Monday, October 31, 2011

Generic Reasoning

Have you ever noticed how if you're thinking about something, you start noticing it everywhere? For example, if you are contemplating the purchase of a soul-crushing Scandinavian station wagon, you start seeing them every other block, right?

Lately, we've been thinking about generic pharmaceuticals and preemption. Naturally, we're confronting the issue all over the place. Maybe it's because courts are eagerly embracing Mensing and ridding their dockets of bogus cases. Or maybe plaintiff attorneys are getting creative (and desperate) in devising ways to escape the clutches of Mensing.

We remember seeing generics everywhere in the early 1980s. Most supermarkets had entire aisles filled with those plain white and blue-labeled generics: string beans, chili, corn flakes, orange juice, rutabagas, etc. The 1984 movie Repo Man had a running gag about the proliferation of generics. The characters read a newspaper called "Paper". Guys pick up a six-pack of "Drinks" from a convenience store. Emilio Estevez goes home to find his drug-addled parents planted in front of the television, too stoned to make dinner, but telling him there's food in the refrigerator. Sure enough, sitting on a shelf is a can of "Food".

In the pharmaceutical market, generics are big, big business. They are also now big, big litigation.

You might think that last week's decision in Hughes v Mylan, Inc., 2011 U.S. Dist. LEXIS 123544 (E.D. Pa. Oct. 25, 2011), is no big deal. It merely remands a case that had been removed on Mensing grounds. And the more we think about Hughes, the more we think it should be no big deal. It's the plaintiff lawyers who are trying to tease undue significance out of it.

The problem is that the Hughes opinion is - how do we say this? - far from pellucid.
There are multiple plaintiffs, whose cases were consolidated for the remand motion. Those plaintiffs sued Mylan in Pennsylvania state court, alleging injuries from fentanyl patches. We have the usual collection of claims, including negligence, strict liability, warranty, etc. The theories involve failure to warn and (significantly, as we shall see) design defect.

We said that the plaintiffs sued Mylan. In fact, they sued several Mylan entities, which were citizens of different states. One of those states was Pennsylvania. The presence of Pennsylvania Mylan would seem to block removal ... unless Pennsylvania Mylan was fraudulently joined.

While the plaintiffs' cases were pending, the U.S Supreme Court issued the Mensing decision, which held that failure to warn claims against generic manufacturers were preempted. Once the original deadline for removal has passed, a notice of removal can be filed within 30 days of receipt of "an amended pleading, motion, order or other paper" making the case removable. 28 USC section 1446(b). The Hughes court held that the Mensing decision does not constitute the type of "other paper" permitting removal. But the plaintiffs had amended their complaint to try to escape Mensing, and that amended complaint probably triggers 1446(b), so on to the removal analysis.

As alluded to above, the analysis in Hughes is a bit vague, but we know right away it isn't headed anyplace good. The first line in the opinion is: "A number of people died using Defendants' pain relief product and as a result Plaintiffs sued in the Philadelphia Court of Common Pleas". 2011 U.S. Dist. LEXIS 123544 at 9. Really? Nothing like assuming causation, right? Forgive us if we think that this sentence - which has nothing to do with any removal analysis - sounds like the opening line from a plaintiff's brief. Then we read about a million times in the opinion that there is a presumption in favor of remand. It's amazing how many times a presumption is invoked to supply a fig leaf for an ugly or unclear ruling.

The Hughes opinion also contains a number of snappy lines, though we're seldom sure what they mean:

"The flaw in the Mylan defendants' arguments is their assumption that somehow a 'landmark' Supreme Court ruling lessens the standard to prove fraudulent joinder." 2011 U.S. Dist LEXIS 123544 at 24. . Huh?


"[B]eing able to point to an 'amended pleading' which may serve as a basis for removal does not unlock the doors to the federal courthouse". Id. at 23. Well, it is Halloween, after all, so we guess we ought to be happy to see a straw man.


"The Mylan Defendants may ultimately win the war, but they are stuck fighting on the turf Plaintiffs selected." Id. at 24. As usual, war imagery offers more heat than light.


"Mensing merely provides a framework for the state court to adjudicate Plaintiffs' claim; it is not a hook that lands these cases in federal court." Id. at 27.

You get the idea. ... Or do you?

It seems clear that Mensing precludes the plaintiffs' failure to warn claims against Mylan. The Hughes court doesn't ever rule on that issue. It basically says, Tell it to the state court. All we get is, "Plaintiffs have stated a reasonable basis for their claims against Mylan. Thus, this court need not address the ultimate outcome of Plaintiffs' claims following Mensing because a state court is the proper forum for that issue." Id. at 27. We dare you to read the opinion and tell us what the "reasonable basis" is for the failure to warn claims, given that Mensing is the law of the land.

In any event, according to the Hughes court, it doesn't matter, because the plaintiffs also alleged design defect claims against Mylan Pennsylvania. The Hughes court points out that "Negligent design defect claims remain actionable under Pennsylvania law." Id. at 27, citing Lance v. Wyeth, 4 A.3d 160, 165 (Pa Super Ct 2010). True enough - the Superior Court did persist in the curious Pennsylvania sport of always always always treating strict liability claims differently from negligent claims, and bizarrely held that even though there cannot be strict liability design defect claims against FDA-approved pharmaceuticals, there can be negligent design defect claims. We expect the Pennsylvania Supreme Court to overturn that result, and we would have liked to see a federal judge make the prediction that that's exactly what would happen. Moreover, Lance came out before Mensing, and it would be perfectly reasonable to follow the reasoning of Mensing to mean that a bioequivalent generic cannot constitute a design defect. But the Hughes court doesn't go anywhere near that issue. The presumption against remand ends up being a presumption against further thought. The shame of it is that now plaintiffs are running around saying that a federal court has ruled that design defect claims are a way to circumvent Mensing. No, the district court was really straining not to rule on anything.


It occurred to us that maybe the district court was bothered by the odd procedural posture of the removal and the fraudulent joinder theory. The fact is that if Mensing precludes the claims against Mylan-Pennsylvania, it precludes the claims against all the Mylans. In truth, the removal is really just an argument that the whole case lacks merit, and the district court seems to believe that such arguments can be made just as well to the state court. That is the "common defense" notion used by the Southern District of Illinois to remand cases. We criticized that notion as being weird, because it essentially says that there's removal if the claims against only the nondiverse defendant are specious, but no removal if the claims against all defendants are bogus. The Seventh Circuit in the Walton case eventually spanked the "common defense" theory and put it to bed.

Anyway, the Hughes court didn't go off on that now-retired theory. Rather, it's as if the court didn't want to look at any theory at all, besides the "heavy burden" facing any removing defendant. We get some tough-sounding rhetoric but no real substance. It's even more disappointing than those generic string beans.

Friday, October 28, 2011

Dear Doctor Letters As The Next Warning Frontier – Kapps Vs. Winter

Under the learned intermediary rule, for a warning claim to succeed, at a bare minimum the prescribing (or sometimes another) doctor at least has to read the allegedly defective warning.  After all, there’s a causation element to every warning claim – the defect (whatever’s allegedly wrong with the warning) has to cause the injury.  If the prescribing physician never even read the purportedly inadequate warning, none of those inadequacies could have affected his/her treatment of the patient.  This common-sense notion, that a warning that’s not read cannot be causal, has been bedrock law in prescription medical product liability litigation for decades:


In re Trasylol Products Liability Litigation, 2011 WL 2117257, at *5 (S.D.Fla. May 23, 2011) (applying Alabama law) (“no record evidence indicating that [the prescriber] read the warning that Plaintiff claims was inadequate”); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1293, 1296 (N.D. Ala. 2003) (prescriber “did not even read the package insert”; thus he “he did not rely on [defendant’s] warnings”).


Gebhardt v. Mentor Corp., 15 Fed. Appx. 540, 542 (9th Cir. 2001) (“evidence at trial showed that [the prescriber] did not read or rely upon the allegedly inadequate warnings of the [defendant’s] device”) (applying Arizona law).


Ramirez v. Plough, Inc., 863 P.2d 167, 177 (Cal. 1993) (where plaintiff “neither read nor obtained translation of the product labeling . . . there is no conceivable causal connection between the representations or omissions that accompanied the product”) (over-the-counter drug case; plaintiff did not read warning); Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299, 308, 318-319 (Cal. App. 2008) (“[t]here can be no proximate cause where, as in this case, the prescribing physician did not read or rely upon the allegedly inadequate warnings promulgated by a defendant about a product”); Lord v. Sigueiros, 2006 WL 1510408, at *3-4 (Cal. Super. April 26, 2006) (prescriber “admits that he had not read the [drug’s] label before prescribing it to the decedent”), aff’d, 2007 WL 4418019, at *4 (Cal. App. Dec. 19, 2007) (“evidence does not raise an issue of material fact regarding causation because [the prescriber] testified that he did not read the warning label prior to or after prescribing [the drug] to [plaintiff]”); Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir. 2004) (“the doctor who prescribed [the drug] . . . failed to read [the defendant’s] published warnings before prescribing the drug.  Because the doctor testified that he did not read the warning label that accompanied [the drug] or rely on information provided by [the manufacturer's] detail men before prescribing the drug to [plaintiff], the adequacy of [the] warnings is irrelevant") (applying California law); Latiolais v. Merck & Co., 2007 WL 5861354, at *3 (C.D. Cal. Feb. 6, 2007) (the “inserts played no role in his decision to prescribe” because “[the prescriber] could not recall if he ever read the package insert”), aff’d, 302 Fed. Appx. 756 (9th Cir. 2008).


