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We know sports-courtroom analogies are overused, hackneyed, timeworn, trite (you get the idea).  But, nevertheless they can be useful and provide a little color to what might otherwise be viewed by some (of course, not us) as dull legal goings on.  For instance, we could simply report that the District of Maryland tossed out another case against a generic prescription drug manufacturer.  Grinage v. Mylan Pharmaceuticals, Inc., 2011 U.S. Dist. Lexis 149667 (D. Md. Dec. 30, 2011).  Or we could say –
A four-round hard glove fight took place in at 101 W. Lombard Street, Baltimore in the final days of 2011.  The fight pitted local Beatrice “the Plaintiff” Grinage against West Virginia’s own Mylan “the Defendant” Pharmaceuticals.  Catherine C. Blake, United States District Judge acted as referee.  The stakes were Grinage’s claim for the wrongful death of her husband allegedly caused by his ingestion of generic Allopurinal.  From the minute the bell rang, it was evident that the Defendant, with the law on its side, had the reach advantage.  In the first round, the Defendant had Grinage reeling from a right uppercut.  In the second, the Defendant’s left jab, right cross combination almost finished the Plaintiff off.  The Plaintiff hung in for two more rounds, but the devastating blows from the prior rounds had taken the wind from the Plaintiff’s sails.  With one last hook, the Plaintiff went down; the bell rang and Mylan emerged victorious.   And the crowd went crazy!!
OK, back to reality.  The punches were really Mensing and TwIqbal and they were as effective as any roundhouse and equally impervious to all plaintiff’s bobbing and weaving.
Round One – Failure to Warn:  Plaintiff tried to dodge Mensing by arguing efficacy over substance.  If claims regarding the substance of the generic drug warning are preempted, plaintiff claimed that generic drug manufacturers should have tried to harder to provide the warning they were allowed to give.  Grinage, 2011 U.S. Dist. Lexis 149667, *10.  Plaintiff argued that the defendant should have “employed more effective communication to healthcare providers and consumers” through things like Dear Doctor letters, training programs and public notifications.  Id.  To be clear, plaintiff’s contention was that the defendant could have met its duty to warn by using these methods of communication “without including substantial new warning information.”  Id. at *12.  However, even if Mensing leaves open for consideration a claim for “effective communication,” you still have to plead causation:

Here, there is no allegation that [plaintiff] and his doctor did not see the labeling as it was approved and take into consideration the information included therein . . . . Nor has [plaintiff] alleged any other facts sufficient to support a reasonable inference that further communications consistent with the approved label would have affected the choices made by [plaintiff] or his doctor.

Id. at *13.  Down goes failure to warn.
Round Two – Defective Design:  This is where Mensing and TwIqbal work a really effective combo.  Maryland state courts are divided over whether the proper test for determining if a prescription drug is defectively designed is risk-utility or consumer expectation.  The latter fails under Mensing:

An ordinary consumer forms her expectations regarding the safety of drugs from her doctor or from the drug’s label. Thus, if [a drug] is dangerous beyond the expectations of the ordinary consumer, that can only be a symptom of [the manufacturer’s] failure to update its label or communicate effectively with doctors. For reasons articulated above, any state law defective design claim predicated on this theory is pre-empted by FDA labeling regulations.

Id. at *18.   But plaintiff’s design defect claim couldn’t be helped by application of the risk-utility test because she failed to plead any facts regarding the utility of the drug or the availability of less dangerous alternatives.  In steps TwIqbal.  “Here, no factual allegations are included that raise the right to relief on a risk-utility design defect theory above the speculative level.”  Id. at *19.  Down goes design defect.
Round Three – Breach of Implied Warranty:  With the plaintiff on the ropes, the breach of warranty claims topple over with very little resistance.  First, a breach of warranty of merchantability requires proof of the existence of a defect.  Id. at *20-21.  See rounds one and two.  Second, a breach of warranty of fitness for a particular purpose requires an allegation of a particular purpose “as distinguished from the ordinary or general use to which the goods would be put by the ordinary buyer.”  Id. at *21.  No such allegation means no such claim.  Down goes breach of warranty.
Round Four – Fraud:  Plaintiff is staggering and it doesn’t take much to secure the knockout.  Fraudulent representations allegedly made to the plaintiff or his doctor – preempted under Mensing. Id. at *22-23.  Fraudulent representations allegedly made to the FDA – insufficiently pled to meet the heightened requirements of Rule 9(b):

The complaint contains no reference to any specific communication to the FDA that constituted a misrepresentation, or to any specific studies or other information improperly omitted from filings or other communications with the FDA.

