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[Drug and Device Law] Thumbs Up - The Ten Best Prescription Drug/Medical Device Decisions of 2014
We at the DDLaw blog wish all our readers a Happy New Year as 2014 recedes inexorably into our rear-view mirror. We hope that your 2014 was pleasant and (if you’re on our side of the “v.”) prosperous. We’re celebrating the new year in our usual style, with our annual top ten best prescription medical product liability litigation decisions of 2014. Some people don’t need an excuse to throw a party. We have many excuses here, and we’re going to tell you about a lot of them in this post.
So, to the envelopes please – we present to you our picks for the ten best judicial decisions of 2014 (and ten more honorable mentions) involving drugs, medical devices, and (if there were any) vaccines. We do limit ourselves to drug/device litigation, as well FDA-related cases raising similar issues. That’s why you won’t find on our list the Supreme Court’s personal jurisdiction decision in Daimler AG v. Bauman, ___ U.S. ___, 134 S. Ct. 746 (2014), even though it might end up having greater beneficial impact on drug/device mass torts than any decision we list below. Cars are simply too far afield, so even for a United States Supreme Court decision, we won’t dilute the drug/device nature of our list that much.
1. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014). The Sixth Circuit addressed one of the most significant issues of current prescription medical product liability, innovator liability, under the laws of no fewer than 22 states. The court predicted that none of the 22 states (for some reason there’s not an appendix discussion of Louisiana) would adopt innovator liability. That’s the biggest wipe out of innovator liability since Conte (2008 #-1) was decided back in 2008. Given how dangerous this theory could become if it ever obtained widespread traction, the number of states involved, and the lack of anything adverse in the opinion, we rank Darvocet as this year’s number one best opinion. The unanimous opinion recites all the familiar reasons why it’s not a good idea to shift liability for 80% of the prescription drugs sold today onto the backs of the 20% market share still maintained by innovator manufacturers – who received no economic benefit, and had no control over, the production and sale of generic drugs. We lauded Darvocet here, and discussed it in more depth here .
2. Caldwell v. Janssen Pharmaceutica, Inc., 144 So.3d 898 (La. 2014). Contingent fee lawyers, under contract to the Louisiana state AG (“aspiring governor”), obtained a $330 million verdict under three state statutes claiming that the defendant’s marketing defrauded various state benefit programs. As we thought it might, the Louisiana Supreme Court reversed, and ordered entry of judgment for the defendants. That is, “go away and take nothing.” It seems that the AG had overlooked one tiny – OK, not so tiny – thing in presenting the state’s case. There was utterly no evidence of fraud, zero evidence of misrepresentation, nor a scrap of proof that any prescribing doctor (it was a prescription drug, after all) relied on the non-existent misrepresentations. The statutes required “fraud” or “false statements,” so the court enforced their express terms, finding the AG’s looser constructions “absurd.” It rejected the same sort of generalized proof that characterized last year’s (2013 #-1) awful Neurontin trilogy. Causation necessarily ran through the prescribing physicians, and the AG didn’t even offer such evidence. So much for contingent fee counsel litigating on the cheap. We hailed the Louisiana Supreme Court’s sanity here.
3. Huck v. Wyeth, Inc., 850 N.W.2d 353 (Iowa 2014). Huck is the first state supreme court opinion rejecting innovator liability. Parallelism would have had us list Huck number one, given last week’s designation of Weeks (the first supreme court going the other way) as our worst opinion. So why not? Two reasons: First, Huck allowed “duty to update” liability against generic manufacturers. While those are rather bad claims (for the reasons discussed here), they’re still claims, so that’s one drawback. Second, Huck might be a plurality opinion, although it gives no such indication. Otherwise, Huck is refreshingly strong stuff. It joins an “overwhelming” majority of appellate courts to reaffirm the “well-settled” rule that product liability lies only against those involved in the manufacture and sale of products. Huck follows Restatement (Third) of Torts, Products Liability §7 as to negligent misrepresentation. Cases like Weeks and Conte are “outliers.” Huck even used a car analogy similar to the one we used in describing the potentially vast scope of non-manufacture liability. We celebrated Huck here.
4. Corber v. Xanodyne Pharmaceuticals, Inc., 771 F.3d 1218 (9th Cir. 2014) (en banc). Corber eliminated what had once seemed like an emerging circuit split on a critical CAFA (Class Action Fairness Act) removal issue. Plaintiffs’ counsel had filed dozens of misjoined complaints, each with at least one non-diverse plaintiff and all with just under the 100 plaintiffs that would have triggered CAFA’s “mass action” removal provision. All these actions – many hundreds of plaintiffs – were filed in various California state trial courts. Compared to this type of gamesmanship, removal before service is bush league. Then plaintiffs took their gaming the system one step too far. They sought “coordination.” Bang! Defendants removed under CAFA. Corber, contrary to a Ninth Circuit panel, held that these removals were proper. Such coordination necessarily embraced some form of joint trials, so the requirements of CAFA were satisfied. An express request for a joint trial isn’t necessary. Since there isn’t any form of coordination in California, except for all purposes, Corber goes a long way to eliminating this practice in the nation’s largest state. We extolled Corber here.
5. Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014). We consider this the best generic preemption decision of 2014. Other decisions did what Drager did, but Drager did it first. The biggest potential leftover issue from Bartlett/Mensing was the Court’s reluctance to explicitly extend its design defect holding to formulations of design defect other than risk utility. Other formulations exist, most notably “consumer expectation,” but also “absolute liability” (which no jurisdiction actually has) and anarchy (Missouri). We looked at things differently: with warning and design changes preempted, and plaintiffs unable to argue withdrawal from the market, in 99% of the cases, there’s nothing else left. We put a district court case (Fosamax) in our honorable mentions last year (2014 #+20) simply for recognizing this. Then Drager comes along and looks at generic preemption our way. Design defect is out. There is no material (to preemption) difference among the different design defect formulations because no matter what, relief predicated on a change in design is preempted. Subsequent courts have followed Drager, thus eliminating the sort of plaintiff-side salami-slicing that went before. That’s not all. Drager had more goodies for the defense: Express warranty claims are preempted, because they would require label changes. Opposition to fraud preemption is “frivolous.” Maryland doesn’t recognize duty to test or implied warranty in the context of prescription drugs. We gave Drager our stamp of approval here.
6. Ortho-McNeil-Janssen Pharmaceutical, Inc. v. State, 432 S.W.3d 563 (Ark. 2014). Another contingent fee-driven state AG action bites the dust, this one having yielded a $1.2 billion verdict. An FDA warning letter does not create a false claim under that (or, we’d like to think any) state’s statute. This one ranks somewhat lower than Caldwell – even though the verdict was larger – because the rationale for overturning the verdict (and the AG’s theory) is somewhat peculiar, based partially on a codification error. However, the court also held that the warning letter at the center of the AG’s claim was inadmissible as evidence because it was hearsay, and its presence was extremely prejudicial, since the state waved it around throughout the trial. We blew that Arkansas Supreme Court a kiss, here.
7. Booker v. Johnson & Johnson, ___ F. Supp.3d ___, 2014 WL 5113305 (N.D. Ohio Oct. 10, 2014). This is a case we had been waiting for. There’s good language in Bartlett (2013 #+1) that prior FDA approval is required for any design changes to both innovator and generic drugs. The logical import of that language is that design defect claims involving all prescription drugs, innovator as well as generic, should be barred by “impossibility” preemption. That’s exactly what Booker held, evaluating a Georgia-law claim in the Ortho-Evra MDL. We don’t ordinarily run “breaking news” posts about trial-court opinions, but Booker merited it. We broke the news here.
8. Bowerman v. Takeda Pharmaceuticals U.S.A., 442 S.W.3d 839 (Ark. 2014). Two cases from Arkansas! In this one, the Arkansas Supreme Court shot down an Actos plaintiff’s attempt to create a new cause of action for “illegal exaction.” This would have allowed any taxpayer to sue over state reimbursement of prescriptions of any prescription medical product that the taxpayer-plaintiff claimed was “defective.” The mischief that could have caused is obvious. It didn’t happen. A unanimous court held that this claim was bogus. Prescribing an FDA-approved drug was not “unlawful,” nor was state reimbursement of such prescriptions. Indeed, the state could not refuse to pay for properly prescribed drugs. Nor, because the drugs were prescribed, could reimbursement be considered “arbitrary.” We spread the good news here.
9. Martin v. Medtronic, Inc., ___ F. Supp.3d ___, 2014 WL 36352921 (D. Ariz. July 23, 2014) and ___ F. Supp.3d ___, 2014 WL 6633540 (D. Ariz. Nov. 24, 2013) (two related opinions). Just as it was hard to say what was the worst InFuse case of the year, it’s also hard to determine which of these decisions was the best. We’ve settled on the Martin case for several reasons: (1) the result is a complete dismissal, which is pretty basic; (2) the discussion is quite thorough without becoming tedious; (3) the court applies to parallel claims our preferred “narrow gap” view of the intersection between express and implied preemption; (4) Martin rejects the Ramirez (2013 #-9) case from the same judicial district (Arizona); and (5) these decisions correctly recognize “off-label promotion” as a purely federal concept with no state equivalent. The only claims that survive preemption are those alleging false off-label promotion and (because Martin was bound by Stengel (2013 #-2)), inadequate reporting. Both of those claims are TwIqballed, and as to the reporting claim, Martin specifies that the plaintiff has to plead causation, which even Stengel recognized wouldn’t be easy. It wasn’t. Plaintiffs couldn’t carry it off, so their failure to report claim was dismissed by the second Martin opinion. Martin II is the best post-Stengel opinion on adverse event reporting and causation that we’ve seen. That opinion is also useful for prohibiting false off-label promotion claims not specific to the plaintiff’s prescriber as “fraud on the market” theories. We expressed are satisfaction with the first Martin opinion here.
10. Shannon v. Fusco, 89 A.3d 1156 (Md. 2014). Shannon was decided by a state high court, but it’s a narrower issue than the others above. The issue was one of our long-time pet peeves – informed consent claims against prescribing doctors alleging liability for failure to inform patients that a particular use was off-label. Ignoring overwhelming authority, an intermediate Maryland court had allowed the theory. The Maryland Court of Appeals squashed that in no uncertain terms. To physicians in informed consent cases, FDA regulatory status is not a risk, not a benefit, nor even “other pertinent information.” The practical implication of Shannon, and other cases so holding, is that with such allegations not a basis for physician liability, physicians won’t be pointing the finger at our clients over FDA-related information. We blogged about Shannon here.
That’s it for our top ten, but the good news just kept coming in 2014. We want to give shoutouts to more favorable decisions that didn’t crack our top ten. YO!