Allen v. Mentor Corp., 2006 WL 861007, at *5, *7 (D. Conn. March 31, 2006) (prescriber “failed to inform himself with respect to the [device] by reading the [package insert], a source of which he was aware and failed to find and read”; “nothing to suggest that the warnings . . . affected [the prescriber’s] conduct since he did not read them”).

District of Columbia

Mampe v. Ayerst Laboratories, 548 A.2d 798, 802 (D.C. 1988) (prescriber “specifically stated on several occasions that he did not rely on the manufacturer's warnings as a source of information”; plaintiff “therefore could not prove that the alleged inadequacy in [defendant's] warning was a proximate cause of her injuries”).


Rounds v. Genzyme Corp., 2011 WL 692218, at *3 (M.D. Fla. Feb. 18, 2011) (prescriber’s “failing to read the warning” warranted dismissal); Fields v. Mylan Pharmaceuticals, Inc., 751 F. Supp.2d 1260, 1263 (N.D. Fla. 2009) (“[w]here a physician fails to review the warnings issued by the manufacturer, proximate cause cannot be established”).


Tongate v. Wyeth Laboratories, 580 N.E.2d 1220, 1228 (Ill. App. 1991) (“that the physician failed to read the package inserts and the PDR negated any possible negligence on the part of the defendant and that the physician’s negligence was the intervening, independent and sole proximate cause”); Ashman v. SK & F Lab Co., 702 F. Supp. 1401, 1405 (N.D. Ill. 1988) (“[p]laintiffs offer no evidence that [the prescriber] consulted the [drug’s] label at the time he prescribed”).


Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992) (“additional warnings would not have assisted [plaintiff] where the nurse [selecting the drug] did not read the label”).


Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1235 (10th Cir. 2001) ([the prescribing nurse’s] “failure to read the label - a basic task which she was trained to perform - was an efficient intervening cause of [plaintiff’s] injury”) (applying Kansas law).


Felice v. Valleylab, Inc., 520 So.2d 920, 927 (La. App. 1987) (in “[the prescriber’s] own testimony she admitted that she had never read the warning label on the device itself, and that she had never read the manual.  An adequate warning or instruction would have been futile”); Hall v. Elkins Sinn, Inc., 102 Fed. Appx. 846, 849 (5th Cir. 2004) (the prescriber “acknowledges that he never read the warning . . . therefore, [defendant’s] warning (adequate or inadequate) played no role in the events leading to [plaintiff’s] injury”) (applying Louisiana law); Dykes v. Johnson & Johnson, 2011 WL 2003407, at *5 (E.D. La. May 20, 2011) (the prescriber “never read the warning, and thus the warning played no role in the events leading to plaintiff's injury”).


Dunn v. Lederele Laboratories, 328 N.W.2d 576, 583 (Mich. App. 1982) (“the doctor quit reading the inserts and PDR reprints.  Thus, further notice by way of drug labels would not have altered the doctor’s conduct”); Formella v. Ciba-Giegy Corp., 300 N.W.2d 356, 359 (Mich. App. 1981) (the “fact [the prescriber] failed to read the package inserts and PDR negates any possible negligence on the part of [the manufacturer] in not emphasizing the hazards in those publications”); Cronin v. Boots Pharmaceuticals, Inc., 1996 WL 149173, at *2 (Mich. App. Feb. 16, 1996) (“[g]iven the lack of evidence that [the prescriber] ever consulted or relied on defendants’ package insert warnings in treating plaintiff, it cannot be said that those warnings played any role in the doctor’s decision to prescribe”); William Beaumont Hospital v. Medtronic, Inc., 2010 WL 3998103, at *6 (E.D. Mich. Oct. 8, 2010 (“failure to heed clear warnings can be a superceding cause”).


Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, at *23 (D. Minn. Sept. 27, 2011) (“doctors don’t read instructions for use in great detail every time”; plaintiff conceded unread warnings not causal); Treuchel v. Eli Lilly & Co., 2009 WL 5216930, at *12 (E.D.N.Y. Dec. 21, 2009) (“[plaintiff’s] prescriber did not rely on printed warnings. . . .  [Plaintiff] cannot meet his burden.  He failed to elicit any testimony from [any] prescriber suggesting that a different warning . . . would have changed the prescribers' decisions to continue prescribing [the drug] to [plaintiff]”) (applying Minnesota law); Johnson v. Zimmer, Inc., 2004 WL 742038, at *9-10 (D. Minn. March 31, 2004) (no causation where surgeon “had never, in any context, seen the warnings”).


Oakberg v. Zimmer, Inc., 211 Fed. Appx. 578, 581 (9th Cir. 2006) (“it is undisputed that neither [the prescriber nor plaintiff] read the [product’s] package insert.  Accordingly, even if the additional warning were printed in the package insert, they would not have been read”) (applying Montana law).

New Hampshire

Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 135, 146 (D.N.H. 2010) (the “[prescriber] made clear that he never reviewed [defendant’s drug] label before treating [plaintiff] and that nothing about it influenced his decision to prescribe the drug”); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *7 (D.N.H. Sept. 14, 2010) (“[plaintiff’s] doctor did not read or rely upon [the drug’s] label before prescribing the drug to her”).

New Jersey

Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1261 (N.J. 1999) (“a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all”); Strumph v. Schering Corp., 606 A.2d 1140, 1148, 1150 (N.J. Super. App. Div. 1993) (the “[prescriber] testified that he had not even read the PDR entry”; “conclud[ing] that plaintiffs failed to present any evidence from which a jury could reasonably find that the alleged inadequacy of defendant’s warnings regarding [the drug] affected the decision of plaintiff’s doctors to prescribe the drug”) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (expressly adopting dissenting opinion as the opinion of the court); Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005) (“there is every indication that Plaintiff's doctor, . . . did not read package inserts”).

New York

Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y.A.D. 2007) (“to prove proximate cause, a plaintiff has the obligation to adduce proof that had a warning been provided, she would have read the warning and heeded it”; plaintiff “chose not to read the consent forms”) (direct plaintiff warning claim); Banker v. Hoehn, 718 N.Y.S.2d 438, 441 (N.Y.A.D 2000) (“in the absence of reviewing any operating manuals for the [device]” by the prescriber, summary judgment granted on lack of proximate cause).

North Dakota

Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *4 (D.N.D. Sept. 5, 2000) (“[c]ase law supports the proposition that a physician’s failure to read the warnings, including package inserts and the Physician Desk Reference, essentially negates any possible liability on the part of the manufacturer).”


Oppenheimer v. Sterling Drug, Inc., 219 N.E.2d 54, 58-59 (Ohio App. 1964) (prescriber “specifically said – ‘I don't recall specifically reading the precautions’”; “[i]t can hardly be said that he relied upon anything produced by the defendant”).


Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 458 n.3 (Pa. Super. 1973) (“[e]ven if [the manufacturer] had failed to adequately warn of dangers, said reason is not actionable in the case of a prescription drug, where the prescribing physician did not rely on the package insert”); Nelson v. Wyeth, 2007 WL 4261046 (Pa. C.P. Phila. Co. Dec. 5, 2007) (“[defendant’s] alleged failure to adequately warn could not have been the factual cause of [plaintiff’s injuries] since the prescribing physician did not read nor rely upon any of [defendant’s] warnings as contained in the label accompanying the prescription drug”), aff’d mem., 970 A.2d 489 (Pa. Super. 2009); Berry v. Wyeth, 2005 WL 1431742, at *5 (Pa. C.P. Phila. Co. June 13, 2005) (“[the prescriber] testified that he never read any warnings provided, thus any different warning (even a more adequate warning) would also have gone unread.  Therefore, [plaintiff] was unable to establish that [defendant’s] alleged failure to warn was the proximate cause”); Mazur v. Merck & Co., 767 F. Supp. 697, 712 (E.D. Pa. 1991) (“it is solely the responsibility of the learned intermediary to read [the package insert] and inform the patient of its meaning”; “[t]hat [the learned intermediary] may not have seen the package circular does not implicate [the drug company]”), aff’d, 964 F.2d 1348 (3d Cir. 1992).


Rodriguez v. Stryker Corp., 2011 WL 31462, at *11 (M.D. Tenn. Jan. 5, 2011) (prescriber “made the decision to use the pain pump entirely on his own”), reconsideration denied, 2011 WL 672555 (M.D. Tenn. Feb. 17, 2011).


Pustejovsky v. Pliva, Inc., 623 F.3d 271, 277 (5th Cir. 2010) (prescriber “did not recall ever reading the package insert for the drug or consulting the Physician's Desk Reference.  Her lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff’s] burden”) (applying Texas law); Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999) (“[plaintiff] has failed to present evidence that the failure to warn was a producing cause of her injury [because] . . . the surgeon who . . . us[ed] the [product], testified that at no time prior to [plaintiff’s] surgery had he read [defendant’s] package insert or any other [of its] literature”) (applying Texas law).


Stanback v. Parke, Davis & Co., 657 F.2d 642, 644, 645 (4th Cir. 1981) (prescriber’s testimony “established that he had not read the package insert accompanying the vaccine”; “[w]hatever may be said about [the prescriber’s] policies and . . ., it is clear that they precluded [defendant’s] failure to warn from having any effect whatsoever on [plaintiff’s] injury”) (applying Virginia law); Rule v. Best Industries, Inc., 1997 WL 499937, at *2, 121 F.3d 700 (4th Cir. Aug. 25, 1997) (“[the prescriber] did not even read the materials provided by [the defendant]. . . .  It would not have mattered what [defendant’s] warnings said, and the alleged lack of warning was not a proximate cause of [plaintiff’s] injury”) (applying Virginia law).


