Tuesday, June 30, 2009

An Avandia Removal Spat

Egad -- yet another post on removal!

We'll try to keep it mercifully brief.

In In re Avandia Marketing, Sales Practices and Prods. Liab. Litig., [That caption about covers the waterfront, doesn't it?] MDL No. 1871, 2009 U.S. Dist. LEXIS 51558 (E.D. Pa. June 18, 2009), GlaxoSmithKline removed two "Avandia supposedly increases the risk of heart attack" cases from state court. GSK removed the Martinez case from a state court in New Mexico and the Brown case from North Carolina. Both were then transferred to the MDL in Philadelphia, and Judge Rufe ruled on plaintiffs' motions to remand.

In Martinez, the main question was whether the GSK detail representative, Carmen Hoss, was fraudulently joined on a product liability claim. Plaintiff alleged that GSK deceived the world about the supposed cardiac risks of Avandia. But plaintiff also pleaded that Hoss was aware of those cardiac risks and supposedly misrepresented them, so plaintiff could sue Hoss for the misrepresentation. 2009 U.S. Dist. LEXIS at *13-*14. GSK said that Hoss wasn't aware of any supposed cardiac risks of Avandia and so was fraudulently joined.

Think for a minute about plaintiff's alleged scam: GSK is supposedly trying to hide the risks of its drug from the world, but nonetheless tells its sales reps about those very risks?! Judge Rufe acknowledged that "GSK's argument [that there was no suggestion that the sales rep knew of the alleged risks] has some appeal -- it is difficult to imagine a scenario in which a drug company divulges otherwise secret information about the dangers of its products in training materials or educational sessions given to sales representatives." Id. at *17.

But New Mexico state law doesn't require specificity in pleading, and the general (and implausible) allegations of Hoss's knowledge of Avandia's risks "are potentially sufficient under New Mexico law." Id. at *20. The court thus remanded the Martinez case.

We have three reactions to that.

But we can't reveal the first reaction in polite company, so we'll keep it to ourselves.

Our other two reactions are legal, so we'll keep typing: First, this holding means that removal is easier in states with rules that require fact pleading (such as Pennsylvania) than in states that permit mere notice pleading (such as New Mexico). The additional details required in a fact pleading state will make it harder to support spurious claims. That's a curious result, but it's not necessarily wrong: State court rules govern pleadings in state courts, and those rules may affect removal issues.

Second, we assume that the Twombly/Iqbal pleading standards (which we've discussed here and here, among other places), which now apply in federal court, will over time be adopted in some state courts -- particularly state courts with rules of procedure modeled on the Federal Rules. Thus, over time, "implausible" state court complaints will no longer state claims, and defendants will have more opportunities to remove based on fraudulent joinder.

The other Avandia removal was in the Brown case. The question there was whether GSK's principal place of business was in North Carolina or Pennsylvania. (Brown was a citizen of North Carolina. If GSK's PPB was in North Carolina, then the parties would not be diverse, and the court would have to remand the case.) Applying the "center of activities" test, which the Third Circuit uses to determine a corporation's principal place of business, Judge Rufe found that, as of late 2008, GSK's principal place of business was in Pennsylvania. Diversity existed, and plaintiff's motion to remand Brown was denied. Id. at *29.

As to that holding, we note only that on June 8, the Supreme Court granted certiorari in Hertz v. Friend, No. 08-1107, which presents the question "[w]hether the location of a nationwide corporation’s headquarters can be considered for purposes of determining principal place of business for diversity jurisdiction citizenship under 28 U.S.C. § 1332." The cert petition (here's a link, courtesy of SCOTUS blog) notes that courts currently use four different tests to determine a corporation's principal place of business; the Third Circuit's "center of activities" test is just one of the four.

Thus, a decision in Hertz v. Friend (which the Supreme Court will presumably decide in late 2009 or early 2010) may provide guidance on the appropriate way to determine a corporation's principal place of business.

Monday, June 29, 2009

Another Severance Of Med Mal Claims To Preserve Diversity As To Products Defendants

We posted earlier this month about Joseph v. Baxter, in which Judge James Carr (of the Northern District of Ohio) severed and remanded claims against the non-diverse health care providers to create diversity as to the drug company defendant.

We raised a few questions at the end of that post, asking, among other things, whether the holding was limited to situations where (1) the drug company removed before it was aware that health care providers had been named as defendants or (2) a federal multidistrict litigation proceeding was pending.

Judge Carr's back!

And we learned moments ago that the answer is "no" -- to both of our questions!

In Judge Carr's court, if a plaintiff sues both non-diverse health care providers (on medical malpractice claims) and an out-of-state drug company (on product liability claims), the federal court can sever and remand the med mal claims and retain jurisdiction over the then-diverse products claims.

That's the result in DeGidio v. Centocor, No. 3:09CV721, slip op. (N.D. Ohio June 29, 2009) (here's a link). Ohio citizen DeGidio sued non-resident drug companies -- Centocor, Johnson & Johnson, and Ortho-McNeil Pharmaceutical -- on product liability claims and, in the same complaint, sued Ohio resident health care providers -- Dr. Ray Miller and Nurse Jane Doe -- on medical malpractice claims related to DeGidio's ingestion of the drug Remicade.

The drug companies rolled all their strength up into one ball and removed the case to federal court. DeGidio moved to remand. The drug companies asserted that the health care providers were dispensable parties, so the federal court could sever the claims against the medical malpractice defendants and remand them to state court, creating diversity jurisdiction as to the product liability defendants.

That's exactly what Judge Carr did: He severed and remanded the claims against Dr. Miller and Nurse Doe, and then retained jurisdiction over the remaining, diverse product liability lawsuit.

At that point, the judge didn't have to address the drug companies' arguments that the health care providers had either been fraudulently joined (because plaintiff hadn't provided an affidavit of merit as to the med mal claims) or fraudulently misjoined (because the med mal and products claims couldn't properly be brought in a single case, under the logic of Tapscott v. MS Dealer Serv. Corp., 77 F.3d 1353, 1360 (11th Cir. 1996)).

If Judge Carr's logic catches on with other judges, we predict that you'll see an awful lot of drug companies removing cases on this ground and asking federal courts to sever and remand the med mal claims.

Wham, Bam; Thank You, Kamm!

You know the "review of remand order" story, because we wrote about it earlier this month:

28 U.S.C. Sec. 1447(c) authorizes a federal trial court to remand a case to state court for either (1) lack of subject matter jurisdiction or (2) defects "other than lack of subject matter jurisdiction." Objections to subject matter jurisdiction can of course be raised at any time. But motions to remand "on the basis of any defect other than lack of subject matter jurisdiction must be made within 30 days after the filing of the notice of removal."

Section 1447(d) then says that a remand order "is not reviewable on appeal or otherwise." Courts have interpreted section 1447(d) to apply only to remand orders issued under section 1447(c). Thus, if a trial court remands a case on a ground not specified in 1447(c), the remand order may be reviewable.

We're simple guys, and our heads spin easily. We thus keep trying to simplify our world, so we can understand it and explain it to our clients.

We figure there are three kinds of motions to remand: (1) Motions to remand based on lack of subject matter jurisdiction (i.e., a lack of diversity or less than $75,000 in controversy, or the absence of a federal question), (2) motions to remand based on defects in the removal procedure (e.g., the defendant blew the deadline for removing the case or all defendants didn't join in the notice of removal), and (3) motions to remand that involve decisions on substantive questions of law apart from subject matter jurisdiction or the removal process (e.g., a motion to remand based on an abstention doctrine).

The first kind of motion to remand -- for lack of jurisdction -- can be made at any time. The second kind of motion -- for a defect in the removal process -- must be made within 30 days or is waived. The third kind of motion -- based on substantive law unrelated to jurisdiction or the removal process -- is not governed by section 1447 at all.

And -- take a deep breath -- the first two types of motions are not reviewable by appellate courts, but the third type may be.

Turns out this is exactly right.

But what a mess it is.

Kamm v. ITEX Corp., No. CV-06-00943-AJB, slip op. (9th Cir. June 15, 2009) (link here), involved a contract dispute. The contract contained a forum selection clause saying that any action for breach of contract would "be filed . . . in the courts of the State of Oregon." Id. at 7108. Kamm filed a complaint in state court. ITEX removed. Kamm moved to remand thirty-one days later. Id. The trial court granted the motion to remand, and ITEX appealed.

What result?

The facts seem so easy, but somehow it feels like we're in our first year of law school all over again.

The case turns on how the court categorizes a motion to remand based on a forum selection clause.

That kind of motion ain't jurisdictional. A forum selection clause does not deprive a federal court of subject matter jurisdiction. M/S Bremen v. Zapata Off-Shore Co., 407 U.S. 1, 12 (1972).

So is removal in violation of a forum selection clause a "defect other than lack of subject matter jurisdiction"? If it is, then Kamm had to move to remand within 30 days, which he had failed to do (and thus had waived his objection to removal). Also, if a forum-selection-motion-to-remand involves a "defect other than lack of subject matter jurisdiction," then that motion falls within section 1447(c) and the corresponding bar on appellate review contained in section 1447(d). If appellate review were barred, then the Ninth Circuit would have had to dismiss ITEX's appeal.

Judge William Fletcher spied all the issues and wrestled with this nicely.

He concluded that a motion to remand to enforce a forum selection clause does not involve a "defect" in the removal process, but rather involves an independent legal question. Id. at 7112-14. Thus, Kamm was not required to bring that motion to remand within 30 days, and the Ninth Circuit had jurisdiction to hear the appeal. The Ninth Circuit thus reached the merits and affirmed the trial court's remand order. Id. at 7115.

In one sense, we're happy: We generally root for defendants at this blog, but we'll get over that here. The Ninth Circuit reached a reasonable result, and the court grappled with this issue comprehensively.

In another sense, however, we're sad: As practicing lawyers, we have to live in this crazy, mixed up world, and we have to explain it to our clients, and we have to provide legal services at a fair price.

And here's the state of play: Whenever a plaintiff moves to remand on a non-jurisdictional ground, we must figure out whether the non-jurisdictional ground qualifies as a "defect" within the meaning of section 1447. If it does, then the plaintiff must move to remand within 30 days, and there will be no appellate review of a remand order. But, if the motion does not involve a "defect," then the motion need not be made within 30 days (although it must still be made "on a timely basis," id. at 7114), and appellate review will be available.

And remember: That's just in the Ninth Circuit!

