Monday, March 30, 2015

Limiting the Damage from One-Sided Ex Parte Interviews of Doctors

This post originates from the non-Reed Smith side of the blog, only.

We’re going to take a walk once again onto the uneven ground of ex parte interviews of treating doctors, an area in which Plaintiffs’ counsel too often seem to be handed the higher ground.  Plaintiffs’ counsel always seems to get the opportunity to conduct doctor interviews.  They then talk to the doctors about the plaintiff’s medical records, course of treatment, diagnosis and prognosis, but those are only the preliminaries.  That’s not what they’re there for.  They're lawyers.  They’re there to litigate.  They want opinions on key litigation issues like causation, warnings and marketing.  So plaintiffs’ counsel shows the doctors documents that they never saw before or ever had any reason to see and uses them to try to generate plaintiff-friendly opinions. 
Defense lawyers, on the other hand, often don’t have the same opportunity.  In New Jersey, for instance, judges rarely allow ex parte interviews by defense counsel in mass tort litigation, even though the New Jersey Supreme Court has authorized such interviews, as a general matter, in tort litigation.  On the other end of the spectrum, New York allows defense counsel to conduct ex parte interviews of treating doctors whether it be in an individual tort action or as part of a mass tort litigation—though our experience with such interviews (known as Arons interviews) is that courts sometimes place authorization and notification requirements on defense counsel that allow plaintiffs’ counsel the opportunity to speak to the doctor first and learn which documents defense counsel may show the doctor.  It’s still much better than no interview at all.  (We blogged about the varying approaches of different states here.)

That leads us to a California state court decision issued ten days ago in the Actos litigation.  See Yotam v. Takeda Pharmaceuticals North America, Inc., No. BC411687 (Cal.Sup. Ct. Mar. 20, 2015).  There, plaintiffs’ counsel had been conducting ex parte interviews with treating doctors in much the way that we have come to expect.  They were meeting with doctors alone and showing them internal company documents, no doubt those with the seemingly worst language they could find.  Then, no doubt, some doctors, armed with little to no context, foundation or understanding of how the company operates and makes decisions, express ill-conceived opinions about marketing and which snippets of internal information or isolated data should have been included in the warning.  Doctors are often also given a handful of minutes to look at pre-highlighted clinical studies and, with no time to scientifically analyze them, asked to offer opinions.  Then, a few days later, plaintiffs’ counsel elicits those newly-minted opinions at a deposition.  Blindsided, defense counsel scrambles to either illustrate the doctor’s lack of foundation for the opinions in the hope of later excluding them or, in the alternative, place the documents in context so as to undermine or reverse the doctor’s opinions.  Through this process, plaintiffs’ counsel has conjured up a stealth, undisclosed expert witness, one with the added credibility of having treated the plaintiff.  Defense counsel is left to simply watch the end product unfold in front of her at a deposition.  

This is hardly a fair-handed way to conduct discovery.  

So, the defense counsel in Yotam asked the court to stop it.  They moved the court for one of two orders: either (1) limit plaintiffs’ counsel’s ex parte interviews to a plaintiff’s treatment, diagnosis and prognosis or, instead, (2) allow defense counsel the opportunity to also interview treaters using the same type of documents that the doctors likely never saw before.  While neither of these solutions would grant the defense the same access as plaintiffs’ counsel – that is, the defense wouldn’t be allowed a straight-up interview on a plaintiff’s treatment, diagnosis and prognosis (which presumably was previously disallowed by the court) – it would make the process a bit fairer, allowing defense counsel, before the deposition, to undo or better inform certain of the doctor’s newly-minted opinions.  

The court agreed to option 1.  That’s the right decision.  As the court put it, treating doctors are “percipient” witnesses.  For those (like us) who need to look that word up, it means that they are real witnesses.  They are there to discuss what they perceived in treating the plaintiff, not opinions later concocted during litigation.  Sure, doctors are experts in their field.  But that doesn’t mean they can be willy nilly used as undisclosed experts in the litigation.  “While the treating physicians are percipient ‘experts’ (and may in fact provide fact and opinion testimony), they are not designated experts.”  Id. at 13.  They court laid out the new limitations on Plaintiffs’ counsel:
Plaintiffs' counsel may meet ex parte with treating physicians and ask them questions about the information obtained by an examination of their patients.  Plaintiffs' counsel may then use the information learned from the ex parte contacts to tailor deposition questioning.  As Defendants note, during deposition, Plaintiffs' counsel may show the treating physicians medical articles and documents [those which have been deemed confidential) and ask them whether they would have made prescribing decisions had they known certain facts at the relevant time.

Id.  That’s right.  These solo interviews, which defense counsel does not get to conduct, should not be used as a breeding ground for undisclosed, litigation-created opinions.  

Now, this is a good result, but only from the position from which the defense was forced to operate—having no ex parte access to doctors at all.  To be completely fair, the defense should have the same access to doctors that the plaintiffs’ counsel has.  The defense should be allowed to meet with the treaters and discuss plaintiff’s treatment, diagnosis and prognosis.  Doctor-patient confidentiality has been waived.  Plaintiffs put their treatment at issue the moment that they filed suit, leaving no meaningful basis to limit doctor interviews to only plaintiff’s counsel.  That said, this was an impressive victory in which defense counsel limited the damage from an already uneven playing field. 