Douglas v. Bussabarger, 438 P.2d 829, 831 (Wash. 1968) (no proximate cause where the prescriber “did not read the labeling which was on the container)”.

West Virginia

Meade v. Parsley, 2010 WL 4909435, at *9 (S.D.W. Va. Nov. 24, 2010) (“[m]any courts have declined to find proximate causation in pharmaceutical failure-to-warn suits when the patient (or the prescribing physician if the learned intermediary doctrine is applicable) did not read the defendant manufacturer’s allegedly inadequate warning”) (plaintiff, since West Virginia does not recognize learned intermediary rule); In re Zyprexa Products Liability Litigation, 2009 WL 1514628, at *12 (E.D.N.Y. June 1, 2009) (“no evidence that [plaintiff] ever read any of defendant's warnings of possible risks”) (plaintiff, since West Virginia does not recognize learned intermediary rule) (applying West Virginia law).


Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 856 (10th Cir. 2003) (“when a physician fails to read or rely on a drug manufacturer's warnings, such failure constitutes the intervening, independent and sole proximate cause of the plaintiff's injuries, even where the drug manufacturer’s warnings were inadequate”) (applying Wyoming law).

We can see a few justifiable exceptions – such as affirmative overpromotion.  If a defendant’s detailer said “don’t bother reading the warnings” and the doctor didn't, then an obvious alternative means of causation presents itself.  Ditto, if the doctor read something else that originated with the defendant.  But the first seems vanishingly small (particularly nowadays), and the second is a reflection of changing media by which drug information is disseminated in the era of the Internet.

What we don’t want to see is a trend – possibly driven by post-Mensing plaintiffs forced by preemption to make Dear-Doctor-letter (called “Dear Health Care Provider (DHCP) Letters” by the FDA) claims – that Dear Doctor letters are some sort of deus ex machina Superman that makes causation problems vanish in failure-to-read situations.  It’s not really an argument to say “defendant should have sent a Dear Doctor letter at just the right time and the prescriber would have read it.”

So in that vein, we’ll look at two recent cases that have dealt with Dear Doctor letter issues – one that we think ultimately got it right, and another that we think didn’t delve nearly deeply enough into the nature of this sort of claim.

The first case – the good one – is the recent Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701 (D. Minn. Sept. 27, 2011), decision that we overviewed here.  Kapps was also a failure-to-read case (so we've cited it above), since the skilled tertiary care heart specialists who used the device weren’t about to consult the package insert concerning a device that they had undoubtedly used many times before.  Id. at at *23.

Regular readers may recall – but may not, so we’ll remind you – that the most unusual thing about Kapps was that the device had been reprocessed by someone (Ascent) unaffiliated in any way with the original manufacturer (Biosense), and the reprocessor had gone so far as to substitute its own name and labeling for the original manufacturer’s.  That led to the plaintiff’s primary causation problem:
Ascent usurped one of Biosense’s functions as a manufacturer – the function of providing instructions to customers – when Ascent replaced Biosense’s instructions for use with Ascent’s own.  Thus, if [plaintiff’s] claim depended on an argument that Biosense negligently failed to include certain warnings in its instructions for use, [that claim] would fail for lack of causation:  [plaintiff’s] damages could not have been caused by the omission of a warning from Biosense’s instructions for use, because Ascent replaced Biosense’s instructions with its own, and thus Biosense’s instructions did not accompany the catheter that injured [plaintiff].
2011 WL 4470701, at *23.  That’s actually a variant of the failure-to-read argument when you think about it, because the manufacturer’s instructions weren’t with the product any longer, and thus weren’t available to be read by anyone.

The plaintiff in Kapps, aware of this problem, advanced a Dear Doctor letter claim to fix his causation problem.  Such a “supplemental” warning, according to plaintiff, should have said “Dear Doctor, we have had a few reports of entrapment of this catheter in the mitral valve.  Please be very careful with its use in the atrium, et cetera.”  2011 WL 4470701, at *23.  Of course, plaintiff’s Superman-style letter would be sent to the medical community at just the right time to be read and heeded by the plaintiff's prescriber.  Id.  That’s what Superman does – show up at just the right moment (usually to save somebody falling).

Well, the court in Kapps lets Superman leap over the first obstacle, “at least for the sake of argument” – the manufacturer’s warnings not being with the product anymore didn’t necessarily defeat a Dear Doctor letter claim:
The fact that Ascent, in reprocessing the catheters, also became a manufacturer in some respects does not change the fact that Biosense was the catheters’ original manufacturer and sold the catheters to doctors. The Court therefore finds – at least for the sake of argument – that Biosense had a duty to warn doctors of the risk of mitral-valve entrapment.
Kapps, 2011 WL 4470701, at *23.

So where’s the kryptonite?

It might be in another argument – unfortunately not developed by the defendant – that the FDA might limit either the timing or substance of a Dear Doctor letter.  The plaintiff’s expert certainly didn’t have any idea.  2011 WL 4470701, at *24.  We don’t claim to know for sure, either, since the only regulation we could find with reasonable effort was 21 C.F.R. §200.5, which discusses what Dear Doctor letters should look like, but shies away from the more important question of when they are required.  This regulation just states “occasionally,” which doesn’t help very much.

There’s also an FDA “draft guidance” about Dear Doctor letters – something utterly without binding legal effect – that states that the FDA "should" be "consulted" about whether to send a Dear Doctor letter and what it should say.  Again, not all that helpful in litigation (other than as the basis for an expert opinion).  But that draft does tell us this:  Dear Doctor letters are for “important new information” – they’re not for rehashing something that doctors already should know:
[A] DHCP letter is used to inform health care practitioners about important new information about a drug.  In most cases, the new information is about an important new safety concern that could affect the decision to use a drug or require some change in behavior by health care practitioners, patients, or caregivers to reduce the potential for harm from a drug.  In some cases, the new information is about how to improve the effectiveness of a drug.
Draft guidance at 3 (emphasis added).  New.  New.  New.  New.  Moreover, Dear Doctor letters should “avoid discussion of non-critical information that could obscure the more important information.”  Id. at 4. The only other FDA-recognized use for a Dear Doctor letter is “to correct misinformation in advertising or other types of prescription drug promotion.”  Id. at 3.

Because the defendant didn’t have any regulatory argument developed, Superman got a free pass to leap over another obstacle:
[I] it seems reasonable to expect [plaintiff] to show that Biosense could have sent out the type of “Dear Doctor” letter that [plaintiff] calls for without violating those [unknown FDA] regulations.  But neither party has discussed the regulations covering “Dear Doctor” letters. The Court therefore will assume, for the sake of argument, that Biosense could have issued the warning advocated by [plaintiff].
Kapps, 2011 WL 4470701, at *24.

The court next identified, but passed by, another possible generalized causation argument, “also assum[ing], again for the sake of argument, that [plaintiff’s physicians] would have paid closer attention to a “Dear Doctor” letter than to instructions that accompanied the [device].”  Id.  No kryptonite yet.

Still, the plaintiff lost in Kapps.


Causation on the most fundament level.

Would the hypothetical letter have done any good in the plaintiff’s case?  No.  “[Plaintiff] cannot show that either [physician] would have done anything differently if Biosense had sent out the “Dear Doctor” letter proposed.”  2011 WL 4470701, at *24.  In short, the court found no evidence that Superman would have been able to save the day.

First, the plaintiff's Dear Doctor letter was garbage – or, as the opinion more gently puts it, “virtually content-free.”  2011 WL 4470701, at *24.  All it would have said was for surgeons “to be very careful” in light of “a few reports of entrapment of this catheter in the mitral valve.”  Id.  So what?  Doctors threading heart catheters are probably being “careful” anyway.
Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”?  Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart.
Id. Well, duh.

Second, plaintiff in Kapps had no evidence – in particular no affirmative statements from either doctor – what different actions a Dear Doctor letter of the sort being proposed would have prompted.  One of the physicians wasn’t even deposed.  Thus as to him, “[t]here is not a shred of evidence in the record that, had [he] been warned that he should be careful about mitral-valve entrapment, he would have done anything differently.”  Id. at *25.  As to the other physician, who was deposed, he “testified that in the time since [plaintiff’s] procedure, [he] has not changed anything about how he uses [the device].”  Id.  If “direct personal knowledge” of a risk didn’t change anything, plaintiff’s vague Dear Doctor letter certainly wouldn’t have.  Id.

Third, not even a heeding presumption (not adopted in Minnesota) would have saved the claim.  Assuming (the Kapps opinion made a lot of pro-plaintiff assumptions, before throwing out the case) that such a thing existed, it only presumes heeding, not causation:
What is presumed under the heeding presumption is that the omitted warning would have been heeded, not that the heeding of the omitted warning would have prevented the plaintiff's injury. . . .  Biosense is being faulted for not warning [the physician] to “be very careful” in manipulating the [using the device].  But there is no reason to believe that [he] was not being very careful.  Put differently, there is no evidence that, if [he] had heeded the warning to be very careful, he would have done something differently – and thus there is no evidence that the absence of that warning caused [plaintiff’s] injuries.
Kapps, 2011 WL 4470701, at *25 n.22.

Finally, we have some kryptonite to kill the Dear Doctor letter Superman.

