Tuesday, August 31, 2010

Federal circuit again affirms the rejection of a vaccine/autism claim

Last Friday, the U.S. Court of Appeals for the Federal Circuit affirmed the second of the three defense verdicts in the test cases alleging that the measles-mumps-rubella vaccine causes autism. Cedillo v. Secretary, HHS, No. 2010-5004, slip op. (Fed. Cir. Aug. 27, 2010). Although the Cedillo decision turns on the specific facts of the case and does not contain an across-the-board rejection of the vaccines-cause-autism theory, Cedillo adds to the growing body of decisions rejecting this theory.

As we told you in May, the plaintiff in the first vaccine/autism case decided by the Federal Circuit abandoned on appeal the widely discredited theory that thimerosal causes autism. The plaintiffs in Cedillo clung to a version of that theory but with no better results.

The plaintiff parents contended that the ethyl mercury in thimerosal damaged their daughter’s immune system, which made her body unable to clear the measles virus found in the MMR vaccine. As a result, they claimed, the measles virus persisted in her body and caused autism and other medical problems. Slip op. at 4-5. To establish that this theory could apply specifically in their daughter’s case, plaintiffs had to prove that she had the measles virus in her body, and they offered test results from a for-profit, non-accredited laboratory called Unigenetics, which is no longer in business. The Special Master found those test results unreliable for many reasons. Without this key piece of evidence, plaintiffs could not prove specific causation, and they lost for that reason alone. For good measure, the Special Master also rejected plaintiffs’ general causation theory. The Court of Federal Claims affirmed. Id. at 8-10.

On appeal, the Federal Circuit upheld the Special Master’s conclusion that the Unigenetics test results were unreliable. Plaintiffs concentrated their appellate fire on the admission of evidence from a government expert whose underlying data was not disclosed to them, but the court found the admission of that evidence was not error for many reasons specific to the procedural Vaccine Rules and the facts of this case. Id. at 14-22. In any event, the court held, the Special Master had said that he would have reached the same decision even without this expert’s testimony, so the lack of disclosure didn’t really matter. Id. at 21-22. Since plaintiffs’ specific causation theory was based on the presence of measles virus in the child’s body, the court affirmed the rejection of plaintiffs’ claim. Id. at 22. The court therefore concluded that it need not address the other grounds for the Special Master’s decision – e.g., general causation. Id.

Because we think the vaccines-cause-autism theory is based on junk science and harms public health by giving some people a reason not to have their children vaccinated, we would prefer a clear declaration from a federal appellate court rejecting this theory once and for all. But such categorical rulings are rare in the law. Courts are constitutionally, or perhaps Constitutionally, inclined to decide individual cases on their facts rather than the bigger questions lurking in those cases. In time, the answer to the larger questions becomes apparent from the answers to many individual questions. By rejecting another of plaintiffs’ many different attempts to show that vaccines cause autism, Cedillo makes it clearer than ever that this theory is bunk.

And We Can Spell "10b-5" Too

Last year the Ninth Circuit, in a case called Siracusano v. Matrixx Initiatives, 585 F.3d 1167 (9th Cir. 2009), issued a really troubling decision, holding that reports of adverse product events - although not even the plaintiff claimed that they were statistically significant - were enough to get past a motion to dismiss in a securities action alleging that these reports should have been disclosed to investors.

We didn't blog about it at the time because it wasn't a drug or device (Matrixx makes Zicam, which is an OTC homeopathic remedy for the common cold) and it wasn't a products case.  Siracusano was in the back of our minds, however, when we decided to put together our adverse event report cheat sheet, where we've collected cases standing for the proposition that such reports don't prove anything in civil litigation.

Well, fast forward about a year.  The Supreme Court (thankfully) granted certiorari (that's Latin for "appeal" (sort of), for you non-lawyers) in Siracusano last June.  At that point both we (that being Bexis and the securities litigation group at Dechert) and the Advanced Medical Technology Association, better known as AdvaMed, the world's largest medical technology association, thought it was high time to get involved.

So AdvaMed retained us to file an amicus brief arguing that:  (1) adverse event reports are inherently unreliable, incomplete, biased (including being media-driven), and for several other reasons not valid evidence of causation; (2) because of the aforementioned unreliabilty, etc., it's prudent for publicly traded companies not to disclose such reports as relevant to investors (as opposed to FDA disclosure, which is an entirely different matter) before their statistical significance is determined, and insignificant reports thus fail the scienter element of Rule 10b-5; and (3) bad things would happen to life science companies if Siracuso were affirmed - forced disclosure of hundreds of thousands of questionable reports, and consequent distortion of the information available to investors by a flood of statistically insignificant data.

Anyway, having helped write it, we think the Dechert amicus brief's pretty darn good (so does AdvaMed, here's what it has to say), and we invite anybody interested in either the statistical uses and misuses of adverse event reporting (especially in the medical device context) or in the securities law implications of forced disclosure of adverse event reports upon the life sciences industry to take a look.

AdvaMed wasn't the only one to file, of course.  An important Supreme Court case (that being most of them) brings with it a raft of filings by interested parties, and Siracusano is no exception.  Here's a link to the ABA's site where all of the defense side briefs (the plaintiffs haven't filed yet) are available (just go to "Matrixx Initiatives, Inc., v. Siracusano, Docket No. 09-1156" - its in alphabetical order).

Monday, August 30, 2010

Thinking Outside the Label

The off label issue surfaces often in drug-and-device litigation, even where it should remain wholly submerged. Plaintiffs view off-label promotion as a way of altering the risk-benefit calculation, undermining preemption, and, of course, parading "bad conduct" in front of the jury. Strangely, the off-label attack occasionally is brought in cases where the plaintiff's use was on-label -- though judges are starting to shut that sort of thing down, if only on Rule 403 grounds.

Let's face it: off-label can flat-out sound bad. "Off-label" makes one think of "out-of-bounds." That negative connotation is especially virulent when a company witness agrees that off-label promotion is "wrong, illegal, unethical, causes halitosis" or whatever else the plaintiff lawyer lobs in at hour six of a deposition. It takes some doing to make juries - or even judges - understand what off-label really means.

The defense has a few things going for it. Doctors invariably testify that the option of off-label use is necessary. That is particularly true in oncology and pediatrics. Moreover, it is hard to see the harm from the sharing of truthful, non-misleading information about off-label use. To the latter point, the First Amendment should have a little something to say about whether the FDA or juries should be able to punish truthful speech. But we'd be kidding ourselves if we didn't acknowledge that the off-label issue is a mess. Companies are getting really, really good at training and monitoring sales representatives so as to minimize the risk of off-label promotion. Nevertheless, once aggressive plaintiff lawyers get their hands on thousands of sales call-notes, they'll come up with something at least vaguely malodorous.

Put aside our whining about how off-label issues can distort a product liability case; the treatment of off-label issues in this country amounts to bad policy. That is the gist of a recent article that is worth reading: Osborn, "Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information," Yale Journal of Health Policy, Law, and Ethics, Volume X, 299-56 (2010). (The article is available here.) Osborn argues that consumers are hurt by the unclear, draconian enforcement of the prohibition against off-label promotion. That crazy-quilt enforcement, whether by juries or AUSAs, ends up increasing the cost of drug development, inhibiting the adoption of effective new uses, and limiting the dissemination of scientifically valuable information. Osborn at 306.

Osborn does not address one policy ground we've seen urged in support of prohibiting off-label promotion -- that such promotion devalues the NDA process. The concern is that a company could do minimal research and get a drug approved for a narrow use, and then devote most of its marketing to an unapproved use. But most cases we've seen involve companies that were vigorously studying expanded uses and aiming to submit a supplemental NDA. In any event, it's not as if the government seems to care. It doesn't distinguish between the vast majority of conscientious companies versus those few that are gaming the system.

It's utterly unclear what off-label conduct will land one in the soup. Maybe that shouldn't be a surprise. After all, the ugly truth is that enforcement against off-label promotion rests on legally shaky grounds. The FDA and DOJ get there via sleight-of-hand, with the requirement that "labeling" (interpreted incredibly broadly) must provide "adequate directions for use," leading to the regulation-invented concept of an "intended use," which, if it lacks such directions (as it probably will for an off-label use), leads to a finding that the drug is "misbranded," leading to potential criminal exposure. Osborn at 309-10. Such "logic" is hardly compelling. But there it is.

From such an unclear foundation, we get unclear FDA rules. What's impermissible off-label promotion and what's permissible exchange of scientific information? Are sales reps doing something wrong merely by visiting doctors whose use would predominantly be off-label (eg, pediatricians)? Is it "consistent with" approved labeling to discuss a likely mechanism of action if that mechanism is not disclosed in the label? Osborn at 319.

An additional problem is that the FDA lacks transparency in its rulemaking and enforcement. The 2009 guidance on reprints is welcome, but it was much delayed and there are still more questions than answers. The result is rather like what Bentham called "dog-law": the dog gets whacked with the newspaper and has no idea why. There's no fair notice or predictability. In addition, FDA warning letters are paltry, one-off, perfunctory efforts. Compare them to SEC No Action letters, which discuss specific facts against a broad framework of laws, rules, and regulations. Osborn at 320-21. The FDA doesn't issue nearly enough guidances, whether or not they are explicitly identified as such. For example, the FDA asked for comments in the wake of the Thompson v. Western States Medical Center, 535 US 357 (2002) case, which held that the FDA's ban on advertising compound drugs violated commercial free speech rights. That was nice. There were many comments. And then? The "FDA failed to take action, publish its views, or otherwise seek to resolve the questions raised by Thompson." Osborn at 323.

