Source: http://newslawonline.blogspot.com/2015_03_01_archive.html
Timestamp: 2018-05-24 23:13:31
Document Index: 186926083

Matched Legal Cases: ['§ 1396', '§ 337', '§ 337', '§337', '§337', '§337', '§337']

March 2015 | Law
[DK GreenRoots] Recap of Seattle & Puget Sound Kos meet up
Since there was so much environmental stuff discussed I thought you'd be interested.
http://www.dailykos.com/story/2015/03/31/1374352/-Seattle-Puget-Sound-Kos-Spring-Forward-on-3-29-15
Posted by Law at 3:21 PM 0 comments
[Drug and Device Law] Breaking News - Reinforcement For Buckman
We’ve been watching for Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 2015 WL 14194231 (U.S. Mar. 31, 2015), ever since we spotted an intriguing footnote mentioning the certiorari grant in Ouellette v. Mills, ___ F. Supp.3d ___, 2015 WL 751760 (D. Me. Feb. 23, 2015) (other aspects of Ouellette discussed here). Ouellette noted:
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?”). . . .
Id. at *3 n.5.
Any time courts mention private rights under the FDCA, we think back to Supreme Court’s implied preemption reasoning in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), specifically:
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).
Id. at 349 n.4, and:
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).
So do the Court’s two statutorily-based reasons in Armstrong. First, as in Buckman, Congress simply did not allow private enforcement:
[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.
The Court’s second reason is why medical device plaintiffs shouldn’t be allowed to enforce vague FDA Current Good Manufacturing Practices that do nothing more than state that the defendant should adopt some sort of process for doing X, Y, or Z: Such vague standards are “judicially administrable”:
[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.
Posted By Bexis to Drug and Device Law at 3/31/2015 02:45:00 PM
Posted by Law at 11:45 AM 0 comments
[Drug and Device Law] That One Particular Deposition
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.
So, all in all, that one single line of direct and unrefuted testimony from plaintiff’s prescriber carried the day. While we’ve seen it before, it doesn’t make it any less fantastic, especially when put in context of what we can only assume based on our experience to be the vast discovery that has occurred in the litigation overall. That made us stop to think about we should be thinking about as we approach prescriber depositions. The list is long and varied. It depends on jurisdiction (heeding presumption state or not), on the facts (drug withdrawn or still on the market), on the doctor (assess confidence, experience). So this is more like a wish list of testimony you might want to try to get – where appropriate -- and that you may want to keep in mind as you prepare for that one particular deposition:
Establish that the drug was an effective treatment (preferably for a number of medical conditions)
Establish that the benefits outweighed the risks for most patients
Establish that the prescriber weighed the risks/benefits for this patient AND concluded that the benefits outweighed the risks for this patient
Establish either
that the prescriber was aware of the very risk of which plaintiff suffered at the time he/she prescribed the drug OR
that the prescriber continued to prescribe the drug to plaintiff after learning about the risk OR
that the prescriber, now knowing about the risk, would still have prescribed it to plaintiff
Establish that in general the prescriber continues to prescribe the drug
Establish that other medications were not efficacious for this particular plaintiff
Hit the highpoints on this list and you might just be basking in some of that Caribbean sunshine Jimmy’s always singing about.
Posted By Michelle Yeary to Drug and Device Law at 3/31/2015 10:44:00 AM
Posted by Law at 7:44 AM 0 comments
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Posted by Law at 6:17 PM 0 comments
[Drug and Device Law] Limiting the Damage from One-Sided Ex Parte Interviews of Doctors
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.
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.
Posted By John J. Sullivan to Drug and Device Law at 3/30/2015 03:15:00 PM
[Drug and Device Law] Result-Driven Affirmance of Birth Defect Verdict
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.
Posted By Eric Alexander to Drug and Device Law at 3/27/2015 04:59:00 PM
Posted by Law at 1:59 PM 0 comments