Here are our Honorable Mentions: (11) Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014) (discussed here) – The best “one-two punch” case, that is generic preemption and no innovator liability, of the year. What raised it above others was its holding that the “parallel claims” exception to express PMA preemption has no place in implied preemption; (12) Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23, 2014) (discussed here) – We’ve always hated West Virginia’s unique rejection of the learned intermediary rule. Karl was the worst case in our inaugural list back in 2007. Tyree removed medical devices and drugs not marketed direct-to-consumer from Karl’s scope. Let’s hope those limits stick; (13) Chapman v. Procter & Gamble Distributing, LLC, 766 F.3d 1296 (11th Cir. 2014) (discussed here) – An excellent Daubert opinion excluding expert opinions on both general and specific causation); (14) United States ex rel. Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014) (discussed here) dynamite FCA case rejecting theories that would make mere FDCA violations (here, of GMPs) into a false claim, without much more; (15) Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. 2014) (discussed here) – The goal is to move Bartlett/Mensing preemption beyond generic drugs. Thompson did so, holding a dosage-related consumer fraud claim preempted against an innovator drug because that required prior FDA approval; (16) Mack v. Stryker Corp., 748 F.3d 845 (8th Cir. 2014) (discussed here) − Useful decision on state of the art in a pain-pump case. It considered and flatly rejected an adverse decision from another circuit; (17) Public Citizen v. HHS, ___ F. Supp.3d ___, 2014 WL 4388062 (D.D.C. Sept. 5, 2014) (discussed here) – Plaintiffs can’t use FOIA to obtain reportable event summaries, disclosure log summaries, and descriptions of the content of detailing sessions that a manufacturer was required to fill under a corporate integrity agreement; (18) In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 751 F.3d 150 (3d Cir. 2014) (discussed here) – A complete generic preemption win that was particularly welcome after last year’s bad Pa. intermediate appellate decisions (2013 #-4); (19) Locke v. Ethicon Inc., ___ F. Supp.3d ___, 2014 WL 5819824 (S.D. Tex. Nov. 10, 2014) (discussed here) – Important post-Bauman showing “how to” eliminate non-diverse plaintiffs who can’t obtain personal jurisdiction over “their” defendants while avoiding fraudulent joinder/misjoinder problems; (20) Seavey v. Globus Medical, Inc., 2014 WL 1876957 (D.N.J. March 11, 2014) (discussed here) – This decision combines lots of valuable language about off-label use and promotion, with a great result on causation.
Looking over our 2013 lists, nothing’s changed – for better or worse – on our bottom ten from last year, except for Weeks, which did the same (bad) thing after reargument. The United States Supreme Court passed on both the Neurontin cases and Stengel. The Pennsylvania Supreme Court denied an appeal in the Reglan generic preemption cases, so they go back to square one (unless the U.S. Supreme Court intervenes). Still, with the law being what it is, those are nuisance cases. Still, look for lots of them in Philadelphia.
Ditto for our 2013 top ten list. They’re unchanged. As discussed last week, we did lose our #17 honorable mention, Payne, to reversal.
Looking farther back, the Caldwell case we discussed above reversed our #2 bad case from 2012, meaning that the worst two from that year are both gone, which is a first. Whitener (2012 #-7) while not formally reversed, died in the wake of Bartlett in 2014. See Whitener v. PLIVA, Inc., 2014 WL 1276489 (E.D. La. March 27, 2014). On the good side, POM Wonderful (2012 #+8) was reversed by the Supreme Court, but not on preemption or primary jurisdiction grounds, so not much seems to have been lost.
Looking ahead, the Caplinger (2013 #+9) appeal in the Tenth Circuit remains pending, so that one’s still at risk. There will certainly be an appeal in the Actos MDL of the decisions there that made our 2014 bottom ten list. The California Supreme Court in Bristol-Myers-Squibb will rule on personal jurisdiction post-Bauman, with an eventual appeal to the United States Supreme Court likely regardless of the result. Generic preemption remains pending before the United States Supreme Court in Teva Pharmaceuticals USA, Inc. v. Superior Court, on duty to update and dear healthcare provider issues, with the Solicitor General last week responding to the Court’s request for views that certiorari should not be granted. See 2014 WL 7169712 (SG brief). A similar certiorari petition (2014 WL 7185615) has recently been filed in the adverse Pennsylvania Superior Court trio (2013 #-4), which has a significant issue overlap with Teva.
As we predicted, the FDA’s proposal to change the rules to eliminate generic drug preemption didn’t get finalized in 2014. The FDA postposed it to fall 2015. Frankly, we don’t expect it ever to go into effect.
So next stop, 2015. We wish an equally Happy New Year to all our readers on the right side of the “v.”
--
Posted By Bexis to Drug and Device Law at 12/31/2014 08:00:00 AM --
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Re: [DK GreenRoots] Markos on reducing his carbon footprint
This is encouragement A.Siegel to your idea of a response to Kos diaries in this regard.
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Re: [DK GreenRoots] Markos on reducing his carbon footprint
Yes, home energy audits. Excellent suggestion.
We just bought our first house three months ago, and that's one of the to-do items at the top of my list for the house. (Well, that, and fixing the downstairs toilet that won't flush unless you manually lift the lever that covers the drain from the tank.)On Mon, Dec 29, 2014 at 6:10 PM, Sven Eberlein <sveneberlein@gmail.com> wrote:
agreed. great idea, it can never hurt to expand the conversation. Especially now that he's come out as an energy geek!
Sven
On Dec 29, 2014, at 3:06 PM, George Mokray <gmoke@world.std.com> wrote:
>
>> On Dec 29, 2014, at 5:47 PM, A Siegel <siegead@gmail.com> wrote:
>>
>> Highly recommended series ... and interesting on multiple levels.
>>
>> Part of which is that Markos links this to policy in terms of what he cares about (no fracking, not sending money to large corporations, etc ...) but doesn't really get into policy (like discussed in Invisible Energy: http://getenergysmartnow.com/2010/08/04/energy-bookshelf-the-power-of-invisible-energy/). And, when discussing refrigerators for example, no reference to things like Pres Obama comments: http://getenergysmartnow.com/2011/02/07/president-highlights-refrigerators-to-the-us-chamber-of-commerce-to/) nor to the value/importance of linking energy efficiency into the home financing process: http://getenergysmartnow.com/2010/10/15/addressing-home-affordability-through-efficiency-in-financing-process/
>>
>> I am contemplating writing a response diary -- praising the hell out of this while making suggestions. (For example, how come Markos doesn't suggest home energy audit? How many are going to be as geeky as him?????)
