11 Ekim 2012 Perşembe
Trespass Conviction of Church Member Reversed
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In a 2-1 decision in Semenick v. State of Indiana, (IN App., Oct. 9, 2012), and Indiana appellate court reversed the criminal trespass conviction of a long-time church member who was evicted from church services by an off-duty police officer acting as a security guard after the church member complained that a volunteer greeter was speaking too loudly with others during the service. The majority held that the church member had a right to be on church premises and there was no evidence that the off-duty police officer had authority to take sides in a dispute between members and ask one of them to leave. Judge Mathias dissenting argued that defendant's conduct during services was disruptive. The jury, he argued, could reasonably conclude that defendant did not have a contractual interest in the property at issue, and knowingly or intentionally refused to leave the Church after having been asked to do so by an agent of the Church.
German Court Refuses To Excuse Muslim Girl From Co-Ed School Swimming Classes
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Gatestone Institute reports on a Sept. 28 decision by the Hessian Administrative Court in Germany refusing to excuse a 12-year old Muslim girl from co-ed swimming lessons in her school. The court, emphasizing that religious minorities must avoid segregating themselves, said that the girl's religious beliefs could be accommodated by her wearing a full-body swimsuit (also known as a "burkini"), as do several other Muslim girls at her school. The girl's lawyer said the 12-year old does not want to wear a burkini because it makes her look ugly, and seeing other boys and girls in short clothes violates her modesty. Because of the importance of the case, the court is asking the Federal Administrative Court to review the decision.
10 Ekim 2012 Çarşamba
The FDA On Warning Letters - They're Sure Not Final
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Remember that case about ear candles? Given the product, we had some fun with it in our earlier posts. Well, it turns out that the ear candling folks are nothing if not persistent. They appealed the second opinion, Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940 (D.C. Cir. 2012), to the Supreme Court. As our post indicated, this opinion turned (in part, but a large part) on the “finality” of an FDA warning letter.
The Supreme Court appeal has given the FDA the opportunity to state its formal opinion about how it views the “finality” of warning letters. See Brief for the Respondents [FDA] in Opposition, Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454, 2012 WL 3991471 (filed Sept. 11, 2012). To put it succinctly, they aren’t final at all.
Since it’s Friday and we’re lazy, we’ll simply quote for you some of the FDA’s reasoning on why its warning letters aren’t legal determinations of anything. Here’s what the FDA has told the United States Supreme Court:
If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action. Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].” FDA, Regulatory Procedures Manual, 4-1-1 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.” Ibid.
FDA Holistic Candlers br. at *5.
[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. As FDA has explained, warning letters give “firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.” Regulatory Procedures Manual 4-1-1. An enforcement action - typically a seizure or an injunction - is not inevitable, and indeed, most warning letters do not result in enforcement action. See FDA, Enforcement Statistics Summary Fiscal Year 2011 (reporting 1720 Warning Letters, but only 15 seizures and 16 injunctions), http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf. Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.” Regulatory Procedures Manual 4-1-1 (emphasis added). Consistent with the Regulatory Procedures Manual, the warning letters at issue here stated that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Pet. App. 43 (quoting FDA warning letter) (emphasis and internal quotation marks omitted). Relatedly, the warning letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”
Id. at *9-10 (emphasis original).
Nor did the warning letters finally determine the “rights or obligations” of petitioners with regard to the distribution of ear candles, or trigger “direct and appreciable legal consequences.” Bennett, 520 U.S. at 178. Rather, the letters “request[ed]” that petitioners “take prompt action to correct [the identified] deviations” from the FDCA, and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Pet. App. 39. The letters served only to communicate FDA's position with regard to ear candles, and to warn recipients about the possibility of future enforcement action. See Regulatory Procedures Manual 4-1-1. The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.” Ibid.
Id. at *10-11.
FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. See Pet. App. 47. Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review. Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA. If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA.
Id. at *14.
So there you have it, from the proverbial horse’s mouth. And what should be the consequences of the non-final nature of FDA warning letters. Here are a few − there may well be more, the more we think about this: (1) without enforcement they’re not admissible evidence, being considerably less than a bare criminal indictment; (2) any attempt to give a warning letter binding collateral estoppel effect would be a violation of Due Process, since such letters are not appealable; (3) warning letters are nothing like the enforcement actions mentioned in the concurrence in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (4) as warning letters are not legally enforceable, they shouldn’t be the basis of an negligence per se action; and (5) being tentative and subject to change at any time, a warning letter should not be the type of evidence reasonably relied upon by experts in the field (assuming there is a “field” as to which expert testimony is permissible in the first instance).
The Supreme Court appeal has given the FDA the opportunity to state its formal opinion about how it views the “finality” of warning letters. See Brief for the Respondents [FDA] in Opposition, Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454, 2012 WL 3991471 (filed Sept. 11, 2012). To put it succinctly, they aren’t final at all.
Since it’s Friday and we’re lazy, we’ll simply quote for you some of the FDA’s reasoning on why its warning letters aren’t legal determinations of anything. Here’s what the FDA has told the United States Supreme Court:
If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action. Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].” FDA, Regulatory Procedures Manual, 4-1-1 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.” Ibid.
FDA Holistic Candlers br. at *5.
[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. As FDA has explained, warning letters give “firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.” Regulatory Procedures Manual 4-1-1. An enforcement action - typically a seizure or an injunction - is not inevitable, and indeed, most warning letters do not result in enforcement action. See FDA, Enforcement Statistics Summary Fiscal Year 2011 (reporting 1720 Warning Letters, but only 15 seizures and 16 injunctions), http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf. Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.” Regulatory Procedures Manual 4-1-1 (emphasis added). Consistent with the Regulatory Procedures Manual, the warning letters at issue here stated that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Pet. App. 43 (quoting FDA warning letter) (emphasis and internal quotation marks omitted). Relatedly, the warning letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”
Id. at *9-10 (emphasis original).
Nor did the warning letters finally determine the “rights or obligations” of petitioners with regard to the distribution of ear candles, or trigger “direct and appreciable legal consequences.” Bennett, 520 U.S. at 178. Rather, the letters “request[ed]” that petitioners “take prompt action to correct [the identified] deviations” from the FDCA, and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Pet. App. 39. The letters served only to communicate FDA's position with regard to ear candles, and to warn recipients about the possibility of future enforcement action. See Regulatory Procedures Manual 4-1-1. The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.” Ibid.
Id. at *10-11.
FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. See Pet. App. 47. Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review. Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA. If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA.
Id. at *14.
So there you have it, from the proverbial horse’s mouth. And what should be the consequences of the non-final nature of FDA warning letters. Here are a few − there may well be more, the more we think about this: (1) without enforcement they’re not admissible evidence, being considerably less than a bare criminal indictment; (2) any attempt to give a warning letter binding collateral estoppel effect would be a violation of Due Process, since such letters are not appealable; (3) warning letters are nothing like the enforcement actions mentioned in the concurrence in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (4) as warning letters are not legally enforceable, they shouldn’t be the basis of an negligence per se action; and (5) being tentative and subject to change at any time, a warning letter should not be the type of evidence reasonably relied upon by experts in the field (assuming there is a “field” as to which expert testimony is permissible in the first instance).