Kapps thus gives defense counsel a decent roadmap of the types of arguments that can defeat Dear Doctor letter-based warning claims:

  • Is a Dear Doctor letter within the scope of the defendant’s duty to warn?  If the prescription medical product is not the defendant’s own product, unlike Kapps, where that was an important point, then probably not.  That’s why a Dear Doctor letter shouldn’t help a generic-only plaintiff against the branded manufacturer.  If the branded product isn’t being sold anymore – generally, or to this particular physician, or to this particular patient’s health plan – there shouldn’t be any duty to send such a letter.
  • Is the defendant allowed by FDA regulations to send a Dear Doctor letter concerning the risk at issue?  From what little we’ve been able to discover in a few minutes on the FDA’s website, we’d have to say that the kind of “reminder” letters, "consistent" with existing labels, mentioned in some of the generic cases aren’t likely to pass muster.
  • Is there evidence that Dear Doctor letters in general are likely to influence the plaintiff’s prescriber’s behavior?  How many such letters does he get?  Does s/he read them?  What kind of information actually changes prescribing behavior?  Examples?  Here, it would really help if either the defendant or, even better, the prescriber, had software installed that kept track of the prescriber’s receipt of and opening of Dear Doctor letters.
  • Is there evidence that this particular proposed Dear Doctor letter would have changed the outcome of this particular case?  Other causation evidence – failure to read warnings; prior knowledge of the risk; “I wouldn’t do anything differently” testimony – will help here.  So would information that the same physician received Dear Doctor letters about other, equally or more serious, risks and still uses those products in the same way.  Again, software that keeps track of this kind of thing would be most useful.

So that’s Kapps.  On the other side of the ledger is Winter v. Novartis Pharmaceuticals Corp., 2011 WL 5008008, slip op. (W.D. Mo. Oct. 20, 2011).  Winter let a Superman-type warning claim (maybe a Dear Doctor letter; maybe something else – the opinion isn't entirely clear) save the day for the plaintiff.  Winter is a blatant failure-to-read case.  The prescriber wasn’t just ignorant – he was loudly ignorant.  He testified that he didn’t ever read any of the defendant’s drug labeling because the lot of it was “useless”:
[The prescriber] cannot recall a patient with [cancer] to whom he did not prescribe [the drug] prior to that point.  [The prescriber] has testified that he never read the package inserts for [drug] while practicing . . ., but that this was because [the defendant] produced them in a way that made them useless to a practitioner.

Id. at *1.

Here’s the first point where Winter sluffs off an issue.  Exactly how were the warnings “useless”?  The opinion doesn’t say.  We think that could be plenty important.  The format, almost entirely, as well as a lot of the content, of drug warnings is prescribed by FDA regulations.  Is this doctor saying that the FDA-mandated aspects of the label are why he finds it “useless.”  Does the doctor not read any drug labeling at all?  That would make causation impossible to prove, since such aspects of the label would be impossible for  the manufacturer to change.  Winter, however, passes by this issue entirely.

Anyway, for whatever reason, the doctor in Winter proclaimed his failure to read the relevant warnings.  Under the abundant precedent cited above, that should lead to a no-causation summary judgment ruling.

But here comes Superman (called “communications”) to the rescue.  Dear Doctor letters?  Sure.  In fact, one was apparently sent to onr non-reader prescriber in Winter.  But here comes an issue of fact – the same doctor who didn’t bother with package inserts, may not have bothered with Dear Doctor letters either, only we can’t be sure:
[Defendant] highlighted these latest changes in a Dear Doctor letter dated September 24, 2004, but the parties dispute whether [the prescriber] ever received this letter.
Winter, 2011 WL 5008008, at *1.  The same doctors who don’t read drug labels, probably don’t read anything else either – but when caught, they plead ignorance, and ta-da, that’s a “dispute.”  Here’s another example of a problem needing a technological fix.  Paper Dear Doctor letters leave no paper trail, unfortunately.  Software does.  Sending Dear Doctor letters by email means that a doctor who, as in Winter “ma[kes] himself ignorant,” id. at *2, won’t be able to hide behind that ignorance any longer.
Get modern - win cases.

Rather than actually grapple with (or at least mention) the causation questions, as Kapps did, the opinion in Winter contented itself with vague generalities:
But even assuming [defendant’s] claims are true, [plaintiff] has still shown that genuine issues of material fact exist as to causation on her claims.  First, [the prescriber] has testified that he did not read the package inserts for [the drug] medication because [defendant] produced these inserts in a way that made them useless to practitioners.

2011 WL 5008008, at *2.  Okay, but there’s not a scrap of affirmative evidence of causation in that statement.  How could anything different in an insert that’s “useless” change this doctor’s treatment?  No idea.  And if it’s inherent in how the FDA requires inserts to be drafted, then it would be afirmatively impossible.

Further, [plaintiff] has argued that [defendant] had a duty to reflect the known side effects of its medication in articles and communications through sales representatives, both of which could have reached [the prescriber] and changed the course of events despite his not reading package inserts.
Id. There's Superman.  Something, who knows what, saying exactly the right thing at exactly the right time.  What “communications”?  Could it be a Superman Dear Doctor letters – timed, of course, just right so that Superman can save the day?  Stay tuned.

But to us this sort of rank “could have” speculation doesn’t cut it – not where the plaintiff has the burden of showing causation.  There’s no mention of any evidence that this doctor – who didn’t read drug warnings, and couldn’t say if he’d even received Dear Doctor letters – read articles, let alone changed his practice in reliance on them.  Nor is there evidence that this doctor ever did anything in reliance on “communications,” either via Dear Doctor letters or in person via sales representatives.  If such evidence existed, we’d expect to see some mention of it in the Winter opinion, but we’re left scratching our heads.

Superman causation arguments – be they Dear Doctor letters, articles, or some sort of "underpromotion" by sales representatives, should require affirmative proof.  If a Dear Doctor letter is postulated, there needs to be evidence that the same doctor reacted positively to other similar letters involving comparable risks.  If an article (or a Dear Doctor letter) is postulated, there must be some basis that a proper basis for such an article (or letter) in fact existed at the “just in time” moment that the plaintiff's Superman swoops in.  The kind of mushy non-evidentiary, non-analysis in Winter makes a mockery of the burden of proof.

Not too long ago we took to task a pro-plaintiff law review article that whined about “evidence based medicine.”  Right now, we’d be happy just to have evidence-based litigation., instead of the Winter of our discontent.

Wednesday, October 26, 2011

Seriously, We Couldn’t Make This Stuff Up

            We often go out of our way to infuse our posts with humor – or at least we try for a few chuckles.  But sometimes, a case finds its way to us that doesn’t need to be “punched up” with witticisms or amusing anecdotes because the facts themselves are comically simplistic and frankly, we’re not sure we could make them any funnier (not that we won’t try).  So, with minimal elaboration, we bring you the case of Milton v. Robinson, 131 Conn. App. 760 (Conn. App. 2011).
            We should start by saying this is not a typical product liability case.  Rather, plaintiff filed suit against a university, hospital and manufacturer based on her involvement in a clinical trial.  Plaintiff alleged that as a result of participating in the trial she suffered an adverse allergic reaction.  Let’s start there.  What was this adverse reaction that warranted the filing of a lawsuit including claims by plaintiff’s husband for loss of consortium and emotional distress?  A rash!  Milton, 131 Conn. App. at 767.   Really?  A lawsuit over what was described as a back full of mosquito bites?  Id.  We checked; Walgreen’s carries Calamine lotion for $5.00 a bottle. 
On a slightly more serious note, we should point out that when plaintiff discussed the risks of the trial with one of the investigators, the investigator specifically mentioned the possibility that plaintiff could suffer from “rashes and allergic reactions.”  Id. at 765.  Rashes were also warned about in the informed consent form plaintiff signed.  Id.  So clearly, plaintiff didn’t have a failure to warn claim.
But we haven’t even scratched (sorry!) the surface of what makes this case so odd.  How about the fact that plaintiff wasn’t given the study drug, but rather -- the placebo!  Id. at 767.  By definition, a placebo is a substance containing no medication.  So, what plaintiff had an allergic reaction to was one of the inactive ingredients -- polysorbate 80.  Polysorbate 80 is commonly used as a solubilizing agent in intravenous medical preparations and an additive to tablets (more importantly it is also used as an emulsifier in foods, particularly in ice cream). In other words, we bet if you looked around your kitchen and bathroom, you are going to find some polysorbate 80. 
So, when we first picked up this case, we thought the fact that it was about a placebo was going to be the punch line, but as we read further, we realized that as with most good comedies, this case had many layers.  Ultimately, the case was dismissed because plaintiff did not meet her burden of proof on standard of care – which needs to be proven through expert testimony.  And, well, plaintiff’s experts were simply a farce.
Expert No. 1 – Plaintiff’s Husband:  He was disclosed as an expert on, among other things: the risks of polysorbate 80; informed consent; failure to warn; FDA clinical study protocols; and design defect.  Id. at 773-774.  Wow – is he an epidemiologist, a clinical investigator, a pharmacologist?  Nope.  He’s “an artist and film producer.”   Id. at 775.  Told you we couldn’t make this stuff up.  Somehow, the court wasn’t convinced that the fact that her husband “researched” polysorbate for the past . . .eight years,” id. at 774, qualified him as an expert – at least as to anything relevant to his wife’s lawsuit.  Now, maybe if his wife was claiming to have been scarred by seeing the latest big screen adaptation of The Three Musketeers  . . .
On to Expert No. 2 – The Allergist:  He was proffered as an expert on the standard of care, the adequacy of the trial design and causation.  Id. at 769. At least this one was a doctor, but let’s take a closer look.   
  • His specialty is mold-related allergies;
  • Prior to becoming involved in the case, he was completely unfamiliar with polysorbate 80;
  • He had never designed nor acted as a clinical investigator in a phase III clinical trial;
  • He was unfamiliar with FDA regulations concerning phase III clinical trials;
And our personal favorites:
  • Before rendering his opinion, he had not reviewed plaintiff’s medical records; and
  • He had not read the study protocol which was the subject of his opinions.     
Id. at 775-778.  Not surprisingly, the appellate court found that the trial court “did not abuse its discretion in deciding that [the doctor] lacked the requisite knowledge or experience to assist the jury in determining the pertinent matters in issue.”  Id. at 778.  An understatement to say the least.
            To recap – plaintiff alleged that she got a rash from a placebo and she attempted to prove her claim with testimony from her artist-husband and a mold-specialist who hadn’t read her medical records or the clinical study at issue.  Maybe you’re tee-heeing a bit, maybe you’re shaking your head in disbelief, maybe you’re questioning why we even bothered with this – but what we bet you are all wondering is whether there is polysorbate 80 in Cherry Garcia?

