July 2015

Photo of Rachel B. Weil

We admit it.  We (and “we,” in this instance, should be read in the singular) are fans of certain social media, particularly the one that involves “posting” on a “wall” then sitting back and basking in the “likes.”  We tend to eschew any intellectually-challenging material that may be available on this medium.  Instead, when we are not ourselves posting pictures of the Drug and Device Law Rescue Pets, we most enjoy reading accounts of others’ rescues of doggies and kitties.  (Don’t start – we know.)   These stories always begin with horrific, heart-wrenching facts but generally wend their way to satisfying endings.

Today’s case, Taylor v. Intuitive Surgical, Inc., 2015 Wash. App. LEXIS 1442 (Ct. App. Wash. July 7, 2015), follows a similar formula, although the ending is happy only for “learned intermediary” jurisprudence, not for plaintiff’s unfortunate decedent.  Taylor involved the da Vinci System, manufactured by defendant Intuitive Surgical, Inc. (“ISI”).   The highly complex da Vinci system allows surgeons to perform minimally-invasive prostatectomies, remotely operating small instruments inserted through very small incisions in the patient’s body.  Taylor, 2015 Wash. App. LEXIS at *3.

Apparently, ISI tightly controls physician access to its system.  We are not sure how, but the opinion describes a specific credentialing process under which every surgeon is required to be credentialed, before using the da Vinci system, by the hospital where the procedure will be performed.  Each hospital sets its own credentialing protocol.  Surgeons must initially perform proctored cases – two, or a number set by hospital protocol.  Id. at *4-5.  Next, ISI requires surgeons to “choose simple cases for their first four to six unproctored procedures and to slowly progress in case complexity.”  Id. at *5 (internal punctuation and citation omitted).   During their early surgeries, “surgeons are advised to choose patients with . . . BMI of less than 30 and no prior history of lower abdominal surgery.”  Id. Continue Reading No Duty for Device Manufacturer to Provide Separate Warnings to Hospital, According to Washington Court of Appeals

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In over eight years, we’ve never before blogged about a European development in prescription medical product liability.  The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt – Die Gesundheitskasse, Nos. C‑503/13, -504/13, slip op. (4th Chamber March 5, 2015) (that’s a mouthful, so we’ll call it “BSMG” for short), causes us to make an exception.

First, a bit about the court.  According to the EU’s website, one of the functions of the CJEU is to “interpret[] EU law to make sure it is applied in the same way in all EU countries.”  So this is essentially the highest EU court for all matters governed by EU legal directives.  Wikipedia adds that the CJEU almost always sits in “chambers” – units of less than the whole – so the “Fourth Chamber” designation is as far as this case is going to go, since it was not assigned to the en banc “Grand Chamber” at the outset.  Thus the BSMG decision is a final, high-court legal interpretation that will apply throughout Europe.

BSMG interpreted “Directive 85/374/EEC,” id. at ¶1, which is the general EU product liability directive enacted back in 1985.  While BSMG involved medical devices, the decision rests entirely on the general product liability directive, and does not even reference the later EU directive for medical devices, Directive 93/42/EEC.  To us, that’s the first takeaway from BSMG – since it is based entirely on the general product liability directive, it could potentially apply to any product:  prescription drugs, or even automobiles, presenting the same sort of acute risks at issue in the decision.

The important facts are these.  BSMG is actually two cases, both brought by European third party payors (“TPPs”) seeking reimbursement of medical costs that they incurred as a result of “defective” medical devices – and not just any medical devices, electronically operated implants, specifically pacemakers and implantable cardioverter defibrillators.  Thus, these devices were both:  (1) life sustaining, and (2) presented life threatening risks should they fail to function properly.  The risk of potential fatal consequences was extremely important to the opinion.Continue Reading Bad News from Europe for Makers of Life-Saving Medical Devices

Photo of Eric Alexander

Last month, we described the proposal by the American Bar Association’s Standing Committee on Medical Professional Liability concerning legislation on “defective medical products” and punitive damages for “patient harm allegedly caused” by them.  Over the last month, we have seen statements issued by a number of professional groups urging the ABA Delegates to reject the …

