We update our cheat sheet devoted to ediscovery for defendants differently than the others. Because of the broad nature of the topic – these cases arise in a wide variety of non-drug/device contexts – other personal injury, employment, civil rights, occasionally even criminal litigation. That means we have to research them separately to find what
Search results for: failure to update
Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent
By Bexis on
As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA. Validating such allegations could have much broader implications – on everything from statements made to insurance regulators to child abuse reporting requirements – but, even limited to the FDA, it creates precisely the same perverse incentive “to submit a deluge of information that the [FDA] neither wants nor needs” that supported preemption of other tort claims challenging the accuracy/completeness of FDA submissions in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 (2001). But the Supreme Court denied certiorari in Stengel, so life goes on.
To the extent that Stengel had any redeeming feature, it is found in the 7-judge concurrence (a majority opinion, really, since 11 judges were sitting for the en banc decision), which recognizes that causation is particularly problematic where a federal agency with preemptive power is a middle-man in state-law litigation:
Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist. To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries. But at this juncture − a request for leave to amend their complaint – [plaintiffs’] allegations of causation are adequate.
Stengel, 704 F.3d at 1234-35 (concurring opinion). Stengel cited to the causation theory described in Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011):
[Plaintiff’s] primary causation theory is that if [defendant] had reported the true number of injuries and malfunctions related to [the risk] caused by the [device], this information would have appeared on the FDA’s MAUDE internet database [of adverse events reported about medical devices] and in medical journals, and with this information [the prescriber] would not have recommended the [device] to [plaintiff] for treatment.
Id. at 776.
Continue Reading Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent
Another Make Work Project In New Jersey – Duty To Update Claims
By Bexis on
This post is not from the Dechert side of the blog.
The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”). So have federal courts of appeals.
If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.
Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims
InFuse Update
By Michelle Yeary on
We often report on cases that are dismissed at the pleadings stage but in which plaintiff is afforded an opportunity to “fix” his or her complaint. And almost as often, we refer to this as plaintiff getting a “second bite at the apple.” Not overly creative, but it conveys the point nicely. In the InFuse cases, for instance, the large majority of plaintiffs’ claims have been dismissed as preempted. Typically, the claims that survive preemption are for fraud and misrepresentation and more often than not those have been dismissed for pleading deficiencies. Less often do we see blogworthy decisions on the result of plaintiff’s second bite. So we were surprised to happen upon two such decisions in the InFuse litigation issued just days apart. Plaintiff’s second attempt in one case was more well received by the court, but even that decision has some positive notes for defendants.
To start, we’ve posted a lot about the great success defendants have had in the InFuse litigation defeating off-label promotion claims. So, we aren’t going to reiterate all the details. You can check out all our posts on the InFuse cases here, including our post on Martin v. Medtronic which is one of our follow-up cases today.
In Martin, the court dismissed all of plaintiff’s claims. The preempted claims (fraud based on the labeling, failure to warn based on off-label promotion, design defect, negligent failure to warn based on labeling, negligent design/manufacture, and negligence based on off-label promotion) were dismissed with prejudice. Plaintiff was given leave to amend her remaining claims: fraud based on misrepresentations in off-label promotion, failure to report adverse events to the FDA, and breach of express warranty. Martin v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 164980 at *8-9 (D. Ariz. Nov. 24, 2014). She didn’t fare much better on the second go-round. First, plaintiff re-pleaded all of her preempted claims and the court quickly dismissed them again. Id. at *11-12.Continue Reading InFuse Update
Two Quick Updates – Mesh and Pain Pump
By Michelle Yeary on
It is the Friday of Memorial Day Weekend. Barbecues are being fired up. Beach towels are being scattered on sandy dunes. Pools are opening (probably still a tad early for a dip in the Mid-Atlantic/Northeast states). Fittingly, we came across two decisions this week that warrant mentioning but don’t require much heavy lifting. Perfect blog-material for the unofficial start of summer celebration.
