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This post comes from the Cozen O’Connor side of the blog, not the Reed Smith side.

Last July, in the Tapia v. Davol, Inc. hernia patch case, Davol won its motion to dismiss the plaintiff’s failure to warn claim.  2015 U.S. Dist. LEXIS 98521 at *16-17 (S.D. Cal. July 28, 2015).  The court was clear on why.  While plaintiff alleged facts on what was supposedly missing from the warnings, he alleged no facts suggesting that his own doctor didn’t receive a warning or that, if he had, he would not have prescribed the patch to plaintiff.  In other words, plaintiff did not allege facts to suggest proximate causation.  The court was explicit:

As to Defendant’s second argument regarding causation, while Plaintiff alleges the specific defect in Defendants’ product and specific warnings they failed to provide, he does not allege that Defendants failed to warn his own prescribing physician and that his own physician would not have used the Patch if warnings had been given.

Id. at *16-17.  Allegations about “‘physicians’ in general and the ‘healthcare community’” didn’t provide facts to suggest the existence of proximate causation.  Plaintiff needed to allege “facts as to his own prescribing physician.”  Id. at *17.Continue Reading How Easy Is It to Allege Proximate Causation in a Medical Device Case

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

Smith & Nephew, Inc. continues to push the plaintiffs out of court in a hip implant case pending in federal court in New Jersey.  Earlier this year, Smith & Nephew won its motion to dismiss plaintiffs’ first complaint because it contained almost no facts and plaintiffs’ counsel opposed the motion with nothing more than a tardy letter attaching medical records, correspondence and no legal authority.  See Becker v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 6853 (D.N.J. Jan. 20, 2015).  We blogged about it here.

The court gave plaintiffs another chance, however, and plaintiffs took it.  Things didn’t get any better.  To quote Bugs Bunny’s sign from the classic Gashouse Gorillas episode: “Was this trip really necessary?”   It wasn’t.Continue Reading The District of New Jersey Holds That You Can’t “Discover” Your Way to a Parallel Violation Claim

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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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Any time you find yourself drawing an analogy to asbestos lawsuits, you know you’re in trouble.   We have too often heard plaintiff lawyers or, worse, judges advocate for borrowing procedures from asbestos litigation.  Almost always those procedures would make it easier for plaintiffs to ‘prove’ little things like product identification, and would abridge defendants’ rights…

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This past week you probably heard the low monotone sound that emanates from Patriot head coach Bill Belichick’s mouth whenever he’s explaining deflate-gate and trying to muster up the energy to drool out words that ultimately reveal only that he’s not interested in saying them. His barely operating mouth doesn’t tell you what his eyes so clearly communicate: “This is stupid.  It was a blowout.  It’s stupid, stupid, stupid.  Really stupid.”  His eyes make a better point than his mouth.  It was a blowout and was always going to be.

The same is true of Becker v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 6853 (D.N.J. Jan. 20, 2015).  Like most blowouts, you knew it early on.  Before the court even began analyzing the defendant’s motion to dismiss, it said this, which we describe as foreshadowing with a mallet:

Plaintiffs did not timely respond to the motion.  On December 3, 2014, after their response to the motion was due, Plaintiffs mailed the Court a short letter asking the Court to deny the motion.  Citing no case or other authority, the letter attached what it alleged were medical records of Deborah Becker and an earlier letter from Plaintiffs’ counsel to Defendant’s counsel describing those records.  Plaintiffs later filed the letter and attachments on ECF.

Id. at *3.  Uh-oh.  This was a mismatch from the start.  On one side, we have no cases, no authority, an almost fact-less complaint, and a letter to the opponent that attaches some medical records that was later filed with the court in lieu of a brief, amended complaint or something legal sounding like that.  On the other side, we have TwIqbal and New Jersey product liability law.  If you deflated defendant’s brief by removing half the authorities, you’d still get a blowout.Continue Reading Deflate-Gate Wasn’t the Only Blowout Last Week

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A federal court in Washington produced yet another preemption decision dismissing a complaint in the hip implant litigation.  Hernandez, v. Stryker Corp., 2014 U.S. Dist. LEXIS 171697 (W.D. Wa. Dec. 11, 2014).  The plaintiffs’ complaint referenced two FDA warning letters and a product recall but failed to allege facts connecting any of that to plaintiff’s injury.  Moreover, while the warning letters identified alleged failures to follow cGMPs, plaintiffs alleged nothing to suggest that the FDA specifically imposed those cGMPs on the hip implant device.  And, since parallel violation claims must mirror FDA requirements specific to the approved medical device, plaintiffs’ allegations failed to establish a basis for a parallel violation claim.  Plaintiffs’ express warranty claim had similar flaws.  And so the court dismissed the complaint in its entirely.