Id. at *23-24.  And, we would argue this fraud claim is also preempted by Buckman, but we’ll settle for a Rule 9 dismissal.  Down goes fraud.
Another bout goes in the books in favor of generic drug manufacturers.  Thanks to Adam S. Ennis  at Jackson Kelly PLLC for passing this one along.

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On January 25, 2012 (Bexis’ birthday), between 12:00-1:00 p.m. (EST), our friends who publish the Physicians Desk Reference are putting on a free webinar entitled “‘Duty-To-Warn’ in the Digital Era: Emerging Issues.”  You can register for it online here.

And did we mention, it’s free?

Here’s a brief description of the subject matter:

Manufacturers have a legal responsibility to communicate the known risks associated with their medications and ‘duty-to-warn’ responsibilities have traditionally been fulfilled by publishing labeling information online or in reference texts.

However, as physician workflow consolidates around electronic health record systems, manufacturers may increasingly find themselves under scrutiny regarding their ‘duty-to-warn’ efforts – how and where they provide safety messaging will make the difference.

Hear industry experts share the latest developments in:

  • ‘Duty-to-warn’ relating to medical malpractice litigation and product liability management, including an update on the Supreme Court’s recent cases and the impact on generics.
  • The increasing role of technology in the evolution of ‘duty-to-warn’ benchmarking.
  • The growing responsibility on regulatory and marketing operations regarding ‘duty-to-warn’ in healthcare IT systems.
  • The importance of labeling information in the physician’s electronic workflow.

Why do we care?

Well, Steve McConnell of our blog (the guy who mostly writes the funny Monday posts) is one of the panelists, and he’s going to be presenting much of the legal framework for the webinar.  Other panelists include Christopher L. Gaenzle, Assistant General Counsel for litigation at Pfizer; Richard E. Hinson, and former senior marketing executive at Roche; Jay H. Stone, M.D., an interventional cardiologist at the Shore Cardiac Institute in Toms River, N.J.  The moderator is Brian McDonough, .M.D., a syndicated medical correspondent.

So if you’d like to interact with Steve, and learn something about the interface between technology and defending litigation involving prescription drugs and medical devices, drop in on this webinar.  For additional information, contact Jason Willett at (415) 644-3926 or by email at jason.willett@pdr.net.

