New Amendment To Rule 26 Concerning Expert Disclosures

If you're involved in drug and device (or any) product liability litigation, you're dealing with expert witnesses.  And if you're dealing with experts, you'll want to think about the proposed amendments to Fed. R. Civ. P. 26 that (if all goes smoothly) could go into effect on December 1, 2010.

They deal essentially with two things:  (1) what expert witness productions and privileges, and (2) what to do about independent witnesses qualified to offer expert opinions.

Both are very interesting.

As to expert witnesses, we've blogged before (all right, not us, but a guest post) about some of the gamesmanship that goes on with respect to the production of material that an expert "considered" - including drafts of expert opinions - under the current draft of Fed. R. Civ. P. 26(a)(2)(B), which mandates broad disclosure and contains a comment that most courts have interpreted as overriding work-product and even attorney-client privileges with respect to anything that's shown to an expert, even if the expert does not rely.

That language, and how courts intrepreted it, led to a lot of unintended consequences.  There's the litany of questions at expert depositions about every meeting the expert has had with counsel, what notes were taken, and what drafts exist.  There's the engagement of two parallel sets of experts, with one set designated as "consulting" (that is, non-discoverable), so that attorneys can interact with at least one set of experts in peace - and then, when everything's done, the "testifying" expert adopts the product of all that as his/her pristine report.  There's so much gamesmanship that, in a lot of cases, the parties agree to stipulate out of this language.  Why is all this done?  Because every now and then, some lawyer screws up and the other side gets really valuable.  See, e.g., Synthes Spine Co., L.P. v. Walden, 232 F.R.D. 460 (E.D. Pa. 2005), for a cautionary tale.

Anyway, after 12/1/10, a lot of this (although probably not all) should be a thing of the past.  The rules committee has amended Rule 26(a)(2)(B) to limit expert disclosures to "facts or data" (not the broader term "information") that the witness considered.  The new draft specifically recognizes work product privilege for drafts and attorney communications with experts with a couple of exceptions in an entirely new section, Rule 26(b)(4)(B-C).  Here's the new language in toto:

(B) Trial-Preparation Protection for Draft Reports or Disclosures. Rules 26(b)(3)(A) and (B) protect drafts of any report or disclosure required under Rule 26(a)(2), regardless of the form in which the draft is recorded.


(C) Trial-Preparation Protection for Communications Between a Party’s Attorney and Expert Witnesses. Rules 26(b)(3)(A) and (B) protect communications between the party’s attorney and any witness required to provide a report under Rule 26(a)(2)(B), regardless of the form of the communications, except to the extent that the communications:

(i) relate to compensation for the expert’s study or testimony;
(ii) identify facts or data that the party’s attorney provided and that the expert considered in forming the opinions to be expressed; or
(iii) identify assumptions that the party’s attorney provided and that the expert relied upon in forming the opinions to be expressed.

 Thus the only exceptions to the scope of the privilege are compensation (including compensation over the entire course of related litigation), what the attorney gave the witness to consider (so we'll still be able to establish if the attorney did the expert's research for him/her), and what assumptions the attorney told the expert to make (so we'll still be able to establish if the attorney did the expert's thinking for him/her).

All the other stuff - draft reports, notes, oral conversations, etc. - are now explicitly protected from discovery by the work product doctrine and the usual requirements of that doctrine.  That means that attorneys on both sides can talk to their experts unimpeded, let them take notes, let them prepare drafts, edit those drafts, etc., free from fear of inadvertant disclosure, gotcha games and all the rest the the current version of Rule 26 has engendered.   In short, it will no longer be necessary to treat experts as if they were radioactive.

It also marks the final recognition by the Rules Committee of the role that expert witnesses play in modern litigation - that they're a part and parcel of a party's case and not part of some sort of independent search for the truth.  For those seeking utopia, there's still the option of a court appointed expert under Rule 706, but experts are now essentially no different than co-counsel, legal assistants, and the like as far as work product is concerned.

A few other things to think about with this new rule.  First, it's not retroactive, and the earliest it could go into effect would be December 1, 2010.  Increasingly, as we get closer to this deadline, we'll have to keep it in mind when considering discovery scheduling.  We're on our own until then.  Second, there doesn't seem to be any intent to affect substantive Daubert decision-making.  The stuff necessary to establish that an expert has abdicated his research or reasoning to the attorney is still discoverable.  Third, since some parts of expert notes might be discoverable under the exceptions in new Rule 26(b)(4)(C), it's probably a good idea to have the expert designate specifically when any notes are of conversations with retaining counsel.  It's still a good idea to take that sort of rudimentary precaution to make assertion of privileged status easier.

That's one part of the amendment to Rule 26.  The other has to do with designation of experts who are not retained by parties.  In our neck of the woods that usually means treating physicians and other health care providers.  There's a new section, Rule 26(a)(2)(C), that provides that non-retained experts don't have to provide reports to be entitled to give opinions.  The attorney designating such a witness simply has to describe the anticipated testimony:

(C) Witnesses Who Do Not Provide a Written Report. Unless otherwise stipulated or ordered by the court, if the witness is not required to provide a written report, this disclosure must state:

(i) the subject matter on which the witness expected to present evidence under Federal Rule of Evidence 702. 703. or 705 and
(ii) a summary of the facts and opinions to which the witness is expected to testify.

This rule is intended to make it easier to get opinion, as well as fact, testimony from persons such as treating physicians (but also employees of corporate parties) who aren't being paid for their testimony and thus can't be expected to jump through the hoops erected for retained experts.  It's expected to put a halt to the "you can ask facts but not opinions" fights that currently crop up at depositions of this sort of witness.

The new Rule 26(a)(2)(C) draws no distinctions between the sides.  Thus, defendants are as free to designate and describe the opinion testimony of plaintiffs' treating physicians as plaintiffs are.  The amendment commentary states:

A witness who is not required to provide a report under Rule 26(a)(2)(B) may both testify as a fact witness and also provide expert testimony under Evidence Rule 702, 703, or 705.  Frequent examples include physicians or other health care professionals and employees of a party who do not regularly provide expert testimony.  Parties must identify such witnesses under Rule 26(a)(2)(A) and provide the disclosure required under Rule 26(a)(2)(C). The (a)(2)(C) disclosure obligation does not include facts unrelated to the expert opinions the witness will present.

Rules Appendix at C-29.

That's got us thinking.  Well, if we can freely designate treaters as expert witnesses, then it follows that we can talk to them, doesn't it?  With the federal rules now explicitly recognizing both sides' equal rights to call treaters as experts for the first time, this amendment should lend additional force to what's already the majority rule:  that state-law proceduraly restrictions on defendants talking to treaters - other than privileges (which are usually waived by a plaintiff's filing suit) - are inapplicable in federal court.  We've discussed that rule before here.  And, as we've also discussed before, HIPAA expressly exempts the "lawful process" of "judicial proceedings" from it's scope.

We offer no predictions on the ultimate result, but we've now got another arrow in our quiver in our search for equal rights to informal interviews of treating physicians.

Online Appellate Opinion Sources – Rating The Websites

When we’re blogging, we frequently have to track down appellate opinions that haven’t been added to Lexis or Westlaw yet – let alone been published.  That means that we’re repeat users of the websites that courts have established (or in some cases not) to provide the public, such as us, with access to their newly issued opinions.  So for something a little different, we’re going to provide you with a list of these website pages, as well as any opinions of our own, about the strengths and weaknesses of each.


Don’t expect actually to read this post from beginning to end – it’s dreadfully boring.  Just remember it’s here whenever you need to get a slip opinion quickly.

Federal Courts

Supreme Court:

The most recent United States Supreme Court opinions are found here. The site’s okay in that it lists opinions by chronological order and has the full name of the case.  It also tells you who wrote them, if you know the abbreviations (the first letter of the Justice’s name, and if that’s ambiguous, the first letter of the first name as well).  But for the nation’s highest court, we frankly expected better.  There’s not a hint on the page what any of these cases are about; even whether they’re civil, criminal, or administrative in nature.  Maybe the Court thinks that all its opinions are so important and well-known that people who come to its site know that.  If they do, they’re wrong, at least about us.

First Circuit:

First Circuit opinions are located here.  The page is pretty bare bones, with just dates, caption names, and the court of origin.

