Search results for: three strikes

“Legal conclusions, though, are not entitled to the assumption of truth.” If that were the only point we could take away from Wright v. Howmedica Osteonics Corp., No. 5:17-cv-459, 2017 U.S. Dist. LEXIS 168785 (M.D. Fla. Oct. 12, 2017), we would be satisfied.  We understand notice pleading and such, but we have seen all…

Over the weekend, we watched one of our favorite “chick flicks,” a holiday-themed montage entitled “Love, Actually.”  One of our favorite characters, played by the ever-brilliant Bill Nighy, is an over-the-hill former pop star who resorts to superimposing cheesy holiday lyrics on a familiar melody in an (ultimately successful) attempt to manufacture one last comeback.  A disc jockey, hearing this effort for the first time, exclaims, “How the mighty have fallen!”  This crossed our mind as we read today’s case, a decision on Daubert motions in a leftover breast implant case.

Twenty-some years ago, we cut our Drug and Device teeth on breast implant litigation, arguing motions in the infant Mass Tort Program in Philadelphia  Back then, the high-profile litigation, involving claims that breast implants caused serious auto-immune diseases in recipients, commanded high levels of attention and resources and produced some landmark verdicts.  Now, with the vast bulk of the litigation long settled, key defendants in bankruptcy, and many of plaintiff’s claims resoundingly debunked, all that remains are isolated opt-outs, like In re Dow Corning, Corp., Ezra v. DCC Litigation Facility, Inc., 2015 WL 5737997 ( E.D. Mich. Sept. 30, 2015), a primer on Daubert’s raison d’etre.

Plaintiff in Ezra claimed that her silicone gel implants caused

muscle aches and pains all over her body; metallic taste in the mouth; chronic problems with diarrhea; dizziness/vertigo problems; chronic low-grade fevers; frequent yeast infections; chronic fatigue; severe headaches; loss of taste and smell; memory loss and loss of concentration; frequent gastrointestinal problems; sinus problems with ear aches; difficulty swallowing; problems with choking; easily bruised with slow healing of bruises and cuts; spider veins on legs and feet; coldness of hands, fingers, feet, toes and face; muscle spasms; problems with rashes; tingling and numbness in extremities; difficulty breathing; unexplained dental problems; excessive hair loss; as well as emotional, physical and financial losses.

Ezra, 2015 WL 5737997, at *1.   She proffered the testimony of three causation experts, and defendant moved to exclude all three.Continue Reading Three Strikes and Out of Court for Breast Implant Opt-Out

We’ve written about the Actimmune off-label marketing litigation before (here and here). Hey, we even named a prior Actimmune decision Honorable Mention in our Top Cases of 2009 post. And now, it seems the Actimmune litigation has finally met its demise. You can get more detail about the backstory from our prior posts, but here’s the quick synopsis: the plaintiffs filed consumer and third-party payor (TPP) class actions against InterMune and others, alleging that the defendants illegally marketed the drug Actimmune off-label for treatment of idiopathic pulmonary fibrosis (IPF), a nasty lung disease, when Actimmune was ineffective to treat IPF. Originally, the plaintiffs raised a host of fraud-based claims, which the court blew out for failure to plead with particularity. In a bit of deja vu, the plaintiffs took another hack at stating a viable claim, but the court dismissed all fraud-based claims with prejudice.
Which brings us to take three. This time, the plaintiffs tried to state a claim under California’s Unfair Competition Law (UCL), and the TPP plaintiffs also tried to assert a claim under Missouri’s Merchandising Practices Act (MMPA). Again, the court dismissed all claims. With prejudice. See In re: Actimmune Marketing Litig., 2010 U.S. Dist. LEXIS 90480 (N.D. Cal. Sept. 1, 2010). See ya, Actimmune litigation.
Taking apart the UCL claim, the court noted that the plaintiffs had one more shot to plead a non-fraud UCL claim, under the UCL’s “unlawful” and “unfair” prongs. Id. at *16. But the plaintiffs failed to plead such a claim consistent with their TwIqbal obligations. The plaintiffs pointed to alleged off-label marketing as “evidence” that the defendants’ conduct was “unlawful” under the UCL. Id. at *17. Unfortunately for the plaintiffs, they forgot that it is not enough to allege unlawful conduct “in the air” – you also have to establish that the alleged violation caused harm. Id. at *18 (statute requires showing of injury “as a result of” the alleged violation). And here’s the best part: the UCL’s causation element requires proof of “actual reliance.” Id. at *24-25. In other words, “the ‘as a result of’ language places the burden on plaintiffs to establish that they actually relied upon the representations delivered through defendants’ off-label marketing.” Id. at *23.Continue Reading One, Two, Three Strikes You’re Out