Friday, March 27, 2015

Result-Driven Affirmance of Birth Defect Verdict

            We have said it before – birth defect cases are hard.  Juries and judges are sympathetic where the individual whose health is at issue had no say in the matter.  We have also said that we do not like it when judges frame the insistence of the defendant on things like proof of proximate cause as an attempt to avoid liability, as if liability were the default where the plaintiff has a tangible injury.  We may or may not have said that we do not like it when opinions refer to plaintiffs by their first names, especially when only women and children get that discourtesy.  We have said over and over that we do not like it when the decision in Levine is held up like an anti-drug preemption talisman, particularly after Mensing and Bartlett.  So, we are not terribly surprised that the large trial verdict over birth defects in the child of a woman taking her mother’s anti-seizure medication while pregnant was affirmed in Gurley v. Janssen Pharms., Inc., No. 239 EDA 2014, 2015 Pa. Super. LEXIS 112 (Pa. Super. Mar. 16, 2015), but we were still somewhat perturbed by the tone and less-than-probing analysis of the opinion.
            Plaintiffs were a minor child born with a cleft lip, his mother, and his father.  The minor plaintiff was referred to by his first name, as was his mother.  The father was only ever referred to by his full name or as the “husband” of the mother (listing her first name).  The mother’s mother, who was taking the same anti-seizure drug on a prescription from another doctor and was the sole source for her daughter’s use of the drug while pregnant, was also referred to by her first name.  We have been known to parse words, but that is some paternalistic nonsense.  Maybe we would not read it like that if the opinion had been written by a judge from a different demographic, but it does seem to fit with the rest of the opinion.  Plaintiff’s mother was first prescribed the medication for “juvenile myoclonic seizures” in March 2006, and received and filled refills that should have carried her through July 2007, three months before she became pregnant.  She would not have taken the medication while pregnant if not for taking medication obtained by her own mother on her (the minor’s grandmother’s) own prescription for a different indication (migraines).  The opinion never addresses 1) whether it was legal for the minor plaintiff’s mother to take the drug (as we addressed here), 2) whether it was foreseeable—the only claim presented to the jury was for negligent failure to warn, after all—for the minor plaintiff’s mother to take the drug while pregnant under these circumstances, or 3) the knowledge of the physician who prescribed the drug to the minor plaintiff’s grandmother about the risk of birth defects or the impact of additional information on the decision to prescribe to her.  Even though one of the issues on appeal highlighted the lack of evidence of proximate cause through either prescribing physician, the opinion’s only discussion of the grandmother’s prescription—the one that allegedly caused the injury—was  that “Sandra [grandmother] testified that her family was having financial difficulties and she filled her prescription instead of Haley’s [mother] to save money on the insurance co-pay.”  2015 Pa. Super. LEXIS 112, *2 n.4.  This would be the “financial hardship” exception to both the requirement of proximate cause or the in pari delicto defense.  But we are getting ahead of ourselves.

            The crux of plaintiffs’ case was that the drug was Pregnancy Category C according to the FDA-approved label when the minor plaintiff’s mother took the drug.  Category C is the middle category, but the required labeling language is fairly serious:  “(Name of drug) has been shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in (name(s) of species) when given in doses (x) times the human dose. There are no adequate and well-controlled studies in pregnant women. (Name of drug) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”  21 CFR 201.80(f)(6)(i)(c) (the current version is quoted).  The opinion does not quote the drug’s actual label, what exactly plaintiffs contended it should have said instead, or what new post-approval evidence allegedly required different labeling.  It does say that FDA reclassified the drug up one category to Category D in 2011 without saying what evidence led to that change.  Under the current regulation, Category D’s mandatory labeling template language is “(Name of drug ) can cause fetal harm when administered to a pregnant woman. (Describe the human data and any pertinent animal data.)  If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.”  The trial court had already determined that the defendant was unable to unilaterally change the Pregnancy Category or how the label described the risk of birth defects, but let the plaintiffs argue that the defendant could have requested a change.  With this as their theory of liability, plaintiffs won an $11 million verdict and defendant appealed following the denial of its post-trial motions.

            The first issue on appeal was preemption of the sort we have called impossibility preemption.  The court only needed to consider three cases to determine that preemption did not bar plaintiffs’ claim:  Levine, Maya v. Johnson and Johnson, 97 A.3d 1203 (Pa. Super. 2014), and Mensing, which the court dismissed out of hand as applying only to generic drugs.  The discussion of Levine noted that the availability of the Changes Being Effected (CBE) route for a labeling change prior to FDA approval for the particular drug and labeling change at issue in Levine meant that complying simultaneously with state and federal law was not impossible.  2015 Pa. Super. LEXIS 112, **12-16.  Mayawhich was not dismissed out of hand as applying only to OTC drugs—merited an honorable mention in our ten worst list last year.  Faced with these cases, the defendant offered a “specious” argument to try to “circumvent” and “evade” Levine.  In between the vitriol, the court’s reasoning came down to the unexamined statement that “the FDA’s CBE regulation allows drug manufacturers to make certain changes to update and strengthen safety information in its label before receiving the FDA’s approval.”   Id. at *16 (emphasis added).  If it had wanted to, the court could have looked to many of our posts on when CBEs can be used, when they cannot, and the implications of the difference.  It could have looked to the recent FDA draft guidance on “Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format.”  It could have looked to the record as to whether plaintiffs had post-approval evidence that allowed an argument that a CBE would have been allowed for the proposed labeling change.  Or it could have just realized that the trial court’s motion in limine ruling precluding the claim that defendant could have changed its label unilaterally was based on the unavailability of a CBE, which distinguished the case from Levine, particularly if Bartlett and its progeny had been considered.  It did none of these.  Instead it looked to whether evidence that FDA had rejected a Prior Approval submission to change the Patient Package Insert to discuss a different birth defect satisfied Levine’s unique “clear evidence” standard—it did not and the unspoken presumption against preemption held.  Id. at **18-19.
            The treatment of the second issue—the lack of evidence of proximate cause—was no more rigorous.  To start, the court framed the issue as whether the drug “proximately caused Brayden’s [minor plaintiff’s] cleft lip,” which is not the issue.  The proper issue is whether the alleged negligent act—not requesting, at some point between the drug’s approval and the drug’s use during pregnancy, that FDA permit a revision of the drug’s label consistent with recategorizing the drug from Pregnancy Category C to Pregnancy Category D proximately caused the minor plaintiff’s injury.  There should be three parts to this inquiry under South Carolinas learned intermediary doctrine and the allegations here:  1) whether the record evidence supported that a request should have been made, 2) whether the record evidence supported that such a request would have led to a timely labeling change, and 3) whether the record evidence supported that such a timely labeling change would have avoided the birth defect (by leading the prescriber to do something different).  The court did not address the first two parts.  Because it was plaintiffs’ burden to prove proximate cause, the conclusion on preemption based on the lack of clear evidence that FDA would not have accepted the proposed labeling change does not obviate the need for plaintiffs to have proved that FDA would have accepted it.  Without such proof, the impact of a theoretical labeling change on the physician who prescribed to the minor plaintiff’s mother or the physician who prescribed to the minor plaintiff’s grandmother is irrelevant.