Second Circuit:

The Second Circuit makes us work.  We have to start here, and then click on a menu for today’s or this week’s opinions, and choose either “opinions” (what we usually want) or “summary orders” (which we rarely look at).  All this work isn’t particularly rewarding, since all we get is the opinion name and date – not even the court below.  New York may be the city that never sleeps, but the Second Circuit’s website is sleepy.

Third Circuit:

You get two choices: precedential opinions and non precedential opinions.  Both are by date, give the docketed name and tell you what court the appeal was from.

Fourth Circuit:

The Fourth Circuit’s almost unique among the federal appellate courts (at least the ones we frequent) in that it’s hosted by PACER.  That’s not a bad thing, either.  In addition to the basics, the site also contains short-phrase descriptions (“criminal,” “civil private”) that at least tell us something about the substance of the opinion.  There are other problems with PACER, but the Fourth Circuit’s website isn’t one of them.

Fifth Circuit:

We don’t like this one very much. To start with, it’s organized by docket number rather than date – except for the most recent cases.  Docket numbers are important to court clerks, but frankly, we don't give a damn. We’re generally searching by date, and that means we have to look through the whole list of cases – and the list is generally pretty long. The Fifth is a busy court.

Sixth Circuit:

We think that the Sixth Circuit’s opinions page is designed by the same folks who did the First Circuit. Yawn.

Seventh Circuit:

Like the Second, you have to click through on this page to get any opinions, but at least it’s only a choice between “today” and “this week.”  Once we get to the opinions, it’s a little better, with a “case type” column that at least gives us some idea what’s in there.

Eighth Circuit:

We like the Eighth Circuit’s opinion page. It’s got the best substantive description of its opinions hands down. At this site, we never click on an opinion involving a drug company as a defendant only to find that it’s an employment discrimination case we don’t care about. The other circuits would do well to study how this one does it.

Ninth Circuit:

It’s a pretty good page for a busy court.  It’s by date, and it provides both court of origin and a subject matter code.  And it’s all sortable, too, if we’d like to see, for example a list of all “civil” cases.  There’s a drop down that takes the user to a separate page for unpublished opinions.

Tenth Circuit:

This one’s probably the worst of the lot, although it’s got relatively nice graphics.  It’s another site with a docket number fetish.  If you miss even one day, the site takes away even the names of the opinions.  And even for the day’s current opinions, it’s just the docket number and name. There’s no substantive description, or even court of origin.

Eleventh Circuit:

There are several views on the Eleventh Circuit’s page.  Probably the best one for our purposes is this one. It’s organized by date and gives the complete name.  But someone has decided that the lower court docket number is more important than any topical description.  Nobody but a court clerk would make that choice. Some other views also have a “type” code that could really use a glossary to be understandable.

District of Columbia Circuit:

Check that – the Fourth Circuit’s not unique.  The DC Circuit uses PACER too. We don’t use this one much, but we thought we’d include it for completeness’ sake.  We're glad we don't; it’s not very good.  It’s by docket number rather than date or name, and no other information is provided.  You can click through to a month-by-month search, which provides more opinions, but not more information about them. D on’t choose the by day option, either. We did, and had no idea what we were looking at.

State Courts

Alabama:

Alabama appellate courts don’t believe in online opinions.  Uniquely, the Alabama Supreme Court’s website  doesn’t have any opinion option at all.  Neither does its unified judiciary page.  Alabama Getaway indeed.

Alaska:

Alaska Supreme Court opinions are available here.  It’s a pretty bare bones operation, but it still beats Alabama’s.

Arizona:

Arizona Supreme Court opinions are here. From this page choose the year. After doing that for, say, 2010, the results are pretty slim – date, docket name, docket number. The Arizona intermediate appellate decisions, segregated by court, are much more informative, here and here.

Arkansas:

Start here, where there are links to the most recent opinions for both the state’s supreme and intermediate appellate courts.  Then you can click through either court until eventually arriving at a chronological list of dates on which opinions issued.  Arkansas makes us work for its opinions.

California:

They don’t tell you a whole lot about them (especially with California’s peculiar writ practice that puts “Superior Court” in the name of a lot of opinions, but California appellate opinions are here. There’s a dropdown menu that allows a choice of Supreme Court or intermediate court opinions, along with date criteria - all on the same page.

Colorado:

If the Colorado Supreme Court keeps its opinions on its website, we can’t find them.  So we ended up here.  But we must admit, we didn’t try all that hard before going to the Colorado Bar Association’s somewhat more user friendly opinion page instead.  Still, it would be nice if they put the names of the opinions where we could see them.

Connecticut:

If you’re lucky enough to want an opinion on the day of filing from a Connecticut appellate court, it will be here. Otherwise you’ll have to click through to the “archives” for either the Supreme or appellate courts of the state.

Delaware:

Bang!  And you’re right there.  Both Supreme and Superior courts (granted, it’s not a big state).  Very accessible and well organized – although the “description” could use a bit more specificity.

District of Columbia:

The Court of Appeals for the District of Columbia maintains a search page for its opinions here.  Recent opinions are available by month.  Just names and numbers, though.

Florida:

The opinions for both the Supreme Court and the five DCAs are available from this page.  Clicking through, the Supreme Court opinions are here (without much description beyond the case name) and there are also links to the individual District Courts of Appeals if you click through enough screens.

Georgia:

The Georgia Supreme Court’s opinion page itself isn’t much, but it has links to recent opinions by year.  The link we’re putting up next will eventually expire, but here is the page for the 2010 opinions – most recent ones at the bottom (different than most of the sites we’ve seen).  No descriptions, just case names and docket numbers. The Georgia Court of Appeals has a completely different site.  Neither site links to the other, which is odd.  We didn’t find any opinions on the Court of Appeals’ site.

Hawaii:

Aloha!  The opinion page is really easy to use without a lot of clicks - but will probably expire and be changed when 2010 ends.  Both Supreme and appellate decisions all in one place organized by date.  No real substantive descriptions, though.

Idaho:

The Idaho Supreme Court keeps a good opinions page as these things go. There’s even a short description of each of the cases, and criminal cases are segregated on a different page that we never have to look at.  The same is true of the opinions for the state’s intermediate appellate court, available here.

Illinois:

Illinois Supreme Court opinions are available here. There’s a handy-dandy summary available for each case, although the takes an extra click. The opinions are sortable in various ways, although I doubt we’d ever get past the default mode.  Good page.  The Illinois intermediate court opinions are available here, although without any helpful summaries.

Indiana:

Indiana Supreme Court opinions are collected chronologically here, and possibly here (although there were no really recent opinions when we checked).  The same is true for the Indiana Court of Appeals, here and here. There are no substantive descriptions on any of these pages.

Iowa:

You have to do a lot of clicking but it’s all there – eventually. The Iowa Supreme Court posts its most recent opinions here and archives them here. They even tell us what’s coming here. The same set of links are available on the Iowa intermediate appellate court page.  Oddly the Court of Appeals has very useful summaries here, while the Supreme Court has none.

Kansas:

Kansas has everything (Supreme and appellate) all on one convenient page.  Convenience trumps everything else, though.  There are nothing but docket names and numbers as a guide to what’s in these opinions.

Kentucky:

There’s a lot of idiosyncratic terminology in Kentucky. The supreme court’s called the Court of Justice, and its opinions are called “minutes.”  They’re available here.  All that page contains are dates, but clicking on each date opens up a nifty window with very useful summaries of the cases.  The Kentucky Court of Appeals keeps its minutes (opinions) here.  It’s the same kind of click-on-the-date deal, but without the nice substantive summaries.

Louisiana:

The Louisiana Supreme Court site’s an odd duck (or should that be pelican).  There doesn’t seem to be an archive of recent opinions as such, but the page for “news releases” will – after clicking on the releases described as “opinion” – yield first the name of the case and then the opinion. That’s not particularly user friendly, but we didn’t see any other way to get there from here.

Maine:

There’s not a lot of description, but clicking here takes one directly to recent Maine Supreme Judicial Court opinions.

Maryland:

Opinions of both the Maryland Court of Appeals (the state’s supreme court) and the Maryland Court of Special Appeals (the intermediate appellate court) are available here.  But several more clicks are required to get to the opinions themselves.  It’s necessary to select the court and then sort (typically by date).  Cases from 2010 are available here (MCA) and here (MCSA), but these links will no longer be current at the end of the year.  Neither page has any description of the cases beyond their captions.