Drug manufacturers are not insurers against injury from or while taking medications.  Neither are distributors or pharmacies.  Just because a patient experiences a complication while taking a medication, including the very condition the medication is supposed to help prevent, does not mean that some person or entity should be liable to the patient for her injuries.  Sometimes, there is no fault or liability to be found.  We do not think these are controversial principles, but we find that they apply to more than a few of the cases giving rise to the decisions about which we expound.

We also find that missing facts from complaints can speak volumes.  Similarly, when a plaintiff waits until the third complaint to add case-specific factual allegations that should have been there from the start or when factual allegations pop in and out of serial amendments you have to question the basis for those allegations.  At least we do.  As inveterate curmudgeons, we tend to think bare-bones, boilerplate allegations are unlikely to be supported if the case gets to the merits.  Of course, part of the game for some plaintiffs is to get past pleadings and hope the defendants opt for settlement instead of paying the costs of defense.  The Twombly and Iqbal decisions tightened pleading standards, and thus improved the chance of success on motions to dismiss in federal court and some states have followed along.  The hole, and source of our periodic grumbling, is how often dismissals are without prejudice and accompanied by leave to amend.  Too often, it seems that the provision in Fed. R. Civ. P. 15 that courts “should freely give leave when justice so requires” leads to leave even when it should be obvious that amendment will be futile, not to mention a waste of judicial resources.Continue Reading Five Strikes Needed To Dismiss A Questionable Case

For most of you, it has been a long time since you thought much about criminal law. Do you remember the hypothetical about the murder victim who perished on a desert hike and it was difficult to pinpoint the criminal(s) because one person had poisoned the water in the victim’s canteen, one had replaced the…

We’ve written several times (here, for example) about the Biomaterials Access Assurance Act (BAAA), 21 U.S.C. section 1604 et seq., and how it issues a get-out-of-litigation-free card to suppliers of raw materials and components. Today’s case, Connell v. Lima Corp. et al., 2019 WL 403855 (D. Idaho Jan. 30, 2019), supplies another…

Everybody knows that it is three strikes and you are out in baseball.  (Bexis and Ken Burns could discuss the history of baseball’s rules on balls and strikes in the nineteenth century, but we will stick with the public consciousness at least since “Take Me Out to the Ball Game” became popular.)  In MDL product liability litigation, there is no magic number of times that proffered general causation experts must get knocked out before it is apparent that no plaintiff suing over the injury at issue will have a viable case.  In boxing, many jurisdictions have a three knockdown rule, where a knockout victory is awarded if the opponent is knocked down to the canvas three times in the same round.  In litigation, there is no such rule, nor would the parties ever agree on what constitutes the same round.

The Zoloft MDL in the Eastern District of Pennsylvania has been playing this out.  First, the MDL court excluded the generic causation opinion of the plaintiffs’—all of them, since this is common discovery—epidemiology expert.  Next, the court excluded the general causation opinions of three separate experts who focused on purported mechanisms.  It looked like plaintiffs were dead in the water.  Then, plaintiffs got a mulligan—yes, we are mixing sports metaphors like some courts mix up the standards for expert evidence on medical causation—and were allowed to put up another expert on general causation, this time a late-designated, frequent flyer biostatistician.  (Along the way, a motion to reconsider was denied and, across town, a state court excluded the causation opinions of an epidemiologist and mechanism expert in an individual case.)  Now, after every apparent opportunity for plaintiffs to do better, the court also excluded the general causation opinion of the new expert in In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342, 2015 U.S. Dist. LEXIS 161355 (E.D. Pa. Dec. 2, 2015).Continue Reading Another Zoloft Rule 702 Win: How Many Strikes Before The Plaintiffs Are Out?

Back in our AUSA days we prosecuted many drug cases. That was a significant part of our job.  The defendants were uniformly unsavory and many were violent. That being said, the mandatory minimum sentences were often crazily high.  Sell 50.1 grams of crack and eat ten years.  If you had a prior drug conviction (hardly…

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