly, but let’s remind you of the background. The plaintiffs had been arrested for suspected drunk driving.　 Both submitted to breath tests administered using the Alcotest device, which reported, for each, a blood alcohol concentration (BAC) above .08%. Alcotest readings are admissible in DWI prosecutions as evidence of a per se violation of the DWI statute. The plaintiffs each pleaded guilty to DWI. They did not challenge the Alcotest readings at that time, and the reason for that (we surmise), requires even more background. During the roll-out of the Alcotest, twenty individuals charged with DWI challenged the admissibility of their Alcotest results, and their cases were consolidated for consideration of the evidentiary challenge. The case was called Chun. 　During the Chun case, a Vice-President of the company that manufactured the Alcotest testified that he was “100 percent convinced” that the device was capable of producing accurate readings; that he “strongly believed” that the device was scientifically reliable; and that no maintenance was needed other than verifying proper operation at the time when the unit is calibrated. In 2008, the Supreme Court of New Jersey concluded in the Chun case that the Alcotest was scientifically reliable and that its results would be admissible and could be used to prove a per se violation of the DWI statute.Continue Reading Closing Time for the New Jersey Alcotest Product Liability Case

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We (in the peculiarly singular sense) last posted on the day after Thanksgiving, a day sometimes referred to as Black Friday because of the number of retailers that offer purportedly discounted prices to lure eager holiday shoppers.  We have discussed before how the moniker seems more appropriate for other historic events.  It was probably apparent from that post that shopping, particularly at brick-and-mortar stores, is not our favorite thing to do.  We do know, however, that others can be drawn to certain, packed locations by the lure of a good deal.  So too—seamless transition, huh?—can plaintiffs flock to jurisdictions where their lawyers expect a good deal from judges and juries.  Assuming subject matter and personal jurisdiction exists, an assumption we think may be less likely to be foregone in the future, the plaintiff generally gets to pick where the defendant will have to show up to see what kind of deal it can get.

Once jurisdiction exists, there are two vehicles for a defendant to move a case.  The first often has less utility—a motion to transfer to another court within the same state (or to a different federal court when the case is in federal court, which plaintiffs generally try to avoid in the first place).  Consolidation of cases involving the same product through the application of aggregation procedures limits the availability of motions to transfer, but transferring from one court in a state in which the big drug or device manufacturer does not want to be to another court in the same state may not improve the deal much.

The second vehicle is to claim that the forum, typically meaning anywhere in the state where sued, is an inconvenient one for the defendant and the case.  There is some basic appeal for the plaintiff’s response to a forum non conveniens motion lodged by a defendant sued in its own state—how can it be inconvenient for you to be sued in your own state?  Because many drug and device manufacturers are based in, or have subsidiaries that are based in, New Jersey, and because one of the mass tort judges in New Jersey was generally thought to be somewhat inclined to one side of the v., Atlantic County, New Jersey, became a favorite destination for litigation tourists.Continue Reading Inconvenient (Forum) Shopping in New Jersey

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Express warranty is one of those claims that is often raised in prescription medical product liability actions, but seldom pursued with any intensity.  A lot of express warranty claims drop out right away because most courts, under TwIqbal or equivalent state pleading rules, require plaintiffs to plead the precise language of the purported warranty.  As a bunch of cases from our TwIqbal Cheat Sheet establish, most plaintiffs can’t even do that – demonstrating that the majority of express warranty claims are patently bogus.

Express warranty can assume greater importance in preemption cases. Some courts view “express warranty” as based on voluntarily-made statements that aren’t governed by the FDA and thus don’t involve preemptive “requirements” when made by manufacturers of PMA medical devices.  That sentiment is particularly strong in the Third Circuit.  See Horn v. Thoratec Corp., 376 F.3d 163, 168 n.7 (3d Cir. 2004); Michael v. Shiley, Inc., 46 F.3d 1316, 1325 (3d Cir. 1995). Also, a number of states have tort reform statutes that abolish just about all pre-existing common-law causes of action.  Express warranty is often one of the few exceptions allowed in addition to the statutory cause(s) of action.

The latter scenario was the occasion of the Third Circuit’s excellent smack down of an exclusively express warranty class action in In re Avandia Marketing, Sales Practices & Products Liability Litigation (D’Apuzzo), ___ F. Appx. ___, 2014 WL 5334729 (3d Cir. Oct. 21, 2014).  Plaintiff D’Apuzzo, a New Jersey resident, sought to bring a no-damages class action for purely economic loss to recover “for the higher cost, including co-payments” that he allegedly suffered because the drug in question was more expensive but purportedly no better.  Id. at *1.  New Jersey, however, has a comprehensive product liability statute that both abolishes common-law causes of action and prohibits actions for purely economic loss.  Id. at *1 & nn.7-8.  The statute was clear, and New Jersey authority controlling, so plaintiff appealed only the dismissal of his express warranty claims.Continue Reading Third Circuit: “Safe and Effective” Isn’t an Express Warranty

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This post is from Bexis:

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

Drug & Device Resources

Bexis’ Book

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