FDA Regulatory Muscles: Ripped and Oiled
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Here's a shocker: your average drug and device law lawyer seldom hoists more weight at any one time than 22 ounces of F.3d or three ounces of The Glenlivet. There is usually a long, nerdy history behind this state of indolence. For example, when we were in high school, we got a varsity letter for being a "Mathlete." Take that in for a moment. That's right, we were on the Math team. The true jocks snickered. But it was not entirely funny to them. They thought we pencil-necked geeks were devaluing their football and track letters. They were probably right. They were also - let's be honest about this - thoroughly repulsed by the more academic types.
Let's say two things about that (now that we have the big megaphone of the blog and now that those mesomorphs can no longer menace us at our locker):
(1) Who has the last laugh now? When she was in high school, we used to tell the Drug and Device Law Daughter that she should befriend the wonks because some day they might flower into a Bill Gates or Marc Zuckerberg. Did she listen? She did not. And what do you suppose will happen to the hockey player and Goth who captured her young heart? The closest they will come to Microsoft or Facebook will be inputting customer data at a bad retail job or posting a bong as their profile picture. Now she is in college and dating an engineering student. Maybe there's hope. Maybe some day money will flow toward us, not away from us. Maybe we won't have to eat cat food in our dotage. Maybe we should veer away from this digression.
(2) That repulsion went both ways. The wrestlers went around on match days incessantly spitting into a cup (kind of like a Texas plaintiff lawyer during a deposition). One guy in our class got into bodybuilding quite early. The movie Pumping Iron came out around this time. It was Arnold Schwarzenegger's break-through. Schwarzenegger was remarkable for more than his trolley-car sized biceps. He was also inordinately clever at getting into his competitors' heads. He would give them "the wrong advices" (a preview of Schwarzenegger's charming battles with the English language) whilst crushing their egos. Our classmate emulated Schwarzenegger by carrying a can of protein powder around and occasionally disrobing in class to display his "guns" and "pythons". He is now a self-help maven on the Internet and claims he can uncover your past lives and make them "work for you". Perhaps he takes control over those past lives the same way he took control over things back in 1977: with threats and headlocks.
One might have thought that after four years of a fine liberal arts education and then three years of that hazing ritual known as law school, that we would cease to have very much to do with the bodybuilding cult. One would be wrong. We spent a year on a case defending a nutraceutical company accused of making a bad product and phony claims. These folks operate on a wholly different level from companies that manufacture prescription drugs or class III devices. The word "aggressive" does not begin to do them justice. One of our key company witnesses was a champion body-builder who had some sort of Ph.D. We can not remember what the Ph.D was for, but this guy clearly knew a few things. He had taken a hearty dislike of the plaintiff's lawyer. The night before he was to be deposed, he downed a concoction of herbs and other goodies that would render his breath toxic and his gastrointestinal system explosive. It worked. The deposition was extremely unpleasant for the plaintiff lawyer. (As it was for everyone there except, perhaps, the witness.) The deposition did not last very long.
As we said, nutraceuticals are different from pharmaceuticals. But they are both regulated by the FDA. And therein lies the tale of today's case, Cytosport, Inc. v. Vital Pharmaceuticals, Inc., 2012 U.S. Dist. LEXIS 126976 (E.D. Cal. Sept. 6, 2012). Cytosport makes Muscle Milk, a ready-to-drink protein shake in an octagonal bottle. Vital Pharmaceuticals makes Muscle Power, a ready-to-drink protein shake in an octagonal bottle. Cytosport sued Vital under the Lanham Act, claiming that the Muscle Power product infringed on its trademark and trade dress for Muscle Milk. Vital counterclaimed, arguing that the Muscle Milk trademark was invalid and deceptive because Muscle Milk contains not a drop of milk. Thus, this is a case concerning intellectual property. Linger on the richness of that. Much of the back-and-forth in the case involves competing surveys, with competing experts opining as to whether consumers were confused. You don't want our opinion on that, do you?
Anyway, you ask, what does any of this have to do with drug and device law? First, we don't like your tone of impatience one little bit. This sort of 'roid rage does not become you. Frankly, you're scaring us. Second, relax. The Cytosport case is fun. No heavy lifting required. Vital's counterclaim cited a warning letter sent from the FDA to Cytosport taking issue with the use of the word "Milk." According to Vital, the FDA warning letter should prompt the court to find the "Muscle Milk" trademark to be deceptive and, hence, invalid under 15 U.S.C. section 1125(a). If all this sounds vaguely reminiscent of Pom Wonderful, LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012), it should. The Cytosport court leaned heavily on the Pom Wonderful case, which it characterized as follows: "When the FDA extensively regulates a certain area and does not act to enforce its regulations, the Lanham Act may not be used by a private party to 'usurp, preempt, or undermine FDA authority.'" Cytosport, 2012 U.S. Dist., LEXIS 126976 at *17, quoting Pom Wonderful, 679 F.3d at 1176. Which way does Pom Wonderful cut in this Muscle contest? The Cytosport court says that Pom is not wonderful news for the Vital counterclaim, because "the FDA regulates the use of the term 'milk' on food labels. The FDA is aware of Cytosport's labeling and has not acted." Id.
But wait a minute, what about the FDA warning latter? And here, we encounter the same point that we blogged about yesterday. A warning letter is not a final action. It does not mean anything until it culminates in some final action by the FDA. A warning letter is an invitation to dialogue and compliance. It is almost like that semi-surprising notion in first-year Contracts class about how an advertisement is not in itself an offer, but merely an invitation to the customer to make an offer. Here is how the Cytosport court dealt with the FDA warning letter: "The fact that the FDA sent a warning letter to Cytosport concerning its labeling does not require a different finding. FDA warning letters are informal and advisory, and do not amount to an FDA action." Id. Vital then offered a back-up position: "the Court should defer granting judgment until the FDA issues a final decision on Cytosport's use of 'Muscle Milk.'" Id. at *18. Nice try. The Cytosport refused to defer. The FDA's final decision might end up supporting Cytosport, supporting Vital, or falling somewhere in between. But "the Pom holding is clear that the claims are barred until the FDA issues its decision, not that they are stayed or deferred." Id.
That is the part of the case that matters to us. Once again, private causes of action cannot muscle in on the FDA's turf. That is good news for all of us high-minded defense hacks. We put the "clean" in the clean-and-jerk. (Guess who puts in the other part.) Further, an FDA warning is tentative, incomplete, and - ta da - meaningless. More good news. Where it counts, the Cytosport opinion is a strong one for us. Use it. Hold it up. Flex with it. Feel the burn.
There are other bits that do not matter as much to us or that we don't understand. For example, Vital also brought "two state law claims which reference the FDA regulations to show that Cytosport's use of the term 'Milk' is inconsistent with FDA regulations." Id. The court holds that these state law claims "are not barred by the ruling in Pom because the FDA specifically permits states to create labeling requirements that are identical to the FDA's and establish independent causes of action for those claims." Id. Sounds like more "parallel claim" Hell to our ears. Also, the court upholds Muscle Power's advertising assertion that it has "600% less sugar and 187% less fat than Muscle Milk." Id. at *37. We agree with Cytosport that there is something mathematically nonsensical about saying that something has "600%" less of something.