First, we want to report that the Eighth Circuit has affirmed summary judgment in defendant’s favor in another Pain Pump case – Mack v. Stryker, — F.3d –, 2014 WL 1876124 (9th Cir. May 12, 2014) (Minnesota law). That court joins the Sixth Circuit (Rodriguez v. Stryker Corp., 680 F.3d 568 (6th Cir.2012)) in finding that the defendant manufacturer could not be liable as a matter of law because the alleged risk was not scientifically knowable at the time of plaintiff’s surgery. Similar to Rodriguez, the Eighth Circuit reviewed 12 articles relied on by plaintiffs to establish that the risk was knowable. The court (in a 2-1 decision) concluded that these articles proved nothing about the particular device at the time in question. This state-of-the-art issue is critical in the Pain Pump litigation and this appellate decision certainly tightens the binds on plaintiffs who had earlier pain pump surgeries.
Before our detractors start yelling Krumpelbeck is the law of the Sixth Circuit, here is what the Eighth Circuit had to say about that:
A separate panel of the Sixth Circuit decided a similar case to Rodriguez less than three months later, and it reversed a district court’s decision to grant summary judgment to a pain pump manufacturer without acknowledging Rodriguez. See Krumpelbeck v. Breg, Inc., 491 F. App’x 713 (6th Cir.2012) (unpublished). Krumpelbeck and Rodriguez directly conflict. We decline to consider Krumpelbeck because it is not the law of this circuit and likely not the law of the Sixth Circuit due to Rodriguez’s prior publication. See Rutherford v. Columbia Gas, 575 F.3d 616, 619 (6th Cir.2009) (“A published prior panel decision remains controlling authority unless an inconsistent decision of the United States Supreme Court requires modification of the decision or this Court sitting en banc overrules the prior decision.” (quotation and citation omitted)). Additionally, we do not find it persuasive.
Mack, 2014 WL 1876124 at *10 n.6. Neither do we.Continue Reading Two Quick Updates – Mesh and Pain Pump
Don’t Forget About A Prescribing Physician’s Failure To Read Warnings
By Bexis on
For some reason, we recently found ourselves comparing our favorite defenses to our favorite rock bands. Preemption, of course, would be The Beatles, and Daubert/Frye the Rolling Stones. The learned intermediary rule could be Bob Dylan (I know, we’re showing our age, here). Comment k could correspond to Led Zeppelin, and state of the art might be The Who.
And it seems that, for each of these bands, there’s a song we really like that gets slighted (in our opinion) when it comes to air time on classic rock stations. For The Beatles that would be It’s All Too Much. For the Rolling Stones, when you discount those songs generally considered too raunchy for mainstream radio (one from Beggars Banquet, one from Let It Bleed and one from Goats Head Soup, you can guess which ones), we’d say the disrespected Stones song we like most is Child of the Moon. For Bob Dylan, we almost never hear Desolation Row on the radio (and thanks to Zimmerman’s late-in-life conversion to copyright trolldom, you won’t find a decent studio version on YouTube, either). For Zep, we’d award the buried treasure award to Immigrant Song. And finally, for The Who, we’ve always been peculiarly partial to the Punk and the Godfather.
Somewhat similarly disrespected as a defense to warning causation has been the prescriber’s failure to read the relevant warnings. One of the benefits of the learned intermediary rule is that it replaces self-interested plaintiffs with highly trained medical professionals when it comes to warnings, and in particular with respect to warning causation. While a plaintiff with dollar signs in his/her eyes will typically testify to whatever is necessary to establish warning causation (“Oh, yes, if I had only known about that risk, I would have rejected my oncologist’s recommendation and never taken the drug.”), medical doctors are most interested in the effective treatment of their patients, and thus typically tell it like it is. The truth often is that, for one reason or another, the prescribing physician did not rely on the particular warning in question, and thus a different one wouldn’t have made any difference.
There are a number of fact patterns that lead to physician non-reliance, the golden boy of the bunch being when a doctor (a trained professional, after all) already knew about the risk in question and thus did not need to be warned about it. Another commonly seen warning causation defense is when the doctor testifies that none of the plaintiff’s warning sophistry matters, s/he would still treat the plaintiff the same way today.Continue Reading Don’t Forget About A Prescribing Physician’s Failure To Read Warnings
An Infuse Update
By Michelle Yeary on
This post is from the non-Reed Smith side of the blog only.