Tuesday, October 25, 2011

Even in Minnesota, You Can't Do That

We're involved in HT litigation, so we can't comment much, but readers will want to look at Rick v. Wyeth, Inc., ___ F.3d ___, Nos. 3354, et al., slip op. (8th Cir. Oct. 25, 2011).  Trying to take advantage of Minnesota's notoriously long statute of limitations, the plaintiffs, who had originally filed in their home state (New York), filed diversity actions in the District of Minnesota, as soon as the defendant moved for summary judgment on the original, state court action based on their home state's statute of limitations.  The defendant won the summary judgment motion in the plaintiffs' home state.  In Minnesota federal court, the plaintiff argued that the home state ruling was "procedural" and didn't require dismissal.  The district court agreed with the defendant and held that the home state ruling required dismissal on grounds of res judicata.

Well, now the Eighth Circuit has affirmed, holding that, where the defendant has obtained a final order of dismissal of a plaintiff's original action under the plaintiff's home state statute of limitations, that order also requires dismissal of any subsequent action filed in Minnesota in an attempt to take advantage of the longer statute of limitations.  Rick, slip op. at 8-9.

The Rick ruling should put an end to at least one form of shennanigans involving the Minnesota statute of limitations (now changed by statute, by the way, but only prospectively) no matter what product is involved.

The Noose Tightens Around TPP Economic Loss Claims

Yesterday, the Eleventh Circuit affirmed dismissal – for failure to state a claim – of TPP economic loss claims in the Trasylol litigation.  See Southeast Laborers Health & Welfare Fund v. Bayer Corp., No. 10-13196, ___ Fed. Appx. ___, slip op. (11th Cir. Oct. 24, 2011).  That’s good news for our clients and bad news indeed for peddlers of bogus TPP claims.

The reason the TPP lost is quite simple.  The TPP had a lot of theories, but no facts – specifically “no facts indicating how it would have independently evaluated Trasylol’s medical appropriateness” aside from leaving the decisions to prescribing physicians (which the TPP disclaimed) or to the FDA (any attempt to challenge FDA approval was a preempted “fraud on the FDA” claim) or to the market (which without more, is barred under New Jersey law).  Slip op. at 15.

The TPP tried New Jersey consumer protection law, the federal RICO statute, and New Jersey law of warranty – and lost on all three. Strike three, you’re out.

The court spent most of its analysis on the New Jersey consumer protection claim, and largely applied the same conclusions to the remaining two claims.  As to that claim, the court held:

(1) There’s no presumption of reliance applicable to a New Jersey consumer protection claim.  Slip op. at 9-10. New Jersey rejected fraud on the market several years ago. Id. at 10-11.

(2) Consumer fraud claims can’t be based upon allegations “that absent the [defendant’s] allegedly fraudulent conduct, a medication would not have been on the market.”  Slip op. at 12.  That’s a form of fraud on the FDA, and it’s been preempted since Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001):

A theory of causation relying solely on an allegation that the medication in question would not have been on the market absent the alleged fraudulent conduct is no more than a state law “fraud on the FDA” theory, a theory that has been specifically rejected by the Supreme Court.
Slip op. at 13 (citing Buckman).

(3) A “medical necessity” claim must be accompanied by some allegations that the TPP actually would have conducted an separate review of such necessity”

On the facts alleged, the only causal nexus between the revelation of Trasylol’s true risk profile and [plaintiff’s] determination not to pay for Trasylol is merely a repackaged form of indirect causation – relying either on the FDA’s approval decisions for Trasylol or a market capable of efficiently digesting the truth and relaying it to [plaintiff] in the form of a market price.  Contrary to [plaintiff’s] suggestion, either theory of causation is far from direct, and foreclosed by the relevant case law.
Slip op. at 15.

(4) There’s no presumption of causation either.  Slip op. at 17.  It's almost pathetic how much TPP plaintiffs seek to displace real evidence with supposed "presumptions" (that don't exist).

The analysis of the RICO claim was failure to plead causation reprised, only this time phrased in terms of the indirectness analysis of our good friend, Holmes v. Security Investor Protection Corp., 503 U.S. 258 (1992).  Slip op. at 19-20.

The implied warranty claim saw the rejection of yet another unsupported presumption claim – this time with a holding that drugs were not “per se unmerchantable” simply because they are allegedly harmful.  Slip op. at 22. The court saw it as something of a cheeky argument since no specific harm to anyone is alleged (why all TPP claims are bogus):

[Plaintiff] does not allege that Trasylol failed to [work] or that it or any of its members were physically harmed by Trasylol.  Moreover, Southeast has failed to identify any case law to support its theory that the potential of a drug to cause harmful side effects, in the abstract, renders a drug per se unmerchantable, even as to plaintiffs that did not suffer the side effects.  Thus, the complaint does not allege that Trasylol is unfit for the ordinary purpose for which it was sold.
Slip op. at 23 (emphasis added).  It is a good idea – if making an argument predicated on injury – that injury at least be alleged.

Anyway, we’re running out of ways to say the TPP economic loss claims are meritless.  So we’ll leave it at that – they are.

Thanks to our friends at Sidley for sending this opinion along.

Monday, October 24, 2011

There'll Always Be Posner: Thumbs Up on Preemption

The New Yorker's current issue has a fine article on Pauline Kael. The weekend Wall Street Journal had a similar piece. Why the wall-to-Wall Street coverage of a film critic who wrote reviews from 1953 to 1991 and died in 2001? Two reasons: (1) the Library of America is coming out with a collection of Kael's reviews -- it's called "The Age of Movies," and that title says something about Kael's preeminence; and (2) there's a new biography by Brian Kellow -- "Pauline Kael: A Life in the Dark."

All of this reminded us of how excited we were back in the 70's and 80's every week to pull a copy of The New Yorker out of the mailbox and flip to Kael's latest review. Her opinions mattered and she made movies matter. She dismantled silly critical systems (her attack on Andrew Sarris's auteur theory spills as much blood as ink on the page) and demolished fatuous high-culture/low culture distinctions (Kael and John Simon had some nasty exchanges). There's no doubt that Kael could be inconsistent and overwrought. Her famous review of the Italian neo-realist classic "Shoeshine" was as much about her personal romantic travails as about the movie. Kael wrote some incendiary, almost nutty things, comparing the premiere of "Last Tango in Paris" to the first perfomance of Stravinsky's "Rites of Spring," denigrating "Chinatown" for celebrating nostalgia "openly turned to rot," and praising Brian DePalma incessantly, even for possessing a "gassy, original comic temperament."

If one goes back and reads Kael's reviews, they can come across as artifacts of a culture war that ended long ago, where nobody won. Her prose was incandescent -- illuminating, politically incorrect, and done. The New Yorker article says that Kael's followers (critics like Edelstein and Denby have been called "Paulettes") and fans simply had faith that Kael's judgment was right. Think of Aristotle's "Rhetoric" and its tripartite analysis of what makes someone persuasive: Kael won us over not as much by logos (logic), or pathos (emotional appeal), as by ethos (the audience's sense of the inherent excellence of the speaker). Few readers knew Kael personally, so it was the power of her prose itself that convinced us of Kael's superiority. In fact, Kael is one of the very few writers whose every fresh word would reliably command our attention, change our minds, and make us want to fling our pens or keyboards in despair because somebody else out there wrote miles better than we ever could.

Another such writer, as you have likely guessed from the title of this post, is Judge Posner. His writing matters rather more to us than that of a film critic. We merely watch movies; we practice law. Thinking about Kael's opinions prompted us to think some more on why Posner's opinions are compelling. He, too, is bigger than any single system or theory. His writing is concrete and confident. (We read recently that interviews with jurors showed that the single attribute that made them credit witnesses was conspicuous confidence. It's easy to trust someone when it's clear that they trust themselves.) It's also true that Posner's opinions persuade on a level beyond pure logic. Indeed, we espy as much ethos as logos or pathos working on behalf of a Posner opinion.