Massachusetts:

The supreme court (technically the Supreme Judicial Court) of the state (technically the Commonwealth) of Massachusetts has some sort of arrangement with Westlaw to handle dissemination of the Court’s recent opinions starting here.  Clicking on “opinions” for either the supreme or intermediate appellate courts generates a free search of the opinions for the last week or so.  For anything before that, there’s an opinion archive here. There’s no information about what the cases are about.

Michigan:

One-click recent opinion service for the Michigan Supreme Court is available here, although this link will expire with the end of the current court term.  No information is provided beyond the name of the case.  The court’s non-expiring link to “recent opinions” is here.  Recent opinions for both the Michigan Court of Appeals can be found here, but it really helps to know what you’re looking for first. This uniquely uninformative set-up gives only dates – not even opinion names.  The names don’t appear until the individual files are unzipped.

Minnesota:

The Minnesota Supreme Court puts its most recent opinions here. They come with very helpful summaries.  A similar page exists here for the Minnesota Court of Appeals.  However, only the most recent opinions are kept at these pages.  We’re not sure whether these pages expire or not, but if they do, links to the current “most recent opinions” pages for both courts are available here.  There’s a free online archive and other resources for older opinions, and information about that is available here. This is one of the most user-friendly court systems we’ve encountered.

Mississippi:

We weren’t sure what to expect after our experience with Alabama, but were pleasantly surprised.  Recent Mississippi Supreme Court opinions, organized by “hand down date” are available here.  One click on the selected date and a pretty well organized list of opinions appears with considerable information (although not necessarily a subject matter description).  An identical set up for the Mississippi Court of Appeals is here.

Missouri:

Recent Missouri Supreme Court opinions are located here.  Clicking on any of the dates creates a drop-down menu with not only the cases by name, but also some of the most detailed “overview/summaries” that we’ve seen anywhere.  Kudos for that.  All Missouri appellate court decisions are available in essentially the same format here.  If only Mo. App. opinions are desired, they’re available, by district, here (eastern), here (southern), and here (western).

Montana:

The most recent Montana Supreme Court opinions are here.  Nothing but case names and docket numbers are provided.  Anything more than a month old requires a rather involved search that can be performed here.  Comparatively, it's a rather difficult to use site.

Nebraska:

Recent Nebraska Supreme and Court of Appeals decisions are available by week here.  Clicking on the desired week just gets you case names and docket numbers.  Quite convenient but not very informative.

Nevada:

The most recent Nevada Supreme Court decisions are available on this page as “advance opinions.”  There are only case names and dates.

New Hampshire:

The New Hampshire Supreme Court posts its opinions (both recent and otherwise) here. One click on the date leads to a list of opinions by name.  For comments, see Nebraska.

New Jersey:

Recent opinions for both the New Jersey Supreme Court and the Appellate Divisions of the New Jersey Superior Court are available by name, here.  While there’s not a lot of info about the opinions, it doesn’t take a lot of clicks to get to them, either.  There’s a separate link at the very bottom for “squibs,” which leads to opinion summaries, but for some reason the squibs don’t link back to the opinions, so they’re rather frustrating to use.  Some New Jersey trial court opinions are also available, both published and unpublished. Although it’s not directly on-point for this post, we can’t resist also pointing out the New Jersey mass tort webpage, which we’ve found extremely helpful.

New Mexico:

Recent New Mexico appellate decisions are here for the New Mexico Supreme Court, and here for the New Mexico Court of Appeals. They are not in date order, however, so be careful.  There are no summaries.  Really recent slip opinions are here (supreme) and here (intermediate).

New York:

This page is the best place to start for New York appellate decisions online.  It’s got links that take you to the New York Court of Appeals (the state’s highest court) here.  From there, a click on the desired month turns up a relatively bare-bones list of opinions by name.  From the original page there are links to opinions (descriptions likewise limited) for each of New York’s appellate departments:  First, Second, Third, and Fourth. There’s also a search function here for finding New York trial court decisions.

North Carolina:

North Carolina appellate opinions start here. There are yearly links for both the supreme and appellate courts. Clicking on them pulls up lists of opinions with useful short summaries.

North Dakota:

Recent North Dakota Supreme Court opinions are available through this page. Once the relevant time period is selected, a list of opinions with useful case summaries appears.

Ohio:

One-click shopping for the most recent Ohio Supreme Court opinions is available here with links going back to the first of the year.  There’s a useful “topics/issues” box to check, which will rerun the default search with additional information.  There are 12 Ohio appellate divisions.  To get their opinions, go here, then pick one of the twelve and click on that link.  At the bottom of the page for any (we think, we didn’t check every single one) the chosen court, there’s a link for “opinions,” which brings up a similar list – although in the appellate courts, the “topics/issues” box being on is the default setting.

Oklahoma:

We had to hunt a bit, but we found the opinion page on Oklahoma Supreme Court's site.  Opinions are available by year - such as for 2010 - but there are no summaries.  Ditto for the Oklahoma Court of Civil Appeals, here.

Oregon:

Oregon Supreme Court opinions are available here. From there, click on the desired month or year.  All that’s there are case names and docket numbers.  Ditto the Oregon Court of Appeals here.

Pennsylvania:

The Pennsylvania Supreme Court releases all of its opinions online here.  Unfortunately, the court releases all of its other orders on the same page, so a lot of sifting is required through denials of appeals, etc.  There’s a lot of chaff here with the wheat.  The information’s a little sparse, with only the name of the authoring justice along with the case name and docket number provided.  Only the current month’s opinions and orders are listed, but links are provided for older ones.  There are similar setups for both of Pennsylvania’s statewide appellate courts, the Superior Court (general appellate jurisdiction) here and the Commonwealth Court (for appeals involving governmental entities).  Don’t even think about looking for trial (“Common Pleas”) opinions in one place – the Pennsylvania Unified Judicial System isn’t that unified.

Rhode Island:

The Rhode Island Supreme Court makes all of its opinions available here.  Click on the link for the desired year and – whoa! – excellent case summaries turn up.  Rhode Island is one of the few states that puts its trial court opinions online in a single place (as opposed to having to dig them out court by court) here.

South Carolina:

The most recent South Carolina Supreme Court opinions, with helpful descriptions are found here, with additional links available for older opinions.  Ditto the South Carolina Court of Appeals, at the same link – just go to the “Opinions/Orders” dropdown menu and select first “Published Opinions” and then “Court of Appeals.”

South Dakota:

South Dakota Supreme Court decisions are available here. Names and docket numbers only.

Tennessee:

The Tennessee Supreme Court uniquely offers its opinions by “quarter” here.  Clicking on a selected quarter yields not only opinion links, but useful summaries.  There’s a similar arrangement for the Tennessee courts of appeals here, which collects them all, regardless of division.

Texas:

Recent Texas Supreme Court opinions are available here – just select the desired time period.  There aren’t any substantive summaries, just descriptions of the relief granted.  There are 14 different Texas courts of appeals.  To get their opinions, start here, and pick the particular region.  Then choose “Released Orders/Opinions” and then open the date.  Finally, the opinion names and links appear.  Again, no descriptions that are worth anything.  All the court of appeals websites seem to work the same, although we didn’t check every last one of them.

Utah:

The current year’s opinions for the Utah Supreme Court are available here. Ditto the Utah Court of Appeals, here. These are bare bones – just case names and docket numbers.

Vermont:

Links to the most recent Vermont Supreme Court opinions are here. There’s no information beyond the usual case name and docket number.

Virginia:

This is really convenient.  All Virginia Supreme Court opinions are available here in chronological order (newest on top) – with substantive descriptions. They go back literally years, but they’re all in one directly accessible place: no clicks, no pop up boxes.  If only every state were this simple.  Ditto the Virginia Court of Appeals here.

Washington:

Online access to Washington appellate court decisions starts here.  For the Supreme Court, try here. For the Court of Appeals, go here for Division I, here for Division II, and here for Division III. Only names and docket numbers are provided. Really recent opinions are also available here.