Other circuits may classify "defects" differently or may solve this entire riddle in some other way.

And all of that is just to decide which court will hear your case! Only after we decide that can we start to worry about who should actually win on the merits.

We're not really here to cry on your shoulder.

But we will anyway.

Please don't blame us for the high cost of providing legal services. Sometimes it's the law itself that inflicts these things on us.

Saturday, June 27, 2009

WSJ On Twombly and Iqbal

Today's Wall Street Journal has an article advising the world that Ashcroft v. Iqbal was one of the most important cases for business in this year's Supreme Court Term.

Film at 11!

Here we criticized ourselves when we didn't publish a post about Iqbal until May 26, a full week after the decision had come down. (But we quickly recovered, joining the fray in the blogosphere here and here.)

Thank you, Wall Street Journal, for making us feel better about our original sluggishness.

Friday, June 26, 2009

Cost Of Litigation Drives Accutane Off The Market

Bloomberg News reported this moments ago:

"Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease."

Here's our take: The cause of inflammatory bowel disease is unknown. There's essentially no scientific evidence linking Accutane to that condition. (Here's a link to our post from a couple of years ago reporting on the MDL judge's rejection of plaintiffs' general causation evidence supposedly linking Accutane to IBD.) Despite the absence of scientific evidence, juries have repeatedly awarded millions of dollars to folks who developed IBD after taking Accutane. (Here's a link to one example.) So Roche Holding is now giving up the ship.

If you ever need another example of the cost of litigation driving a beneficial drug off the market, add Accutane to your list.

UPDATE: Here's a link to the New Jersey Lawsuit Reform Alliance's statement on this subject, which resembles ours. A reader has also advised us that Accutane faces generic competition, which folks thinking about this situation should consider.

Scratch Three More Zyprexa Plaintiffs

Judge Weinstein granted three more summary judgment motions yesterday in the Zyprexa mass tort. The reasoning is essentially the same for two of them - the statute of limitations ran, and there was no warning causation under the learned intermediary rule. The third case had no statute of limitations issue, and was solely a causation decision. Briefly:

In Morrison v. Eli Lilly, the drug helped the plaintiff with fewer adverse effects than any of the other medications he tried. There was evidence that the plaintiff refused to be taken off the drug despite weight gain. Plaintiff's medical records and his treater's deposition demonstrated knowledge of associations between the drug and weight gain/diabetes, well before the statute of limitations ran. Thus, under the Missouri discovery and learned intermediary rules, the claims were time barred. There was also no causation, as the physicians prescribed and maintained the plaintiff on the drug with knowledge of its potential effects because it was effective in treating the plaintiff's psychological condition.

In Leggett v. Eli Lilly, the plaintiff had been locked up as criminally insane, but the drug helped enough that he could be released. For almost twice the period of the relevant California statute of limitations, plaintiff's medical records and his treater's deposition demonstrated knowledge of associations between the drug and weight gain/diabetes. There was also no causation under the learned intermediary rule because the treater testified that he would prescribe the drug regardless of any diabetes warning because it helped the plaintiff so much.

In Neal v. Eli Lilly, use of the drug alleviated the plaintiff's various auditory hallucinations and suicidal depression. All four of the treating physicians were aware of the alleged diabetes association, and prescribed the drug anyway, given its beneficial effect on his condition. Because no additional warning would have changed the result, there was no causation under California law. There was no medical causation either, because the plaintiff's expert had been thrown out, and his treaters doubted that the drug caused plaintiff's diabetes.

Thursday, June 25, 2009

Some Thoughts On Pleading And Proving FDA Actions

This post is largely about drug and medical device litigation “inside baseball.” Some of it’s going to be really technical. So if you’re looking for philosophical musings, or just a chuckle or two over the latest bizarre goings on in our neck of the woods, come back later.

But if you’ve ever had to worry about pleading and proving FDA actions without formal discovery – especially doing it on Rule 12 motions to dismiss or motions for judgment on the pleadings – pull up a cyber chair.

The problem of getting what we know that the FDA did properly before a court on a motion that’s largely based upon the pleadings is something we’ve touched upon before. That post examined the use of judicial notice in Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008). Colacicco was (and we do mean "was", since the opinion was vacated on other grounds by the Supreme Court after Wyeth v. Levine) a drug preemption case.

One of the defendants in Colacicco (it was a consolidated appeal) had done something we consider to be rather risky – it raised a preemption issue via a motion to dismiss. We’ve always been hesitant about doing that because a motion to dismiss is limited to considering the complaint, and we think that preemption motions have a greater chance for success when they present a more detailed record of what the FDA actually did - as opposed to just what the plaintiff claims the FDA did.

Colacicco was important in that respect because the court employed judicial notice to bring an extensive FDA record before it on a motion to dismiss:
  • FDA rejection of several citizen’s petitions involving a different drug. 521 F.3d at 269.
  • FDA approval letters for the drug in question. Id. at 270 & n.16.
  • Certain FDA talk papers concerning either the drug in question or that class of drug. Id. at 270, 273.
  • An FDA Public Health Advisory, concerning the risk at issue and the class of drug. Id. at 270-71, 273.
  • The drug’s labeling. Id. at 273 n.18.
  • An FDA public notice concerning the risk at issue and the class of drug, that took place after the injuries in question. Id. at 273.
  • Revised classwide labeling, also post-dating the injuries in question. Id. at 273-74 & n.20.
  • An FDA news bulletin concerning the revised classwide labeling. Id. at 273-74.
Judicial notice in Colacicco offered a way around the record problems otherwise inherent in a pleadings-based motion. Basically, if the information is available on the FDA’s website (or presumably on other unimpeachable Internet sources), it’s subject to judicial notice under Colacicco.

Several things have happened since then. First, and most notably, Colacicco itself was vacated in the wake of Levine. That’s hardly fatal to the evidentiary points we discussed in our prior post, since the plaintiffs only appealed the preemption issue – and nothing having to do with judicial notice. That much is clear from the plaintiffs’ petition for certiorari and reply in support of that petition. Still, in light of the Colacicco GVR (grant, vacate, remand) order, it’s prudent to look for other cases that also involve judicial notice of FDA actions and related information.

Second, the Supreme Court decided Levine and raised the bar for implied preemption based upon FDA actions concerning prescription drugs. Given the various preemption criteria set out in Levine, we don’t expect to see many preemption motions brought in prescription drug cases before the summary judgment stage – which means after substantial discovery. The problem of getting evidence of FDA actions before the court is thus unlikely to arise very often in future prescription drug preemption motions.

Third, the Supreme Court’s decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), recognizing broad express preemption in cases involving PMA medical devices has had the opposite effect. With express preemption firmly established in PMA medical device cases, we expected, and have seen (see our post-Riegel device preemption scorecard for details), a lot more medical device preemption motions being made on Rule 12 motions.

Getting FDA information – including but not limited to the fact of PMA approval – properly before the court on such motions becomes critical. See Kavalir v. Medtronic, Inc., 2008 WL 4087950, at *4 (N.D. Ill. Aug. 27, 2008) (denying preemption motion without prejudice where “FDA internet pages” offered as evidence of PMA approval did not establish the “specific form” of approval that the “specific” product involved in the litigation had received). The most persuasive source for establishing PMA approval is, of course, the FDA itself.

Fourth, the Supreme Court has toughened up pleading standards under Fed. R. Civ. P. 8, first in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and more recently in Ashcroft v. Iqbal, 129 S. Ct. 1937 (U.S. 2009). We’ve been all over this issue, here, here, here, and here, from the moment Twombly was first decided two years ago.

While we’ve naturally concentrated on how the heightened standard affects plaintiffs, it’s possible that our side might have to – or, more likely, want to – plead more FDA-related allegations in support of our defenses. That would be another way to get around the problem that occurred in Kavalir, since under Fed. R. Civ. P. 10(c) “[a] copy of a written instrument that is an exhibit to a pleading is part of a pleading for all purposes.”

Fifth, there may be other reasons, having nothing to do with preemption, that we want to take judicial notice of a particular FDA action in a particular case.

Before we discuss cases, we wish to point out, as we have before, that to the extent the FDA action in question is formalized and published in the Federal Register, it is subject to mandatory judicial notice. Congress has said so. 44 U.S.C. §1507 (“[t]he contents of the Federal Register shall be judicially noticed”); Thuringer v. American National Red Cross, 2006 WL 406353, at *3 (N.D. Iowa Feb. 17, 2006) (“the plain language of §1507 states that judicial notice of the regulation is mandatory”). See McKenney v. Purepac Pharmaceutical Co., 83 Cal. Rptr.3d 810, 819 n.1 (Cal. App. 2008) (FDA’s views on preemption published in the Federal Register subject to judicial notice); Alpharma, Inc. v. Pennfield Oil Co., 2008 WL 1990783, at *9 (D. Neb. May 5, 2008) (FDA “rules” published in Federal Register “are judicially noticed”) (citing statute).

As far as cases, here’s what we’ve found. In Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008), the court did exactly what we’ve been talking about – it took judicial notice of the defendant’s PMA approval in the context of a Riegel-based motion to dismiss:

Plaintiff argues against taking judicial notice of facts surrounding the FDA’s approval, stating that “disputable findings exist concerning the Defendant's compliance. . . .” However, this does not contradict the putative fact in question, which is only that the FDA approved [device] as a Class III device pursuant to the PMA process. . . . Neither of these [compliance-related] questions contradict the clear, undisputed, and publicly available fact put forward by Defendant; that the FDA approved [the device] as a Class III device. As a matter of law, this approval is granted only upon completion of the PMA process. Therefore, this Court takes judicial notice of the fact that [the device] is a Class III device approved by the FDA pursuant to the PMA process.

Id. at *1 (emphasis added). Heisner was followed, as to judicial notice, in Bausch v. Stryker Corp., 2008 WL 5157940, at *3 (N.D. Ill. Dec. 9, 2008). See Rivelli v. MH & W Corp., 890 A.2d 978, 982 (N.J. Super. A.D. 2006) (taking judicial notice of FDA drug approval).

