Wednesday, November 30, 2011

Class Action Smackdown

Class action plaintiff lawyers have been known to do some pretty sleazy things.  Don’t just take our word for it.  Check out the ALI’s recently adopted Principles of the Law of Aggregate Litigation §§1.05, 3.08 (2010), and especially the cases and articles cited in the Reporter’s Notes.  Class action plaintiff lawyers also have to satisfy the “adequacy of representation” prong of Rule 23(a) in order to get a class certified.  When can the former preclude the latter?

That was the question in the recent decision by the Seventh Circuit in Creative Montessori Learning Centers v. Ashford Gear LLC, No. 11-8020, slip op. (7th Cir. Nov. 22, 2011).  Creative Montesori isn’t a drug/device case – far from it – but it’s a useful reminder about another way to defend against class actions.  Moreover, we recommend that defense counsel read it with an eye towards the type of discovery that would be appropriate to prove the sorts of representation issues that the Seventh Circuit has declared relevant (and potentially dispositive) to class certification.

You’ve probably heard of “patent trolls” – entities that produce nothing of value, only litigation over questionable patents.  Well, Creative Montessori involves what could be called “fax trolls” – a law firm that specializes in bringing suits under a federal statute (the so-called “Telephone Consumer Protection Act”) that imposes “draconian” penalties for sending unsolicited faxes.  Slip op. at 2.  The firm apparently scraped the bottom of the barrel rather thoroughly to dig up the purported plaintiffs for the suit in question, engaging in two types of conduct that the appellate court took issue with:

  • First, they "obtain[ed] material from [a fax broadcaster’s] files on the basis of a promise of confidentiality that concealed the purpose of obtaining the material, a purpose inconsistent with maintaining confidentiality and likely to destroy [the broadcaster’s] business.”  Creative Montessori, slip op. at 6.  This case was not the only such breach of confidence.  According to the opinion, the same firm brought “more than 50 similar class action suits based on information” from the same source.  Id. at 6.
  • Second, once the firm identified the fax recipients, it solicited their participation in the class action suit by “implying in the letter to [the would-be plaintiff] that there already was a certified class to which the [plaintiff] belonged.”  This “would constitute misconduct . . . because the communication was misleading.”  Id. at 6-7.

The district court ignored these incidents in deciding to certify the class, holding that the alleged misconduct was properly the province of “bar authorities.”  Creative Montessori, slip op. at 7.  The lower court went on to hold that “only the most egregious misconduct” by would-be class counsel “could ever arguably justify denial of class status.”  Id. at 2.  The Seventh Circuit, in a unanimous decision by Judge Posner, vehemently disagreed.  Any serious allegation of misconduct by class counsel undercuts the adequacy of their representation:
Misconduct by class counsel that creates a serious doubt that counsel will represent the class loyally requires denial of class certification. . . .  A serious or, equivalently, a “major” ethical violation, should place on class counsel a heavy burden of showing that they are adequate representatives of the class.

Id. at 10-11 (citations omitted).  A lesser standard, without the burden being on class counsel to justify their adequacy in such circumstances, is merely an invitation to class action lawyers to profit from their own ethical misdeeds:

To rule that only the most egregious misconduct “could ever arguably justify denial of class status,” as the court went on to hold, would if taken literally condone, and by condoning invite, unethical conduct.

Id. at 10 (emphasis original).

The court therefore vacated class certification and remanded – with the explicit instruction to “re-evaluate the gravity of class counsel’s misconduct and its implications for the likelihood that class counsel will adequately represent the class.”  Creative Montessori, slip op. at 11.

There’s even more to Creative Montessori than we’ve discussed (such as that the would-be class representative probably never even received a fax), so it’s worth a read by anyone defending class actions of any sort.  The opinion is a ringing reiteration of the principle that “actions have consequences,” something that lawyers, as well as children, should bear in mind.  Moreover, by expressly linking ethical lapses – not limited in any way to the solicitation of clients – the opinion underscores the need for properly targeted discovery, at the class certification stage, into potential misconduct by class counsel.

Tuesday, November 29, 2011

Nevada Formally Adopts The Learned Intermediary Rule

When you add together the plurality (p. 958 n.16)  and one of the dissents (p. 969) in Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994), there's a majority in favor of the learned intermediary rule.  Thus, we've included Nevada in our post that lists all of the states adopting the rule,  Still, when we have to mix and match like that, there's a little doubt in the back of our minds that we're not on as sound ground as we might have liked.

No longer.  In Klasch v. Walgreen Co., ___ P.3d ___, 2011 WL 5878054 (Nev. Nov. 23, 2011), we got a little Black Friday gift from the Nevada Supreme Court.  Without even mentioning Allison, the court formally adopted the rule - this time unanimously - and, in the same case, extended it to pharmacists:
Traditionally, the learned-intermediary doctrine has been used to insulate drug manufacturers from liability in products-liability lawsuits.  Under the learned-intermediary doctrine, a drug manufacturer is immune from liability to a patient taking the manufacturer's drug so long as the manufacturer has provided the patient's doctor with all relevant safety information for that drug.  It is then up to the patient's doctor—who has the benefit of knowing the patient's specific situation—to convey to the patient any information that the doctor deems relevant.

Jurisdictions adopting the learned-intermediary doctrine in the context of pharmacist/customer tort litigation have put forth a similar rationale:  that between the doctor and the pharmacist, the doctor is in the best position to warn the customer of a given medication's generalized risks.  Or, viewed more pragmatically, the doctrine prevents pharmacists from constantly second-guessing a prescribing doctor's judgment simply in order to avoid his or her own liability to the customer.  In this sense, the learned-intermediary doctrine preserves the pharmacist's role as a conduit for dispensing much-needed prescription medications.

Because we believe that these public-policy considerations are sound, we adopt the learned-intermediary doctrine in the context of pharmacist/customer tort litigation.  Accordingly, Nevada pharmacists have no duty to warn their customers of the generalized risks inherent in the prescriptions they fill.

2011 WL 5878054, at *3 (footnotes to out-of-state learned intermediary cases omitted).

All is not sweetness and light, however, in Klasch - at least not for pharmacies.  The court holds that pharmacies having actual knowledge of a "customer-specific risk" can be liable for not notifying either the doctor or the customer of that risk.  Id. at *5.  Although the facts look pretty bad for the plaintiff (the doctor prescribed with knowledge of the alleged risk, id. at *1), that wasn't the basis of the pharmacy's summary judgment motion, so the court reversed while practically inviting the defendant to try again on a fuller record.  Id. at *5-6. 

Two Post-Mensing Firsts

In a post-Mensing world, plaintiffs -- faced with almost certain dismissal of any claim based on labeling, promotion or warnings -- are scrambling to re-define their claims against generic drug manufacturers.  They are most certainly looking for their port in a storm.  As our faithful readers know, we are keeping track of post-Mensing generic drug preemption decisions here -- an ever growing list of dismissals of failure to warn claims. 

Today, however, our focus is on how Mensing is being applied to some of plaintiffs’ “alternate” theories of liability.  So we bring you two cases -- Gross v. Pfizer, Inc., ___ F. Supp.2d ___, 2011 WL 5865267 (D. Md. Nov. 22, 2011) (metoclopramide) and In re Fosamax Litigation, 2011 U.S. Dist. Lexis 135006 (D.N.J. Nov. 21, 2011) (alendronate sodium) (thanks to Anita Hotchkiss at Goldberg Segalla for forwarding this one).  A quick note of interest for brand-defendants – in Gross, the court had dismissed plaintiff’s claims against the brand defendants because she had not ingested the brand-name drug.  Gross, 2011 WL 5865267, *1.  Post-Mensing, the court denied plaintiff’s motion to reconsider its judgment in favor of the brand defendants.  Id. 

Now back to generics.  In both cases, generic defendants moved to dismiss all of plaintiffs’ state law claims as preempted.  First, both courts quickly and easily dismissed plaintiffs’ failure to warn claims.  Id. at *3 (plaintiff conceded her inadequate labeling claims were preempted); In re Fosamax, 2011 U.S. Dist. Lexis 135006, *34 (“Plaintiffs’ claims of failure to warn are squarely preempted by Mensing).  In In re Fosamax, the court also went on to find that nothing in the 2007 Food and Drug Administration Amendments Act (“FDAAA”) changes the generic preemption analysis

Accordingly, the Mensing analysis is not affected by FDAAA because the Generic Manufacturers are still unable to unilaterally change drug labeling without special permission and assistance, which is dependent on the exercise of judgment by a federal agency.

Id. at *37-38 (citation and quotation marks omitted).

Next, the courts explained that plaintiffs’ omission of the words “failure to warn” in certain claims, doesn’t make them any less failure to warn claims.  In Gross, for instance, plaintiff unsuccessfully argued that her negligence claim for concealing important safety information survived Mensing.  Gross, 2011 WL 5865267 at *4.  Really?  Concealing safety information isn’t a failure to warn claim?  Likewise, the Fosamax court made short shrift of plaintiffs’ breach of express warranty, fraud, misrepresentation, failure to conform to representation, negligent misrepresentation and violation of consumer protection statutes “because the gravamen of these allegations is the insufficiency of [the] labeling.”  In re Fosamax, 2011 U.S. Dist. Lexis 135006 at *43. 

After doing away with all of the labeling-based claims, these courts examined two additional claims designed to circumvent Mensing – negligent continued selling and design defect.  In Gross, plaintiff brought negligence claims alleging the generic manufacturer had a duty to cease selling metoclopramide.  The court acknowledged that that very argument had been adopted by the Eighth Circuit and therefore rejected by the Supreme Court in Mensing.  Gross, at *3.  In holding the “stop selling” claims preempted, the court stated that it

is aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce. Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.  

Id.  The Fosamax court also didn’t buy the “stop selling” argument.  In re Fosamax, at *36, n.5 (“To accept Plaintiffs' argument that Generic Defendants could have simply stopped marketing alendronate sodium, this Court would have to directly contravene binding law;” “it is essentially a re-argument of Mensing.”).

