[Drug and Device Law] "May the Odds Be Ever in Your Favor" - The Ten Best Prescription Drug/Medical Device Decisions of 2015

The iconic Hunger Games line, “may the odds be ever in your favor” pretty much sums up how we feel about our top ten best decisions of 2015.  These are results that put the “happy” in Happy New Year – which we wish all our readers as the year in question draws to its inevitable close.

So, with cannons sounding for the plaintiffs involved, we give to you our picks for the ten best judicial decisions of 2015 (along with our customary ten additional honorable mentions) involving prescription drugs and medical devices. 

  1. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., ___ F.3d ___, 2015 WL 8538119 (6th Cir. Dec. 11, 2015).  This year’s number-one arrived relatively late, but it was definitely worth the wait.  When we first read Bartlett (2013 +1), we were struck by the Court going out of its way to state expressly that the FDA-pre-approval requirement for design changes applied to all prescription drugs.  That reference to “branded or generic” had to have a purpose.  Yates is the first court of appeals expressly applying the logic that all design changes requiring prior FDA review are preempted.  Post-approval, the FDA must review all “major” or “moderate” changes to drug design, rendering simultaneous compliance with an immediate state-law duty to use a different design impossible.  A “pre-approval” design defect claim (that the defendant should have submitted a different design to the FDA in the first instance, was speculative and would have required FDA approval of the different design in any case.  This “never-start selling” claim was also preempted because it was the same as the “stop-selling” claim rejected in Bartlett.  States cannot preclude the sale of what the FDA approved.  The bad Wimbush case (2008 -1) – from the same court of appeals (indeed, both originating in N.D. Ohio) – is limited to its facts (a drug already removed from the market), and doesn’t prevent preemption of design defect claims where the FDA continues to approve the product.  Application of a good No. 1 decision to confine a bad No. 1 decision is indicative of another good No. 1 decision.  Beyond that, Yates-based preemption would erase the non-generic stop-selling claim allowed in Pennsylvania in Lance (2014 -2).  Yates suggests that design defect claims against branded prescription drugs (and eventually §510k devices) are on their way out.  We wasted no time yacking about Yates here.
  2. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  Over the last couple of years, there have been a lot of good trial court decisions on off-label promotion and preemption (most, but not all, involving Infuse).  None of those decisions was better than Caplinger (2013 +9).  Because it was so good (a complete dismissal), Caplinger could be appealed.  This year it was affirmed, and the affirmance was just as good.  Off-label use does not provide plaintiffs with a get-out-of-preemption-free card.  If Congress had wanted to exempt off-label use (which it knew about, see 21 U.S.C. §396), from preemption, it would have done so expressly.  Claims that would require changes to labels or design are “different from or in addition to” what the FDA approved and are preempted.  Challenges to the legality of purported off-label promotion are purely matters of federal law and thus aren’t equivalent to any recognized state-law claim.  Indeed, to the extent plaintiffs identified any federal regulations at all, their claims “substantially exceed[ed]” them.  Adulteration/misbranding are FDCA, not state-law, violations.  If Congress wishes to set a different balance, it can, but until it does, all the plaintiffs’ litany of claims about off-label use/promotion of a PMA medical device are preempted.  The fact that plaintiffs have sought Supreme Court review in Caplinger (#15-321) only underscores its significance as a preemption milestone.  We celebrated Caplinger here and here.  Full disclosure:  Reed Smith is involved in Caplinger, so consider this entry a non-RS post.
  3. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015).  Where it exists, federal preemption is the strongest defense our clients have.  So it shouldn’t be much of a surprise that our top three decisions are all appellate courts recognizing that FDCA-related preemption extends to new areas.  Celexa was the first appellate decision recognizing that Mensing (2011 +1) impossibility preemption cannot be limited to generic drugs.  Celexa was brought by some rather self-important plaintiffs seeking, under state law, to enjoin the sale of an FDA-approved drug because the efficacy data on which approval was based was allegedly wrong.  That presented a problem – the efficacy data at issue had already been reviewed by the FDA, and plaintiffs offered nothing new.  Since the rationale Levine (2009 -1) employed against preemption was that innovator manufacturers were free to change their labels based on “new” information (the changes being effected (“CBE”) exception), a label-related claim that fell outside the scope of the CBE exception, here, that involved only “old” information, was preempted.  While this type of informational claim isn’t all that common, the principle that Celexa established – that Mensing’s implied preemption logic extended beyond generic drugs – is critical.  We pointed out the broader implications of Celexa here.