Another important judicial notice case is In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 590 F. Supp.2d 1282 (C.D. Cal. 2008). In Epogen/Aranesp the court had this to say about jurisdiction of drug labeling:


On a motion to dismiss, the Court may take judicial notice of facts that are not “subject to reasonable dispute.” Under Fed. R. Evid. 201, a fact is not subject to reasonable dispute when it is “capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” The Court grants [the] request as to . . . labels for [the drug] that are publicly available on the FDA website, finding that the labels are documents not subject to reasonable dispute.
Id. at 1286. The court (Judge Gutierrez) relied upon its prior decision in securities litigation involving the same drugs. In that earlier case, also on a motion to dismiss, the court granted judicial notice of drug labeling and an FDA public health advisory – both of which were were available on the FDA’s website. In re Amgen Inc. Securities Litigation, 544 F. Supp.2d 1009, 1023 (C.D. Cal. 2008). Labeling was also granted judicial notice in: Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768, 776-77 (W.D.N.C. 2008), and Ebel v. Eli Lilly & Co., 536 F.Supp.2d 767, 781 (S.D. Tex. 2008), aff’d, 2009 WL 837325 (5th Cir. March 30, 2009) (unpublished).

Judicial notice is routinely given to FDA guidance documents, which are also available on the FDA’s website. See Johnson v. Pozen, Inc., 2009 WL 426235, at *1-2 (M.D.N.C. Feb. 19, 2009); In re Nuvelo, Inc., Securities Litigation, 2008 WL 5114325, at *2 (N.D. Cal. Dec. 4, 2008); Construction Laborers Pension Trust of Greater St Louis v. Neurocrine Biosciences, Inc., 2008 WL 4370010, at *5 (S D Cal. Sept. 23, 2008); Construction Laborers Pension Trust of Greater St Louis v. Neurocrine Biosciences, Inc., 2008 WL 2053733, at *7 (S.D. Cal. May 13, 2008); In re Intrabiotics Pharmaceuticals, Inc. Securities Litigation, 2006 WL 708594, at *8 (N.D. Cal. Jan. 23, 2006); see McGuire v. Dendreon Corp., 2008 WL 1791381, at *4 (W.D. Wash. April 18, 2008) (taking judicial notice of “FDA regulatory protocols,” which we guess means guidance documents).

An FDA public health advisory received judicial notice in Horne, 541 F. Supp.2d at 776-77. The same is true of FDA press releases in Matthews v. Donald, 2007 WL 2593086, at *1-2 (N.D. Ga. Sept. 4, 2007), and Wright v. Henderson, 2007 WL 2484317, at *2 (N.D. Ga. Aug. 28, 2007), and of an FDA safety alert in Rozzelle v. Rossi, 2007 WL 2571935, at *6-7 (W.D. Pa. Aug. 31, 2007).

The filing of adverse event reports with the FDA was granted judicial notice in Rollins v. St. Jude Medical, 583 F. Supp.2d 790, 804-05 (W.D. La. 2008).

A chart of drug approval dates in a document posted on the FDA’s website received judicial notice in Dimmick v. United States, 2006 WL 3741911, at *6 n.1 (N.D. Cal. Dec. 15, 2006).

Unspecified “FDA letters” were granted judicial notice in Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939, 945 n.1 (E.D. Wis. 2008), amended, 2009 WL 151573 (E.D. Wis. Jan. 22, 2009). Unspecified evidence that certain advertisements were submitted to the FDA received judicial notice in In re Bextra & Celebrex Marketing Sales Practices & Product Liability Litigation, 2006 WL 2374742, at *11 (N.D. Cal. Aug. 16, 2006).

FDA amicus briefs concerning preemption were judicially noticed in McKenney, 83 Cal. Rptr.3d at 819 n.1.

Finally, we’re not exactly sure what FDA documents were subject to judicial notice in In re Zyprexa Products Liability Litigation, 549 F. Supp.2d 496 (E.D.N.Y. 2008), but since Judge Weinstein literally “wrote the book” on evidence (including Fed. R. Evid. 201 governing judicial notice), we felt we should include it. The Zyprexa opinion first states generally that “[p]ublic documents issued by government agencies such as the Food and Drug Administration (“FDA”) may also be considered.” Id. at 501 (discussing judicial notice). Thirty pages later – following an extensive discussion of the history of the drug, the opinion concludes, “[t]o the extent that judicial notice was taken of any evidence, the court complied with” Rule 201. Id. at 530-31. See also Meyers v. Bayer AG, 735 N.W.2d 448, 332 n.1 (Wis. 2007) (blanket judicial notice of various FDA “public records”); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 203 & n.4 (E.D. Pa. 2007) (same).

On a related topic, in Banks v. County of Allegheny, 568 F. Supp.2d 579, 596 & n.9 (W.D. Pa. 2008), the court took judicial notice that a particular drug was “a medically acceptable course of treatment, relying upon “strategies” for control of the disease in question that were available on the website of the Centers for Disease control.

One last thing that we found – not specifically FDA-related, but still of interest – is that there is recent precedent for taking judicial notice of the contents of published medical literature. See United States v. Pfizer, Inc., 2009 WL 1456582, at *10 (E.D.N.Y. May 22, 2009).

Beyond judicial notice, there’s a technical issue about getting proper links to FDA PMA approval data that's available on the FDA’s website. This has been a pain in the you-know-what because, while individual PMA approval information is available (if you know where on the FDA’s website to look), the weblinks aren’t stable. By that we mean the links generated by the search function on the FDA site expire in about a month or so.

Thus these FDA-generated PMA links aren’t very good to put in briefs supporting a dispositive motion, because by the time the briefing is finished, the links in the initial brief don’t work any more. Recently, however, we got this tip from Dave Gossett over at Mayer Brown on how to solve that problem.

Here’s what to do. The trick to creating FDA website addresses for PMAs that don’t go bad in a few weeks is not to use the link for the database search result that appears with the results of performing a search. Those expire. Instead, it’s necessary to find and use the URL for the actual search itself.

Don’t understand? Well, neither did we at first. So we’ll give you an example. We’ll use the ninety-ninth supplement to the nine hundred and ninety ninth PMA that the FDA received in 1999 (like the FDA would ever approve that many devices in one year). That way we won’t have to worry about numerical typos, at least.

We could do the links with actual PMA and PMA supplement numbers, but we don’t want to single out any particular device. So remember, that since we’re using made up numbers, the made-up links aren’t going to go anywhere.

From the FDA’s PMA search page (assuming this was an actual PMA, which it isn’t) the following link would bring up the approval data for PMA #P990999, Supplement S099:


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?start_search=1&PMANumber=P990999&SupplementNumber=S099
It’s just a matter of plugging in the PMA number and PMA supplement number for the device that’s of interest. These numbers, if not already known to counsel, will be available from the client once the identity of the particular device in question is established. It’s always been available, so we guess that this sort of track-back capability exists for all PMA-approved devices.

Whenever a different PMA number or PMA supplement number is desired, just change the numbers that appear after the “PMANumber” or “SupplementNumber” parts of the URL we just posted. Note that (most practitioners, of course, already know this) the first two numbers of the PMA number are for the year in question. If that number is less than a thousand, a “zero” is necessary right after the year. Ditto for any PMA supplement with a supplement number under one hundred. It’s necessary to include the proper number of zeros as place holders.

The same process should work to link to FDA approval information for any supplement to any PMA that’s on the FDA’s system. If only the original FDA-approved PMA is desired (no supplement), just replace the “SupplementNumber” portion of that search screen with the phrase “SupplementType=NONE”. That is,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?start_search=1&PMANumber=P990999&SupplementType=NONE

will give you a link to the original PMA (no supplement) for the first example we used above. Also, on the search result for any PMA supplement, there’s a link directly to the approval data for the original PMA.

Now, it’s not always necessary to know the details of the device (or to bother the client for them) in order to get this information. The search functions on the FDA’s search page aren’t limited to PMA and PMA supplement numbers. It’s possible to search for devices in other ways – such as using the trade name for the device or the date that the PMA (or supplement) was approved. Once the necessary PMA and PMA supplement numbers are obtained, they can be plugged in as already described.

Since URLs in the form of:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?start_search=1&PMANumber=P******&SupplementType=****
trigger the search function itself, they will automatically link to a newly created temporary file on the FDA website each time they are used. Thus they won’t expire like the URLs for the actual search results do. For that reason, this type of link stays active permanently and can be used in filing briefs that the court might not read for several months.

If you use FDA evidence as often as we do, this is good stuff to know.

Strike Three; You're Out!

It only took five years and two reversals on appeal, see In re St. Jude Medical, Inc., 425 F.3d 1116, 1119-21 (8th Cir. 2005); In re St. Jude Medical, Inc., 522 F.3d 836 (8th Cir. 2008), but the class action allegations in the St. Jude/Silzone litigation are finally history. The trial court reluctantly ("on a blank slate" the court would have certified the class, yet again) struck those allegations the other day. Here's a copy of the opinion. In the wake of the latest reversal (which we discussed here), the plaintiffs had tried to substitute "omissions" for affirmative misrepresentations in their allegations, but even a class-action-friendly judge couldn't stomach that hair splitting.

We doubt the Eighth Circuit would permit a third Rule 23(f) interlocutory appeal.

The long-running St. Jude saga is an excellent example of why class-action tolling of the statute of limitations in mass tort cases is inequitable and should not be allowed, a subject we've discussed before (just click on our "tolling" label on the right hand side of the screen (scroll down) for those posts). There's no way in logic or law that dilatory plaintiffs suing over this device should be entitled to over five years of tolling based upon meritless allegations of a supposed nation-wide class based upon extraterritorial application (questionable in and of itself) of one state's consumer fraud statute.


Wednesday, June 24, 2009

The State Of The Big Firm Blogosphere

Beck thinks only about drug and device law. Herrmann sometimes veers off-topic and thinks about blogging.

This morning's post, a frolic and detour about big firm blogging, is Herrmann's work alone.

We took a peek at Kevin O'Keefe's recent report on the State of the AmLaw 200 Blogosphere to see whether blogging is catching on at big firms. Kevin reports that 41 percent of the AmLaw 200 now have blogs, which is a 110 percent increase in the last two years. Those numbers speak for themselves.

We then thought about three other things.

First, we expected to see that many of the blogs that Kevin identifies had withered on the vine. It's remarkably easy to start blogging, and unspeakably difficult to stick with it. We figured that many of the blogs on the list would not have posted recently.

We were surprised. It looks as though many of the blogs are quite active. In our unscientific survey (we did not look at all 227 blogs), we stumbled across only a few blogs that had plainly died. The "Benefits Biz Blog" hasn't published a post since November 11, 2008; we'd say that one's toast. Similarly, the "Climate Change Law Blog" last posted on February 2, 2009; either those guys are on sabbatical or that one's done. Likewise for the "Daily Dose of IP," which last posted on April 30, 2009; we think the fat lady's singing there, too.