            As noted above, the knowledge or decision making of the doctor who prescribed the pills that the minor plaintiff’s mother took while pregnant was not examined at all.  The reasoning for ignoring these issues was as follows:  “The fact that Haley obtained the Topamax for a few months using her mother’s prescription instead of her own because of the family’s financial difficulties does not permit Appellant to evade liability for Brayden’s injuries.”  Id. at **24-25.  We might have said it like “The fact that the drug used during pregnancy was illegally obtained when minor plaintiff’s mother did not have her own legal prescription creates an obvious break in the causal chain between defendant’s alleged negligence and the plaintiffs’ injuries.”  We might have added something about the lack of evidence that the proposed labeling change would have meant the minor plaintiff’s grandmother would not have received a prescription.  But nobody asked us.  There is also an obvious gap in the evidence of proximate cause from the testimony of the physician who last prescribed the drug to the minor plaintiff’s mother several months before she became pregnant, with plaintiffs relying on:

Q: Did you have any knowledge in March of 2006 of Topamax putting a patient at an increased risk for cleft lip or cleft palate, more specifically, the unborn child at risk for cleft lip or cleft palate?
A: No.
* * *
Q: If you had been aware of a risk with Topamax and a risk of a cleft lip or cleft palate to an unborn fetus, is that a risk that you would have taken into consideration when prescribing it to Haley in March of 2006?
A: Yes.
Q. If you had been aware of cleft lip or cleft palate as a risk with Topamax when you prescribed it to Haley in March of 2006, would it have altered your prescribing habits?
A: It would have had a major impact, I think.

Id. at *23.  This testimony does not come close to indicating that the proposed labeling change would have come to the prescriber’s attention, let alone changed his decision to prescribe to the minor plaintiff’s mother.

            The third issue urged on appeal was that the $11 million verdict for a birth defect that was largely repaired through a relatively simple surgery was excessive.  Much like an NCAA bracket after a few thirteen and fourteen seeds pull off upsets, this argument is usually dead in the water.  It was here too, as damages for an apparently life-long impact on the minor plaintiff’s “self-esteem, confidence and his ability to have a simple conversation with others” can be set high—the non-economic damages were about 97% of the verdict—by a sympathetic jury without shocking the court’s “sense of justice.”  We assume that this case will be heading up to the Pennsylvania Supreme Court, which may have its own sense of justice about allowing an $11 million verdict to stand where the proposed labeling change could not have been made unilaterally, there was no evidence that FDA would have acceded to a request to make it, and there was no evidence that making it would have prevented the minor plaintiff’s exposure with pills prescribed to his grandmother.


Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine.   In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23, 2014), as we reported, the Court held that the learned intermediary doctrine governed a medical device manufacturer’s duty to warn when the manufacturer had never engaged in direct-to-consumer advertising. We are pleased to report that such displays of common sense are no longer confined to the mesh litigation.

In O'Bryan v. Synthes, Inc., 2015 U.S. Dist. LEXIS 32361 (S.D.W.Va. Mar. 17, 2015), the plaintiff alleged that Synthes was liable for failure to warn her that the metallic fixation plate implanted to repair her fractured fibula could fail if subjected to full weight-bearing before the bone had healed.  Synthes moved for summary judgment on the plaintiff’s warnings claims.  As the Court discussed, the plate’s package insert contained detailed warnings to exactly this effect in both the “Warnings” and “Precautions” sections.  Nevertheless, plaintiff argued that her doctor did not provide her with the package insert, and that she would not have undergone her implant surgery if she had known the device could fracture in less than four weeks.  O'Bryan, 2015 U.S. Dist. LEXIS 32361 at *12. 

The Court gave Plaintiff’s argument the back of its hand.  Citing Tyree, the Court held, “Because Defendant Synthes is a ‘manufacturer of medical devices,’ the learned intermediary doctrine applies to the Plaintiff’s failure to warn claims.”  Id. at *17 (citation to Tyree omitted).   The Court emphasized that Tyree limited the application of State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (2007), the West Virginia Supreme Court’s decision rejecting the learned intermediary doctrine, to cases involving “prescription drug manufacturers and manufacturers engaged in direct-to-consumer (“DTC”) advertising.”  Id (more on this later).  Granting summary judgment for Synthes on plaintiff’s warnings claims, the Court held, “This Court finds the analysis and reasoning in Tyree particularly persuasive in this case involving implantation of a plate or medical device with no evidence of direct to consumer advertising.  The learned intermediary doctrine requires Synthes to warn only the plaintiff’s treating physician about the Synthes plate.”   Id. (internal punctuation and citation omitted).   Synthes, of course, had done just that.  And plaintiff’s warnings claim was dispatched to an appropriate learned intermediary graveyard.

We remain troubled by a window the Tyree opinion left open.  The O'Bryan court’s proclamation that the learned intermediary doctrine applied because Synthes was “a manufacturer of medical devices” buys into Tyree’s insistence that there is a distinction, for learned intermediary purposes, between prescription drugs and prescription medical devices, rendering device manufacturers more deserving of the doctrine’s constraints.  There is no such distinction (99.9% of all cases treat them identically), and, ever optimistic, we await such a proclamation in a West Virginia prescription drug case.  In the meantime, O'Bryan is another positive link in the jurisprudential chain.  

Thursday, March 26, 2015

Let’s Talk InFuse

            This post is from the non-Reed Smith side of the blog only.