  4. David v. Medtronic, Inc., 188 Cal. Rptr.3d 103 (Cal. App. 2015).  CAFA provides that actions including more than 100 plaintiffs are removable to federal court as “mass actions.”  Predictably, the other side started filing complaints with dozens (but never 100) of blatantly misjoined plaintiffs from all over the country with nothing in common except suing over the same drug/device.  There would always be a couple of plaintiffs from the forum state, and a couple of plaintiffs from the defendant’s home state to destroy diversity as another ground for removal.  This gamesmanship has been particularly widespread in California.  The David decision goes a long way to putting a stop to this in the nation’s largest and most litigious state by affirming severance of all the out-of-state plaintiffs on the basis of forum non conveniens, since the defendant wasn’t based in California either.  There were Bauman personal jurisdictional problems with the case, and the court recognized that the “same transaction” standard for joinder wasn’t met by anybody anywhere in the country claiming the same injuries from the same product.  The medical treatments were different, and so were the doctors, hospitals, and the informational and temporal context in which each individual case arose.  The non-California claims could be brought in those plaintiffs’ home states, so litigation tourists go away and stop clogging our courts.  Peripheral claims against nominal defendants don’t count against forum non conveniens, and if plaintiffs chose, they could continue with those peripheral claims in California.  We harmonized with David’s beautiful music here, and put the decision in perspective here.  Full disclosure:  David is a Reed Smith case, so this entry is also non-RS.
  5. Sergeants Benevolent Ass’n Health & Welfare Fund v. Sanofi-Aventis United States LLP, 806 F.3d 71 (2d Cir. 2015).  We admit we were a bit depressed after the Third Circuit went south in the Avandia decision (2015 -3).  Then along came the Second Circuit to cheer us up again.  Like Avandia, SBA was a third-party payer RICO case; unlike Avandia court of appeals shut the SBA plaintiffs down.  The allegations had a Buckman-like tinge – that a questionable clinical study supported FDA approval, and then the defendants promoted off-label.  Because RICO is a federal statute, however, preemption isn’t a defense.  But causation is.  SBA rejected the doctors-don’t-matter refrain from Avandia.  To the contrary, prescribing physicians are central where prescription medical products are concerned.  “Generalized proof of causation was impossible because of the intervening actions of prescribing physicians.”  The varying effects of differing misrepresentations on independent decision makers make causation impossible to prove on anything but an individualized basis.  Against an FDA-approved drug, plaintiffs could not claim that “nobody” would have used it had the purported “true” risks been know.  That is “stop selling” by another name.  Nor could plaintiffs avoid the learned intermediaries’ role with “simplistic” statistical analysis.  Plaintiffs could not get to a class action by dumbing down the elements of their substantive claims.  Thus some inordinately long-running litigation (more than seven years) finally came to an end.  We bid SBA adieu here.
  6. Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  Holy cow.  Bye-bye baby.  Outta here!  When we (well, Bexis) started advocating the First Amendment as a defense in the off-label promotion context twenty years ago, there wasn’t much traction.  Bone Screw cases turned out to be much easier to win on other grounds.  Fast forward two decades − past WLF, Pearson, Western States, Sorrell (2011 +5), and Caronia (2012 +7) − and things sure have changed.  At least in the Second Circuit, thanks to Caronia, truthful off-label promotion is First Amendment-protected speech, which the FDA (and, by extension, private plaintiffs) cannot prosecute.  Amarin was the first case in which the regulated manufacturer went head-to-head with the FDA, stuck it out, and won in court.  The plaintiff company’s science wasn’t what the FDA considered “substantial evidence,” but it was valid science.  What the plaintiff company wanted to tell potential prescribing physicians was truthful, properly disclaimed, and thus not “false or misleading” even though it concerned off-label use.  The FDA doesn’t want to appeal.  We went yard over Amarin here and here.