West Virginia:

For the recent opinions of the West Virginia Supreme Court (there is famously no intermediate appellate court), start here.  Clicking on “current term list” on the left hand side produces a list of the year’s opinions.  Beware the organization, though.  Only the most recent week’s opinions are at the top.  Below that they’re organized by docket number.  There are no descriptions, only case names and numbers.

Wisconsin:

For Wisconsin Supreme Court opinions, start at this page and select a time period:  “today,” “this week,” “this month,” or your choice.  A list of case names sorted by release date (unless the default is changed) will pop up. There are no summaries.  Ditto for the Wisconsin Court of Appeals here.

Wyoming:

The recent opinions of the Wyoming Supreme Court are here. There are no summaries, but all of the parties are listed, which helps some.

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HD Or Not HD: That Is The Question

Another non-drug/device case recently caught our eye, not only because it allows us to parody Shakespeare, but because of its potential implication for all those companies that are based in New Jersey and get sued under the liberal New Jersey Consumer Fraud Act as a result (and as we all know, there is a considerable drug/device presence in the Garden State). The question in the case was one that would have plagued the Prince of Denmark – whether ‘tis nobler in the mind to suffer the slings and arrows of outrageous picture, or to take arms against Samsung?

Nathan Cooper decided to take the latter approach. In Cooper v. Samsung Electronics America, Inc., 2010 WL 1220946 (3d Cir. Mar. 30, 2010), Cooper sought to represent a nationwide class of purchasers of Samsung’s 1080p HDTVs. Cooper’s beef was that he paid a premium price for the 1080p capability, only to learn that the HDTV he bought could not accept a 1080p signal via an input known as “HDMI.” The lower court blew out the warranty claims on failure to provide notice to Samsung, and knocked out the fraudulent concealment claim for failing to plead with particularity. Id. at *2-3. The Third Circuit affirmed those rulings, but that really isn’t the part we found interesting, because the court next went on to tackle the consumer fraud claim alleged by Cooper.

In the lower court, Cooper had pled a claim under the New Jersey CFA. The district court decided that Arizona law should apply, because Cooper, an Arizona resident, bought his TV in Arizona. So the district court sua sponte converted the New Jersey CFA claim into an Arizona CFA claim, and then declined to dismiss that claim. Id. at *2. Cooper decided to take a gamble – he was so determined to have New Jersey’s liberal CFA apply that he agreed to dismiss with prejudice the AZCFA claim so that he could challenge the application of Arizona law on appeal. Id.

The gamble didn’t pay off. The Third Circuit noted that New Jersey’s choice of law rules had changed since the time of the District Court’s decision. New Jersey used to apply the “government interest” test, but in November 2008 the New Jersey Supreme Court adopted the Second Restatement’s “most significant relationship” test for determining which state’s law applies (the case is PV v. Camp Jaycee, 962 A.2d 453 (N.J. 2008), for all you choice of law nuts out there). Id. at *3. But this change of law didn’t matter – under either test, Cooper’s consumer fraud claim should have been decided under Arizona law, not New Jersey law. Id. at *3-4. Cooper argued that New Jersey law should apply since Samsung is headquartered there, but the court disagreed and concluded, “[t]he transaction in question bears no relationship to New Jersey other than the location of Samsung’s headquarters.” Id. at *3. Looking at the “most significant relationship” factors enumerated by the court, id. at *4, it is easy to see how the court reached this conclusion:

(a) the place where Cooper acted in reliance on the alleged misrepresentations – Arizona
(b) the place where Cooper received the alleged misrepresentations – Arizona
(c) the place where the defendant made the representations – Arizona (although Cooper argued that the alleged fraud was conceived, created, and orchestrated from Samsung’s home office in New Jersey)
(d) the place where the parties are located – tie
(e) the place where the “tangible thing which is the subject of the transaction” – i.e., the TV – was located – Arizona
(f) the place where plaintiff was to render performance (payment) under the contract – Arizona.

There was a dissent, by Judge Ambro, which echoed the advice of Polonius – “Take each man’s censure, but reserve thy judgment.” Judge Ambro believed the court should have vacated and remanded to the district court to apply the new choice of law rules articulated in Jaycee. Id. at *4. But then Judge Ambro also went on to complain about the majority’s choice of law analysis, which was cursory. Most importantly, the same triptych of choice of law arguments that plaintiffs make all the time, especially in drug and device cases, were “trippingly on the tongue” of Judge Ambro: (1) New Jersey has an overriding interest in deterring fraudulent conduct occurring within its borders by domestic businesses; (2) New Jersey’s liberal protections will not frustrate other states’ interests in protecting consumers, but will in fact further those interests; and (3) the New Jersey legislature intended its CFA to have wide-ranging effect and apply to sales made by New Jersey sellers wherever those sales were made. Id. at *4-5.

In the end, though, the majority brushed aside these concerns. Arizona was clearly the state with the “most significant relationship” to the claim, because Arizona was “the state in which the television was marketed, purchased, and used.” Id. at *4. So in New Jersey, the law of the state where the product was purchased and used – or, in our cases, the state where the drug was prescribed, used, and (possibly) was the cause of alleged harm – should govern, and courts should not reflexively apply New Jersey’s liberal CFA simply because the manufacturer has headquarters in the state. Or as Hamlet would say, all that matters is the place where the transaction and harm allegedly occurred; “the rest is silence.”

Parisian Can't Can't

They do the can-can in Paris - but Suzanne Parisian can't - can't testify as an expert in the Trasylol MDL.  This is one of those opinions when it's best to start at the end:

Plainly stated, Dr. Parisian is an advocate, presented with the trappings of an expert but with no expectation or intention of abiding the opinion constraints of Rule 702.  She comes armed with a Report designed to be broad enough to allow her to gather and stack inference upon inference in order to offer her "takeaway" or "take home message" with respect to intent, knowledge, or causation in a manner unrelated to any regulatory expertise.  Her testimony is unreliable and would not be of assistance to the jury.

In re Trasylol Products Liability Litigation, slip op. at 40-41 (S.D. Fla. April 27, 2010).

What subjects, specifically, was Dr. Parisian precluded from opining about?

• Foreign regulatory actions; slip op. at 17.
• Historical summary and comments on specific documents; slip op. at 18, 22-23, 33-35.
• Claimed violations of FDA regulations; slip op. at 38-39.
• What the FDA knew at various times; slip op. at 18-19, 35.
• Corporate knowledge/intent; slip op. at 20-21, 34-35.
• Ethical standards for drug companies ("bad company" opinions); slip op. at 21-22.
• Pure, utter speculation; slip op. at 39-40.

The opinion also features an extended dissection of Dr. Parisian's performance on cross examination that will warm the cockles of the hearts of every defense counsel ever to have encountered the good doctor on the stand.  See slip op. at 23-31.  Enjoy!

Vanderwerf - A Cautionary Tale

We liked the district court summary judgment grant in Vanderwerf v. SmithKline Beecham Corp., 529 F. Supp.2d 1294 (D. Kan. 2008) a lot.  It made our honorable mention list for best decisions of 2008 - which is something for a district court opinion in a one-off case.  Before that, we discussed it in our learned intermediary rule lessons, both beginner and advanced, and named it as one of our warning causation greatest hits.  An earlier decision in the same case, Vanderwerf v. SmithKlineBeecham Corp., 414 F. Supp.2d 1023, 1027 (D. Kan. 2006), was also notable because of its elegant disposal of a FDCA-based negligence per se claim., as we observed here.

So we were waiting to see what the Tenth Circuit did with the appeal.  As it turns out, it dismissed it yesterday - as untimely filed.  Ouch.  That's embarrassing, maybe worse.  We'll describe what happened, so it doesn't happen to our readers (at least, we hope, to those on our side of the "v.").  After summary judgment was entered, the plaintiff filed a reconsideration motion under Fed. R. Civ. P. 59.  Then nothing happened.  For seven months, nothing happened.  Plaintiff got frustrated (we assume).  Frustration can lead to foolish acts.  The problem is that a Rule 59 motion tolls the 30-day time period for appealing only  if there is an order "disposing of" that motion.  That's what Rule 4(a)(4)(A)(iv) says in black and white.  But in Vanderwerf the plaintiff simply withdrew the motion - without getting any ruling whatsoever - and filed a notice of appeal.

Bad move.  The Tenth Circuit held that the notice of appeal was filed 6 month too late and dismissed the appeal.