The recent opinion in Turek v. General Mills, Inc., No. 10-3267 (7th Cir. October 17, 2011), is an example. There is no doubt it's a Posner opinion. It begins with an observation that both the parties and the lower court flubbed important matters of jurisdiction and class action procedure. It ends with a refusal even to address some of the plaintiff's arguments because they are so frivolous or unintelligible. We see this again and again in Posner's opinions. It may be that he does this just because these sorts of mistakes are more common than we'd like to admit, and because it's important that they be addressed. Maybe advocates will do a better job for fear of a judicial skewering. After all, if you had a case in front of Posner, wouldn't you prepare extra hard? But we can't help but think that Posner is also marking territory with these rhetorical maneuvers. It's as if he's saying, before the argument and at its close, something like, 'Now, you all understand who I am, right? And that I'm much. much smarter than anyone else in the room, right?' Yes. Yes, we understand that.

Turek is a food case, not a drug or device case. But Posner's treatment of the preemption issue has relevance for us. He discusses preemption in clear, concrete terms, and it makes us forget for a moment how tortuous the issue can seem in so many cases. And when it's Posner doing it, it convinces us that the issue really is simple. And, oh, by the way, the defendant wins.

The plaintiff in Turek complained that advertisements for chewy bars misleadingly claimed that the bars supplied "35% of your daily fiber." That claim was allegedly misleading because the principal fiber, by weight, was inulin extracted from chicory root. According to the plaintiff, inulin extracted from chicory root is less beneficial and less "natural" than fiber one gets from eating bananas, onions, and other vegetables. Hmmm. Isn't chicory root also natural? As Posner reasons, the complaint attempts to state a "garden variety consumer protection claim." Slip op. at 5. That garden variety claim is preempted by the Food, Drug, and Cosmetic Act, which forbids states from imposing any requirement in food labeling that is not "identical" to the federal act. Thus, the only way for the plaintiff's claim to survive is if state law (here, Illinois) imposes a requirement identical to federal law. It has to be state law, because the FDCA provides no private right of action.

This is all familiar stuff for drug-and-device-law fanboys and fangirls, isn't it? It sounds like the parallel violation exception discussed by some courts analyzing federal preemption issues. We used the word "discussed" but too often the correct word is "butchered." We can think of no worse mangling of preemption and parallel violations than the misbegotten opinion in Bausch, which we wept over here and many other places. Bausch is a Seventh Circuit opinion. Posner was not on the panel. We cannot believe that the Bausch opinion, which is bereft of logos, ethos, pathos, or common sense, could have survived Posner's scrutiny. Bausch is bathos.

Turek shows why. Rather than mooning over whether some clause or comma in the FDCA might support the plaintiff's argument that consumers shouldn't suffer the inferiority of chicory fiber (assuming any such inferiority exists -- and we don't even if the court must), Posner concludes that the issue is quite simple: are any of the plaintiff's proposed disclaimers about chicory fiber found in "identical" form in the federal law? They are not. "[C]onsistency is not the test; identity is." Slip op. at 7-8. Simplicity itself. Why is such simplicity, to say nothing of clarity, almost never found in preemption opinions?

And then Posner adds "icing on the cake." Id. at 8. The Illinois Consumer Fraud and Deceptive Business Practices Act does not apply to "actions or transactions specifically authorized by laws administered by any regulatory body or officer acting under statutory authority of this State or the United States." 815 ILCS 505/10b(1). The labeling of the chewy bars was all specifically authorized by federal law. The plaintiff bit off more than she could chew. (And courts like Bausch, which strain to find a parallel action, chew more than they bite off.) Will we surprise you when we say that some courts purporting to do a preemption and parallel violation analysis, where the issue supposedly is whether state law parallels federal law, end up so exhausted teasing some sort of requirement out of federal law that they actually forget to see whether state law supports the claim?

We don't insist in happy endings in movies, but we do in judicial opinions. For some reason, we are reminded of Kael's review of "Funny Girl," and how she described the end of the movie as a "gorgeous piece of showing off, that makes one intensely, brilliantly aware of the star as performer" and of the star's "pride in performance: The pride is justified."

We're not comparing the Seventh Circuit to Ziegfeld's Follies. Reading a judicial opinion on a computer monitor isn't quite like sitting in the dark and watching a performance. But, yeah, we like Posner's opinion.

Friday, October 21, 2011

Finally, Some Good Propofol News

We have to admit the news has been pretty dreary out of the Nevada Propofol litigation recently.  As far as the state litigation is concerned, we can only hope that the defendants do better on appeal than in the trial court (it would be hard to do worse).

There was some good news, however, from the federal side of the litigation – demonstrating once again the wisdom of removal. At least there won’t be any class action.  See Rader v. Teva Parenteral Medicines, Inc., No. 2:10-cv-00818 (JCM) (RJJ), slip op. (D. Nev. Oct. 5, 2011).

The plaintiff alleged that he was one of over 60,000 patients who had been “exposed to a risk of possible exposure to blood-borne pathogens due to unsafe injection practices” at a certain medical clinic.  Slip op. at 2.  Oddly, but predictably, plaintiff did not sue the actual perpetrators of these “unsafe” practices (who were already criminally prosecuted), but only the makers of the Propofol, who allegedly committed the heinous act of selling the drug in containers of a size approved by the FDA.  The drug was perfectly sterile until the incompetent doctors got ahold of it.

This just shows how kooky litigation has gotten these days.  Doctors don’t sterilize their instruments and who gets sued?  The drug that was used in the procedure.

Very predictably, the putative class representative didn’t allege any injury at all – or even actual exposure – only a “risk” of exposure.  He wanted some sort of testing, slip op. at 3, which was another of the problems with the litigation, since Nevada rejects medical monitoring as a cause of action.  Badillo v. American Brands, Inc., 16 P.3d 435 (Nev. 2001).  See Slip op. at 8.  The only common issue we see is whether the plaintiff should be subject to Rule 11 sanctions.

But we digress.

Class certification was denied on numerous grounds:

(1) The class definition was garbage.  The mere fact of membership in the supposed class could not be determined without an individualized inquiry – indeed, no fewer than five individualized questions had to be answered before class membership alone could be ascertained, which must be some sort of record.  Slip op. at 5-6.

(2) The class representative was inadequate.  Specifically he was a bankrupt who no longer had standing to bring any claims, as they were now the property of the bankruptcy estate.  Slip op. at 6.  We’d be interested to know whether he listed the claim as an asset in his bankruptcy filings, since most plaintiffs we’ve seen in similar situations don’t do that either.

(3) The class representative was doubly inadequate.  Not only was he a deadbeat, but he split his causes of action, opting only for the no-injury claims (that don’t exist under Nevada law), and thus exposing everyone else to losing other claims for more important (if less amenable to class action treatment) injuries.  Slip op. at 6-7.

(4) Common issues did not predominate. There were scads of individual issues:  product exposure, disease exposure, product identification, differences in product characteristics, alternative causation, differing treatments, differing exposures, and damages, to name a few.  Slip op. at 7-8.

(5) Emotional distress damages, as a matter of law, are not amenable to class action treatment.  Slip op. at 9.

We’ll be adding Rader to our ever lengthening cheat sheet of class action denials (federal division).

Thursday, October 20, 2011

There They Go Again

A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon destroying accepted government programs like Medicare.

Whether one believes that President Reagan’s election was a good thing or a bad thing, there’s no denying that his disarming line was effective in dispelling his opponent’s attempt to sow fear of his then unknown policies.

We’ve confronted similar situations ourselves as, periodically, some law review article or another decides to tilt at the windmill of FDA regulatory informed consent claims in off-label use cases.  Bexis dealt with that topic in a law review article he wrote long before he wised up and started blogging.  Beck & Azari, “FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions," 53 Food & Drug L.J. 71 (1998) (available here).

Here on the blog, we addressed this topic back in 2007, critiquing an article that advocated informed consent suits against doctors for not discussing the non-FDA-approved status of off-label use, essentially as a means of indirectly punishing drug companies for allegedly promoting such uses too effectively.

We’re pleased to say that nothing came of that 2007 article.  The law is still as we stated back then.  Legal information, like whether a 50 mg dose is FDA approved but a 75 mg dose isn’t, remains beyond the pale of informed consent.  Only the actual medical risks/benefits/alternatives of, say, our hypothetical 50 mg (on-label) versus 75 mg (off-label) are relevant to informed consent:
[T]he FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery.  The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results.  The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure.  It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed.

Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001) (Bexis’ case); accord, Earle v. Ratliff, 998 S.W.2d 882, 891-92 (Tex. 1999); Hansen v. Universal Health Services, 974 P.2d 1158, 1159-60 (Nev. 1999); Packard v. Razza, 927 So.2d 529, 534 (La. App. 2006); Blazoski v. Cook, 787 A.2d 910 (N.J. Super. A.D. 2002) (Bexis’ case); Alvarez v. Smith, 714 So. 2d 652, 654 (Fla. App. 1998); Osburn v. Danek Medical, Inc., 520 S.E.2d 88, 92 (N.C. App. 1999), aff’d mem., 530 S.E.2d 54 (N.C. 2000) (Bexis’ case); Klein v. Biscup, 673 N.E.2d 225, 231 (Ohio App. 1996) (Bexis’s case); Balderston v. Medtronic Sofamor Danek, Inc., 285 F.3d 238, 239 n.2 (3d Cir. 2002) (applying Pennsylvania law) (Bexis’s case); Bogle v. Sofamor Danek Group, Inc., 1999 WL 1132313 *7 (S.D. Fla. April 9, 1999) (Bexis’s case); In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 107556 (E.D. Pa. March 8, 1996), reconsideration denied, 1996 WL 900351 (E.D. Pa. May 21, 1996) (Bexis’s case); cf. Daum v. Spinecare Medical Group, 61 Cal. Rptr.2d 260, 271-73 (Cal. App. 1997) (FDA regulatory status outside common law informed consent; discussion of status only required where FDA regulations say so).