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It offends our sensibilities (and sense of self-preservation) when we see a lawsuit in a jurisdiction that is home to neither the plaintiff, nor the defendant, nor any of the activities that gave rise to the claims. Often, the only things the jurisdiction was home to were the plaintiff attorneys and a set of maddeningly pro-plaintiff judges and juries. One would think that a court system and its taxpayers would feel aggrieved at devoting labor and money to resolve disputes for someone else from someplace else, but there are miscreants in the works who manage to ignore the expense side of the equation and instead focus only on the chimerical benefits of litigation tourism or the miscreants’ misplaced sense of self-importance. (Remember, we practice in Philly. We have whiled away many hours in City Hall courtrooms watching Texas lawyers representing Utah plaintiffs suing a New Jersey company, all in front of Center City Philly jurors who would no doubt rather do their jobs, spend time with their children, or discuss the moribund status of the Phillies, Flyers, Sixers, and pretty much any home team here above Little League.) The problem is that the law on personal jurisdiction was perfectly elastic, and the laws of venue and forum non conveniens were all too easily disregarded or distorted.

But at least personal jurisdiction has been set aright by the Supreme Court. When we were in law school, during the era of Duran Duran and Footloose, we were taught that there was personal jurisdiction over a large corporation so long as said corporation had systematic contacts with a jurisdiction – which, being a large corporation, it pretty much always did. Then, in 2014, when we had grudgingly moved on to the Black Keys and Guardians of the Galaxy, the Supreme Court in the Bauman case limited general jurisdiction to corporations that were “at home” in the jurisdiction (usually meaning place of incorporation or principal place of business), and limited specific jurisdiction to cases where the corporation’s suit-related conduct created a substantial connection to the state.

The impact of Bauman was immediate and profound and wholly beneficent. We have had the pleasure on a number of occasions (here and here, for example) of reporting on cases in which the new Bauman jurisdiction architecture slammed shut the gate on plaintiff forum-shopping. This Spring we discussed the Neely case from the Kansas federal district, where the court held that a drug company that registered to do business in Kansas and then actually had the temerity to conduct some business there had not thereby succumbed to general jurisdiction. That was a good result.Continue Reading Missouri Court Applies Bauman; Merely Doing Business Did Not Show Enough for Personal Jurisdiction

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This case is from the non-Reed Smith side of the blog only.

Today’s case is a simple and straightforward message to plaintiffs – you can’t use §1404 transfers to create an MDL after the Judicial Panel on Multidistrict Litigation (“JPML”) has said no.  That is precisely what plaintiffs were asking the court to do in Krupp v. Eli Lilly and Co., 2015 U.S. Dist. LEXIS 83762 (M.D. Fla. Apr. 6, 2015).  Apparently two plaintiffs’ firms had filed 47 Cymbalta cases in 29 different federal courts around the country (presumably plaintiffs’ home jurisdictions) and then petitioned the JPML for the creation of an MDL, alleging an additional 2700 claims in the pipeline.  The JPML declined finding that the cases were in different procedural postures, the bulk of the common discovery had already taken place and with only 2 plaintiffs’ firms, coordination should not prove burdensome.  Id. at *3.

Not happy with that result, plaintiffs appear now to be asking the 29 federal courts with pending Cymbalta cases to transfer them to the Southern District of Indiana – defendant’s home jurisdiction.  Plaintiffs allege that they will then also file the rest of their cases there to create “a de facto MDL.”  Id. at *4.  Plaintiffs argue that transfer of all cases (i) will allow plaintiffs to share costs, (ii) will be more convenient to defendant, and (iii) will promote judicial efficiency.  Id.  Even assuming these are true assertions – they don’t justify a plaintiff’s request for a §1404 transfer.Continue Reading MDL Shenanigans Disallowed