We recognize the severity of today’s holding, and empathize with the plight of parties who are effectively prohibited from filing a notice of appeal because of the inaction of a district court. But we must rely upon the unambiguous standard we have consistently applied to the timeliness requirements of Rule 4.

Slip op. at 14.

Morals of the lesson:  (1) read the frigging rules before you file any motion - such as a motion to amend or reconsider a judgment - you're not 100% familiar with, because this stuff can be more complicated than you think; (2) read the frigging rules before you do something unusual - such as withdraw a motion without getting a ruling; and (3) if you've had a Rule 59 motion pending longer than 30 days after entry of an otherwise appealable judgment, no matter how frustrated you might get you've got to get some sort of an order disposing of it, otherwise your appeal will be too late, because the appeal period has already run.

If you don't do any of these things, at least make sure to notify your carrier.

A story to warm the hearts of defense lawyers

Everyone likes to hear stories about how someone overcame obstacles, right? Magazines and television shows are filled with heartwarming stories of triumph over adversity. Well, Lewkut v. Stryker Corp., No. 09-cv-3695 (S.D. Tex. April 16, 2010), is the story of how a federal court, aided by plucky defense counsel, overcame common obstacles to the early resolution of a preemption defense and granted a motion to dismiss.

Egon Lewkut had problems with his artificial hip replacement, a Howmedica Osteonics Trident System, and sued. The defendant manufacturer moved to dismiss, arguing that all claims were preempted because the FDA had given premarket approval to the Trident System. And here was where Howmedica encountered its first obstacle: courts ruling on motions to dismiss generally can consider only the facts alleged in the complaint, and you can bet that this plaintiff (like most others) made sure to keep the facts concerning the FDA’s approval of the Trident System out of the complaint. Absent essential facts, courts often feel compelled to deny a preemption motion to dismiss and let the case proceed at least with discovery about the device’s FDA approval.

Howmedica overcame this obstacle by establishing the relevant facts surrounding the PMA approval with documents from the FDA’s public records, which were available on the FDA’s website. Id. at 5 n.1. The court found this move was proper based on the established principle that courts can consider documents outside of the complaint when those documents are matters of public record. Id.

As we’ve discussed before, judicial notice is a handy technique to keep in mind in deciding whether to raise a preemption defense in a motion to dismiss or wait until summary judgment. Sometimes lawyers shy away from moving to dismiss because they think that establishing FDA approval requires an affidavit of someone at the company to supply the device’s regulatory history, and most courts won’t consider substantive affidavits at the motion to dismiss stage. Lewkut shows an alternative way to prove those facts to a judge – or at least to judges comfortable with the idea that documents available on the FDA’s website are public records.

The second obstacle may have interest only to preemption geeks like us, but we’ll tell you about it anyway. This device had several component parts. Lewkut targeted the acetabular shell component, which initially received FDA clearance through the section 510(k) – read, no preemption – process. Later on the FDA gave premarket approval to the Trident System. Asserting the non-preemptive nature of §510(k) clearance, Lewkut argued his claims should survive. The court took a careful look at the FDA record from the public documents available on its website and concluded that the FDA had re-approved the acetabular shell component when it gave premarket approval to the entire device. Slip op. at 9. The FDA’s previous approval of this component through the 510(k) process did not matter. Id. The court said that it was not appropriate to separate the component parts of a device for purposes of preemption and that FDA approval of the device included the component that is part of the device. Id. at 10-11.

Having reached this conclusion, the court necessarily found that preemption applied to state law claims concerning the Trident System, including the acetabular shell. Id. at 13-14. But here is where Lewkut threw out the final obstacle to Howmedica’s triumph: his complaint included a claim that his Trident System was “adulterated” under section 351(h) of the Food, Drug, and Cosmetic Act, which allegedly was demonstrated by the recall of acetabular shells manufactured in Ireland in 2008. Id. at 14. Lewkut claimed his “adulteration” claim constituted a parallel violation claim that was immune from preemption under Riegel. The court said he was right about Riegel preemption but found another way over this last hurdle to get to the preemption finish line: our old friend, 21 U.S.C. § 337(a). As we’ve discussed many times, this section provides that only the federal government can enforce the prohibition on adulterated devices. Slip op. at 15. The Lewkut court concluded that “Plaintiff’s allegations, even to the extent that they present parallel state claims and are exempt from Riegel, are nonetheless preempted by the federal statute that explicitly precludes private enforcement of federal laws regarding ‘adulterated’ devices.” Slip op. at 16-17. In reaching this conclusion, the court relied heavily on In re Medtronic, Inc. Sprint Fidelis Leads Product Liability Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009), one of our top 10 decisions of 2009, and gave the back of the hand to Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009), one of our least favorite decisions. Slip op. at 13. The court therefore found that all claims were preempted and dismissed the complaint.

For any lawyer defending device companies, this is a heartwarming story with a happy ending.

Dukes v. Walmart - On to the Supreme Court, We Hope

We just got word that certification of the world's largest class action, Dukes v. WalMart, slip op. (9th Cir. April 26, 2010) (en banc), was affirmed in large part in a 137-page whopper of a decision.

The court describes its action as follows:

We affirm the district court’s certification of a Federal Rule of Civil Procedure 23(b)(2) class of current employees with respect to their claims for injunctive relief, declaratory relief, and back pay. With respect to the claims for punitive damages, we remand so that the district court may consider whether to certify the class under Rule 23(b)(2) or (b)(3). We also remand with respect to the claims of putative class members who no longer worked for Wal-Mart when the complaint was filed so that the district court may consider whether to certify an additional class or classes under Rule 23(b)(3).

Slip op. at 6146-47 (footnote omitted). 
Bexis briefed the punitive damages issue, which was remanded.  As to that issue, the court held:

[T]he district court did abuse its discretion by failing to analyze whether certifying Plaintiffs’ punitive damages claims under Rule 23(b)(2) caused monetary damages to predominate, notwithstanding its decision to require notice and an opportunity for Plaintiffs to opt-out of the punitive damages claims.

Slip op. at 6217.  There are a couple of dissents.  While the Supreme Court can't often be predicted, this one is as close to a "sure thing" as there is.  And it's the Ninth Circuit - notorious for a high reversal rate in the Supreme Court on a wide range of issues.

More later.

No Knock on Wood

SCOTUS short-lists are sort of like Golden Globe ceremonies or TMZ episodes for law nerds like us. We get giddy when the Sunday talking heads gush about the likely candidates, or warn about who’s out of the mainstream and might provoke a filibuster. One of the short-listers is Diane Wood, a judge on the Seventh Circuit Court of Appeals. There would be a certain symmetry if she replaced retiring Justice John Paul Stevens, who was also on the Seventh Circuit.

We’ve seen some reports labeling Judge Wood as a “liberal”. For those of us who took courses with her at the University of Chicago Law School, that label is surprising. Professor Wood seemed down-the-middle and devoid of ideology (which ain’t easy at U of C). In any event, we decided to see what Judge Wood has written on topics that occasionally show up in our happy little blog. There isn’t much, but what we’ve seen looks solid. (Take that, talking heads!)

Lack of Causation: Schrott v. Bristol-Myers Squibb

Judge Wood’s only opinion regarding medical devices, Schrott v. Bristol-Myers Squibb, 403 F.3d 940 (7th Cir. 2005), involved a woman who alleged that breast implants caused her to suffer headaches, dizziness, nausea, and memory loss. Plaintiff’s doctor had told her that her neurological symptoms were unrelated to the breast implants. That doctorly advice did not stop plaintiff from suing Bristol-Myers Squibb for strict liability, negligent failure to warn, breach of implied warranty, negligent infliction of emotional distress, and violation of the Illinois consumer fraud act.

As a threshold matter, Judge Wood thought it “frivolous” of plaintiff to argue that the Daubert standard should not be applied to her expert because (1) the claim arose before Daubert was decided, and (2) it was based on state law claims. Schrott, 403 F.3d at 943. Judge Wood cited Hanna v. Plumer, 38 U.S. 460 (1965). No surprise there, but it made us feel nostalgic (like when “Don’t You Want Me Baby” by Human League comes on the radio) since some of us learned about that case in a Civ Pro course taught by Professor Wood in the 1980's.