The Fosamax court also dismissed plaintiffs’ design defect claims on the identical sameness rationale used in warning cases.  In Mensing, the Supreme Court

found that generic manufacturers have a federal duty of "sameness" to, at all times, insure that the label for the generic drug is identical to the label adorning the corresponding reference-listed drug.

Id. at *28.   As with the label, federal law requires that the “active ingredient of the [generic] drug is the same as that of the listed drug.”  Id. at *33 (citation omitted).

Hence, the "duty of sameness" also applies in the context of generic drug design. Mensing stands for the principle that a federal duty of sameness arising out of FDA's regulatory requirements preempts any conflicting tort duty arising under state law.

Id.  Because federal law requires generic Fosamax to have the same active ingredient as brand-name Fosamax, the generic defendants could not have changed the design of the drug and therefore, plaintiffs’ design defect claims are preempted.  Id. at *34.

So, at least in these two courts, plaintiffs have yet to find a safe harbor in which to dock and remain adrift in the swirling seas of Mensing. 

Monday, November 28, 2011

The Difficulty of Quantifying the Effect of TwIqbal

When we took stock of things to be thankful for last week, we focused on family, friends, and health. Amidst the turkey, sweet potatoes, and cranberries (the real ones, not the canned stuff), there was little room for professional considerations (or, as our Texan friends call it, bidness). You see, despite our nerdiness, we actually do possess a sense of perspective. If we did make a list of legal-reasons-to-be-thankful, we'd include, along with the Washington Legal Foundation and Judge Posner, our old buddies Twombly and Iqbal.

But have those cases really made a difference? A couple of weeks ago we linked to an article by Professor Hubbard that concluded, after the requisite quantitative analysis, that Twombly might not have had much concrete effect. Color us surprised and somewhat disillusioned. We thought we were getting served up with stuffing and gravy, and instead someone passed us the turnips.

We got a peak at a forthcoming (volume 121) Yale Law Journal article, "Locking the Doors to Discovery? Conceptual Challenges in and Empirical Results for Assessing the Effects of Twombly and Iqbal on Access to Discovery." It's a fine article, well worth a read. We don't want to steal Mr. Gelbach's thunder, so we'll merely summarize a couple of the key ideas.

As a preliminary matter, pardon us for an aw-shucks moment as we note that the article refers to the debate in Pennumbra between some of our bloggers and Penn Professor Stephen Burbank over the merits of TwIqbal. But the focus of the new article isn't whether TwIqbal is good or bad, it's whether those cases have changed anything. Those cases have certainly caught the attention of the judiciary; as of July 2011, Twombly has been cited by courts over 45,000 times, and Iqbal over 25,000 times. The question is whether all of that is only lip service.

Gelbach canvasses the existing literature, which goes both ways. Gelbach's fundamental insight is that party reactions to the new doctrine - selection effects -- must be considered. Simply comparing before and after rates of dismissals can be misleading. If plaintiffs file fewer or different cases, or if defendants file more motions to dismiss, or if parties alter settlement strategies, the dataset against which motions to dismiss are measured is altered.

The dataset Gelbach mines is from the Federal Judicial Center, which seems to be the gold standard and which underlies most of the analytical literature. The Yale article then sprinkles a bunch of equations across the pages, producing an effect on us not unlike tryptophan. To his credit, the author bemoans "tedious algebra." But the result is far from tedious. TwIqbal appears to have had a profound influence. True, the percentage of dismissals has hardly budged, but it looks like defendants are filing more motions to dismiss. The bottom line, according to Gelbach, is that "at least 18 percent of all cases facing MTDs in the post-Iqbal period failed to reach discovery because of the switch to heightened pleading." Further, contrary to concerns expressed by some, TwIqbal seems to have had less, not more, effect on employment and civil rights cases. That is because there is less of a defendant selection effect for those cases, as defendants already usually filed motions to dismiss against them.

The article alludes to the issue of whether TwIqbal has increased social costs (more motions) or reduced them (sifting out meritless cases). Guess which way we vote? There is also a recommendation for further research: "If Twombly and Iqbal have culled mostly low-merit cases, then there should have been a noticeable drop in the number of cases where plaintiffs lose at defense summary judgment." We're not so sure about that. Sad to say, merit or lack thereof does not always animate the decisions of some judges. Specious notions of docket management, or deep-rooted hostility to dispositive motions, where judges think the whole game is about compelling settlement whether the cases have merit or not, taint the dataset. Meritless cases settle. Is that good or is that a pity?

In any event, Gelbach's article is undeniably interesting, and it restores our affection for TwIqbal. We might even put them back on our Holiday gift list.


Friday, November 25, 2011

Aredia/Zometa – One Step Forward, One Step Back

On November 18, 2011, the defense scored a victory in the New Jersey Zometa/Aredia mass tort program, when the court granted a motion to apply New Jersey punitive damages law.  The plaintiff was a Virginia litigation tourist who brought suit in New Jersey state court despite his treatment having nothing to do with the state.  See Irby v. Novartis Pharmaceuticals Corp., 2011 WL 5835414, slip op. (N.J. Super. Nov. 18, 2011).  Both sides had agreed on Virginia substantive law governing the plaintiff’s causes of action, but they scuffled over choice of law in punitive damages.

Why?  This isn’t the first time we’ve considered choice of law in punitive damages.  New Jersey has a statute that precludes punitive damages against FDA approved drugs.  N.J.S.A. 2A:58C-5(c).  Not only that, but the New Jersey appellate courts have held that the only significant statutory loophole – fraud on the FDA – is preempted.  See McDarby v. Merck & Co., 949 A.2d 223, 272 (N.J. Super. A.D. 2008).  So, where a product is FDA approved, application of New Jersey law is tantamount to a dismissal of the punitive damages claim.

The defense even had to overcome a presumption that the law of the place of injury (Virginia, in Irby) governs.  The court considered the various factors laid out by Restatement (Second) of Torts §145 (1965), to find that the presumption was defeated.  The court held that New Jersey had a more significant relationship than Virginia to the issue of punitive damages.  The location of plaintiff’s injury was “‘fortuitous’ because the place of injury bears little relation to [defendant’s] alleged punitive conduct,” given that it “is headquartered in New Jersey,” that the drug (Zometa) “was widely distributed throughout the United States,” and “nothing in NPC’s sales, marketing, or distribution practices suggests that the alleged injury was more likely to occur in Virginia than in any other state.” Slip op. at 7.

The court also held that the next §145 factor, location of the allegedly injurious conduct, favored New Jersey because conduct at issue for punitive damages would have occurred in the defendant’s New Jersey corporate headquarters.  Id. at 8-9.  The plaintiff failed to prove that the conduct occurred in the company’s international Swiss headquarters.  Id. at 9 & n.4.  Irby also held that the relationship between plaintiff and defendant was centered on New Jersey because plaintiff’s punitive damages claims “stem from [defendant’s] New Jersey business activities.”  Id. at 10.

A serious comity issue also popped up, since “punitive damages are generally intended to regulate conduct within the bounds of an interested state” and, based on the finding that the alleged misconduct occurred in New Jersey, “interstate comity would be least offended by the application of New Jersey law to the issue of punitive damages.”  Id. at 12.  That's a bit of a bootstrap, but it worked.  More importantly, New Jersey has decided to limit punitive damages by statute when FDA-approved drugs are involved, and plaintiff, having chosen to come to New Jersey when she could have filed suit in Virginia, was not really in a position to assert comity.  Id. at 15-16.  Finally, the court held that prior law was basically split concerning the punitive choice of law question.  Id. at 17.

Thanks to Joe Hollingsworth, of Hollingsworth LLP, both for winning the motion and passing it along.

Why there’s such a fierce fight over choice of law in punitive damages in the Aredia/Zometa litigation is demonstrated by another recent decision that’s not so favorable to our side.  In Fussman v. Novartis Pharmaceuticals Corp., 2011 WL 5836928 (M.D.N.C. Nov. 21, 2011), the court denied post-trial motions – most of them – in a case that had produced a verdict of $287,000 in compensatory damages, and $12,600,000 in punitive damages.  Id. at *1. When you’ve got runaway juries awarding blatantly unconstitutional punitives that run almost 44 times compensatories, there’s good reason to fight such claims tooth and nail.

Fortunately, North Carolina has a statute (N.C.G.S. §1D-25) that limits punitives to three times the compensatory award, so that post-trial motion, at least, was granted in Fussman.  Id.

The other motions were denied.  As to the motions for judgment, it’s hard to say exactly why, except that the court was not about to reverse the jury’s verdict.  Fussman, 2011 WL 5836928, at *3-4.  Where's the beef?

There’s not much more meat to the discussion of punitive damages in Fussman.  The court finds those claims unpreempted in light of Wyeth v. Levine, but doesn’t really explain itself.  Fussman, 2011 WL 5836928, at *4 (still where's the beef). But we did find an interesting footnote about fraud on the FDA, which states, in pertinent part:

[T]he claim presented in the present case was not based on alleged fraud on the FDA or alleged violation of any federal laws or regulations. . . .  Thus, while it is undisputed that “fraud on the FDA” claims are preempted by federal law, the present case does not involve “fraud on the FDA” claims.  Instead, the willful and wanton conduct alleged . . . involved . . . investigating side effects and communicating with medical professionals.

Id. at *4 n.6. On one hand, Fussman sheds some light on Irby – since it doesn’t look like the plaintiffs could muster a case under the New Jersey fraud on the FDA exception, even if it wasn’t preempted under McDarby.  On the other hand, since plaintiff was not claiming a violation in Fussman, we’re a bit surprised not to see anything about N.C.G.S. §99B-6(b)(4), which specifically requires consideration of “[t]he extent to which the labeling for a prescription . . . drug approved by the United States Food and Drug Administration conformed to any applicable government . . . standard that was in effect when the product left the control of its manufacturer.” We’ve already posted on the effect of governmental compliance on punitive damages.