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The trial judge in the second Risperdal trial denied plaintiff’s post-trial motion for a new trial, upholding the jury’s determination that plaintiffs hadn’t proven that Risperdal caused plaintiffs’ gynecomastia (male breast growth).  Cirba v. Janssen Pharmaceuticals, Inc., 2015 WL 4081909 (Pa. Ct. Comm. Pl. June 30, 2015).  Given the court’s summary of plaintiff’s weight and history of Risperdal use, the jury’s verdict seems pretty darn reasonable:

There was clear evidence that [plaintiff] had gained significant weight after he stopped taking the drug in 2007.  He is presently 6’1” and 272 pounds.  Since Defendant is clearly overweight, had not consumed Risperdal since 2007, had never complained of gynecomastia until 2013, and there were no photos prior to puberty to support his causation claim, the jury came to the reasonable conclusion that Risperdal did not cause his present condition.

Id. at 2.

Nonetheless, plaintiff tried to get the verdict overturned in several ways.

He argued that the court should have disallowed causation testimony by his nurse practitioner, who had prescribed him Risperdal and treated him for almost eight years, including a six-year period leading up to his first complaint of gynecomastia during which he took no Risperdal.  She testified that weight gain, not Risperdal, caused the growth in his chest.Continue Reading Court of Common Pleas Leaves Standing Janssen’s Victory in Second Risperdal Trial

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Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and superseded), and Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (en banc)—which kept alive a version of the innovator liability that had been rejected almost everywhere else.  The Alabama Supreme Court—in 2013 and again in 2014—deviated from the well-established principle of product liability that liability for an injury allegedly produced by a particular product may run to the manufacturer of that product but not to the manufacturer of some other product that did not allegedly injure the plaintiff.  Recognizing the weakness of Weeks, in 2015, the Alabama legislature re-affirmed the need for any product liability plaintiff to prove an injury from the defendant’s product, not just “a similar or equivalent product.”  Because Alabama’s law is not retroactive, there is a gap for plaintiffs in pending cases to try to impose liability on manufacturers of drugs they did not take.

Before we knew the days of Weeks were numbered, we highlighted how the Northern District of Alabama had distinguished the Weeks theory that “a brand-name-drug company may be held liable for fraud or misrepresentation . . . based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company” from the plaintiff’s theory that the innovator should be liable for “failing to ensure that [plaintiff] received the Medication Guide,” which plaintiff conceded provided adequate information on risks and indications for the drug.  Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073. *12 (N.D. Ala. Jan. 14, 2015).  Without support from Weeks, no putative breach of a duty by the innovator could give rise to liability.  Id. at *13.  We characterized the holding in another case from the same district, Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014), as “If Weeks does not allow innovators to be tagged for [run-of-the-mill product liability] claims, absent fraud allegations that will need to be pleaded in detail and eventually supported by lots of evidence, then the effect of Weeks may end up being pretty narrow.”Continue Reading The Elephant in the Room in Alabama

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“If it doesn’t fit, you must acquit.”  In the granddaddy of today’s reality TV shows, this buzz-phrase became synonymous with “use your head before you rely on a demonstration.”  The plaintiff in Hutson v. Covidien Holdings, Inc., et al., 2015 U.S. Dist. LEXIS 85223 (S.D. Ohio June 30, 2015), would have done well to pay heed.  As you will see, the demonstration on which his expert relied – the stuff of a high school science fair, and not in a very good school district – played a large part in ensuring that the expert’s testimony would never see the light of day.

In Hutson, plaintiff underwent a root canal.  The dentist used a needle to inject anesthesia into plaintiff’s gums, but ignored the needle box’s label, which warned not to “bend or alter needle shaft prior to use” and not to “insert the needle shaft all the way to the hub as needle breakage and possible injury may result.”  Hutson, 2015 U.S. Dist. LEXIS 85223 at *1-2.  The dentist did both – twice – and the needle broke off in plaintiff’s gum tissue.  Because no portion was sticking out, oral surgery was eventually required to remove the needle.  Id., at *2.  (Yes, we are also feeling queasy.)

