FDA, Off-Label Uses and the Internet – Something New for 2012 (Well sort of)

It is the end of the year – a time to look back and reflect and a time to look forward and ponder.  We’ve already looked back and posted about the best  and worst prescription pharmaceutical and medical device cases of the year.  So, on this the last posting-day of 2011, we’d thought we’d look at something aimed toward the future – FDA’s Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.  As this is just a draft guidance right now, we don’t really know what the future holds, but we thought this looked a bit like an FDA New Year’s Resolution – FDA resolves to admit the internet exists and to figure out what to do about it.  We just aren’t sure they are going about it the right way.  Sort of like resolving to lose weight, but going about it by cutting back to only 2 doughnuts per day – it’s really not going to get the job done.

Off-label promotion – just the words leave our clients shivering.  Pharmaceutical and medical device manufacturers walk a fine line between providing current, relevant, and accurate medical information to their clients (health care professionals) and being accused of violating FDA regulations against off-label promotion.  Even the FDA admits that:

FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.

Draft Guidance at 6.  How to accomplish that scientific communication without running afoul of FDA regulations is the tricky part.  And, the FDA is now admitting, technology has made it a bit trickier.

The FDA hasn’t said much about internet promotion in any context, so this guidance is interesting just for admitting the internet exists.  Even more interesting is the recognition that there is a lot of information floating around on the internet and not all of it is good.  For instance, a consumer recently prescribed a drug for an off-label indication can post a question on Yahoo! Answers and it can be answered by anyone – no medical degree, no pharmaceutical experience, no scientific background required.  So, we were encouraged by the FDA’s admission that maybe the drug and device manufacturers might offer better answers than Aunt Millie or anonymousknowitall@server.com:

Furthermore, as these firms are regulated by FDA and have robust and current information about their products, FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products.

Draft Guidance at 3.

But, the FDA is still trying to hide the off-label ball; trying to force anything substantive to be non-public.  Drug and device manufacturers have long been aware of the FDA’s rules regarding how it should respond to non-public requests (phone calls, direct emails, one-on-one communications) for off-label information about their products and those rules really haven’t changed – the response has be specifically tailored, truthful, non­-misleading, accurate, balanced, and scientific.  But what about those internet questions – those posted on product websites, chat rooms, discussion boards, etc.  When Aunt Millie responds to those public questions, her response – no matter how inaccurate – is out there for the whole world to see.  So, shouldn’t the specifically tailored, truthful, non­-misleading, accurate, balanced, and scientific response by the manufacturer get equal all-access status.  Not according to the FDA:

[B]ecause product information posted on websites and other public electronic forums is likely to be available to a broad audience and for an indefinite period of time, FDA is concerned that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).

Draft Guidance at 10.  So, anonymousknowitall’s response can linger forever to be discovered years later by someone searching at random for information about a product, but a drug manufacturer’s informed medical response has to be hidden under a rock.  Essentially, the manufacturer can respond to a public request for off-label information only by providing contact information where the requester can make a non-public request.  Draft Guidance at 11. 

Therefore, any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question, should occur solely between the firm and the individual who made the request. Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum.

Id. 

This is simply weird.  The FDA admits that the information itself, properly vetted and hemmed in by mandatory disclosures and fair balance (not the Fox News kind, either) requirements is not misleading if done privately.  How could it possibly be misleading when it’s public?  Especially when the alternative is so easy.  If the FDA is worried about the information somehow going stale, the posting companies could be made to keep track of where they post and update the information accordingly.  That’s not hard.  We do it all the time on our own scorecards.

The public/private distinction is just silly – the FDA is making a mockery of free speech yet again for its bureaucratic reasons.  Equally silly is the FDA’s solicited/unsolicited distinction.  The same information that the FDA admits is truthful and beneficial in one context becomes illegal in another, for reasons having nothing to do with the content of the speech and everything to do with the FDA’s seeming death wish to continue banning truthful off-label promotion.  Well we have seen the future and it is Sorrell – we fervently hope.

Still, we guess it is better than nothing.  Some people will get beneficial information for some of their medical problems.  We can only hope that when someone requesting information about a drug gets a response from anonymousknowitall claiming to “know it all” and a response from the drug’s manufacturer saying “please call us,” they do the latter.

But doesn’t the FDA know that it’s impossible to censor the Internet?  We trust it will find out the hard way like every other would-be Savanorola or Breen Master of the Web before them.  Before the Civil War, the Post Office censored the mail to remove abolitionist literature.  May the FDA’s attempt meet with the same historical fate.

In hopes of hastening that eventuality we’d like to point out – to any of you entrepreneurs out there – that the FDA’s Draft Guidance creates the possibility for a wonderful online business opportunity.  The partial censorship that the FDA is proposing practically cries out for some industrious on-line aggregator to defeat it, and make a buck doing it.  Here’s how:

(1) There are lots of authoritative sources listing accepted off-label uses.  There’s a list in the Physicians Desk Reference.  There are the three compendia that Medicare uses in determining whether to reimburse off label uses.  See 42U.S.C. §1396r-8(g)(1)(B)(i) (listing the American Hospital Formulary Service Drug Information, the United States Pharmacopeia-Drug Information, and the DRUGDEX Information System).

(2) Some enterprising soul – unaffiliated with any FDA regulated entity, of course – could send non-public emails, compliant with the Draft Guidance, to companies requesting information about all the off-label uses contained in these lists.  We’d recommend a separate email for each off-label use.  There’s no business reason for the recipient companies not to respond with compliant replies, since sales are sales.

(3) Collect all of the non-public responses and create a website – like “offlabeluse.com” or something similar; then post all the responses for the cyber world to see.  Google’s spidering capabilities take care of the rest.  The world gets useful information, the aggregator’s website charges for it in one way or another, money is made, and censorship is defeated.  Win-win.

And, if you run with this idea and it makes you rich, don’t forget your friends at the Drug and Device Law Blog (a modest finder’s fee would not be looked upon negatively!)

            Happy New Year! 

Top Ten Best Prescription Drug/Medical Device Decisions Of 2011

Happy Christmas/Hanukkah/solstice and Merry New Year to all our readers.  May your 2012 be filled with winning arguments, TwIqbal dismissals, and summary judgments.  There’s not much of 2011 left now, although we’d be overjoyed for one or more last-minute decisions to come down and warrant a change to the list that follows.


What list is that?

Why our list of our favorite drug/medical device judicial decisions of 2011, of course.  And what a list it is.  Between three United States Supreme Court decisions, four (maybe five, depending on how we count) court of appeals decisions, and two more by state supreme courts, only one federal trial court opinion was able to make this year’s cut.

We’ve even heard tell that some firms (we won’t name names) have actually advertised their involvement with cases on our past top ten list.  We should be flattered at that – we suppose.  But such considerations don’t enter into our rankings, which are purely subjective opinions.  Anyway, without further ado, here are our best of 2011 – the decisions that made us rush to our computers to blog about, and cases that we hope will help our (and your) clients in the coming year.

1. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  It’s such a big win for preemption that it has to be number one, even though generic manufacturers are the only immediate beneficiaries.  Not only was it a win, but after Wyeth v. Levine, 555 U.S. 555 (2009), a lot of commentators had written generic preemption off – but not us, as we pointed out here almost a month before Mensing was decided.  Mensing also reveals a Court that is about as evenly split as it is possible to be on the presumption against preemption, with four justices saying no, four saying yes, and Justice Kennedy (who else on this Court?) supporting preemption without feeling the need to address that issue.  What shoots Mensing into the top spot is it being an implied preemption case.  This means that its principles are not limited to generic drugs.  So keep in mind Mensing’s test for impossibility preemption:  “whether the private party could independently do under federal law what state law requires of it.”  Id. at 2579.  It’s usable elsewhere.  Consider how that test might play in the context of, say, black box warnings, design defect claims (both drugs and non-PMA devices), Dear Doctor letters, and any other situation where our clients are required to get the FDA’s (or some other federal agency’s) sign off before doing this or that.  Also supporting the #1 ranking is that the reservations we have about some aspects of Mensing have not materialized (see #9 below).  We blogged about Mensing here and here.

2. Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 (2011).  We’re #2!  We’re #2!  This blog has been following Bruesewitz since it was in the district court.  Vaccine defendants effectively ran the table in Bruesewitz.  The main holding is that Congress totally preempted design defect claims as part of the Vaccine Act (the statute creating the current federal administrative compensation scheme for vaccine-related injuries).  As in Mensing, the purported presumption against preemption goes on walkabout.  Bruesewitz also rejected each and every of the plaintiff’s hair-splitting arguments.  After Bruesewitz, there shouldn’t be much left of common-law vaccine litigation, with both warning (assuming the vaccine carries FDA-approved warnings – not a hard thing to do) and design claims preempted.  Bruesewitz also makes a number of useful statements concerning common law issues that, while not binding, we are pleased to add to our defense armamentarium.  The only reason Bruesewitz doesn’t rank higher is because vaccines are a narrower category of litigation than drugs or medical devices.  We listed our favorite bits of Bruesewitz here.

3. Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352 (11th Cir. 2011).  The best third-party payer/economic loss decision of the year.  “Third-party” and “three” go together well, we think.  A defense hat trick, with Rule 12 (no expensive discovery) dismissals affirmed against RICO, consumer fraud, and common-law claims under the law of – get this – 46 different states.  That’s just about every theory plaintiffs advance in this kind of case.  As to each, the basic rationale is pretty much the same, simply paying a theoretically higher price for a safe and effective drug isn’t the kind of loss any of these causes of action is designed to prevent.  Third party payers are by definition insurers, so they can simply raise their premiums.  To be actionable, the drug itself must be either unsafe or ineffective.  But safety/effectiveness claims necessarily vary from patient to patient (and thus from prescriber to prescriber), so third party payer plaintiffs must prove any claims one by one (which, of course, they have no intention of doing).  ILU68 also rules that pharmaceutical companies owe no duty of disclosure to third party payers, thus this decision has to rank very high on our list.  We celebrated it here.

4. Williams v. Mast Biosurgery USA, Inc., 644 F.3d 1312 (11th Cir. 2011). We absolutely hate (see 2011 bottom ten  #1) decisions that relax proof standards where plaintiffs have for whatever reason disposed of the product.  Such decisions only create incentives for plaintiffs to do just that – arrange for the products at issue to become unavailable.  Conversely we really like decisions that reinforce the requirement that there must always be a definable defect in a purportedly defective product.  We especially like decisions that reject use of res ipsa loquitur as an end run around the defect (and sometimes causation) requirement of product liability.  Williams is just such a case, and these issues are treated at some length.  An added bonus to Williams is the careful discussion of the difference between lay and expert testimony in the case of treating physicians.  We blogged about it here.

5. Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011).  Yup, the United States Supreme Court decided two cases on our top ten list on the same day.  Sorrell is not a product liability case, but rather a 6-3 constitutional decision that declares, “[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.”  131 S. Ct. at 2259.  Boom.  Such speech cannot be “silence[d] . . . by censoring its content.”  Id. at 2264.  Double boom.  Our complete description of Sorrell is here.  As we pointed out in that post, and as the dissent pointed stated in the decision, id. at 2678, Sorrell is of particular interest because it puts very distinct handwriting very on the wall implicating the constitutionality of the FDA’s prohibition against truthful promotion of off-label use.  Still, that’s in the future – hopefully in a top ten list yet to come.  But for its great potential (and for being a Supreme Court case), we award Sorrell the #5 spot on our list.

6. Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. 2011).  Everybody knows how much we like TwIqbal.  Courts of appeals follow about four different TwIqbal standards in drug/device cases.  The standard articulated in W-G is the best of the bunch.  Parallel violation claims must be “specifically stated.”  Plaintiffs must allege the “particular” statutory section/regulation supposedly violated.  “Specific” facts must establish the nature of the violation.  Crucial allegations must be supported by “factual detail.”  Seems almost self-evident, but trust us, it hasn’t been.  Not only that, but W-G is also good on PMA device preemption.  A two-fer, and because the court enunciates the toughest TwIqbal standard, we rate it the highest.  We blogged about W-G here .

7. Garza v. Merck & Co., 347 S.W.3d 256 (Tex. 2010).  How often does the best Daubert decision of the year come from a state court?  In Garza the Texas Supreme Court took a hard look at the epidemiological “proof” that the plaintiffs offered in support of a multi-million dollar verdict – and wiped that verdict from the face of the earth.  The studies involved dissimilar populations (as is almost always the case, the plaintiff took less of the drug for less time than the studied population) and didn’t show a statistically significant doubling of the relative risk.  Not only that, under Texas law, there must be two qualifying studies to guard against aberrant, fluky results.  Without those studies, there was no legally sufficient proof of causation in Garza.  Judgment n.o.v. city.  If only federal Daubert decisions stood as tall as Texans.  We gave Garza the old hook-em ’Horns salute here.

8. Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. 2011).  A gutsy judge making a gutsy call in the post-Levine world.  We’ve always argued that the SSRI (“selective serotonin reuptake inhibitor”) suicide cases – especially the adult ones – presented the best factual basis for implied conflict preemption in the prescription drug context.  The FDA record, rejecting such warnings over and over again as scientifically unsubstantiated, is just awesome, which is why the Agency intervened in these cases as amicus curiae.  But unfortunately, the Supreme Court screwed up the law in Levine before it had a chance to review an SSRI case.  After bad decisions all last year (e.g., 2010 bottom ten #3) along comes Dobbs to hold that the SSRI record constitutes the kind of “clear evidence” of FDA rejection that Levine says is needed to support preemption.  Maybe there’s hope yet.  We blogged about Dobbs here.

9. Smith v. Wyeth, Inc., 657 F.3d. 420 (6th Cir. 2011), and Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011).  Virtually unanimous state law before Mensing absolutely required that the plaintiff have used the defendant’s product for any product-related cause of action to exist.  The Supreme Court’s Mensing decision speaks only to preemption and has nothing to do with substantive state law.  Thus, state law after Mensing absolutely requires that the plaintiff have used the defendant’s product for any product-related cause of action to exist.  There’s not a lot of reasoning in either decision – otherwise they’d rank higher – but the bottom line message is crystal clear.  We blogged about Smith here.
10. Kowalski v. Rose Drugs of Dardanelle, Inc., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011) (they take a long time to publish in Arkansas).  Kowalski is a ringing reaffirmation of the learned intermediary rule by the Arkansas Supreme Court, combined with extension of the rule to pharmacists and an ultimately pro-defense outcome.   The court adopts the majority position that the rule precludes any general duty to warn from being imposed on pharmacists, and affirms entry of summary judgment.  Best learned intermediary case of the year.  Our post on the case is here.

That’s the top ten, but our Christmas tree still isn’t bare.  Judicial Claus has left us a bunch of smaller, but still nice, judicial presents over the past year.  We like defense wins, so here are the next ten in summary form:

Honorable mentions: (11) Astra USA, Inc. v. Santa Clara County, 131 S. Ct. 1342 (2011), not a products case, but quite citable as precedent for rejecting private tort actions in the teeth of an exclusive federal enforcement provision similar to the FDCA’s 21 U.S.C. §337(a) (our post here); (12) Walton v. Bayer Corp., 643 F.3d 994 (7th Cir. 2011), putting a decisive an end to fraudulently joined non-diverse pharmacists precluding removal – a commonly used dodge – that’s kept cases trapped in southern Illinois hellholes (our post here); (13) Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011), another good appellate TwIqbal decision, just not quite as good as W-G, due in large part to the plaintiff’s procedural errors (our post here); (14) Degelmann v. Advanced Medical Optics, Inc., 659 F.3d 835 (9th Cir. 2011), Preemption?  In a Class-II device case?  It can happen if the moon and stars align (our post here); (15) Kinetic Co. v. Medtronic, Inc., 2011 WL 1485601 (D. Minn. April 19, 2011), good on preemption, TwIqbal, parallel claims, discovery, and express warranty, all in one opinion (our post here); (16) Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701 (D. Minn. Sept. 27, 2011), a trailblazing decision involving reprocessed medical devices; well-reasoned and mostly favorable to the defense (our post here); (17) In re Digitek Products Liability Litigation, ___ F. Supp.2d ___, 2011 WL 5282595 (S.D.W. Va. Nov. 3, 2011), its excellent discussion of why “adulteration” has nothing to do with product defect will be cited again and again; would rank higher but for its shooting-fish-in-a-barrel aspect (our post here); (18) Gazal v. Boehringer Ingelheim Pharmaceuticals, 647 F.3d 833 (8th Cir. 2011), we don’t usually rank statute of limitations decisions, but this one stands for the general proposition that absence of scientific proof capable of surviving Daubert does not toll the statute of limitations (our post here); (19) In re Prempro Products Liability Litigation, 765 F. Supp.2d 1113 (W.D. Ark. 2011), excellent Daubert decision rejecting a type of claim – product use of less duration/amount than implicated in published studies – that recurs in multiple mass torts (our post here); (20) Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467 (E.D.N.Y. Apr. 24, 2011), an antidote to Y/Y (see 2011 bottom ten #3), excluding Dr. Parisian altogether on Daubert and other grounds (our post here). A half-dozen others – literally – just missed the cut.

