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:
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,

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:******&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.

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