But, for the most part, the big firm bloggers seem to be blogging along.

We also noticed (again, completely unscientifically) that blogs published by lawyers at firms sponsoring multiple blogs seem to be more active than blogs published by lawyers who are writing alone. Our best guess is that the shame factor is at work here: "If those of us in the Labor Practice can post regularly to our blog, then you guys in the Securities Practice should be able to do the same."

We're big believers in shame at the Drug and Device Law Blog: Beck shames Herrmann, and Herrmann shames Beck; if shame were not such a potent force, we'd have abandoned this gig years ago.

We next compared the list of firms with blogs to the AmLaw 200 report on profitability. Of the ten firms with the highest profits per partner (we know, we know! everyone criticizes that metric, but the public is still fascinated by it) in the United States, only one has any connection to a blog. And that "connection" is pretty remote.

Kirkland & Ellis, alone among the top ten PPP firms, has a blogging lawyer. But the efforts of that lawyer -- whose work appears at the Sports Law Blog -- just barely count as a "big firm blog." It's true that the blog's founder is a K&E associate, but the blog is now written by five "contributors" -- most of whom appear to be law professors -- and more than a dozen "guest contributors," who generally have no connection with K&E. And, like our own blog, the Sports Law Blog is not "firm branded." It appears to be the product of the collection of folks who publish it, rather than an institutional effort by the firm.

The other top ten PPP firms -- Wachtell, Quinn Emanuel, Boies Schiller, Sullivan & Cromwell, Paul Weiss, Cravath, Simpson Thacher, Cleary, and Schulte Roth --have no apparent affiliation with any blogs at all.

Make of that what you will.

Finally, our last observation. We're still nuts: So far as we can tell, we're still the only two big firm bloggers who co-host a blog while working at firms that are head-to-head competitors.

We're not sure exactly what that proves. Maybe our approach to this blogging thing doesn't make any sense. Maybe some of our readers think that it's commendable that the two of us can play nicely in the sandbox. Or maybe we just like each other.

Aw, that can't be it.

Anyway, perhaps someone with more spare time than we have can look at the list of big firm blogs and draw more scientific conclusions than we have. The data's there for the mining; someone should take a look.

Tuesday, June 23, 2009

Going After Anyone In The Neighborhood (Adelmann-Chester v. Kent)

Vitek manufactured and distributed Proplast dental implants, used to treat degeneration of the temporal mandibular joint in the jaw. The FDA recalled those implants in 1991. The whole world sued.

Vitek declared bankruptcy.

Dr. Charles Homsy was an officer, director, and shareholder of Vitek.

Homsy skipped the country.

DuPont manufactured a raw ingredient that Vitek used to manufacture the implants.

Courts held that DuPont was protected by the "bulk supplier doctrine," which is an absolute defense to failure-to-warn claims.

Who's a plaintiff to sue?

675 plaintiffs chose to join in a single lawsuit in Louisiana state court to sue, among other, Dr. John Kent, a dentist who was a professor at LSU School of Dentistry and who had served as a scientific advisor to Vitek as it developed the Proplast device.

That's the backstory of Adelmann-Chester v. John N. Kent, D.D.S., 2008-0770, 2009 La. App. LEXIS 1073 (La. App. 4 Cir. June 5, 2009), the case that we're thinking about today.

A bunch of plaintiffs settled their claims and other claims were dismissed as time-barred, leaving a mere 163 plaintiffs when Kent moved for summary judgment. The trial court granted that motion, and the court of appeals affirmed.

Kent had a fair number of dealings with Vitek. He helped to design the implant and obtained patents in that regard. He received a royalty payment when Vitek sold certain products. He acted as a consultant to Vitek and owned some of the corporation's stock. But Kent never participated in fabricating or selling the implants. Id. at *3.

On that record, claims against Kent couldn't survive. Negligence claims didn't work because Kent owed no duty to patients implanted (by other dentists) with the Proplast device. Id. at *20.

Strict product liability claims couldn't work because Kent was not a "manufacturer'"or "professional vendor" of the implants. Id. at *34. (Along the way, the Adelmann-Chester court cited Reeves v. AcroMed Corp., 103 F.3d 442 (5th Cir. 1997), for the proposition that the inventor of a medical device cannot be liable under a product liability theory as a manufacturer or supplier of the product. One of us worked mighty hard to achieve that result in Reeves way back when, so we're delighted to see that the precedent is making a lasting impact.)

People other than "manufacturers" or "vendors" can be liable for failure to warn only if they fail to pass on to product users an adequate warning that the manufacturer provided. Since plaintiffs offered no evidence of any warning provided with the Proplast device, Kent couldn't be liable for failing to pass that warning along. Id. at *36.

The court also noted that, although there may have been negligence in the production of the Proplast device, there was no evidence that Dr. Kent personally had been negligent in the particular activities that he performed. Id. at *33-*34.

Those holdings undercut each of plaintiffs' legal theories, so the appellate court chose not to address assorted other alleged errors identified by plaintifs on appeal.

We're pleased to see the Louisiana Court of Appeal hold the line in this case. When a primary defendant isn't around to pay claims, and a bunch of plaintiffs are claiming injury, it's easy for courts to ignore the law and look for anyone in the neighborhood to hold liable. (Think about the tertiary asbestos defendants, for example.)

But defendants have rights, too. A scientist (or dentist, or physician) can properly choose to perform specific roles for a medical device company -- helping to design a product and giving scientific advice -- and to invest in the company -- presumably because the scientist thought the company was selling a good product -- without agreeing to manufacture or sell the product. If the scientist breaches a duty in the role that he or she agreed to undertake, then the scientist can properly be held liable.

But the scientist shouldn't be held liable to the entire world, after the fact, simply out of a perceived need to hold someone -- anyone! -- liable to pay damages to allegedly injured plaintiffs. That result would upset the parties' appropriate expectations when they originally entered their arrangements, and would cause many scientists to refuse to work with medical device companies, which would surely work to society's collective detriment.

Monday, June 22, 2009

Daubert In A Med Mal Context

A couple of issues in Svindland v. The Nemours Hospital, 2009 U.S. Dist. LEXIS 43315, No. 05-417 & 05-441 (E.D. Pa. May 19, 2009), caught our eye -- namely: (1) whether to exclude comparative risk evidence and (2) whether to allow plaintiffs to discover the raw clinical data that formed the basis of published medical articles.

Svindland involved two medical malpractice cases brought by the parents of infants who died after heart surgery performed by Dr. Norwood. Plaintiffs claimed that Dr. Norwood did not cool the infants pre-operatively (don't ask!) for long enough to protect the infants' organs and that the informed consent process for the surgery was inadequate.

The cases have a long procedural histroy, with which we won't bore you.

Ultimately, plaintiffs wanted to introduce expert testimony comparing mortality data from other hospitals to show that Dr. Norwood's mortality rates were unusually high. That's of interest because we've seen plaintiffs make similar attempts to compare different drugs having the same indication. In Svindland, the court rejected this testimony under Daubert.

The first data set was based on ICD-9 billing codes (for insurance reimbursement), rather than IPCCC treatment codes. The billing codes can be misclassified or fail to describe accurately the specific nature of the surgery being performed. Id. at *15. The other data set did not contain information about patient co-morbidities and reported only 30-day survival rates. Id. at *16-*17. And, even if the underlying data were sufficient, plaintiffs' expert intended to use the RACHS-1 method of comparing the surgical data, and that method "was designed to compare the whole body of work of a given program to a national standard for each classification group. It was not meant to compare one surgery to another surgery, or to look at the performance of an individual surgeon for a particular operation." Id. at *18-*19. The court thus excluded the expert testimony.

Plaintiffs also wanted to introduce and compare "evidence of morbidity and mortality by introducing isolated pages of medical records of other patients who had poor outcomes or who died following pediatric open-heart surgery." Id. at *19. In other words, plaintiffs wanted to create their own anecdotal case studies. The Court found that evidence to be both irrelevant and, if relevant, more prejudicial than probative. "Even if mortality rates might seem relevant to the plaintiffs' informed consent claims, the plaintiffs have not persuaded the Court that the mortality data that they would seek to introduce have taken into account co-morbidities or have otherwise been risk-adjusted so as to be relevant to the surgeries at issue." Id. at *22.

The second issue is trickier, but no less interesting. Plaintiffs served subpoenas "to obtain the raw data underlying publications of studies done" at a hospital where Dr. Norwood had previously worked, and which included data about some of Norwood's earlier surgeries, "to allow their expert to independently evaluate the data and offer an opinion on whether the cooling technique at issue increased the risk of adverse surgical outcomes." Id. at *24.

This is a delicate issue for practicing lawyers (such as the two of us) to discuss in public, because our clients' needs vary with the situation. If the published studies support our clients' position, then we may well resist any effort by our opponents to obtain and reanalyze the underlying raw data. On the other hand, if the published studies do not support our clients' position, then we may seek to compel disclosure of that data to permit our experts to review and reanalyze it. For a less biased (and more scholarly) approach to this issue, you might look at Bill Childs' article about discovery into the peer review process, The Overlapping Magisteria of Law And Science: When Litigation and Science Collide, 85 Neb. L. Rev. 643 (2007).

To avoid having our own words quoted back at us some day, we take no position on the propriety of subpoenaing raw data underlying a published study. Instead, we'll just report on the court's holding.

In Svindland, the court held that the hospital did not have to disclose data underlying the published studies. The court chose not to address the public policy issues, such as whether permitting litigation-related discovery into the raw data underlying scientific research would chill medical research.

Instead, the court ruled on narrower grounds: "The data are not relevant to show what Dr. Norwood knew when he operated on Ian Svindland or Michael Daddio. Nor will they prove the applicable standard of care [at the times of the surgeries]. They also will not shed further light on the issues of proximate and but-for causation." Id. at *30. The court also thought the data might unduly confuse the jury, so the court denied plaintiffs' motion to compel and granted the defendants' motion for a protective order.

If you're ever on that side of the issue, you might put Svindland to use.