In another interesting, and more disturbing, footnote, Fussman essentially nullifies the “reasonable likelihood” statutory (N.C.G.S. §1D-35) standard for risk of harm in punitive damages claims out of existence.  2011 WL 5836928, at *7.  The court holds that no particular percentage likelihood is required for a prima facie case of punitive damages to exist, only that there be an unspecified “connection.” That seems pretty shaky to us, since it would theoretically allow an increased risk from one in a bazillion to two in a bazillion to support a punitive award, notwithstanding the inclusion of a “likelihood” of harm element in the statute.  Nor is the cited precedent particularly persuasive.  Everhart v. O’Charley's Inc., 683 S.E.2d 728, 738 (N.C. App. 2009), discussed an entirely different statute – “related to” as used in N.C.G.S. §1D–15 – and so is not at all on point.  Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1389 (4th Cir. 1995), was decided under Virginia common law, and thus has no conceivable relevance to the interpretation of a North Carolina statute.

It’s hard to say, given the vagueness of other parts of the Fussman opinion, but the likelihood point looks like a good appellate issue to us.  Maybe we’ll look into it in some future post

The evidentiary rulings in Fussman are more of "where's the beef?"  If the defendant actually did open the door to subsequent remedial measures by asserting them affirmatively, then we can’t fault that ruling.  See 2011 WL 5836928, at *7.

We can’t be as charitable to the court’s hearsay ruling, though.  The facts aren’t particularly important, but we don’t see how use of hearsay “to establish what information [defendant’s] employees had received from [its] consultants, and the actions [those] officials took in response,” id., can possibly be anything other than relying upon such evidence for “the truth” of what it states.  Id. Unless the information is considered to be true, then it’s not capable of proving any of those things.

The decision on admission of “national sales figures” to prove anything “related to” the plaintiff doesn’t make any sense.  How national sales could be relevant to one individual is beyond us.  Id. at *8. We’ve heard of this kind of thing being admitted in punitive damages cases on various reprehensibility grounds, but never on the rationale offered in Fussman.

So within three days of one another, each side won one in Aredia/Zometa.  That dance seems unlikely to end anytime soon.

Wednesday, November 23, 2011

They Can't Do It To Us; We Can't Do It To Them

This just in.  In an important case concerning discoverability of expert materials in Pennsylvania, the en banc Superior Court has overturned a prior panel decision that allowed discovery of correspondence between expert witnesses and the lawyers who retained them.  Here's the opinion:  Barrick v. Holy Spirit Hospital, 2011 Pa. Super. 251, slip op. (Pa. Super. Nov. 23, 2011).  Both sides are limited to the expert discovery provided in the rules, that being "the substance of the facts and a summary of the grounds for each opinion."  Slip op. at 18.  Thus, Pennsylvania will not become home to the sort of expert discovery that the federal rules were recently amended to preclude.

Turkey, Mashed Potatoes and a Dollop of Preemption

Tomorrow is Thanksgiving – the biggest American “eating” day of the year.  So we thought we’d share a few fun facts.  Did you know the average person on Thanksgiving eats around 4,500 calories?  (By the way, that's more than double the daily amount a person should eat).  For instance, on average one cup of mashed potatoes is 238 calories.  One cup of stuffing is 363 calories. One cup of eggnog is 342 calories and a slice of pumpkin pie will set you back 323 calories. We haven’t even gotten to the sweet potatoes covered in marshmallows, the cranberry sauce or the gravy.  Yikes! 

On a day like Thanksgiving -- when let’s face it, we are going to eat it anyway -- maybe it is better not to know things like you’ll have to walk 30 miles or swim for 5 hours to work off your Thanksgiving feast.  But, for most of the other days of the year, we generally like knowing what is in the food we are eating (if you really want to know, check out this article about how the average Thanksgiving dinner is chock-full-of chemicals – just not enough to kill us).  So, while as drug and device lawyers we focus on the "D" in FDA, as consumers we appreciate the "F".  And, when there is a favorable preemption decision in the food arena, it piques our interest as drug lawyers and as eaters. 

That is exactly what we get in the case of Jones v. Dinequity, Inc., 2011 Cal. App. Unpub. LEXIS 8724 (Cal. App. Nov. 14, 2011).  Defendant is the parent company of the popular restaurant chain, Applebee’s.  Applebee’s menu includes a selection of “Weight Watchers” items for which it lists the grams of fat, grams of fiber and calories.  Id. at *2.  Plaintiff filed a putative class action on behalf of California residents who ordered Weight Watchers menu items at Applebee’s claiming discrepancies between the actual and the posted nutritional information and seeking relief under California’s consumer rights statutes.  Id.  Plaintiff based her allegations on independent laboratory testing of certain menu items.  Id.  The court found plaintiff’s state law claims were preempted by the Food, Drug, and Cosmetic Act (FDCA) and its 1990 amendment, the Nutrition Labeling and Education Act (NLEA) because plaintiff was attempting to impose on Applebee’s a broader obligation than that required by the federal government.  We like the sound of that.

We all know that when you flip over a package of food in the supermarket, you are going to see a Nutrition Facts Panel.  That panel on packaged foods is required by the NLEA and its content is heavily regulated by the FDA – much like drug labeling.  But, prior to some 2010 amendments, restaurants like Applebee’s were exempted from those mandatory labeling requirements.  So, restaurants could “voluntarily” decide to include on their menus nutrient content or health benefits claims regarding their food.   And, that’s where food and drugs part company – there is no such thing as “voluntary” labeling of a drug.  A pharmaceutical manufacturer can’t opt to include additional information in its label, but a restaurant (and any other food manufacturer) can.

But, just because it’s voluntary, doesn’t mean it isn’t regulated – and we’re back on familiar ground.  The NLEA says is that if a restaurant chooses to make “nutrient content claims” – statements such as “low sodium” or “contains 100 calories” -- they must meet the requirements of §343(r) which governs claims on food labels regarding levels of nutrients or the relationship of such nutrients "to a disease or health-related condition."  The NLEA also contains an express preemption provision preventing states from imposing "any requirement on nutrient content claims in the label or labeling or food that is not identical to the requirement of section 343(r).”  Id. at *9.  What does §343(r) require?  That

restaurants making nutrient content claims are subject to the reasonable basis standard.  [I]n lieu of analytical testing, restaurants may show they have a reasonable basis for making the claim.

Id. at *8-9 (citation and quotation marks omitted).  But the plaintiff’s claims were based on analytical testing – and that’s where preemption comes in.

            While plaintiff attempted many arguments to avoid preemption, the one most interesting to us non-food lawyers was her claim that consumer protection laws “are not preempted by the NLEA because they do not impose labeling requirements, and thus fall outside the federal statutory scope.”  Id. at *15.  To make her argument, plaintiff misplaced her reliance on a pesticide labeling case that actually supported the defense position (Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005)), but she could just have easily cited any number of drug or device cases that likewise would have gone against her.  Whatever the context, it afforded the court an opportunity to make a nice preemption statement:

Here, plaintiff is suing under regulatory state laws proscribing deceptive practices. The gravamen of her claim is that the menu labels are not precisely accurate as shown by lab testing, and are thus deceptive.  This imposes a broader obligation on defendant's food labeling than the federal "reasonable basis" standard, by seeking to enforce a more exacting standard of compliance. Thus, her state law claims are preempted . . . to the extent they exceed the federal standard.

Jones, at *15-16. 
            The court also quickly dismissed plaintiff’s argument about the “strong presumption against preemption” finding that the “presumption is inapplicable when Congress has shown its clear and manifest purpose to preempt.”  Id. at *17.

            Because plaintiff’s complaint also contained a “brief, general allegation that defendant lack a reasonable basis for the menu postings,” id. at *4, the court entertained what appears to be a purported parallel claim to enforce the federal food labeling regulations. Id. at *18.  After considering the evidence, the court concluded that Applebee’s procedures for determining nutrient levels were reasonable and plaintiff “presented no competent evidence to the contrary.”  Id. at *22.  So, it was a win-win for the defense. 

            As for Thanksgiving, we say forget the calories, the fat, the sugar, the sodium, the chemicals and go for it.  Loosen the belt a few notches and enjoy.  Then you can start that 30 mile walk at midnight (or sooner) at your local mall!

Tuesday, November 22, 2011

E-Discovery For Defendants Cheat Sheet

After getting the latest favorable Facebook discovery decision in Largent v. Reed, and seeing that Largent cited to a recent New York case that we didn’t know about, we’ve come to the (probably belated) conclusion that the fast-developing area of e-discovery for defendants with respect to social media maintained by plaintiffs is worthy of a cheat sheet to keep up with the cases as they’ve come down.  So here it is – a compilation of all the favorable opinions we’re aware of concerning the right of defendants to take the offensive on e-discovery in personal injury cases, rather than merely having to grin and bear it on the receiving end.  As with our other posts of this nature, it's in purely chronological order, and we’ll update it whenever we learn of additional case law, so if you on the right side of the “v.” win something, feel free to pass it along to us.

By the way, we've cited some Canadian cases as well, because, particularly early on, they've been cited several times on this side of the border.  The citation forms may look unusual to American lawyers, but we've tried them out.  This is how they appear on WL.