Breaking out the old crystal ball, we note, in looking ahead to next year, that two of 2010’s bottom ten (Hamilton #4 (DTC exception to learned intermediary rule and Lance #6 (negligent design in prescription drug cases)), both from intermediate state appellate courts, have been accepted for further review by their states’ respective highest courts.  A third 2010 stinkeroo (Bartlett #8 (strict liability design defect without an alternative design requirement)) is in the First Circuit Court of Appeals in a much changed, and hopefully improved, post-Mensing environment.  No results in any of these yet, but we’re hopeful of having at least some good news to report in the coming year.  In one way or another, Bexis has managed to involve himself in all three of these further appeals, so we expect prompt – if not necessarily fulsome (client concerns control, after all) – reporting.  More truncated coverage is possible in Daniel (#8 of this year’s bottom ten (punitive damages despite FDA compliance)), as it is also a Dechert matter accepted for further appeal.

Beyond prior listings, this U.S. Supreme Court term (at least so far) doesn’t have nearly as many cases with interesting potential impact on the drug/medical device product liability arena.  One that might is Kiobel v. Royal Dutch Petroleum (our post here), which could nullify a horrible Alien Tort Statute decision, Abdullahi v. Pfizer, 562 F.3d 163 (2d Cir. 2009) (#2 on our worst list for 2009).  The issue before the Court in Kiobel is very broad and rather remote – whether that statute has any applicability at all to corporations – so it’s not specifically drug/device related.

Other notable pending appeals we’re aware of:  In Weeks v. Wyeth, the Alabama Supreme Court will become the first state high court to consider Conte branded/generic issues.  We blogged about that, here and here.  The Second Circuit will almost surely decide the Caronia case (our posts here and here), where the constitutionality of the FDA’s prohibition against truthful off-label promotion is squarely at issue.  It’s the same circuit that, last year, favorably decided the First Amendment Sorrell decision (see 2010 top ten best  #8) that the Supreme Court turned into our #5 above.  Finally, the Virginia Supreme Court has before it the question of cross-jurisdictional class action tolling, as we mentioned here.  Again, we hope to have more good news to report.

Happy new year to all.

A Tale Of Two – No, Three – Drugs

It was the best of times, it was … no, check that, it was the best of times.  In the recent decision, Wendell v. Johnson & Johnson, 2011 WL 6291792 (N.D. Cal. Dec. 15, 2011), the moving defendants all received summary judgment, so it was just the best of times.

 

Wendell itself is something of a three ringed circus, insofar as the facts involve three drugs – mercaptopurine (also known, for reasons unknown to us, as "6-MP," which has the advantage of being shorter), Remicaid, and Humira – and the interaction between their respective warnings.  The only simple thing about the facts is there is only one prescribing physician.

 

Here goes.

 

In 1998, the plaintiff’s decedent was diagnosed with inflammatory bowl disease (“IBD”), a nasty autoimmune condition.  Prescriber, who didn’t ordinarily review drug labeling – but did just enough to preclude summary judgment on that basis – began drug treatment.  Initially, the treatment featured Prednisone.  Unfortunately Prednisone is well-know among those who prescribe and use it (such as Bexis’ daughter, for a while) for causing adverse reactions approximately 100% of the time.

 

The decedent didn’t like the reactions, and Prednisone isn’t a very good long-term treatment for a chronic condition anyway.  Thus, by 1999, the prescriber went with 6-MP to try to get the decedent off Prednisone.   6-MP isn’t without its own risks, either.  “At the time [the prescriber] prescribed 6–MP he was aware of a paper reporting the occurrence of lymphoma [that’s a kind of cancer] in adults taking the drug.”  The prescriber warned the decedent about this, although he might have said “malignancy” rather than the precise type.

 

Apparently, the attempted substitution didn’t work all that well, because almost three years later the poor man is still taking both Prednisone and 6-MP. All this (and a lot of what follows) is from the “Background” section of Wendell, 2011 WL 6291792, at *1-5, by the way.

 

Still trying to get the decedent off Prednisone, the prescriber, now in mid-2002, discusses adding Remicade to the mix.  Remicade is an “anti-tumor necrosis factor” drug – an “TNF inhibitor.”  The tumor necrosis factor in the body causes inflammation, and inflammation is a major problem in a whole host of autoimmune conditions, including IBD.  Unfortunately, “tumor necrosis” means exactly what it sounds like – tumor death.  Tumor necrosis factor also kills tumors. Inhibit TNF, as this type of drug does, and one of the body’s defenses against cancer goes away.

 

Thus, Remicade (and probably all TNF inhibitors) is also associated with increased risks of malignancies.  It’s a trade-off:  almost a certainty of less inflammation for an increased risk of possible cancer.

 

The prescriber knew this, too. And “virtually always” informed his patients of an increased risk of tumors and malignancies.

 

In 2005 and 2006, more information became available about a possible synergistic effect between 6-MP and Remicade, involving a particularly dangerous form of lymphoma.  This development culminated in 2006 with an FDA black box warning about using these drugs in combination.

 

The prescriber was contemporaneously aware of all of this.  Fortunately, the stuff also worked.  By mid 2006, the decedent’s IBD was in remission.  He was taken off Remicade.

 

One problem with autoimmune conditions is that once they’re beat, they don’t always stay beat.  Half a year later, in November, the decedent had a relapse.  Instead of Remicade and 6-MP, the prescriber prescribed Humira and 6-MP. When asked why he had switched from one TNF inhibitor to another, the prescriber stated:

 

So in November ′06, we had been aware for some time of complication of hepatosplenic T-cell lymphoma, so that would have been part of my discussion with the family.  Ease of therapy is always a discussion with Humira versus Remicade.

Wendell, 2011 WL 6291792, at *4.

 

However, it was also true that, at that time Remicade bore the aforementioned black box warning about cancer risk, while Humira did not.  The prescriber said, essentially, that the black box didn't make much difference to him, since he already was aware of the risk and discussed it with his patients.  In addition to being easier to administer, Humir, also had (the prescriber said, we have no independent idea) a "superior" safety profile for other reasons, primarily being 100% human (as opposed to being produced from genetically modified mice) in its origin.

 

Wendell is a product liability suit, so necessarily the worst happened.  After using this second TNF inhibiter for seven months, the decedent got the nasty lymphoma warned about in the Remicade black box and died.

 

On this record the makers of Humira and 6-MP moved for summary judgment under the learned intermediary rule.  The maker of Remicade did not (also for reasons unknown to us).

 

The court granted the motions.

 

Here’s why.

 

The prescriber knew full well about the risks involved when he prescribed those drugs.  It didn’t matter that the black box warning was only on Remicade, because he saw it on that drug before prescribing the other one.

 

California law is quite good, going back even before Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004), on there being no duty – or no causation – where plaintiffs demand that physicians be warned about things they already know:

 

[The prescriber] knew of the risk of malignancies associated with 6–MP and Humira, but still prescribed the medication.  Thus, there is insufficient evidence to create a material dispute of fact as to whether the warnings that Plaintiffs contend should have been given would have changed [the decedent’s] treatment.

Wendell, 2011 WL 6291792, at *6.  Indeed, the prescriber had known about the risk of 6-MP since day one – and probably warned the plaintiff about it way back then.  Id.