Friday, June 19, 2009

Addendum to Yesterday's Off-Label Use Post

Sometimes we just happen to speak too soon. That happened yesterday, with our "rant" about off-label promotion. If we'd just waited until a day later, we'd have been able to incorporate the new opinion on that subject from the Epogen/Aranesp litigation. Here's the money quote, from our perspective, in that opinion, about truthful off-label promotion:
Plaintiffs could not predicate RICO and state consumer fraud claims on what are, in essence, misbranding claims, absent allegations that [defendant] made false or deceptive statements. This is because off-label promotion is not inherently fraudulent; truthful off-label promotion of drugs does not violate RICO or state consumer protection laws. Rather, it violates the FDCA. But the law is very clear in that only the federal government, and not a private plaintiff, may enforce the FDCA.

In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, No. 2:08-ml-01934-PSG-AGR. slip op. at 9 (C.D. Cal. June 17, 2009). Now we don't think the FDA can prosecute truthful off-label promotion either, given the First Amendment, but private attempts to penalize truthful scientific speech are even more dangerous, given that they are subject to no enforcement standards whatever.

Thursday, June 18, 2009

Our Latest Rant On Off Label Promotion

We have been frequent critics of the FDA’s efforts to prohibit truthful promotion of off-label uses. We’ve argued that these restrictions contrary to the public health because they limit the ability of the most knowledgeable party (the drug manufacturer) to communicate with the medical community about the risks and benefits of cutting edge medical therapy. Actually, even the FDA (sometimes) admits this:

FDA does recognize, however, the important public health and policy justification supporting dissemination of truthful and non-misleading [information] on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities. Once a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product’s approved labeling. . . . These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care. Accordingly, the public health may be advanced by healthcare professionals’ receipt of [information] on unapproved new uses of approved or cleared medical products that are truthful and not misleading.

FDA Guidance on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (available here).

We’ve called these restrictions unconstitutional because truthful scientific speech is protected by the First Amendment from governmental suppression on the basis of its content. We’ve proposed alternatives that would encourage more, not less, truthful speech about off-label uses while providing incentives to add new uses to FDA-approved drug labeling.

We’re thinking all these thoughts again, for a couple of reasons. The first reason is what appears to be (at least to the limited extent that we follow medical science) the most compelling off-label use situation since we began blogging more than two years ago. Over the last couple of weeks there’s been a rash of stories in the media (as this Google search demonstrates) that a drug called Zileuton – approved by the FDA for the treatment of asthma – might be effective in treating, or even preventing, chronic myeloid leukemia (“CML”), which is a common form of this disease. The coverage even reached northern Maine, where Bexis was on vacation.

CML is a serious condition – a killer. According to the National Cancer Institute:

The median survival is 4 to 6 years, with a range of less than 1 year to more than 10 years. Survival after development of an accelerated phase is usually less than 1 year and after blastic transformation is only a few months.

The same site says that there are about 5,000 new cases a year, with somewhat under 500 deaths, in the US alone.

We’ll leave the medicine and science to doctors and scientists, but insofar as we understand it, apparently the same gene (called “Alox5”) creates the chemicals that cause inflammation (why it's important to asthma) and also those that are essential to leukemia cancers. Thus, the researchers who discovered this dual genetic activity tried Zileuton – which inhibits the activity of this gene – on special mice that had CML (they were at the Jackson Laboratories, which is pretty much the mother ship of "knock-out" mice). They found that Zileuton worked better than the most effective currently approved drug for CML - at least in mice.

From what we gather, doctors who treat leukemia consider this development a least a potential medical breakthrough.

It’s also an off-label use. That’s why we’re intentionally not linking to the website (which we easily found) of the manufacturer of Zileuton. We're self-censoring because we don’t want to do anything that might get the manufacturer in trouble with the FDA.

We don’t have any independent knowledge about Zileuton, but if Wikipedia is to be believed, that drug's been around since 1997. Given how long drugs typically spend in development, this probably (we don’t know, we’re guessing) means that it was patented several years earlier. Drug patents typically run seventeen years, which means that Zileuton’s patent might well expire before clinical trials designed to confirm the recent research could be completed. With imminent generic competition, there's no incentive to spend the megabucks that such trials cost.

So the use of Zileuton to treat CML is likely to remain an off-label use, even if the initial research is borne out in clinical practice, and this drug turns out to be the best treatment (and perhaps even a prophylactic) for a pretty common form of cancer with a high death rate. That, in turn, means that it’s quite possible we’re looking at an eventual off-label use/standard of medical care treatment.

The off-label status of the use prohibits "promotion" of the use by the manufacturer. So the manufacturer of the Zileuton – which by statutory requirement receives all adverse drug incidence reports from doctors – cannot, for fear of illegal “promotion,” truthfully inform the public about the risks and benefits of Zileuton in treating CML. And didn’t somebody state recently that, “manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.” Wyeth v. Levine, 129 S. Ct. 1187, 1202 (2009)? It seems we’ve heard that name somewhere.

For this reason, we think the FDA’s restrictions on the manufacturer truthfully telling the public what it learns about off-label uses are absurd – and dangerous. We’re dealing with a potential medical breakthrough involving a drug that’s immediately available for off-label use in life-or-death treatment decisions. It may be better than anything else available; it may not. Nobody knows the optimal dosage regimen for the treatment of CML. It may be different from the on-label treatment for asthma. But we expect that a lot of doctors treating possibly terminally ill CML patients are going to try to find out over the next few years.

And if something goes wrong with this off-label use, the manufacturer’s going to be sitting out there with a litigation target on its back, no matter what it does.

And that brings us to the second reason we’ve been thinking about off-label use recently.


There’s a new case, Riley v. Cordis Corp., ___ F. Supp.2d ___, 2009 WL 1606650 (D. Minn. June 5, 2009), that anybody interested in preemption and off-label use should read. While it’s a PMA device case, and thus a lot of the discussion involves Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), enough of the discussion in Riley addresses implied preemption under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), that the case can also be of use in defending off-label use allegations involving prescription drugs – like the Zileuton/CML situation just described.

Riley involved a drug-eluting stent – a nifty recent development that combines a stent (a tube of sorts that physically holds an artery or vein open) with the delivery of a drug that independently helps prevent occlusion of the affected vessel. Like any prescription drug or medical device, this product has risks. As the Riley court stated:

After implantation, the [] stent slowly releases [a drug] to prevent the artery from being narrowed through restenosis (the build-up of new tissue). But the release of [the drug] also slows the normal healing process; specifically, it slows the beneficial growth of a thin, slippery layer of endothelial cells over the stent and arterial wall. Before this healing process is complete, there is an increased risk of blood-clot formation.

2009 WL 1606650, at *1. Plaintiff alleged that she got a clot, and that it caused a heart attack. Id.

Drug-eluting stents are considered by the FDA to be medical devices requiring PMA – and thus they're protected by preemption under Riegel. Given that a drug is also involved, presumably the FDA could have regulated such a combination product as a drug, but the Agency has chosen to apply its device rather than its drug regulatory scheme to this particular type of product.

This particular stent was approved for only a limited use – certain types of problems with arteries of a certain size. One thing plaintiff claimed was that the FDA had not approved the stent for was something called “direct stenting,” which means implanting the stent without first using a balloon catheter (that is, the type of device at issue in Riegel) to expand the diameter of the vessel prior to implantation. 2009 WL 1606650, at *2.

Five points to Gryffindor if you’ve guessed by now that the plaintiff’s surgery involved direct stenting.

So the plaintiff in Riley – looking for a way around Riegel preemption, played the off-label use card for all it was worth.

Fortunately, in Riley the off-label use card turned out to be the deuce of clubs.

Predictably, the plaintiff in Riley argued that preemption did not apply to “parallel” claims. 2009 WL 1606650, at *3. That’s where things start to get interesting. Employing analysis similar, but not identical, to that used in In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), Riley applied both express and implied preemption principles to narrow this exception – although, oddly, the court never cited Sprint Fidelis (for our discussion of this aspect of Sprint Fidelis, see here).

To escape express preemption under Riegel, a “parallel” claim “must be premised on the breach of a state-law duty that is the same as a duty imposed under the FDCA (or one of its implementing regulations).” Riley, 2009 WL 1606650, at *3. Thus “the conduct that is alleged to give the plaintiff a right to recover under state law must be conduct that is forbidden by the FDCA.” Id. If the manufacturer’s conduct wasn’t prohibited, then to impose tort liability would impose the dreaded “additional or different” state requirement that the FDCA expressly preempts.

But that’s not enough. In Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court also recognized that “enforcing the FDCA is the exclusive province of the federal government.” Riley, 2009 WL 1606650, at *3 (quoting Buckman).
Thus, a private litigant cannot sue a defendant for violating the FDCA. Similarly, a private litigant cannot bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA-that is, when the state claim would not exist if the FDCA did not exist.
Id. (not quoting Buckman).

Riley found only a “narrow gap” between the preemption Scylla of Riegel and the Charybdis of Buckman:

The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted [under Riegel]), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). For a state-law claim to survive, then, the claim must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.

Id. at*4 (emphasis added).

Plaintiff Riley wasn’t able to thread that needle – and thus attacked off-label use instead. The first attack was pretty weak. He claimed that Riegel express preemption “only applies when the medical device is used in a manner that was reviewed and approved by the FDA.” Riley, 2009 WL 1606650, at *4. There was a slight problem with that argument. All right, a not-so-slight problem. Riegel itself involved an off-label use. Id. So plaintiff argued, in effect, ignore Riegel because the off-label use point was “not actually argue[d].” Id.

That didn’t work very well. The court in Riley responded with a long block quote from Buckman (including, we have to note, a cite to a law review article one of us wrote), and concluded that preemption in Buckman existed “in part because the Court did not want to deter off-label use of medical devices.” Riley, 2009 WL 1606650, at *5. In light of Buckman, plaintiff’s anti-off-label use argument was illogical:

Under [plaintiff’s] theory, though, a manufacturer of a medical device could scrupulously adhere to the FDA’s every command and meet every requirement. . .and nevertheless be sued under the tort law of any of the fifty states because a health-care provider, without the manufacturer’s consent or even knowledge, decided to put the device to an off-label use. Given what the Supreme Court said in Buckman about the off-label use of medical devices, it seems highly unlikely that the Court intended to create such a loophole in Riegel.

Id. We like this analysis especially because, as we alluded to earlier, Buckman was an implied preemption case, so the same rationale would also apply to prescription drugs – such as Zileuton being used off-label to treat (or prevent) CML.