  7. Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 135 S. Ct. 1378 (2015).  It’s from the Supreme Court and it involves prescription drugs, but it’s not directly applicable to product liability.  It is relevant to, and reinforces, first, the Buckman preemption rationale against private enforcement of statutes like the FDCA where private enforcement is not allowed; and, second, why alleged violations of vague regulations cannot escape preemption.  Armstrong involved a Medicare statute, not the FDCA, but the reasoning is the same – indeed Buckman is a fortiori because the FDCA’s prohibition against private enforcement is express, whereas that in Armstrong was only “implied.”  The implication came from the statute’s provision of a single remedy for violations, one conferring no rights to individuals.  No private enforcement was allowed because “express provision of one method” of enforcement “suggests that Congress intended to preclude others.”  On the second point, the Medicaid statute’s requirements were vague, and thus “judicially unadministrable,” providing a second basis for Congress wanting the remedy that it provided to be exclusive.  The same reasoning should preempt the holdings of a number of courts allowing “parallel” claims purporting to enforce vague FDA manufacturing-related regulations.  We discussed the implications of Armstrong here.
  8. State ex rel. J.C. v. Mazzone, 772 S.E.2d 336 (W. Va. 2015).  Just as in California (see Martin, above), forum-shopping litigation tourists took it on the chin in West Virginia.  Instead of Bauman, however, this case was decided solely on old fashioned forum non conveniens grounds.  It was the same game playing, though – dozens of out-of-state plaintiffs misjoined in the same complaint.  Because neither the plaintiffs nor the defendant was from West Virginia, and plaintiffs could all sue in their states of residence, West Virginia was an inconvenient forum.  The ordinarily “great deference” given to a plaintiff’s choice of forum is diminished where a nonresident sues over matters not arising in the state.  The defendant’s difficulty in obtaining discovery from fact witnesses in plaintiffs’ home states worked sufficient “injustice” to support the forum non conveniens finding.  All of the considerations discussed by the court would be the same in any litigation tourist case against an out-of-state corporation, thus Mazzone, if followed by the trial courts of West Virginia, effectively ends multi-plaintiff, out-of-state, CAFA avoiding complaints in this state.  We explained the significance of Mazzone here.
  9. In re Zoloft (Sertraline Hydrocloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015).  The best Daubert decision of 2015 was either this one or a similar decision (both excluding the same expert) in the Lipitor MDL.  We chose this one because Zoloft involved a higher degree of Daubert difficulty, since there actually were some (older, smaller, and otherwise less persuasive) studies that reached adverse, statistically significant results.  The plaintiffs, and their result-oriented statistical expert, were ultimately done in by more recent, more powerful studies that refuted the supposed connection between cardiac birth defects and Zoloft that plaintiffs’ expert tried very hard to invent.  This was a do-over – plaintiffs had their first batch of experts all excluded under Daubert − so this guy was their last chance, and they knew it.  Everything was heavily litigated, and, the lengthy opinion thoroughly addressed Daubert issues like a priori reasoning, statistical significance and p-values, cherry-picking, after-the-fact statistical manipulations, confounding, and re-analysis of published data.  Daubert is the second strongest MDL defense strategy (after preemption) and as the year draws to a close, the result here means that all the cases in the Zoloft MDL are likely subject to summary judgment.  We analyzed Zoloft here, after complaining about the do-over here.
  10. In re Incretin-Based Therapies Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 6912689 (S.D. Cal. Nov. 9, 2015).  The Levine (2009 -1) clear evidence test for implied preemption in prescription drug cases can be met – that’s the lesson of Incretin.  It’s tough, but it can be done, and successful preemption can shut down an entire MDL.  Plaintiffs claimed that the drug caused a disease (pancreatic cancer).  Trouble is, the FDA decided time and time again that any causal link was “indeterminate” and shouldn’t appear on the drug’s label.  Plaintiffs’ experts could manipulate the data (such as notoriously inaccurate – the court acknowledged this – adverse event reports) all they wanted, but the fact remained that the FDA had looked at everything and said “no.”  Hence, preemption existed under Levine’s “would have rejected” standard, which the court refused to make worse than the Supreme Court already had.  The court recognized that, when the FDA calls for data from all manufacturers of a class of drugs, it has more evidence at its fingertips than any one of the competing manufacturers, which was unlike Levine.  Nor is it necessary that the FDA definitively rule out causation; a conclusion that causation hasn’t been shown to the FDA’s regulatory standards is enough.  Finally, plaintiffs cannot avoid preemption by arguing fraud on the FDA.  That’s preempted, too, and plaintiffs can’t second-guess the FDA’s administrative process.  What the FDA considers, or not, is within the discretion of the Agency.  A final plus factor in Incretin was that both federal and state judges had heard argument of the motion, and the state judge agreed.  We announced that Christmas had come early in Incretin-land here and mentioned the state-court’s concurrence here.