Then the Department of Justice ups both the stakes and the confusion by suing companies under the False Statement Act even when the off-label promotion is not, in fact, false. The government also seems indifferent as to whether there is a causal link between the alleged off-label promotion and prescriptions. Osborn at 326. At the same time, "some arms of the government, such as the military, actively encourage off-label use by purchasing and providing drugs specifically intended for off-label use". Osborn at 304. But really now, who expects the government to be consistent?

Osborn also points out that the cases coming out of the US Attorney's offices in Boston and Philadelphia have been aggressive, "innovative," and devoid of "any apparent policy coordinating". Osborn at 323. Those cases might earn some agents credits and some AUSAs style points, but it's hardly the stuff of consistent policy and fair notice. What we have, according to Osborn, is "the government's de facto policy of limited rulemaking and broad enforcement." Osborn at 307.

To make matters worse, companies are under enormous pressure to kowtow to or settle with the FDA or the prosecutors when they challenge off-label statements. Companies have to live with the FDA every day, and the prospect of debarment following a successful prosecution -- a virtual corporate death sentence -- is too much to risk. Osborn at 327.

What this means is that there is a "paucity of federal judicial review". Id. At least if there was substantial case law people would have a better idea of what the rules are. Even in First Amendment jurisprudence the FDA's last minute safe-harbor two-step in the Washington Legal Foundation litigation muddied the issue of dissemination of peer-reviewed reprints regarding off-label uses -- which is apparently exactly what the FDA intended. Take a look at the Washington Legal Foundation "DDMAC watch" write-ups to see how the FDA treats the First Amendment like teenagers treat speed bumps in the mall parking lot.

Osborn gives some concrete examples where enforcement of the prohibition against off-label promotion has led to unclear results that probably have deprived some patients of drugs that would have helped them:

- Gilead Sciences Viread

- Cephalon's Provigil

- Genentech's Avastin

- Allergan's Botox

If you unfamiliar with any of these unhappy stories, Osborn does a nice job of summarizing them and why the government's enforcement likely did consumers more harm than good. Osborn at 332-39.

Osborn then discusses an "alternative model," the United Kingdom. Osborn at 340-49. Across the Atlantic there are fewer prosecutions, more government-industry collaboration, more self-regulation (including by competitors), and clearer rules. And nobody seems to suffer from any of it. Well, maybe plaintiff lawyers do. We haven't asked.

We know a lot of lawyers who stop reading law review articles halfway through. They find the first part, which analyzes the issue and provides heaps of nifty case cites, extremely useful. But they tend to ignore the second part, which typically offers a proposed solution. Here, Osborn's dissection of off-label enforcement - laying out how and why it is such a problem - is spot on. But his call for more self-regulation and a movement toward the British system will sound to some ears a wee bit unrealistic. We just can't see ourselves strolling into the Philadelphia Court of Common Pleas and pointing to the British example. And to be fair, that's not what Osborn is suggesting.

Indeed, Osborn makes some concrete, incremental suggestions that are eminently sensible and might make the American system of enforcement less of a lottery system:

- FDA should promptly issue clear rules on a number of the "hot"issues, such as consulting agreements, the internet, CME, and activities of Medical Science Liaisons;

- HHS should oversee most off-label investigations and only egregious cases should be referred to the DOJ;

- increased use of reasonable statutory civil penalties rather than waving the criminal hammer;

- giving the FDA more money to process supplemental NDAs for expanded indications; and

- Congress should clarify that the False Claims Act does not apply when there is no false statement.

Osborn at 353-55.

To this list we would add our wish that courts would confine the off-label issue to cases where it really applies and where a prescriber says that the promotion really made a difference. Granted, we're saying that out of self-interest. The policy benefit would be a nice bonus.

Friday, August 27, 2010

Duty To Test Cheat Sheet

In the last month, we’ve seen two more appellate decisions definitively rejecting the idea of some sort of separate cause of action – apart from warning or design defect – for “failure to test,” whatever that might be.  In the drug area, as we reported before, the Pennsylvania Superior Court thoroughly killed the concept in Lance v. Wyeth:
[Plaintiff] also maintains that her alleged her causes of action, including her claims for “unreasonable marketing” and “negligent failure to withdraw,” are sustainable because they are akin to a failure to inspect and/or test claim.  Citing Hoffman v. Sterling Drug, Inc., 485 F.2d 132, 140-41 (3d. Cir.1973), [plaintiff] argues that a failure to test claim is valid cause of action. We disagree.
In Hoffman, the United States Court of Appeals for the Third Circuit applied Pennsylvania law and concluded that there was sufficient evidence for the jury to find that the manufacturer failed to adequately test its drug to discover potentially harmful side-effects.  485 F.2d at 140-41.  Regardless of the Hoffman decision, which is not binding upon this Court, Pennsylvania law has not recognized an independent tort for negligent failure to test.  In fact, we have held that “the claim for ‘negligent failure to test’ is not a viable cause of action recognized by our courts[.]” Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. 2003), aff’d, 881 A.2d 1262 (Pa. 2005).
If there is a duty to test and/or inspect in Pennsylvania, it does not exist as an independent cause of action, but rather, is subsumed within [plaintiff’s] other claims. . . . Therefore, even if there is a general duty to inspect and/or test under Pennsylvania law, it would be subsumed within [plaintiff’s] design defect claims and/or any potential failure to warn claim that [plaintiff] may have had. Because failure to test is not an independent cause of action in Pennsylvania, [plaintiff’s] arguments to the contrary fail.
2010 WL 2991597, at *7-8 (Pa. Super Aug. 2, 2010) (some citations omitted).

Then along comes the South Carolina Supreme Court, and (as we also mentioned before) it does a number on the purported duty to test in Branham v. Ford Motor Co.:
In addition, [defendant] asserts there is no separate “failure to test claim” apart from the duty to design and manufacture a product that is not defective and unreasonably dangerous. We agree, for if a product is not in a defective condition unreasonably dangerous to the user, an alleged failure to test cannot be the proximate cause of an injury. The failure to establish that the seatbelt sleeve was in a defective condition unreasonably dangerous to the user for purposes of the strict liability claim requires the dismissal of the companion negligence claim.
2010 WL 3219499, at *2 (S.C. Aug. 16, 2010).