 

Then it gets really interesting.  Plaintiffs love to claim than any post-injury change in prescribing habits means that the same change could have been induced earlier had only there been adequate warnings.  But rarely is there any real proof of this.  In Wendell the court required some supporting evidence, and when none was forthcoming, pitched the claim:

 

Nor is there evidence that a warning specific to pediatric patients or specific to treatments combining 6-MP with TNF-blockers would have led [the prescriber] to stop prescribing 6-MP alone or in combination. . . . Contrary to [plaintiffs’] contention, evidence that [he] ceased prescribing TNF-blockers in combination with 6–MP after [the decedent’s injury] does not prove that he would have changed his prescription practices based on the warning they suggest. A warning about rare occurrences . . . associated with therapy combining 6-MP and Remicade is bound to have less persuasive power than an instance of the disease affecting a doctor's own patient follow[ing] that therapy.

Id. at *7 (emphasis added).  In the end, the issue (at least as to 6-MP) boiled down to prescription despite prior knowledge, “[T]he undisputed fact is that [the prescriber] was already aware of the risk of lymphomas associated with 6-MP, but still chose to prescribe the drug.”  Id.

 

Touché.

As to Humira, given the timing of the first prescription, the causation fight was won for these reasons:

 

• As with 6-MP, a mere subsequent change in prescribing habits, with no additional affirmative evidence, did not mean that it would have happened earlier had there been different warnings.  Id.
• The “better safety profile” wasn’t linked to black box warnings, or to cancer risk at all, but to a 100% human origin product having fewer allergenic risks – a major concern with an autoimmune patient.  Id. at *8.
• With the prescriber already knowing about the risk, there’s no evidence that the different state of warnings (black box versus no black box) played any part in the prescription decisions.  Id.
• Since the prescriber had prescribed other drugs with cancer risks, whether or not the prescriber believed that Humira had that risk was not by itself causal.  Id.
• The plaintiff parents’ self-serving statements that they would never have allowed the treatment had they been warned, was immaterial, since the decedent was an adult and made his own treatment decisions.  Id.

 

In states like California, where the basic law concerning learned intermediary causation is well established, collecting analogous fact patterns where causation is defeated as a matter of law is the name of the game.  Wendell has some good ones.

 

Many Happy Returns

Today is Boxing Day, when we, along with millions of other Americans, scamper off to the Mall to return those Christmas presents that just didn't quite fit (physically or spiritually or aesthetically) our needs. So buh-bye jelly-of-the-month club (we're diabetic), Hello Kitty lounge pants (wrong size), Three Stooges talking bottle-opener (we love hearing "nyuck, nyuck, nyuck" whilst popping the top off a Yuengling, and that's why we already have one), and the boxed DVD set of all the episodes of Punky Brewster (like we said, we're diabetic).

We wish we could take back some of the crummier cases we saw this year, and exchange them for something better. Luckily, something like that happened with one of the cases that made it onto last week's Ten Worst list. We bemoaned Lefaivre v. KY Pharmaceuticals Co., 636 F.3d 935 (8th Cir. 2011), for permitting an improper private FDCA violation claim to go forward. More recently, a subsequent iteration from that litigation suggests the claims won't go very far forward, because there is no ascertainable loss. In Polk v. KV Pharmaceuticals Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011), the same basic claim was dismissed pursuant to Fed. R. Civ. P. 12(b)(6). The plaintiffs filed a putative class action, alleging that they had used Metoprolol Succinate tablets, and had gotten less than they expected because the FDA found that the defendants were not in compliance with current good manufacturing practices. That FDA finding means that the tablets were "adulterated" within the meaning of 21 U.S.C. section 351(a)(2)(B).

The plaintiffs tried to rely on the Consent Decree entered into between the defendants and the FDA. But in the Consent Decree preamble the parties disclaimed liability, The plaintiffs argued that the disclaimer was "inconsequential" and that the findings in the Consent Decree provided evidence of liability. The court disagreed and concluded that the Consent Decree contained "only allegations that were neither admitted nor denied by Defendants as well as the express denial of liability by the Defendants." 2011 WL 6257466 at *4. Therefore, the Consent Decree was evidence of nothing except that a settlement was reached between the defendants and the FDA. So far so good.

And it's about to get better. The plaintiffs' central claim is that the medication was worth less than what they paid for it, in light of the adulteration. But there was no evidence that the tablets posed any health risk to consumers. The court then followed the reasoning of Myers-Armstrong v. Actavis Totowa, LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009), a case we applauded here. Noncompliance with good manufacturing practices is insufficient in the face of no actual "manifestation of a defect that results in some injury or rational fear of injury" to state a cognizable claim. 2011 WL 6257466, quoting Myers-Armstrong. Put simply, there's no evidence that "adulteration" equals ascertainable loss. Therefore, the claims under both the Missouri consumer protection statute and breach of warranty fail.

The Polk case is like finding another present under the tree after you thought you were all done. Or it's like taking back that weird "The Scream" inflatable and exchanging it for something serviceable and solid, like a Yellow Submarine ice cube tray, or a nice, pro-defense ruling.

Removal News

There hasn’t been a lot of talk about this, but Congress just passed, and the President signed, something called the" Federal Courts Jurisdiction and Venue Clarification Act of 2011," H. R. 394, P.L 112-63, copy here.  As far as we’re concerned, this new act (we’ll call it, creatively, “the Act”) is as significant for what it didn’t do as for what it did.


The Act completely rewrote 28 U.S.C. §1441(b).  Why’s that important?  Because the literal language of §1441(b) – “removable only if none of the parties in interest properly joined and served is a citizen of the State in which such action is brought” – is what allows removal prior to service to trump the so-called “forum defendant” loophole.  As we’ve pointed out in many posts (most of which you can access from here), the “and served” qualifier to the forum defendant loophole means that, if an otherwise diverse action is removed before an in-state defendant is served, then that defendant’s citizenship, according to the statute, must be ignored and the action is properly in federal court.

That’s the express language of the statute.  The plaintiffs have responded with a mushy, result-oriented counter-argument that surely Congress didn’t mean what it said; that result would be absurd. As we’ve mentioned, some benighted courts have bought that rationale.

Well, that argument just went out the window.  Why?  Because in the Act (the 2011 one mentioned above), Congress had the opportunity to change §1441(b) if it was uncomfortable with the result dictated by that section's express terms.  It didn’t.  Quite the contrary, while Congress completely rewrote §1441(b) in the Act, it retained (and arguably improved, see this law review article, pp. 162-63) the “properly filed and served” language verbatim in the new version.  After the Act, here’s how §1441(b) now reads:

(b) REMOVAL BASED ON DIVERSITY OF CITIZENSHIP. – (1) In determining whether a civil action is removable on the basis of the jurisdiction under section 1332(a) of this title, the citizenship of defendants sued under fictitious names shall be disregarded.

(2) A civil action otherwise removable solely on the basis of the jurisdiction under section 1332(a) of this title may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.

Act §103(a)(3) (emphasis added).

Thus Congress reenacted the identical language of the statute that plaintiffs claim creates an “absurd” result.  When amending statutes, Congress is presumed to appreciate how the existging language is being interpreted in the courts.  E.g., Forest Grove School Dist. v. T.A., 129 S.Ct. 2484, 2492 (2009) (“Congress is presumed to be aware of a[] . . . judicial interpretation of a statute and to adopt that interpretation when it re-enacts a statute without change”) (citation and quotation marks omitted) (there are lots of similar cases).  Obviously, in the case of removal before service, Congress didn’t consider elimination of the forum defendant rule to be “absurd” in the least.   Rather, the forum defendant rule is itself an anachronism of earlier times when local prejudice against “foreigners” – that is, those from other states – was much greater than in the extremely mobile society of the Twenty-First Century.

So we think that the Act, by re-enacting verbatim the “and served” caveat to the forum defendant rule, has effectively ratified the validity of pre-service removal as a means of escaping hellhole jurisdictions where diversity is otherwise present.

What else is there in the Act?