The court also blew away the plaintiff’s next argument – that because the off-label use had not specifically been approved by the FDA, there were no applicable FDA “requirements” that could be a basis for preemption. Another slight (well, not-so-slight) problem: this argument was “inconsistent with the text of the statute." Riley, 2009 WL 1606650, at *5. That’s because, under the express terms of the FDCA (this textual argument wouldn’t apply to drugs) “the question is not whether there are federal requirements applicable to a particular use of a device; the question is whether there are federal requirements applicable ‘to the device.’” Id. (emphasis original).

Plaintiff also argued that, because there was an off-label use, the FDA couldn’t have known of the particular use, and therefore there was no preemption. The court countered that “nothing in Riegel even hints that whether a state-law claim is expressly preempted. . .turns on the nature or extent of the information made available to the FDA at the time it approved a device.” Riley, 2009 WL 1606650, at *6. Further, if the lack of information was allegedly deliberate, the plaintiff was alleging fraud on the FDA and was preempted under Buckman. Id.

Having thus crashed the last off-label use argument into the Riegel/Buckman brick wall, plaintiff in Riley seized upon the already mentioned combination nature of the product – claiming that because the stent was “coated with a drug,” Riegel was ousted by the implied preemption analysis of Wyeth v. Levine. Riley, 2009 WL 1606650, at *6. This argument, while creative, was nonsensical:
It makes no sense – indeed, it would probably be impossible – to pick apart the components of a medical device and apply different preemption analyses to different components. Because the FDA regulated the [] stent as a medical device, the Court applies the express preemption analysis of §360k(a) to the entire device.

Id.

Plaintiff’s last general preemption argument – lashing out at the FDA as “a poorly run agency that is not able to ensure the safety of the medical devices it reviews” – also failed. The court declined to get into “policy,” holding that “[i]f [plaintiff] believes that [preemption] represents a poor policy choice, his argument is better addressed to Congress.” Riley, 2009 WL 1606650, at *7. Hear! Hear! If only the Supreme Court had been so wise in Levine. Tort suits brought under state law are not a proper vehicle for challenging the merits of federal policy.

Having rejected all of plaintiff’s general preemption arguments, the court went on to throw out each of the plaintiff’s specific claims. Some of these holdings raise additional off-label use points. Plaintiff claimed, for example, based upon an FDA regulation (21 C.F.R. §801.4), that any manufacturer that so much as knew about an off-label use is obligated to change its label to warn about it. Riley, 2009 WL 1606650, at *7-8. In this respect, the FDA’s restrictions on off-label promotion backfired on plaintiff – since only very limited promotion was permitted:
[F]ederal law at the time relevant to this action explicitly permitted manufacturers to promote off-label uses of their devices by disseminating certain types of information about those off-label uses-and to do so without having to provide instructions or warnings about those off-label uses. It seems highly unlikely that, at the same time, §801.4 was forcing manufacturers who knew of off-label uses of their devices but did not promote those off-label uses to provide instructions or warnings. It would make no sense to impose on manufacturers who were not promoting off-label uses of their devices a duty to instruct or warn, but to impose no such duty on manufacturers who were promoting off-label uses.

Id. at *8 (emphasis original). Thus, mere knowledge of an off-label use cannot, consistently with the FDA’s regulatory scheme, give rise to a duty to warn.

The only warning claim that might survive (but was inadequately pleaded) was that the defendant engaged in off-label promotion that was not only prohibited by the FDCA, but which was also inaccurate, and thus might support a traditional state-law inadequate warning claim. Riley, 2009 WL 1606650, at *10. Here’s where another of our favorite Supreme Court cases Bell Atlantic Co. v. Twombly, 550 U.S. 544 (2007), comes into play. To state a non-preempted claim of this sort, the plaintiff must be able to allege – with at least some “plausible” factual support:
  • “that [defendant] affirmatively promoted the use of the [] stent” for the off-label use plaintiff’s surgeon performed, which should “identify a particular oral or written communication” demonstrating such promotion;

  • “that [defendant] was aware or should have been aware of the dangers inherent in those off-label uses and yet failed to warn of those dangers or give adequate instructions about those off-label uses”;

  • “that implanting the [] stent in a particular off-label way caused [plaintiff’s] heart attack”; and

  • “that, had [defendant] adequately warned or instructed about this particular off-label use, [plaintiff’s] physician would not have implanted a [] stent (or would have implanted it in a different way).”
Riley, 2009 WL 1606650, at *11. The Court was “frankly skeptical” that plaintiff could, consistently with Fed. R. Civ. P. 11, make these allegations. Id. But being a good sport, the court was willing to let them try.

A similar fate awaited for plaintiff’s fraud claims – except that, instead of the Twombly standard, the plaintiff was required to plead “with specificity” under Fed. R. Civ. P. 9(b). Riley, 2009 WL 1606650, at *12. Because the court concluded it was impossible for plaintiff to meet this stricter pleading standard, the fraud claims were dismissed with prejudice. Id. at *13.

Plaintiff alleged a raft of other claims in Riley. Only two merit any real attention. The court’s express warranty analysis was fairly standard among post-Riegel decisions: allegations based upon information approved by the FDA were preempted, but allegations based upon information (assuming there was any) not approved by the FDA were not preempted. Riley, 2009 WL 1606650, at *13-14. Typically, the express warranty allegations were “uninformative.” Id. at *13. Thus plaintiff was required to replead in accordance with Twombly. Id. at *15. Good luck. Our experience is that plaintiffs, forced to plead all the elements of express warranty usually can't do it – if they could have, they would have the first time around.

Finally, as to manufacturing defects, the plaintiff in Riley could not rely upon FDA inspections that took place after the stent in question was implanted. 2009 WL 1606650, at *15. This time plaintiff had pleaded too much, rather than too little. Pleading everything that had ever gone wrong during the device’s entire regulatory history was a no-no. Rather, the only allegations that might possibly survive were those that could be causal of the plaintiff’s injury:

[Plaintiff] does not clearly allege that any of [defendant’s] violations actually resulted in the manufacture of a single defective stent, much less that the particular stent that was implanted in [plaintiff] was defective. Obviously, [plaintiff] cannot sue [defendant] for negligently manufacturing stents that were implanted in other people.
Id. at *15. Having seen numerous complaints that flagrantly violate this common-sense stricture, we’re quite pleased to see one get thrown out.

In Buckman the Supreme Court ruled that off-label use was both legal and medically proper. It can also be life saving, as the recently-discovered off-label treatment for leukemia could well turn out to illustrate. Thus, we’re pleased to find decisions like Riley that refuse to punish a manufacturer with additional liability simply because a physician chooses to use its drug or device off-label in treating a patient.

Wednesday, June 17, 2009

Pennsylvania News Flash: Bugosh Appeal Dismissed

Over a blistering two-justice dissent (Saylor and Castille), the Pennsylvania Supreme Court just dismissed the appeal in Bugosh v. I.U. North America, Inc., No. 7 WAP 2008, as improvidently granted.

Bugosh was the case that the Court had taken expressly to address whether to change Pennsylvania product liability law from its current idiosyncratic form of limited, but extreme, strict liability, to the more mainstream Restatement Third reasonableness-based approach.

While the dismissal order gives no reason, Bexis (who filed an amicus brief for PLAC in Bugosh) believes that the status of the defendant as an intermediate seller, rather than as an actual manufacturer (it was an asbestos case) was the basis for the dismissal. The Third Restatement treats intermediate sellers more "strictly" than manufacturers.

This result leaves Pennsylvania law more confused than ever, as recently the Third Circuit predicted that Pennsylvania would adopt the Third Restatement. See Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38 (3d Cir. 2009). We blogged about Berrier here. Thus, in state court, the old Azzarello-based (that's Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978), for you non-Pennsylvanians) form of strict liability prevails, while the federal courts are bound by Berrier to apply the Third Restatement in diversity cases based upon Pennsylvania law.

We can only hope that the Pennsylvania Supreme Court resolves this rather bizarre situation quickly - but it's now been almost six years since Azzarello was explicitly called into question in Phillips v. Cricket Lighters, 576 Pa. 644, 841 A.2d 1000 (2003).

Tuesday, June 16, 2009

The Volokh Conspiracy On Our Ethics Question

We asked this morning why (1) it seemed ethical to offer into evidence an inadmissible document on the hope that opposing counsel wouldn't object and the document would be admitted, but (2) it seemed less ethical to effect a late removal to federal court on the hope that opposing counsel wouldn't object and the case would remain in federal court.

Our readers are plainly the strong, silent type, since only a few of you have posted comments responding to our question.

But David Bernstein took a shot at our question over at the Volokh Conspiracy, and he has commenters coming out his eyeballs.

Professor Bernstein's "own view, putting aside the formal rules of professional conduct, is that attorneys' first obligation should be to the integrity of the legal system, and not to their clients' interests. Even so, I'm not sure I'd say 'no' to either question, given that a yes answer means that incompetent attorneys who don't realize they are violating the rules would have an advantage over competent attorneys."

But the commenters to Bernstein's post are all over the lot. Thus, for an assortment of reactions to the ethics question we posed this morning, please take a look at Volokh.

And we extend a warm welcome to our new readers from the Volokh Conspiracy.

Calling For The Views Of The Solicitor General

We wrote last week that the Supreme Court had asked for the views of the Solicitor General as to whether the Court should grant certiorari in the vaccine preemption case of American Home Products v. Ferrari. We noted that, if the SG spoke in favor of granting cert, that would significantly increase the likelihood of a grant.

A new study examines empirically the effect of a Call for the Views of the Solicitor General (or "CVSG"). A description of the article appears here at the National Law Journal. But, if you don't care to read the whole thing, here's the money quote:

"• The overall grant rate increases from 0.9 percent to 34 percent following a CVSG from the Court. In other words, the Court is 37 times more likely to grant a petition following a CVSG. For petitions on the paid docket, the grant rate increases even more, to 42 percent; a paid petition is 47 times more likely to be granted following a CVSG.

"• The Court follows the recommendation of the solicitor general 79.6 percent of the time, when that office recommends either a straight grant, deny, or grant/vacate/remand."

We're delighted to see that empirical work confirms the conventional wisdom on this point.

Taking A Run At Things

Our recent post about the reviewability of remand orders prompted a spirited off-line discussion that has morphed into today's issue.

We don't have an answer for you today; we're just launching a question into the blogosphere, and we'll see what comes back.

Here's our question.