That’s our top ten, but as usual our side’s noteworthy wins in 2015 didn’t stop with ten.  Thus, we’re acknowledging ten more favorable decisions this year that fell just short of cracking our top ten.

Here are our Honorable Mentions:  (11) Shepherd v. Vintage Pharmaceuticals, LLC, ___ F. Supp.3d ___, 2015 WL 6956767 (N.D. Ga. Nov. 4, 2015).  Plaintiffs don’t dare bringing personal injury class actions against prescription medical products much anymore.  Shepherd is a timely reminder why that’s true.  We blogged about denial of class certification here.  (12) In re Accutane Litigation, 2015 WL 1504304 (N.J. Super. Law Div. April 2, 2015).  The court’s ruling that the drug’s warnings were adequate as a matter of law pretty well shut down this long-running litigation, as discussed here and here.  (13) PomWonderful, LLC v. FTC, 777 F.3d 478 (D.C. Cir. 2015).  The First Amendment applies to the FTC, too, and truth is not to be judged by the FDA’s “substantial evidence” test.  We celebrated another appellate free speech win  here.  (14) Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), and Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 5836973 (S.D. Ohio Oct. 2, 2015).  These twin decisions would have ranked higher, except that Yates stole some of their thunder.  Rheinfrank I was a relatively rare finding of preemption against plaintiff’s most dangerous warning claims under the Levine (2009-1), as well as some useful state-law (Ohio) rulings.  Rheinfrank II added design defect preemption.  We discussed Rheinfrank here, and Rheinfrank II here.  (15) Johnson v. Smithkline Beecham Corp., 2015 WL 1004308 (E.D. Pa. March 9, 2015).  How many of us – particularly in mass tort litigation – have thought that many of the plaintiffs’ cases are so patently weak as to be frivolous and sanctionable?  In this case, the court granted sanctions, based on the statute of limitations and product identification.  We never blogged on this case because of Reed Smith’s involvement in the litigation, but it merits an honorable mention.  (16) In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286 (N.D. Ill. Nov. 9, 2015).  TRT deflated the last-ditch generic plaintiffs’ argument that generic drugs that did double duty as FDA reference listed somehow lost the protection of preemption.  We got a rise out of that, here.  (17) Shuker v. Smith & Nephew, PLC, 2015 WL 1475368 (E.D. Pa. March 31, 2015), certif. for appeal denied, 2015 WL 4770987 (E.D. Pa. Aug. 13, 2015).  Component parts, off-label use, failure to report – you name it, plaintiffs threw it at PMA preemption – without success, as we discussed here.  (18) Mink v. Smith & Nephew, Inc., ___ F. Supp.3d ___, 2015 WL 7356285 (S.D. Fla. Nov. 19, 2015), the FDA has increasingly conditioned its approval of a product on the manufacturer conducting post-approval clinical trials.  Does participation in such a trial avoid preemption.  Fortunately, as a matter of first impression, Mink said “no” – a result we liked, here.  (19) Latimer v. Medtronic, Inc., 2015 WL 5222644 (Ga. Super. Sept. 4, 2015).  Believe it or not, the best reasoned trial court-level Infuse decision anywhere might just be state trial judge’s opinion from Bexis’ home town of Atlanta, Georgia.  Read it and marvel, here.  (20) In re Actiq Sales & Marketing Practices Litigation, 307 F.R.D. 150 (E.D. Pa. 2015).  Nationwide third-party payer class action alleging state-law causes of action.  While denial of certification is the rule, this opinion is jam-packed with the defense-side goodies that we detailed here.

Looking over our 2014 lists, we’re pleased that our number one bad decision, Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (2014 -1), was erased by the legislature before that opinion even had time to receive a reported citation.  Unfortunately, courts arrogate to themselves authority to change law retroactively while refusing that power to legislatures, so there could still be some Weeks-governed stragglers.

All the other bad boys from 2014 still survive, although Lance (2014 -2) is menaced by Bartlett (2013 +1) preemption.  Discretionary review in Hardin (2014 -5) and  Scott (2014 -7) failed.

An appeal in Actos (2014 -3 and -9) vanished with a settlement, however, the pre-suit spoliation rationale of the earlier Actos decision (2014 -9), has been done away with by the new Rule 37(e)(2) (effective 12/1/15 and discussed here), limiting severe sanctions for intentional spoliation to intent related to “the litigation.”

Our entire roster on the plus side of the 2014 ledger is intact, although as we mentioned last week Corber (2014 +4) was a victim of drive-by distinguishing by a subsequent panel.  On the other hand, the preemption result in Booker (2014 +7) was effectively affirmed by Yates. 

Looking ahead, the California Supreme Court in Bristol-Myers-Squibb will eventually rule on personal jurisdiction post-Bauman – almost certainly a top- or bottom-ten case depending on result, with an eventual appeal to the United States Supreme Court likely, again regardless of the result.  United States Supreme Court certiorari petitions are currently pending in this year’s POMWonderful (good) and Reckis (bad).  Guvenoz may join them, the Illinois Supreme Court having denied review, but the Supreme Court has turned down all post-Bartlett generic preemption (including Pennsylvania (2014 -4) and Iowa (2014 +3)) to date.  Other cases almost sure to land on our top- or bottom-ten list for 2016 Cisson v. Bard, currently pending in the Fourth Circuit, on the issue of admissibility of FDA §510k clearance, and the Arizona Supreme Court’s review of Watts (2105 -6), concerning the learned intermediary rule.

Finally, on the administrative front, as we predicted, the FDA’s proposal to change the rules to eliminate generic drug preemption got nowhere in 2015.  It’s now not even scheduled to be finalized administratively until July, 2015, at the earliest.  Given the legal hurdles that await after a final rule, frankly, we don’t expect it ever to go into effect.  We’re a lot less certain what will happen with the FDA’s proposal (discussed here) to amend the “intended use” regulations that it has used to prohibit truthful off-label promotion.  Here’s hoping the Agency is forced to confront First Amendment issues so that, assuming this rule is finalized, the validity of the FDA’s ban can likewise be challenged directly via appeal from the Agency’s final rule.

