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

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

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

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Recently someone asked the listserv for members of the Product Liability Advisory Council (“PLAC”) whether a plaintiff’s demand for the videotaping of a defense expert’s non-destructive examination of the components of an explanted medical device can be resisted. It seemed like an interesting question, and we like PLAC, so we decided to look for product liability cases where such demands had been made – recognizing, of course, that just as the other side might want to demand this of us, we might also wish, in certain cases, to require the same of the other side.

The brief answer to the question posed is “yes, it can be resisted.”Continue Reading Videotaping Opposing Expert Product Examinations

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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 post is from the non-Reed Smith side of the blog.

We’ve reported on multiple sets of in limine and summary judgment rulings coming out of the Pelvic Mesh MDLs (see here, here, here and here for example).  And there is a new batch just in.  Like the other rulings coming out of this litigation, they are a mixed bag.  As is our usual procedure, we are going to primarily focus on the positive and we’ll skip over a lot of the redundant and more mundane rulings.  It should make for a short, but hopefully informative post.

All of the rulings were entered in Bellew v. Ethicon, Inc., No. 2:13-cv-22473 (S.D. W. Va.), a bellwether case in the Ethicon Pelvic Mesh MDL.  We’ll start with the in limine rulings which can be found at Bellew, 2014 U.S. Dist. LEXIS 165709.  Many of the motions were standard – by defendant to exclude evidence of other allegedly bad acts (denied without prejudice); by plaintiff to exclude evidence of other allegedly good acts (denied in part (granted only as to things defendant agreed they would not introduce at trial)); by defendant to exclude that it no longer sells the product at issue (granted); by plaintiff to exclude evidence of 510k clearance (granted).

There was one motion in limine, however, that caught our attention as one we see more commonly brought by defendants.  Although, this issue can cut both ways, so we aren’t going to offer much commentary here.  Plaintiff moved to exclude “opinion testimony from treating physicians.”  Id. at *24.  The reason this is more often a defense motion is the unlevel playing field we’ve railed against for years.  Plaintiffs have unfettered, ex parte access to the treaters.  So, they often use that time to show the doctor things like medical literature the doctor had never read, corporate documents the doctor would never have otherwise seen, or information that post-dates the doctor’s treatment of the plaintiff.   All of this is done in an attempt to secure opinion testimony on causation.  Now, if the treater is retained by plaintiff as an expert and prepares an expert report, his opinions, like those of any other properly disclosed expert, are scrutinized under Daubert.  The problem comes when plaintiff tries to proffer the causation opinion without the expert report.Continue Reading A Collection of Ethicon Mesh Rulings

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One or more of its variants appears in the vast majority of expert reports and transcripts for expert testimony on medical causation:  “reasonable degree of medical/scientific certainty/probability.”  Sometimes, it is attached as a seeming exclamation point at the end of direct testimony of an expert at trial with an exchange like “Were all of your opinions here held to a reasonable degree of medical certainty?” and “Yes, they certainly were.”  What does “reasonable degree of medical certainty” mean?  Does it mean something different than “reasonable degree of medical probability”?  If “certainty” means 100% and “probable” means more than 50%, then why are the words “reasonable degree” included in these phrases?  We leave the surveys and exposition of research dating to the 1907 Esso v. Teric case to Bexis and will simply offer that most experts, lawyers, and judges use these phrases reflexively, without pondering their meaning.  Clearly, “reasonable degree of medical certainty” plays some role in distinguishing guesswork from something on which a jury can place weight when deciding cases.  These words also come from substantive law and operate independent of the familiar procedural requirements of things like Fed. R. Evid. 401-403 & 701-03 and Daubert.  Independence means that expert opinion on medical causation could pass the “certainty” requirement and still not be sufficiently probative and reliable to be admitted, which happens all the time.  The flip side is rarer, where expert testimony that passes Daubert
might still fail because it is not sufficiently certain for state law.