Judge Wood also saw little merit in plaintiff’s efforts to get around the statute of limitations (via relation back, discovery rule, and continuing violation theory). Judge Wood doesn’t actually explain why these arguments fail - - but that’s okay because we never buy those arguments and, anyway, the “even more fundamental problem” with the case was that the record showed no causative link between the implants and injury and no basis to recover for “fear of developing cancer” because there was no evidence such fear was reasonable. Schrott, 403 F.3d at 943-44.
Similarly, Judge Wood held that the Illinois consumer fraud claim flunked causation and pretty much everything else: (1) there were no damages, (2) the package inserts disclosed the medically relevant risks, (3) the medical community knew of the risks, (4) the plaintiff’s doctor knew of these risks, and (5) plaintiff “did not show what causal link existed between the disclosers (or omissions) and her damages.” Id. at 944-45.

Maybe we’re just fanboys, but it looks like Judge Wood hit all the right issues in all the right ways.

The Sophisticated Intermediary: Taylor v. Monsanto

We write a lot about the learned intermediary doctrine, usually focusing on doctors or other health care providers. Judge Wood addressed the “sophisticated intermediary” doctrine in Taylor v. Monsanto, 150 F.3d 806 (7th Cir. 1998). Westinghouse employees sued Monsanto for alleged effects of PCBs that Monsanto had sold to Westinghouse. Judge Wood’s opinion starts with a nice turn of phrase: “At least to the outside observer, some cases appear to be unevenly balanced clashes between a titan of industry and a hapless individual. This case is not one of them.” Taylor, 150 F.3d at 807. We wouldn't mind using that line in the next trial where we're facing plaintiff lawyers who have not only their own jet but also their own airstrip.

Back to the case. Under Indiana law, there is no duty to warn the ultimate user if the product is sold to a “sophisticated intermediary” whom the manufacturer adequately warned. The key issues in the case were whether Monsanto breached a duty to Westinghouse’s employees or, rather, whether “Monsanto reasonably relied on Westinghouse itself to warn its employees of the damages associated with PCBs, and that Monsanto’s warnings to Westinghouse were adequate.” Id.

In drug and device cases, it’s usually straightforward whether the doctor (or whoever) is a learned intermediary. It’s simply a matter of status. Not so with a “sophisticated intermediary.” That issue can require a more probing inquiry into knowledge or experience, not just status. Judge Wood found that Westinghouse was a “sophisticated intermediary” with respect to its employees because Westinghouse had participated in federal and industry task forces and working committees about PCBs.

Judge Wood rejected plaintiffs’ attempt “to fine-tune” the sophisticated intermediary doctrine and render Westinghouse sophisticated only as far as environmental risks but not human safety risks. Taylor, 150 F.3d at 808-09. Plaintiffs “failed to point to a shred of evidence in the record suggesting that Westinghouse was ignorant or unsophisticated about the health effects of PCBs.” Id. at 809. Instead plaintiffs “relied on conclusory and self-serving allegations unsupported by the record, which do not preclude summary judgment.” Id.

Because Westinghouse was a sophisticated intermediary, the issue now was whether Monsanto had warned Westinghouse. Judge Wood alluded to “reams of uncontroverted evidence in the record that Monsanto consistently warned Westinghouse about PCB dangers,” going back as far as 1959. Id. Plaintiffs claimed that in 1975 Monsanto assured Westinghouse in a letter that there had been no human harm in 40 years of proper PCB handling, which was the “wink” from Monsanto assuring Westinghouse that PCBs were safe. Id. at 810. Unfortunately for plaintiffs, Judge Wood read the rest of the letter, which was replete with warnings of injury and death. Id.

Failure of Formulaic Pleadings: Brooks v. Ross

This past fall, Judge Wood worked with our favorite duo (not counting Batman and Robin or Sonny and Cher), Iqbal and Twombly, in deciding a
§ 1983 due process case, Brooks v. Ross, 578 F.3d 574 (7th Cir. 2009). Plaintiff had been the only member of the Illinois Prison Review Board who had voted in favor of a particular prisoner’s application for parole. Plaintiff was subsequently indicted for corruption and ultimately acquitted. Plaintiff became a plaintiff when he sued people (including a state policeman, the Illinois Attorney General, and other Prison Review Board members) whom he claimed had conspired to prosecute him wrongfully. This, friends, is a true Chicago story.

Judge Wood found the plaintiff’s complaint similar to the alleged conspiracy in Twombly and held that vague allegations of conduct not inherently illegal cannot survive the pleading requirements of Twombly. Brooks, 578 F.3d at 581-82. Judge Wood then gave us a two-fer by measuring the complaint against Iqbal, concluding that the allegation that the defendants committed illegal conduct by “knowingly, intentionally, and maliciously prosecut[ing] Plaintiff . . . in retaliation for Plaintiff . . . exercising rights and privileges under the Constitutions and laws of the United States and State of Illinois” was “merely a formulaic recitation of the cause of action and nothing more.” Id. at 581.

This case is a straightforward application of Twombly and Iqbal, even if the facts evoke The Shawshank Redemption. Indeed, none of these cases is likely to crop up if there are confirmation hearings, and none will make the nattering nabobs on Fox or MSNBC chortle.

And that’s reassuring.

(We’re grateful to Erin Carter at Dechert for reviewing Judge Wood’s Greatest Hits)

The Un-Dead on "Parallel Requirements," Preemption, and Punitive Damages

He may be gone - dead in the blogging sense - but Herrmann continues to provide scholarly commentary about issues we care about from beyond the cyber-grave.  Dave Alden, Mark's former colleague at Jones Day, just sent us a copy of an article the he, Herrmann, and Brad Harrison wrote entitled "The Meaning Of The Parallel Requirements Exception Under Lohr And Riegel," 65 N.Y.U. Ann. Survey of Am. L. 545 (2010).  It's also on Westlaw at 65 NYUANSAL 545.  The article discusses a lot of what we've already said here about parallel violation claims, and preemption:  (a) discussing Lohr, Buckman, Bates, and Riegel on the subject, (b) that parallel violation claims can't just be disguised private attempts to enforce the FDCA without falling afoul of Buckman, since implied preemption can work independently of express preemption (c) to avoid interference with the FDA's prosecutorial discretion, private parallel claims can't be brought where the FDA hasn't acted., (d) warning letters and the like aren't enforcement, and thus don't without more count as parallel claims, (e) negligence per se claims, in addition to being subject to implied Buckman preemption, have a lot of other drawbacks, such as being contrary to the congressional purpose of 21 U.S.C. §337(a), (f) parallel claims aren't parallel if the FDA wouldn't enforce the relevant regulation in the same fashion, and (g) manufacturing claims can't survive without a concrete violation of a specific regulation that applied to the device at issue.

The big advantage of Herrmann's article is that, while you can't cite one of our blog posts in a brief, you can cite a law review article.  The new Herrmann article is worth a read for that reason alone.

But there's more.  The last part of the article (pages 579-83) is a thought-provoking discussion of the "relatively uncharted" intersection between preemption and punitive damages.  The article explores a conflict between punitive damages and 21 U.S.C. §331(f), which deals with civil liability under the FDCA.  Specifically, §331(f) requires certain determinations in assessing civil penalties, which juries don't, and can't, do.  Also, it sets caps on civil penalties ($15,000 for a single violation and no more than $1,000,000 in the aggregate), and precludes them altogether in a number of circumstances - all of which under Due Process mandates receive substantial deference in a punitive context.  Finally, §331(f) provides a "safe harbor" under certain circumstances.  Thus, the Herrmann article concludes:

If a jury assessing punitive damages relating to a state law claim that parallels federal good manufacturing requirements is not required to assess whether there was “a significant and knowing departure from [those] requirements” or “a risk to public health,” then the state law damages remedy may impose requirements that go beyond federal requirements, and §333(f)(1)(B)(i)’s “safe harbor” is nullified.  Furthermore, even if the jury does make those assessments, there is no guarantee that the jury’s determinations will track what the FDA’s decisions would have been.

Id. at 583.  We don't know if we've ever seen punitive damages assessed on an unpreempted parallel claim in a medical device case (at least since these concepts were created), but if we do, now we've got a new argument.

If Mark ever gets tired of his in-house job, we'd be happy to take him on as a blogger again.