So now we’re done with 2015.  All in all, a pretty good year.  We wish a Happy New Year to all our readers, especially to those  on the right side of the “v.”.

Posted By Bexis to Drug and Device Law at 12/31/2015 08:00:00 AM

You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.

[MMIT New Moon Manifesting call Jan 7th - NEW 6 month sign up option - Music of the Spheres

 New Moon Manifesting Call
January 7, 2016 6:00 pm PST
7:00 pm MST 8:00 CST 9:00 pm EST

Pre -registration ends at 5:30 pm PST day of event.
Greetings Dear One...
Capricorns powerful determined energy is ready to support
you in structuring your goals for 2016!  Prepare for the
new year with this powerful new moon! 

(Watch your emails for a New Year Numerology Call.
Details Coming soon. Save the date Jan. 12, 2016)

Join DaKara Thursday January 7th as you'll take a magical
journey into sacred space within the meadow.
CLAIM 3 things for yourself for 2016!
We will step into a magical underground amphitheater
and be embodied through the Music of the Spheres
Allowing the tones, sounds and frequencies to
anchor your hearts desires!

  Allow the energy of Earth to assist you in creating a strong foundation for 2016. Capricorn - the fish tailed goat can launch you into action with your goals and desires. Manifesting
anything takes action!   Capricorns determined energy
can support you to take action steps in 2016!

Deep within your heart is a magic ready to be accessed the unfolded carrying you forward in your divine uniqueness!

  First you will release what is no longer serving you by bringing down the light to clear, balance, transform and heal the part
of you that is holding you back to manifesting what you are wanting.
  What wishes or goals are you ready to bring into the physical?

  Join us as we journey deep within, where you will set your intentions, goals and what you are ready to achieve in its highest form and raise your vibrational frequency and then anchor that into your physical body.   We will chant your wishes into the part of your being that creates miracles in your life!

Sign up now and be entered to win a private
session with DaKara! Details below!
What are you desiring? What choices are you ready
to step into energetically?
What's holding you back?
 Allow the energy of  Earth  ~ Capricorn to support and transform you in manifesting your true purpose this
life time. Playing with the energy of Cardinal Earth!
What Miracles await you?
Sign up now to learn more about Astrology or for the
Healing and Meditation or both!

New Moon

January 9, 2016
5:30 pm PST – 8:30 pm EST
20 degrees Capricorn

 Register now with a chance to WIN a one on one 20 min
session with DaKara! (Value $80)

pre-register until
January 7th, 3:00 pm PDT
to be in the drawing.
You now have the option to sign up for 6 months
of New MoonCalls and receive one month free. 
This is the best deal for those  who attend the calls regularly.  You will only have to sign up onto
the list once and will be automatically entered into
the drawing to win a one on one with DaKara.

Cost Only $90.90 for January through June 2016
Or pay monthly
Pre Register for only $18.18 and receive the replay too!
($30 Value) Post class price $21.21
Sign up in advance and save.
 During the meditation I will guide you into the sacred circle of healing light where the real magic happens!
  Learn about the energy of this new moon.You will experience a powerful healing,and be guided into the manifesting matrix to support your dreams and wishes!
Powerful Healing and Meditation to help you transform what is no longer serving you.  The healing meditation is a separate recording so you can easily listen over and over to that portion to work on and transform several areas of your life.
  Call duration approx  60 minutes
(usually closer to 70 minutes as I tend to over deliver!)
Pre -registration ends at 5:30 pm PST day of event.
Share from attendee!
"DaKara's new moon guidance is thoughtful and insightful. ​Her clear intuitive direction to
capture what the stars and the universe are simply magical. I was laid off last year and
since have been writing new moon checks. It's nothing short of a miracle that I've been
able to cover my bills. I love that DaKara keeps it simple by directing one to ask for more,
and not in the form of money. It was especially comforting for me in the recent call
where she suggests writing a check for sustenance. Thank you for being a
guide to supporting people to live a life that is large and glorious!!"
Melissa Grillo, CA