  1. Mackelprang v. Fidelity National Title Agency, Inc., 2007 WL 119149 (D. Nev. Jan. 9, 2007). Discovery of social media is allowable, to the extent relevant to the case, but discovery should come from the plaintiff, rather than directly from My Space.
  2. Dexter v. Dexter, 2007 WL 1532084 (Ohio App. May 25, 2007). Not a discovery case, but frequently cited.  Publicly available posts on MySpace were not entitled to any reasonable expectation of privacy.
  3. Murphy v. Perger, 2007 CarswellOnt 9439 (Ont. Super. Oct. 3, 2007) (Canada).  Discovery of plaintiff’s Facebook account authorized. Social media to which many people have access has no reasonable expectation of privacy.
  4. Beye v. Horizon Blue Cross Blue Shield, 2007 WL 7393489 (D.N.J. Dec. 14, 2007). Discovery of plaintiff’s Facebook and MySpace accounts authorized.  There is no reasonable expectation of privacy in information shared with others.
  5. Leduc v. Roman, 2009 CarswellOnt 843 (Ont. App. Feb. 20, 2009) (Canada).  Refusal to allow discovery of plaintiff’s Facebook account was an abuse of discretion.  Social media are not privileged, even if restricted as “private.”  A plaintiff must identify any relevant materials posted on Facebook, public or private.
  6. Moreno v. Hanford Sentinel, Inc., 91 Cal. Rptr.3d 858 (Cal. App. April 2, 2009).  Not a discovery case, but frequently cited.  A plaintiff cannot bring an invasion of privacy action concerning republication of information that he voluntarily posted on MySpace.  There can be no expectation of privacy in publicly posted information.
  7. Bishop v. Minichiello, 2009 CarswellBC 871 (B.C. April 7, 2009) (Canada).  Discovery of plaintiff’s hard drive was proper to determine how much time plaintiff spent on Facebook.
  8. Kent v. Laverdiere, 2009 CarswellOnt 1986 (Ont. Super. April 14, 2009) (Canada).  Discovery of plaintiff’s Facebook and MySpace accounts was proper.
  9. Ledbetter v. Wal-Mart Stores, Inc., 2009 WL 1067018 (D. Colo. April 21, 2009).  Subpoenas directly to Facebook, My Space, Inc., and were proper discovery of plaintiff’s accounts.
  10. Bass v. Miss Porter’s School, 2009 WL 3724968 (D. Conn. Oct. 27, 2009).  Discovery of plaintiff’s Facebook account was proper.  Plaintiff’s withholding of relevant information justified sanction of production of entire Facebook page.
  11. Romano v. Steelcase Inc., 907 N.Y.S.2d 650 (N.Y. Sup. Sept. 21, 2010).  Discovery of plaintiff’s Facebook and MySpace accounts authorized.  Social media are not privileged, even if restricted as “private.” Social media are discoverable, and have no reasonable expectation of privacy.
  12. McCann v. Harleysville Insurance Co., 910 N.Y.S.2d 614 (N.Y.A.D. Nov. 12, 2010).  While the defendant had yet to establish entitlement to discovery of any particular item, prospective refusal to allow any discovery of plaintiff’s Facebook account was an abuse of discretion.
  13. EEOC v. Simply Storage Management, LLC, 270 F.R.D. 430 (S.D. Ind. May 11, 2010).  Discovery of plaintiffs’ Facebook and MySpace accounts authorized.  Social media have no reasonable expectation of privacy.  Targeted social media discovery is not burdensome or oppressive.
  14. Barnes v. CUS Nashville, LLC, 2010 WL 2265668 (M.D. Tenn. June 3, 2010).  Discovery of plaintiff’s Facebook account authorized.  Due to plaintiff’s intransigence, the magistrate will “friend” plaintiff and review the account for discoverable information.
  15. McMillen v. Hummingbird Speedway, Inc., 2010 WL 4403285 (Pa. C.P. Jefferson Co. Sept. 9, 2010).  Discovery of plaintiff’s Facebook account authorized.  There is no “social network privilege.” Social media are discoverable, and access “should be freely granted.”
  16. Sparks v. Dubé, 2011 CarswellNB 80 ¶¶52-58 (N.B.Q.B. Feb. 4, 2011) (Canada).  Imposing litigation hold on plaintiff to prevent deletion of Facebook information.
  17. Zimmerman v. Weis Markets, Inc., 2011 WL 2065410 (Pa. C.P. Northumberland Co. May 19, 2011).  Discovery of plaintiff’s Facebook and MySpace accounts authorized.  No privilege exists for information posted in the non-public sections of social websites.  Social media have no reasonable expectation of privacy.
  18. Offenback v. LM Bowman, Inc., 2011 WL 2491371 (M.D. Pa. June 22, 2011).  Discovery of plaintiff’s Facebook account authorized. Social media are discoverable.  There is no need for judicial in camera review of social media before it is produced.
  19. Katiroll Co. v. Kati Roll and Platters, Inc., 2011 WL 3583408 (D.N.J. Aug. 3, 2011).  A party’s intentional destruction of Facebook evidence could constitute spoliation, but unintentional alterations do not.  Parties “control” their Facebook pages for purposes of discovery.
  20. Held v. Ferrellgas, Inc., 2011 WL 3896513 (D. Kan. Aug. 31, 2011).  Discovery of plaintiff’s Facebook and job search accounts authorized.  Targeted social media discovery is not burdensome or oppressive.
  21. Patterson v. Turner Construction Co., 931 N.Y.S.2d 311, 312 (N.Y. App. Div. 2011).  Affirming grant of Facebook discovery.  Social media are not privileged, even if restricted as “private.”
  22. Sourdiff v. Texas Roadhouse Holdings, LLC, 2011 WL 7560647 (Mag. N.D.N.Y. Oct. 24, 2011).  Discovery of plaintiff’s Facebook and MySpace accounts authorized.  Plaintiff's counsel must review the sites' content, including any deleted items, and turn over to the defendant all information related in any way to the plaintiff's physical or emotional condition, injuries, damages, activity level, employment, or concerning this lawsuit.
  23. Largent v. Reed, 2011 WL 5632688, slip op. (Pa. C.P. Franklin Co. Nov. 8, 2011).  Discovery of plaintiff’s Facebook account authorized.  Social media are discoverable, and have no reasonable expectation of privacy. Social media are not privileged, even if access is restricted.  The Stored Communications Act does not apply to discovery from plaintiffs.  Targeted social media discovery is not burdensome or oppressive.
  24. Davenport v. State Farm Mutual Automobile Insurance Co., 2012 WL 555759 (M.D. Fla. Feb. 21, 2012).  Discovery of plaintiff's social media sites allowed.  Plaintiff must produce every photograph of the her that is posted on any social media site, whether or not she posted them (that is, including “tags”).  As a practical matter, the scope of production will be limited by the "custody and control" limits on discovery.
  25. Trail v. Lesko, 2012 WL 2864004, slip op. (Pa. C.P. Allegheny Co. July 3, 2012).  I don't usually put denials on cheat sheets, but this is Judge Wettick, and this decision is likely to become the standard in Pennsylvania.  Discovery of social media sites (plaintiff or defendant) is allowed unless "unreasonably intrusive."  In order to be entitled to discovery, the moving party must show a reasonable likelihood of the site containing relevant evidence, not available elsewhere, that will have an impact on the outcome of the case.

Sunday, November 20, 2011

Seventh Circuit Delivers Potential Circuit Split on MDL Procedure

We have offered multiple posts (83 and counting) on Multi-District Litigation. Some of those posts might seem at odds with each other. But as Emerson said, "A foolish consistency is the hobgoblin of small minds." As Whitman said, "Do I contradict myself? Very well then, I contradict myself. I am vast; I contain multitudes." And Charles Barkley, after all, once claimed he had been misquoted in his autobiography. The problem with taking any sort of position on MDL procedure is that you never know which side of the issue you might occupy.

The theory behind Multi-District Litigation is that consolidation of pretrial proceedings should produce efficiency. Who's against efficiency? You'd be surprised. (Or maybe you wouldn’t.) If an MDL really resulted in streamlined litigation that is less expensive, without any alteration in substantive rights and outcomes, one would be hard-pressed to squawk. But MDLs can change things in substantive ways. First, creating an MDL inevitably inspires plaintiff lawyers to file boatloads of iffy cases, with the idea of docking them in the MDL for the duration and eventually racking up additional settlements and attorney fees. Second, an MDL puts you in front of a different judge -- the transferee judge. That, friends, can make all the difference in the world. In all likelihood, one side will be much happier with the transferee judge, and the other side will pine for remand just to get away from the transferee judge.

This scenario showed up in the recent case of FedEx Ground Package System, Inc. v. United States Judicial Panel on Multidistrict Litigation, No. 11-2438 (7th Cir. Nov. 17, 2011). It's not a product liability case, but it addresses an interesting wrinkle of MDL procedure. FedEx delivery drivers filed class actions against FedEx, alleging that FedEx had inappropriately treated them as independent contractors rather than employees. The Joint Panel on Multi-District Litigation (the JPML -- the defendant in the Seventh Circuit case) sent the cases to a veteran district court judge in South Bend, Indiana. That judge issued a summary judgment in FedEx's favor, ruling that the drivers were, indeed, independent contractors. That ruling resolved all claims in 22 cases, teeing them up for appeal to the Seventh Circuit. But there were 12 other cases with some surviving claims. What would happen to them? The transferee district judge decided to remand those cases to the transferor districts, which would deal with the other claims. Any appeals, including appeals of the ruling by the transferee judge, would be appealed to the circuit court for that transferor court. That would, of course, open the prospect of inconsistent rulings on the contractor-employee issue.

Not surprisingly, FedEx was happy with the transferee court's substantive ruling as to how to characterize the drivers' status. For all we know, FedEx might've also been happy staying in the Seventh Circuit. So FedEx asked the transferee court to issue Rule 54(b) partial final judgments in the 12 cases, and all the cases would go up to the Seventh Circuit. Following FedEx's approach would ensure that the same appellate issues would go to the same court. Makes sense. But the transferee court decided that consolidated proceedings were over, and ordered remand of the cases to the transferor courts. Following the transferee court's remand approach would ensure "that all issues in the same case, involving the same parties and the same facts, will be appealed at once, and to the same circuit." Slip op. at 4. Arguably, that might also make sense.

The JPML thought it was a close issue, but gave great weight to the district court's remand recommendation: "In most instances the transferee judge has an acute sense about the procedural steps necessary to advance the litigation in the fairest and most efficient way." Id. at 5. Did FedEx take those rulings lying down? It did not. Instead, FedEx filed a petition for mandamus with the Seventh Circuit, seeking to overturn the JPML decision and to prevent what FedEx saw as a premature remand.

The Seventh Circuit, like the MDL panel, saw the issue as a close one, and concluded that the choice between the two methods was "best left to the transferee court and JPML, without trying to impose a rigid rule for all cases and circumstyances." Id. at 6. Given the tough standard for a mandamus petition, the JPML's ruling would stand.

