[DK GreenRoots] Something new on the Spaceship Earth instrument panel
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[DK GreenRoots] Global justice and Reconciliation
http://www.dailykos.com/story/2014/11/30/1348410/-Climate-change-global-justice-and-reconciliation
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[DK GreenRoots] Lima - What can we expect
Post by Mattias Söderberg, Co-Chair of the ACT alliance advisory group on climate change advocacy, and senior advocacy advisor at DanChurchAid, Denmark post:
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[DK GreenRoots] All eyes on Lima
Please join Joshua Weise for a brief overview of the state of affairs going into COP 20 -- be sure to watch the short video by WWF.
Joshua Wiese is Project Director for Global Call for Climate Action, responsible for running GCCA's Adopt a Negotiator and Fresh Air projects. Fresh Air is a GCCA initiative that connects climate and energy bloggers to relevant work being done by GCCA partner organizations.
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[MMIT Super White Light Friday Special -Only10 remain on the TWO for ONE - ends at Midnight PST
Share:
Greetings Dear One...I sent out an email yesterday for the "Super White Light Friday" special... there are only 5 of these spots left. Get the support on your healing, spiritual journey, path now at this special discounted price. Or gift one or both sessions as a gift.See below for the details on the special or click here http://bit.ly/WhiteLightFriPlease follow all directions as noted on the website.Here is a super special my guides asked me to share with you! This have never been offered before and I doubt it will be ever again. This is for one day only - yes, you guessed it on Super White Light Friday - I have never been one to go out shopping on the day after Thanksgiving, I tend to avoid that kind of crazy energies.Special Details:Buy one 30 minute session at regular price of $90.00 and receive an additional 30 minutes to keep or gift to another. (You can gift both if you choose - read below)
So here's how it works:1. Offer good starting now, until Friday November 28, 2015 Midnight Pacific Standard time (PST) West coast of the USA.2. One per person - sorry this offer is too good to allow more than one.3. You must include in your payment (add to the NOTES section on Paypal) the names of those you are gifting the one or two 30 minute sessions to or if one or both sessions are for you. If not noted, my staff will mark both sessions for you personally. (Since this could create a paperwork challenge - I am asking you to include it up front to keep this as simple as possible.)4. If you currently have a package of time - this purchase can be added to that package. (Please note that when making payment.)5. You or your gift recipient will have 6 + months to use the time with me. Time Expires 6-30-15.Click on this link http://www.hpthealing.com/gratitude-special/ to make your special purchase.Much love and blessings to you as we move into this holiday season.With that said.... if you have a challenging time with family this time of year, then this special for one on one time can assist you in moving past that!Blessings of Gratitude!
DaKaraP.S. if you have any questions, please use the "Contact Us" page at www.HPTHealing.comP.S.S. What are you ready to shift in your life? Yes, even in 30 minutes huge and profound healing and shift can and does occur!P.S.S.S. What old pains and emotions are keeping you stuck? Allow the gift of the light and energies of the guides to shift that for you!.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:.
DaKara Kies, Master Energy Healer, Miracle Rainmaker, HPT Master. Certified Inspiration, Money & Relationship Coach. Intuitive Reader, Feng Shui Consultant & Artist
www.DaKara.comwww.HPTHealing.com
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www.DaKaraEssences.comDaKara's Flower Essences for Petswww.Pet-Calm.com www.Pet-Ease.comShare:
[Drug and Device Law] Nothing Helps With Post-Thanksgiving Indigestion Quite Like A Heaping Helping Of Express Preemption
OK, we made that up. It is not true at all. A complete lie, much like “The Dallas Cowboys are America’s Team.” Or “Eating turkey makes you sleepy because of its high tryptophan content.” Or “The pilgrims left England because of their desire to wear stylish hats.” Or “Lawyer advertising for drug and device cases serves an important role in improving medical care.” If you did your duty as an American yesterday and gorged yourself on an assortment of turkey, stuffing, tubers, cranberry compotes, pie, and football, then you may be feeling somewhat bloated today. You have many options to address that feeling, including taking a walk outside before returning to leftovers and more football. Reading this post about a recent express preemption decision will not help with indigestion, but it should not hurt either.