            The InFuse litigation has certainly given us quite a lot to talk about – and almost all of it positive.  It has been a treasure trove for defendants on off-label marketing and promotion claims.  We’ve collected this bounty of riches here.  While each case has its own nuances, they are all really slight variations on a theme – the almost unanimous rejection of plaintiffs’ attempts to use off-label marketing to thread the preemption needle.  While the reasoning varies from court to court, the over-arching message is the same – off-label marketing does not change the preemption analysis.  The InFuse device, regardless of how it was used by a particular surgeon in a particular surgery, is a PMA-approved, Class III device and therefore covered by both Riegel express preemption and Buckman implied preemption.  Very little slips through the small space between the two. 

            If you want a more complete history of the InFuse litigation, we point you to our collection referenced above.   For even casual readers of our blog, we think you’ve probably seen some of our writings on the topic and so we aren’t going to wade back through the details.  Today’s post is more of an update.  Here are the latest four InFuse victories.

Truthful v. Untruthful Promotion

            First up is Byrnes v. John Small, 2015 U.S. Dist. LEXIS 33555 (M.D. Fla. Mar. 18, 2015).  This case is fairly typical for InFuse.  Failure to warn and design defect claims are preempted, id. at *13-14, *17-19.  We will point out that this is another court that understands that the FDA approves devices, not “specific uses” of devices.  Id. at *18.  More importantly, Byrnes is also another outright rejection of our least favorite InFuse case, Ramirez, and points out the poor logic of that ruling.  Id. at *18-19.   

            That leaves fraud and misrepresentation based claims which most courts, present company included, hold are not preempted.  The reasoning however is very important to understanding why allegations of off-label promotion in and of themselves don’t trigger a shift in the preemption analysis:

The Court emphasizes that is ruling applies only to untruthful off-label promotion. . . .  To the extent that Plaintiffs are suggesting that a claim premised on truthful off-label promotion is not preempted, the Court disagrees.  Such a claim would be impliedly preempted because, even if off-label promotion were prohibited under the FDCA, Plaintiffs have failed to identify a state law duty to refrain from off-label promotion. 

Id. at *15-16, n.2 (emphasis in original).   This court places the focus on the right thing – not whether the promotion by the defendant was on-label or off-label, but rather whether it was truthful or untruthful.  The FDCA prohibits false and misleading promotion and it is in this context that there is the possibility for a state law claim to run parallel to (not conflict with) a federal requirement.  We stress “possibility” because outside of preemption, the reason most of the InFuse claims fail is because plaintiffs can’t meet the heightened pleading standards for fraud.  For instance, in Byrnes, plaintiff’s fraud claim was dismissed because plaintiff “only allege[s] in a vague and conclusory manner that Medtronic ‘fraudulently concealed and misrepresented’ the dangers of the off-label use.”  Id. at *16.  Plaintiff’s misrepresentation and express warranty claims suffered the same fate.  Id. at *21, *24-25.

No Causation; No Plaintiff-Created FDCA Requirements

            In Jones v. Medtronic, 2015 U.S. Dist. LEXIS 29827 (D. Ariz. Mar. 6, 2015) we focus on two primary takeaways – well, three if you include yet another complete rejection of Ramirez, which we certainly do.  Id. at *29.  Our first takeaway was the dismissal of plaintiff’s claim that Medtronic should have provided additional safety information, beyond that required by the FDCA, specific to the off-label use.  The court correctly interpreted this as an attempt by plaintiff to “write in a new provision and add to the requirements provided by the FDA.”  That’s definitely a conflict with federal requirements and so no question it was preempted.  Id. at *27.

            Second, like we mentioned above, often fraud claims get by preemption, but fail just as quickly on other grounds.  Here that ground was causation:  “Missing from [plaintiff’s] allegation is that Defendant fraudulently induced her doctor to use Medtronic products in her surgeries.”  Id. at *22 (emphasis in original).  Usually, courts give plaintiffs an opportunity to fix this type of deficient pleading, but here plaintiff’s causation problems were too large to surmount.  In her complaint, plaintiff actually alleged “she has no idea of what specifically caused her injuries” and that it may be impossible to establish which of the specific devices used in her surgery caused her injuries.  Id. at *23-24.  Sounds to us like this could have been the start, middle, and end of the decision on all counts, but we won’t argue that point since the court ultimately came to the right conclusion and dismissed this case in its entirety.

Round 2 Goes to Medtronic

            Our last two cases are truly updates because we’ve seen them both before.  We previously reported on Scovil here and Schouest here.  And we are happy to report, both cases stay in the win column. 

            The new Scovil can be found at 2015 U.S. Dist. LEXIS 25708 (D. Nev. Mar. 2, 2015).  The prior decision was entered when the case was jointly filed by the two Scovil brothers (Leigh and Brett) and was pending in Arizona.  The Arizona court dismissed certain of plaintiffs’ claims as preempted but as to those that remained, it severed Brett Scovil’s claims and transferred them to Nevada.  After an amended complaint was filed in Nevada, Medtronic again moved to dismiss.  Id. at *2-3.  To the extent plaintiff re-pleaded claims that were previously dismissed by the Arizona decision – the result was no different, the claims were dismissed.  What that boils down to is that plaintiff is left with a Stengel failure to advise the FDA of adverse events claim, a fraud and misrepresentation claim, and possibly an express warranty claim.  On that last one, plaintiff has to amend his complaint with allegations of the specific affirmations made by defendant to him or his surgeon and how those affirmations became part of the basis of the bargain.  Id. at *32. 

            And the new Schouest opinion can be found at 2015 U.S. Dist. LEXIS 34673 (S.D. Tex. Mar. 20, 2015).  It is exactly what we hope for when a court gives a plaintiff a do-over – a complete dismissal. 