Once a mathlete, always a mathlete.
Let's say two things about that (now that we have the big megaphone of the blog and now that those mesomorphs can no longer menace us at our locker):
(1) Who has the last laugh now? When she was in high school, we used to tell the Drug and Device Law Daughter that she should befriend the wonks because some day they might flower into a Bill Gates or Marc Zuckerberg. Did she listen? She did not. And what do you suppose will happen to the hockey player and Goth who captured her young heart? The closest they will come to Microsoft or Facebook will be inputting customer data at a bad retail job or posting a bong as their profile picture. Now she is in college and dating an engineering student. Maybe there's hope. Maybe some day money will flow toward us, not away from us. Maybe we won't have to eat cat food in our dotage. Maybe we should veer away from this digression.
(2) That repulsion went both ways. The wrestlers went around on match days incessantly spitting into a cup (kind of like a Texas plaintiff lawyer during a deposition). One guy in our class got into bodybuilding quite early. The movie Pumping Iron came out around this time. It was Arnold Schwarzenegger's break-through. Schwarzenegger was remarkable for more than his trolley-car sized biceps. He was also inordinately clever at getting into his competitors' heads. He would give them "the wrong advices" (a preview of Schwarzenegger's charming battles with the English language) whilst crushing their egos. Our classmate emulated Schwarzenegger by carrying a can of protein powder around and occasionally disrobing in class to display his "guns" and "pythons". He is now a self-help maven on the Internet and claims he can uncover your past lives and make them "work for you". Perhaps he takes control over those past lives the same way he took control over things back in 1977: with threats and headlocks.
One might have thought that after four years of a fine liberal arts education and then three years of that hazing ritual known as law school, that we would cease to have very much to do with the bodybuilding cult. One would be wrong. We spent a year on a case defending a nutraceutical company accused of making a bad product and phony claims. These folks operate on a wholly different level from companies that manufacture prescription drugs or class III devices. The word "aggressive" does not begin to do them justice. One of our key company witnesses was a champion body-builder who had some sort of Ph.D. We can not remember what the Ph.D was for, but this guy clearly knew a few things. He had taken a hearty dislike of the plaintiff's lawyer. The night before he was to be deposed, he downed a concoction of herbs and other goodies that would render his breath toxic and his gastrointestinal system explosive. It worked. The deposition was extremely unpleasant for the plaintiff lawyer. (As it was for everyone there except, perhaps, the witness.) The deposition did not last very long.
As we said, nutraceuticals are different from pharmaceuticals. But they are both regulated by the FDA. And therein lies the tale of today's case, Cytosport, Inc. v. Vital Pharmaceuticals, Inc., 2012 U.S. Dist. LEXIS 126976 (E.D. Cal. Sept. 6, 2012). Cytosport makes Muscle Milk, a ready-to-drink protein shake in an octagonal bottle. Vital Pharmaceuticals makes Muscle Power, a ready-to-drink protein shake in an octagonal bottle. Cytosport sued Vital under the Lanham Act, claiming that the Muscle Power product infringed on its trademark and trade dress for Muscle Milk. Vital counterclaimed, arguing that the Muscle Milk trademark was invalid and deceptive because Muscle Milk contains not a drop of milk. Thus, this is a case concerning intellectual property. Linger on the richness of that. Much of the back-and-forth in the case involves competing surveys, with competing experts opining as to whether consumers were confused. You don't want our opinion on that, do you?
Anyway, you ask, what does any of this have to do with drug and device law? First, we don't like your tone of impatience one little bit. This sort of 'roid rage does not become you. Frankly, you're scaring us. Second, relax. The Cytosport case is fun. No heavy lifting required. Vital's counterclaim cited a warning letter sent from the FDA to Cytosport taking issue with the use of the word "Milk." According to Vital, the FDA warning letter should prompt the court to find the "Muscle Milk" trademark to be deceptive and, hence, invalid under 15 U.S.C. section 1125(a). If all this sounds vaguely reminiscent of Pom Wonderful, LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012), it should. The Cytosport court leaned heavily on the Pom Wonderful case, which it characterized as follows: "When the FDA extensively regulates a certain area and does not act to enforce its regulations, the Lanham Act may not be used by a private party to 'usurp, preempt, or undermine FDA authority.'" Cytosport, 2012 U.S. Dist., LEXIS 126976 at *17, quoting Pom Wonderful, 679 F.3d at 1176. Which way does Pom Wonderful cut in this Muscle contest? The Cytosport court says that Pom is not wonderful news for the Vital counterclaim, because "the FDA regulates the use of the term 'milk' on food labels. The FDA is aware of Cytosport's labeling and has not acted." Id.
But wait a minute, what about the FDA warning latter? And here, we encounter the same point that we blogged about yesterday. A warning letter is not a final action. It does not mean anything until it culminates in some final action by the FDA. A warning letter is an invitation to dialogue and compliance. It is almost like that semi-surprising notion in first-year Contracts class about how an advertisement is not in itself an offer, but merely an invitation to the customer to make an offer. Here is how the Cytosport court dealt with the FDA warning letter: "The fact that the FDA sent a warning letter to Cytosport concerning its labeling does not require a different finding. FDA warning letters are informal and advisory, and do not amount to an FDA action." Id. Vital then offered a back-up position: "the Court should defer granting judgment until the FDA issues a final decision on Cytosport's use of 'Muscle Milk.'" Id. at *18. Nice try. The Cytosport refused to defer. The FDA's final decision might end up supporting Cytosport, supporting Vital, or falling somewhere in between. But "the Pom holding is clear that the claims are barred until the FDA issues its decision, not that they are stayed or deferred." Id.
That is the part of the case that matters to us. Once again, private causes of action cannot muscle in on the FDA's turf. That is good news for all of us high-minded defense hacks. We put the "clean" in the clean-and-jerk. (Guess who puts in the other part.) Further, an FDA warning is tentative, incomplete, and - ta da - meaningless. More good news. Where it counts, the Cytosport opinion is a strong one for us. Use it. Hold it up. Flex with it. Feel the burn.
There are other bits that do not matter as much to us or that we don't understand. For example, Vital also brought "two state law claims which reference the FDA regulations to show that Cytosport's use of the term 'Milk' is inconsistent with FDA regulations." Id. The court holds that these state law claims "are not barred by the ruling in Pom because the FDA specifically permits states to create labeling requirements that are identical to the FDA's and establish independent causes of action for those claims." Id. Sounds like more "parallel claim" Hell to our ears. Also, the court upholds Muscle Power's advertising assertion that it has "600% less sugar and 187% less fat than Muscle Milk." Id. at *37. We agree with Cytosport that there is something mathematically nonsensical about saying that something has "600%" less of something.
Once a mathlete, always a mathlete.