The opinion in Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 U.S. Dist. LEXIS 156563 (D.S.C. Nov. 4, 2014), carved up the product liability claims asserted in connection with a Class III device, specifically a cardiac defibrillator. As our readers know, the Medical Device Amendments of 1976 served up express preemption for Class III devices—basically, those approved though a Pre-Market Application—as to state law requirements that are “different from, or in addition to” the FDA requirements. 21 U.S.C. §360k(a). This has been interpreted by the Supreme Court to bar product liability actions premised on claims that do not impose “parallel” duties on manufacturers. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); our numerous posts on the subject. A parallel claim is a “narrow exception to the rule of preemption” into which some courts strain to stuff plaintiff’s claims. We sometime post on how it grinds us that courts, particularly federal courts sitting in diversity, extend existing state law to allow a claim that would be predicted on non-compliance with an FDA requirement such that imposing liability would not add to the federal requirements on the manufacturer. Like here. We do not have that situation in Hesik, which (drum)sticks with South Carolina law as is. We do have a few twists on the typical arguments we see in cases like this, including that plaintiff had the giblets to move for summary judgment himself.
The plaintiff in Hesik suffered heart block and atrial fibrillation when defendant’s defibrillator allegedly failed within a year of its implantation to replace another, fried defibrillator. Defendant evaluated the defibrillator and found areas of blood, areas that were deformed and bubbly, and areas of heat damage—descriptions of many turkeys yesterday that are less desirable for defibrillators. Accordingly, the defendant dished out a $25,000 credit to the explanting hospital under its five-year vintage warranty and $2500 to the plaintiff under its Unreimbursed Medical Expense Program. Around the same time, the defendant issued a notice that some of its defibrillator models could fail because of a weakened bond between the header and case, which we assume is somewhere near the wishbone. Plaintiff mixed these facts with a sprinkling of citations to regulations and unrelated late-reported manufacturing changes and cooked up both an alleged irrefutable admission of product defect and parallel claims. Although such allegations might let the plaintiff squeeze past a motion to dismiss—as we assume Hesik did here—on summary judgment, the plaintiff needs some proof with his pudding. (As we know from The Wall, er, something about eating meat before pudding. They were speaking British and we are still on heels of an American holiday, so the details are unimportant.) The court sliced, diced, and chiffonaded—seriously, if you not chiffonading your leafy herbs, you are an amateur—the proof proffered for each cause of action and found three of four preempted. Negligent design and manufacturing and strict liability were trussed up and cooked in the same pot. Agreeing with Bass v. Stryker Corp., 669 F.3d 501, 515 (5th Cir. 2012), discussed here, that parallel claims could be premised on the failure of the device to conform to the PMA’s specifications, the court had to look at the evidence of non-conformance—something Bass did not do in the motion to dismiss context. A granular-level look was not a must, because “Plaintiff has failed to offer any evidence that creates a genuine issue of material fact as to how the Defibrillator deviated from the PMA’s specifications.” 2014 U.S. Dist. LEXIS 156563, *20. Implicit in the analysis—embreaded, if you will—was that proof of device failure does not equate to proof of nonconformance with the design and manufacturing specifications for the product made a requirement by PMA approval. Without the right evidence, plaintiff’s negligence and strict liability claims were toast.
Implied warranty claims often travel hand in oven mitt with design defect claims, such that some jurisdictions do not permit both in the same case. In South Carolina, implied warranty claims require proof that the product, as designed, was unreasonably dangerous to the user; finding the difference between this version of implied warranty and design defect claim is like distinguishing between a sweet potato and a yam after you mash them up and cook with brown sugar, cinnamon, butter, and perhaps a marshmallow or twenty. Here, plaintiff pressed that the implied warranty was breached because the product failed within a year. This was easily seen as an attempt to lard an additional requirement on the manufacturer of the defibrillator beyond what was already imposed by FDA. Plaintiff also tried to pour past preemption by asserting claims predicated on violations of federal regulations. We would have liked to see an appetizer of whether South Carolina had such a claim before the entrée of whether plaintiff had mustard the right proof. The regulations the plaintiff had cited—defining implantable pacemakers as Class III devices and stating that express preemption does not apply to “requirements of general applicability . . . such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)”—could not be tied to plaintiff’s device and its alleged failure, so the analysis was cut short. “[W]here a plaintiff relies on nothing more than unsupported violations of general regulations in support of a parallel cause of action, preemption bars the claim.” Id. at *27 (citations skimmed off by bulb baster).