>
> Blower door tests.
> The upcoming CA and EU zero net energy building standards.
> Lots of things to suggest. Go for it, you energy geek you.
>
> Solar IS Civil Defense,
> George Mokray
>
> PS: Merry Happy New and Bah Humbug!
>
> --
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Re: [DK GreenRoots] Markos on reducing his carbon footprint
agreed. great idea, it can never hurt to expand the conversation. Especially now that he's come out as an energy geek!
Sven
On Dec 29, 2014, at 3:06 PM, George Mokray <gmoke@world.std.com> wrote:
>
>> On Dec 29, 2014, at 5:47 PM, A Siegel <siegead@gmail.com> wrote:
>>
>> Highly recommended series ... and interesting on multiple levels.
>>
>> Part of which is that Markos links this to policy in terms of what he cares about (no fracking, not sending money to large corporations, etc ...) but doesn't really get into policy (like discussed in Invisible Energy: http://getenergysmartnow.com/2010/08/04/energy-bookshelf-the-power-of-invisible-energy/). And, when discussing refrigerators for example, no reference to things like Pres Obama comments: http://getenergysmartnow.com/2011/02/07/president-highlights-refrigerators-to-the-us-chamber-of-commerce-to/) nor to the value/importance of linking energy efficiency into the home financing process: http://getenergysmartnow.com/2010/10/15/addressing-home-affordability-through-efficiency-in-financing-process/
>>
>> I am contemplating writing a response diary -- praising the hell out of this while making suggestions. (For example, how come Markos doesn't suggest home energy audit? How many are going to be as geeky as him?????)
>
> Blower door tests.
> The upcoming CA and EU zero net energy building standards.
> Lots of things to suggest. Go for it, you energy geek you.
>
> Solar IS Civil Defense,
> George Mokray
>
> PS: Merry Happy New and Bah Humbug!
>
> --
> You received this message because you are subscribed to the Google Groups "DK GreenRoots" group.
> To unsubscribe from this group and stop receiving emails from it, send an email to dk-greenroots+unsubscribe@googlegroups.com.
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> Visit this group at http://groups.google.com/group/dk-greenroots.
> For more options, visit https://groups.google.com/d/optout.
--
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Re: [DK GreenRoots] Markos on reducing his carbon footprint
> On Dec 29, 2014, at 5:47 PM, A Siegel <siegead@gmail.com> wrote:
>
> Highly recommended series ... and interesting on multiple levels.
>
> Part of which is that Markos links this to policy in terms of what he cares about (no fracking, not sending money to large corporations, etc ...) but doesn't really get into policy (like discussed in Invisible Energy: http://getenergysmartnow.com/2010/08/04/energy-bookshelf-the-power-of-invisible-energy/). And, when discussing refrigerators for example, no reference to things like Pres Obama comments: http://getenergysmartnow.com/2011/02/07/president-highlights-refrigerators-to-the-us-chamber-of-commerce-to/) nor to the value/importance of linking energy efficiency into the home financing process: http://getenergysmartnow.com/2010/10/15/addressing-home-affordability-through-efficiency-in-financing-process/
>
> I am contemplating writing a response diary -- praising the hell out of this while making suggestions. (For example, how come Markos doesn't suggest home energy audit? How many are going to be as geeky as him?????)
Blower door tests.
The upcoming CA and EU zero net energy building standards.
Lots of things to suggest. Go for it, you energy geek you.
Solar IS Civil Defense,
George Mokray
PS: Merry Happy New and Bah Humbug!
--
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Re: [DK GreenRoots] Markos on reducing his carbon footprint
Highly recommended series ... and interesting on multiple levels.
Part of which is that Markos links this to policy in terms of what he cares about (no fracking, not sending money to large corporations, etc ...) but doesn't really get into policy (like discussed in Invisible Energy: http://getenergysmartnow.com/2010/08/04/energy-bookshelf-the-power-of-invisible-energy/). And, when discussing refrigerators for example, no reference to things like Pres Obama comments: http://getenergysmartnow.com/2011/02/07/president-highlights-refrigerators-to-the-us-chamber-of-commerce-to/) nor to the value/importance of linking energy efficiency into the home financing process: http://getenergysmartnow.com/2010/10/15/addressing-home-affordability-through-efficiency-in-financing-process/
I am contemplating writing a response diary -- praising the hell out of this while making suggestions. (For example, how come Markos doesn't suggest home energy audit? How many are going to be as geeky as him?????)
On Tue, Dec 23, 2014 at 2:41 PM, Sven Eberlein <sveneberlein@gmail.com> wrote:
this is great!
http://www.dailykos.com/story/2014/12/23/1349402/-Reducing-electricity-consumption-I-Lighting
Sven
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[Drug and Device Law] Another Ediscovery Front?
On December 18, the FDA published its proposed rule for replacing the venerable package insert with “electronic” prescribing information. The cite is 70 Fed. Reg. 75506, and a link to it is here. We’re not regulatory lawyers, so we’ll leave any debate over whether this proposed rule is good or bad to the folks at the FDA Law Blog.