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A long time ago, when we were just starting out as defense hacks, a mentor told us to beware of the double-standard that lawyers representing big corporations face: we are expected to be virtually perfect in our compliance with every possible rule (even rules whose existence and/or application are doubtful) while plaintiff lawyers can blow every deadline, botch every filing, bobble every rule, and get away with it because they are, pretend to be, or claim to represent, the little guy. For years we thought that double-standard applied. In front of some judges, we still fear the double standard. But we also have lots of friends among the plaintiffs’ bar and we have heard them complain of a double-standard that they face. Maybe everybody in our business labors under the impression that they are uniquely oppressed. Maybe we want to portray ourselves as heroes confronting long odds.
Most judges try to enforce the rules but also try to inject a little bit of flexibility into the system. They will cut litigants some slack, until it becomes clear that the litigant is a serial offender. Indeed, as brutal as the combat can be between plaintiffs and defendants, more often than not we usually find ways to cut each other some slack. There is a bit of ‘there but for the grace of God go I’ in these extensions of merciful courtesies. Nevertheless, if it becomes clear that the rule violations form a pattern of indifference or sloppiness, and if the noncompliance is truly disruptive or prejudicial (and our clients have more than a little input in this sort of calculation) it becomes appropriate to ask the court for enforcement of the rules and implementation of the correct sanction or remedy.
In mass tort litigation, there are two areas where we almost always run into at least some plaintiffs (and their attorneys) who fail to cross the t’s and dot the i’s where it matters: (1) plaintiffs who declared bankruptcy but did not include their tort claims as an asset in bankruptcy, and (2) plaintiffs who died and were not appropriately substituted for per the relevant state procedure. Our friend Joe Hollingsworth called our attention to an example of the latter in the Aredia/Zometa MDL, which has already been so prolific in producing grist for our bloggy mill.
The United States District Court for the Western District of Arkansas granted Novartis Pharmaceuticals Corporation’s motion to dismiss in McDaniel v. Novartis Pharmaceuticals Corporation, Case No. 2:08-CV-02088 (W.D. Ark. Jan. 6, 2012), because a deceased plaintiff had not been properly substituted for, despite representations to the court that the substitution would be accomplished. The case was originally filed in the United States District Court for the Middle District of Tennessee and was centralized in the Aredia and Zometa MDL. The case was ultimately remanded to the Western District of Arkansas, where the plaintiff’s family resided and was set for a February 2012 trial. At the time of trial, the putative plaintiff was the son of the allegedly injured party, who had died as a result of multiple myeloma.
But a lot had happened, or failed to happen, before February 2012. A Suggestion of Death had been filed, and the decedent’s husband was provisionally substituted in as personal representative. But the husband never changed his status from provisional personal representative to personal representative by submitting to the MDL court an order of appointment, as was required by the court’s case management order. Then the husband became incompetent to serve as personal representative. In early 2010, the son took over as provisional representative. But he never made application to be appointed administrator of his mother’s estate and never changed his status from provisional personal representative to personal representative by submitting to the MDL court an order of appointment. No estate had ever been opened for the decedent, and no petition had ever been filed to appoint someone (husband or son) as personal representative. After the passage of substantial time (nearly four years), and on the eve of trial, the plaintiff filed a Motion to Amend Order of Substitution, while the defense filed a Motion to Dismiss the Case.
The plaintiff’s motion was denied, and the defense motion was granted. The court was clearly reluctant to dismiss a case on what seems to be technical grounds, but was just as clearly constrained by the rules and the procedural posture of the case. The court found itself “in the unfortunate situation where, on the eve of trial, Plaintiff requests that this Court travel back in time and cure the procedural missteps done in the course of this litigation,” which “the Court cannot and will not do.” The husband’s and son’s failure to substitute in as personal representative violated three levels of rules: (1) they “failed to follow the terms of the MDL court’s case management order in substituting a proper party in interest within the time period specified by the order and prior to remand of the case” for trial; (2) they “failed to meet F.R.C.P. 25’s requirements for proper substitution of a deceased party”; and (3) they “failed to properly revive the claim according to A.C.A. § 16-62-108 [the Arkansas revival statute] within a year of Mrs. McDaniel’s death.” The court stated, “[t]he simple fact is that Plaintiff’s counsel had plenty of time to correct the procedural deficiency created by the death of Mrs. McDaniel.” Moreover, the “procedural deficiency” is not merely technical. The court lacks jurisdiction over the matter because the husband and son had failed to revive the claim.
Because the rule at issue really mattered, and because the plaintiffs had no viable excuse for ignoring the rule over such a long period of time, the court had no choice. For some rules, there simply is no double standard.

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We just received from defense counsel Matt Wender at Pietragallo Gordon a copy of Moore v. Mylan, Inc., No. 11:1-CV-03037-MHS, slip op. (N.D. Ga. Jan. 5, 2012).  It’s another post-Mensing case holding:  (1) that the plaintiff can only sue a maker of the drug s/he took (whatever that might turn out to be in this case), and (2) dismissing the generic on the basis of preemption.
As to product identification, Moore, applies well-settled Georgia law:

Moreover, the plaintiff needs to establish that the product that allegedly caused the injury was in fact manufactured or supplied by the defendant.  Plaintiffs allegations in her complaint fail to state a claim for strict liability under Georgia law . . . Third, setting aside the lack of specific factual information regarding [defect claims], plaintiff has not even alleged that a phenytoin product designed or manufactured by [one or the other of the defendants] proximately caused plaintiffs injuries.  It is unclear from plaintiffs complaint whether [the branded or generic defendant] manufactured, distributed, supplied, or sold the product that the decedent ingested.