            The first decision left open three claims that could possibly survive preemption.  On negligence, plaintiff couldn’t demonstrate a state law duty to report adverse events to the FDA and didn’t point to any reporting regulation allegedly violated.  Id. at *4.  No Stengel claim.  On express warranty, plaintiff had to identify the specific warranties made to plaintiff or her physician.  Plaintiff made all her same general allegations but added:  “Medtronic made express warranties regarding the safety and efficacy of the Infuse Bone Graft in off-label uses.”  Id. at *5.  Finding this new allegation even broader and less-specific, the court dismissed the warranty claim.  Finally, plaintiff was given a chance to keep her Texas Consumer Protection Law claim if she pleaded which specific statutory duties defendant allegedly violated.  She didn’t do so yet again, so that claim failed too. 

            On fraud and misrepresentation, the court applied the heightened pleading standard and found all plaintiff’s claims lacking.  As to her general fraud claim, the Fifth Circuit requires plaintiff to identify the speaker of the allegedly fraudulent statements as well as when and where the statements were made.  Id. at *12.   Plaintiff failed to satisfy those requirements by not identifying the Medtronic employee who spoke to plaintiff’s physician and/or not identifying a single piece of literature that contained a false statement.  Id.   On constructive fraud, plaintiff failed to allege how Medtronic violated a legal or equitable duty to plaintiff.  Again, plaintiff alleged misstatements of material facts, but “never specifies what those material facts are or how they misrepresented the truth.”  Id. at *15.  And plaintiff’s misrepresentation claim suffered the same fate – no specific misrepresentations.  As to off-label allegations, the court found plaintiff’s allegations that defendant misrepresented the safety of off-label to be “conclusory and general.” 

            Bottom line -- Scovil and Schouest stumbled into Round 2.  Scovil is on the ropes but still standing.  Schouest is down for the count.   

Wednesday, March 25, 2015

Pruning 'Expert' Opinions on Risk-Benefit and Corporate Knowledge

“Ignorance is like a delicate fruit; touch it and the bloom is gone.”  - Oscar Wilde


March 25 is a significant day in legal history.  On this date in 1911, the Triangle Shirtwaist factory in New York City caught on fire, killing 146 workers.  (One of those lost souls was the great-grandmother of a member of the DDL blogging team.)  The factory owners were charged with manslaughter on the theory that they had locked the fire exits to keep the workers from taking smoking breaks on the fire escapes.  The formidable trial lawyer Max Steuer represented the owners and secured a defense verdict by showing that a key plaintiff witness had rehearsed her story a little too well.  Two decades later, on March 25, 1931, the Scottsboro Boys were arrested for rapes they never committed.  Witnesses made up inculpatory testimony.  The trials were a sorry, sordid affair, resulting in death sentences, followed by multiple U.S. Supreme Court decisions on the issues of effective assistance of counsel and racial exclusion of jurors.  To Kill a Mockingbird might have drawn on some aspects of the Scottsboro Boys case, but the real life matter was much more complicated and dramatic.  One of the defendants escaped and was later (much later: 1976) pardoned by, of all people, Governor George Wallace.    


Today’s case is not nearly so epic, but it is nevertheless notable for the trial court’s smart and stout decision to stop a plaintiff expert witness from testifying about things she had no business talking about.  The case is Heineman v. American Home Products Corp., 2015 U.S. Dist. LEXIS 30445 (D. Col. March 11, 2015).  We were far less happy about the Heineman case when we wrote about it here last Summer, when the court missed an opportunity to end the case on clean learned intermediary grounds because it overcomplicated the issue of identifying who was the prescriber.  This time, the court was confronted with the plaintiffs’ proffer of opinions by an expert to the effect that (1) the risks of diet drugs outweighed their benefits, and (2) the defendant’s post-marketing surveillance stunk and it knew its labelling was inadequate.  The expert was Dr. Cheryl Blume.  She is a pharmacologist.  We have blogged about several other cases involving Dr. Blume.  Here, for example.  And here.  And here.  There are others.  You get the idea.  Since, as Dr. Parisian told us at a deposition last year, she is retiring soon, we suppose that Dr. Blume will become the go-to expert for saying what needs to be said, at least as far as DDL plaintiff lawyers are concerned.  We are reminded of something Bill Buckley once said about a former ambassador: “He knows a lot about the Soviet Union, all of it wrong.”   Dr. Blume comes into every case knowing A Lot.       


The Heineman judge conducted a Daubert hearing and took testimony from Dr. Blume.  In its opinion, the court gives a nice blow-by-blow account of the hearing.  First, we learn that “[a]fter several hours of general direct examination of Dr. Blume, the Court called counsel to the bench and observed that, thus far, the Plaintiffs’ questioning of Dr. Blume, though extensive, had not begun to approach the Defendant’s foundational challenges to the recited opinions.  With the consent of counsel, the Court took over the examination of Dr. Blume.”  Heineman, 2015 U.S. Dist. LEXIS 30445 at *13.   Now that’s an involved judge.  Most of the time, from our defense hack perspective, an involved judge is a very, very good thing at a Daubert hearing.  That proved to be the case here.    The judge issued an oral opinion excluding the two opinions at issue, though other of Dr. Blume’s opinions might have been admissible.  If a trial happened, a big part of the defense job  would be making sure that plaintiffs’ lawyers and expert would not smuggle the excluded opinions back into the case. 

Not surprisingly, the plaintiffs were unhappy with the exclusion of the risk-benefit and company conduct opinions.  They moved for reconsideration.  The court took a second-look at the record, then seized the opportunity “to clarify and amplify that ruling.”  Id. at *24.  It made things, if anything, a bit worse for the plaintiffs.  (This reminds us of a high school teacher who, when challenged on the grade for a particular answer on a test, would insist on regrading the entire test.  Invariably,  the supplicant would end up with an overall worse grade.  We did not know it at the time, but this teacher had a very judicial approach to motions for reconsideration.)        