Each month we are given time to till the soil of what we
want to manifest...
The Dark of the Moon time or also known as 'Balsamic' Moon.  About 2.5 days before each new moon, we are in this extremely fertile time to go within and focus on what we are choosing to manifest in our lives. Using the energy of the astrology sign the new moon is in, as well as the house the new moon touches on for you, we will create the energy within the group to support you on your journey!
By signing up in advance, your name will be entered into a drawing for a 20 min session with me on the phone or via Skype!
How does it get any better than that?
In this class you will learn/experience:
  • Learn about the energy of the sign of the new moon.
  • Learn the Sabian Symbol of the new moon.
  • Learn about the energy of the houses.
  • I will offer a live healing to clear and relinquish the energies that maybe holding you back around what you are wanting to manifest during the upcoming new moon.
  • Meditation to assist you in creating!
If you have your birth chart, have it handy for the call! If you need  a chart go to www.Astro.com to get a free chart... or sign up to get a mini new moon reading with me to personally assist you!
Go to====>>>> http://NewMoonCheck.com/mini-readings/
Not able to attend the live call?  Sign up now to receive call in details and access to the replay!
 I will send out the replay recording within 24 hours of the call! 
Plenty of time to listen and be ready for the new moon!
Pre -registration ends at 5:30 pm PST day of event.

Love & Blessings
Team DaKara

P.S. Share this with your friends and family!

P.S.  Take advantage now of the special 6 month sign up.  It ends when pre-registration ends.  Receive one month free.  Next month I will offer the same price but for 5 months.  This will simplify the process for you as a regular to the calls  :)

P.S.S.   Happy New Year!
Soon I will be putting the final touches on the January 12th Numerology call details.   Learn about the coming year 9 and how to calculate your personal year number and how those two numbers may play together.

P.O. Box 4338
Everett, WA 98204, USA

Journeys Into Wholeness
DaKara Kies, Author, Master Energy Healer, 
Light Alchemist, Sacred Transformationist,
Certified Inspiration, Money & Relationship Coach.
Intuitive Reader, Feng Shui Consultant & Artist



[Drug and Device Law] N.D. Mississippi Invokes Buckman in Rejecting Plaintiff Efforts to Screw Up Product Liability Law

We are determined not to end 2015 on a bad note.  Thus, we turn, as we do with surprising frequency (and as we did last week), to a federal court decision out of Mississippi for a heaping helping of solid legal reasoning.  The case is Estes v. Lanx, Inc., 2015 U.S. Dist. LEXIS 171184 (N.D. Miss. Dec. 23, 2015), and the court got everything right.  The case involves the usual panoply of product liability claims against a spinal fixation system.  After a surgery on the plaintiff in 2011, two pedicle screws fractured.  A revision surgery was performed in 2012. The plaintiff then sued, claiming that the pedicle screws were negligently designed or manufactured, that the defendant breached warranties as to the pedicle screws, and that the defendant had failed to obtain FDA clearance for the spinal fixation system. 


Mississippi has a Products Liability Act (the MPLA) that supplants common law claims, such as negligence or negligent misrepresentation.  We wish every state enacted a product liability act.  In fact, we wish every state enacted the MPLA.  The MPLA requires a design defect claim to suggest a feasible alternative design.  The plaintiff offered no such alternative design, so that theory was dismissed.  The manufacturing defect and failure to warn claims also foundered, though there were wrinkles to those claims, and the court’s ruling on those wrinkles made the decision even better.


The plaintiff’s amended complaint alleged that the “Pedicle Screws are not made in accordance with the defendants’ [sic] specifications or performance standards.”  But the plaintiff never stated how the pedicle screws at issue deviated from manufacturing specifications.  Nor did the plaintiff reference any manufacturing specifications at all.  Rather, the plaintiff was reduced to arguing that the mere proof of malfunction created a genuine issue of material fact as to a manufacturing defect under the MPLA.  Unfortunately for the plaintiff, Mississippi law says no such thing.  There needs to be proof of an actual manufacturing defect.  At this point, the plaintiff fell back on an accusation of spoliation, alleging that the defendant should have collected and maintained the broken pedicle screws after their removal. But remember what John Adams said about facts being stubborn things.  It was undisputed that while the screws were not recovered after surgery, they had not been destroyed by the defendant or any of its representatives.  Because there was no genuine issue of material fact as to bad faith on the part of the defendant, no spoliation instruction was warranted, and because there was no evidence of manufacturing defect, the manufacturing defect claim was dismissed. 


Any failure to warn claim flunked the learned intermediary doctrine, because the plaintiff failed to establish that the treating physician would not have used the product had he received an adequate warning.  Indeed, the treating physician did testify in his deposition “that he was aware of the risks of spinal fusion surgery and implantation of fusion devices, including the possibility of device failure.”  That is not surprising.  Most spinal surgeons undoubtedly know this. Further, even knowing those risks, the doctor testified he still used the spinal fixation system.  The wrinkle here is what the plaintiff alleged had not been disclosed.  The plaintiff was not focused only on undisclosed medical risks.  Instead, the plaintiff alleged that the defendant had a duty to inform the hospital and the attending physician that the spinal fixation system had not been properly cleared and that a standalone 510(k) had not been submitted to the FDA.  Again, there was no showing of warning causation.  The doctor did not testify that a warning about the alleged FDA procedural problem would have changed his prescribing decision.  Moreover, the plaintiff’s “own expert testified that connecting the Plaintiff’s injury with the alleged failure to properly file with the FDA would be improper as it was too speculative.”