That sort of case-by-case, defer-to-the-district-court ruling doesn't provide a lot of certainty for future litigants. It is also in tension with In re Food Lion, Inc., Fair Labor Standards Act "Effective Scheduling" Litig., 73 F.3d 528 (4th Cir. 1996). In that case, the Fourth Circuit issued a writ of mandamus to the JPML to undo its orders transferring cases back to their original transferor courts to ensure that all related appeals would go to the Fourth Circuit itself. So we have a circuit split, right?

The Seventh Circuit didn't think so. The Seventh Circuit did not understand the Fourth Circuit's Red Lion opinion to announce "a sweeping holding that all MDL cases must be managed to ensure that all related appeals go to only the circuit with jurisdiction over the transferee court." Slip op. at 7. Moreover, the claims in Red Lion arose under federal law, so uniformity was a key consideration. By contrast, the FedEx plaintiffs asserted "rights under the laws of many different states." Id.

Normally, we expect that circuit splits draw the attention of the Supreme Court of the United States. But maybe the Seventh Circuit's purported distinction will permit the SCOTUS to avoid the issue -- and, given the seeming desire of the SCOTUS to whittle its docket down to 19th Century levels, maybe that is exactly what will happen. In addition, it's not as if the issue inspires huge excitement or comes up all that often. After all, Red Lion came down 15 years ago.

As we said up top, we cannot take a position on this issue, because we could conceivably end up on either side of it. The prospect of dueling Daubert decisions in an MDL is not particularly palatable, and we foresee the usual plaintiff forum-shopping, but we've dealt with worse. And maybe we'll want to tease a remand out of a hostile judge. Believe it or not, opposing lawyers have sometimes seen fit to takes our blog posts and try to wedge them down our gullet and argue that we're being inconsistent. One would almost think they'd never read Emerson, Whitman, or Barkley.

Friday, November 18, 2011

Another Excellent Facebook E-Discovery Opinion

Here's a rarity for us - two e-discovery posts in a row.  This one's about another of our favorite topics, e-discovery for defendants.

We've just been gifted with (thanks, Dan) a downright scholarly opinion on the discoverability of a plaintiff’s relevant Facebook information from a Court of Common Pleas in rural Pennsylvania.  The case is Largent v. Reed, No. 2009-1823, slip op. (Pa. C.P. Franklin Co. Nov. 8, 2011).  It’s not a drug/device case (it's an auto accident), but if you’re seeking discovery of a plaintiff’s Facebook account, it’s well worth the read.  In particular, there’s probably the best discussion of how Facebook works, from a privacy – or non-privacy, as would be a better term – perspective than any other opinion we’ve yet seen.  The discussion of Facebook, its privacy settings, tagging, and the like, is on pages 3-5.

The reason for the Facebook discovery in Largent is typical:   The plaintiff “testified that she suffers from depression and spasms in her legs, and uses a cane to walk.,” but on her Facebook page, she posted “several photographs that show her enjoying life . . . and a status update about going to the gym.”  Slip op. at 6,8.  Obviously the latter is relevant to debunk the former (although, amazingly, the plaintiff contested that, too).

Briefly, the legal conclusions in Largent are these:

(1) A plaintiff’s social networking is discoverable.

It is clear that material on social networking websites is discoverable in a civil case. Pennsylvania’s discovery rules are broad, and there is no prohibition against electronic discovery of relevant information. Furthermore, courts in other jurisdictions with similar rules have allowed discovery of social networking data.”
Slip op. at 8 (referring to a number of cases, all of which this blog has discussed in prior ediscovery posts).

(2) There’s no basis for social networking to be considered privileged.  “There is no confidential social networking privilege under existing Pennsylvania law.”  Largent, slip op. at 9.  That’s because, given the inherently public nature of social networking, “[t]here is no reasosable expectation of privacy in material posted on Facebook.”  Id.  Further, “making a Facebook page ‘private’ does not shield it from discovery.” Id. (citing, inter alia, Patterson v. Turner Construction Co., 931 N.Y.S.2d 311, 312 (N.Y. App. Div. 2011) (“postings on plaintiff's online Facebook account, if relevant, are not shielded from discovery merely because plaintiff used the service's privacy settings to restrict access, just as relevant matter from a personal diary is discoverable”)).  In sum:

[T]here can be little privacy on a social networking website.  Facebook’s foremost purpose is to “help you connect and share with the people in your life.”  That can only be accomplished by sharing information with others.  Only the uninitiated or foolish could believe that Facebook is an online lockbox of secrets.
Largent, slip op. at 10 (emphasis original).

(3) A plaintiff’s Facebook account is not protected from discovery by the Stored Communications Act (“SCA”), 18 U.S.C. §§ 2702-03 . That’s because the discovery is directed to the plaintiff as the account holder, rather than against Facebook itself, which conceivably could be covered by the statute’s archaic (by cyberspace standards that means 1986) definitions:

{Defendant] seeks the information directly from [plaintiff].  The SCA does not apply because [plaintiff] is not an entity regulated by the SCA.  She is neither an [computing or communications service], and accessing Facebook or the Internet via a home computer, smartphone, laptop, or other means does not render her an [entity covered by the SCA].  She cannot claim the protection of the SCA, because that Act does not apply to her.
Largent, slip op. at 11.

(4) The discovery is properly targeted.  Plaintiff put her health at issue, thus “[a]ny posts on Facebook that concern [her] health, mental or physical, are discoverable, and any privilege concerning such information is waived.”  Slip op. at 12.

Photographs posted on Facebook are not private, and Facebook postings are not the same as personal mail.  [Plaintiff] points to nothing specific that leads the Court to believe that discovery would cause unreasonable embarrassment.  Bald assertions of embarrassment are insufficient. . . .  Facebook posts are not truly private and there is little harm in disclosing that information in discovery.
Largent, slip op. at 12-13 (footnote omitted).

Facebook and other electronic discovery for defendants are definitely here to stay.  In particular, all defendants in mass tort (and other) litigation should be requesting, as well as receiving, litigation hold notices to prevent destruction of relevant electronic information maintained by plaintiffs.

Thursday, November 17, 2011

Hip Checked – Plaintiffs’ Ediscovery Ploy Rebuffed In New Jersey

Ediscovery is dreadfully expensive.  Plaintiffs are dedicated to keeping it that way, as they know that anything that drives up a defendant’s litigation costs (and mass tort ediscovery falls disproportionately on defendants) increases the settlement value of even meritless cases – and any mass tort has lots of meritless cases.

All too often judges, not wanting to get bogged down in the technical details of ediscovery (which is 99% of it), let the plaintiffs get away with running up the defendants tab.

But occasionally, even the judges get fed up with the obvious churning that goes on in ediscovery.

That’s what happened in In re DePuy ASR™ Hip Implants Litigation, No. BER-L-3971-11, slip op. (N.J. Super. Oct. 18, 2011).  In the course of telling rogue plaintiffs that they had gotten all the ediscovery they were going to get, the ASR court also struck a blow for federal-state coordination in mass tort cases, which makes this relatively short opinion doubly notable.

As is often the case with mass torts, there are parallel actions involving the ASR hip implant, a federal MDL and also a bunch of plaintiffs who managed to stay out of federal court by taking advantage of the “forum defendant” loophole to diversity jurisdiction.  In New Jersey, such state-court plaintiffs are aggregated in that state’s own mass tort program.

As also often happens, the federal ASR MDL was quicker out of the blocks. The federal plaintiffs and defendants got together and hammered out an ediscovery protocol.  Under that protocol, the defendant produced over 10,000,000 pages of electronic documents – more than any litigant (or probably group of litigants) could possibly hope to read.  All of this was done in strict accordance with the federal MDL agreement, which specified the formats and compatibilities that the production had to take.

Back in New Jersey state court, however, some plaintiffs decided that they didn’t like the federal protocol. At a cost of over $1,000,000 (to which, of course, these plaintiffs were not about to contribute a dime), they demanded a do-over with a different format, compatible with different (they claimed, cheaper) software.

The court said no.  The federal MDL protocol was the product of extensive negotiations, and was good enough for New Jersey as well.  It is important to coordinate federal and state mass tort litigation involving the same product:

[T]his Court is committed to the coordination of this litigation not only with the MDL but also with other jurisdictions. . . .  The Manual For Complex Litigation (Fourth) §20.31 (2009) . . . encourages cooperation by and between MDL and State Court judges. . . .  Furthermore, the Manual states "Federal and State Court Judges frequently cooperate informally and effectively to coordinate discovery and pre-trial proceedings in mass tort cases." Id. at §22.4.  The New Jersey Mass Tort (non-asbestos) Resource Book, (3d. Ed.), November 2007, embraces this concept. . . .  This Court is satisfied that the MDL Protocol is reasonable.  It is clear that the MDL Protocol is the result of a "give and take" by and between highly skilled counsel in the MDL and other State court jurisdictions.  The MDL Protocol is not the format initially proposed by defense counsel but, as indicated above, presents a reasonable accommodation after negotiations by and between counsel, all of whom were on equal footing. . . .  To permit or otherwise Order a format unique to New Jersey would cause an undue hardship on the Defendants . . ., [and] would be of no ascertainable benefit to . . . plaintiffs.
ASR, slip op. at 3-5.  Putting aside ediscovery, important as that is in and of itself, this is one of the best statements extolling federal/state cooperation that we've seen.

Bravo for the court for striking a blow for common sense – and for federal-state coordination.  And congratulations to Susan Sharko, over at Drinker Biddle, for advancing the cause of sanity in ediscovery.

Wednesday, November 16, 2011

Once More With Feeling - Removal Before Service

God only knows how many times we’ve posted on the topic of removal before service, because we can’t count that high.  We did take a look through our “removal” topic tag and figured out that our last post about this subject was back in May.  Well, a reader recently sent us a new decision, so we’ve found an occasion to bring up this old saw again.

Briefly, for you newbies, what’s the big deal with removal before service?  First, “removal” in this context refers to the process for getting cases out of state court (generally thought of – by both sides – as more plaintiff-friendly), and getting them into federal court (conversely considered more defense friendly).