We’re product liability litigators, so when we hear about “electronic” anything, one thing we think about is ediscovery. Currently, with paper package inserts, when we’re taking discovery, all we have is the prescriber’s say so about whether s/he reviewed the insert, and when. Nor do we have any sure way of knowing exactly what version of drug/device labeling the prescriber reviewed. The date of the visit that produced the prescription, when placed against the history of the relevant labeling provides a pretty good idea, but there’s always a chance that the product sat on a shelf somewhere through a label change or two.
If the FDA’s proposal to shift to electronic distribution of the prescribing information that’s now in package inserts takes effect all that could change. The main avenue of distribution envisioned by the FDA would be a “single, comprehensive Web site” − an online “repository” operated by the FDA itself:
The proposed rule would require manufacturers and applicants to distribute electronically prescribing information by submitting the labeling in an electronic format that FDA can process, review, and archive . . . to FDA each time the labeling content is changed. The submitted labeling would be distributed via FDA's labeling repository Web site (labels.fda.gov), which is a publicly available Web site.
79 Fed. Reg. at 75511. The proposed rule is silent about whether the FDA’s website would track “hits” and more specifically their source, but there’s no technical reason that would make such tracking impossible. The FDA’s proposal is likewise silent on how long the Agency could or would preserve tracking information about hits.
In the past, the FDA has sometimes preempted civil discovery. See 21 C.F.R. §20.63(f)(2) (preempting civil discovery of identities of persons who file adverse event reports with the Agency). There’s no indication in the current proposal of such preemptive intent. Thus, the FDA should expect to be on the receiving end of a host of third-party ediscovery requests (we doubt the FOIA would apply to requests for such individualized information) for when Dr. X accessed the repository for information about Drug Y. Such requests could come from either the plaintiff or defense side.
Another ediscovery front also suggests itself. If the Agency proves obstreperous (or preemptive), then litigants could direct similar ediscovery at the prescribers themselves. Their computer systems may track when Doctor X accessed the FDA repository for information about Drug Y.
For once, we’re talking about ediscovery directed to persons other than our clients.
Whoops, that’s not entirely true. The FDA’s backup plan, for situations where internet access is questionable, is for manufacturer-operated 24-hour telephone hotlines:
Under proposed §201.100(c)(5), the manufacturer or applicant would be required to ensure that the toll-free telephone number is current, fully functioning, and maintained so that there is always an alternate method to obtain the current prescribing information if the requestor cannot access the FDA’s labeling repository Web site. The toll-free telephone number service would be required to be available 24 hours a day, 7 days a week.
79 Fed. Reg. at 75515. Just as with the FDA-run repository, the FDA’s proposal is silent about whether toll-free number operators would be required to keep physician- and drug-specific contact information, and if so for how long.
The FDA obviously hasn’t given civil litigation the slightest thought in formulating the current proposal. The words “litigation” and “discovery” (or any variants) do not appear anywhere in the Federal Register announcement. It would probably be a good idea if somebody required it to consider the issue. The comment period for the proposed rule closes on March 18, 2015.
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Posted By Bexis to Drug and Device Law at 12/29/2014 08:25:00 AM --
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[Drug and Device Law] When It Comes to Class, Objective Is Better Than Subjective
We again post the day after a holiday, when stores are flooded with shoppers—this time exchanging gifts purchased last time. We discuss a case involving discussions of “consumer value” and “fair market value.” So, you might think we would go back to that shopping well. No. We have decided to zag. To us, the opinion on class certifications in Saavedra v. Eli Lilly & Co., No. 2:12-cv-9366-SVW (MANx) (C.D. Cal. Dec. 18, 2014), slip op., evokes another seasonal activity, playoff football. Depending on how you count the requirements, plaintiffs in a purported class action need to clear three or four hurdles to get the certification they want. Class certification tends to be a vehicle to settlement, which is what the lawyers who drive class action litigation really want, particularly in the consumer protection context. Tripping over one of the hurdles typically means the journey was a waste. In the NFL, four of the twelve playoff teams each need to win three straight games to hoist the Lombardi Trophy; the other eight each need to win four straight. Teams that lose in the Conference Championship or Super Bowl tend to view the season as a failure, not a success. The teams and players do profit from incomplete playoff runs, but we are not shaken from our view of the parallel here.
In the top division of college football, there is now a playoff of four teams. The winner will have to win two straight games. This would be on top of the conference championship game and “rivalry week” game that each had to win over the preceding weeks. (Again, three or four hurdles, depending on how you view it.) We can assume that the three teams that lose in the playoffs will not be “happy to have been here.” The four universities will have profited quite a bit from the playoffs—and the players not all (which is a different discussion entirely)—but only one will have succeeded once it is done. Still, once the playoffs start, the champion will be measured objectively: which team won two playoff games? In the past, before there was a playoff, the crowning of a champion or champions of this division of college football was a matter of subjectivity: based on the individual view of the voters of the various groups that might anoint a champion, which team had the best season? That subjectivity irked fans. Even with mounds of statistics to measure performance, the lack of the definitive measurable—the results of playoff games—was unsatisfying. (Yes, we know that the four playoff teams are selected with a large measure of subjectivity, but work with us.)