Basile v. H&R Block - It's Finally Over (and That's a Good Thing)
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Today's guest post is by Jim Sargent, of Lamb McErlane, who was one of the winning attorneys in the Basile v. H&R Block decision his post discusses. Way to go Jim (and everybody else on the team)! Bexis and Jim go back a ways, since Bexis wrote PLAC amicus briefs in the Samuel-Bassett case that Jim mentions in this post. As always, the guest blogger gets all the credit/shoulders all the blame for his post (unless the links don't work - that would be Bexis' fault).
Basile, although not a drug/device opinion, is an important class certification decision in Pennsylvania.
*******************
The Pennsylvania Supreme Court’s most recent decision on class actions is in Basile v. H&R Block, Inc., ___ A.3d ___, 2012 WL 3871504, slip op. (Pa. Sept. 7, 2012) ("Basile III"). Basile was a putative class action commenced way back in 1993, claiming that the defendant breached a fiduciary duty to its customers by not sufficiently disclosing that its “rapid refunds” of federal taxes actually were high interest consumer loans. Plaintiffs claimed that the defendant was a "fiduciary" as a way of avoiding reliance and individualized issues that prevent certification of this sort of claim.
The class was certified in 1997 by the late Judge Bernard Avellino, based on a “presumption” that an agency relationship existed between the defendant and some 600,000 customers. Over the next 15 years there then ensued 9 separate appeals – the case was before the Superior Court 5 (twice before the court en banc) times and the Supreme Court 4 times – which well may make it the longest appellate record in Pennsylvania history.
On the first appeal, the Supreme Court rejected the notion that any agency relationship supported Plaintiffs’ claim that a fiduciary duty existed between the defendant and the class. Basile v. H & R Block, Inc., 761 A. 2d 1115 (Pa. 2000) ("Basile I"). In its September 7, 2012 opinion the Court reiterated that it meant what it said the first time, rejecting the contention that a “confidential relationship” (the “fiduciary” claim under another name) existed, thus knocking out the remaining foundation for Plaintiffs’ claim.
In the course of the 19 year history in Basile, the Supreme Court clarified the law of agency, Basile I, supra, 761 A. 2d 1115, the aggrieved party doctrine (after some Superior Court funny business with appellate issues), Basile v. H & R Block, Inc., 973 A. 2d 417 (Pa. 2009) ("Basile II"), and now, in this latest opinion, the “confidential relationship” doctrine.
Probably most important in the long term, though, is what the Court had to say about the principles governing class certification. .
Its September 7 Basile III opinion reversed the Superior Court and affirmed the trial court decertification order. Think about what the Superior Court had done. It had held that that this class had to be certified; that decertification was an abuse of discretion. Writing in a 6-0 decision (Justice Orie-Melvin attended argument but is now suspended from the Court), Justice Saylor disposed of some eighty-year-old dictum, and held that a “confidential relationship” sufficient to give rise to a fiduciary duty is “‘intensely fact-specific,’” 2012 WL 3871504, at *7-8, and not suited to class-certification. The Court therefore held that the class was properly decertified.
Justice Saylor’s rulings on class action procedure and his reflections generally on the class action mechanism bear taking specific note. Speaking for a unanimous court, he rejected the Superior Court’s attempt to flip the burden of proof on class certification. Evidence sufficient to defeat summary judgment (where all inferences benefit the plaintiff), does not create grounds for certification of a class (where the plaintiff bears the burden). To support class certification facts must be “properly determined . . . not assumed.” 2012 WL 3871504, at *6. “[D]eferring close consideration of class certification to the time when facts are determined by a jury at trial (namely, in connection with the verdict) is incompatible with the governing procedural rules.” Id.
Towards the end − after once describing class actions as “collectivized treatment,” id. at *6 − the opinion returns to this theme, stating: “We are cognizant of the tendency toward sanctioning the use of class actions as a convenience to address colorably meritorious claims in an aggregate fashion, where these might not otherwise be capable of being redressed practically on an individual basis.” Id. at *8. However, the Court rejected this temptation, holding that the approach to class treatment reflected in Pennsylvania’s class action rules “stems from limitations inherent in the judicial rulemaking process, the impact of collectivized treatment of individual claims on defendants’ substantive rights,” and “the limited policymaking role of the courts (as compared with the legislative branch) in terms of manipulating substantive law.” Id.
[Editor's note: On this blog, we refer to the "tendency" that Court rejected in Basile III "judicial triumphalism."]
The Court’s rejection of Plaintiffs’ invitation to fashion a judicial solution to a legislative problem should be applauded. In contrast, 9 months earlier in Samuel-Bassett v. Kia Motors America, Inc., 34 A.3d 1 (Pa. 2011), the same Court approved certification of a class of automobile owners on claims of out-of-pocket expense for brake repairs under an express warranty, where there was no proof that each class member had sustained any (let alone similar) repair expenses. The Court stated: “…a certification proceeding is a preliminary inquiry whose purpose is to establish who the parties to the class action are ‘and nothing more.’” 34 A.3d at 21-22 (quoting Pa. R.C.P. No. 1707 cmt). That plaintiff was not required to prove anything about the defendant’s liability at the certification stage and the trial court was prohibited from factoring the perceived adequacy of the “underlying merits of the class’s claims into the certification decision.” Id. at 22. The Court continued: “By the same token, pre-trial class certification proceedings do not require a mini-trial; the class is not obligated to establish liability during the class certification phase.” Id. (citations omitted). The Court then discounted the importance of individual proof of out-of-pocket costs for each class member: “As our previous analysis shows, [plaintiff] and the class adduced sufficient evidence during certification proceedings to show a common source of liability. Any question regarding individual expenditures resulting from varying attempts to repair the defect was not a ground to reject the commonality found on other issues, to defeat the predominance of common issues and, ultimately, to deny certification of the class at the preliminary stages of trial.” Id. at 28.
But less than a year later, the Court is rejecting, unanimously, “assumed facts” and requiring “close consideration of class certification”in the name of “limitations inherent in the judicial rulemaking process” and “the limited policymaking role of the courts” in Basile III.
There is no easy explanation for the differences between Samuel-Bassett and Basile III. It may be significant that Samuel-Bassett languished with the Court for 3 1/2 years after argument (during which time Basile II author Justice Greenspan left the bench), whereas Basile III was decided with lightening speed for the Court (4 months from May 8 argument to September 7 decision).
Some will always say, most particularly Plaintiff's counsel in Samuel-Bassett, that the two decisions can be distinguished purely on the grounds of "waiver," since the Samuel-Bassett Court concluded that defense trial counsel had waived objection to the molded verdict after trial. But Justice Saylor’s strong dissent in Samuel-Bassett argued that there was no waiver and that Samuel-Bassett would not be cited as a waiver case in the future. 34 A.3d at 64. Moreover, "waiver" usually gives appellate judges a quick exit, and yet Chief Justice Castille wrote an 80-page opinion in Samuel-Bassett that labored hard to justify the result, which certainly didn't conserve judicial resources, and is not convincing.