Given that this decision, while good, offers no groundbreaking law, and that, more importantly, it’s the holiday season, this is a perfect opportunity for a holiday jingle. Last week, Paul McCartney discussed his song Wonderful Christmas Time on the Tonight Show.  Perfect.  For those who need to rekindle the tune in their heads, here it is.Continue Reading Simply Suing One More P-M-A Device

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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

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What’s left of the OxyContin litigation produced a recent decision that addresses a myriad of procedural and substance issues, some of which we often see and others not so much. If you don’t recall, in 2007, Purdue Frederick Corp. and some of its executives pled guilty to criminal charges related to the marketing of OxyContin and paid approximately $600 million in fines.  That was almost 7 years ago.  The plaintiff in Luberda v. Purdue Frederick Corp., 2014 U.S. Dist. LEXIS 41951 (D.S. Car. Mar. 28, 2014), on the other hand, filed his complaint in 2013 in South Carolina – six years after those guilty pleas and ten years after he became addicted to OxyContin.  Although the court’s opinion doesn’t provide much detail on the background of the case, it appears that the plaintiff was asserting negligent and fraudulent failure to warn claims and attempting to assert a private right of action under South Carolina’s criminal statute on misbranding.  He sued nine companies within the Purdue Frederick family of companies and almost two-dozen executives.

This history created a background ripe for motion practice.

Personal Jurisdiction

Many of the individual defendants moved to be dismiss for insufficient service of process and/or lack of personal jurisdiction.  Two of them won their insufficient service of process motions.  They never signed for the certified mail that carried their summons and complaint.  Id. at *12-13.  Those two defendants and approximately 20 others also won dismissal because they did not have sufficient minimum contacts with South Carolina to be sued there.  The court laid out a useful primer on the procedure for analyzing personal jurisdiction:

The party seeking to invoke personal jurisdiction over a nonresident defendant bears the burden of proving the existence of personal jurisdiction.  ESAB Group, Inc. v. Centricut, LLC, 34 F.Supp.2d 323, 328 (D.S.C.1999).  At the pretrial stage, the burden of proving personal jurisdiction over a nonresident is met by a prima facie showing of jurisdiction either in the complaint or in affidavits. In determining whether a prima facie showing has been made, the Court may consider the uncontroverted allegations in Plaintiff’s pleading.  However, whenever the allegations in Plaintiff’s pleading are contested by sworn affidavit, Plaintiff can no longer rest on those allegations.  Instead, it then becomes Plaintiff’s burden to present an affidavit or other evidence proving that jurisdiction exists over the nonresident defendant.  See Wolf v. Richmond Cnty. Hosp. Auth., 745 F.2d 904, 908 (4th Cir. 1984); Clark v. Remark, 993 F.2d 228 (table), 1993 WL 134616, at *2 (4th Cir. 1993).

The Court summarily dismissed a multitude of defendants because plaintiff simply didn’t make a prima facie showing of personal jurisdiction.  Id. at *11-12.  For four of the defendants, however, the court determined that their affidavits and the complaint didn’t clarify whether they were involved in company’s decision-making regarding the marketing of OxyContin.  Id. at *15.  So the court denied the motions of these defendants, but without prejudice to their raising the arguments again at the summary judgment stage after the plaintiff had a chance for “jurisdictional discovery.”  Id. at *16.

Learned Intermediary Doctrine

The court also applied the learned intermediary doctrine to the plaintiff’s negligent failure to warn claim. Plaintiff’s allegations were, in essence, this: “Defendants owed Plaintiff a duty to properly warn of the potential for and/or risk of addiction associate (sic) with their product.” Id. at *17.  That’s wrong.  South Carolina recognizes the learned intermediary doctrine, and as we all know under that doctrine the manufacturer’s duty to warn runs to the prescribing doctor, not the patient.  Id. at *17-18.  The plaintiff has the burden to show – and allege – that the “undisclosed risk was sufficiently high that it would have changed the doctor’s [prescribing] decision.” Id. at *18.  The court dismissed the claim but gave the plaintiff a chance to amend his pleading to add factual allegations suggesting that his doctor would have changed his prescribing decision had there been a different warning.  Id.Continue Reading An OxyContin Decision That Addresses Everything from Negligence Per Se Claims to Personal Jurisdiction

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If you even dally in one or more of the most popular social media sites (Facebook, Twitter, instagram), then you’ve probably heard about Throwback Thursday — or if you are super cool, #tbt.  Nobody is exactly sure when it started, but by 2013 it was thoroughly ensconced in our social media habits.  Purportedly there are somewhere around 23 million pictures tagged #throwbackthursday on Twitter alone.

What is Throwback Thursday?  Some say it’s an excuse to post your most angelic baby picture or a photo of yourself from anytime in the past when you were thinner than you are now. Or, perhaps post an embarrassing old photo of a friend.  All are legitimate throwbacks.  The only real requirement seems to be a picture so old you actually had to snap a photo of a physical picture to be able to post it.  So, that means you probably need to reach back at least 5 years.

Well, this post reaches back almost 20 years for some of us (Bexis and Yeary).  A time when not only were photos in hard copy, but so were our filings. Mad dashes to the courthouse to beat the 4:00 pm closing rather than hitting the submit button at 11:59 pm. Making dozens of copies to serve on all the parties rather than sending a pdf by email.   Ahh, the feel of warm pages fresh off the printer and the frenzy of cab rides to the airport to make the last Federal Express flight of the night. Sweet memories.Continue Reading It’s Throwback Thursday

Drug & Device Resources

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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