Since 2007, the only contrary authority that we know of was a rogue South Dakota federal court, predicting (in blatant violation of Erie principles) that South Dakota, uniquely, would allow a regulatory informed consent claim.  We excoriated DeNeui v. Wellman, 2009 WL 4847086 (D.S.D. Dec. 9, 2009), here.  Even in DeNeui, however, the regulatory informed consent claim proved to be a lousy theory.  The plaintiff lost at trial, proving that at least sometimes juries have more sense than judges.

On the good side of the ledger, Maryland’s highest court agreed, in University of Maryland Medical System Corp. v. Waldt, 983 A.2d 112 (Md. 2009), that purported informed consent “expert” testimony, solely on the point that off-label use is not FDA “approved,” was excludable as not “material” in an informed consent case:
[Plaintiffs] proffer was that [their expert] would testify about the approved uses of the neuroform stent. . . .  The intermediate appellate court explained . . . that the only proffered (albeit vaguely) substantive testimony of [plaintiffs'] expert] was that the neuroform stent device was not approved for use on [the patient’s] type of [condition].  This is not a proffer of a risk inherent to the procedure that [the patient] underwent. . . .  We agree with the intermediate court that no testimony was proffered concerning the material risks of the procedure that would make out a prima facie case for informed consent.

Id. at 129-30 (partially quoting lower appellate court).  Thus now, as in 2007, there is no appellate authority, either in federal or state court, supporting a claim for FDA regulatory informed consent anywhere in the country.

But now, here they go again – trying to scare us that off-label use “may not be safe or effective,” and therefore, if doctors don’t use the magic word “unapproved” they should be liable for breach of informed consent.  We've just read a (relatively) new article, Rosoff & Coleman, “The Case For Legal Regulation Of Physicians' Off-Label Prescribing,” 86 Notre Dame L. Rev. 649 (2011), also available online here, that once again attempts to resurrect claims for FDA regulatory informed consent.

The Rosoff article relies on statistics that “[m]ost physicians don’t keep track of FDA-approved uses of drugs,” p. 652 n.13, and advocates forcing these “ignorant,” id., doctors to learn the FDA regulatory status of all the drugs they use so they can regurgitate that information to their patient.  We don’t think that’s a good use of scarce physician time.  We’d much rather that doctors spend whatever time they have left for education brushing up on the medical risks and benefits of their therapies.  That’s what doctors are trained to do.  Tracking the ins and outs of drug approvals on the FDA’s website should be left to us lawyers.

But leaving well enough alone would mean less litigation, and Rosoff and company can’t have that.  They perceive a need – not presently being met – for the law to “micromanage medical practice.”  Article at 675.  After all, more litigation means more jobs for lawyers.  More jobs for lawyers means that law students might find more jobs.  Ultimately, that might mean more jobs (or at least not fewer jobs) for law professors and law review editors (at least to an economic determinist).  The Rosoff article would require doctors to learn the FDA regulatory status of hundreds of drugs and medical devices and then, on threat of being sued, doctors would have to describe standard of care medical treatments (which many off-label uses are) as “unapproved” so patients will be scared away from such treatments.

At least the Rosoff article recognizes that there are various types of off-label use.  It classifies them as: (1) “OLU justified by high-quality evidence”; (2) “OLU justified by some but not high-quality evidence”; (3) “OLU justified by the need or desire to innovate”; and (4) what they call “unjustified” (we’d say “experimental”) off-label use.  Article at 652.  Indeed, there are literally hundreds of well-accepted off-label uses listed in compendia such as the United States Pharmacopeial Drug Information, and the American Hospital Formulary Service Drug Information for which federal government programs provide reimbursement notwithstanding their off-label status.  Alternatively, the Physicians Desk reference also lists “routine” off-label uses for hundreds of “specific medical problems.”  PDR at “forward.”

So what’s the fuss?  Why should doctors have to go beyond their well-established duties of discussing medical risks and benefits (such as that “experimental” off-label use isn’t backed by any medical evidence that it will be safe or effective) and discuss FDA regulatory status as well?

The Rosoff article counters by stating “it is difficult to imagine that there is not a more material fact than that a proposed treatment’s – in this case, an OLU’s – safety and efficacy have not been established." Article at 654.  That sort of argument stuffs the rabbit deep in the hat.

Established by whom?

There are many drugs – typically generics – and many medical conditions – chiefly uncommon ones – as to which the effectiveness of treatment has been established by decades of clinical experience.  Running the sort of clinical trials that the FDA requires for approval is expensive as all get out (a technical term).  If there’s no patent protection, or only a small market, there won’t be FDA approval no matter how safe or effective the use is.  Again, we’re economic determinists.

Or maybe there is FDA approval.  Suppose a company is pushing a new drug use through FDA channels, which can take years.  On date X the use is off-label, even though a bunch of published studies have been run and the material is being considered by the FDA.  On date X +1, the FDA approves the use.  Why should the informed consent discussion be different on date X, as opposed to date X +2, when every scrap of medical information is identical?  Why should doctors have to keep track of FDA approvals?

We say they shouldn’t.

Whether safety of effectiveness of a particular drug use is “established” for purposes of medical treatment (as opposed to FDA regulatory purposes) depends on the quality of the medical information on which the treatment is based.  That’s what doctors are trained to evaluate.  That’s all we think they should be legally required to discuss with their patients in informed consent discussions.

The Rosoff article runs away at high speed from these situations.  No, they say, we’re worried only about “problematic” off-label use:
It is antithetical to patient welfare to prescribe such products because they may be affirmatively harmful.  Even if they are not, they preclude alternative approaches with a proven track record of effectiveness.  Prescribing problematic OLU is anachronistic medical ethics because modern ethics call for evidence-based medical practice and, correspondingly, preclude experimentation outside of formalized trials with built-in safeguards to protect patient-subject health and decisional autonomy.  By definition, problematic OLU are the opposite of evidence-based medical practice.  And by definition, they are experimental, albeit with more or less of a basis for trusting in the outcome of the experiment depending on the degree of evidentiary support at issue.  On the latter point, it has been well over fifty years since Nuremberg, when societies around the world – including the United States – rejected the notion that experimenting with patients, even ostensibly in their own interests, was permissible in the absence of consent for the experiment.

Rosoff article at 680.  So “problematic’ off-label use is what the Nazis did.  Let’s break out our “definitions” and define it as “non-evidence based” and “experimental” (Rosoff has a philosophy degree, so he knows that he who defines the terms, wins the argument).  That’s what needs greater “regulation” (but they advocate lawsuits, not real regulation), not the well established stuff.  Article at 656-67.  Sorry, we don’t buy that, either.  Who is going to define what’s “problematic” and what’s not?

Lawyers whose sole financial interest is in bringing lawsuits, that’s who.  The Rosoff article’s primary – indeed only – concrete recommendation is to resurrect regulatory informed consent as a cause of action.  Article at 682-84.

That means we get inevitable litigation creep.  Lawyers certainly can’t be trusted to sue only over something truly “problematic.”  Look at what the food fascists sue over in California, one timely example that comes immediately to mind.  Or see our prior post about plaintiffs arguing that doctors have some sort of informed consent duty to tell patients about preemption.  No legal doctrine safe from abuse – certainly not one as malleable as “informed consent.”  Doctors are by and large litigation averse people, and if they weren’t, their insurers are.  Allow a pure regulatory informed consent claim anywhere, and doctors will be forced to subscribe to the Code of Federal Regulations everywhere.  There's a big camel behind that nose.

And as a practical matter, the claim is totally unnecessary, because doctors already have a duty to be informed about the medical basis of the treatments they prescribe.  It’s called “evidence based medicine.” We’re in favor of it and we discussed it at some length here.  If treatment A is reasonably effective, and treatment B is based on a wing and a prayer, we don’t need any new cause of action to enforce safe medical practice.  Patients should get the comparative medical evidence, and if they don't there's already a cause of action for that, traditional informed consent.

Conversely, if there’s really no well established alternative to an off label use, then what good does it do, after the doctor has said “you’ve got six months to live but a few case reports suggest that treatment X might help,” to add – “oh, by the way, the FDA hasn’t approved it either.”

None. Nada. Zilch. Zip.

You don’t have to believe our pro-defense blather to demonstrate the strong potential for litigation creep.  It’s visible, plain as day, in the Rosoff article itself.  Check out page 672, where the article describes a “pedicle screw used off-label as an ‘internal fixation device’ in the context of spinal fusion surgery” as a form of “experimental OLU” to which its proposed remedies would apply.  The article's discussing bone screws, and we happen to know a little about bone screws.  And the truth about bone screws is that they’re about as far from “experimental” or "problematic" as you can get.

Rather, pedicle screw fixation was, and is, the medical standard of care – so much so that the FDA itself was unable to organize the usual clinical trials, precisely because it would have been unethical to withhold standard of care treatement.  Rather, the FDA had to resort to a retrospective cohort study to resolve the labeling issue and get the approved labeling for bone screws caught up to medical reality.  Again, don’t believe us (if you don't want to).  It’s all laid out in the Federal Register by the FDA itself.  See 63 Fed. Reg. 40025-41 (FDA Jul. 27, 1998).