Others will say that the two decisions can't be reconciled. After all, Justice Saylor, who vehemently dissented in Samuel-Bassett, wrote for the unanimous court in Basile III. They will say there are now two alternative sets of policies in Pennsylvania: the "class actions are favored" rationale and acceptance of collectivized proof in Samuel-Bassett and the proscription against using procedural vehicles to change substantive law in Basile III – the second of which appears to line up better with the evolving federal standards articulated in Hydrogen Peroxide and Dukes.
It may be that, Justice Saylor, who is next in line to be Chief, will usher in a new era. Or perhaps the Court is slowly awakening to the misuse of the class action mechanism in circumstances where the effect is to relieve plaintiffs of the burden of proving all elements of their claims. Philadelphia has earned a reputation nationally for favoring plaintiffs in class actions that might not fly in other jurisdictions. See The City of Unbrotherly Torts, Wall St. J., Dec. 3, 2011 (noting that Philadelphia state court is a “destination of choice” for plaintiff classes due to fewer settlements and higher verdicts); see also Am. Tort Reform Found., Judicial Hellholes 2011-2012, at 3–8 (2011) (listing Philadelphia as the number one “judicial hellhole”); id. at 2 (“Judicial Hellholes have been considered places where judges systematically apply laws and court procedures in an unfair and unbalanced manner.”) (emphasis omitted); id. at 3 (“Of greatest concern is the Complex Litigation Center (CLC) in Philadelphia, where judges have actively sought to attract personal injury lawyers from across the state and the country.”). In Daniel v. Wyeth, Nos. 63-64 EDA 2011, before the Supreme Court from the decision of a panel of the Superior Court overturning the trial court's JNOV on punitive damages, Justice Castille was reported to have remarked that sustaining the award would result in Pennsylvania being labeled a "judicial hellhole." Legal Intelligencer, 9/12/12. Perhaps the Court finally has gotten the message.
Basile, although not a drug/device opinion, is an important class certification decision in Pennsylvania.
*******************
The Pennsylvania Supreme Court’s most recent decision on class actions is in Basile v. H&R Block, Inc., ___ A.3d ___, 2012 WL 3871504, slip op. (Pa. Sept. 7, 2012) ("Basile III"). Basile was a putative class action commenced way back in 1993, claiming that the defendant breached a fiduciary duty to its customers by not sufficiently disclosing that its “rapid refunds” of federal taxes actually were high interest consumer loans. Plaintiffs claimed that the defendant was a "fiduciary" as a way of avoiding reliance and individualized issues that prevent certification of this sort of claim.
The class was certified in 1997 by the late Judge Bernard Avellino, based on a “presumption” that an agency relationship existed between the defendant and some 600,000 customers. Over the next 15 years there then ensued 9 separate appeals – the case was before the Superior Court 5 (twice before the court en banc) times and the Supreme Court 4 times – which well may make it the longest appellate record in Pennsylvania history.
On the first appeal, the Supreme Court rejected the notion that any agency relationship supported Plaintiffs’ claim that a fiduciary duty existed between the defendant and the class. Basile v. H & R Block, Inc., 761 A. 2d 1115 (Pa. 2000) ("Basile I"). In its September 7, 2012 opinion the Court reiterated that it meant what it said the first time, rejecting the contention that a “confidential relationship” (the “fiduciary” claim under another name) existed, thus knocking out the remaining foundation for Plaintiffs’ claim.
In the course of the 19 year history in Basile, the Supreme Court clarified the law of agency, Basile I, supra, 761 A. 2d 1115, the aggrieved party doctrine (after some Superior Court funny business with appellate issues), Basile v. H & R Block, Inc., 973 A. 2d 417 (Pa. 2009) ("Basile II"), and now, in this latest opinion, the “confidential relationship” doctrine.
Probably most important in the long term, though, is what the Court had to say about the principles governing class certification. .
Its September 7 Basile III opinion reversed the Superior Court and affirmed the trial court decertification order. Think about what the Superior Court had done. It had held that that this class had to be certified; that decertification was an abuse of discretion. Writing in a 6-0 decision (Justice Orie-Melvin attended argument but is now suspended from the Court), Justice Saylor disposed of some eighty-year-old dictum, and held that a “confidential relationship” sufficient to give rise to a fiduciary duty is “‘intensely fact-specific,’” 2012 WL 3871504, at *7-8, and not suited to class-certification. The Court therefore held that the class was properly decertified.
Justice Saylor’s rulings on class action procedure and his reflections generally on the class action mechanism bear taking specific note. Speaking for a unanimous court, he rejected the Superior Court’s attempt to flip the burden of proof on class certification. Evidence sufficient to defeat summary judgment (where all inferences benefit the plaintiff), does not create grounds for certification of a class (where the plaintiff bears the burden). To support class certification facts must be “properly determined . . . not assumed.” 2012 WL 3871504, at *6. “[D]eferring close consideration of class certification to the time when facts are determined by a jury at trial (namely, in connection with the verdict) is incompatible with the governing procedural rules.” Id.
Towards the end − after once describing class actions as “collectivized treatment,” id. at *6 − the opinion returns to this theme, stating: “We are cognizant of the tendency toward sanctioning the use of class actions as a convenience to address colorably meritorious claims in an aggregate fashion, where these might not otherwise be capable of being redressed practically on an individual basis.” Id. at *8. However, the Court rejected this temptation, holding that the approach to class treatment reflected in Pennsylvania’s class action rules “stems from limitations inherent in the judicial rulemaking process, the impact of collectivized treatment of individual claims on defendants’ substantive rights,” and “the limited policymaking role of the courts (as compared with the legislative branch) in terms of manipulating substantive law.” Id.
[Editor's note: On this blog, we refer to the "tendency" that Court rejected in Basile III "judicial triumphalism."]
The Court’s rejection of Plaintiffs’ invitation to fashion a judicial solution to a legislative problem should be applauded. In contrast, 9 months earlier in Samuel-Bassett v. Kia Motors America, Inc., 34 A.3d 1 (Pa. 2011), the same Court approved certification of a class of automobile owners on claims of out-of-pocket expense for brake repairs under an express warranty, where there was no proof that each class member had sustained any (let alone similar) repair expenses. The Court stated: “…a certification proceeding is a preliminary inquiry whose purpose is to establish who the parties to the class action are ‘and nothing more.’” 34 A.3d at 21-22 (quoting Pa. R.C.P. No. 1707 cmt). That plaintiff was not required to prove anything about the defendant’s liability at the certification stage and the trial court was prohibited from factoring the perceived adequacy of the “underlying merits of the class’s claims into the certification decision.” Id. at 22. The Court continued: “By the same token, pre-trial class certification proceedings do not require a mini-trial; the class is not obligated to establish liability during the class certification phase.” Id. (citations omitted). The Court then discounted the importance of individual proof of out-of-pocket costs for each class member: “As our previous analysis shows, [plaintiff] and the class adduced sufficient evidence during certification proceedings to show a common source of liability. Any question regarding individual expenditures resulting from varying attempts to repair the defect was not a ground to reject the commonality found on other issues, to defeat the predominance of common issues and, ultimately, to deny certification of the class at the preliminary stages of trial.” Id. at 28.