Scenario one:

I know that a document is multiple hearsay. I have no good faith argument as to why the document is admissible into evidence. I nonetheless offer it into evidence at trial.

Opposing counsel is asleep at the switch and doesn't object. The document is therefore admitted into evidence.

No problem, right? My conduct is not unethical and may in fact be required by the duties counsel owes to a client.

Scenario two:

I blow the 30-day deadline in which to remove a lawsuit to federal court. I have no good faith argument as to why the case is removable.

But I figure: "Heck, I'll remove it anyway. Opposing counsel may be asleep at the switch and not file a motion to remand within 30 days. If plaintiff doesn't timely move to remand, the objection to removal is waived, and my case can be tried to judgment in federal court."

Is that ethical?

We've heard a lot of different reactions to that.

No one seems to think that counsel sins by offering inadmissible evidence at trial, hoping that opposing counsel won't object.

But people have very different reactions to removing a non-removable case, hoping that opposing counsel won't object.

Some folks have said that both types of conduct are ethical.

Some have told us that the proffer of evidence is oral, but the notice of removal is written. Rule 11 attaches only to writings and so doesn't apply to the offer of evidence.

So we changed the hypo, asking now whether the conduct is "ethical," rather than whether the conduct "violates Rule 11."

And some folks have said that they can't quite put a finger on it, but removing a non-removable case (and hoping for a waiver) is somehow more offensive than offering an inadmissible document into evidence (and hoping for a waiver).

The academic blogosphere was happy to respond when we posted about Twombly and Iqbal (here, here, and here, among other places). We'll be curious to see if that same gang (or someone else) can help us with our ethics hypo.

Have at it.

Monday, June 15, 2009

Blast From the Past - A Baycol Affirmance

Last Friday, the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) issued a long awaited (some three years long) decision in the Baycol case, Pauley v. Bayer. We've been interested in Pauley because the trial court opinion being appealed was probably the best Pennsylvania/state court generally authority on inadmissibility of anecdotal adverse event reports. See Pauley v. Bayer Corp., 2006 WL 463866 (C.P. Phila. Co. Jan. 26, 2006).

Years ago - before blogging - Bexis represented a non-manufacturing defendant in Baycol litigation. As to that defendant, the litigation has long since resolved, but out of an abundance of caution, we'll stick strictly to the legal conclusions in Pauley for the duration of this post.

In the first place, we warn you that Pauley - in the Superior Court - is an unpublished, non-citable memorandum opinion, despite its being 27 pages long and addressing issues of first impression in the Pennsylvania appellate courts. Nevertheless, we're discussing it for three reasons: (1) there's no reason Pauley can't be cited outside Pennsylvania, (2) it contains a significant discussion of Ohio law, and (3) the Superior Court non-citation mandate may well violate the Open Courts provision of the state's constitution.

Here are the main holdings in Pauley:

(1) Both Ohio and Pennsylvania follow the learned intermediary rule. Pages 12-14.
(2) Adverse event reports ("AERs") are anecdotal and thus "generally unreliable and not scientifically verified," thus a drug manufacturer has no duty to inform physicians "comparative AERs" (that is, that AERs are purportedly more common for one drug than another) Pages 15-17.
(3) Because the drug's label had a specific contraindication of the particular co-prescription (prescribing drugs simultaneously) combination at issue in the case, the warning was adequate as a matter of law regardless of AERs involving the contraindicated combination. Pages 18-19.
(4) An expert who admitted that he was not an MD and thus not qualified to make medical diagnoses was properly precluded from testifying to the diagnoses of patients in a clinical trial. Pages 21-24.
(5) Animal toxicity studies were properly excluded "because the data was not probative of the drug’s actual effect on humans." Pages 25-27.

Better late than never - and better unpublished than not at all.

Physician Confusion: Do Physicians "Sell" Prescription Drugs?

Does "situational ethics" mean that your ethics change to fit the situation?

Because "practical lawyering" sure seems to mean that your legal status should change to fit the situation.

We couldn't help but laugh when we read Hadley v. Wyeth Laboratories, Inc., No. 14-07-01055-CV, slip op (Tex. App. [14th Dist.] May 28, 2009) (link here).

There's nothing funny about the opinion on its face. Dr. Hadley and Wyeth had both been named as defendants in a "diet drug" (Pondimin/Redux) product liability case. Both successfully moved for summary judgment based on the statute of limitations. Dr. Hadley filed a cross-claim against Wyeth, claiming that he was an innocent seller entitled to indemnity from the product manufacturer under Texas Civil Practices and Remedies Code Sec. 82.

The parties filed cross-motions for summary judgment on the indemnity claim. The trial court granted Wyeth's motion and denied Hadley's, and the appellate court affirmed. The court of appeals held that physicians are not, under the common law, "considered sellers for products liability purposes," because physicians are primarily providing medical services, not goods, and "the essential nature of the relationship [between physician and patient] is . . . a professional, medical one."

The court also held that the statutory definition of "seller" does not expand the common law definition so as to include physicians. Under the statute, a seller must be "engaged in the business of selling," and physicians are not: Physicians "are not selling the medication for commercial purposes but are engaged in the business of providing professional medical services."

So why, you might ask, did we think that was funny?

We spend our lives watching physicians tell courts that physicians are not "sellers" of prescription drugs and devices. A "seller" of a product may theoretically be liable on a product liability claim, because a "seller" is arguably in the chain of distribution of the product. A physician named as a defendant in a product liability case will thus scream that he's not a "seller."

And "sellers" may also be theoretically liable under contract theories because of the nature of the relationship between "buyer" and "seller."

So, nine times out of ten, physicians insist that they are not sellers of prescription products.

That's what we're used to.

And along comes Hadley. The situation changes, and a physician decides that it would be convenient to be deemed a seller.

But that's not enough to make us laugh. (We're easy, but we're not that easy.)

No, no, no.

We wouldn't have laughed unless we had represented the medical device defendants in Balderston v. Medtronic Sofamor Danek, 285 F.3d 238 (3d Cir. 2002). There, a prescribing physician, Dr. Balderston, sued the companies that manufactured the medical devices he prescribed. Balderston alleged that the companies had deceived him about the FDA regulatory status of the medical devices, which exposed Balderston to lawsuits by patients claiming that he had not given them appropriate informed consent.

Balderston had blown the statute of limitations on any conventional claims, so he sued under the Pennsylvania Unfair Trade Practices and Consumer Protection Law, which had a six-year limitations period. But to have standing under the UTPCPL, a plaintiff must be a "purchaser" of a product.

You guessed it: In Balderston, the plaintiff pleaded that a physician is not a seller of a prescription medical product, but rather a buyer -- a "purchaser" -- of them.

So there you have it: Physicians do not sell prescription medical products. Unless it's convenient to do so, and then they do.

And, in the right situation, physicians are not sellers but buyers -- "purchasers" of the products they prescribe to their patients.

It's enough to make your head spin.

Or at least to make you ponder the meaning of the phrase "situational ethics."

Thursday, June 11, 2009

An Accutane Appellate Win

This just in:

Yesterday afternoon, the Eleventh Circuit affirmed, in an unpublished opinion, the trial court's grant of summary judgment in an Accutane-suicide case. Stupak v. Hoffman-La Roche, Inc., No. 07-15980, slip op. (11th Cir. June 10, 2009) (link here).

In a nutshell, Stupak, age 17, was prescribed Accutane in December 1999 to treat acne. In May 2000, while still taking Accutane, Stupak committed suicide. Plaintiff pleaded product liability claims saying that ingestion of the drug caused the suicide.

The MDL trial court granted summary judgment to Hoffman-La Roche on the ground that the warning on the product was adequate and plaintiff could not prove proximate cause. Yesterday, the Eleventh Circuit affirmed, holding that the package insert mentioned the risk of suicide. Plaintiff asserted that the warning was inadequate because it didn't mention the possibility of a suicide "without premonitory symptoms" -- warning signs of depression, for example -- but the record contained no evidence that Roche knew that Accutane could cause suicide without those symptoms.

Because this is an unpublished decision, it will have limited value as a precedent. But since it's an appellate court affirming an MDL trial judge's grant of summary judgment, it might reinforce the trial judge's willingness to grant summary judgment in other Accutane cases.

UPDATE: Moments after we published this post, an alert reader sent us this note:

I believe this is Rep. Bart Stupak's son. Rep. Stupak has been a vocal critic of ACCUTANE for many years - see, e.g., http://www.house.gov/stupak/accutane.shtml.

The Learned Intermediary Rule And Expert Witnesses

Quite some time ago (at least a month) a reader asked us to comment on how the learned intermediary rule affects the need for expert testimony to prove the adequacy of warnings pertaining to drugs and medical devices. Well, that request wasn't the kind of thing that had any time urgency on it, so we’re only now getting around to it.

We hope it’s better late than never.

The question of expert witnesses and warnings comes up because the learned intermediary rule only requires warnings to medical professionals – and not to ordinary people like plaintiffs/patients. In the law, when one is dealing with the requirements of a profession (such as medicine, but any profession, really) those requirements are typically proven through the testimony of an expert witness who is a member of that profession, and thus is competent to offer an opinion as to what those professional requirements are.

It's not a controversial point.

So the context of the learned intermediary rule, the adequacy inquiry becomes: Since the warning must be adequate as to the physician, is it necessary for a plaintiff (since the plaintiff bears the burden of proving a warning is inadequate) to present the testimony of a physician with an opinion that the warning wasn’t good enough to alert doctors to the full extent of the risk?

From what we can tell, most courts to consider the issue have required such expert testimony.
The most recent decisions we’ve found addressing this question are Montagnon v. Pfizer, Inc., 584 F. Supp.2d 459, 463 (D. Conn. 2008), and Colville v. Pharmacia & Upjohn Co., 565 F. Supp.2d 1314, 1321 (N.D. Fla. 2008). Coincidentally, both involve the same drug, Depo-Provera, a contraceptive alleged to reduce bone density (there’s considerable doubt whether that’s even a compensable injury, but that’s an issue for another post).

Colville dealt with the more common situation – where the plaintiff didn’t have any expert who purported to opine on the adequacy of the warning as to the medical profession. The first question was whether the issue was one of substantive state law (the state of Florida), or a procedural matter under the Federal Rules of Civil Procedure. The court considered it substantive, and looked to the Florida Supreme Court:

The manufacturer's duty to warn of the drug’s dangerous side effects is directed to the physician rather than the patient. Therefore, the adequacy or inadequacy of the warning to inform a physician must, except in the more obvious situations, be proved by expert testimony.