On its own initiative (which we applaud), the Estes court raised the issue of whether  the plaintiff’s claim that the spinal fixation system had not received proper FDA 510(k) clearance was foreclosed by Buckman.  The court’s brief discussion of this point makes our flinty defense hearts warm and our minds optimistic.  The court asked for further briefing as to whether federal law impliedly preempts the causes of action based on the propriety of submissions to the FDA.   It is hard to see how the plaintiff wriggles out of that problem, particularly with a smart judge reading the briefs. 


Finally, the breach of warranty claims also got consigned to the dustbin.  There was no evidence of any express warranty being made to the plaintiff, or that the plaintiff relied on any such warranty (including whether the spinal fixation system had been properly cleared by the FDA).  Lack of reliance also eliminated the claim for breach of an implied warranty of fitness for a particular purpose.  Finally, the claim for breach of implied warranty of merchantability was dismissed because there was no proof that the plaintiff had attempted to contact the defendant when it was discovered that the pedicle screw was broken, or that the defendant had been afforded an opportunity to cure.   Mississippi is a state that follows warranty law to the letter. 


Thank you Mississippi, land of Faulkner, Viking ranges, great ballet, Manning football stars not named Peyton, and lovely product liability decisions. 

Posted By Steve McConnell to Drug and Device Law at 12/30/2015 07:30:00 AM

You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.

[Drug and Device Law] Odd Facts Lead to Unfortunate Split Preemption Decision

            We are no strangers to odd facts leading to odd results.  The law develops in response to situations.  When new or different situations arise, courts have to interpret the existing law and then apply it to the new circumstances.  Usually the changes evolve over time – a twist here, a turn there.  Legal precedent is hardly ever a straight line.  There are even a few right angle turns and the occasional u-turn.  Sure, there are a few straightaways as well – concepts so deeply rooted as to withstand almost any challenge.  But more often than not, when there is a true dispute, it’s about those twists and turns. The places where authority is split or where the precise issue has yet to be dealt with.  And when you have both unique facts and split authority – you get decisions like Raab v. Smith & Nephew, Inc., -- F.Supp.3d --, 2015 WL 9026631 (S.D.W.Va. Dec. 15, 2015).

            Plaintiff underwent a hip resurfacing surgery in which defendant’s PMA, Class III medical device was implanted.   Due to a fracture of the device, a revision surgery was needed during which some of the PMA device components were replaced with Class II, §510k cleared components.  Plaintiff suffered complications after that surgery as well and eventually underwent a third surgery where all of the defendant’s devices were removed.  Id. at *1.

            Recognizing that she would be facing a preemption challenge to any allegations concerning the PMA device, plaintiff broke her complaint into three sections.  Section I focused exclusively on the first surgery and purported to allege parallel violation claims premised on the FDCA’s Current Good Manufacturing Practices (CGMPs).  Section II focused on the revision surgery and off-label use/promotion allegations.  Id. at *2.  Section III was directed only at the Class II device that was inserted during the second surgery and alleged strict products liability, breach of implied and express warranties, and failure to warn.  Id. at *3. 

            The Raab decision is long and thorough.  It devotes pages to discussing the FDCA, pre-market approval and 510k clearance.  It also contains a detailed discussion of the core preemption decisions – albeit slightly skewed in our opinion.  It is in the application of that precedent where things get a little wonky.

            As to the PMA device, plaintiff’s only allegations were that defendant failed to comply with the CGMPs – general, open-ended, non-device specific regulations that state that the defendant should adopt some sort of process for doing X, Y, or Z.  Plaintiff did not cite to a single PMA, device-specific regulation that defendant allegedly violated.  Id. at *12.  You don’t have to look too far on this blog to uncover what we think of CGMP claims – they are “intentionally vague and flexible standards” that “lack the specificity necessary to support a parallel claim.”  Id.  The Raab court acknowledges but discounts the courts to have so ruled.  Instead, Raab questions why the “generality” of the federal regulation should make a difference in determining whether plaintiff has stated a parallel claim.  We don’t need to go back to Riegel to answer that question.  The Supreme Court addressed it this year in Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 2015 WL 1419423 (U.S. Mar. 31, 2015):

Explicitly conferring enforcement of this judgment-laden standard upon the Secretary alone establishes, we think, that Congress wanted to make the agency remedy that it provided exclusive, thereby achieving the expertise, uniformity, widespread consultation, and resulting administrative guidance that can accompany agency decisionmaking, and avoiding the comparative risk of inconsistent interpretations and misincentives that can arise out of an occasional inappropriate application of the statute in a private action.
Armstrong, 2015 WL 14194231, at *5.  The Supreme Court has spoken --  vague statutory provisions coupled with an express administrative remedy, precludes private enforcement in the courts. 