Inspired by these two recent decisions – one in our pharma sandbox, and the other a more general product liability case – we’ve decided to make the non-existent duty to test the subject for our latest cheat sheet.  So that’s what the rest of this post is, a list of all the cases we could find where the misbegotten idea of some separate and independent duty to test has been rejected by a court.  No half-measures here.  To get on this list the court has to hold that there is no separate duty to test apart from well-established product liability claims for warning, design, or (maybe) manufacturing defect.
  1. West v. Broderick & Bascom Rope Co., 197 N.W.2d 202, 212 (Iowa April 13, 1972) (rope sling). “For testing to be material, substantial evidence must be introduced of a defect in the article.”  Verdict for plaintiff reversed and remanded for new trial.
  2. Lindquist v. Ayerst Laboratories, Inc., 607 P.2d 1339, 1349-50 (Kan. Mar. 1, 1980) (anesthetic). “The defective condition is the failure of [defendant] to properly warn.” “[T]he plaintiff cannot succeed where he fails to allege or prove that tests or inspections would have been effective” to “produce[] more conclusive results” that would support a changed warning.”  Jury instruction properly refused.
  3. Lewis v. Envirotech Corp., 674 S.W.2d 105, 114 (Mo. App. Sept. 11, 1984) (slurry pump). “There is no case law in Missouri to support plaintiff’s “failure to test” theory.” Motion for new trial denied.
  4. Jones v. Ortho Pharmaceutical Corp., 209 Cal. Rptr. 456, 462-63 (Cal. App. Jan. 3, 1985) (oral contraceptive).  Refusing to let plaintiff shift burden of proof with failure to test claim couched as FDCA-based negligence per se.  Refusing to “presume that had defendant conducted the clinical studies plaintiff contends should have been done, those studies would have established” causation.  Nonsuit affirmed.
  5. Pridemark Custom Plating, Inc. v. Upjohn Co., 702 S.W.2d 566, 576 (Tenn. App. July 29, 1985) (polyurethane foam insulation). Verdict for plaintiff reversed because jury should not have been independently charged on failure to test.  “[Defendant’s “failure to test did not cause plaintiffs’ damages and is not an issue on which the jury should be instructed.”
  6. Shires v. Celotex Corp., 1988 WL 1001970, at *2 (E.D. Pa. March 30, 1988) (cigarettes).  “Any duty defendants may have had to test their [product] would appear to be logically subsumed within plaintiff's defective design or defective manufacture claims.  That is, if the defendants’ failure to test their [product] resulted in the sale of ‘defective’ [products] which ultimately injured plaintiff’s decedent, then the flawed design or manufacturing process would be the proximate cause of plaintiff's injuries, not the failure to test.”  Summary judgment granted.
  7. Cipollone v. Liggett Group, Inc., 683 F. Supp. 1487, 1499 (D.N.J. April 21, 1988) (cigarettes).  “[A]ny claim based on such a failure [to test] is subsumed in plaintiff's failure to warn or alternative design claims.” “[A]bsent a showing that defendants’ inactions resulted in a more dangerous product (either because of a lack of warning or safer design), plaintiff has suffered no actionable injury.”  Directed verdict granted.
  8. Kociemba v. G.D. Searle & Co., 707 F. Supp. 1517, 1527-28 (D. Minn. Feb. 16, 1989) (IUD).  The most widely cited authority for refusing to recognize independent duty to test claims.  “[T]he reason that manufacturers are under a duty to test their products is to discover defects or dangers associated with use of the products. Once the manufacturer has discovered a defect or danger the manufacturer should either change the product’s design or manufacturing process, or warn consumers of the danger associated with using the product. Thus, unless the manufacturer's breach of its duty to test leads the manufacturer to produce a product that is defective in design, manufacture, or warning, no injury can result.”  Judgment n.o.v. (that's "non obstante verdicto" or notwithstanding the verdict) granted.
  9. Pennington v. Vistron Corp., 876 F.2d 414, 419-20 n.5 (June 28, 1989) (applying Louisiana law) (cigarettes). Negligent failure to test “is . . . not actionable per se, but instead is a variation of the failure to warn theory.”  Summary judgment affirmed.
  10. Adams v. G.D. Searle & Co., 576 So.2d 728, 730-31 (Fla. App. Jan. 18, 1991) (IUD). “The duty to test . . . is a subpart of a manufacturer’s duty to design a product with reasonable care, and thus is subsumed in the plaintiffs’ claims for defective design and failure to warn.”  Summary judgment affirmed.
  11. Fane v. Zimmer, Inc., 927 F.2d 124, 130-31 (March 8, 1991) (internal fixation tube and plates) (applying New York law).  Alleged negligent failure to test could not be causal when all product liability claims dismissed.  Directed verdict affirmed.
  12. Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 n.5 (5th Cir. Feb. 3, 1992) (Thorotrast) (applying Texas law).  Plaintiff’s “negligence claims, such as the alleged failure to adequately test [the product], are subsumed within” a failure to warn claim. Summary judgment affirmed.
  13. MacDonald v. Monsanto, 1995 WL 581942, at *1-2 & n.3 (5th Cir. Sept. 13, 1995) (unpublished, in table at 68 F.3d 470) (herbicide).  Louisiana’s product liability statute “does not recognize a cause of action for failure to test . . . except insofar as the failure to test . . . renders the product unreasonably dangerous.”  Under prior common law, “failure to properly test must result in either a defect or a failure to warn, and a plaintiff must proceed under one of these theories.  Accordingly, the failure to test per se does not give rise to a cause of action except insofar as it renders the product unreasonably dangerous.”  Summary judgment affirmed.
  14. American Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420, 437, 439 (Tex. June 20, 1997) (cigarettes).  Summary judgment against negligent failure to test claim affirmed where “the negligent testing claim is inextricably intertwined with [plaintiffs’] negligent failure to warn claim.”  The “negligent testing claim is inextricably intertwined with advertising and promotional materials because [plaintiffs] allege only that [defendant] should have tested its products to determine the dangerous characteristics about which [it] should have warned consumers.”
  15. Joseph v. Jamesway Corp., 1997 WL 524126, at *6 (Del. Super. July 9, 1997) (stationary bicycle).  “[U]nless the manufacturer’s breach of its duty to test leads the manufacturer to produce a product that is defective in design, manufacture, or warning, no injury can result.  If the manufacturer designs the product safely, manufactures the product safely, and provides an adequate warning of dangers inherent in the use of the product, then a failure to test the product cannot, standing alone, cause any injury. The duty to test is a subpart of the other three duties because a breach of the duty to test cannot by itself cause any injury.”  Summary judgment granted.
  16. Green v. General Motors Corp., 709 A.2d 205, 216 (N.J. Super. App. Div. March 18, 1998) (automobile).  “[A] failure to test or of inadequate testing may be evidential as an explanation of why a design was defective, but it is not in itself proof of a separate basis for liability.”  Held to be harmless error in decision affirming plaintiff's verdict.
  17. Vassallo v. Baxter Healthcare Corp., 696 N.E.2d 909, 921 (Mass. July 16, 1998) (breast implant).  “[E]vidence of failure adequately to test a product is relevant to claims of design, manufacturing, or warning defects, but does not furnish a separate, independent basis for liability.”  Held to be harmless error in decision affirming plaintiff's verdict.
  18. Lambert v. General Motors, 79 Cal. Rptr.2d 657, 660-61 (Cal. App. Nov. 18, 1998) (automobile).  Verdict vacated because liability for failure to test was incompatible with lack of defect.  “Even if [defendant] did not test the [product] . . ., in the absence of a defect, those omissions would not be important. Testing, for example, would not disclose the existence of a defect where there is none.”
  19. Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr. 2d 252, 264 (Cal. App. Jan. 7, 1999) (breast implant).  Directed verdict against failure to test claim affirmed.  “[T]he duty of testing and inspecting has no significance apart from the results of the product’s design and manufacture and the relevant warnings.”  Where other defect claims are dismissed, “nothing remains upon which to hang the testing and inspection duties.”
  20. Theriot v. Danek Medical, Inc., 168 F.3d 253, 256 (5th Cir. March 10, 1999) (bone screws).  “[Plaintiff] is arguing that he should be permitted to proceed to trial if [defendant] cannot demonstrate that it adequately tested its product.  There is no basis in the [Louisiana product liability statute] or case law for such a rule.” Summary judgment affirmed.
  21. Clark v. Danek Medical, Inc., 1999 WL 613316, at *3 n.4 (W.D. Ky. Mar. 29, 1999) (bone screws).  “[I]nadequate testing” claim is “subsumed” by warning claim.  Summary judgment granted.
  22. Harris v. Danek Medical, Inc., 1999 WL 1117106, at *3 (M.D. La. July 22, 1999) (bone screws).  Summary judgment granted against failure to test claim. Quoting and following Theriot).
  23. Tompkins v. R.J. Reynolds Tobacco Co., 92 F.Supp.2d 70, 91 (N.D.N.Y. March 3, 2000) (cigarettes).  Summary judgment granted against “negligent failure to test,” as it relates either to warning or design defect claims and satisfies neither.
  24. Patton v. Country Condo Ass’n, 2000 WL 33728374, at *4 (III. App. July 7, 2000) (unpublished) (insecticide).  “Where plaintiffs alleged a failure to test, they have alleged an incomplete tort.  The failure to test is not a negligent act in itself; rather, a failure to test leads to a failure to correct either a manufacturing defect or a failure to warm of harm resulting from the product.  Thus, the duty to test does not cause injury by itself but is a subpart of designing a safe product, manufacturing it safely, and providing adequate warnings of dangers inherent in the use of the product.”  Dismissal of testing claim affirmed.
