Source: http://newslawonline.blogspot.com/2015/03/
Timestamp: 2019-04-24 19:03:38+00:00

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Since there was so much environmental stuff discussed I thought you'd be interested.
The State also asserts that where the Plaintiffs have no private right of action under the FDCA, the Supremacy Clause does not create one. This Court has already resolved that issue in favor of the Plaintiffs in light of Pharmaceutical Research and Manufacturers of America v. Concannon, 249 F.3d 66, 73-74 (1st Cir. 2001). However, the Supreme Court has granted certiorari on a similar, potentially dispositive question. See Armstrong v. Exceptional Child Ctr., Inc., 567 Fed. Appx. 496 (9th Cir. 2014), cert. granted, 83 U.S.L.W. 3077 (U.S. Oct. 2, 2014) (No. 14-15) (“Does the Supremacy Clause give Medicaid providers a private right of action to enforce § 1396a(a)(30)(A) against a state where Congress chose not to create enforceable rights under that statute?”). . . .
The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a).
In the present case, by contrast, we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government. 21 U.S.C. § 337(a).
Id. at 352 (distinguishing Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984)).
Thus, we were wondering whether, when the Supreme Court decided Armstrong, it would have anything to say about respecting Congressional decisions, such as the FDCA’s §337(a), by precluding private enforcement of other statutes that also bear such “clear evidence” of congressional intent.
Armstrong was decided today. We were not disappointed.
In Armstrong, a health care provider paid by Medicaid funds sued the state of Idaho over allegedly illegal underpayment, asserting that the Supremacy Clause gave it the right to enforce its interpretation of what it considered to be the federal Medicaid payment scheme. Not only did the Court reject private enforcement, but it relied in part on its “preemption precedent” to do so. 2015 WL 14194231, at *4.
To say that the Supremacy Clause does not confer a right of action is not to diminish the significant role that courts play in assuring the supremacy of federal law. For once a case or controversy properly comes before a court, judges are bound by federal law. Thus, a court may not convict a criminal defendant of violating a state law that federal law prohibits. Similarly, a court may not hold a civil defendant liable under state law for conduct federal law requires.
Id. (citing, inter alia, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013)) (emphasis added).
Specifically as to congressional intent, the Court in Armstrong held that the plaintiff could not bring an “equitable” action to enforce its view of the Medicaid statute. Congress did not grant such a right. “In our view the Medicaid Act implicitly precludes private enforcement . . ., and respondents cannot, by invoking our equitable powers, circumvent Congress’s exclusion of private enforcement.” Id. at *5. That sounds a lot like Buckman’s implied preemption rationale based on §337(a).
[T]he sole remedy Congress provided for a State’s failure to comply with Medicaid’s requirements . . . is the withholding of Medicaid funds by the [government]. As we have elsewhere explained, the express provision of one method of enforcing a substantive rule suggests that Congress intended to preclude others.
Armstrong, 2015 WL 14194231, at *5 (citation and quotation marks omitted) (emphasis added). Ditto, Buckman – indeed, the explicit text of §337(a)’s prohibition of prvate enforcement is a fortiori from Armstrong, under the same reasoning.
[I]t does so when combined with the judicially unadministrable nature of [the Medicare statute’s] text. It is difficult to imagine a requirement broader and less specific than [the] mandate that state plans provide for payments that are “consistent with efficiency, economy, and quality of care,” all the while “safeguard[ing] against unnecessary utilization of . . . care and services.” Explicitly conferring enforcement of this judgment-laden standard upon the Secretary alone establishes, we think, that Congress wanted to make the agency remedy that it provided exclusive, thereby achieving the expertise, uniformity, widespread consultation, and resulting administrative guidance that can accompany agency decisionmaking, and avoiding the comparative risk of inconsistent interpretations and misincentives that can arise out of an occasional inappropriate application of the statute in a private action.
Id. (citations and quotation marks omitted) (emphasis added). Many of the FDA regulations that we see plaintiffs trying to advance as supposed “parallel claims” are equally vague. Combined with the express prohibition on private enforcement in §337(a), everything that the Court found preclusive of private enforcement in Armstrong also should be preclusive in medical device preemption cases. “The sheer complexity associated with enforcing [the vague statutory provision] coupled with the express provision of an administrative remedy . . ., shows that the [statute] precludes private enforcement of [that provision] in the courts.” Id.
As we see it, Buckman just received some timely reinforcement. It does not escape our notice that the court that Armstrong smacked back into line – the Ninth Circuit – was also the source of Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), which similarly ignored Buckman in this respect.
In pharmaceutical litigation, discovery is almost always massive. Plaintiffs depose dozens of company witnesses, often over several days and sometimes in multiple jurisdictions. Defendants have to produce millions of pages of documents of which usually only a handful are ever used at depositions and trial. Both sides retain several experts in various areas of specialty and each expert produces a voluminous report supported by thousands of pages of back-up materials. The time and costs associated are staggering. And when all of that is said and done and you actually get to the discovery related to one particular plaintiff, there is one particular deposition that can make all the difference – the prescriber.
There are any number of cases, too many reported on by this blog alone to count, where the prescriber’s testimony was the linchpin for the defense. But in the overwhelming machine that is mass tort discovery, it might be easy to overlook that one particular deposition. Like Jimmy Buffett’s One Particular Harbor – this one particular deposition can be a haven. “Sheltered from the wind . . . where all are safe within.” OK, prescriber testimony is that idyllic, but allow us a little poetic leeway.
The reason for our focus on the prescriber today is a recent win in the Avandia litigation, Schatz v. GSK, 2015 U.S. Dist. LEXIS 37411 (E.D. Pa. Mar. 24, 2015), where the defendant embraced that one particular deposition. Faced with several claims that all essentially boiled down to failure to warn claims, GSK moved for summary judgment on the ground that plaintiff could not establish causation. The crux of defendant’s argument was that plaintiff could point to no evidence that had the prescribing doctor received a different warning, he would have altered his prescribing habits. Id. at *9. And since that’s the standard under Pennsylvania law, plaintiff’s claims should be summarily dismissed.
What did the prescriber say at his deposition -- that if plaintiff presented to him today, knowing everything he now knows about the risk of bone fractures, he would still have prescribed Avandia. Id. Like the hum of “drummers and night sounds” on a tropical island – music to our ears.
Plaintiff tried a few different methods of combating this testimony but none prevailed. First, plaintiff argued that the prescriber also testified that if the warning had been in a black box it would have “caught his eye,” but that testimony wasn’t enough to create a genuine issue of material fact as to whether the enhanced warning would have deterred his decision to prescribe in this case. Id. at *10-11. Second, plaintiff pointed to testimony that the doctor routinely relies on Dear Health Care Provider letters. But the court found that immaterial here because the doctor continued to prescribe Avandia to plaintiff for months after defendant’s letter was distributed. Id. at *11-12. Next, plaintiff claimed that after she suffered multiple fractures, her prescriber researched the issue and decided to stop her Avandia prescription. But, this was not enough to overcome the prescriber’s direct testimony that he wouldn’t have changed his original decision to prescribe the drug. Id. at *12. Finally, plaintiff tried to use expert testimony but that testimony was geared toward studies done after plaintiff had stopped taking Avandia and was about “older” women, which plaintiff was not. Id. at *13.
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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.
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.
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.
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 impossibilitypreemption. 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. Maya—which 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 Carolina’s 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.
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?
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?
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.

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