In that Federal Register publication – not cited in any of the Rosoff article’s 139 footnotes – the FDA “confirmed” that bone screws used for pedicle fixation raise “no new issues relating to the[ir] safety or effectiveness.”  Id. at 40027.  Over four years of FDA analysis, and a huge cohort study, determined:
  • The data “reviewed as a whole . . . demonstrate[d] the safety and effectiveness of pedicle screw spinal systems.”  Id. at 40028 (item 2).
  •  “[P]edicle screw spinal systems exhibit adequate mechanical strength, rigidity, and fatigue resistance.”  Id. at 40033 (item 17).
  • The “incidence” of “adverse outcomes is no greater when a pedicle screw spinal system is used.”  Id. at 40031 (item 4).
  • “[P]remarket approval is not necessary to provide reasonable assurance of safety and effectiveness.”  Id. at 40034 (item 22).
So please excuse us when we scoff at the Rosoff article’s claim to limit its proposal to “problematic” off-label uses.  That’s a tissue-paper thin pretext that vanished when the article itself asserts that a use that the FDA actually did approve was nonetheless “experimental.”  If Rosoff et al. couldn’t do their homework well enough to avoid branding well-established (no longer) off-label uses as “experimental,” we have zero confidence that, in practice, lawyers litigating cases (or judges adjudicating them) would be any more careful.  Make no mistake about it, whatever legal restrictions the Rosoff article aims at “problematic” off-label used would also be asserted against all other off-label uses – probably without even a decent period for plausible deniability.

There are, however, a lot of good reasons for off-label use, even of the “problematic variety.  One is the lack of good alternatives. Take Alzheimers, for example.  We saw a story not too long ago in the Science News (about the limit of our capacity to digest technical issues) about some scientific evidence (a mouse study and anecdotal brain scan results) suggesting that certain antidepressants may reduce the plaques that are characteristic of the disease.  That’s certainly not enough for FDA approval, but with no good treatment alternative, what’s unethical about trying it?  We assume that current informed consent – involving medical risks, benefits, and alternatives – is given.  Why is anything more, particularly the fact that the FDA hasn’t approved these drugs for that use, needed?  Why would the Rosoff article equate such a thing with Nazi experiments?  Their home state of North Carolina (article at 665) certainly wouldn’t.  There is no “per se rule requiring the jury to be instructed that a health care provider in every instance has a duty to inform a patient of the experimental nature of a proposed treatment procedure."  Osburn, 520 S.E.2d at 92.

The Rosoff article also bases its proposals to litigate FDA regulatory status on an assertion, admittedly not based on any “empirical” data, that “most patients erroneously believe that the drugs their doctors prescribe for them have been determined – somehow, by someone – to be safe and effective for the uses to which they will be put.”  Article at 673.  It then goes on to argue, based on nothing more than personal prejudices, that doctors have some duty to correct that misconception.  See Id. at 683 (“since it appears that most patients mistakenly believe that FDA approval codes for safety and efficacy . . .  FDA status is medically material information”).  Well, poll after poll after poll (that's actual “empirical” data) has shown that a majority of Americans believe in angels.  Heaven help us if Rosoff’s argument was applied to the clergy.

But more to the point, there’s no precedent in creating a duty to warn based upon a admittedly “mistaken” belief.  Doctors (or anybody) cannot be held liable for not clearing up a public misconception that they had no part in creating.  The law is (and always has been) that there is no duty to rescue someone from a peril not of the defendant’s own making.  E.g.:
We know of no principle of law by which a person is liable in an action of tort for mere nonfeasance by reason of his neglect to provide means to obviate or ameliorate the consequences of the act of God, or mere accident, or the negligence or misconduct of one for whose acts towards the party suffering he is not responsible. If such a liability could exist, it would be difficult, if not impossible, to fix any limit to it.

Estate of Cilley v. Lane, 985 A.2d 481, 489 (Me. 2009); see generally Restatement (Second) of Torts §314 (1965) (“that the actor realizes or should realize that action on his part is necessary for another's aid or protection does not of itself impose upon him a duty to take such action”).  This isn’t to say that pro-liability law professors haven’t tried to create such a duty, e.g., Weinrib, "The Case for a Duty to Rescue," 90 Yale L.J. 247 (1980), but the law has had too much common sense to adopt such nebulous liability.  The Rosoff article is, plain and simple, an attempt to create a duty to rescue in the particular area of off-label use.

Nowhere is the Rosoff article’s disrespect, bordering on contempt, for the medical profession more apparent than it’s blowing off the argument (as “specious”) that it’s onerous to force doctors to learn, and then discuss with their patients the FDA regulatory status of anything and everything that’s used off-label.  These are the guys, after all, who couldn’t be bothered to learn the correct FDA regulatory status of bone screws before condemning them as “experimental” when in fact that use has been approved by the FDA since 1998.  The pace of medical advance is high and increasing.  So are the numbers of patients a lot of doctors have to see in this era of managed care.  There's less time to talk to patients, so the quality of discussion has to go up, not be diverted into legalisms.  Meanwhile the FDA is being starved of necessary resources (see Wyeth v. Levine, 129 S. Ct. 1187, 1203 n.11 (2009) (collecting data)). Thus, the gap between what doctors can do therapeutically for their patients and what the FDA can do gets ever larger.  We don’t know where Rosoff et al. expect doctors to get all this additional time to look up FDA regulatory information every time they propose what may be an off-label use, see Article at 685, but we’d hope that instead doctors would educate themselves about new medical information.  That’s real “evidence-based medicine” – not using absence of FDA approval as some sort of “proxy” for the real thing.  Article at 683.

Nor is it correct to say, as the Rosoff article does, that if we don’t allow regulation by lawsuit, there’s no regulation of informed consent with respect to FDA regulatory status.  While the FDCA precludes the FDA from regulating off-label use, informed consent practices relating to off-label use (and anything else) are subject to state regulation if the state cares to do so.  Cf. Cordray v. Planned Parenthood Cincinnati Region, 911 N.E.2d 871 (Ohio 2009) (describing state regulation of off-label use of abortifacient drug). No state anywhere has chosen to adopt – legislatively or regulatorily – a informed consent requirement that physicians discuss FDA regulatory status of off-label uses.  The Rosoff article laments the lack of actual state-law regulation, even by medical malpractice:
The best indication of the ineffectiveness of medical malpractice law as a tool to regulate OLU is probably the dearth of published cases, either reported (useful as precedent in future cases) or unreported (officially unavailable as precedent) in which off-label use by a medical provider was a focus of the plaintiff's case.  Furthermore, the substance of the published decisions reinforces the suggestion from the numbers that off-label prescribing is a weak basis for finding liability against a physician.

Article at 666.  Actually, the approach of the states to off-label use goes beyond what the Rosoff article cares to admit.  Most state regulation of off-label use is exactly the opposite of the “cut off reimbursement” philosophy of the article (pp. 688-89, advocating non-reimbursement by both government programs and private insurers), and instead has sought to increase reimbursement of off-label uses.  E.g., N.J. Stat. §26:1A-36.9(c).

We draw a different conclusion than the Rosoff article from the consensus of state laws.  We think that this uniform lack of action by any of the the fifty states is telling.  If no state has chosen to impose a regime of regulatory informed consent, that tells us:  (1) that the supposed “problem” to which the Rosoff article seeks a an admittedly “new” and “controversial” solution (Article at 659), isn't really that much of a problem, and (2) the prevailing common law, limiting informed consent to medical risks and benefits, has gotten it right.  If it ain’t broke, don’t fix it.

Thus, we think that the Rosoff article combines the worst attributes tort triumphalism (a belief that lawsuits can solve anything), with a chilling disrespect for science and medicine – especially the ability of doctors to exercise their professional judgment independently in the best interests of their patients.

Doctors deserve more credit than that. They’re highly trained professionals. If an off-label use is prevalent, that’s usually because it works better than the alternatives.  Indeed, that’s one (of many) reasons that third-party payer cases based on off-label use have almost uniformly failed – because the TPPs can’t allege, let alone prove, that off-label uses for which they seek recovery don’t help patients.  See Our Third-Party Payer posts here.  Thus, in the great majority of cases, the new/old FDA regulatory informed consent cause of action the Rosoff article advocates could serve only to harm to patient treatment – by deterring patients from receiving standard of care medicine (as we showed above, it would be impossible to limit the claim to “problematic” uses) in the mistaken belief that, because the FDA hasn’t passed on the treatment, there must be something wrong with it.  This cause of action would only encourage more lawsuits, and higher costs for everything, without increasing patient safety one iota, since existing informed consent already requires discussions of actual medical risks and benefits – just not the through-a-glass-darkly “proxy” of FDA regulatory status.

Our bottom line is this. There are good reasons why appellate court in the country that's considered whether to expand informed consent to include FDA approval status has said "no."  There are good reasons why no state statute or regulation requires anything of the sort.  The law of informed consent already requires patients to be told about medical risks and benefits – regardless of FDA regulatory status.  If the situation is so dire that some experimental treatment with unknown risks is indicated, then patients should be told about that medical uncertainty.  Do off-label uses have medical risks? Absolutely, but so do all prescription drugs, which is why they require prescriptions in the first place.  In both on- and off-label use situations, patients should be (and legally are required to be) told about those medical risks directly.  They should not be bothered with an FDA legal status that often means only that research into new drugs is more profitable than research into drugs with little or no patent protection left.

The only people who profit from injecting legal information such as FDA regulatory status into medical informed consent discussions are lawyers.  For anyone actually needing medical care, as opposed to needing a legal job after graduating from law school, we think that’s a truly lousy idea.