  25. Neri v. R.J. Reynolds Tobacco Co., 2000 WL 33911224, at *19 (N.D.N.Y. Sept. 28, 2000) (cigarettes).  There is “no case law to support the existence of a separate claim for negligent testing,” and “these particular allegations [are] incorporated under the causes of action for failure to warn and negligent design.” Summary judgment granted.
  26. Oddi v. Ford Motor Co., 234 F.3d 136, 143-44 (3d Cir. Oct. 13, 2000) (automobile).  “We have found no authority to support [plaintiff’s] contention that Pennsylvania recognizes an independent tort for “negligent failure to test.”  “[W]hether we view [plaintiff’s] theory as crashworthiness or negligence arising from a failure to test, he must establish a defect in the design of the truck in order to recover.”  Summary jusgment affirmed.
  27. Linsley v. C.R. Bard, Inc., 2000 WL 343358, at *6 (E.D. La. Mar. 30, 2000) (surgical mesh).  Summary judgment granted against plaintiff’s “only . . . argument that [defendant] did not adequately test its product.”
  28. Mercer v. Pittway Corp., 616 N.W.2d 602, 626-27 (Iowa Sept. 7, 2000) (smoke detector).  Reversible error requiring new trial to submit separate negligent testing claim to jury.  “[T]he evidence presented by plaintiffs in support of their negligent testing claim is in reality a negligent failure to warn claim.”
  29. LaBelle v. Philip Morris, Inc., 243 F. Supp.2d 508, 519 (D.S.C. July 5, 2001) (cigarettes).  Summary judgment granted.  “Pennsylvania law has not explicitly recognized an independent tort for 'negligent failure to test.'”
  30. Stapper v. GMI Holdings, Inc., 2001 WL 1664920, at *5-6 (Cal. App. Dec. 31, 2001) (unpublished) (garage door opener).  Verdict for defendant affirmed.  “[A] manufacturer's breach of its duty to test cannot, standing alone, suffice to impose liability on the manufacturer for a plaintiff's injuries.  For liability to attach, there must be evidence that the manufacturer’s failure to test adequately led it to produce a defectively designed or dangerous product which in turn caused the injuries.  In other words, a failure to test cannot be deemed the cause of injury if there is no defect or danger to be disclosed by testing.”
  31. In re N Phenylpropanolamine Litigation, 2002 WL 244858, at *1 (Pa. C.P. Philadelphia Co. Feb. 5, 2002) (PPA).  “No such independent tort [for negligent failure to test] exists.”  Sustaining preliminary objection.
  32. Miller v. Pfizer Inc., 196 F.Supp.2d 1095, 1124 n.97 (D. Kan. Feb. 11, 2002) (Zoloft). Summary judgment granted.  “The duty to warn and the duty to test are, for all practical purposes, coextensive.”
  33. Stitt v. Philip Morris, Inc., 245 F.Supp.2d 686, 694 (W.D. Pa. March 13, 2002) (cigarettes).  Motion to dismiss granted.  “Pennsylvania law . . . does not recognize an independent cause of action for negligent testing. Rather such claims are subsumed within a plaintiff's claim for defective design or failure to warn.”
  34. McClain v. Metabolife International, Inc., 193 F. Supp.2d 1252, 1257 (N.D. Ala. March 27, 2002) (ephedrine).  “Plaintiffs have not directed the Court’s attention to a single authority supporting the maintenance of such a claim under Alabama law, nor is the Court independently aware of any such authority.  Therefore, summary judgment with respect to Plaintiff's negligent failure to test” claim, as a separate cause of action, is granted.”
  35. Bergfeld v. Unimin Corp., 226 F. Supp.2d 970, 982 (N.D. Iowa April 8, 2002) (silica sand).  Summary judgment granted.  Failure to test claim “is merely another way of arguing that [defendant’s] labels should have warned against using [the product].”
  36. McCroy v. Coastal Mart, Inc., 207 F. Supp.2d 1265, 1279 (D. Kan. June 21, 2002) (drink dispenser).  Judgment n.o.v. granted.  Failure to test does not lie without a product defect.  “Liability is premised not on the fact of injury alone, however, but upon the manufacturer’s failure to take reasonable steps to discover a defect in its product before a defective condition causes injury.  Having already found that plaintiffs failed to establish sufficient evidence of a defect, the court also finds insufficient evidence for a jury to impose liability for a failure to inspect or test.”
  37. Messer v. Amway Corp., 210 F.Supp.2d 1217, 1234 (D. Kan. June 13, 2002) (paint remover).  Summary judgment granted.  Negligent testing claim is a variant of failure to warn.
  38. Smith v. Daimlerchrysler Corp., 2002 WL 31814534, at *5 (Del. Super. Nov. 20, 2002) (automobile).  “In Delaware, there is no separate cause of action failure to test or inspect in a products action. The duty to inspect is part of the larger duty to design a product with reasonable care.” Summary judgment granted.
  39. Ashton v. Aventis Pasteur, Inc., 2003 WL 21361355, at *6 (Pa. C.P. Philadelphia Co. May 22, 2003), aff’d, 851 A.2d 908 (Pa. Super. 2004) (vaccine).  “[N]egligent failure to test is not an independent tort under Pennsylvania law.”  Sustaining preliminary objection.
  40. Dow Agrosciences LLC v. Bates, 332 F.3d 323, 333 (5th Cir. June 11, 2003), reversed on other grounds, 544 U.S. 431 (2005) (preemption) (herbicide).  “[A] negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.”  Summary judgment affirmed.
  41. Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. Nov. 24, 2003), aff’d mem., 881 A.2d 1262 (Pa. 2005) (cigarettes).  “[T]he claim for ‘negligent failure to test’ is not a viable cause of action recognized by our courts.  Summary judgment affirmed.
  42. Solo v. Trus Joist MacMillan, 2004 WL 524898, at *13 n.26 (D. Minn. March 15, 2004) (furnace).  “The duty to test . . . is not a separate cause of action under Minnesota law, but rather a subpart of the duties to safely design and manufacture products and to provide adequate warnings.”  Summary judgment granted.
  43. Irion v. Sun Lighting, Inc., 2004 WL 746823, at *16 (Tenn. App., April 7, 2004) (halogen lamp).  “We find no basis for this alleged duty to independently test in Tennessee law. Under the Tennessee Product Liability Act the test is whether the product was defective or unreasonably dangerous.”  Summary judgment affirmed.
  44. Williams v. Dow Chemical Co., 2004 WL 1348932, at *18-19 (S.D.N.Y. June 16, 2004) (pesticide).  Under Florida law, “a manufacturer’s duty to inspect and test is not a separate cause of action,” “is subsumed in the plaintiffs’ claims for defective design and failure to warn,” and “is dismissed as duplicative.”  Summary judgment granted.
  45. Villegas v. Deere & Co., 135 Fed. Appx. 279, 281 (11th Cir. June 13, 2005) (forklift).  “Georgia does not recognize a cause of action for negligent testing.”  Summary judgment affirmed.
  46. Jones v. Leslie Controls, Inc., 2005 WL 1581503, at *5 (Cal. App. July 7, 2005) (unpublished) (asbestos).  Verdict vacated for new trial because liability for failure to test is incompatible with lack of defect.  “Since [the manufacturer] has been exonerated of liability for manufacture, design and warning, nothing remains upon which to hang the testing and inspection duties.”  “[U]nless the manufacturer’s breach of its duty to test leads the manufacturer to produce a product that is defective in design, manufacture, or warning, no injury can result.”
  47. Kunzie v. Family Medical Care, P.A., 2005 WL 6317652 n.1 (Fla. Cir. Aug. 25, 2005) (Lamictal).  “Negligent testing . . . is subsumed into plaintiff’s claims of defective design and failure to warn and does not constitute a separate cause of action.”  Summary judgment granted.
  48. Laisure-Radke v. Par Pharmaceutical, Inc., 426 F. Supp.2d 1163, 1168-69 (W.D. Wash. March 31, 2006) (generic Prozac).  Washington product liability statute preempts common-law negligence claims for “negligent failure to test or otherwise investigate.” Summary judgment granted.
  49. In re Prempro Products Liability Litigation, 2006 WL 1897267, at *4 (E.D. Ark. July 11, 2006) (hormone replacement therapy).  “[T]he ‘failure to test’ claim is simply a component of [plaintiff’s] failure to warn and negligence claims,” not an “independent cause of action.”  Summary judgment granted.
  50. In re Prempro Products Liability Litigation, 2006 WL 1981902, at *4 (E.D. Ark. July 13, 2006) (hormone replacement therapy).  “[T]he ‘failure to test’ claim is simply a component of [plaintiff’s] failure to warn and negligence claims,” not an “independent cause of action.”  Summary judgment granted.
  51. Graham v. Medtronic, Inc., 2006 WL 2194012, at *2 (M.D. Fla. Aug. 2, 2006) (external defibrillator).  Claims dismissed for failure to state a claim “to the extent they attempt to assert a cause of action for negligent failure to inspect and test the device.”
  52. Latiolais v. Merck & Co., 2007 WL 5861354, at *3 n.1 (C.D. Cal. Feb. 6, 2007), aff’d, 302 Fed. Appx. 756 (9th Cir. 2008) (Zocor).  Summary judgment granted against failure to test. “[T]his liability theory is subsumed by the manufacturer's duty to warn, and it does not change the premise of Plaintiff's claims, which is that [defendant’s] failure to warn of any product defects or dangers-tested or not-ultimately caused [injury].”
  53. Conway v. A.I. DuPont Hospital for Children, 2007 WL 560502, at *5 (E.D. Pa. Feb. 14, 2007) (applying Delaware law) (cardiac stent).  “[C]ourts have concluded that a ‘failure to test’ is encompassed by claims for design defect and failure to warn.”  Motion to dismiss granted.
  54. Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 318 n.32 (E.D. Pa. March 28, 2007) (pediatric vaccines).  “[U]nder Pennsylvania law an inadequate testing claim does not support an independent claim for relief in strict product liability.” Judgment on the pleadings granted.
  55. Burley v. Kytec Innovative Sports Equipment, Inc., 737 N.W.2d 397, 408 & n.6 (S.D. Aug. 1, 2007) (sports training equipment).  “A manufacturer’s duty to test and inspect traditionally does not give rise to an independent cause of action for products liability.”  Summary judgment affirmed.