The Court asked Dr. Blume whether a retrospective risk-benefit review was something that she typically did.  You know, as opposed to a litigation-driven, result-oriented piece of hocus-pocus.  Dr. Blume is nothing if not savvy.  She told the court that as part of her corporate practice, “she would occasionally conduct retrospective risk-benefit reviews for existing drugs, such as when her company purchased the rights to domestically distribute a drug that was already in use overseas.  She explained that ‘we would be given opportunities to license products, the same drill that I gave you in such detail was also undertaken, and at the end of it, the pencil went down and we said ‘we can’t take the risk.’  The benefits sometimes were great, but for our size company and the goals of our company, we couldn’t take the risk of what we saw lurking in there.’”  Id. at *16.  That’s pretty clever.  It can be tougher to test an opinion based on experience than one based on, say, peer-reviewed literature.  But it was not clever enough. 


The court saw that Dr. Blume’s “assessment as to risk-benefit is not tied to any objective standard.  It is instead, a function of her experience and expertise.”  Id. at *22-23.  Of course, Rule 702 does permit an expert to rely upon experience and expertise in formulating an opinion.  Still, when an expert is relying primarily on experience, the witness is required to explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts.  The problem in this case is that the corporate risk-benefit analysis that Dr. Blume relied on – which had a heavy business component - was utterly different from the health and safety risk-benefit opinions being offered in this case.  Basically, Dr. Blume said that the diet drugs could, at most, produce a loss of a couple pounds, which she characterized as a “de minimis” benefit.  Dr. Blume did not identify any specific or generally accepted measure that experts in the field use to quantify the “benefit” associated with a drug, or how “benefits” and “risks” are compared. She did not compare the weight loss benefits among different drugs.  She did not consult with the other experts about the  medical benefits of the weight loss.  In sum, in “determining the benefits of the drugs, it does not appear that Dr. Blume brought any more expertise to bear on the question than would any layperson (or, at least, any layperson advised of the weight loss data for the drugs.)”  Id. at * 27-28. Moreover, Dr. Blume conceded that she could not make a risk-assessment for any particular patient. 


So much for the risk-benefit opinion.


Now on to the sort of expert opinion that is not aimed to help the jury, but, rather, is aimed to supplant the jury.  We hardly see a case where plaintiffs do not produce an expert armed with little more than literacy and indignation, who reads company documents with a certain point of view,  and who pronounces the company to be a bad actor.  In Heineman, Dr. Blume read company documents and did not like them even a little.  (Or maybe she liked them a lot.)  According to her, the corporate documents demonstrate that people in the company’s safety surveillance department did a poor job and also knew that the product labelling was inadequate.  (At least, we think that is what the proffered opinion was.  As the court remarked, this opinion varied and was hardly pellucid.)  The court saw this opinion for what it was, and for what it was not:  “the opinion really isn’t that [the Defendants] failed to conform with the standard of care: it is that corporate documents demonstrate that [the Defendants] failed to conform as to the standard of care….I find that Dr. Blume has no methodology that is reliable for determining what the documents demonstrate.  Ultimately, the plaintiffs will be able to put on the documents at trial, and the jury will decide what the documents demonstrate.”  Id. at *32.  Dr. Blume offered no “specialized knowledge” that would “help the trier of fact to understand” the corporate documents themselves.  Id. at *32-33.  There was no evidence that the company documents “themselves are so opaque or incomprehensible that the trier of fact requires Dr. Blume’s assistance to parse them.”  Id. at *33.  The usual payoff point for the plaintiffs would have been for an expert to race through a carefully culled set of documents, assisted by PowerPoint slides with colorful call-outs, with the expert sorrowfully/angrily concluding that the company knew better, but decided to value dollars over lives.  It is a closing argument masquerading as an expert opinion.  At the heart of the opinion is a perusal of documents followed by a Vulcan mind-meld as to what people at the company truly knew and believed.  The Heineman court joined “a number of the other courts in finding that Dr. Blume may not testify as to what [the Defendant] knew or didn’t know.”  Id. at *41.


Dr. Blume’s opinions were offered to help the plaintiffs, not the jury.  As a result, they were not able to do either.


Tuesday, March 24, 2015

New Jersey Casts a Broader Net (Opinion Rule)

It wasn’t too long ago that, down the shore, New Jersey hosted one of the most notorious litigation hellholes in the country.  That’s not the case anymore, as the current (2014-15) ATRA Judicial Hellholes report explains in a suitably defense-oriented way.  That’s good news because so many of our clients are headquartered in New Jersey.

But the substantive law, as well, played a part in Joisey gaining a reputation as an unusually pro-plaintiff forum.  That’s been changing too – for some time, as we pointed out here.  Earlier this month we reported that the Accutane mass tort in New Jersey finally went to ground (or to the dogs), as the state court belatedly recognized what federal judges applying Daubert had known for years – allegations that the drug caused intestinal injuries were scientifically bogus from beginning to end, and at all points in between.  See In re Accutane Products Liability, 511 F. Supp.2d 1288 (M.D. Fla. 2007).

Last week, the New Jersey Supreme Court took another step in the right direction on the expert front in Townsend v. Pierre, ___ A.3d ___, 2015 WL 1058036 (N.J. March 12, 2015), by reaffirming and strengthening the state’s “net opinion rule” for expert witnesses.

The what you say?

For those of you not steeped in New Jersey law, think back to the most memorable (or at least the most quoted) statement in General Electric Co. v. Joiner, 522 U.S. 136 (1997) – “nothing in either Daubert or the Federal Rules of Evidence requires . . . admi[ssion of] opinion evidence that is connected to existing data only by the ipse dixit of the expert.”  Id. at 146.  Well, the New Jersey net opinion rule is a lot like that – a ban on ipse dixit − and just as important in the perpetual struggle against the other side’s hordes of junk scientists.

Townsend wasn’t a prescription medical product case.  Heck, it wasn’t even a product liability case.  Its expert analysis, however, will be equally applicable to all civil litigation in the Garden State for years to come.  Townsend involved an accident where a left turning car (Pierre) collided with a motorcycle driven by the plaintiff (Townsend).  Who sues whom in this situation is essentially determined by the laws of physics.  Motorcyclists tend to come off worse in collisions with four (or more) wheeled vehicles.  See Duane Allman and Berry Oakley.