Plaintiffs do all sorts of things to get cases into their preferred state-court forums (fora? fori? foræ?).  One of them is to take advantage of the so-called “forum defendant” exception to federal diversity (that is, the plaintiff and defendant are citizens of different states) jurisdiction.  That exception allows a diverse plaintiff (say, from North Carolina) to sue a defendant (say, a large drug company) in the defendant’s home state.  This trick is employed when the defendant has the misfortune of being located in a state (say, Pennsylvania, New Jersey, or California) that also contains a judicial hellhole favored by the plaintiff’s bar.

Well, the “forum defendant” exception is purely statutory, and the statute, 28 U.S.C. §1441(b), provides that only defendants “properly joined and served” at the time of removal count as forum defendants.  Defendants recently figured out (all right, we admit, we helped a little bit) that if the case could be removed ASAP, before the plaintiff had time to serve the forum defendant – the forum defendant no longer defeated the removal of an otherwise diverse case under the best reading of the statute, because it hadn't been "served" as the statute requires.

In removal before service cases, the opposing arguments are:  On the defense side – even if Congress probably didn’t intend (or even think about) this twist, the plain language of the statute provides that removal before service trumps the forum defendant rule.  On the plaintiff’s side – even though we took advantage of the forum defendant loophole to have a plaintiff from Upper Dogpatch bring suit in the defendant’s home hellhole, it’s too much “gamesmanship” to allow defendants to take advantage of their removal before service loophole to our loophole.

Anyway, we’ve painted the scene.  So here’s what’s just happened.  In Christison v. Biogen Idec, Inc., No. C 11-4382 RS, slip op. (N.D. Cal. Nov. 14, 2011), a plaintiff from Utah (not usually thought of as a judicial hellhole) chose to sue several non-Utah defendants, including Elan, a California corporation in California state court (a full-fledged judicial hellhole).  The defendants (or at least Biogen) got wise to the suit and got it out of Dodge within a week of its being filed – before plaintiff could serve process on Elan.  Id. at 2.

Plaintiff argued gamesmanship.  Defendants argued plain meaning.  The court came down solidly on the side of Congress meaning what it says – and that Congress can change it if they didn’t:

There is no dispute, however, that Elan had not been served with summons and complaint at the time that defendant Biogen Idec, Inc. filed the operative notice of removal.  The plain language of the removal statute permits removal where no defendant who has been “properly joined and served” is a resident of the forum. 28 U.S.C. §1441(b) (emphasis added). . . .  [T]he mere absence of . . . delay here does not warrant adopting a judge-made rule departing from statutory text.  Not only does it remain true that Congress can amend the statute if there in fact is a significant problem with “gamesmanship” . . . plaintiff could have avoided the issue, of which his counsel undoubtedly was aware, by ensuring that he served Elan prior to giving Biogen notice of the filing.
Christison, slip op. at 1-2 (following Carreon v. Alza Corp., 2010 WL 539392 (N.D. Cal. Feb. 9, 2010), which we cited in our last removal before service post) (emphasis original).

Thanks to reader Joe Blute of Mintz Levin for sending along this case.  By the way, as part of this post, we also searched for other good removal before service decisions since our last post in May and found nothing useful.  If you’re out there sitting on something good, please – like Joe Blute – send it along to us.

Tuesday, November 15, 2011

Gotta Love a Classic

            OK, we’ll admit it – we are caught up in the buzz about the new Muppet Movie and are glad we still have kids young enough to use as an excuse to go see it (really, we’d go see it anyway, but nice to have the cover story).  Word on the street is this isn’t a re-boot – Hollywood’s latest term for going back to the well when they can’t come up with an original idea – but rather a return to the 1970s Muppets we all remember so fondly.  One of the secrets to the Muppets’ success – a little something for everyone.  For the kids, the characters are bright and colorful; the songs upbeat and peppy; and for a puppet show, much of the humor is visual and slapstick.   For the adults, we await the appearance of the guest star cameos (Steve Martin, Mel Brooks, Madeline Kahn for the original movie; Jason Segel, Zach Galifinakis and Sarah Silverman for 2011) and the one-liners.  Who can forget such classics as:

Bernie: You, you with the banjo, can you help me? I seem to have lost my sense of direction!
Kermit: Have you tried Hare Krishna?

What about:

Kermit: That's pretty dangerous building a road in the middle of the street. I mean, if frogs couldn't hop, I'd be gone with the Schwinn.
We could go on, but we’ll just “hop” right to it (Wacka, Wacka!). 

            In our search for new and exciting cases to bring you this week, we tripped over a few classics ourselves.  So, while not really new or terribly exciting – they do add to our stories.  The first a tale of continued success in extending Pennsylvania prescription drug law to medical device cases and the second a re-affirmation of the need for expert testimony to prove a design defect.  Not as iconic as a bear and a frog on a cross-country road trip in a Studebaker (“Bear left; Right Frog”), but worth citing just the same.

            In Horsmon v. Zimmer Holdings, Inc., 2011 U.S. Dist LEXIS 130415 (W.D. Pa. Nov. 10, 2011), the court dismissed plaintiff’s claims for strict liability, breach of implied warranties and breach of express warranty based on Pennsylvania law.  The claims involved alleged defects in components of a hip implant.  The court quickly rejected plaintiffs’ strict liability and breach of implied warranty claims as not recognized by Pennsylvania.  A few weeks ago, the Eastern District of Pennsylvania did the same thing.  We told you then it wouldn’t be the last time.   Like in that Eastern District case, the plaintiff in Horsmon also failed to allege “any particular affirmation of fact or promise” to show the existence of an express warranty.  Horsmon, 2011 U.S. Dist LEXIS 130415, *11.  No express statement equals no express warranty.  Claim dismissed.  As an aside, the court noted that while the parties disagreed about whether reliance was required for a breach of express warranty claim, the court did not need to reach that issue.  Id. at *13 n.4.  You know our position.

            In a second case that caught our eye, Niehaus v. United Seating & Mobility, Inc., 2011 U.S. Dist. LEXIS 127228 (S.D. Ill. Nov. 3, 2011), the plaintiff’s claims were dismissed on summary judgment for failure to offer expert testimony in support of his design defect claim.  The facts are a bit different than our normal fare.  Plaintiff is disabled and requires use of a motorized wheelchair.  He hired defendant to repair his wheelchair and the defendant gave him a loaner.  Plaintiff was injured when he fell out of the borrowed wheelchair which he claimed had a defective joystick and seatbelt.  Niehaus, 2011 U.S. Dist. LEXIS 127228, *1. 

The court acknowledged both that expert testimony is typically required to maintain a design defect claim and that “the determination of whether expert testimony is necessary . . . is judged according to the facts and issues involved in a case.”  Id. at *6.   The court went on to compare the Niehaus wheelchair scenario to a case involving a crutch that collapsed (we’ll forego the rubber crutch gag, but are reminded of when Kermit first saw the "Doc Hopper's French Fried Frog Legs" billboard and said:  “All I can see are millions of frogs with tiny crutches.”).  Where the product in question was a “simple crutch” and the question for the jury was “whether the crutch performed properly when it collapsed” – the matter was one within the jury’s common understanding and experience and no expert testimony was required.  Id. at *9.  In the case of a wheelchair, with its numerous components and motorized parts, specialized knowledge is required.  So, the court dismissed the case because “it would be pure speculation if the jury were to be allowed to assess the design and manufacture of the wheelchair in the absence of expert testimony.”  Id. at *10. 

Two simple, straightforward cases.  Two good decisions.  Sometimes re-visiting the classics is just what we need.   Like “Drinks are on the House!”  It works every time.  

Medical Monitoring - Another Individualized Issue

Medical monitoring is an odd-duck (we would say illegitimate) tort because it's almost 100% dependent upon a particular procedure - the class action - for its existence.  Procedure, of course, is not supposed to alter the substantive law, but in medical monitoring it has.  Thus, kill the medical monitoring class action and one largely kills the tort.

We blogged not too long ago about the Third Circuit's decision in Gates v. Rohm & Haas Co., 655 F.3d 255 (3d Cir. 2011), because of that court's evaluation of the presence of individual medical/exposure in medical monitoring claims.  The finding in Gates on the predominance question, we thought, pretty much closed the coffin on class certification of medical monitoring claims, at least under Pennsylvania law.

Kill the class action and we kill the tort.

Here's another recent opinion putting some nails in the coffin:  Fiorentino v. Cabot Oil & Gas Co., 2011 WL 5239068 (Disc. Sp. Master M.D. Pa. Nov. 1, 2011).  The special master's ruling arises in a somewhat odd context, a discovery dispute.  It's not entirely clear, but we think it's a fracking case - part of the latest environmental guerilla war in these parts (although with natural gas less carbon-intensive than coal, we're not sure what the fight is really supposed to be about).

In Fiorentino, a bunch of plaintiffs were seeking medical monitoring.  As usual, they alleged no personal injury at all, only some vague "future risk."  Rather cheekily (and unwisely, as it turned out) they refused to turn over their medical records.  The defendants pursued the issue, arguing that they needed medical records to evaluate whether the plaintiffs really required monitoring beyond what they would have had to get anyway, given their pre-existing medical conditions.  That's element six of medical monitoring in Pennsylvania.  Fiorentino, 2011 WL 5239068, at *3 (listing elements).  We'll call it the "over-and-above" element for short.

The plaintiffs claimed that their individual records were "completely irrelevant" because the over-and-above element was judged solely against what was "normally prescribed for the general public."  The defendants viewed this over-and-above element as requiring monitoring beyond that "normally recommended for that particular plaintiff."   2011 WL 5239068, at *3.

General public versus particular plaintiff.

Common issue versus individualized issue.

Class certification versus no class certification.

Kill the class; kill the tort.

The decision in Fiorentino came down squarely on the side of the over-and-above element requiring individualized proof:
The fundamental principles of tort law and the evolution of the medical monitoring claim throughout Pennsylvania Supreme Court decisions leads to the prediction that the Supreme Court would require each plaintiff to demonstrate that the monitoring regime recommended for her is different from the monitoring regime recommended for her absent the alleged exposure.  In other words, each plaintiff's individual medical condition/history is relevant to establishing the medical monitoring claim.
 2011 WL 5239068, at *6 (emphasis added).  There follow (follows? - interesting grammatical conundrum) several pages of analysis in support of that conclusion, which we commend to anyone defending a medical monitoring claim (and not just in Pennsylvania).  We won't go into all that now.