  56. Tuosto v. Philip Morris USA Inc., 2007 WL 2398507, at *11 (S.D.N.Y. Aug. 21, 2007) (cigarettes).  “‘Failure to test' is not a cause of action under New York’s strict products liability law.”  Judgment on the pleadings granted.
  57. Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294, 1306 n.15 (D. Kan. Jan. 9, 2008) (Paxil).  “[P]laintiffs’ testing claims are subsumed in plaintiffs’ warning claims because their theory is that proper testing would have resulted in more adequate warnings.”  Summary judgment granted.
  58. Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208, 215 (E.D. Va. Feb. 12, 2008) (vaccine).  Judgment on the pleadings granted against failure to test claims. “ Virginia recognizes only three ways in which a product may be unreasonably dangerous,” and failure to test is not one of them.
  59. Stratford v. SmithKline Beecham Corp., 2008 WL 2491965 at *6 (S.D. Ohio June 17, 2008) (Paxil).  A claim for failure to test (“negligent pharmaco-vigilance”) is outside the three specified defects recognized in Ohio’s product liability statute, and is dismissed without prejudice to being repleaded as a proper claim.
  60. Bailey v. Wyeth, Inc., 2008 WL 2856146 (N.J. Super. Law Div. July 11, 2008) (hormone replacement therapy).  Failure to test claim barred by presumption of adequacy of FDA-approved labeling, as claim amounted to an attack on the risk information in the label.  Summary judgment granted.
  61. Singh v. Toyota Motor Corp., 2009 WL 2477774, at *4 (Cal. App. Aug. 13, 2009) (unpublished) (automobile).  Jury properly not charged separately on duty to test.  “The duty of testing . . . has no significance apart from the test results of the product's design. . . .  In other words, the duty to test is subsumed within the duty to design, and a breach of the duty to test cannot by itself cause any injury if no defect in the design has been found.”
  62. Oxford v. Foster Wheeler LLC, 99 Cal. Rptr.3d 418, 435 (Cal. App. Sept. 9, 2009) (asbestos in boilers).  Verdict vacated for new trial because liability for failure to test is incompatible with lack of defect.  “The negligent testing theory, however, would be inconsistent with the jury’s finding for defendant on liability for design defect.  Even if defendant failed in this respect, there could be no causation of injury or recovery for such failure if there was no defect in the product.”
  63. Tuosto v. Philip Morris USA Inc., 672 F.Supp.2d 350, 354 n.2 (S.D.N.Y. Nov. 19, 2009) (cigarettes).  “‘[F]ailure to test’ is not a cognizable claim under New York products liability law.”  Motion to dismiss granted.
  64. McSwain v. Sunrise Medical, Inc., 689 F. Supp.2d 835, 847-48 (S.D. Miss. Feb. 8, 2010) (wheelchair).  “[T]he negligence claim for failure to conduct adequate testing would, like a negligence claim for defective design or failure to warn, would be subsumed by the [Mississippi product liability statute].”  Summary judgment granted.
  65. Phillippi v. Stryker Corp., 2010 WL 2650596, at *2 (E.D. Cal. July 1, 2010) (pain pump).  “When the warnings accompanying a prescription product adequately inform the physician of dangers inherent in its use, the manufacturer’s alleged failure to test that product cannot, by itself, either cause injury or be a source of liability of the manufacturer.  Imposing liability for breach of a purported 'independent duty to conduct long-term testing' would be beyond the pale of any known California tort doctrine, because, inter alia, the causal link between Plaintiff's known harm, and the unknown outcome of the hypothetical testing is entirely speculative.”  Summary judgment granted.
  66. Lance v. Wyeth, 4 A.3d 160, 168-69 (Pa. Super Aug. 2, 2010) (fen-phen).  If a duty to test exists at all it is subsumed by other claims.  Rejecting older, contrary precedent.  See above for quote.  Summary judgment affirmed.  An appeal is pending in the Pennsylvania Supreme Court.  See Lance v. Wyeth, 15 A.3d 429 (Pa. 2011)
  67. Branham v. Ford Motor Co., 701 S.E.2d 5, 9 (S.C. Aug. 16, 2010) (automobile).  Without any conventional product defect rendering the product unreasonably dangerous, there is not duty to test.  See above for quote.  Reversible error requiring new trial to charge jury on separate theory.
  68. Torkie-Tork v. Wyeth, 757 F. Supp.2d 567, 572-73 (E.D. Va. Dec. 15, 2010) (hormone therapy).  There is no separate duty to test under Virginia law.  A duty to test would improperly eliminate the state of the art from defense from negligence and expand the "reason to know" standard.
  69. Krumpelbeck v. Breg, Inc., 759 F. Supp.2d 958, 972-73 (S.D. Ohio Dec. 27, 2010) (pain pump).  No duty to test for unknown risks imposed by either Ohio product liability statute or the FDCA.
  70. Rodriguez v. Stryker Corp., 2011 WL 31462, at *9-10 (M.D. Tenn. Jan. 5, 2011) (pain pump).  "[I]t is clear that there is no broadly recognized 'duty to test' in Tennessee."  Any duty to test for currently unknown risks would be "unreasonable."  Motion to alter judgment denied, Rodriguez v. Stryker Corp., 2011 WL 672555 (M.D. Tenn. Feb. 17, 2011).
  71. Moore v. Ford Motor Co., 332 S.W.3d 749, 761 & n.7 (Mo. Jan. 25, 2011) (automobile).  Requiring warnings about failure to test "would confuse rather than serve the purpose of warnings."  Failure to test may only be an aspect of a warning or design defect claim.
  72. Hall v. Sunjoy Industries Group, Inc., 764 F. Supp.2d 1297, 1302-03 (M.D. Fla. Feb. 18, 2011) (patio chair).  Florida does not recognize a separate claim for failure to test.
  73. Pavelko v. Breg, Inc., 2011 WL 782664, at *8 (D. Colo. Feb. 28, 2011) (pain pump).  No duty to test for unknown risks imposed by either Colorado law or the FDCA.
  74. Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 570 (E.D. Pa. March 30, 2011) (hormone therapy).  Pennsylvania does not recognize a tort for negligent failure to test.
  75. Salvio v. Amgen, Inc., 810 F. Supp.2d 745, 751-52 (W.D. Pa. Aug. 18, 2011)  (Enbrel).  Pennsylvania does not recognize a tort for negligent failure to test.
  76. St. Clair v. Nellcor Puritan Bennett LLC, 2011 WL 5331674, at *8-9 (D. Ariz. Nov. 7, 2011).  Arizona does not recognize negligent testing as a distinct theory of liability.
  77. Couick v. Wyeth, Inc., 2012 WL 79670, at *7 (W.D.N.C. Jan. 11, 2012).  North Carolina does not recognize negligent testing as a distinct theory of liability.
  78. Todd v. Stryker Corp., 2012 WL 2922727, at *4 (E.D. Cal. May 1, 2012) (pain pump).  California does not recognize failure to test as an independent theory of liability in either negligence or strict liability.  "Imposing liability for breach of a purported independent duty to conduct long-term testing would be beyond the pale of any known California tort doctrine."
  79. Rodriguez v. Stryker Co., 680 F.3d 568, 574 (6th Cir. May 21, 2012).  In Tennessee, the duty to test “collapses into the failure-to-warn claim."  "The law does not require a company to test for hidden risks that neither it nor the medical community had a reasonable basis to suspect.”
  80. Hogue v. Pfizer, Inc., 2012 WL 11944897 (S.D. Ohio Sept. 27, 2012).  No duty to test is claim allowed under Ohio product liability statute.  Alleged violation of federal duty not actionable under exclusive product liability statute.
  81. Huggins v. Stryker Corp., 932 F. Supp.2d 972, 987 (D. Minn. March 25, 2013).  Neither failure to test nor “Failure to review scientific literature” are independent causes of action under Minnesota law.
  82. In re C. R. Bard, Inc., 2013 WL 3821280 (S.D.W. Va. July 23, 2013).  Georgia does not recognize failure to test as a separate cause of action.  Evidence of failure to test prior to sale may be relevant to design, warning, or punitive damages.  Testing evidence may not be used to argue for warnings about matters not within the state of the art of the time of sale.
  83. Ball v. Takeda Pharmaceuticals America, Inc., 963 F. Supp.2d 497, 506 (E.D. Va. Aug. 8, 2013).  Virginia does not recognize a separate claim for failure to test.
  84. Baird v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 5890253, at *2, slip op. (E.D. Ky. Oct. 31, 2013).  Kentucky does not recognize a separate claim for failure to test, "because it is simply a failure-to-warn claim in disguise."
  85. Baker v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 6698653, at *3 (N.D. Cal. Dec. 19, 2013) (IUD).  Holding that “California law does not recognize an independent cause of action for failure to test.”
  86. Drager v. PLIVA USA, Inc., 741 F.3d 470, 477 (4th Cir. Jan. 28, 2014).  There can be no separate claim for negligent failure to test under Maryland law.
  87. Small v. Amgen, Inc., 2 F. Supp.3d 1292, 1299 (M.D. Fla. March 6, 2014).  There is no separate claim for negligent failure to test under Florida law.
  88. Centeno v. Bayer Healthcare Pharmaceuticals, Inc., 2014 WL 4809565, at *3 (S.D. Ill. Sept. 26, 2014).  There is no separate claim for negligent failure to test under California law.
  89. Houtz v. Encore Medical Corp., 2014 U.S. Dist. Lexis 170481, at *7-8 (M.D. Pa. Dec. 10, 2014).  There is no separate claim for negligent failure to test under Pennsylvania law.
  90. Phillips v. C.R. Bard, Inc., 2015 U.S. Dist. Lexis 7513, at *17-18 (D. Nev. Jan. 21, 2015).  There is no independent duty to test under Nevada law.
  91. Wise v. C. R. Bard, 2015 U.S. Dist. Lexis 14310, at *18 (S.D.W. Va. Feb. 7, 2015). There is no independent duty to test under West Virginia law.
  92. Lonon v. Globus Medical, Inc., 2015 U.S. Dist. Lexis 28494, at *7 (S.D. Ga. March 9, 2015). There is no independent duty to test under Georgia law.
  93. Trahan v. Novartis Pharmaceuticals Corp., No. 3:13-cv-00350, slip op. at 15-17 (M.D. Fla. March 26, 2015).  There is no independent duty to test under Florida law.  Testing is merely a subpart of design, warning, or manufacturing defect claims.
  94. Barton v. Lowe’s Home Centers, Inc., ___ A.3d ___. 2015 Pa. Super. Lexis 552, at *18 (Sep. 24, 2015).  A separate cause of action for failure to test is not viable in Pennsylvania in either strict liability or negligence.
  95. Tsavaris v. Pfizer, Inc., 2016 WL 375008, at *4 (S.D. Fla. Feb. 1, 2016).  There is no independent duty to test under Florida law.