But less than a year later, the Court is rejecting, unanimously, “assumed facts” and requiring “close consideration of class certification”in the name of “limitations inherent in the judicial rulemaking process” and “the limited policymaking role of the courts” in Basile III.
There is no easy explanation for the differences between Samuel-Bassett and Basile III. It may be significant that Samuel-Bassett languished with the Court for 3 1/2 years after argument (during which time Basile II author Justice Greenspan left the bench), whereas Basile III was decided with lightening speed for the Court (4 months from May 8 argument to September 7 decision).
Some will always say, most particularly Plaintiff's counsel in Samuel-Bassett, that the two decisions can be distinguished purely on the grounds of "waiver," since the Samuel-Bassett Court concluded that defense trial counsel had waived objection to the molded verdict after trial. But Justice Saylor’s strong dissent in Samuel-Bassett argued that there was no waiver and that Samuel-Bassett would not be cited as a waiver case in the future. 34 A.3d at 64. Moreover, "waiver" usually gives appellate judges a quick exit, and yet Chief Justice Castille wrote an 80-page opinion in Samuel-Bassett that labored hard to justify the result, which certainly didn't conserve judicial resources, and is not convincing.
Others will say that the two decisions can't be reconciled. After all, Justice Saylor, who vehemently dissented in Samuel-Bassett, wrote for the unanimous court in Basile III. They will say there are now two alternative sets of policies in Pennsylvania: the "class actions are favored" rationale and acceptance of collectivized proof in Samuel-Bassett and the proscription against using procedural vehicles to change substantive law in Basile III – the second of which appears to line up better with the evolving federal standards articulated in Hydrogen Peroxide and Dukes.
It may be that, Justice Saylor, who is next in line to be Chief, will usher in a new era. Or perhaps the Court is slowly awakening to the misuse of the class action mechanism in circumstances where the effect is to relieve plaintiffs of the burden of proving all elements of their claims. Philadelphia has earned a reputation nationally for favoring plaintiffs in class actions that might not fly in other jurisdictions. See The City of Unbrotherly Torts, Wall St. J., Dec. 3, 2011 (noting that Philadelphia state court is a “destination of choice” for plaintiff classes due to fewer settlements and higher verdicts); see also Am. Tort Reform Found., Judicial Hellholes 2011-2012, at 3–8 (2011) (listing Philadelphia as the number one “judicial hellhole”); id. at 2 (“Judicial Hellholes have been considered places where judges systematically apply laws and court procedures in an unfair and unbalanced manner.”) (emphasis omitted); id. at 3 (“Of greatest concern is the Complex Litigation Center (CLC) in Philadelphia, where judges have actively sought to attract personal injury lawyers from across the state and the country.”). In Daniel v. Wyeth, Nos. 63-64 EDA 2011, before the Supreme Court from the decision of a panel of the Superior Court overturning the trial court's JNOV on punitive damages, Justice Castille was reported to have remarked that sustaining the award would result in Pennsylvania being labeled a "judicial hellhole." Legal Intelligencer, 9/12/12. Perhaps the Court finally has gotten the message.
New Jersey OTC Preemption Decision
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We don’t spend much time on this blog on over-the-counter (“OTC”) drugs, but when OTC crosses paths with preemption in our own backyard, we can’t help but be interested. And as this case also had a few other interesting bits, we thought we’d share it. The case is Crozier v. Johnson & Johnson Consumer Cos., Inc., 2012 U.S. Dist. LEXIS 140320 (D.N.J. Sep. 28, 2012). The product at issue is one of many in J&J’s Neosporin brand line. Neosporin is well known as a topical antibiotic cream, but in fact there are many products in the line, including “Neosporin NEO TO GO! first aid antiseptic/pain relieving spray.” Note the difference in our description of the cream and the spray. The former contains an antibiotic, the latter an antiseptic. Plaintiff claims this is confusing. Specifically, plaintiff alleges that J&J’s labeling and marketing of the antiseptic spray under the Neosporin brand misleads consumers to believe that the spray contains antibiotics. Id. at *3-5. So plaintiff in Crozier (and its companion case McNamee v. J&J), brought a putative class action against J&J alleging violations of the New Jersey Consumer Fraud Act and breach of implied warranty. J&J moved to dismiss. First, we recommend the court’s nice discussion of the Twiqbal standard for motions to dismiss which includes a rejection of plaintiff’s attempts to rely on either pre-Twiqbal law (“Plaintiffs seem unaware that pleading standards in federal court have changed in the past five years”), id. at *11, or state law (“The Federal Rules of Civil Procedure govern the procedure in all civil actions and proceedings in the United States district courts.”). Id. at *12. Although, it ends with an equally well-stated justification for allowing plaintiffs in diversity cases an opportunity to amend when their complaints don’t come up to Twiqbal snuff. If the case was, as Crozier was, originally filed in a state court with more liberal pleading standards “it is important for the Court to exercise its discretion in favor of permitting Plaintiffs to attempt an amended pleading” that meets the “enhanced” federal standard. Id. at *13. We are long familiar with second bites at the apple and also well aware that they often fail to satisfy as well. So, while we prefer a dismissal with prejudice, we’ll take what we can get.Next, in response to the motion to dismiss, plaintiff cited, referenced, and quote materials obtained in discovery in other proceedings and described television ads she alleged supported her claims. But, as the court reminds, this is a motion to dismiss:
To the extent that Plaintiffs reference exhibits in their Opposition to establish facts beyond those pled in the Complaint, the Court must disregard them. Plaintiffs cannot add factual allegations in Opposition; the mechanism for curing pleading deficiencies is to file an amended complaint . . . It is axiomatic that the complaint may not be amended by the briefs in opposition to a motion to dismiss.Id. at *16. Then the court turned to the substance and rather quickly ruled that plaintiff’s labeling-based claims were expressly preempted. 21 U.S.C. §379r provides that express preemption for OTC drugs:
Except as provided in subsection . . . (e) . . . of this section, no State or political subdivision of a State may establish or continue in effect any requirement – that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title [that means an OTC drug]; and that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter . . . .21 U.S.C. §379r(a). For a more fulsome discussion of OTC preemption (and the exception thereto) see our post here. So New Jersey becomes yet another state to recognize OTC preemption:
Federal regulations . . . specify the required content on over-the-counter medication labels and, with 21 U.S.C. § 379r, Congress preempted state law claims regarding such labels. Any of Plaintiffs' claims that pertain to the spray's label are preempted.Id. at *24-25. Plaintiff tried to argue that preemption didn’t apply because she wasn’t alleging that the product’s label was inaccurate but rather that it was misleading – that consumers would be confused by the antiseptic spray carrying the Neosporin brand name. The court didn’t see the distinction:
FDA regulations cover the entire label, including indications of a product’s brand name, and thus preempt challenges to a label, even if the challenge is not based on inaccuracy or incompleteness. . . . . [Since] the FDA specifically considered brand name confusion in drafting its regulations; Plaintiffs' present claims pertaining to the spray's label are preempted.Id. at *26-27. The court, however, was unwilling to extend its preemption decision to all of plaintiff’s marketing claims. While the court agreed that “claims based upon FDA-approved statements in product labeling and advertising are preempted,” id. at *29 (emphasis added; citing Carter v. Novartis Consumer Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008)), it turned to Rule 9(b) to dismiss plaintiff’s consumer fraud claims. And as we’ve seen time and time again, plaintiff failed to plead any, let alone sufficient, facts to establish causation:
The Complaint[] contains no information about when Plaintiffs saw J&J's advertising, when or where they bought the spray, why they bought the spray, whether they bought the spray because they thought it contained antibiotics, or whether Plaintiffs even noticed the Signature Gold Mark and trade dress. In short, [the] Complaint [does not] allege[] with particularity the gravamen of Plaintiffs' claims, i.e., that Plaintiffs bought the spray specifically because its advertising contained the Neosporin trade dress and signature gold mark, thus leading them to believe that the product contained antibiotics. Plaintiffs' failure to plead that they were misled is fatal, particularly given the specificity that Rule 9(b) requires for NJCFA claims.Id. at *32-33. But, as we indicated earlier, the court was inclined to let the plaintiff try it again – at least as to consumer fraud claims based on marketing activities. The court tossed out plaintiff’s breach of warranty claims due to no allegation of a product defect. Id. at *39-40. Those claims are gone and aren’t coming back. Not a complete victory, but plaintiff has her work cut out for her.