The icing on the cake would have been if the last claim had been preempted, but sometimes cake is better without icing. Here, the express warranty claim—permitted in South Carolina for “any affirmation of fact or promise,” even relayed indirectly to the buyer—was grounded in a voluntary act—the claim that the product would function without failure for five years or certain payments would be made to re-dress any failure. In the context of express preemption—as opposed to the mélange of implied preemption—voluntariness can mean no preemption. Nothing about the PMA process or other FDA requirements required the manufacture to sauce its defibrillator with a warranty, let alone the piquant one used here. Thus, the express warranty claim “presents no risk of interference with the federal medical device regulatory scheme, and the claim escapes express preemption” like some green bean casserole might escape your child’s mouth. Id. at *25. And, as with the vegetables left on the plate (or maybe table cloth), after the rest of the meal has been consumed, who are we to be greedy? * * *
As you may have surmised, we have not-so-cleverly imbedded a variety of food and drink terms throughout the post. In case, you need some further distraction before tackling the dishes from last night or whatever else you will be doing this morning, feel free to do our little word search. If you mark up the post in some efficient way and send your results to Bexis, then he will tally the results (like a scorecard of actual scores for once). The one who identifies the most will get a mention in a future post, which is almost as good as winning something. --
Posted By Eric Alexander to Drug and Device Law at 11/28/2014 08:04:00 AM --
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[DK GreenRoots] Thanks for nature - Video & Photos
Happy Thanksgiving everybody:
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[DK GreenRoots] I Racked Up $2000 Campaign Debt Fighting Fracking; Can You Help Me Retire It?
Please help Seneca Doane if you can. He has been a longtime member of Daily Kos. Thank you, Ned/JnH
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[MMIT Happy Gratitude Day! Sending you Love!

Everett, WA 98204, USA
[Drug and Device Law] A Thankful Strain
“Our rural ancestors, with little blest,
Patient of labor when the end was rest,
Indulged the day that housed their annual grain,
With feasts, and off'rings, and a thankful strain.”
― Alexander Pope, Imitations of Horace
Today isn't officially a holiday, but the preparations for Thanksgiving make it terribly difficult to put in a productive day at the office. (Some uncharitable types will wonder how this day is different from any other for this particular scribe.) Because we will spend at least as much time today picking up organic butter, a bourbon pecan pie, and Beaujolais nouveau as we will perusing babbling briefs, we are thankful. Tomorrow we will plant ourselves at table, poised between gluttony and gratitude.
We decided to canvass our DDL blog colleagues on what was making them thankful. Not surprisingly, some mentioned the learned intermediary doctrine, preemption, and statutes of limitations. There were also shout-outs for Netflix, cornbread sausage dressing, and Eos lip balm. One particularly high-minded blog editor was thankful to be at a law firm that recognizes the value of thought leadership. “It takes a lot of non-billable time to write this blog. A lot! But it is important to our clients and to the patients who need their medicines and devices, and it is important to us.” Just so.
Naturally, Bexis had the most to say. We will quote his list of thanks:
· I’m thankful to DARPA for the internet, without which none of what we’ve done would be possible. There are some things that the government can do right.
· I’m thankful to the tobacco companies for carrying the laboring oar in creating preemption in product liability cases. Cipollone was the first time the United States Supreme Court found preemption in product liability litigation.
· I’m thankful for Alfred Caronia standing up to the FDA when nobody else would.
· I’m thankful for Obamacare because everyone deserves access to life-saving drugs and medical devices, and while I personally would prefer a single-payer system, it was the best we could hope for under the circumstances.
· I’m thankful for off-label use because without it my daughter might have been crippled by juvenile dermatomyocitis, for which there was no on-label treatment.