Thursday, August 26, 2010

Federalism Prevails In Third Circuit

We say it often: tragic facts lead to bad law. And the case we ranked #4 on our list of worst drug/device decisions of 2009 was definitely a case of tragic facts (and, as you can guess, we didn't like the law too much). In that case, an infant who was born with Down Syndrome and a combination of heart defects went to a children’s hospital in Delaware, where the infant underwent a procedure that included the implantation of a stent (this stent had not been approved by the FDA). Unfortunately, the infant developed two rare and life-threatening conditions: protein losing enteropathy (PLE) and plastic bronchitis (PB). The infant’s guardians sued the hospital, the doctors, and the device manufacturer on a host of common-law negligence, strict liability, fraud, and warranty claims, and threw in a “medical monitoring” claim for good measure. The District Court judge in ED Pa. allowed the Delaware-law medical monitoring claim to proceed against the defendants – even though the Delaware Supreme Court had never ruled on the issue. In fact, the District Court allowed that medical monitoring claim to proceed at the same time it dismissed all those other common law causes of action. In other words, medical monitoring “in the air.” Totally novel (you can read more about the case here and here)….and so the case landed at #4.

Now that you know the back story, here’s the latest chapter. A couple days ago, the 3rd Circuit affirmed in part and reversed in part the district court. See M.G. v. A.I. duPont Hospital For Children, 2010 WL 3310720 (3d Cir. Aug. 24, 2010). Affirmed in part and reversed in part sounds like splitting the difference, but in this case, it means a total defense win. The 3rd Circuit affirmed the District Court’s grant of summary judgment as to all the standard common law claims, on the unsurprising ground that the plaintiffs had to prove, by expert testimony, a causal link between the defendants’ conduct and the injuries. Id. at *4-5. The plaintiffs’ expert failed to testify that the harm would not have occurred “but for” the alleged deviation in the standard of care. Id. at *5. In fact, the expert conceded that PLE and PB can develop even absent negligence, and that he did not know whether the stent or the procedure caused the injuries. Id.

But that’s not the part that really interests us. We are locked in on the second part of the opinion – the 3rd Circuit’s reversal of the decision to allow the medical monitoring claim to proceed. And in the interest of full disclosure, we should tell you that Bexis not only wrote an amicus brief on behalf of the Product Liability Advisory Council in this appeal, but came up with a winning argument: The district court overstepped its bounds in “predicting” a novel expansion of Delaware law. Id. at *5-6. In fact, it’s something that we’ve written about in this blog. So yeah, we’re pretty happy to see the 3rd Circuit agree with us. Here’s the problem, as we, and the 3rd Circuit, see it. We have no guidance from the Delaware Supreme Court about whether medical monitoring is a stand-alone tort, or whether it is instead a remedy (in other words, is it a claim or is it a measure of damages). Id. at *5. In the absence of guidance, the District Court should have done the safe thing and dismiss the claim. It's called federalism. Instead, the 3rd Circuit agreed that “the District Court erred in extending Delaware law beyond the bounds of the recognized medical monitoring claim in which a plaintiff alleges long-term exposure to a proven toxic substance with known tendencies to produce serious future medical injuries.” Id. at *6. Not only did the District Court recognize a stand-alone cause of action for medical monitoring – something neither the Delaware Supreme Court nor the Delaware legislature has done – but the District Court then took the further leap of predicting that Delaware would in fact recognize a standalone medical monitoring cause of action outside the “toxic tort” context where medical monitoring claims usually arise (think chemical spills or plant explosions). Id. This was a few leaps too many for the 3rd Circuit:

[T]he District Court’s prediction that the Delaware Supreme Court would permit a claim for medical monitoring on this record requires several “leaps” from the current state of the law, generally, let alone Delaware law. Here, there is no toxic or hazardous substance, as such. While unapproved devices are termed “adulterated,” they are not necessarily harmful, and certainly not toxic. Moreover, the risk here is not a risk of “contracting a serious latent disease.” Rather, it is a risk of the need for further care. Further examinations are not to “monitor” the risk of disease, but to perform routine oversight.

Id. at *7. So we can erase #4 from our bottom 10 list of 2009. The medical monitoring claim here was a real stretch: (1) not a toxic tort, but a device/malpractice case; (2) not a claim for monitoring a latent disease, but a claim for medical checkups; (3) not a claim tethered to a viable negligence or strict liability theory, but a standalone claim; and last but certainly not least (4) not a claim that had EVER BEEN RECOGNIZED IN DELAWARE.

We understand the desire for compassion, to throw this poor family something. It’s tragic what happened, and it will surely be expensive to get the injured infant the care she needs. At the same time, the 3rd Circuit decision in M.G. confirms once again that tragic facts should not lead us to ignore the rule of law, or the principles of federalism.

Tuesday, August 24, 2010

A thumb and a finger or two outweigh a bad shoulder

We told you last year about a district court’s favorable Daubert ruling in one of the cases alleging that a bupivacaine shoulder pain pump caused chondrolysis (a breakdown of the cartilage in the shoulder joint). The district court rejected a well-qualified doctor’s general causation opinion under Daubert and, for good measure, rejected his specific causation opinion. The Eleventh Circuit recently affirmed that ruling in an opinion available here. Kilpatrick v. Breg, Inc., No. 09-13813 (11th Cir. Aug. 12, 2010).

Because the Eleventh Circuit opinion approvingly rehashes the trial court opinion we analyzed last year, we’ll just give you the highlights:

Animal studies: Studies of bupivacaine use on cows and rabbits were not reliable under Daubert because, among other reasons, the studies did not provide data on the human equivalent of the dose given to the animals or explain how their results applied to humans. Id. at 16, 21.

Case reports: Unreliable because they did not include any statistical analysis, account for other causes, or reach a conclusion about the general causation of chondrolysis. Id. at 13-14, 17-18.

Editorial: An editorial is not a scientific study or even a case report. Everyone who reads scientific literature knows that an editorial does not provide an adequate basis for a scientific judgment, and even plaintiff’s expert Dr. Poehling agreed. Id. at 19.

Claim that expert relied on articles not identified in his deposition: On appeal, Kilpatrick argued that his expert relied on six articles that the district court did not consider. But those articles “are nowhere mentioned in Dr. Poehling’s deposition testimony despite extensive and repeated requests by Breg’s counsel exhorting Dr. Poehling to identify every single article and study he relied upon.” Id. at 22. The good doctor’s vague reference to various other articles on his home computer did not allow him to rely on those articles because he did not identify the articles. Id.

Any lawyer who has tried to pin down an expert about what, exactly, the expert relied on should recognize this testimony and be gratified with the result. Sometimes that hard work at deposition pays off on appeal.

Background risks: A reliable methodology should consider background risks, the court said, but neither Dr. Poehling nor the articles upon which he relied considered the background risks of chondrolysis. Id. at 24. That failure placed the reliability of his conclusions in doubt. Id.
Temporal relationship: Other than the unreliable literature, the only support for Dr. Poehling’s specific causation opinion was the temporal relationship between Kilpatrick’s shoulder surgery and chondrolysis. The court reiterated that temporal relationship is inherently unreliable to show specific causation. Id. at 25, 27.

Differential diagnosis: Dr. Poehling tried to support his specific causation opinion with differential diagnosis, a reliable methodology, but his application of that methodology was flawed. “In order to correctly apply this methodology, Dr. Poehling must have [compiled] a comprehensive list of potential causes of Kilpatrick’s injury and must have explained why potential alternative causes were ruled out.” Id. at 26. He didn’t do that. He ruled out only two causes and could not explain why unknown or idiopathic alterative causes were not ruled out. Id.
Even though its opinion confirms that the trial judge was right, the Eleventh Circuit concluded by emphasizing the broad discretion given to district courts when conducting a Daubert analysis. The appellate court referred to the deference given to the district court’s Daubert analysis as “the heavy thumb – really a thumb and a finger or two – that is put on the district court’s side of the scale.” Slip op. at 29 (citation omitted). And so the trial judge’s decision to give the expert the thumb was affirmed.

Monday, August 23, 2010

South Carolina Rollover Reversal

Both the blogosphere and MSM covered the South Carolina Supreme Court's recent reversal of a $31 million verdict in a Ford Bronco rollover case. Branham v. Ford Motor Co., 2010 S.C. LEXIS 291 (South Carolina August 16, 2010). Most of the discussions of the Branham case focused on the plaintiff lawyer's inflammatory closing argument and/or the strange (and prejudicial) alignment of parties. But even though it was not a drug or device case, the Branham opinion contains other rulings that might affect our clients in significant (and positive) ways.

The facts are straightforward. Hale was driving her 1987 Ford Bronco under the speed limit. The passengers were children, including her daughter in the front passenger seat and Plaintiff Branham in the backseat. The children were "all excited." Branham, 2010 S.C. LEXIS 291 at *1. No one was wearing a seatbelt. Hale turned to the backseat to tell the kids to quiet down. (You just know a bunch of jurors at this point are nodding and thinking, "Been there.") When she took her eyes off the road, the Bronco veered. Hale overcorrected and the vehicle rolled over. Branham suffered a brain injury.

Branham sued both Ford and Hale. Branham brought negligence and strict liability claims against Ford regarding the rear seatbelt system and the vehicle's handling and stability. Branham alleged that Ford negligently failed to test the rear seatbelt sleeve and that Ford should have used a different suspension system. One of the witnesses called by Plaintiff was a former vice-president at Ford. That sort of thing is what we defense lawyers politely call a "challenge." The jury awarded $16 million in compensatory damages and $15 million in punitives.