            The discussion of these CGMP claims gets even more muddled when the court adds to the equation (a) a malfunction theory (because the device failed it must be defective); (b) negligence per se (pushing aside Buckman implied preemption), Raab, 2015 WL 9026631 at *13; and (c) a disregard for TwIqbal.  As to TwIqbal, the court’s reasoning seems to mirror it’s feelings on the CGMPs – general and non-specific is fine to withstand a motion to dismiss and allow the plaintiff to get to discovery.  But this ignores that the TwIqbal plausibility standard is a factual sufficiency standard and that the Supreme Court has said that Rule 8 “does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.”  Ashcroft v. Iqbal, 129 S. Ct. 1937, 1950 (2009). 

            The ultimate holding of Raab on preemption as to the PMA device is that a claim that the FDA-approved design was defective is preempted but plaintiff is given leeway on the claims that the defendant failed to comply with the CGMPs.  Id. at *15.  See id. at *20n.1 (“This Court determines that the plaintiffs’ first two claims for relief are not preempted only to the extent they allege noncompliance with federal regulations and the FDA approval process.”). 

            Section II of plaintiff’s complaint focused on plaintiff’s doctor’s decision to revise her surgery using some Class II medical device components – in other words, off-label use.  Plaintiff’s first claim was that defendant failed to file a PMA supplement seeking approval for the way the device was utilized by her surgeon.  Here the court got it right – the FDA does not regulate the practice of medicine.  Id.  “Accordingly, to the extent the plaintiffs seek to impose liability on the defendant based on [her doctor’s] off-label use of the BHR system, they seek to impose a requirement that is in addition to any provision of federal law and are expressly preempted from doing so.”  Id. 

            The allegations then switch from off-label use to off-label promotion.  Here the court recognizes that a claim based on the device’s labeling would be preempted but that as to other promotion, the decisions are split and the split centers on whether the FDCA prohibits off-label promotion across the board or whether that off-label promotion also must be false and misleading.  Id. at *16.  The court concluded it did not have to weigh in on that debate, finding that for these claims, plaintiff did not meet the TwIqbal standard: 

The claim for relief neither identifies a specific federal standard applicable to any device manufactured by the defendant nor describes how such violation supports a negligence claim under West Virginia law. As such, the fourth claim for relief does not sufficiently plead a valid parallel claim
Id.  But even more interesting about this portion of the decision is that the court seems to be saying that the “misbranding” regulations relied on by plaintiffs are non-specific enough to support her parallel violation claim:

What all of these these asserted violations have in common is an allegation that the defendant was negligent because it failed—in unspecified ways—to market its product in accordance with statutory provisions that merely empower the FDA to impose regulations of its choosing on devices it chooses to define as “restricted.” Critically though, Plaintiffs do not allege that any of the devices at issue were actually classified as restricted devices under § 360j(e), nor do they specify any regulation or restriction enacted by the FDA under any of the cited statutory provisions and made applicable to any device manufactured by the defendant.
Id. at *17 (plaintiff’s off-label promotion claim “fails to create an inference that any federal law was violated because it does not identify any substantive federal requirement made applicable to any device at issue).  This is what we mean when we say odd facts make for odd law.  Here it seems to have led to a split in authority within the decision.  We won’t quibble with the second ruling.

            That brings us finally to Section III – straight state law claims against the Class II devices used in the revision surgery.  As to strict liability design defect, the court once again relied on the malfunction theory to allow plaintiff’s claim to proceed beyond the pleadings stage.  Id. at *18.  The court likewise and not surprisingly allowed the failure to warn claim to stand as well.  Id.  On her breach of warranty claims, the court ruled that an implied warranty of merchantability claim is co-extensive with the design defect claim and therefore allowed for the same reasons.  Plaintiff’s claim for breach of implied warranty of fitness for a particular purpose was dismissed because plaintiff failed to allege a particular purpose that differed from the device’s ordinary purpose.  Id.  The court also dismissed the express warranty claim because plaintiff failed to allege any representations as to quality made to her or on which she relied.  Id.

            So, if you tally everything up – plaintiff can take some discovery on the alleged CGMP violations but she can’t use them to sustain a challenge to the FDA-approved design of the PMA device and her design defect and failure to warn claims regarding the 510k cleared device remain.  While there’s quite a bit of reasoning and language in this decision we could live without, the overall holding isn’t horrendous.  And that’s about as far as we’ll go on this one.

Posted By Michelle Yeary to Drug and Device Law at 12/29/2015 11:07:00 AM

You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.