Moore, slip op. at 12-14 (citations omitted); accord id. at 32 (additional causes of action).  Plaintiff’s complaint was so poorly pleaded that that product identification was wholly lacking as to any defendant.  Other branded related rulings are:  (1) all warning claims other than as to the plaintiff’s physician are barred by the learned intermediary rule, id. at 9-10; and (2) fraud claims were not pleaded with particularity, id. at 29-30.
As to preemption, the court held that the fact that the defendant generic was also a reference listed drug (“RLD”) did not preclude preemption.  As far as we know, Moore is the first decision thoroughly discussing RLD issues.  The court holds:  (1) that being the RLD for one strength of a generic product does not give the generic manufacturer the ability to change the label unilaterally on another strength of drug.  “Thus, because 100-mg and 300-mg are two different products, plaintiff has not shown any authority that would have required [defendant] to change the label of 100-mg to conform to the 300-mg label.”  Slip op. at 21-22.  (2) The RLD for the strength that the plaintiff used continued to be a branded product, therefore the Mensing rationale for preemption fully applied.  Id. at 22.  (3) There’s no authority that becoming an RLD gives a generic manufacturer rights to change the label unilaterally:

[P]laintiff has not shown how [defendant] acquired all of the same rights as a brand name drug manufacturer simply by manufacturing one drug that was an RLD.  Plaintiff has not shown that [defendant’s] manufacture of one RLD converted [defendant] into brand name drug manufacturer with the right to use the CBE process to change the label of any of its drugs.

Id. at 21-22.
Another notable generic preemption ruling in Moore is that any claim that the defendant should simply have stopped selling its product is preempted.  Id.  at 34 n.14.
Plaintiff was given leave to file an “amended complaint [that] should address the concerns in this order.”  Id. at 37.
We’ll be adding Moore to both our generic preemption and branded/generic scorecards.

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Not quite a year ago we had a little fun commenting on the Daubert dismissal of a suit involving something called an “ear candle.”  As we said back then:

[W]e never thought about lighting a candle in our ear.  That seems a little strange.  Maybe even a little risky.  We can’t think of a good reason to plant a candle in an ear, and we can think of a pretty good reason not to: hot wax.  That might hurt.

Apparently the FDA had similar qualms.  We’ve just learned from reading Holistic Candlers & Consumers Ass’n v. FDA, ___ F.3d ___, 2012 WL 5831 (D.C. Cir. Jan. 3, 2012), that:  (1) those who make candles for people to shove in their ears (at least 15 different entities) and set on fire actually have their own lobbying group (that’s scary – are UFO believers next?); (2) some people actually believe shoving a lit candle in your ear is a healthy thing to do (that’s scarier); and (3) the FDA is on the case (that’s probably good, although one might wonder about the Agency’s enforcement priorities).
So why do we care about people who stick lit candles in their ears?
Because – aside from keeping a straight face – the Court of Appeals makes a point about FDA warning letters that needs to be kept in mind whenever such things surface in product liability litigation.  Such letters, including the 15 issued in this case, don’t mean squat as supposed statements of FDA regulatory positions:

FDA’s warning letters . . . neither mark the consummation of the agency’s decisionmaking process nor determine the appellants’ legal rights or obligations.  The letters plainly do not mark the consummation of FDA’s decisionmaking. . . .  FDA warning letters . . . giv[e] firms an opportunity to take voluntary and prompt corrective action before [the FDA] initiates an enforcement action. . . .  Nor do the letters represent a decision determining rights or obligations, or one from which legal consequences flow. . . .  [A] Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].  Although a warning letter communicates the agency’s position on a matter, it is only informal and advisory and does not commit FDA to taking enforcement action. . . .  In short, an FDA warning letter compels action by neither the recipient nor the agency.