As already mentioned, Branham sued Hale as well as Ford. "At trial, Branham did not seriously pursue the claim against Hale." 2010 S.C. LEXIS 291, *2. Hale cross-claimed against Ford, but that action was severed. At trial, Hale and her counsel sat on the plaintiff's side of the courtroom. The lawyer for Hale cross-examined only one witness, Branham's economic expert. It was not exactly a probing cross-examination: "[H]ow many millions are in a billion?" Id. at * 64. No doubt co-defendant Ford looked over at Hale's counsel and said something like, "Thanks. Thanks a lot." Meanwhile, when Branham's lawyer in closing argument addressed the liability of defendant Hale, here is what he said: "[S]he took her eyes off the road. But did she do something that was wrong. She did what all reasonable drivers would do, which was she tried to get back on the road." Id. Golly, we're waiting for a plaintiff lawyer to be nearly so understanding and generous in the next closing argument against one of our clients.

Nevertheless, the trial judge treated Ford and Hale as co-defendants and -- get this -- they split the 'defense' peremptory challenges. That's nutty. The good news is that the South Carolina Supreme Court made clear that a trial court has discretion to realign parties to prevent the sort of unfairness that occurred in Branham. Id. at * 67. The bad news is that the decision whether or not to realign the parties "lies within the sound discretion of the trial court and will not be disturbed on appeal absent a showing of an abuse of discretion and resulting prejudice." Id. Both abuse of discretion and prejudice seem present here, but because Ford did not preserve the issue for review, the South Carolina Supreme Court spoke only in generalities. Retrial, if it happens, will be interesting.

Remember how even-handed and -- gosh darn it -- sweet, Branham's closing argument was about defendant Hale? Not quite the same when it came to Defendant Ford. The South Carolina Supreme Court concluded that "[t]he closing argument of Branham's counsel was designed to inflame and prejudice the jury." Id. at * 50. Branham's counsel persistently embroidered on the theme of dollars over lives: "This is how Ford looks at this. That little bit of thirty people being killed every year didn't matter. Those thirty extra people getting killed in a year didn't matter to them because it was just a little bitty number." Id. at *50-51. And he goes on. And on. Maybe if he said it once or twice he would have gotten away with it. [We knew a plaintiff lawyer who always seemed to get away with improper questions or arguments by promising the judge that he "wouldn't dwell on it." How does that work? And yet it did. And Branham's attorney should have followed that example, or the advice of the Talking Heads: "Say something once, why say it again?"] This argument is not only inflammatory and monotonous, it improperly asked "that the jury punish Ford for harm done to Branham and others." Id. at * 52 (emphasis in original). So, kudos for getting a $31 million verdict, but maybe not-so-much if that verdict was obtained via a closing argument that had reversal written all over it.

Branham's attorney jacked up the punitive damages in another impermissible way. He "went far beyond the pale in submitting evidence of Ford's senior management compensation." Id. at * 62. The evidence included salaries, bonuses, and stock options for several members of Ford's management. The South Carolina Supreme Court had no problem finding that "admission of this evidence was error and highly prejudicial." Id. at * 63. Of course, when plaintiffs cross-examine company executives they always elicit testimony on compensation, on the theory that such compensation might affect credibilty. So juicy is this sort of testimony that there's a danger a plaintiff might call a company executive to the witness stand merely to highlight compensation. And so we offer a modest proposal: if the executive testifies in defendant's case, then compensation is fair game during cross-examination by the plaintiff, but if the plaintiff calls the witness the court should perform a thorough 403 analysis before permitting questioning on compensation.

Some of the other rulings have more applicability to our fun-filled field.

The trial judge dismissed Branham's strict liability attack on the seatbelt sleeve because the seatbelt sleeve was simply not defective. Not surprisingly, Ford believed that this finding should also compel the dismissal of the negligence claim. The trial judge disagreed with Ford but, fortunately, the Supreme Court agreed with Ford. After all, if there's nothing wrong with the seatbelt, where's the negligence? Branham claimed that Ford negligently failed to test the seatbelt, but the South Carolina Supreme Court agreed with Ford that "there is no separate 'failure to test claim' apart from the duty to design and manufacture a product that is not defective and unreasonably dangerous." Id. at * 6. Thus, the Branham case is significant for finally interring the failure-to-test claim.

As in many jurisdictions, South Carolina has both a consumer expectations and risk-utility test for product liability claims. The plaintiff's case will often disappear if the plaintiff is forced to show a less dangerous feasible alternative. (A lawn mower without blades would be safer, but it wouldn't be feasible.) The less dangerous alternative is part of the risk utility test, not the consumer expectations test. On appeal in Branham, Ford argued valiantly for application of the risk utility test when the claim is defective design. More important (for our purposes), Ford argued successfully. The court was persuaded that while a consumer expectations test might make sense in a manufacturing defect case, the risk utility test should apply to a design defect claim because it centers upon the alleged defectively designed product and provides "objective factors" for the jury. Id. at * 28. Accordingly, the South Carolina Supreme Court announced a major product liability ruling that will affect many cases going forward: "In sum, in a product liability design defect action, the plaintiff must present evidence of a reasonable alternative design. The plaintiff will be rquired to show how his alternative design would have prevented the product from being unreasonably dangerous." Id. at *33.

Thank you, Ford. Whether that new test will change things for Ford on retrial is unclear. It is possible that plaintiff can make out a less risky alternative. Branham's expert testified that the Bronco used twin I beams when a McPherson strut would have been safer. But Branham's attorney relied on several bits of Ford internal documents generated after the accident and also relied on evidence of similar accidents that were not sufficiently similar. Both bothered the court. In particular, the court found that "Ford was prejudiced by Branham's unrelenting pursuit of post-distribution evidence on the issue of liability." Id. at * 36-37. The court recognized that as a matter of policy, the law should encourage manufacturers continually to try to improve their products. Id. at 42-43. Thus, whether the 1987 Bronco was defectively designed "must be determined as of the 1986 manufacture date of the vehicle. Ford's 1986 design and manufacture decision should be assessed on the evidence available at that time, not the increased evidence of additional rollover data that came to light after 1986." Id. at *43. Whether Branham can prove a less risky alternative without the post-distribution and other accidents evidence remains to be seen.

In its verdict, the jury apportioned responsibility 55% to Ford and 45% to Hale. With joint and several liability and the reality of Ford's balance sheet vs. Hale's, it's clear that Ford would have been on the hook for the full amount. The South Carolina Supreme Court held that "[a]llocating fault between Ford and Hale served no legitimate purpose." Id. at * 54. The trial court justified the allocation question "to ensure that any punitive damage award was supported by a negligence cause of action, and not the strict liability claim." Id. But Ford had proposed a detailed verdict form that would have specified findings of negligence or design defect . As happens all too often, the trial court rejected the defendant's detailed verdict form. It's as if some courts don't want things to be too clear. The problem with the form used by the court was that the jury "would take the cue from the apportionment question and inflate the actual damage award to ensure Branham received a full recovery from the one deep-pocket defendant." Id. at * 56. That conclusion reflects an admirable degree of realism in an appellate court decision.

Maybe we're wrong, but it seems that South Carolina sees a disproportionate amount of mass tort liability litigation. Consequently, the Branham decision is disproportionately significant. And we are disproportionately pleased with it.

Friday, August 20, 2010

Bartlett’s Not-So-Familiar In Limine Rulings

In putting together yesterday’s post on second-guessing the FDA, we took a look at the Bartlett litigation in New Hampshire.  Lo and behold, we discovered that, in the past couple of weeks the ever-thorough Judge Laplante has issued a slew of other opinions on in limine motions.

Scads of issues got decided (the trial’s probably going on as we speak) – we’ll just give you what we think are the highlights. This is not a complete list.

Adverse Event Reports:  Admissible only to prove “notice” – that’s a big deal in Bartlett because of the defendant’s failure to survey medical literature.  Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3092649, at *1 (D.N.H. August 2, 2010).  Plaintiff has to establish that AERs are “reasonably relied upon” before her experts can use them to form opinions.  Id.  We generally agree, since the FDA has repeatedly made clear  that AERs can’t validly be used to reach conclusions about causation.

Subsequent Label Changes:  In a ruling we disagree with the court let some of these in because they were “mandated” by the FDA, and supposedly the rule excluding subsequent remedial measures “applies only” to “voluntary” changes.  2010 WL 3092649, at *2-3.  We’ve addressed that elsewhere, and pointed out that FDA-“mandated” changes are routinely excluded on this basis.  We note that the opinion itself is internally inconsistent, stating at one point that an FDA “recommendation” can come in.  Id. at *2.  A "recommendation" is not a "mandate" - even if there is such a thing as a "mandated" exception.

Contra-Factual “Hypothetical” FDA Actions:  In rulings we whole-heartedly support, the court precluded either side from speculating what the FDA might have done, had this or that circumstance been different.  2010 WL 3092649, at *5; Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3156555, at *3 (D.N.H. July 26, 2010); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2889114, at *3, 14 (D.N.H. July 22, 2010).  Claims that the FDA might have done something different encourage the jury to ignore what the FDA actually did, which we consider pernicious.