The Model Uniform Product Liability Act of 1979

It's not strictly drugs and devices, but a PLAC colleague recently asked for a copy of the The Model Uniform Product Liability Act of 1979.  A bit of looking around determined that it was published in the Federal Register at 44 Fed. Reg. 62714 (Commerce Oct. 31, 1979) but surprisingly the text wastn't anywhere on the web.

It used to be that that would just be frustrating.  But as bloggers we can now do something about that.  So here, for anybody who needs it, is a copy of the Model Uniform Product Liability Act  of 1979.

You Have Been Warned - Now Do Something About It

We never know what will happen when we post something. Earlier this week we tossed up a short post about a case involving FDA warning letters – at least that’s what we thought.

What we got back was a rip-roaring comment from the attorney for the plaintiff in the case, Regenerative Sciences, Inc. v. FDA, 2010 WL 1258010 (D. Colo. March 26, 2010).  Her beef was, dammit, the case didn’t involve an FDA warning letter, but rather an untitled letter, and you guys are smart enough to know better.  But we’ll let Kelly Lightfoot smack us down in her own words:

In Regenerative Sciences, Inc. v. FDA, the FDA did not issue a Warning Letter to Regenerative Sciences, Inc. (“RSI”).  The FDA sent an Untitled Letter.  As regulatory counsel, we all understand there is a significant difference between these two types of letters.  You understand this distinction, as well, as you blogged about it on August 14, 2007 in your post titled “Untitled (As In “Untitled Letters”).  The Untitled Letter is used by the Agency when the Agency is uncertain about an issue and when the Agency does not know if there has been an actual violation.  The Warning Letter is issued for actual violations that may lead to Agency enforcement if not corrected.  In the case of RSI, the Untitled Letter is merely a low-level communication expressing the Agency’s stance on the practice of medicine and use of autologous stem cells. It is not proof of any wrongdoing by RSI.

She’s right, you know - well, in part.

But honest, officer, it wasn’t our fault.

Blame it on the judge – we do.

Our excuse is that the court in Regenerative Sciences, twice in the opinion, called the FDA correspondence at issue a “warning letter.”  2010 WL 1258010, at *7 (“the July 25, 2008, FDA warning letter”); id. (“Regenerative has already received a warning letter from the FDA on July 28, 2008”).  We only know what we read, and reading this opinion, we thought – with justification, we add – that it was a warning letter case.

But if even a judge can get this wrong….

Hey, that means it’s probably a good topic for a longer post, so here goes.

First of all – everybody knows that the FDA issues warning (and other) letters.  But since it’s an administrative agency, Congress had to give it the power to do that.  Here’s where that power comes from: The Food, Drug and Cosmetic Act (“FDCA”) expressly gives the FDA authority to address “minor violations . . . by suitable written notice or warning.”  21 U.S.C. §336.  Hence, point number one; if the FDA is content to address some possible violation by letter, by definition it’s a “minor violation.”  It has to be, otherwise, by statute, the FDA has to resort to some other enforcement tool.

Now, for the letters themselves. The FDA issues lots of kinds of letters – there are closure letters, acknowledgement letters, REMS letters, NIDPOE letters, recall letters, and the letters formerly known as “approvable” or "not approvable.”  But the FDA letters we usually encounter in litigation are one of three types:  (1) “warning” letters; (2) “untitled” letters, and (3) “advisory” letters.  So those three are all we’re discussing today – three, no more, no less. Three shall be the number, and the number of the counting shall be three.

Warning Letters

We’ll start with warning letters, which are the most serious of the lot.  But even a warning letter is not any form of FDA enforcement action.  Instead, as the FDA reiterated in its brand, spanking new “Regulatory Procedures Manual" only a few weeks ago (it’s dated March 2010); a warning letter is but a prelude to possible enforcement.  Instead of enforcement, a warning letter is intended to bring about voluntary compliance:

[I]t is the Food and Drug Administration’s (FDA’s) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice.

FDA Regulatory Procedures Manual §4.1.1 (“Warning Letters”), at p. 4-1.  Warning letters “are based on the expectation that most individuals and firms will voluntarily comply.”  Id.

Thus – and this was the point we were making in the earlier post about the Regenerative Sciences case – the FDA does not consider a warning letter to be any form of final agency action:

A Warning Letter is informal and advisory. It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action.

Id. §4.1.1 at p. 4-2.  Now, the FDA does this for its own somewhat nefarious reasons, specifically because it doesn’t want to get sued over what it puts in warning letters.  But, as we’ll get into, leaving things with warning letters tentative and up in the air like this does, and should, have consequences for the admissibility of these letters in civil litigation.

Another thing that the FDA’s Regulatory Procedures Manual makes pretty clear is that warning letters are “not appropriate” if alleged violations are “repeated,” “continual,” “intentional,” “flagrant,” or “willful”; or if “[t]he violation presents a reasonable possibility of injury or death.”  Id. §4.1.1 at pp. 4-2 to -3.  What does that do for us?  Well, it means essentially that FDA warning letters shouldn’t have any significance in a punitive damages case.  That’s because punitive damages generally are only available where the defendant's conduct is all of the things that the FDA says aren’t properly addressed in warning letters.

Untitled Letters

The next category is the “untitled” letter.  An untitled letter is even less than a warning letter.  “An Untitled Letter cites violations that do not meet the threshold of regulatory significance for a Warning Letter.”  FDA Regulatory Procedures Manual §4.2.1, at p. 4-26.  Thus, among other things, an untitled letter “does not include a warning statement that failure to take prompt correction may result in enforcement action.”  Id. at p. 4-27. That’s pretty much all the FDA has to say about untitled letters.

An untitled letter of this sort is what Ms. Lightfoot told us was actually at issue in Regenerative Sciences.

Advisory Letters

Finally, the FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) also has (or possibly “had,” since we’ve only encountered these letters in a pre-FDAAA context) a program that lets manufacturers send in samples of proposed advertising for evaluation before the ads are ever shown.  DDMAC’s evaluations are contained in “Launch Campaign Advisory Letters,” which we just call “advisory letters.”  The DDMAC program is/was voluntary, so it’s not even included in the FDA’s Regulatory Procedures Manual.

We did find DDMAC advisory letters discussed in the FDA’s “2007 Report to the Nation: Improving Public Health Through Human Drugs.” The FDA describes this program as:

When requested, we review advertisements and other promotional materials before drug companies launch marketing campaigns that introduce new drugs or new indications or dosages for approved drugs.  In 2007, we issued 129 advisory letters to companies regarding their promotional materials for launch campaigns.

Id. at 44.

Yeah, yeah, we know – you can’t very well cite us in a brief, although we've been cited in law review articles.  Sad to say, we don’t know of any case (if we’re wrong, tell us) where what we’ve just discussed is discussed in any organized fashion – save one.  There’s a pretty good discussion of the various types of FDA letters in Bailey v. Wyeth Inc., 2008 WL 2856146 (N.J. Super. July 11, 2008).  Unfortunately, Bailey is a really long opinion, and Westlaw doesn’t deign to put page citations on what it calls “trial orders,” so you’ll have to hunt for it – or else cite the Lexis version (2008 N.J. Super. Unpub. Lexis 3004).

As we mentioned in the earlier post, our opponents practically drool at the sight of FDA warning and other letters – since they’re usually critical of one aspect or another of our clients’ marketing activity.  So when the other side’s not busy denying that anything the FDA does is mandatory (when it comes to opposing preemption), they’re busy waving these letters around as if they’re conclusive proof that we did something wrong and should have to pay gazillions of dollars.

We, of course, say that’s crock.

But what do courts say?

Well, the courts are pretty near unanimous in holding that warning and untitled letters aren’t “final” in any meaningful sense.  FDA “letters are not final agency action . . ., as there has been no final agency action, let alone action that has been or could be judicially reviewed.”  Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., 586 F.3d 500, 508 (7th Cir. 2009) (affirming a nice discussion at 547 F. Supp.2d 939, 946-47).  “[T]he type of informal letter issued by the FDA . . . does not constitute . . . formal or final agency action.”  Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 562-63 (9th Cir. 1992).  Such letters are “informal communications.”  Professionals & Patients for Customized Care v. Shalala, 56 F.3d 592, 599 (5th Cir. 1995).  “Warning letters merely establish a dialogue between the FDA and the [addressee] and do not necessarily lead to further sanctions.”  Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1378 (9th Cir. 1983).