Also named as a defendant was a property owner on the corner where the collision happened, on a theory that “overgrown shrubbery” on the property obscured the driver defendant’s view of the approaching motorcycle.  Townsend, 2015 WL 1058036, at *1.  Trouble was, there was no evidence to support that theory, and affirmative evidence against it:

[Driver] testified that shrubbery on the property initially obscured her view when she was stopped at the stop sign at the intersection, but that she edged forward, starting and stopping four times until her view of oncoming traffic was unimpeded.  A passenger in [driver’s] vehicle corroborated [this] testimony that when she turned left, she had an unobstructed view of approaching traffic.  The record contains no testimony to the contrary.


Did plaintiff drop this factually unsupported theory of liability?  Of course not.  This is Joisey.  Evidence?  I don’t need no stinkin’ evidence!  I have an expert.

Umm….  Not so fast.

The expert’s first ploy was to “assume” the wrong thing – that the “relevant location . . . was behind the stop sign,” even though three people had testified that the car had inched forward well past the sign.  Townsend, 2015 WL 1058036, at *3.  The expert followed that up by simply disregarding testimony that got in the way of his opinion:

I am mindful of the testimony of [the driver] regarding her allegedly stopping four (4) times before proceeding.  However, given . . . that she never saw the approaching motorcycle, I reasonably conclude that she did not have an unobstructed view . . .  when she proceeded into the roadway.

Id. at *4.  All the uncontradicted testimony to the contrary “must have been mistaken.”  Id.  For support, “[t]he expert offered neither factual evidence nor expert analysis contradicting [driver’s] recollection.”  Id.

That led to multiple defense motions to strike the expert’s proposed testimony as a “net opinion,” which the trial court granted.  Id.  The New Jersey Appellate Division, however, reversed, holding that the driver’s testimony was subject to “credibility” challenge by virtue of the expert’s testimony, and therefore a jury question was created.  A “hypothetical question” to the expert, assuming facts that had no basis in the factual record, was enough, according to that court.   Townsend v. Pierre, 60 A.3d 800, 804 (N.J. Super. App. Div. 2013).

Umm….  Not so fast.

The New Jersey Supreme Court ruled – unanimously – that the expert’s opinion had no factual support, and therefore was an excludable net opinion.

The net opinion rule is a corollary of N.J.R.E. 703 which forbids the admission into evidence of an expert’s conclusions that are not supported by factual evidence or other data.  The rule requires that an expert give the why and wherefore that supports the opinion, rather than a mere conclusion.

Townsend, 2015 WL 1058036, at *7 (citations and quotation marks omitted).  The first takeaway is that the “net opinion” rule is alive and well in New Jersey.

Sounding like a Daubert court expounding on the evils of expert ipse dixit, Townsend further explained:

The net opinion rule . . . mandates that experts be able to identify the factual bases for their conclusions, explain their methodology, and demonstrate that both the factual bases and the methodology are reliable.  An expert’s conclusion is excluded if it is based merely on unfounded speculation and unquantified possibilities. . . .  [W]hen an expert speculates, he ceases to be an aid to the trier of fact and becomes nothing more than an additional juror.

Townsend, 2015 WL 1058036, at *8 (citations and quotation marks omitted).  A net opinion cannot satisfy a party’s burden of proof.  Id.

Invalid assumptions create a net opinion.  No testimony put the driver behind the stop sign.  “In an attempt to reconcile his opinion with the testimony, [the expert] reconstituted the facts.  He asserted that [the driver’s] testimony about her accident was wrong.  In this crucial respect, [his] proposed expert testimony is an inadmissible net opinion.”  Townsend, 2015 WL 1058036, at *10.

Nor could the proponent of this factually baseless opinion conjure up a basis through a hypothetical question.  “Expert opinion is valueless unless it is rested upon the facts which are admitted or are proved.”  Id. at *11 (citation and quotation marks omitted).  A hypothetical cannot be used to “supply” facts that don’t exist.  Id.

[A] hypothetical question . . . in which the expert would be asked to assume that [the driver’s] account of the accident was mistaken − not only lacks the requisite foundation in the facts, but is premised on a rejection of uncontroverted testimony.  On this record, no hypothetical question that conforms to our standard can salvage the causation opinion.

Id. at *11.

From now on (if not before), any New Jersey expert opinion needs to be analyzed in accordance with the strengthened net opinion rule.  The court in Townsend found no fault with either the expert’s qualifications or his opinion on duty, id. at *9, but defeating the causation opinion was all that was necessary to a grant of summary judgment.  Id. at *11.  Similarly, in drug and device cases, causation claims are often bases on “assumptions” – particularly about what is stated in medical literature – that turn out to be contrary to fact.  Experts in broken device cases often pile one factually unsupported statement on top of another.  As occurred in Townsend, inconvenient facts are frequently ignored without any basis for doing so during bogus “differential diagnoses.”

The net opinion rule in New Jersey should now cast a wider net – removing ipse dixit expert opinions from litigation in that state similarly to federal court practice under Daubert.

Monday, March 23, 2015

Zogenix’s Battle with the Commonwealth of Massachusetts Continues

Last week, the District of Massachusetts issued its decision on Round 3 of the battle between Zogenix, Inc. and the Commonwealth of Massachusetts over Zohydro ER, an extended release hydrocodone drug product that was approved by the FDA in 2013.  See Zogenix, Inc. v. Baker, 2015 U.S. Dist. LEXIS (D. Mass. Mar. 17, 2015).  This is a year-long battle in which Massachusetts has tried to regulate the use of Zohydro, first banning it entirely and later implementing a series of regulations intended to restrict its use.  