In consumer protection class actions premised on an alleged misrepresentation about a prescription drug, the plaintiffs should have to allege an objective harm and an objective way to measure it. When they cannot, they should not have a class (or probably even individual claims of the purported class representatives). Saavedra comes out of litigation over the risks of withdrawal from a prescription antidepressant. We have posted previously on summary judgment on warnings claims in personal injury cases with the same product and risk. Here and here. We have even posted previously on an opinion in Saavedra, which we found less than satisfying even though it found that the learned intermediary doctrine does apply to consumer protection claims about a prescription drug. That opinion invited the plaintiffs, after the opportunity to take discovery, to move for class certification. Eighteen months later, we have the denial of the motion for class certification, which hinged on an unusual and overtly subjective theory of injury. The subjectivity meant that plaintiffs could not clear any of the hurdles for class certification, discussed recently in another consumer protection case from a neighboring court. The Saavedra plaintiffs got to the playoffs, surviving summary judgment and conducting extensive discovery, but flamed out. Much like the Bengals of recent vintage. Asserting claims under consumer protection statutes from California, Massachusetts, Missouri, and New York, the plaintiffs claimed that the risk of complications upon withdrawal from the antidepressant was much higher than the “greater than or equal to 1%” in the drug’s label. While the label’s use of “greater than” makes plaintiffs’ misrepresentation premise dubious, it was plaintiffs’ “novel” theory of how they were harmed that made certification improper:
Plaintiffs argue that class members were harmed because they purchased a product that was represented to have a roughly 1% risk of withdrawal side effects but that actually had an approximately 44% risk of withdrawal side effects. Thus, Plaintiffs claim they were injured because the drug as received was worth less than the drug as represented. However, Plaintiffs do not assert that class members were harmed by being overcharged or by being induced to purchase something that they would have not otherwise purchased. Instead, Plaintiffs argue that the harm was in receiving a product that had less value than the value of the product as class members expected to receive it.
We do not claim expertise in economic theory, but the court seemed pretty adept in unpacking why this was based on “a subjective concept distinct from the fair market value concept commonly used when calculating benefit-of-the-bargain damages.” The ability to calculate damages for a class is part of one of the hurdles for class certification—that common issues predominate over individual issues. Where the damages for each purported class member hinge on what she thought the drug was worth, regardless of what she paid for it, then calculating damages for on a classwide basis is a hard sell. Still, plaintiffs, through their pharmacoeconomics experts, tried. The expert came up with the broad strokes of a valuation scheme based on using a survey to establish the average value consumers—after the fact and probably not consumers who need the drug—ascribe to the drug with two different rates of withdrawal side effects and then applying a refund ratio to whatever a class member actually paid for the drug. This kind of analysis, if permitted, could probably be manufactured for most drugs ever sold, each time coming up with some number to represent how consumers think a drug with less risks is worth more than a drug with more risks, all things otherwise being equal. It would also alter the causation requirements in consumer protection statutes. The court was not willing to do that, particularly for prescription drugs, where what someone pays has little to do with how they value the drug. Not only is “a consumer’s out-of-pocket costs for a drug [] not a proxy for the drug’s value to the consumer,” “a rational consumer would surely pay less than she believes the drug is worth.” For these reasons and various flaws in the expert’s damages model, the court held that plaintiffs “failed to present a method for calculating damages that is tied to their theory of liability.” This ended the chance for a damages class, but the court was not done.
The subjectivity of plaintiffs’ theory also made it a poor fit for classwide proof of reliance and causation, another aspect of predominance. “Because Plaintiffs divorce their injury from price, their asserted injury is akin to subjective disappointment with the product received,” making for individualized inquiries into what physicians treating specific patients, or perhaps the patients themselves, thought about the risk of withdrawal side effects. Re-casting the inquiry into what an “average consumer” thought does not help because “[i]t is unclear to the Court why any individual is harmed when she purchases a product that the average person (but not necessarily the purchaser) subjectively overvalues because of a misrepresentation.” Without a feasible method for calculating classwide damages, the proposed class did not present a superior method for adjudicating the issues. Given “the need for individualized proof of causation and damages” and a “fact-intensive individualized inquiry that will likely be required to show damages,” “a class action would be unmanageable.” This consideration outweighed the factors favoring class treatment that hinged on the low damages for each potential plaintiff.
The plaintiffs even tried to certify an issue class under Fed. R. Civ. P. 23(c)(4) for whether the defendant made materially misleading misrepresentations, which is something like playing for the small trophy as winner of the losers’ bracket. The court viewed this attempt as “an end-run around 23(b)(3)’s predominance requirement.” (Yes, end-run is a football term, and, yes, we have expounded on it before.) Because Plaintiffs were unable “to show that damages can be determined even on an individual basis once liability is decided” and there had been plenty of opportunity to see if a 23(b)(3) class certification was appropriate, the issue class would “not materially advance this case’s resolution.” We do not know if the drug’s label failed to represent the withdrawal risk, if any doctor would have prescribed less drug with a different label, or if any patient paid more because of what the label said. We do know that a class action for alleged violation of consumer protection statutes should not lie where objective damages cannot be calculated and the inquiry into causation would have to proceed on an individual, subjective basis. We are glad that the right result was reached, even if it took a while. Mostly, we are glad that the playoffs are almost here.
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Posted By Eric Alexander to Drug and Device Law at 12/26/2014 03:07:00 PM --
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[Drug and Device Law] Thumbs Down - The Worst Prescription Drug/Medical Device Decisions of 2013
We’re doing our duty. We don’t have to like it. The subject of today’s post is distasteful, but necessary. Here is our annual compilation of the ten worst court decisions of the year (2014) that occurred in prescription drugs and medical device products liability litigation. These are decisions that left us shaking our heads at the colossal injustice of what all-to-often passes for civil justice in this sometimes crazy country of ours. Occasionally, the barbarians are a lot closer than at the gates. If this is memory lane, there may be something to be said for amnesia. But take heart, next week for we’ll be in a more festive mood with our favorites.
