Appreciation of silence has probably never been as important as in this age of near constant noise and distraction – says someone who starts streaming Pandora radio the minute she hits her office in the morning. But with ringing phones, pinging texts, Twitter updates, Facebook pokes, and weather alerts the adage “silence is golden” takes
When a decision says the Court finds much of the reasoning in Bausch, Stengel, and Hughes particularly persuasive, you don’t have to be the Amazing Kreskin to guess that we aren’t going to like the ruling. You just need to be a regular reader of this blog.
Unfortunately, that’s precisely what Waltenburg v. St. Jude Medical, Inc., 2014 U.S. Dist. LEXIS 98369 at *35, *56 (W.D. Ken. Jul. 18, 2014) does say. We’ll give the opinion some credit for a fairly thorough discussion of the relevant case law going both ways on preemption and TwIqbal – but it loses most of its appeal by landing at the wrong end of the spectrum.
The case involves an implantable cardioverter defibrillator (ICD). Plaintiff alleges that certain of the wires (or leads) have eroded causing the ICD to inappropriately administer electrical shocks to plaintiff. Id. at *1-3. The ICD is a Class III, PMA medical device. Defendant moved to dismiss the complaint based on preemption and TwIqbal.Continue Reading Lack of Specificity OK in Kentucky
The genius who devised the theory of evolution. The statesman who defended Western Civilization against the Nazis. The man who freed a subcontinent via the majesty of nonviolent resistance. The greatest basketball player of all time. The composer of Shaft. The Pope’s favorite saint. Our national emblem.
What do these heroes have in common?
Today’s case is Dimieri v. Medicis Pharm. Corp., 2014 U.S. Dist. LEXIS 95409 (M.D. Fla. July 14, 2014). Dimieri ingested Solodyn for the treatment of acne. He discontinued use of Solodyn after experiencing “numbing pain in the crown of his head” and noticing alleged hair loss. He alleged that Solodyn was making him bald. That, apparently, ranks as an injury. He brought a complaint against the defendant for failure to warn, strict liability, breach of warranties, misrepresentation, negligence, and fraud.Continue Reading Court Dismisses Balderdash Solodyn Complaint
This post is from the non-Reed Smith side of the blog.
We’ve all been through it. We’ve spent painstaking hours drafting a brief or a memo. We’ve combed through each page, paragraph, and sentence. We’ve cut, copied, and pasted. Then, when we are satisfied with the result we hand it to someone else to review. We move on to something else, almost forgetting about what we conceived of as masterful and persuasive prose. Until . . . we get the redline.
While there are certainly times when you don’t agree with “suggested” edits that you are given, more often than not the person playing the role of the editor does what you previously believed to be impossible – he/she has improved your product. Inconceivable? Not really. That’s the job of an editor. First, the editor is coming at the project with fresh eyes and more objectivity. Second, a good editor will read the entire piece first giving him a different perspective than the author. Third, think of your editor as your guinea pig. If he didn’t “get it,” it’s unlikely anyone else will either. Fourth, editors pay attention to detail that authors often overlook. Finally, your editor is your partner. Not in the law firm sense, but in the collaborative process sense. You both want the same thing – a better brief.Continue Reading Court Takes A Red Pen to InFuse Complaint
Our first reaction to Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014), wasn’t related to the fact that it involved a federal court recognizing a cause of action previously unrecognized by Massachusetts state courts. Our first reaction was that the case shouldn’t be complicated. The plaintiff participated in a clinical trial involving a bilateral gene transfer, which is a new procedure intended to treat Young-Onset Parkinson’s Disease. Id. at *3. As the “bilateral” in its name implies, a bilateral gene transfer consists of two injections of genes into the brain, one into the right side and one into the left. Id. at *3-4. But (plaintiff alleged) the surgeon gave both injections to the left side. Id. at *4.
It seems fairly easy to identify the problem here. If an engineer designs a twin-engine plane, and the mechanics put both engines on the left side, you’ve got a good idea who made the mistake. If the Doublemint gum company told its casting director to hire blond twins for its commercial, and the casting director hired some guy named Roy, you can be pretty sure who made that mistake too. So whom did the Zeman plaintiffs sue over the improper procedure? The manufacturer and the Institutional Review Board (“IRB”), of course.Continue Reading Federal Court Finds a Duty With Regard to Consent Forms in Clinical Trials That the State Court Had Not Previously Recognized
Imagine our surprise at learning that people are still filing cases alleging rhabdomyolysis resulting from Lipitor use. Lipitor is the best known prescription drug ever (except maybe for Viagra), and the association between rhabdomyolysis and statins is one of the most warned-of drug risks in history. Every doctor knows about it, and litigation involving another
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
We can’t decide whether Anastasi v. Wright Medical Tech., 2014 U.S. Dist. LEXIS 58467 (E.D. Mo. Apr. 28, 2014), is bad or just frustrating. It might just feel bad. The fact section takes you through a soul-crushing, “accepted as true” recitation of plaintiff’s allegations that seems a bit over the top. It goes on
We talk a lot about preemption here. Click on the preemption topic on the side of our webpage (here) and you’ll get pages and pages of posts. That isn’t surprising. Preemption can end a litigation, and we all want to hit the game-winning home run.
But plaintiffs know that too. So, rather than taking preemption head on, we often find ourselves dealing instead with plaintiff’s attempts to get around it via “parallel violations” claims. Now, we have problems with the very existence of such claims. Among other things, they often appear to be improper attempts to bring private rights of action under the FDCA. But, unfortunately, they exist, and courts recognize them. Given that reality, however, we’d like courts to at least view them with a scrutinizing eye. The court in Cline v. Advanced Neuromodulation Sys., Inc., 2014 U.S. Dist. LEXIS 56669 (N.D. Ga. Mar. 31, 2014), did just that.
In Cline, the plaintiff had an opportunity for limited discovery (which we’ll discuss later) into the PMA specifications that came with the approval of an implantable pulse generator (“IPG”) implanted into plaintiff. Plaintiff then filed her third amended complaint in an attempt to state parallel violation claims related to the failure of her IPG. It didn’t go exceedingly well. The court lowered the microscope to look at those claims for what they really were, and almost all them did not survive.Continue Reading A District Court Takes an Exacting Look at Parallel Violation Claims
This post is from the non-Reed Smith side of the blog.
This is apparently the question the court was asking in deciding whether to dismiss Dilley v. C.R. Bard, Inc., 2014 U.S. Dist. LEXIS 47066 (C.D. Cal. Apr. 3, 2014). Now Shakespeare may have been using “wherefore” to have Juliet ask the question “why.”