January 2016

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On New Years’ Eve, the FDA released an interesting, and unsettling, proposed guidance indicating that it has plans to go public with what are essentially regulatory guesses, based on what it calls “emerging signals” that might suggest medical device risks.  The formal title of the proposed guidance is “Public Notification of Emerging Postmarket Medical Device Signals.”  It’s not final, and there is currently open a 60-day comment period that closes March 4, 2016.
Basically the FDA is proposing to make public statements about possible device risks (and can drugs be far behind?) if the “emerging signals” meet the following criteria of “proof” – quotation marks intended:

  1. the information represents a new, potentially causal association, or a new aspect of a known association (e.g., increased rate or severity of event or reduced benefit), between a medical device and one or more adverse events or clinical outcomes;
  2. the available information is reliable and supported by sufficient strength of evidence; and
  3. the information could have important clinical implications for patient management decisions and/or could it significantly alter the known benefit-risk profile of the device.

Proposed Guidance at 6 (emphasis added).  The guidance cautions, however, that such “information has not been fully analyzed, validated or confirmed, and . . . the Agency does not yet have specific recommendations.”  Id. at 4.  Further, the communications that the FDA is proposing “may lack certainty about the significance of the information.”  Id.Continue Reading FDA Proposing Regulatory Shots in the Dark

Posted in FDA
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It’s not as if the standard for amending pleadings is a particularly hot DDL topic, but here we go for the second time this week discussing a case where precisely that was at issue.  This time the case was U.S. ex rel. D’Agostino v. EV3, Inc., 2015 U.S. Dist. LEXIS 173025 (D.Mass. Dec. 30, 2015), and, again, the motion to amend was denied.  The reasons for the denial were futility and undue delay.  The reasons for those reasons are fairly interesting.

But first, permit us to vent about qui tam cases.  That “ex rel” in the caption of today’s case tells you that it is a qui tam case.  The D’Agostino case was brought by a former employee of one of the defendants.  Some might call him a whistle-blower.  Some, as we shall see, might not.  He was a medical device sales rep and he alleged that the defendants violated the federal False Claims Act and the False Claims Acts of twenty-six states and the District of Columbia.  A False Claims qui tam action is brought on behalf of the government.  It is a relic from the Civil War era and arose to address sellers of war goods who were cheating the government.   A do-gooder who knew about the cheating would file an action and get moneys returned to the treasury, with the do-gooder taking a cut.  Everybody wins, right?  By the way, the do-gooder is not actually called a do-gooder; instead, the term “relator” is used.  After the relator files a qui tam action, the government then decides whether it wants to intervene in the case.

In D’Agostino, the governments  did not intervene.  By the light of any sentient onlooker, that decision not to intervene suggests that the case is not especially strong.  It also appears that some of the whistle-blowing was no big deal, because some of the allegations were already matters of public disclosure.  That is not at all atypical of these cases.  While the qui tam plaintiffs bar likes to brag about how it is doing a public service, more often the cases are merely opportunistic lunges for bounties.  That qui tam plaintiffs bar is also indignant that not every state has seen fit to pass its own False Claims Act.  Multiple false claims acts multiply bounties without actually increasing any worthwhile enforcement.  And we have not yet even gotten to the bit about how the allegations of false claims are specious because there is no actual false claim.Continue Reading D.Mass. Invokes Public Disclosure Bar, Demands Specificity, and Refuses to Second-Guess FDA in Dismissing Axium/Onyx Qui Tam Case

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

As we noted yesterday, we aren’t much for New Year’s resolutions.  But this blogger was recently invited to the home of friends who have a slightly different tradition.  On New Year’s Eve, as you leave their home, you are invited to take a slip of paper from a basket sitting by their front door.  On each paper is written a random word.  What you do with the word is up to you.  I was told some people tape them to their computer monitor or tack them on a bulletin board.  Others tuck them in their wallets or purses.  The idea is simply to contemplate the word.  What does it mean?  What does it mean to you?  Does it make you want to do something or not do something?  It is more about reflection than resolution.  Maybe that reflection will lead to something positive – maybe not.  But we find the exercise intriguing.  The idea that just one ordinary, everyday word might have a profound impact.  We are only day 5 into the New Year, but having a 5-minute daily time out to “contemplate” has so far been very relaxing.  If nothing else comes of it, that would still be a win.