Upjohn Co. v. MacMurdo, 562 So.2d 680, 683 (Fla. 1990) (cited in Colville, 565 F. Supp.2d at 1321). Plaintiff offered the testimony of three doctors, but not one of them had an opinion on adequacy. 565 F. Supp.2d at 1321. The court therefore concluded that the warning was adequate, and the defendant entitled to summary judgment due to the plaintiff’s failure to offer expert proof. Id. (also following Paparo v. Ortho-McNeil Pharmaceutical, 2007 WL 121149, at *4 (S.D. Fla. Jan. 11, 2007)).

Montagnon was the same, but different. Again, the plaintiff’s expert “testified at his deposition that he was unable to offer an opinion as to the adequacy of the warnings.” 584 F. Supp.2d at 462. But this plaintiff’s counsel was a little more resourceful – or at least tried to be. Plaintiff claimed that, even in the absence of an outright expert opinion, certain studies established inadequacy of the warning. Id. at 463. But the studies were: (1) equivocal in their language, and (2) arguably rebutted by other studies. Thus, the court held that plaintiff’s warning claim failed in the absence of expert testimony:


[T]here is no expert evidence with which the jury could assess the link between the warnings and the injuries suffered by the consumer. . . . [N]either the Court nor a lay jury is capable of assessing the credibility of [the studies] . . . or comparing the results of these studies with other studies that came to contrary conclusions. . . . Even if expert testimony were not required as a matter of law, the Court finds that no jury of laymen, on the basis of two studies alone . . . could reasonably decide that [defendant]should have rewritten its warnings.
Id. at 463 (discussion of FDA role omitted).

These two cases exemplify the clear weight of the law. The Florida Supreme Court in MacMurdo cited the following precedent as supporting the expert testimony requirement: Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 692 (Miss.1988); Hill v. E.R. Squibb & Sons, 592 P.2d 1383, 1388 (Mont. 1979), and Dion v. Graduate Hospital, 520 A.2d 876, 880 (Pa. Super. 1987).

Does it?

Does it ever. Fortenberry held:

The adequacy of a warning addressed to the medical community may fall into the category of issues requiring expert testimony. Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. The terms and applications of a warning on such a drug, in order to have meaning, must be explained to the jury. This is a subject so distinctively related to some science, profession, business or occupation as to be beyond the ken of the average layman.

Hill stated:


In matters with respect to which a layman can have no knowledge at all, the court and jury must be dependent on expert evidence. The adequacy of a warning directed to physicians is such a matter. This conclusion is consistent with the only other case we have found where on similar facts an attempt was made to reach the jury without expert testimony that the warning was inadequate.
And Dion agreed:

[W]e find that in the instant case the trial court properly concluded that expert testimony was necessary. Without expert testimony, there is a complete absence of evidence to show that the warning was inadequate. Thus, a conclusion that the product was defective could not reasonably or properly be reached by the jury. . . . Frequently, the jury, or the court trying a case without a jury, is confronted with issues which require scientific or specialized knowledge or experience in order to be properly understood. Certain questions cannot be determined intelligently merely from the deductions made and inferences drawn from practical experience and common sense. On such issues, the testimony of one possessing special knowledge or skill is required in order to arrive at an intelligent conclusion. . . . Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. The terms and applications of a warning on such a drug, in order to have meaning, must be explained to the jury. This is a subject so distinctively related to some science, profession, business or occupation as to be beyond the ken of the average layman. Thus, we hold that in a complex products liability action such as this, expert testimony is required to determine whether the drug manufacturer's warning to the medical community is adequate.
As for the follow-on point of whether the expert has to have special training, or can simply be a practicing physician, the decisions we’ve seen have held that more or less any doctor’s opinion will suffice – but we caution that all this precedent is at least a quarter century old. See Mauldin v. Upjohn Co., 697 F.2d 644, 648 (5th Cir. 1983); Mahr v. G.D. Searle & Co., 390 N.E.2d 1214, 1237-38 (Ill. App. 1979); Ortho Pharmaceutical Co. v. Chapman, 388 N.E.2d 541, 553-54 (Ind. App. 1979).

While we think that these cases suffice to illustrate both the general proposition that the learned intermediary rule requires expert testimony that drug/device warnings are adequate as to physicians – and the limitations to that rule – we rather suspect that the initial request that we address the topic was made at least in part with the intent to induce another of our state-by-state surveys. Being gluttons for punishment, we will oblige.

Here is a list of all the cases we know of that require expert testimony to establish adequacy of warnings for products governed by the learned intermediary rule:

Connecticut: Montagnon, supra.

District of Columbia: McNeil Pharmaceutical v. Hawkins, 686 A.2d 567, 583-84 (D.C. 1996) (“persuaded by” Northern Trust v. Upjohn (see Illinois)).

Florida: MacMurdo, supra; Colville, supra; Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1369-70 (S.D. Fla. 2007); Paparo, supra; Timmons v. Purdue Pharma Co., 2006 WL 263602, at *3 n.6 (M.D. Fla. Feb. 2, 2006); Bogle v. Sofamor Danek Group, Inc., 1999 WL 1132313, at *4 (S.D. Fla. April 9, 1999); Broderick v. Danek Medical, Inc., 1999 WL 1062135, at *3 (S.D. Fla. April 9, 1999); McDaniel v. Sofamor Danek Group, Inc., 1999 WL 1062136, at 3 (S.D. Fla. April 9, 1999); Barrow v. Bristol-Myers Squibb, 1998 WL 812318, at 30 (M.D. Fla. Oct. 29, 1998), aff’d, 190 F.3d 541 (11th Cir. 1999) (table); Haggerty v. Upjohn Co., 950 F. Supp. 1160, 1168 (S.D. Fla. 1996), aff’d, 158 F.3d 588 (11th Cir. 1998) (table).

Illinois: Northern Trust Co. v. Upjohn Co., 572 N.E.2d 1030, 1035-36 (Ill. App. 1991) (“such a requirement is the logical extension of the fact that a prescription drug manufacturer's duty to warn is directed to the prescribing physician. For that reason, only a physician or someone with specialized knowledge would be qualified to determine whether the warning was inadequate”); Schrott v. Bristol-Myers Squibb Co., 2003 WL 22425009, at *6 n.3 (N.D. Ill. Oct. 23, 2003) (“failure to present expert testimony independently dooms her negligent failure to warn claim”), aff’d, 403 F.3d 940 (7th Cir. 2005); Woodbury v. Janssen Pharmaceutica, Inc., 1997 WL 201571, at *9 (N.D. Ill. April 10, 1997) (“in order to prove inadequate warnings, plaintiff must show that the expert testimony is admissible”); Langer v. Dista Products Co., 1996 WL 526763, at *2 (N.D. Ill. Sept. 12, 1996); Koncz v. Burroughs Wellcome Co., 1994 WL 178320, at *4 (N.D. Ill. May 9, 1994); Martinkovic v. Wyeth Laboratories, Inc., 669 F. Supp. 212, 215 (N.D. Ill. 1987).

Iowa: Benedict v. Zimmer, Inc., 405 F.Supp.2d 1026, 1033 (N.D. Iowa 2005) (“to show the device was defective because of inadequate instructions or warnings requires expert testimony”).

Louisiana: Sheridan v. Merck & Co., 2003 WL 22902622, at *3 (E.D. La. Dec. 8, 2003); Hornbeck v. Danek Medical, Inc., 1999 WL 1117107, at *3 (W.D. La. Aug. 5, 1999) (summary judgment granted because “plaintiff offered no expert evidence to refute the adequacy of the package insert”); Doucet v. Danek Medical, Inc., 1999 WL 1129648, at *2 (W.D. La. June 28, 1999) (same).

Mississippi: Fortenberry, supra.

Montana: Hill, supra.

New Jersey: Prince v. Garruto, Galex & Cantor, 787 A.2d 245, 252 n.2 (N.J. Super. A.D. 2001) (“expert testimony must address . . . what a qualified and practicing physician would have understood”); Grobelny v. Baxter Healthcare Corp., 2008 WL 2186417, at *2 (D.N.J. May 23, 2008) (“testimony of a physician would be necessary for the trier of fact to understand whether the warning was adequate”).

New York: Mulhall v. Hannafin, 841 N.Y.S.2d 282, 286-87 (N.Y.A.D. 2007) (defendant entitled to summary judgment where plaintiff’s warning expert report was impermissibly “conclusory”).

Ohio: Jones v. Roche Laboratories, 616 N.E.2d 545, 548 (Ohio App. 1992) (“A drug manufacturer's primary responsibility is to provide adequate warnings concerning its product to prescribing physicians. . . . [E]xpert opinion evidence is necessary for that showing”); Graham v. American Cyanamid Co., 350 F.3d 496, 514 (9th Cir. 2003) (“When a plaintiff alleges that the warning given to a prescribing physician is inadequate, the plaintiff must prove his claim through expert medical testimony”); Saraney v. TAP Pharmaceutical Products, Inc., 2007 WL 148845, at*6 n.3 (N.D. Ohio Jan. 16, 2007); Yanovich v. Sulzer Orthopedics, Inc., 2006 WL 3716812, at *12 (N.D. Ohio Dec. 14, 2006), aff’d, 255 Fed. Appx. 957 (6th Cir. 2007).

Pennsylvania: Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1154 (1996) (“expert medical testimony is required to determine whether the drug manufacturer's warning to the medical community is adequate”); Dion, supra; Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 751 (E.D. Pa. 2007) (“the adequacy of a warning in prescription medical device cases must be proven by expert testimony”); Burton v. Danek Medical, Inc., 1999 WL 118020, at *8 (E.D. Pa. March 1, 1999); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *13 (E.D. Pa. Dec. 29, 1998).

South Dakota: Carlsen v. Javurek, 526 F.2d 202, 206 n.5 (8th Cir. 1975 (“plaintiff was not prepared to pursue this issue by offering any expert testimony to support a theory of inadequacy of warning”).

What? Only thirteen states? Are you guys slipping?

Maybe, but this post doesn't prove it. Those are simply the only states that have expressly looked at the issue. At least that we know of. If anybody's got additional cites, well you know how we are.... Send 'em along.


On the other hand, there’s next to no precedent holding that plaintiffs can establish the adequacy of drug/device warnings to doctors without the opinion of a physician who is a member of the class to whom these types of warnings are directed.