Holistic Candlers, 2012 WL 5831, at *2-3 (citation to the FDA’s regulatory procedures manual and quotation marks omitted).
This discussion of FDA warning letters was important in Holistic Candlers because, due to their preliminary nature, “FDA warning letters do not represent final agency action subject to judicial review.”  Id. at *4.  Thus, the litigation was snuffed.
To us it’s important because FDA warning letters don’t even rise to the level of a criminal indictment, let alone a conviction.  An indictment is at least the “initiation of an enforcement action,” whereas an FDA warning letter isn’t even that.  It might even be less than a DOJ target letter (we say “might” because we’re not criminal lawyers, and don’t claim to know all the implications of a target letter).  If mere criminal charges not leading to conviction are not admissible evidence, then a fortiori an FDA warning letter should not be admissible in similar circumstances.  This isn’t the first time we’ve made this point about FDA warning letters, but it’s a point that bears repeating.

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Ringing in the New Year’s been a might slow.  Not too much shaking loose in the Drug/Device law area it seems.  There were some pretty hideous Daubert rulings in Yazmin/Yaz, but not all that much reasoning to support them.  It seems to be a judicial settlement pressure tactic – aimed at defendants – since we read this morning that, immediately after issuing all these bad rulings, the court cancelled the bellwether trial that had prompted the motions in the first place, and required mediation instead.  Anyway, we noted the worst of the bunch in our bottom ten post a week ago, so we’ll leave them at that.

One new case we’ve seen is Roberts v. Albertson’s LLC, ___ Fed. Appx. ___, 2011 WL 6807608 (9th Cir. Dec. 28, 2011) (non-precedential), where the combination of a corner-cutting lawyer and his not-so-bright client resulted in a nice defense win. Roberts involved a medical device, a blood pressure monitor. The plaintiff claimed it didn’t work right and gave deceptively low readings. Allegedly that caused, or was a substantial factor in, the plaintiff having a stroke.

We say allegedly because – well, we’re defense lawyers – but more because plaintiff didn’t have any expert to explain why that was. Usually that kind of thing happens where: (1) causation is pretty darn obvious, or (2) the plaintiff has lost the product and has no other choice. That doesn’t seem to be the case in Roberts. How a mere monitoring device can cause a stroke is anything but obvious, and there’s no mention of a lost product in the case, so we chalk the absence of any plaintiff experts up to the other side not willing to invest anything in the case.

So much the better for us.

So to the client. Plaintiff was prescribed blood pressure medication after the one time he had his blood pressure tested by a doctor, it was elevated. He also bought the home BP monitor that was at issue in the case. It gave him consistently normal readings – plaintiff claims improperly. Supposedly, due to those readings, the plaintiff decided, contrary to doctor’s orders to stop taking his medication and to use a “homeopathic” regimen of his own concoction (fish oil and something called “Co-Q 10”) instead. After abandoning real drugs for that garbage, he had a stroke.

And he didn’t have any experts.

The district court granted summary judgment, and now the Ninth Circuit affirmed, albeit on somewhat different grounds, those being:

• Although there was a discrepancy between the home readings and the one doctor’s reading, “that single discrepancy does not establish that the monitor gave inaccurately low readings.” 2011 WL 6807608, at *2. The directions warned that readings could vary, and any comparison to a single in-office reading wasn’t valid without some kind of expert proof.

• There was no “substantial factor” causation because nothing in the monitor’s directions made it any more, or less, likely – in the absence of any affirmative evidence – that the plaintiff would have stopped taking his prescribed drugs, contrary to doctor’s orders. Id.

• There was no proximate cause. Plaintiff had no evidence that it was “foreseeable” that a malfunction in a home monitor would cause a reasonable man to stop taking prescribed drugs, contrary to doctor’s orders, and go homeopathic. Id. at *2-3

The court didn’t say it in quite this fashion, but we will – product liability is not free insurance against a plaintiff’s own stupid behavior involving drugs or medical devices. A would-be plaintiff who simply stops taking his/her prescribed drugs on his/her own volition has only him/herself to blame.