Notwithstanding the warnings – and the completely predictable result of the dentist’s decision to ignore them – plaintiff chose to sue the needle’s manufacturer, alleging that a manufacturing defect caused the needle to break.  He produced the report of a “clinical engineering” expert, who described his area of expertise as “the applied application of the engineering discipline to all aspects of technology used in the clinical setting.”  Id. at *3 (citation omitted).   The expert opined that “there are four potential causes as to why the subject needle broke, three of which involve a manufacturing defect, but there is not enough data from the subject needle to rank the likelihood of causes.”  Id. at *4 (citation omitted).  We love this stuff.Continue Reading Rule 702 – and a Mechanical Pencil – Doom the Testimony of “Clinical Engineering” Expert

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Two stories in 360 yesterday – the timing was pure coincidence – have us thinking again about the FDA’s muddled and increasingly untenable position on truthful off-label “promotion” – broadly defined as any accurate information disseminated by an FDA-regulated
manufacturer about an  off-label use.

The first of these articles described the oral argument in Amarin, Inc. v. FDA, a case which we’ve been following closely, here, here, and here.  The Amarin case, which challenges the FDA’s truthful off-label promotion ban under the First Amendment in a Caronia-bound court, saw the FDA in retreat (by letter) before argument, but apparently returning to its old absolutist views at the argument itself.  According to 360:

[The government] advanced an aggressive interpretation of the Caronia decision, arguing that truthful statements alone can still be the basis for enforcement if the government demonstrates that a drug was promoted for unapproved uses that weren’t generally recognized as safe and effective.

Again according to 360’s report, the court appeared torn.  On the one hand, it would be highly unusual to enjoin an FDA prosecution that hasn’t even happened, and there are problems declaring particular medical statements “truthful” when the science is evolving.  On the other hand, the FDA allows exactly the same statements in the context of dietary supplements, and Caronia holds what it holds – which isn’t at all what the government argued.Continue Reading Evening The Score On Off-Label Use Information

Photo of Stephen McConnell

During a recent Surfin’ Safari we must have told the DDL Son at least five times to slather on more sunscreen.  Naturally, he engaged in the usual noncompliance-defiance and, naturally, now has a face adorned with a scarlet nose.   Years ago there was a famous commencement address built on the advice that everyone should wear sunscreen.  Sunscreen sometimes makes a cameo appearance in the news of the weird.  We learned that American Army World War II tins of sunscreen and bacon recently turned up on the Salisbury Plain (not so far from Stonehenge).  And we were brought up short when we read that some sunscreen products were recalled because they might ignite.

In this season of Summer Fun and marathon photosynthesis sessions, God Only Knows how ignorant and indifferent so many of us are about the need for sunscreen.  Do you use sunscreen?  (You should – and not just when you are reading the latest Lisa Scottoline thriller at the Jersey Shore.)  Do you know what the SPF (sun protection factor) numbers mean?  (SPF 15 means that only 1/15th of the burning radiation will reach the skin, SPF 30 means only 1/30th will, SPF 50 means only 1/50th will, etc.)  How often should you reapply sunscreen?  (At least every two hours.  Then Do it Again.)  How  much should you use? (Way more than you think.)

Who regulates sunscreen?  (The FDA.  Sunscreen is considered an over-the-counter drug.)

And therein hangs the tale of today’s case, Eckler and Engel v. Neutrogena Corp., — Cal. Rptr. 3d –, 2015 Cal. App. LEXIS 584 (Cal. App. 2d Dist. June 9, 2015).  Two plaintiffs brought slightly different claims that sunscreen labeling was misleading, and those claims were Shut Down by the California appellate court (one that really knows about sunscreen) on grounds of preemption.  Up front in the opinion, the court sums up the issue nicely:  “This case concerns congressional intent with respect to label information on sunscreen products: is it to be determined solely by the federal agency it charged with ensuring uniform labeling for those products, or, in addition, by each state through private civil suits.”  That formulation captures the need for preemption to ensure uniformity and to apply agency expertise.Continue Reading Fun Fun Fun: Cal Court Dismisses Sunscreen Cases on Preemption

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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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