So, now for a few words from the Grinch:
1. Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014). So how does the same case make the bottom ten (also 2013 #-5) two years running? By issuing a lousy opinion on a critical issue, then reconsidering (because – amazingly – the first opinion was issued without oral argument) and then doubling down on the same, ill-considered position. In Weeks Alabama became the only state high court to recognize innovator liability (which we also call “Conte”), meaning that where the innovator didn’t even sell the product, received no economic benefit from the generic prescription the plaintiff took, and indeed may well have been driven out of the market by generic competition, it’s still liable if the generic labeling (and thus its own) is “defective.” Being liable for purported defects in a competing product means, of course, that the costs of such liability can only be recouped by charging ones own customers more for other, non-defective products, but there are more plaintiff lawyers than innovator drug companies in Alabama. This sort of liability, being open-ended and completely uninsurable, is the most thoroughly destructive, and irresponsible theory we’ve encountered since we started this blog, and that’s saying a lot. Alabama getaway indeed. For all these reasons Weeks richly deserves its designation as our #1 worst case of the year. We (the non-Dechert side) chastised the decision here, but that was only a reprise of our original 2013 critique, here – all of which remains valid.
2. Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). Poor Wyeth, having the two worst decisions of 2014 inflicted on it. The year wasn’t very old when Pennsylvania Supreme Court decided that it didn’t need strict liability to impose essentially the same thing under negligence. After taking close to three years to decide this fen-phen case, the theory the court settled on was a real stinker. Would you believe negligent design – with no alternative design requirement? In so doing it all but adopted Restatement Third §6(c) in a prescription drug case, which is also unique for a state high court. We don’t know of any other decision, in Pennsylvania or elsewhere in the country, that does away with the alternative design requirement in a negligence case. To add insult to injury, the court had the chutzpah to claim that this unique, novel result was really just an extant, but utterly unrecognized, part of negligence “duty” all along. What really happened was the creation out of whole cloth of “negligence” liability that amounts to a failure to recall claim – that the product was “too harmful to be used by anyone,” and thus should not be marketed, notwithstanding FDA approval. Maybe the theory is limited to already-withdrawn products (footnote 8 suggests that it might), but maybe not. If not, we think that, eventually, the theory will fall to Bartlett (2013 #+1) preemption (Bartlett was decided just before Lance was decided and was not briefed to the court), for prescription medical products (but not others). All this is bad enough, but there’s also disruptive dicta in Lance questioning (musing about, is more like it) the “underpinnings” of the learned intermediary rule. So we’ll be dealing with that, too, for the foreseeable future. Under the rubric “if this is negligence, who needs strict liability,” we (the non-Dechert side) lacerated Lance here.
3. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832 (W.D. La. Sept. 2, 2014). Much could be said about this 100+ page opinion, and we said some of it here). We slot this particular Actos decision as our #3 worst decision of 2014. For some reason (perhaps embarrassment) the opinion fails to mention in its 52 Westlaw pages or 285 footnotes that the runaway verdict it was upholding was for $9 billion. At trial, the plaintiff was allowed to try a blatantly preempted fraud on the FDA claim under another name. That’s not hard to show, since the opinion states no fewer than 37 times (yes, we counted) that the defendant supposedly “concealed,” “misinformed,” “obfuscated,” “withheld,” or other-similar-verbed information from the FDA. Neither the court nor the plaintiffs are the least bit subtle in their fraud on the FDA rhetoric, so we’re hopeful for an appellate reversal, but in the interim, this outlier verdict will waste everyone’s time and money. That’s the opposite of what an MDL was supposed to do.
4. Mississippi ex rel. Hood v. AU Optronics Corp., ___ U.S. ___, 134 S. Ct. 736 (U.S. 2014). In this case the United States Supreme Court held that a state attorney general action (really brought by contingent fee counsel proceeding in an AG’s name), ostensibly on behalf of all the citizens of a state, did not qualify as a “mass action” under the Class Action Fairness Act (“CAFA”) so as to allow removal to federal court. So state AG actions remain in state court where, combined with the usual “home cooking,” they can generate monstrous verdicts – practically all of which have so far been overturned (more on that next week). Hood is it not ranked higher because, frankly, we always thought this CAFA argument was a very long shot (the Court unanimously rejected it). Since the defense position was already a distinct minority view, Hood didn’t change the legal landscape much. Hood would have been a great victory had it gone the other way, but this result basically continued the status quo. It’s the Supreme Court, so it belongs on the list, but we found other decisions to be worse. We alerted readers to the adverse result here.
5. Hardin v. PDX, Inc., 173 Cal. Rptr.3d 397 (Cal. App. 2014). Hardin has to take the cake for the weirdest liability theory held to state a claim by an appellate court in 2014. It’s a generic drug case (no surprise there), so the plaintiff has a serious preemption problem. When all else fails, use Restatement §324A “Good Samaritan” liability to punish somebody for doing something intended to be helpful. Here, that somebody, or rather those somebodies, had prepared a monograph about the drug that was distributed by the plaintiff’s pharmacist. Plaintiff did not sue the pharmacist, since California law holds that pharmacists don’t have a duty to warn about prescriptions that they properly fill. Plaintiff sued the publisher of the monograph. That didn’t work because of the First Amendment, which is enforced in California by an anti-SLAPP (“strategic lawsuit against public participation”) statute. Plaintiff was as undaunted as the appellate court was credulous of new liability theories. A software manufacturer, whose program allegedly truncated the monograph’s original 8-paragraph text to 5 paragraphs, was also sued, and the court allowed that claim to proceed – despite two layers of intermediaries closer to any purported failure to warn (pharmacist and publisher) both having no duty to the plaintiff as a matter of law. This unfortunate defendant did not make the product, did not write the monograph, and never had any contact with the plaintiff. As we said in our post criticizing Hardin, it was like holding (in pre-electronic times) a maker of white out liable for someone else’s deletion. Another loose nut slides to the coast.