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It’s a National Holiday, and we do not expect to do a heckuva lot of work today. There’s a decent college bowl game tonight and our Flyers will be taking on the Hated Rangers in the Winter Classic outdoor hockey game. There’s a bottle of champagne in the fridge that somehow evaded last night’s jackals-masquerading-as-friends. And it’s time to start working on those New Year’s resolutions.

Experts tell us that New Year’s resolutions are doomed to fail unless the list is short and limited to the important and attainable. We’re going to plug in the treadmill and stop falling for the “If you order dessert I’ll help you finish it” gambit. We also are thinking through some resolutions inspired by one of our Christmas presents, Walter Isaacson’s biography of Steve Jobs:
　
1. As much as we focus on technical areas (e.g., legal procedures , doctrines such as preemption, etc.), we must keep our eye on the basic human aspirations of our consumers (clients, courts, and juries). If there’s one Big Theme in the Jobs bio, it’s that Jobs was a miraculous combination of the technical and the spiritual. Jobs talked about the iPad (and, indeed, the company) residing at the intersection of liberal arts and technology. Jobs cared as much about consumer emotions as he did about computer code. Some science geeks can come up with devices that are intricate, brilliant — and ugly and user-hateful. Jobs arrived at a brilliant synthesis that embraced creativity and technology to produce tools for living. What we as lawyers do isn’t rocket, or even computer, science. But sometimes we focus unduly on technical issues and forget about how real human beings will receive and use what we say.

2. Binary thinking can be a good thing. Jobs invariably called ideas or products “amazing” or dreck (he used a much tougher word). People were either “heroes” or “bozos.” Sure, that viewpoint discards nuance. But it also facilitates action. Jobs had high standards and was decisive. He wasn’t always right, but he certainly made “a dent in the universe.” Groupthink can introduce too much compromise and muddle. We were at a presentation where a consultant said that while most consumer product organizations are promiscuous in their use of focus groups and surveys, Apple’s approach was a bit leaner. Then the consultant put up a photograph of Jobs: that’s how Apple made important decisions. We’ve been in cases where sometimes it seemed that one strong-willed plaintiff lawyer had certain advantages over a defense side frazzled by way too many diverging opinions.

3. Simplicity is the purest form of sophistication. Look at an iMac. It’s simple, uncluttered, beautiful, and invites interaction. By contrast, this post is being typed on something that looks like it was designed by an Uzbekistani death squad. It takes a lot of work to make something complicated seem simple and inevitable, but that effort is worth it, whether it’s with a device, legal brief, graphical presentation, or argument.
　
4. Relentless, even crazy, perfectionism, can be inspiring. Jobs was notorious for insisting that even the inside of Apple products — parts that nobody would ever likely see — had to be beautiful, with straight lines and the right colors. It seems like a maniacal, wasteful approach, but somehow that kind of craftsmanship does manifest itself it to the consumer. It’s a tough standard to meet, but what’s the point of pledging to easy New Year’s resolutions?

5. In the end, the product is the key. When Jobs returned to Apple after his exile, he gave a speech to the troops. He asked: Why is the company in trouble? His answer was blunt: “The products suck.” Jobs wasn’t in the businesses he chose (think also of Pixar) to make money, though he did pretty well in that regard. He wanted to make great products. Of course, one should lead to the other. If you have smart people, sound processes, and all the great intentions in the world, none of it matters if the products aren’t great. It reminds us of something ex-Cubs and Phillies reliever Mitch Williams says about pitching: hitters don’t see how you feel, they see what you throw. Now, you might say two things: (1) this point is perfectly obvious, and (2) how does this notion apply to legal services? Lawyers don’t actually act as if it’s the product that matters. We talk a lot about how smart and insightful and eloquent we are. But what are we actually delivering to the client (and courts and juries)? Where is the actual, ocular proof that what we are doing is helping our consumers? We think we can do better. We have some ideas. At a minimum, those are questions we need to ask ourselves everyday in 2012 and beyond.
　
Happy New Year.

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

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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.

Photo of Bexis

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 inhibitor 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.

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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