The author of today’s post also has a list:
· Thanks to the Pennsylvania Supreme Court for the Tincher opinion. Even if Tincher does not quite render our Commonwealth’s product liability law pellucid, it at least strains out the Azzarello murkiness and muck.
· Thanks for the Serial podcast, which has created a whole new cultural conversation.
· Thanks to the Drug and Device Law Daughter for winding up her semester abroad in India without incident. (Well, almost. She was hit by a car, but apparently it was a very small, slow car.) From her Facebook posts, it is clear that she has had quite an adventure in that marvelous country. It is also clear that she disobeyed our strict instruction not to play with the wild monkeys. Never mind. Come home. All is forgiven.
· Thanks to the Drug and Device Law Son for displaying the number one determinant for success in this world: a motor. His capacity for hard work is especially stunning when we contemplate how our own college days were filled with indolence and things that cannot be discussed in a PG-rated blog.
· Thanks to our fellow DDL bloggers for basically writing most of today’s post for us. (Our indolence continues.)
· Last but not least, thanks to our clients and colleagues who offer support and suggestions. We are even thankful for our critics. If you stop by our house tomorrow, perhaps whilst the Eagles are midway through thumping the Cowboys, we will gladly cut you a slice of bourbon pecan pie.
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Posted By Steve McConnell to Drug and Device Law at 11/26/2014 07:30:00 AM --
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[MMIT Divine - Are you ready to be a part of the Sisterhood?
Share:The Sisterhood of the Sacred Scarves that is!Greetings Dear One...Who and what is the Sisterhood of the scared scarves?The story behind the Spirited Woman Prayer Scarf…"Nancy Mills, the founder of The Spirited Woman, a leading women's empowerment community, founded the Sisterhood of the Sacred Scarves to honor women through scarf and ceremony. The Spirited Woman Prayer Scarf is a symbol of spirit, empowerment and beauty. To date, there have been 12 scarves each representing a different theme - more than 1300 have been sold worldwide, connecting women together energetically. A portion of all scarf proceeds is donated to the Spirited Woman Foundation to help heal and support women through actions of empowerment, The foundation has supported six non-profits to date."Join us as we celebrate the Divine - it lives within you! I am honored that Nancy has asked me again to create our ceremony for this magnificent scarf!"Scarf is in my hands and it is beautiful. I felt the energy in it the moment I unwrapped it. Thanks for everything. Love, Lisa"In honor of DIVINE and our 3rd holiday season together, a sacred healing ritual, "The Essence of Divine" will be led by Master Energy Healer DaKara Kies and Nancy Mills on January 8, 2015 at 5pm PST.Filled with divine radiant energy, each reversible scarf flows with a magical flower-patterned design and gold threads throughout. The scarf comes in two color palettes - Black (this is our first black scarf ever!) and Teal Green - the inside of both scarves is filled with bright colors. As I did with our other scarves, once you pick your favorite color, I will send you the scarf that I am moved to send you by spirit. These scarves have been on a blessed journey and I do catch vibes as I hold them.Keeping in mind the scarf's powerful connection to the inner and outer divine beauty of all women, I purchased a very symbolic rose quartz pendant. These pendants were blessed too, in the sacred mother earth energy of Ojai. You can wear them around your neck, put them on your altar, use them in ceremony, or whatever you wish. They are a magical gift.You can wear the light-weight sheer acrylic scarf as a shawl, wrapped around you, flowing open - a myriad of ways. Each scarf is easy to wash. This scarf is perfect for festive gatherings, meditation, your altar, to wear as a statement of beauty, or to travel in. What a treasured holiday gift to give to someone special!Photos by Lucinda Rae Kinch.