We noticed the Regenerative Sciences case precisely because it labeled them (that is, the untitled letter that the court called a “warning” letter) “tentative and interlocutory.”  2010 WL 1258010, at *7.  Warning “letters do not constitute a final decision by the FDA.”  Perez v. Nidek Co., 657 F. Supp.2d 1156, 1166 (S.D. Cal. 2009).  “[R]egardless of any warning letters that the FDA may have sent . . ., it is clear that the FDA has not completed this investigation.”  Summit Technology, Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299, 306 (C.D. Cal. 1996).  “It is well-settled . . . that an agency’s investigatory activity does not constitute final agency action.”  Genendo Pharmaceutical N.V. v. Thompson, 308 F. Supp.2d 881, 884 (N.D. Ill. 2003).  Thus, an “FDA letter is insufficient to establish a violation.”  Chan v. Orthologic Corp., 1998 WL 1018624, at *20 (D. Ariz. Feb. 5, 1998).

After issuing a warning letter, and receiving a response, there’s nothing to keep the FDA from deciding that the recipient was either in compliance or took adequate steps to come into compliance, and thus that no enforcement action is ever necessary.  See Summit Technology, Inc. v. High-Line Medical Instruments Co., 933 F. Supp. 918, 934 n.9 (C.D. Cal. 1996) (rejecting plaintiff’s claim that warning letters indicated illegal conduct; “after further review, the FDA could ultimately decide . . . that [the conduct] is entirely legal”).  The FDA’s procedures provide, and precedent uniformly agrees, that its various regulatory letters decide nothing and enforce nothing.

That’s important because most states have rules of evidence equivalent to Fed. R. Evid. 404(6) (“[e]vidence of other crimes, wrongs, or acts is not admissible” except for enumerated exceptions), and Rule 609 (governing when witnesses can be impeached with criminal “convictions”).  Thus, we’re quite sure that in most jurisdictions evidence of mere arrests or indictments for crimes isn’t admissible when there’s been no conviction.

Arrests and convictions are at least the commencement of what we’d say is criminal “enforcement activity.”  But as we hope we’ve made clear in all the stuff you’ve just read, FDA warning, untitled, and advisory letters don’t even reach the level of an arrest or indictment, and aren’t even enforcement activity at all – according to the FDA itself.  They're more like bureaucratic foreplay.

Because of that, it’s our position that unless and until whatever it is that’s the subject of one of these FDA letters (1) turns into a real enforcement action, and (2) that results in conviction, FDA letters have no business being admitted as evidence in civil trials.

We’ve seen a number of cases that exclude FDA warning and other letters for these types of reasons:  King v. Danek Medical, Inc., 37 S.W.3d 429, 441-42 (Tenn. App. 2000); In re Viagra Products Liability Litigation, 658 F. Supp.2d 950, 966 (D. Minn. 2009); In re Seroquel Products Liability Litigation, 2009 WL 223140, at *4-5 (M.D. Fla. Jan. 30, 2009); Chan, 1998 WL 1018624, at *5; Summit Technology, 933 F. Supp. at 034 n.9.  Similar types of preliminary governmental assessments of possibly violative activity have also been excluded.  See Shoppin’ Bag of Pueblo, Inc. v. Dillon Cos., 783 F.2d 159, 165 (10th Cir. 1986) (FTC investigation of defendant excluded because it was brief and it reached no conclusion about party’s behavior; evidence had little probative value and was highly prejudicial); New York v. Pullman, 662 F.2d 910, 915 (2d Cir. 1981) (non-final agency finding held misleading because it carries “an aura of special reliability and trustworthiness . . . not . . . commensurate with actual reliability”).

Thus, whether it’s an FDA warning, untitled, or advisory letter, the important point is that these are nowhere close to final agency action about anything.  Moreover, as we pointed out here, except between 2001 and 2009, the FDA didn’t even require the legal conclusions in its letters to be reviewed by an actual lawyer before they could be sent.  For these reasons, we don’t think any of these letters should see the light of day in civil litigation.

SCOTUSblog on Preemption after Justice Stevens

The other day, SCOTUSblog, which has to be in the running for the best legal blog there is, ran a lengthy article entitled "How Could The Supreme Court Shift After Stevens?"  Because, as most of our regular readers know, Justice Stevens rather notoriously wrote the anti-preemption majority opinion in Wyeth v. Levine, we wondered whether the article would have something to say about this Blog's favorite constitutional topic - although we have a soft spot as well for the First Amendment - at least when off-label use (not lawyer advertising) is the topic.


So we took a look.  We had to go deep into the article to find it, since the constitutional law types that write articles like this find preemption boring, but sure enough, it's covered.  Here's what the SCOTUSblog piece has to say about preemption post-Stevens:

Preemption is the principle that federal law trumps state law.  It is grounded in the Supremacy Clause of Article VI of the Constitution, which provides that “[t]he Constitution, and the Laws of the United States . . . and all Treaties . . . shall be the supreme Law of the Land.”  Although formally a constitutional issue, preemption questions most often involve the construction of a federal statute (or sometimes a regulation) to determine whether it precludes a state (or local) law.  The Court’s preemption decisions have not pointed in a consistent direction and have tended to turn on their particular context.  Two significant recent decisions have ruled against preemption claims, however, and Justice Stevens authored the majority opinion in both.  One was decided six to three, but only five members of the Court joined Justice Stevens’ opinion. Wyeth v. Levine (2009).  The other was five-to-four.  Altria Group v. Good (2008).  Preemption is thus an important area of the law that could shift with Justice Stevens’ departure towards finding greater federal preemption and thus reduced state authority.  The principal consequence would be to allow fewer state tort suits to proceed.

So now you know as much as we do.  We certainly hope that SCOTUSblog is right on this one.

A warning about FDA warning letters

Lawyers for tort plaintiffs just love it every time the FDA issues a warning letter. To them, FDA warnings = liability (just don’t use the dirty word “preemption”). You can book it that our opponents will use, overuse, and abuse those warnings letters at every opportunity. They will base entire parallel violation claims on FDA warning letters. They will say, citing the warning letter, that the FDA has “found,” “concluded,” “held,” “ruled,” and every equivalent in their thesaurus that the company violated the FDCA and FDA regulations.

It’s our job to put a stop to that.

Now a federal judge in Colorado, with the assistance of the FDA, has given us some good ammunition to respond to those points.

In Regenerative Sciences, Inc. v. FDA, 2010 WL 1258010 (D. Colo. March 26, 2010), the plaintiff was a company that was the target of a warning letter from the FDA about a treatment marketed by the company that used the patient’s own stem cells. Regenerative didn’t like being warned, not one little bit. So it sued the FDA and asked the court to declare that the FDA had no authority to take enforcement action concerning this treatment. The FDA moved to dismiss the complaint, arguing that the warning letter did not represent an FDA final action and that the matter therefore was not ripe for judicial review. Id. at *5.

Chief Judge Wiley Y. Daniel agreed:

[T]he July 25, 2008, FDA warning letter is not a “final agency action,” as defined under the [Administrative Procedure Act]. Instead, it is a “tentative or interlocutory action” which does not constitute a final agency action.

Id. at *7. The court cited two other cases that had reached the same conclusion: Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp. 2d 939, 946 (E.D. Wis. 2008), and Clinical Reference Lab., Inc. v. Sullivan, 791 F. Supp. 1499, 1501, 1503-03 (D. Kan. 1992). The court therefore dismissed the complaint against the FDA. 2010 WL 1258010 at *9. Just what the FDA wanted.

But not the plaintiffs who sue our clients.

We plan to put this decision in our back pocket and pull it out whenever plaintiffs try to attach some legal significance in tort litigation to an FDA warning letter. The Regenerative Sciences decision shows that an FDA warning letter does not reflect a decision by the FDA about anything and certainly not a decision that anybody violated the FDCA. In tort litigation, the letter has no legal import. Nada. Zip. Bupkis. Zilch. As we have ranted about recently, FDA warning letters may be sent by lower-level FDA bureaucrats without clearance from any lawyer at the FDA. All an FDA warning letter means is that some person who works for the FDA – a person who may have no legal training, no supervision, and no authority to make decisions – wrote a letter. That’s it.