A few weeks ago we brought you up to speed on the goings on around the country in the Infuse litigation. We’ve decided not to let the cases pile up again and so, today’s post is on the latest Infuse decision – Eidson v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 144179 (N.D. Cal. Oct. 3, 2013). Like most of the decisions this summer, this one is strong on preemption and ultimately, it dismisses most of plaintiffs’ claims.
Eidson actually involves two related cases – claims by Mr. Eidson and claims by Mr. and Mrs. Bell. The allegations are more or less the same. The Infuse bone graft system is a Class III medical device approved by the FDA through the Premarket Approval (“PMA”) process. The system was approved as a medical device consisting of three parts (a spinal fusion cage, a bone graft substitute, and a spongy carrier) for use in anterior (through the abdomen) lumbar surgery. Both plaintiffs allege that the device was used off-label in their surgeries because it was implanted posteriorly (through the back) and without the spinal fusion cage. Eidson, 2013 U.S. Dist. LEXIS 144179, at *6-7. At the outset, both plaintiffs also abandoned their strict liability design defect claims as barred by California law. Id. at *57-58.
A Rotten Failure-to-Warn Decision Slouches out of Wisconsin
By Stephen McConnell on
“The best lack all conviction, while the worst are full of passionate intensity.”
– Yeats, The Second Coming
We remember the early days of ESPN’s Sportscenter when Stuart Scott constantly complained about how he always had to do the summaries of the week’s crappiest football games (the bad teams back then were Tampa Bay, Green…
The Fifth Circuit Says No: No “Duty of Additional Communication” Claims, No “Duty to Update” Claims; and Just No to Bartlett
By John Sullivan on
While waiting for next month’s Bartlett oral argument and then the Supreme Court’s decision, and as plaintiffs continue to prod and poke to find ways around Mensing, the Fifth Circuit gave us a nice (though unpublished) Valentine’s Day present in Morris v. Pliva USA, Inc., No. 12-30319, 2013 U.S. App. LEXIS 3167 (5th…
Murthy Update – The Case That Wouldn’t Go Away
By Michelle Yeary on
The case of Murthy v. Abbott Laboratories, first came to our attention last year when it took the #8 spot on our list of the top ten worst drug and devices decisions for 2011. That decision, 2011 U.S. Dist. LEXIS 129102 (S.D. Tex. Nov. 7, 2011), without citing any law – and contrary to a lot of law it didn’t cite – announced what amounted to a blanket exception to the learned intermediary rule for all investigational drug cases and carved out a second exception for DTC advertised drugs. You can see our full discussion of this “ugly” decision here. Fortunately, this year’s Texas Supreme Court decision in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) fully embracing the learned intermediary doctrine and rejecting a DTC exception (see our post on Centocor here) undercuts much of the 2011 Murthy decision making it more like a nightmare – we’ve woken up and it found out it wasn’t real (or at least easily discounted).
A few months before the Centocor decision, the Murthy court was at it again in Murthy v. Abbott Labs., 847 F. Supp. 2d 958 (S.D. Tex. 2012). Here they incorrectly predicted that the Texas Supreme Court would recognize a DTC learned intermediary exception and based on that again refused to dismiss plaintiff’s claims based on the learned intermediary doctrine. Id. at 967-973. Since Texas has gone the way of every other state except New Jersey and rejected the DTC exception, that portion of the March 2012 Murthy decision is likewise just part of history.
The remainder of that decision, however, gave us some better news. The court dismissed all of plaintiff’s claims except breach of contract based on Texas’s immunity statute. The statute provides that in a pharmaceutical products liability action “there is a rebuttable presumption that the defendant . . . [is] not liable with respect to the allegations involving failure to provide adequate warnings . . . if the warnings or information that accompanied the product . . . were those approved by the [FDA].” § 82.007 of the Texas Civil Practices and Remedies Code. Since the presumption is rebuttable, the statute also provides certain exceptions to the rule and for a failure to warn claim to survive, plaintiff must adequately plead at least one of those exceptions. In March, the Murthy court found that plaintiff had not sufficiently pleaded any of the exceptions and dismissed her failure to warn, breach of warranty, strict liability and negligence claims accordingly. Id. at 973-77.Continue Reading Murthy Update – The Case That Wouldn’t Go Away