DaKara Kies is a gifted intuitive healer that specializes in clearing core issues and blocks that hold you back from stepping into your true power, passion and purpose. Working with the inner child to bless, heal and nurture that most sacred part of ourselves. Assisting her clients in moving into the flow (chi) of life.As a Master Energy Healer, DaKara is a healer's healer, assisting healers and light workers to clear the blocks to bring forth their gifts to the world. Transforming the very essence of your being into a radiant beacon of light so that your divine purpose unfolds into the richness of your life journey.Through the infinite essential powers of the number eight which numerologically represents the abundant year 2015, we will tap into our own Divine Essence with the power of the Universal Goddess Isis to connect to our own golden strand of divine light and rebirth ourselves into a new year of magnificence.Using our soul fed imaginations to activate our power within, we will step into the flow of the infinity symbol and ride the waves to bring healing, balance, peace, strength and unification into our energy field, as we expand our conscious minds into the deeper awareness of the Divine.DaKara will uplift us through guided meditation and take us on a journey to embrace the Goddess of Healing and Magic and our own Divine nature in a scarf blessing on January 8, 2015 at 5pm PST.During the "live call-in ceremony" - with women from around the world - DaKara will lead us in an interactive ceremony, where we will align with the cosmic essence of the number eight and tap into a new awakening. We will connect to the multi-dimensions and many facets of the Goddess Isis to connect our minds and heart with our own empowered Divine essence by recognizing our own true beingness and the Divine magic within.Held in the energies of the universal divine feminine circle - an enormous connector of strength - through this inspirational ceremony we will continue to join together and connect with each other in our Sisterhood of the Sacred Scarves.This one-hour ceremony is DaKara's and my gift to every woman who purchases DIVINE - our #12 sacred scarf. I am grateful to DaKara Kies for creating this ceremony to celebrate our wearing of the symbolic Spirited Woman Prayer Scarf.You'll receive a copy of the ritual beforehand so that you can follow along and participate fully in this interactive ceremony. I look forward to awakening new Divine energies with you, dear sisters of the sacred scarves.We are pleased to say this is DaKara Kies third scarf ritual ceremony for the Sisterhood. The woman is magic!JOIN THE SISTERHOOD OF THE SACRED SCARVES Feel the support. The collective energy. The joy of giving back.Read More Share:
Everett, WA 98204, USA
BlessingsDaKara.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:._.:*~*:.
DaKara Kies, Master Energy Healer, Miracle Rainmaker,
HPT Master. Certified Inspiration, Money & Relationship
Coach. Intuitive Reader, Feng Shui Consultant & Artist
www.DaKara.com
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www.FengShuiMind.info
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DaKara's Flower Essences for Pets
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[DK GreenRoots] Imagine a better way of life - The Shitty Way!
Imagine the possibilities!
-- With Inhofe taking over in the Senate environmentalists might be feeling a little depressed.
http://www.dailykos.com/story/2014/11/25/1346601/-The-h-tty-Life-2025-Part-1-of-3
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[Drug and Device Law] Thanks for Nothing California
This post is from the non-Reed Smith side of the blog.
This is the official week in the United States for giving thanks. Counting your blessings. Welcoming family and friends to your home. Christmas might get top billing, but Thanksgiving is all about feeling warm and fuzzy. And here at the Drug and Device Law Blog, we’ll get to what we are thankful for tomorrow. Today is a different story. Today we feel more cold and hard. And who is the unfortunate recipient of our negativity at this otherwise festive and lighthearted time – California.
And why is that we don’t want to share our turkey and pumpkin pie with California? Three reasons: negligence, Good Samaritan, and subsequent remedial measures.
Plaintiff Christine Scott sued manufacturer C.R. Bard, Inc. alleging injuries resulting from implantation of that company’s pelvic mesh device. The case went to trial and the jury found the manufacturer negligent and awarded damages (reduced based on finding that surgeon was 40% at fault). Scott v. C.R. Bard, Inc., 2014 Cal. App. LEXIS 1049, at *1 (Cal. App. Ct. Nov. 19, 2014). On appeal, the defendant argued, among other things, that the trial court erroneously submitted the negligence theories of liability to the jury, including negligent training and erroneously admitted evidence of post-surgery events. Id. at *1-2. The court denied the appeal in its entirety. We are blogging about this case because it demonstrates the potholes created by California’s recognition of negligence claims in pharma and medical device cases.