Our takeaway.  Here's yet another way - beyond those already held dispositive in Gates - of demonstrating that common issues do not predominate in medical montoring claims (and after Dukes, predominance cannot be avoided).  Since almost every state that has made the mistake of recognizing medical monitoring claims includes an over-and-above element, the same argument should be available elsewhere.

Kill the class action; kill the tort.

Monday, November 14, 2011

A Couple of Decent Learned Intermediary Cases: Straight, No Chaser

This is our third straight post on the learned intermediary doctrine. Many things in life come in threes. We bet you have an aunt who, every time a famous person departs this vale of tears, announces that two more will shortly follow. Sometimes the rule of three celebrity deaths is fulfilled by a bit of stretching. Academy Award and Nobel Prize winners die, and then crazy auntie issues an I-told-you-so upon learning of the expiration of a minor actor who once played a villain on "Sheriff Lobo." Skeptical though we may be, we cannot deny that art, religion, and politics from all the world's cultures invest a special significance in the number 3. There were three Fates, three witches in Macbeth, three government departments that Rick Perry would eliminate, three Pep Boys, and, of course, Three Stooges.

On an episode of "Who Wants to Be a Millionaire" the $500,000 question was, "How many actors played the Three Stooges?" The contestant was a former clerk of Sixth Circuit Judge Danny Boggs, and he had chosen Judge Boggs as his "lifeline." Judge Boggs is certainly one of the most brilliant judges in America. He is famous for the quiz he sends out to clerk applicants that tests wide-ranging areas of learning. For example, "Distinguish Belisarius from Bucephalus from Bocephus." Anyway, Judge Boggs had to admit on national TV that he couldn't say how many thespians played Stooges. The answer is six: Moe, Larry, Curly, Shemp, Joe Besser, and Curly Joe DeRita. (No, Ted Healy and Emil Sitka don't count.) So the next time you have an oral argument in the Sixth Circuit and are frightened of facing Judge Boggs - who makes any panel "hot" - just remember that you know something he doesn't.

For some reason, our post on Friday about a federal court making up exceptions to the learned intermediary rule out of whole cloth makes us think of the Three Stooges. It was farcical and we half expected the opinion to end in a pie fight. Not so with today's two cases. In both of them, federal courts followed the state law as it was, declined to invent anything new, and sent plaintiffs packing based on the learned intermediary doctrine.

Speaking of brilliant judges, we are especially pleased to see a nice learned intermediary opinion from Judge Weinstein in the Zyprexa Prods. Liability Litigation - Greaves v. Eli Lilly, 2011 U.S. Dist. LEXIS 129443 (E.D.N.Y. Nov. 8, 2011). A lot of interesting things have come from the Zyprexa litigation. Some good, some bad. When we saw an extensive table of contents in the Greaves case, going all the way from Roman numeral I to Roman numeral V, we were expecting the usual Judge Weinstein tome. But the opinion is barely eight pages long, and it gets to the point with clarity and brevity. We'll try to cut to the chase as well as Judge Weinstein does, as he becomes the second federal judge to predict that Rhode Island courts, which haven't yet adopted or rejected the learned intermediary doctrine, would adopt it. The reasoning is straightforward:

-- the learned intermediary doctrine has been adopted in almost every state;

-- there is nothing in Rhode Island law to suggest that the Rhode Island Supreme Court would not adopt it; and

-- given the notoriety of Zyprexa litigation, "the manufacturer has a right to rely on the physician's duty to warn the patient of clearly perceived dangers."

Greaves, 2011 U.S. Dist. LEXIS 129443 at *23.

Judge Weinstein in a prior Zyprexa opinion held that the March 1, 2004 Dear Doctor letter would be considered the latest possible date on which members of the medical community knew or should have known of Zyprexa's relevant risks (weight gain and diabetes). The facts in Greaves confirm the wisdom of that holding. When the plaintiff's doctor treated the plaintiff in May 2004, the doctor discussed those risks with the plaintiff, monitored the plaintiff's blood glucose, and subsequently reduced the dosage after weight gain. The doctor testified that, despite the risks of Zyprexa, he believed it was the right medication to prescribe. Bottom line: "There is no evidence that Dr. Whalen would have altered his prescription decision had the warning that accompanied Zyprexa been different." Id. at *24. As Bocephus would say, "Been There, Done That" and "Everything's Okay."

As we said last Friday, we really really hate it when a federal court conjures up exceptions to the learned intermediary when there is no hint that the state Supreme Court would adopt such exception. Our position is bolstered by a court that approached the issue the correct way in Swoverland v. Glaxosmithkline, 2011 U.S. Dist. LEXIS 127753 (D. Conn. Oct. 5, 2011). The Swoverland opinion appears to be a transcription of an oral ruling from the bench. We actually don't know what drugs are at issue. But we gather that the plaintiff alleged failure to warn under the Connecticut Product Liability Act. The federal court right away observes that Connecticut has adopted the learned intermediary doctrine. But the plaintiff contended that the doctrine should be called off in this case because "these drugs were directly advertised to the consumer and ... were over-promoted by the manufacturer." 2011 U.S. Dist. LEXIS 127753 at *3-4.

Rather than give way to the inner policymaker, fantasy author, or Platonic Philospher King, the judge in Swoverland kept it clean and simple. First, there is no "clear indication from the Connecticut Supreme Court that any of these exceptions, potentially exceptions, are available under Connecticut law." Id. at *4. Second, even assuming these exceptions might be available, the court found them inapplicable because this was not a case where a patient revved up by DTC ads went into the doctor's office requesting the drug but, "rather, the plaintiff went to his doctor with certain medical issues and the doctor, exercising professional judgment, selected the drugs with knowledge of their potentially positive effects as well as their potential negative side effects." Id. at *5. If the usual medical facts apply, then so should the usual legal rules. Also, just as in the Zyprexa case, the doctor stuck by his prescribing decision, even knowing whatever he is supposed to know now. Thus, there was nothing in the record "that would support the suggestion that there was a causal link between the lack of warnings complained of and the harm that befell the plaintiff." Id. at *6-7.

Is there anything we don't like about this pair of learned intermediary decisions? As Bucephalus would say, "Nay."

Friday, November 11, 2011

Ugly Texas Decision Ignores Erie, Tramples State Law

We don't like it, but sometimes we have to present bad news.  Such is the case with Murthy v. Abbott Laboratories, 2011 U.S. Dist. Lexis 129102 (S.D. Tex. Nov. 8, 2011).  There’s a lot of things wrong with Murthy, but one of the worst is that it’s another poster child for a supposed “prediction” of state law that instead running roughshod over it and creates unprecedented liability according to the federal court’s personal predilections.

We’ve posted many times that under the Erie doctrine, in the words of the Supreme Court:

“[a] federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.”
Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975).  Not surprisingly, the Fifth Circuit, which includes Texas, agrees:

[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it.  The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.
Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008).

As always, in conducting this inquiry our task is to predict state law, not to create or modify it – that is, we are to apply existing [state] law, not to adopt innovative theories for the state.
Holden v. Connex-Metalna Management Consulting GmbH, 302 F.3d 358, 365 (5th Cir. 2002) (quoting United Parcel Service, Inc. v. Weben Industries, Inc., 794 F.2d 1005, 1008 (5th Cir. 1986)).

Some decisions, however, like Murthy, just aren’t with the program.  The Murthy decision's disregard for established state law takes the form of creating an orgy of exceptions to the learned intermediary rule.

Here’s how it came about.  The plaintiff in Murthy was somewhat unusual.  She was a participant in an FDA-regulated clinical trial of an investigational drug.  Her treating physician, who had initially treated her with a different drug, 2011 U.S. Dist. Lexis 129102, at *2, also participated (was an “investigator” in FDA parlance) in the study.  As is always the case – and may well be required by FDA regulations – the manufacturer of the investigational drug (called the “sponsor” of the study) bore the costs the study.  As is also customary, the sponsor also compensated the study’s investigators.  There’s nothing in Murtha indicating that any of the financial arrangements were unusual or excessive in the context of clinical trials, simply:

[Defendant] initiated and paid for the . . . study.  In exchange for their participation, [defendant] provided participating . . . patients with a free supply of [the drug] throughout the study's duration.  [Defendant] also compensated the physicians involved in the study, including [plaintiff’s physician].
Murthy, 2011 U.S. Dist. Lexis 129102, at *2.

Anyway, since Murthy is a product liability case, the plaintiff alleges an injury from the study drug and that the warnings in the study materials were inadequate.  One of the study materials, was a “14 minute, 50 second videotape, produced and provided by [defendant] to [plaintiff’s physician].”  Id. at *4.  Of course, plaintiff claimed that this video was deficient as well.  Id.

The defendant raised the learned intermediary rule as a defense.  Here’s where the legal stampede begins.  As a federal district court charged with applying Texas law under the Erie doctrine, the Southern District of Texas was bound to follow:  (1) decisions of the Texas Supreme Court, and (2) predictions of Texas law made by the Fifth Circuit.  Beyond that, it’s on its own, subject to the general constraints of Erie – including the federalist proposition that we discussed above.

Rather than apply the learned intermediary rule, Murthy starts making up exceptions that neither the Texas Supreme Court or the Fifth Circuit have ever adopted.  The first of these is the “direct-to-consumer” exception.  Indeed, the Fifth Circuit had held that Texas would reject such an exception:

[Plaintiff] also argues that because [defendant] engaged in “aggressive” marketing, [defendant] should be liable for not providing adequate warnings in conjunction with that marketing.  This argument is critically weakened by the absence of any evidence on the record that any of the five plaintiffs actually saw, let alone relied, on any marketing materials issued to them by [defendant]. . . .  [E]ven if the facts were in [plaintiff’s] favor, [plaintiff] would still lose.  Two of our cases applying Texas law in this area have concluded that, as long as a physician-patient relationship exists, the learned intermediary doctrine applies.
In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (citations omitted).