Probably of most import to practicing litigators, Congress cleaned up the controversy about whether the 30-day removal period began to run with the first, or with the last, defendant to be served, where (as is usually the case these days) more than one defendant is sued.  Congress adopted the majority (but hardly unanimous) rule measuring time from the date of the last service – the so-called “last served defendant” rule.  See Act §103(b)(3)(B) (creating a new 28 U.S.C. §1446(b)(2)(B) specifically addressing this issue).  Earlier served defendants, even if they independently blew the 30-day removal period, may nevertheless consent to a timely petition filed by a later-served defendant.  Id. (creating a new 28 U.S.C. §1446(b)(2)(C) specifically addressing this issue).

Also, Congress has codified the formerly judge-made (but extremely long-standing) gloss on §1446, and now formally requires that all defendants (except those otherwise statutorily excluded) join in a diversity-based removal petition.  See Act §103(b)(3)(B) (creating a new 28 U.S.C. §1446(b)(2)(A) specifically addressing this issue).

Plaintiffs like to play hide-the-ball with the amount in controversy ("AiC") (currently $75,000 - that hasn't changed) in potentially removable cases.  The Act addresses this problem, as well, by providing that, where the AiC is not plainly stated in the complaint, any later filing (such as discovery) that yields AiC information establishing a demand above the limit required for diversity-based removal is treated as “another paper” that creates a new window for removal of the case.  See Act §103(b)(3)(C) (creating a new 28 U.S.C. §1446(c)(3)(A) specifically addressing this issue).

Also regarding the jurisdictional AiC, any dispute over what the plaintiff is actually demanding is to be resolved by the court on a “preponderance of the evidence” basis (some courts had imposed more restrictive proof standards). Id. (creating a new 28 U.S.C. §1446(c)(2)(B) specifically addressing this issue).  Note, this section of the Act consistently refers to "§1332(a)," meaning that it doesn't apply to AiC disputes under the Class Action Fairness Act, which is codified elsewhere, at 28 U.S.C. §1332(d).

There’s now a catch-all escape valve from the one-year limit (from time of suit commencement) for removing a diverse action.  If the court finds that the plaintiff acted in “bad faith” in any way to prevent removal, the one-year limit doesn’t apply.  See Act §103(b)(3)(C) (creating a new 28 U.S.C. §1446(c)(1) specifically addressing this issue).  This “bad faith” exception also applies to AiC issues.  Id. (creating a new 28 U.S.C. §1446(c)(3)(B) specifically addressing this issue).

Another change involves cases in which there are mixed removable (usually federal question) and non-removable (usually non-diverse tort claims) parts of a complaint.  Under the Act, the entire action can be removed (as at present) but once in federal court it’s now mandatory to sever the non-removable parts of the litigation and remand them to state court.  Conversely, defendants not affected by the removable parts, need not consent to removal.  See Act §103(a)(4) (amending §1441(c)).

Given the date that the Act was enacted, it will become effective on January 6, 2012.  From that day forward, it applies to all commenced in state (for removal purposes) or federal court.

NOTE:  The Act also contains amendments affecting jurisdiction and venue, but that’s beyond the scope of this post. Here are a couple of write ups of the Act that cover those aspects.

The Dregs - The Ten Worst Drug/Medical Device Decisions of 2011

Here we go again.  At the end of every year, we look back over the past twelve months – the highs and the lows – the thrill of victory and the agony of defeat.  We always start with the agony, however, and this year’s no exception.  Despite our best efforts, our side didn’t win everything everywhere.  So as we’ve done for the past four years, we’re handing out lumps of coal right before Christmas, specifically the ten worst prescription medical product liability decisions of 2011.  These noxious weeds seem to pop up all over.  We have federal cases and state cases.  We’ve been burned, of course, by hellhole jurisdictions, but also at least as much (if not necessarily as frequently) in jurisdictions that, until now, hadn’t earned that sobriquet.


Like last year, there’s still a week and a half left for courts to continue plumbing the depths.  There could be a new number one before the end of the year.  But, frankly, we want to get this over with before that vulture over there keels over and falls off its dung heap.  The last week of the year we reserve for the fun stuff, that is to say our top ten best decisions.

So let’s take the plunge – holding our noses all the way.  Here are our ten levels of hellhole, our bottom ten worst judicial drug and device decisions of 2011.

1. DiCosolo v. Janssen Pharmaceuticals, Inc., 951 N.E.2d 1238 (Ill. App. 2011).  The worst drug/device product liability decision of 2011 earned its dubious distinction by encouraging plaintiffs to lose the product that allegedly caused their injuries.  DiCosolo involved a pain killing patch used by a drug addicted (8 different drugs in the bloodstream) decedent whose death was initially ruled a suicide (before the plaintiff's lawyer prevailed on the coroner to alter his findings).  The plaintiff had used recalled patches, but the patch found on the decedent's body was tested and unequivocally did not exhibit any sign of the defective condition that prompted the recall.  No worries, held DiCosolo, the plaintiff can sue over the patch before that – the so-called "penultimate patch – that conveniently had been thrown away and was unavailable for similar testing.  A suspiciously timed affidavit (after a long period of silence) by the financially interested plaintiff just happened to remember seeing the problem that prompted the recall present in the discarded patch.  Thus the plaintiff was allowed to bring in the recall to the jury's attention, even though only a minute fraction of the recalled product had the defect.  That fraction included the only patch that could be tested (all others having since gone missing), but despite that test result, DiCosolo let the plaintiff proceed under res ipsa loquitur, even though a drug overdose is not a visible malfunction.  Nor did DiCosolo trouble itself overly with alternative causes, even though the plaintiff's deficient list had induced the coroner not to test the decedent’s blood for overdoses of several other drugs.  Goes to the weight, the court held, wrongly, since circumstantial proof only holds together in the absence of such causes.  Season this mess with some incompetent fraud on the FDA testimony , and an $18 million verdict was the result.  What’s the message of this terrible decision?  Plaintiffs – throw away your products!  You have nothing (in Illinois) to lose but your cases.  We made our best Calvin and Hobbes face at this unappetising decision here.

2. Hughes v. Boston Scientific, 631 F.3d 762 (5th Cir. 2011). Hughes allowed an improper private FDCA-violation claim – the defendant’s “algorithm” for reporting adverse events allegedly violating some obscure regulation – to masquerade as a tort suit.  Why did plaintiff even bother with such a bizarre claim?  Because the product was a PMA device and all the usual claims were preempted.  This duty-to-report based claim wasn’t even plausibly “parallel” to any tort cause of action ever recognized in Mississippi, so Hughes simply “assumed” that the Mississippi Supreme Court (hotbed of judicial liberalism that it is) would recognize the claim.  Hughes called it “negligence per se” even though Mississippi doesn’t recognize negligence per se where an allegedly-violated statute bars private causes of action.  What about Buckman?  Hughes bobbled that, too, holding that Riegel (unlike Buckman, an express preemption case) “unequivocally held” that there was an exception for parallel claims (actually, Riegel held only that the plaintiffs waived the whole subject).  In one decision Hughes messed up Mississippi common law, express preemption, and implied preemption – a trifecta that warrants a #2 ranking. We vented our frustration at Hughes here.

3. In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 6302287 (S.D. Ill. Dec. 16, 2011).  What happens when one plops a federal MDL in the vicinity of Madison County (yeah, we know, us Philadelphians should talk)?  Whatever it is, it’s not looking very pretty at the moment, having just yielded the #3 worst decision, and the lowest by a trial court.  Before Y/Y, even the worst MDL Daubert decisions at least clipped the wings of the other side’s Through-the-Looking-Glass coterie of purported “FDA experts.”  Not this time.  In a spectacular abdication of judicial gatekeeping authority, the Red Queen, the Mad Hatter and the rest get to testify unrestrained – even about purported FDA-related fraud and foreign regulations.  Y/Y will overdose the jury with FDA-related fantasy until the supposed “law” bears only passing resemblance to what the FDA actually enforces.  All this in a state – Illinois – where the highest court forbids FDCA-based common-law causes of action (see Martin v. Ortho, 661 N.E.2d 352 356-57 (Ill. 1996)) – something that supposedly matters under Lexecon.  We haven’t blogged before about this lump of coal in our stockings because it just happened.