And speaking of wins . . . . let’s talk about Hernandez v. Walgreen Company, 2015 Ill. App. LEXIS 986 (Ill. App. Ct. Dec. 28, 2015).  Here a single word made all the difference as well – duty.  Actually the lack thereof is what is important.  Suit was brought on behalf of the estate of the decedent who died allegedly from methadone intoxication.  Id. at **2.  Plaintiff sued the decedent’s doctor who had prescribed the methadone for back pain and the pharmacies that had filled the prescriptions.  Id.Continue Reading No Pharmacy Duty, No Pharmacy Liability

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This post does not come from the Reed Smith side of the blog.

Some of us here at the DDL Blog aren’t fans of typical New Year’s resolutions.  You never follow through, and you end up with an unused ab cruncher, a juicer of some sort that stays in the box, and a refrigerator full of rotting fruits.  We prefer atypical resolutions, ones that are more like affirmations.  For instance, I resolve to re-subscribe to Netflix.  I resolve to sleep even later on Sundays.  I resolve to deepen my relationship with chocolate.  I definitely resolve to continue to drink scotch.  Those are viable resolutions, ones that we’ll follow through on.  They remind us what we like to do and that we should do them.  No guilt.  You only feel good.

Along these lines, we hope that some plaintiffs’ counsel have resolved this New Year to miss deadlines.  Courts don’t always enforce missed deadlines.  But when they do the defense usually benefits.  In Thorn v. Medtronic, Inc., 2015 U.S. App. LEXIS 22582 (6th Cir. Dec. 15, 2015), an infuse case, the trial court granted defendant’s motion to dismiss based, for the most part, on preemption.  Id. at *3.  The court entered judgment.  Mr. Thorn, the plaintiff, did not appeal.

Thereafter, he sought leave to amend his complaint and add a fraud count.  Id.  He made the ordinary FRCP 15 amendment arguments—the defendant would not be prejudiced and an amended complaint would be in the interests of justice.  Id.Continue Reading Plaintiff Tries To Amend Under Fed. R. Civ. P. 15 But Is Denied Under Fed. R. Civ. P. 59 & 60

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Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined.  Much like the origins of the Jedi or the major end-of-year holidays as we know them, one would expect a clearer published record of how this came to be.  There can be a tendency to read back from recent experience and imbue our past selves with more knowledge or foresight that we actually had.  For preemption of design defect claims against branded prescription drug manufacturers, we know we have been arguing for it for years and we are not quite sure why it took so long for a Circuit Court to adopt it.  As we noted a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did find preemption, and did it pretty definitively.  So definitively that it took our spot as top decision of 2015.  Along the way, the court declined to follow a prior decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), which itself reversed decisions of the trial court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting summary judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying motion to alter judgment), each of which included the holding that pre-approval design defect and negligence claims were preempted.  It is with the Longs/Wimbush decisions where our story starts, subject to some back story and with a healthy dose of links to past posts.

We first note, however, that it has long been our view, expressed in many posts and elsewhere, that design defect does not make much sense as a theory of liability for a prescription drug.  In most cases, what the plaintiff alleges made the drug excessively risky and thus defectively designed cannot possibly be changed without making it a different drug.  One of the principles of pharmacology is that changes to the chemical compound will typically affect both the desired and undesired effects in the body–or as the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.”  133 S. Ct. 2466, 2475.  Rarely, a true change to the “design” of the active compound can be identified—maybe chop off this ethyl group or change it from a racemic mixture to a stereoisomer—that will plausibly reduce the pertinent risk, while maintaining benefits and avoiding new risks.  Even where that kind of proposed design change exists, the change would make the drug a different product, not a better version of the same product, which is what design defect is supposed to be about.  There may be some cases where a plaintiff claims that a different balance of a combined drug’s ingredients, or an
inactive ingredient, or the delivery system should be changed to reduce the risk without making it a different drug. Even those cases, though, seem better suited to warnings-based claims.Continue Reading The Saga of Preempting Prescription Drug Design Defect Claims

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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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