When California rejected strict liability for pharmaceuticals and then medical devices, it did so on the ground that public policy favored bringing new beneficial drugs/devices to market even though they were accompanied by risks. Therefore, a medical device manufacturer cannot be held strictly liable if its device was properly prepared and accompanied by an appropriate warning. Id. at *13 (citing Brown v Superior Court, 751 P.2d 470 (Cal. 1988)). Our reading of this is that a medical device manufacturer can still be liable for a manufacturing defect claim and/or for a failure to warn claim. Bard argued that interpretation to the court – they disagreed. This is the quote from a footnote in Brown that the Scott court chose to focus on instead:
[Drug and device manufacturers] are subject to liability for manufacturing defects, as well as under general principles of negligence, and for failure to warn of known or reasonably knowable side effects.
Scott, at *15. And therein lies the foundation for negligent design claims in California. Seems pretty thin when pitted against the justification for removing strict liability from drug and device litigation, but it’s been enough for some California courts, like this one.
Next, plaintiff got creative. Without strict liability, and having apparently been unable to maintain either a manufacturing defect or a failure to warn claim (directed verdict on the former, defense verdict on the latter, id. at *9-10), plaintiff asserted a negligent training claim. As many device manufacturers do, Bard offered educational opportunities to surgeons. Specifically, surgeons could attend classes, labs or surgery observations related to its pelvic mesh device. Id. at *5. Plaintiff Scott’s surgeon attended one of these sessions, after which her overall impression of the product was that it was safe and superior to other products. Id.
Using this as the hook, plaintiff’s negligent training claim is what is often referred to as “Good Samaritan” liability or “negligent undertaking” liability. We don’t think highly of it no matter what you call it. This concept holds that a person who undertakes to render services necessary to protect another is subject to liability resulting from a failure to exercise reasonable care. First, if manufacturers are going to be exposed to liability for offering training, what’s the alternative? No training. Why risk offering training, if the result is that it will be held against you. Second, California courts have further defined the “undertaking” part of the theory as “to render services to another that the defendant should recognize as necessary for the protection of third persons.” Id. at *17 (emphasis added). It is extremely difficult to comprehend that a one-day class on a medical device is necessary to protect a surgeon’s patients. Medical school, internships, residencies, fellowships – those are necessary. And third, isn’t the court essentially using training to get around the learned intermediary doctrine. They seem to be saying that by attending this class, the surgeon’s independent medical judgment (all those years of necessary medical training) goes out the window. Shouldn’t this really just be part of the failure to warn claim? What information was provided to the surgeon? What information did she independently possess? Was she adequately warned? That last question was answered in the affirmative by the jury – a decision that should have swept away the negligent training claim as well.
Finally, the appellate court upheld the trial court’s decision to admit evidence of subsequent remedial measures (post-surgery FDA regulatory actions). For various reasons, chiefly not to deter defendants from making things safer, the prevailing rule is that subsequent remedial measures aren't admissible to prove that the defendant was negligent before, for not having done what it later did. That’s California’s rule too. Id. at *28-29. The post-1997 version of Fed. R. Evid. 407 (the relevant federal rule) explicitly states that post-accident changes to a product are not evidence that an earlier version of the product was defective. In other words, the federal rule was amended to make it clear that the exclusion of subsequent remedial measures applies to strict liability cases as well. That’s not the rule in California. According to California, “[w]hen the context is transformed from a typical negligence setting to modern products liability, the public policy assumptions justifying this evidentiary rule are no longer valid.” Id. at *29. So, California is practically the only jurisdiction that still allows admission of subsequent remedial measures because “strict liability” is different than “negligence.” That rule is simply nonsensical as we’ve previously discussed here.
But wasn’t this a negligence case? Well, the court got around that by arguing that the post-surgery actions were actually taken by the FDA, a third-party, and that therefore the policy reasons for exclusion didn’t apply in this case. Id. at *29-30. We’ve got posts on that too (here and here) – identifying dozens of cases excluding FDA-mandated label changes and recalls. The fact that the subsequent measure was directed by the FDA doesn’t justify admitting it as evidence.
We want to stop feeling stern and critical now, and slide into the holiday spirit. So, as a prelude to tomorrow’s post and on a personal note, the thing this blogger is most thankful for today is a husband who is willing to brave the supermarket -- 2 days before Thanksgiving and on the eve of the first predicted snowfall -- for ginger and nutmeg.
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Posted By Michelle Yeary to Drug and Device Law at 11/25/2014 01:44:00 PM --
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