4. Forman v. Novartis Pharmaceuticals Corp., 793 F. Supp.2d 598 (E.D.N.Y. 2011).  Judicial hubris is bad.  Judicial hubris that ignores Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), is worse.  Combining the two moves Forman into the #4 slot of our list, ahead of a number of bad appellate cases.  As step one, Forman held that New Jersey appellate courts didn’t know what they were doing when those courts applied Buckman preemption to the fraud-on-the-FDA exception of New Jersey’s punitive damages statute.  As step two, Forman held that predicating punitive damages on a finding of fraud on the FDA was okay, despite the unanimous Buckman holding that this was a no-no and the likelihood that punitive damages can exceed compensatory damages, and thus raise even more acutely the adverse consequences that underscored the Buckman result.  We kvetched about Forman here.

5. Smith v. Bayer, 131 S. Ct. 2368 (2011).  The Supreme Court overturned one of our sentimental favorites, In re Bridgestone/Firestone, Inc. Tires Products Liability Litigation, 333 F. 3d 763 (7th Cir. 2003) (Bexis played a part), and held that, because state class action rules (even if verbatim identical to federal Rule 23) might be interpreted differently, federal denial of class certification wasn’t preclusive against the same plaintiff’s lawyers seeking to certify an identical class action in some state court.  While we don’t like plaintiffs being allowed a second bite of the apple – and it’s a Supreme Court decision – we only rank Smith #5 because, frankly, the whole problem’s become a bit anachronistic.  Smith involved a class action that had lain dormant, hiding in the weeds for many years.  In the interim, Congress did a rare intelligent thing and passed the Class Action Fairness Act, which moved most of the class actions we care about into federal court.  After CAFA uniform (and tougher) class certification standards make the two-bites-at-the-apple issue much less salient than it had been back in the days of Bridgestone/Firestone.  We regretted Smith here.

6. Lefaivre v. KV Pharmaceutical Co., 636 F.3d 935 (8th Cir. 2011).   Lefaivre allowed what amounted to an improper private FDCA-violation claim to survive as a “breach of implied warranty” action.  Supposedly, Levine somehow limits Buckman even though not even Levine itself claimed to do that.  How Lefaivre could give precedence to a two-justice concurrence (about already adjudicated violations) over the 7-justice Buckman majority, which recognized no such exception, is also mystifying.  Topping everything off is blatant confusion (if not outright wrong-headedness) – a unique statement that Buckman was somehow a “field preemption” case.  All this is worthy of our #6 spot.   It certainly didn’t help matters that the defendant had entered into a consent decree containing damaging statements.  Bad facts (if they even qualify as "facts") clearly helped make bad law.  We rolled our eyes at Lefaivre here. At least there’s a silver lining, since the case has once again been tossed, this time on compensable loss grounds.  See Polk v. KV Pharmaceutical Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011).  Redemption anyone?

7. Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909 (Pa. Super. 2011), is an unfortunate punitive damages (aren’t they all?) decision by an appellate court in a large state.  Thus it weighs in (and us down) at #7.  Daniel allowed punitive damages even though the FDA indisputably had never charged the defendant with any relevant regulatory violation.  The basis for punitive damages was apparently failure to test – which doesn’t even rate as an independent cause of action in Pennsylvania.  Not only that, the plaintiff in Daniel got away with playing “hide the expert,” resulting in the jury hearing the recorded opinion of an expert that the expert later testified he had recanted.  Beneath all this was a moot footnote (choice of law not being disputed) that the law of the defendant’s principal place of business (Pennsylvania has no tort reform whatever concerning punitive damages) should control for punitive damages purposes over the law of the plaintiff's state of residence, a distinct minority position.  But in the silver lining department, the Pennsylvania Supreme Court has accepted an appeal concerning the punitive damages aspect of the case.  See 2011 WL 6034401 (Pa. Dec. 5, 2011).  We blogged about Daniel here and here.

8. Murthy v. Abbott Laboratories, 2011 WL 5416333 (S.D. Tex. Nov. 8, 2011).  Without citing any law – and contrary to a lot of law it didn’t cite – Murthy announced what amounts to a per se rule that any doctor receiving compensation for participating in a clinical trial involving an investigational drug can’t qualify as a learned intermediary under Texas law (although, of course, both side's experts can be paid much more).  Since physician compensation in this situation is routine, Murthy amounts to a blanket exception to the learned intermediary rule for all investigational drug cases.  Murthy also stretches – á la Hamilton (2010 bottom ten #4) – to carve out a second exception, for DTC advertised drugs, even though there wasn't any DTC advertising, since the prescriber okayed the information at issue.  Except, Hamilton at least was a state court with ostensible authority to change state law.  Murthy was a diversity case, without any such pretense, so its adventurous rulings exceeded that court’s power under our federal system, not to mention disregarded contrary Fifth Circuit authority.  Sigh.  At least this decision goes bye-bye if the Texas Supreme Court reverses Hamilton.  We called out Murthy's abuse of judicial power here.

9. Slater v. Hoffmann-LaRoche Inc., 771 F. Supp.2d 524 (E.D. Pa. 2011).  One of the things that made Madison County such a notorious hellhole back in the day was how the local federal courts collaborated (probably as much for docket control as anything else) in trapping defendants in state court.  We’re starting to see something similar between the Eastern District of Pennsylvania and the current #1 hellhole, Philadelphia (where we happen to be based).  To prevent removal of a case from – guess where – Slater held that a publisher could conceivably be sued for the “inadequate” contents of warnings that it printed.  The First Amendment implications are obvious, which is why Pennsylvania courts have rejected similar (non-drug/device) claims against book publishers.  But Slater ignores Pennsylvania law and holds, on the basis of one distinguishable (brought against a pharmacy, not a publisher) Massachusetts case that maybe, somehow, Pennsylvania law might impose liability on publishers for substantive errors in what they publish.  We published our own views on Slater here.

10. Brewer v. SmithKline Beacham Corp., 774 F. Supp.2d 720 (E.D. Pa., Mar. 24, 2011), Patton v. SmithKline Beecham Corp., 2011 WL 6210724 (E.D. Pa. Dec. 14, 2011), and Maldonado v. SmithKline Beecham Corp., 2011 U.S. Dist. Lexis 142578 (E.D. Pa. Dec. 12, 2011).  Maybe we’re being too parochial, but here’s another example of a federal court bending (or worse) the law to trap defendants in the Philadelphia hellhole.  These three decisions run roughshod over several provisions of Delaware corporate law (supported by the Third Circuit's interpretation) and admittedly deviate from the terms of the Supreme Court’s “nerve center” jurisdictional test – all because "form" supposedly shouldn’t triumph over "substance."  Hey, this is corporate law, which is all about form, since corporations are legal fictions to begin with.  The result in Brewer, et al., deprives companies with a significant Philly presence of otherwise perfectly legal means of changing residence for purposes of diversity jurisdiction, in effect creating sort of a “product line exception” to corporate law generally.  They also create an incentive for companies to up and leave Pennsylvania altogether.  We excoriated Brewer here.

Before we take our much-deserved long, hot shower, for the record we need to mention a couple of truly awful decisions that otherwise would fall through the cracks.  Both Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010) (covered here) and Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (covered here and here), were decided in that ten-day window between our 2010 worst decisions post and the end of 2010.  Thus, this terrible twosome isn’t really eligible for discredit in 2011, but was timed to avoid censure in 2010.  Stevens was adverse in several ways, most notably on the questions of cross-jurisdictional class action tolling and creating a duty to warn treaters not even in the same field as those who prescribed the drug.  Bausch – that’s easy – it’s quite simply the worst TwIqbal decision ever, at least from an appellate court.  We couldn’t let those two stinkers slouch away unscathed.