Aredia-Zometa Daubert Doubleheader
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It is never a slow news day as long as Aredia-Zometa litigation is going on somewhere and as long as Joe Hollingsworth is kind enough to update us. Last week, Novartis prevailed on a Daubert motion and consequently got out on summary judgment in Luttrell v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 142816 (E.D. Wash. Oct. 2, 2012). The Luttrell case had been part of the ongoing Aredia and Zometa Multi-District Litigation. In Luttrell, the plaintiff offered the usual Aredia-Zometa allegation - that he developed osteonecrosis of the jaw (“ONJ”) as a result of his use of Aredia and Zometa to prevent or significantly delay the deep bone pain, pathologic bone fractures, and spinal cord collapse that accompany multiple myeloma. Not so usual was the usage history. The plaintiff had taken a single dose of Zometa in June 2005 and eleven doses of Aredia by June 2006. The lawsuit was filed in March 2007. The plaintiff then restarted his Aredia therapy in May 2007. By the time of dispositive motions, the plaintiff had abandoned his manufacturing defect and express warranty claims and had not provided any substantive argument in favor of his implied warranty claim, leaving only his claims for strict liability and negligent failure to warn. The court found these causes of action collapsed by the Washington Products Liability Act into a failure to warn claim that requires the plaintiff to prove cause in fact and legal cause.
The court granted the defendant's Daubert motion against the plaintiff's case-specific causation expert, Dr. Richard Jackson. Dr. Jackson purported to apply a differential diagnosis to identify the plaintiff as having Bisphosphonate-Related ONJ (“BRONJ”). The court observed that Dr. Jackson’s BRONJ diagnosis was not equivalent to an opinion that Mr. Luttrell’s BRONJ was actually caused by bisphosphonate use, calling into close question the “fit” of Dr. Jackson’s expected testimony. More crucially, the court held that Dr. Jackson failed to provide any scientific basis for how he ruled out other potential causes of Mr. Luttrell’s alleged BRONJ: “Several bald assertions buried in the transcript of a deposition as to the ‘unique’ behavior of BRONJ as compared to other causes of ONJ or other contributing factors does not qualify Dr. Jackson’s testimony as sufficiently reliable under Daubert.” The plaintiff also designated five of his treating physicians as non-retained expert witnesses. The judge concluded that the plaintiff’s reliance on statements in medical records authored by these doctors was insufficient evidence that the doctors had admissible causation opinions, particularly where several of the doctors had testified to the contrary at deposition. Moreover, the judge found the doctors to lack sufficient expertise to prove causation. Because the plaintiff lacked evidence to establish that his alleged injury was caused by Aredia and Zometa, the court granted summary judgment.
The Luttrell court also granted summary judgment on an independent basis, the plaintiff’s inability to establish warning causation, i.e., that if adequately warned of the risk his physician would have “‘take[n] a different course of action.’” After acknowledging that “[t]he legal standard for the court to remove the issue of causation from the jury is extremely high,” the court found “compelling evidence” in the fact that Dr. Brady prescribed, and the plaintiff accepted, continued Aredia therapy shortly after the plaintiff filed suit against NPC – at which point “both Dr. Brady and Luttrell were aware of the possible dangers of bisphosphonates, but still decided to use the drug.” Yes, that is something that we in the defense biz would call a Pretty Good Fact For Us. “Restarting the drug after filing the lawsuit is powerful and conclusive evidence that is incapable of a difference of opinion by any reasonable trier of fact.”
Now we go from one corner of the country, the Pacific Northwest, to the opposite corner, the Northern District of Alabama. Just two days after Luttrell, the court in NASCAR and SEC territory granted the defendant's Daubert motion against another plaintiff specific causation expert in another Aredia-Zometa MDL case, Harvey v. Novartis Pharm. Corp., No. 2:06-cv-1140-VEH (N.D. Ala. Oct. 4, 2012). In Harvey, the plaintiff alleged that his mother developed ONJ as a result of her use of Zometa. The plaintiff sought to rely upon the testimony of Dr. Jason Miller, an oral surgeon, to prove that Ms. Harvey developed ONJ due to her use of Zometa. Dr. Miller was a non-retained expert. That is, Dr. Miller was a treating physician, not an expert specially hired for litigation purposes. We have been seeing the use of non-retained experts a lot lately from plaintiffs. (Luttrell, discussed above, is another example.) Why is that? Is it cheapness? Is it laziness? Or is it a perception that non-retained, treating experts are likely to appear more credible to juries?
Whatever enhanced credibility Dr. Miller might have had, it did not cut the Daubert mustard as far as the Harvey court was concerned. The court excluded Dr. Miller’s testimony for two reasons. First, although the court recognized that Dr. Miller was an experienced oral surgeon, the plaintiff did not establish that oral surgeons in general and Dr. Miller in particular are qualified to opine on the cause of ONJ. Nothing in Dr. Miller’s credentials qualified him to offer such an opinion. Further, Dr. Miller testified that determining the cause of Ms. Harvey’s osteonecrosis was irrelevant to him because it did not affect his treatment and that his opinion about the cause of Ms. Harvey’s osteonecrosis was an assumption.
The Harvey court noted that the Sixth Circuit’s ruling in Thomas v. Novartis Pharm. Corp., 443 F. App’x 58 (6th Cir. 2011), another Aredia-Zometa case where the defendant obtained summary judgment after prevailing on its Daubert motions, was “strongly persuasive.” In Thomas, the oral surgeon has extensive training but not in determining the cause of an individual’s ONJ. The same was true in Harvey. The court rejected the plaintiff’s reliance on other judicial decisions, including one in which a court seemed to admit causation testimony from an oral surgeon based in part upon “the sincerity of the surgeon’s belief.” As the Harvey court explained, “sincerity alone is not enough to qualify an expert under Rule 702.” Hard to believe it was only after practicing law for 26 years that we learned that sincerity is a much overrated virtue.