Murthy did not follow the Fifth Circuit, which it was bound by stare decisis to do, but instead followed a recent intermediate Texas appellate decision, Centocor, Inc. v. Hamilton, 310 S.W. 3d 476 (Tex. App. 2010), which had applied a DTC exception on similar – and similarly misguided – facts:  those being that since the video was provided to the prescribing physician, and not directly to the patient, there was no “direct to consumer” marketing at all, since the physician decided to show plaintiff the video.  Murthy, 2011 U.S. Dist. Lexis 129102, at *20-21. We’ve blasted Hamilton ourselves, and the DTC exception generally, but that’s not the point of this post.

Murthy was aware that the Texas Supreme Court had accepted an appeal in Hamilton.  2011 U.S. Dist. Lexis 129102, at *22.  That should have been the end of it.  With:  (1) the United States Supreme Court (and the Fifth Circuit on multiple occasions) imposing a conservative approach to expanding liability; (2) the Fifth Circuit on record against DTC-type exceptions under Texas law; and (3) the Texas Supreme Court poised to decide the very question – every jurisprudential consideration pointed in the same direction:  wait and let the proper court decide the issue. At worst, a terse denial of the motion without prejudice would have been warranted.

But no, Murthy leapt in with both feet, preempting, as it were, the prerogatives of the Texas Supreme Court to declare the law of Texas:

Given the underlying justifications for the learned intermediary doctrine, the Court believes that the Texas Supreme Court will likely agree with the Court of Appeals’ reasoning in Centocor, Inc.
2011 U.S. Dist. Lexis 129102, at *23-24.  To us, that’s just wrong.  Even if Texas law were to embrace a DTC exception to the learned intermediary rule (which we strongly doubt), Murthy should have held its horses and left that state-law decision for the Texas Supreme Court - the court properly empowered to act as arbiter of Texas law.

And believe it or not, that’s the lesser of Murthy’s two evils.

Murthy goes on to make up – out of whole cloth – a supposed learned intermediary rule exception that applies any time a physician receives “compensation” from a drug company:

When a physician receives compensation or gifts from drug companies, his or her role as the neutral decision-maker is diminished.  The Texas Supreme Court would surely not apply the learned intermediary doctrine when the physician’s prescribing practice is compromised by a conflict of interest as overt as compensation by the defendant drug company.  The Court thus concludes that because [plaintiff’s] doctor was compensated by [defendant] at the time he enrolled [plaintiff] in the clinical trial and prescribed her [the drug], [defendant] cannot avail itself of the learned intermediary doctrine.
2011 U.S. Dist. Lexis 129102, at *27.  While the adoption of the DTC decision in Murthy was a usurpation of judicial power properly belonging to the Texas Supreme court, this creation of a second, completely novel, exception is simply lawless.

In the literal sense.

"Surely" Murthy cites some law that supports the creation of create this exception.

Nope.  Nothing.

Not a single case, anywhere in the country has adopted this one.

It’s simply the court’s policy predilections, as justified by a collection of snippets from various articles in “scholarly” literature.  See Id. at 27-31 nn.5-6.  In short.  The Murthy decision made up the law as it went along to fit its notions of proper public policy – precisely what the Supreme Court explicitly forbade courts sitting in diversity jurisdiction from doing.

And this is anything but a narrow ruling.  Since all investigators are compensated for their participation in clinical trials by the sponsors of those trials – with the full knowledge and approval of the FDA – Murthy amounts to a blanket exception barring application of the learned intermediary rule to all clinical trials.

Moreover, the law that went uncited in Murthy has uniformly rejected the proposition that compensation by drug companies ipso facto displaces that learned intermediary rule.

Long ago the Ohio Supreme Court had the same situation before it – the routine receipt of compensation by physician participating in clinical trials.  Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875 (Ohio 1991).  It held that per-patient payments to physicians who enrolled patients in a clinical trial did not compromise any physician’s independence so as to justify ignoring the learned intermediary rule:

[Plaintiff’s physician] determined [plaintiff’s] suitability for the [investigational] program.  He performed a physical examination on [plaintiff] and elicited [her] medical history. . . .  [The physician] retained the right to remove [plaintiff] from the [investigational] study if, in his medical judgment, he felt the circumstances warranted it. . . .

Although [defendant] paid [plaintiff’s physician a fee] for each participant in the [investigational] study program, the evidence does not support a finding that [the physician] was an employee of [defendant] or that [defendant] was acting under the control of [defendant] rather than as a physician exercising his independent judgment. . . .  [Defendant] did not control [the physician’s] judgment, duties and responsibilities as he used [the drug] in the treatment of patients.

Accordingly, we find that [plaintiff’s physician] was acting as an independent physician in dispensing [the drug] to [plaintiff], that he was a learned intermediary and that the trial court correctly instructed the jury on the learned intermediary doctrine.
Id. at 879.  The exact same situation – a compensated investigator – and Tracy reached the opposite result.  Accord Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000) (physician’s participation as investigator in defendant manufacturer’s clinical trial did not preclude him from learned intermediary status) (applying California law).

We faced the same issue in Bone Screw litigation. In Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999), the plaintiff claimed that because her surgeon was also a paid consultant to the defendant, the learned intermediary rule could not apply.  The court found no basis for displacing the rule:

[Plaintiff] argues in this case that the learned intermediary doctrine should not apply because [her physician] was not independent of [defendant] in view of his financial connection with [defendant] as a consultant.  She argues, therefore, that he cannot be considered an intermediary, learned or otherwise. . . .  In this case, however, there is no evidence that the consulting relationship between [the prescriber and defendant] interfered with [the physician’s] independent medical judgment in treating [plaintiff].  On the contrary, the evidence suggests otherwise.  The record shows that [the prescriber] was not committed automatically to the installation of the [product].  In fact, during his first operation . . . he attempted a fusion without implanting any internal fixation device. . . .  [D]epending on a patient’s physical circumstances, he sometimes installed similar devices made by competing manufacturers.  Finally, [plaintiff’s physician’s] consulting relationship with [defendant] involved devices other than [that implanted in plaintiff].
Id. at 163-64 (applying Virginia law).  Again, the opposite result on a fact pattern quite similar to Murthy – since both plaintiffs were initially treated with a different product.

Murthy's not looking like such a "sure" thing after all.

Tracy and Talley are hardly alone.  There’s even a case under Texas law.  In Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334 (Tex. Dist. June 7, 1999), aff’d mem., 2000 WL 991697 (Tex. App. July 20, 2000), another Bone Screw case, the prescribing surgeon had been a presenter at medical conferences for the defendant, and had been compensated with “fees.”  Id. at *20, 24.  Allegations that this supposed “misconduct influenced [the prescriber’s] treatment recommendations because of the fees he received” was “rejected” as a basis for avoiding the learned intermediary rule.  Id. at *24 (citing In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700, 706 (E.D. Tex. 1997), aff’d, 165 F.3d 374 (5th Cir. 1999)).

In In re Zyprexa Products Liability Litigation, 2010 WL 348276 (E.D.N.Y. Jan. 22, 2010), Judge Weinstein was unimpressed by a similar argument, alleging that the plaintiff’s prescriber had taken hundreds of thousands of dollars while “conduct[ing] paid research for at least ten pharmaceutical companies, including defendant,” and “serv[ing] as a paid speaker for at least six pharmaceutical companies, including [defendant].  Id. at *11.  None of those assertions “supports plaintiff’s allegations of bias specific to [defendant] or suggests any motive that [the prescriber] would have to provide biased testimony in this case.”  Id.  Thus, the court entered summary judgment under the learned intermediary rule.  Id. (applying Illinois law).

Similarly in In re Trasylol Products Liability Litigation, 2011 WL 2117257 (S.D. Fla. May 23, 2011), the prescriber’s paid consulting arrangement with the defendant did not preclude application of the learned intermediary rule under Alabama law.  “The fact that he entered into a paid consulting agreement with [defendant] does not, in and of itself, render his decision to prescribe [the drug] for [plaintiff] biased and not based on his independent medical judgment.”  Id. at *4.

Likewise, in Vioxx litigation, a California state court flatly rejected the contention that payments – even large ones – somehow automatically precluded application of the learned intermediary rule:

Plaintiffs argue defendant was aware that [plaintiff’s] physician would not play the role of learned intermediary because it paid him hundreds of thousands of dollars over the years to conduct research and give lectures.  Plaintiffs presented at trial no evidence of actual bias.  On the contrary, [his] physician testified there was none.

Payment to a physician, standing alone, does not deprive the physician of learned intermediary status.  Such payment for research is a widespread practice, yet the court was unable to find a case where a physician who was paid for research was considered to have abrogated his or her role of learned intermediary.  Therefore, such payments alone do not constitute a “special circumstance” for purposes of setting aside the learned intermediary doctrine.  Indeed, if such payments alone sufficed, a manufacturer would have to obtain the patient list of every physician it pays for research in order to somehow provide direct warnings.
In re Vioxx Cases, 2006 WL 6305292 (Cal. Super. Dec. 19, 2006),

Variants of the same argument have also failed when cloaked as attacks on the “credibility” of prescriber testimony that otherwise entitles the defendant to summary judgment under the learned intermediary rule.  In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (applying Oklahoma law), a challenge to credibility based on the prescriber’s “formerly conduct[ing] research for several pharmaceutical companies" got nowhere, as it was “speculation” lacked any “evidence” of improper “influence.”  Id. at 1024. Similarly in Miller v. Pfizer, Inc., 196 F. Supp.2d 1095 (D. Kan. 2002), aff’d, 356 F.3d 1326 (10th Cir. 2004) (applying Kansas law), possible “bias” from the prescriber’s “business relationship” with the defendant (a consulting agreement) was not enough, in the absence of any other evidence, to prevent summary judgment.  Id. at 1129 n.108.

Thus, in our estimation, this second aspect of the Murthy decision is not only wrong – because it runs roughshod over Erie federalism to reach its liability expanding result – but loud wrong – because it reached an outlier result, based upon no supporting precedent, while failing even to acknowledge any of the extensive precedent that rejects that result.