We also had to cut a few other candidates:  Wright v. Aventis Pastreur, Inc., 14 A.3d 850 (Pa. Super. 2011), was a tour de farce concerning preemption of vaccine design defect claims.  Wright added insult to injury, being rushed out while Bruesewitz (see, here) was pending in the United States Supreme Court.  Now, with Bruesewitz thoroughly trumping Wright, the latter just wasn’t important enough for the top ten.  Ditto for Gaeta v. Perrigo Pharmaceuticals Co., 630 F.3d 1225 (9th Cir. 2011), a bad appellate generic preemption case rendered irrelevant by Mensing.  See L. Perrigo Co. v. Gaeta, 132 S. Ct. 497 (2011) (summarily vacating bad decision).  And just missing the cut (maybe not if we weren’t from Philly) is Winter v. Novartis Pharmaceuticals Corp., 2011 WL 5008008 (W.D. Mo. Oct. 20, 2011), which allowed a plaintiff to escape what should have been fatal “I didn’t read the warning” prescriber testimony with a Magical Mystery Tour-like argument involving a Dear Doctor letter exquisitely timed to arrive at just the right moment to make some sort of causal difference with the plaintiff's utterly indifferent prescriber.

And thus the torture endeth.  Now, only the fun stuff is left. Tune again next week when we celebrate the top ten best drug/device decisions of 2011.

A Short PSA on Knowledge

            Before Cartoon Network, Nickelodeon and the Disney Channel, cartoons were reserved for Saturday mornings.  And, if you were a pre-teen boy in the mid-1980s (or are now married to someone who was), you are probably familiar with the G.I. Joe cartoon series.  If so, you also probably know that each episode ended with a public service announcement in which Joe quipped:  “Now you know and knowing is half the battle.”  From that same generation (and still enjoyed by kids today) is Schoolhouse Rock’s “Knowledge is Power.”  Or, while not cartoon-based but just to get a little more current, there is NBC’s series of PSA’s entitled “The More You Know”  All of these are certainly true in the case of a pharmaceutical failure to warn claim – the prescriber’s knowledge is crucial and if the prescriber knew about the risks, there is no failure to warn.

            That’s what a court said last week in Wendell v. Johnson & Johnson, 2011 WL 6291792 (N.D. Cal. Dec. 15, 2011).  At issue was the treatment of inflammatory bowel disease with combination therapy of two prescription drugs – one an immunosuppressive drug and the other a TNF inhibitor (anti-tumor necrosis factor drug).  Studies had reported incidences of lymphomas in patients being treated with this type of combination therapy.  Id. at *2.  In addition, a different TNF inhibitor carried a black box warning regarding the development of lymphomas with concomitant use of the two classes of drugs.  Id. at *3.  Unfortunately, plaintiff was diagnosed with lymphoma and passed away.  Id. at *5.

            Putting aside the adequacy of the defendants’ warnings, the court focused on causation – did the absence of a warning cause the plaintiff’s injury?  Id. at *6.  Here it is all about the doctor’s knowledge.  1) Where did he get his knowledge?  And, 2) what did he know?

            Question 1:  The prescriber testified that  

[h]e received information on medications from multiple sources, including meetings, other professionals in the field, articles and occasional meetings with drug representatives.

Id. at *1.  He also testified “that it was not his regular practice to look at drug labeling.” Id.  He looked at labels more often for new drugs or drugs less familiar to him.  Id.  It was also clear that he relied on medical literature as he was aware of studies regarding the development of lymphomas.  Id. at *2.  Since this isn’t a case where the causal link was broken because the doctor never read the label or never relied on information from the manufacturer, the court moved onto question 2.

            Question 2:   The answer was clear – “[The prescriber] knew of the risk of malignancies associated with [combination therapy], but still prescribed the medication.”  Id. at *6.  In fact, the prescriber in this case, based on his knowledge of the risks, warned his patients of a “nonzero increased risk of serious infections and malignancies related to immunosuppressives and anti-tumor necrosis factor drugs.”  Id. at 2. 

Giving the benefit of the doubt to plaintiff and assuming that the prescriber read the labeling, the court still granted summary judgment to the defendants because “the physician knew of the risk for which the plaintiff sought a warning” and “no harm could have been caused by failure to warn of a risk already known.”  Id. at *6.  Given that the doctor’s own knowledge of the risk did not “persuade[] him to cease recommending or prescribing the drug,” the court found there was insufficient evidence that any additional warning suggested by plaintiffs would have altered the physician’s course of treatment.  Id.  

Finally, it is also worth mentioning the court’s discussion of the prescribing physician’s prescription habits after the incident at issue – a favorite topic of plaintiffs: 

Contrary to [plaintiff’s] contention, evidence that [the prescriber] ceased prescribing TNF-blockers in combination with [the immunosuppressive] after [plaintiff] was diagnosed with hepatosplenic lymphoma does not prove that he would have changed his prescription practices based on the warning they suggest. A warning about rare occurrences of hepatosplenic lymphoma associated with therapy combining [these drugs] is bound to have less persuasive power than an instance of the disease affecting a doctor's own patient followed that therapy.

Id. at *7.  A good point to keep in mind if plaintiffs try to argue the persuasiveness of the doctor’s post-incident prescribing habits.

            So what did we learn from today’s episode?  It’s what you know, not where you learned it that counts! Don’t forget to tune into our next episode where Josie and the Pussycats explain why, like TwIqbal, facts do matter. 

TV and DDL Guide

This is the time of the year when critics and pundits come out with their top (and, sometimes, bottom) ten lists. Bexis will soon recite his most and least favorite court decisions of the year, with his usual withering wit and disproportionate enthusiasm. Some writers have already entered the fray on the mass culture front. Our favorite television critic, Alan Sepinwall, made a pretty good case for the best ten television shows of the year. We found ourselves nodding at almost all of Sepinwall’s selections. We also found ourselves thinking of some of the DDL cases we ran across this year. What does that mean? Clearly, we don’t get out enough.

Here are our tv favorites of 2011, along with our sometimes-logical-sometimes-puerile associations with legal rulings we encountered over the past twelve months.

Game of Thrones – HBO gave us a Tolkien-esque fantasy where dynamic leaders formed shifting alliances to topple one another. The character with whom the audience most identified was beheaded near the end of the season, throwing us (at least those of us who hadn’t read George R.R. Martin’s books) for a loop. Peter Dinklage rightly got some Emmy love as a supporting actor. We can’t wait for the next season to begin. There is already a teaser trailer online here. Season One contained plenty of strategy, sex (including yucky incest), and lots of blood. Naturally, when we think of battles in high places, we think of the Supreme Court’s opinion in Mensing, and how it squared with, or was inconsistent with, Levine. We’d like to think that the presumption against preemption, at least in implied preemption cases, is now as dead as King Robert Baratheon, Khal Drogo, and (sob) Ned Stark.

Boss- Kelsey Grammer played the same character, Frasier Crane, for many years across two sitcoms, Cheers and Frasier. In fact, he tied James Arness (Gunsmoke) for longevity. Grammer has also supplied the voice to our favorite Simpsons villain, Sideshow Bob (12 times and counting). Now Grammer goes dramatic, inhabiting the role of Mayor of Chicago, lording over the City of Big Shoulders like a mighty Colossus. Actually, make that a crazy Colossus, because Hizzonor is starting to lose his faculties. The Mayor has been diagnosed with Lewy body dementia. No doubt some enterprising Chicago plaintiff lawyer will take the case and allege that off-label use of some blockbuster drug caused this malady. Boss gives us another reason to tune to the Starz channel, besides seeing ConAir for the fortieth time. Grammer’s character is crazy, brilliant, colorful, and brutal. For some reason, we began thinking of our favorite Chicago judge, who most definitely is not crazy, but certainly is brilliant, colorful, and, yes, sometimes brutal when the level of advocacy is sufficiently execrable.

Community – This offbeat comedy is set in a community college full of crazy doings. The show is endlessly creative, full of meta-humor, and it pretty much never goes where you think it will go. Consequently, it has abysmal ratings and NBC has placed it on hiatus. (This is the same network that revived Fear Factor.) We cannot think of too many cases involving higher (or not-so-high) education, but we did blog about a case loaded up with perfectly ridiculous allegations against a university hospital. In Milton v. Robinson, 131 Conn. App. 760 (Conn. App. 2011), the plaintiff claimed an adverse reaction from her involvement in a clinical trial. The injury was a rash, and the plaintiff appears to have taken the placebo, not the active drug. The plaintiff proffered her husband as an expert witness. And there’s lots more silliness in that case. We have little difficulty imagining Joel McHale, Chevy Chase, Danny Pudi, and the rest of the cast having a sport with that story.