Rare defines the situation in Valido-Shade v. Wyeth LLC, MDL No. 1203, Civ. No. 12-20003 (E.D. Pa. Nov. 3, 2014), slip op., in a number of respects.  The case is part of the diet drug litigation, which is heading toward its third decade, a rarity among single target litigations.  The injury claimed is pulmonary arterial hypertension, which occurs rarely in the general population–at least actual PAH does.  The particular plaintiff claimed to have been diagnosed with PAH in 2010 after using the drugs in 1996 and 1997.  Although not really explained in the opinion, the reference to “such a long latency period” means that the plaintiff was apparently asymptomatic for the vast majority of the 13 years from last use to diagnosis.  If she had been otherwise, given the ruling in Mingus v. Wyeth, MDL 1203, No. 04-23744, 2006 WL 1050289, *3 (E.D.Pa. Apr. 20 2006), then the plaintiff may have been required to establish her eligibility to sue under a defined exclusion from the Nationwide Class Action Settlement Agreement while her statute of limitations clock ran.  That also would have required her to contend that the drugs she took for “a number of months” produced a disease that was asymptomatic for perhaps a decade by relying on studies that showed a statistically significant increased risk for non-latent disease and no statistically significant risk of latent disease according to the time frames studied.  This same MDL court had previously denied a Daubert challenge to the general causation opinion that the drugs can cause PAH that was asymptomatic for eleven years, In Re: Diet Drugs (Phentermine/ Fenfluramine/Dexfenfluramine) Prods. Liab. Litig, 890 F. Supp. 2d 552 (E.D. Pa. 2012), itself an extension of another court’s denial of a Daubert challenge to general causation opinions for cases with initial symptoms arising more than a year after last use.  Smith v. Wyeth-Ayerst Laboratories Co., 278 F. Supp. 2d 684 (W.D.N.C. 2003).  Given our past involvement with this litigation, these issues, and some of these experts, we are feigning detachment and trying to present it with a modicum of neutrality.  Regardless, this is all quite rare in the world of drug litigation.Continue Reading When Magic Words Are Not

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Is a product defective because it did not perform as hoped?  How about if it failed or even if it broke?  Of course not, and this is doubly true for implanted medical devices because all treatment with medical devices carries risk, including the risk of poor outcomes.  You therefore can’t say an implanted medical device…

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We were surprised by the article in the New York Times this weekend about how the Supreme Court revises some of its opinions years later.  Those changes are picked up in some reporters, but not others.  Some of those changes are relatively minor (e.g., Justice Scalia correcting his statement of what the EPA’s position was on a particular issue) but others are not. The article sent us into a reverie of wishful thinking about ‘correcting’ the Wyeth v. Levine opinion to take into account the non-automatic nature of Changes Being Effected, or to excise Riegel’s frolic and detour on parallel claim exceptions, or to foreclose the Solicitor General’s new, crabbed interpretation of FDA preemption applying only to device-specific actions.  But why stop at Supreme Court opinions?  Looking back over the years, we can think of many things we said and wrote that we’d now like to edit.  That wedding toast where the ex-girlfriend, rather than the bride, was saluted would be fixed.  And now in our dotage we finally realized the correct answer to the question of whether “this makes me look fat.”  It reminds us of the classic definition of a gaffe: telling the truth at the wrong place and time.

Many of the cases we post about here could use a bit of editing.  When the blogging team goes over the cases on offer for any given week, the phrase “mixed bag” comes up more often than any other.  That shouldn’t be surprising.  For every wonderful one-two punch Mensing/anti-Conte case, or every Bausch/Perez train wreck, we get ten cases that are more like what we see regularly in real-life – cases that have a little good and a little bad.  We cannot exactly edit those cases, but we can accentuate the positive in our humble reviews.  That’s what we will do with Kruszka v. Novartis Pharms. Corp., 2014 U.S. Dist. LEXIS 68439 (D. Minn. May 19, 2014).  Kruszka is yet another Aredia-Zometa case where a cancer survivor alleges that the drugs that helped her survive cancer caused osteonecrosis of the jaw (ONJ).  Some of the rulings we like better than others.  While we cannot edit the opinion, we can certainly highlight the good stuff while mumbling sotto voce about the bad. With the glow of the long holiday weekend not yet worn off, we are reluctant to be the deliverer of evil.

The plaintiff in Kruszka was diagnosed with blood cancer in the form of multiple myeloma in 2000.  That cancer resulted in hypercalcemia, a compression fracture in her spine, and lytic lesions in her skull, spine, and bones.  Multiple myeloma patients’ survival rate is approximately six months where no treatment is received.  Doctors told the plaintiff she could expect to live six weeks without treatment.  But she did receive treatment.  Her doctor prescribed Aredia to protect against bone damage and treated the plaintiff with chemotherapy.  She received both branded and generic bisphosphonates.  The good news is that she lived.  The bad news is that a couple of years later she was diagnosed with chronic osteomyelitis (infection in the bone).  The plaintiff was prescribed a prolonged course of four different antibiotics after her prior treatments were determined to be ”suboptimal.”  Dead bone was removed from the jaw area in 2003.  A year later, the plaintiff complained of numbness in her jaw, chin, and lip resulting in difficulty swallowing and chewing, a “deformed face” and other issues.  The plaintiff alleged that the damage to her face and jaw changed her life dramatically, including her speech, eating, social interactions.  She had to give up her church choir.  There is no doubt that the plaintiff earned sympathy.  She was also, as of November 2013, still alive.Continue Reading Rule 702 and Summary Judgment Rulings in Minnesota Aredia-Zometa Case

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Our two favorite television shows occasionally force us to follow subtitles while a character is speaking a harsh (to our ears, anyway) foreign language. In The Americans, the spies in the Russian embassy treat us to long exchanges in their mother tongue, reminding us of the bad old days of Kruschev, Brezhnev, and Tretiak,…

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