First, a history of the earlier rounds: In Round 1, the Massachusetts governor declared opioid abuse and overdosing to be a public health emergency and authorized the department of health to issue an emergency order that banned prescribing, ordering, dispensing or administering Zohydro (it didn’t mention Zohydro specifically, but described a category of drugs that included only Zohydro).  Zogenix moved for a preliminary injunction and won.  The FDA had already approved Zohydro for marketing.  And so Massachusetts’s ban failed, as we put it, the “you can’t do that” test.  The emergence order was preempted.   

In Round 2, with the department of health licking its wounds, various Massachusetts boards of registration stepped into the battle.  Two boards, the Board of Registration in Medicine and the Board of Registration of Physicians Assistants, promulgated emergency regulations that required prescribers, before they could prescribe Zohydro, to provide a Letter of Necessity stating that all other pain management treatments had “failed.”  Also, Massachusetts’s Board of Registration of Pharmacy created certain “handling” requirements, including prohibiting anyone at a pharmacy who wasn’t the actual pharmacist from handling Zohydro.  Zogenix once again sought injunctive relief, arguing that these regulations were preempted.  It won a partial victory.  The court agreed to enjoin the regulation requiring the Letter of Necessity from prescribers.  Its requirement that other pain-management options have “failed” differed from the treatment indication for which the FDA had already approved Zohydro.  And so it was preempted.  The pharmacy regulations restricting the handling of Zohydro stood.  The court did suggest, however, that Zogenix’s challenge to those regulations could be successful if Zogenix were later able to develop facts proving that the regulations would alter pharmacies’ willingness to carry Zohydro.  We blogged about Round 2 here.

After Round 2 but before Round 3, a bit of adjusting happened.  The medicine board and the physicians assistants board changed their regulations.  They no longer require that other pain-management options have “failed” before Zohydro can be prescribed.  Instead, the prescriber must only deem other options to be “inadequate.”  This more closely mirrors the indication for which the FDA approved Zohydro and, with Zogenix putting up little fight, the court lifted its injunction on the Letter of Necessity.  The pharmacy board also changed its regulations.  They now allow pharmacist interns, not just pharmacists, to handle Zohydro.  The other pharmacy board regulations on the handling of Zohydro remained in place.  See Zogenix, 2015 U.S. Dist. LEXIS, at *7-11.

That takes us to Round 3.  Zogenix believed that the pharmacy board’s regulations were still improper, and so it filed a third amended complaint.  Id. at *11.  Massachusetts moved to dismiss.  The court issued its opinion last week.  Zogenix made a number of Constitutional claims based on the commerce, equal protect and contracts clauses, but we won’t address them here.  In short, the court dismissed those claims.  

But Zogenix also claimed that the pharmacy board’s “handling” regulations were preempted.  It argued that “[t]aken together, these requirements continue to impose draconian restrictions on pharmacists’ abilities to stock or dispense Zohydro ER that . . . amount to an effective ban of the drug in Massachusetts.”  Id. (quoting the third amended complaint).  

In support of this argument, it’s important to understand that the pharmacy board’s regulations did more than restrict the handling of Zohydro to only pharmacists and pharmacist interns.  It required Zohydro to be stored in a locked cabinet at all times.  The container for the drug must be child proof.  The prescriber must have sent the pharmacy a Letter of Necessity that includes a diagnosis, treatment plan, verification that other pain-management options are inadequate, an indication that a risk assessment was performed, and an indication that the patient and doctor entered into a pain management treatment agreement or that the prescriber determined that no such agreement was unnecessary.  The pharmacy must also include with each prescription a warning approved by the pharmacy board and provide counseling to each patient on the risks of Zohydro.  Id. at *7-10 n.8.  

Massachusetts responded to Zogenix’s argument by “contending that the claim should be dismissed because it is facially absurd and unbelievable.”  Id. at *14-15. 

The court laid out the legal basis for Zogenix’s preemption claims:

[T]he issue is one of obstacle preemption, which occurs when, “under the circumstances of [the] particular case, [the challenged state law] stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”  Hines v. Davidowitz, 312 U.S. 52, 67, 61 S. Ct. 399, 85 L. Ed. 581 (1941).  The obstacle preemption doctrine holds that “[i]f the purpose of the [federal] act cannot otherwise be accomplished--if its operation within its chosen field else must be frustrated and its provisions be refused their natural effect--the state law must yield to the regulation of Congress within the sphere of its delegated power.”  Savage v. Jones, 225 U.S. 501, 533, 32 S. Ct. 715, 56 L. Ed. 1182 (1912).

Id. at *15.  

Given the unusual posture of this case, granting Massachusetts’ motion to dismiss would be a loss for preemption.  But the court denied the motion.  The court reiterated what it had stated in Round 2— that Zogenix could provide more facts as the litigation moved forward to support its argument that these regulations served essentially as a ban of Zohydro: 
On the record before me last summer, I could not allow Zogenix’s motion to enjoin the “pharmacist-only” BORIP regulation because Zogenix had not offered sufficient evidence of the regulations’ effect on Zohydro’s availability.  2014 U.S. Dist. LEXIS 92382, [WL] at *5.  But I did not foreclose the possibility that “a more detailed submission,” informed by a “record of enforcement,” might show “whether . . . an obstacle [to the FDCA’s objectives] exists.”  Id. Zogenix may be able to show, through survey evidence or third-party discovery from pharmacies and physicians, that Massachusetts pharmacies are not stocking its drug because of handling difficulties caused by the regulations and that their failures to stock the drug are affecting physicians’ prescribing practices.  Zogenix has alleged such facts in its Complaint, and I must take those allegations as true at this stage.  That the defendants are skeptical that the evidence will support those allegations is immaterial, because, if the allegations are proven, Zogenix will be entitled to relief.  The defendants’ motion to dismiss this count is therefore denied.
Id. at *15-16.

And so, the battle will continue.  But now it will be focused very much on preemption and the extent to which the pharmacy board’s regulations affect Massachusetts’ pharmacies’ willingness to carry and dispense Zohydro, an FDA approved drug.  While we’ve been through three rounds already, this battle is only starting to heat up and get interesting.  We’ll keep you posted.