In addition to the plaintiff’s failure to demonstrate that Dr. Miller was qualified to opine on causation, the Harvey court excluded Dr. Miller’s testimony because he did not perform a proper differential diagnosis. Specifically, Dr. Miller never ruled out osteomyelitis as the cause of the osteonecrosis: “As far as the court is aware, Dr. Miller has never offered a reason—other than his assumption—for concluding that bisphosphonate drug use, instead of osteomyelitis, caused Harvey’s osteonecrosis.” Relying on Guinn v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1253 (11th Cir. 2010), the Harvey court found that this lack of a reasonable explanation rendered the differential diagnosis unreliable and hence inadmissible.
It is possible that some of the DDL bloggers were involved in the Guinn case. It is possible that some of the DDL bloggers are being just a wee bit self-aggrandizing in mentioning the Guinn case. It is possible that by admitting that fact, we are showing how sincere we are. But, as the Harvey case shows, sincerity does not make one an expert.
We offer our sincere congrats to Joe and his team on these nice Aredia-Zometa wins. We also offer Joe congrats (perhaps with more jealousy than sincerity) on the amazing success of the Washington Nationals, while our Phillies have put away their bats and gloves and are honing their skills on the golf course.
The court granted the defendant's Daubert motion against the plaintiff's case-specific causation expert, Dr. Richard Jackson. Dr. Jackson purported to apply a differential diagnosis to identify the plaintiff as having Bisphosphonate-Related ONJ (“BRONJ”). The court observed that Dr. Jackson’s BRONJ diagnosis was not equivalent to an opinion that Mr. Luttrell’s BRONJ was actually caused by bisphosphonate use, calling into close question the “fit” of Dr. Jackson’s expected testimony. More crucially, the court held that Dr. Jackson failed to provide any scientific basis for how he ruled out other potential causes of Mr. Luttrell’s alleged BRONJ: “Several bald assertions buried in the transcript of a deposition as to the ‘unique’ behavior of BRONJ as compared to other causes of ONJ or other contributing factors does not qualify Dr. Jackson’s testimony as sufficiently reliable under Daubert.” The plaintiff also designated five of his treating physicians as non-retained expert witnesses. The judge concluded that the plaintiff’s reliance on statements in medical records authored by these doctors was insufficient evidence that the doctors had admissible causation opinions, particularly where several of the doctors had testified to the contrary at deposition. Moreover, the judge found the doctors to lack sufficient expertise to prove causation. Because the plaintiff lacked evidence to establish that his alleged injury was caused by Aredia and Zometa, the court granted summary judgment.
The Luttrell court also granted summary judgment on an independent basis, the plaintiff’s inability to establish warning causation, i.e., that if adequately warned of the risk his physician would have “‘take[n] a different course of action.’” After acknowledging that “[t]he legal standard for the court to remove the issue of causation from the jury is extremely high,” the court found “compelling evidence” in the fact that Dr. Brady prescribed, and the plaintiff accepted, continued Aredia therapy shortly after the plaintiff filed suit against NPC – at which point “both Dr. Brady and Luttrell were aware of the possible dangers of bisphosphonates, but still decided to use the drug.” Yes, that is something that we in the defense biz would call a Pretty Good Fact For Us. “Restarting the drug after filing the lawsuit is powerful and conclusive evidence that is incapable of a difference of opinion by any reasonable trier of fact.”
Now we go from one corner of the country, the Pacific Northwest, to the opposite corner, the Northern District of Alabama. Just two days after Luttrell, the court in NASCAR and SEC territory granted the defendant's Daubert motion against another plaintiff specific causation expert in another Aredia-Zometa MDL case, Harvey v. Novartis Pharm. Corp., No. 2:06-cv-1140-VEH (N.D. Ala. Oct. 4, 2012). In Harvey, the plaintiff alleged that his mother developed ONJ as a result of her use of Zometa. The plaintiff sought to rely upon the testimony of Dr. Jason Miller, an oral surgeon, to prove that Ms. Harvey developed ONJ due to her use of Zometa. Dr. Miller was a non-retained expert. That is, Dr. Miller was a treating physician, not an expert specially hired for litigation purposes. We have been seeing the use of non-retained experts a lot lately from plaintiffs. (Luttrell, discussed above, is another example.) Why is that? Is it cheapness? Is it laziness? Or is it a perception that non-retained, treating experts are likely to appear more credible to juries?
Whatever enhanced credibility Dr. Miller might have had, it did not cut the Daubert mustard as far as the Harvey court was concerned. The court excluded Dr. Miller’s testimony for two reasons. First, although the court recognized that Dr. Miller was an experienced oral surgeon, the plaintiff did not establish that oral surgeons in general and Dr. Miller in particular are qualified to opine on the cause of ONJ. Nothing in Dr. Miller’s credentials qualified him to offer such an opinion. Further, Dr. Miller testified that determining the cause of Ms. Harvey’s osteonecrosis was irrelevant to him because it did not affect his treatment and that his opinion about the cause of Ms. Harvey’s osteonecrosis was an assumption.
The Harvey court noted that the Sixth Circuit’s ruling in Thomas v. Novartis Pharm. Corp., 443 F. App’x 58 (6th Cir. 2011), another Aredia-Zometa case where the defendant obtained summary judgment after prevailing on its Daubert motions, was “strongly persuasive.” In Thomas, the oral surgeon has extensive training but not in determining the cause of an individual’s ONJ. The same was true in Harvey. The court rejected the plaintiff’s reliance on other judicial decisions, including one in which a court seemed to admit causation testimony from an oral surgeon based in part upon “the sincerity of the surgeon’s belief.” As the Harvey court explained, “sincerity alone is not enough to qualify an expert under Rule 702.” Hard to believe it was only after practicing law for 26 years that we learned that sincerity is a much overrated virtue.
In addition to the plaintiff’s failure to demonstrate that Dr. Miller was qualified to opine on causation, the Harvey court excluded Dr. Miller’s testimony because he did not perform a proper differential diagnosis. Specifically, Dr. Miller never ruled out osteomyelitis as the cause of the osteonecrosis: “As far as the court is aware, Dr. Miller has never offered a reason—other than his assumption—for concluding that bisphosphonate drug use, instead of osteomyelitis, caused Harvey’s osteonecrosis.” Relying on Guinn v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1253 (11th Cir. 2010), the Harvey court found that this lack of a reasonable explanation rendered the differential diagnosis unreliable and hence inadmissible.
It is possible that some of the DDL bloggers were involved in the Guinn case. It is possible that some of the DDL bloggers are being just a wee bit self-aggrandizing in mentioning the Guinn case. It is possible that by admitting that fact, we are showing how sincere we are. But, as the Harvey case shows, sincerity does not make one an expert.
We offer our sincere congrats to Joe and his team on these nice Aredia-Zometa wins. We also offer Joe congrats (perhaps with more jealousy than sincerity) on the amazing success of the Washington Nationals, while our Phillies have put away their bats and gloves and are honing their skills on the golf course.
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