6. Payne v. Novartis Pharmaceutical Corp., 767 F.3d 526 (6th Cir. 2014). The name says it all. The Sixth Circuit reversed the “strong” application of warning causation principles that had made the district court opinion in Payne a #17 honorable mention last year. The problem with this Aredia/Zometa case was the same as with most such cases – no evidence that there was any choice but to prescribe this drug, which was effective against cancer, under the circumstances (plaintiff had bone-metastasized cancer). Yes, this drug could cause osteonecrosis, a nasty but not fatal condition, but the prescriber was trying to save the plaintiff’s life. So, the prescribing oncologist testified that he would have prescribed no matter what, but now he gives warnings that patients should have a dental exam because of the osteonecrosis risk. With benefit of hindsight, plaintiff was willing to testify that she would have taken her chances with cancer, and not used the drug at all, had she known about the lesser condition. While admitting that the plaintiff’s testimony was “speculative,” the appellate court found it sufficient, drawing from malpractice and informed consent cases where the physician-patient relationship was implicated. We were pained with that result here.
7. Scott v. C.R. Bard, Inc., ___ Cal. Rptr.3d ___, 2014 WL 6475366 (Cal. App. Nov. 19, 2014). This is a dangerous case for two reasons. First, it used “Good Samaritan” liability (a California favorite) to hold a medical device manufacturer liable for negligently undertaking to train surgeons in the use of its device. Training doctors is a good thing, but if liability can be predicated on allegedly doing it “negligently,” companies will be less likely to do it at all, since they have no training duty (except where imposed by the FDA). Second, it allowed subsequent remedial measures – FDA regulatory actions post-dating the plaintiff’s surgery – into evidence. While an old, loopy California decision from the glory days of strict liability (Ault, decided in 1974) still allows such evidence for “policy” reasons, this wasn’t a strict liability case. Strict liability is not recognized in California for design defect claims against prescription medical products. Thus, the jury learned that the product was later removed from the market. Harmless? No way; the court was California dreaming. We (the non-RS side, that is) discussed that Thanksgiving turkey here.
8. Messick v. Novartis Pharmaceutical Corp., 747 F.3d 1193 (9th Cir. 2014). This is one ugly Daubert decision, reversing a favorable district court ruling. Sure, “fit” requires relevancy, but the “relevancy bar is low.” How low? How about a causation expert who wouldn’t even come out with an opinion that the drug caused the injury? That’s poor. Daubert is supposed to exclude ipse dixit, but Messick allowed in what passed for “differential diagnosis” because the expert “repeatedly referred to his own extensive clinical experience as the basis for his differential diagnosis.” And so the ipse dixit spider was allowed to weave its web in Messick. Sole cause is cast into the dustbin of medico-legal history. A supposedly scientific opinion can be based on “substantial factor” causation. Association thereby morphed into causation. We castigated Messick here.
9. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 355995 (W.D. La. Jan. 30, 2014). This terrible decision imposed discovery sanctions based on conduct that occurred many years before Actos litigation – about bladder cancer – ever existed. Given that timing, whatever the defendant did with respect to this MDL couldn’t be worse than negligence, since nobody plausibly intends to impede unknown future litigation. About the only good thing that could be said about this opinion is “Never again.” Fed. R. Civ. P. 37(e) is being amended to prevent this result in two ways: (1) sanctions must be predicated on “intent” to interfere with “the litigation,” and (2) negligence (Zubulake) is no longer sufficient for sanctions. We discussed this Actos decision (and other issues relating to litigation holds) here.
10. Hornbeck v. Medtronic, Inc., 2014 WL 2510817 (N.D. Ill. June 2, 2014). We’ve settled on Hornbeck as the worst InFuse case of the year. There was competition, particularly from Coleman, an appellate case in California, but for sheer all-around awfulness, Hornbeck takes the cake. Despite the status of InFuse as a pre-market approved device entitled to preemption under Riegel (2008 #+1), Hornbeck refused to preempt anything (even Coleman, bad as it was, preempted a majority of the plaintiff’s claims). That wasn’t even Hornbeck’s most egregious failure. The utter lack of support for its rulings was. Hornbeck is a monument to “I don’t care what the law is, I don’t like preemption, and that’s that.” As readers of this blog know, there are literally dozens of InFuse preemption cases on our device preemption scorecard. Hornbeck cites precisely none of them – not a single InFuse opinion − even those that might support aspects of its outcome. The opinion interprets Bausch as allowing plaintiffs to call anything a “violation.” Hornbeck also gets Illinois law 180° wrong on FDCA-based negligence per se (the Illinois Supreme Court actually rejects it), and even allows component by component analysis, effectively denying physicians any discretion to use components separately. Some opinions simply don’t get it, and Hornbeck is one of those. We didn’t “get” Hornbeck either, and didn’t write a post about it, except for including it in our scorecard.
We’re also sure that Bristol-Myers Squibb Co. v. Superior Court, 2014 WL 3747250 (Cal. App. July 30, 2014), would have made our bottom ten list, had a further appeal not been accepted by the California Supreme Court, thus wiping that personal jurisdiction atrocity (discussed here) from the books. Other near misses were the OTC drug case Maya v. Johnson & Johnson, 97 A.3d 1203 (Pa. Super. 2014) (discussed here), and In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2014 WL 1632149 (S.D. Ill. Apr. 24, 2014) (discussed here), which would import “parallel claims” into generic drug preemption based on impossibility.
You can come out now, we’re done. If you lost one of these monstrosities, you have our condolences. If you haven’t – there, but for the grace of God….
We’re glad this is over, too. Next week you (and we) get the fun stuff: our thumbs up list of the ten best drug/device decisions of 2014.
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Posted By Bexis to Drug and Device Law at 12/24/2014 08:00:00 AM --
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