Parks & Recreation – This mockumentary at first looked like a weak sister to The Office, but it’s now the most consistently fine sitcom on the air. Amy Poehler heads up tv’s best ensemble cast about a municipal department dedicated to creating nice places for its citizens to play. We read somewhere that its take on local politics was somehow inspired by The Wire (only the greatest drama in the history of television). That is so hard to believe that we think it simply has to be a joke. But the show offers a lot of texture. All of the characters are vivid. Aziz Ansari barely reels-in his frantic stand-up persona – which is fine by us. Rob Lowe brings his incredible energy and brings the funny. (We have a theory that guest-hosting on Saturday Night Live is a finely calibrated test for real talent. It turns out that Alec Baldwin, Justin Timberlake, and Rob Lowe are vibrant, open performers. The less said about January Jones, the better.) Adam Scott was already a favorite from his appearances on the Doug Loves Movies podcast, and he plays a splendidly sincere and awkward romantic interest in P&R. How does this show remind us of DDL litigation? Here we must stretch. (Okay, this whole post is a self-indulgent stretcharama.) Playing games or sports in the park can lead to painful injuries. What’s better for pain than a nice pain pump? And what’s better for our defense-oriented selves than a pain pump case where the court soundly rejected plaintiff motions in limine? In Musgrave v. Breg, Inc., 2011 U.S. Dist. LEXIS 113661 (S.D. Ohio Oct. 3, 2011), the court issued a series of pretty good rulings on warning, causation, and Daubert. You can revisit our scintillating coverage of that case, complete with wildly inapposite analogies to George Harrison songs, here.

Breaking Bad – For a couple of years we felt outrage that Bryan Cranston (who played the father in Malcolm in the Middle and an overly-sensitive dentist in five episodes of Seinfeld) prevailed over Jon Hamm (Mad Men) for the best actor Emmy. But that was before we started watching Breaking Bad. (By the way, we still think Hamm should have won an Emmy for his remarkable monologue in “The Wheel” episode at the end of Mad Men season One. We dare you to watch this and disagree.) The folks at AMC have a pretty good thing going where they always have the best drama on the air – either Mad Men or Breaking Bad. Last season’s Breaking Bad was transcendent. Gus Fring (played by Giancarlo Esposito) was the best villain on tv. Unless, you want to call Walter White a villain -- and how could you not? After all, this one-time high school teacher has now become a meth dealer, a child poisoner, and “the one who knocks.” We thought of the Synthes criminal sentencing of executives under the Park doctrine, a story that is sad beyond our poor powers of expression.

Boardwalk Empire – It’s a close call whether this HBO drama belongs on the list. The last couple of episodes of Season Two redeemed what had been a so-so string. We admire Steve Buscemi (Reservoir Dogs, The Big Lebowski, and Ghost World), but aren’t sure he’s a lead, or at least the right lead for this show. The character he’s based on really did run Atlantic City in the 20’s, but he was a tall hulking guy whereas Buscemi is diminutive. Still, the show has terrific production values and some wonderful actors. Plus, it’s always great to see Omar from The Wire back in business, even if he’s wearing spats. The show has two weird parallels to the other HBO drama listed here, Game of Thrones: (1) one of the main characters was killed off, reminding us of what an uncertain universe we dwell in, and (2) the penultimate episode had an incest scene that was beautifully filmed, but it made us squirm. Know what else makes us squirm? Litigation in Atlantic City, both this year and in the past. Nuff said.

Homeland – This Showtime drama is the opposite of Boardwalk Empire insofar as the first four or so episodes were tense and unsettling, but it started to become too conventional. A tale of terrorism and turncoats edged into more standard cop procedural territory. We’ve always adored Claire Danes. Mandy Patinkin cuts back on his usual scenery mastication and is an arresting presence. The third main character is played by Damian Lewis, yet another British actor who plays an American so well that it can be a shocker when you hear him speak in his native voice. (Think of Hugh Laurie in House or Dominic West in The Wire.) Lewis was the lead in Band of Brothers, playing the late, great Richard Winters (who, by the way, deserves a Congressional Medal of Honor. Too bad it’ll be posthumous if it comes.) Homeland oozes with paranoia about the bad intentions of certain foreigners, even though some of the prime threats are domestically-grown. We are reminded of the Heparin case where a plaintiff’s lawyer attempted to exploit anti-foreigner animus by proffering an “expert” on Chinese culture.

Modern Family – This is the only one of our top ten shows that might actually reside in the top ten for ratings. We’ve come a long way from I Love Lucy and Leave it to Beaver. We mentioned this show after Ty Burrell uttered our single favorite line of the year about his fists being England Dan and John Ford Coley. The point of the show is that “Modern” does not necessarily mean dysfunctional, at least not where it really matters. Of course, most of us think of our own families as utterly dysfunctional. How many of us geezers reluctantly signed up for Facebook, only to see five wall postings per day from some nephew whom we remember as a sweet little boy, but who now festoons the internet with the most gross, vulgar twaddle? Yikes. Anyway, there have been interesting developments on the discoverability of social media, such as Facebook. We wrote about it here. And, no, it’s none of your business what our “status” is, and we don’t want to help you win Farmville.

Curb Your Enthusiasm – By every right, Larry David’s comedy should have grown stale and tired in its eighth season. (There’s an interesting intersection of this show and legal affairs. Back in 2003, an outtake from Curb showed that a murder suspect was in Dodger Stadium at the time of the killing. Larry David has gone on record that supplying an alibi to an innocent man might be the one swell thing he has done in his life. Not true: putting JB Smoove on tv also counts as a good deed.) This season’s “Palestinian Chicken” episode is on the Mt. Rushmore of comedy. Someone calls out Larry for being a “social assassin” because he has a genius for saying hurtful things that nobody else will dare say, and he seems to get away with it. It’s kind of like the DiCosolo case, which we wrote about here, where the plaintiff’s lawyer somehow got away with a closing argument accusing the defendant of “killing” the decedent out of “corporate greed run amok,” and of mounting a ”frivolous defense.” We found this argument to be, unlike Curb, not the least bit funny.

Louis – Louis CK constantly walks the line between painful revelation and gut-busting comedy. For a couple of years, Louis CK has been called the “comedians’ comedian.” We’re not sure what that means, though we’d love to be called “the defense hacks’ defense hack.” Louis wrote for other comedians, including Chris Rock. Louis wrote and directed Pootie Tang. (What we wouldn’t do to get that credit into our Martindale-Hubbell listing.) (By the way, JB Smoove was in Pootie Tang. Be honest: what other ABA top 100 blawg brings you the inside dope on Pootie Tang?) Louis now seems to be creeping into the wider public consciousness. He guested on an arc on Parks and Recreation a couple of years ago. On his new show on FX (he earlier did Lucky Louie on HBO) Louis plays somebody very like himself, a comedian battling between commerce and principle, raising two cute daughters who are actually raising him. There were great scripts on entertaining troops in Afghanistan and dealing with a suicidal friend. (Louie’s argument against suicide is one of the best we’ve ever heard.) Here is Louie on relationships: "It's hard to really, like, look at somebody and go, hey, maybe something nice will happen.... Or you'll meet the perfect person, who you love infinitely, and you even argue well, and you grow together, and you have children, and then you get old together, and then she's going to die. That's the best-case scenario." There’s so much wisdom in the show, we’d like to share it with our kids. But a key part of Louie’s comedy is the incessant foul language. To be sure, there have been some cases this year about foul language, but they either haven’t been in our area or they haven’t been that interesting. So we’ll instead mention a case of fowl language. In Gonzalez-Servin v. Ford Motor Co., 2011 WL 5924441 (7th Cir. Nov. 23, 2011), the issue was forum non conveniens. The appellant lawyer failed to address controlling case law. Judge Posner likened that lawyer to an ostrich sticking its head in the sand, even supplying helpful photographs. That’s about as close as the F.3d will ever get to slapstick comedy.

We think it was a great year for television. The proliferation of channels has induced the production of shows that are less broad and more nuanced. It’s fine that lots of people like The Big Bang Theory or Two and a Half Men. But it’s better that somewhere in the 500 channel universe there’s room for Louis and Breaking Bad. If you don’t like what you’re watching, you can change the channel.

Would that we could do that with some of the opinions we read this year.