Legal Opinions by Experts:  The court barred either side’s experts from offering opinions about what FDA regulations meant or about whether X, Y, or Z was “negligent” or “broke the law.”  2010 WL 3092649, at *5; 2010 WL 2889114, at *2-4, *12.  The latter opinion includes one of the best discussions we’ve seen of this issue in an FDA-related case.  E.g.:

Since it is the judge’s role, not a witness’s, to instruct the jury on the law, this court has broad discretion to exclude expert opinion evidence about the law that would impinge on the roles of the judge and the jury or would cause “jury confusion.” Indeed, expert testimony proffered solely to establish the meaning of a law is presumptively improper.
2010 WL 2889114, at *2.  Industry practices, if divorced from opinions on the law, are all right.  Id. at *3 (“customs and practices of an industry are proper subjects for expert testimony”).

If [plaintiff] wants the jury to know what relevant FDA regulations require, she can propose appropriate jury instructions. And if she wants to show the jury that [defendant] violated them, she may do so by introducing evidence of [defendant’s] acts or failures to act, rather than conclusory opinions from her experts . . . .

[The ultimate issue rule is not] a carte blanche for experts to substitute their views for matters well within the ken of the jury. Courts have generally prohibited experts from using the term “negligent” to describe the defendant's conduct in a negligence case where the opposing party objects to it.
2010 WL 2889114, at *12

We generally like this result, even though we’ve frequently had our FDA experts push the envelope, too.  All in all, we’d rather have everybody’s experts stick to professional opinions and leave legal ones to the judge.

Subsequent Medical Literature:  It’s not admissible for notice, because that’s a “chronological impossibility,” 2010 WL 3092649, at *6, but might be admissible on risk/utility if “it does not stray far afield from the pre-purchase information, either in time or content.”  Id. at *6, n.6.  We’re not exactly sure what that last comment means, because these other possible uses weren’t cleanly teed-up, but we’d point out that the state of the art defense is a major issue here.

Withdrawal from the Market:  Plaintiff can’t claim that anything requires withdrawal, but can point out if similar drugs were withdrawn (this being relevant to the peculiar risk/utility theory under which the case is being tried, which was the subject of our second-guessing post). 2010 WL 3092649, at *7.  Plaintiff cannot argue a state-law failure to recall claim because it doesn’t exist, so uses of such evidence have to be limited. Id. at *8.

Collateral Sources:  The court excludes write offs by medical practitioners (that is, that they took less than the amount they nominally billed), as covered by the collateral source rule.  Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2990816, at *2 (D.N.H. July 23, 2010).  We don’t like giving plaintiffs money that they never, in fact, had to pay to anyone, and lots of other courts – most notably our home state of Pennsylvania – say that’s an abuse of the policies behind the collateral source rule.  Moorhead v. Crozer Chester Medical Center, 765 A.2d 786, 789-90 (Pa. 2001).  We point it out because it’s a pretty big issue these days, with states all over the place.  At some point the federal courts ought to certify the question to the New Hampshire Supreme Court.

Number of NSAID Users: The court allows this testimony.  2010 WL 2889114, at *5-6.  We agree. A numerator without a denominator is useless.  Adverse events have to be considered in the context of how many people actually use the drug (or class of drugs).

Thursday, August 19, 2010

On Second-Guessing the FDA

Remember what Wyeth v. Levine, 129 S. Ct. 1187 (2009), supposedly wasn’t about?  We addressed this issue here shortly after the Levine decision.  One thing that Levine wasn’t about (according to the majority, anyway) was a claim that the defendant failed to contraindicate an FDA approved use of the drug in question (Phenergan, in case you’ve forgotten).  We observed:

In particular, the majority [in Levine] held that through the miracles of post-verdict review, the plaintiff’s trial attacks on the FDA and its approval of the IV-push indication disappeared.  [129 S. Ct. at 1194.]  It no longer mattered that the plaintiff had expressly argued that the drug should never be used for that indication (id.: plaintiff “offered evidence that the IV-push method should be contraindicated and that [the drug] should never be administered intravenously”), since the Vermont Supreme Court later declared that the verdict “established only” that the “warning was insufficient.”  There were thus “any number of ways” – all unstated – for Wyeth to change its warnings.  Id.  In this way, Levine was no longer the “failure to contraindicate” case that we always considered it to be.  Id.  Allowing that kind of a claim couldn’t support a majority, so the plaintiff's claim became something else.
We thought that change was significant, because the failure-to-contraindicate issue had been prominent in both the briefing and at oral argument.  See here, here, and here.  That the Levine majority went out its way to emphasize that it was not addressing a failure to contraindicate claim suggested – and still suggests – that there was no majority on the Court for a holding that preemption would not apply to a claim that essentially posited that an FDA-approved use should never be allowed.

Instead, as everyone following preemption knows, the Court held that a failure to warn claim didn’t present a conflict because manufacturers could revise their warnings immediately to take account of new information without FDA prior approval.  Levine, 129 S. Ct. at 1197-98.

To put in starker terms, the majority in Levine shied away from allowing claims that state law could say “no” to a use of a drug to which the FDA had said “yes.”  Except where FDA regulations (allegedly) by their own terms allowed modifications, there wasn’t a majority on the Court for letting the common law go there.

We’re now a little more than a year into the post-Levine era, and already it looks like the other side (definitely) and the courts (all too often) are ignoring the implicit limits of Levine.  We’re seeing more and more claims that seek to second-guess and overturn FDA decisions in the same way that the erstwhile failure-to-contraindicate claim in Levine would have done.

Most notably, and most recently, is yesterday’s decision by the Sixth Circuit in Wimbush v. Wyeth, slip op. , ___ F.3d ___, 2010 WL 3256029 (6th Cir. Aug. 18, 2010).  That’s the case that reversed Longs v. Wyeth, 621 F. Supp.2d 504 (N.D. Ohio 2009) – the name difference having to do with a change in ethe state administrator who is the nominal plaintiff in the case.

Wimbush/Longs involves a claim that went way beyond a change in warnings – in fact, warnings weren’t even involved.  2010 WL 3256029, at *5 (“plaintiff dismissed her failure-to-warn claims and cannot show that Wyeth is strictly liable for defective design under [state law], her only remaining claims are for negligence”).  The Sixth Circuit cloaked that claim in legalistic jargon, calling it a “pre-approval negligence claim.”  Id. at *7.  However, stripping away the jargon, what the plaintiff asserted was quite clear:  that the defendant was “negligent” for ever having submitted the drug to the FDA in the first place, despite the fact that the FDA went ahead and approved the drug for marketing.  See Id. at *6 (“Defendants breached their duty by . . . putting [the drug] on the market in 1996, when [they] knew [it] was unreasonably dangerous”) (quoting complaint); (“claims regarding [defendant’s] acts and omissions, prior to the FDA’s approval, in bringing the drug to market”) (court’s characterization).

Note that plaintiff did not, and could not, allege that the defendants withheld information from the FDA.  That would be a preempted fraud on the FDA claim under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).  Thus, the claim is that the defendants were “negligent” in ever marketing the drug based upon the same information that the FDA had when it approved it.  In other words, that’s a direct second-guess of the FDA’s decision to approve the drug for the use that was prescribed for the plaintiff’s decedent.  This aspect of the case – that although the FDA said “yes” to the use in question, state common law could say “no” – is no different than the failure-to-contraindicate claim that the Levine majority refused to touch with a ten-foot pole.

Nonetheless, the court in Wimbush relied on Levine to hold that it was OK (or, at least, not preempted) for the plaintiff to argue that an FDA-approved drug should never have been marketed at all – or, as the court put it, “negligent for bringing [the drug] to market at all.”  2010 WL 3256029, at *7.

The Wimbush court, we think, wrongfooted its argument from the beginning, characterizing this tort claim as being within “a field which the States have traditionally occupied,” and therefore applying a presumption against preemption.  Id. at *8 (citing Levine).  Whatever our view of whether the warning claim in Levine should have been so characterized, the claim in Wimbush – whether the drug should have been “brought to market at all” – does not (at least since the FDA has existed) reside in a field occupied by state law.  Rather, the FDA decides what drugs are marketed.  Even cases denying preemption in other contexts recognize that:

All prescription drugs marketed in this country must first receive FDA approval.  Manufacturers of new drugs must submit a new drug application (NDA) to the FDA that demonstrates the drug’s effectiveness and safety for its intended use.  The 1962 Food, Drug and Cosmetics Act (FDCA) established this avenue . . . with the core objective of ensuring that drugs are both safe and effective. . . .  New drug approval requires, among other deliverables, the results of successful clinical trials and labeling that accurately portrays the benefits and risks of the drug, as indicated by those trials and other data.
Demahy v. Actavis, Inc., 593 F.3d 428, 431-32 (5th Cir. 2010).

So the first (mis)step on the road to allowing common-law plaintiffs to attack the mere presence on the market of an FDA-approved drug is recognition of a presumption against preemption on the ground that it’s “traditional” for states to make yes/no decisions on whether drugs are safe enough to be sold.

Guided by this misapplied presumption, Wimbush held that it was not “impossible” for the defendant to comply with federal and state law.  But see the rabbit go into the hat.  Its analysis ignores the FDA approval altogether, and focuses instead on the “the process leading up to placing a drug on the market.”  2010 WL 3256029, at *9.  Obviously, if FDA approval itself were considered the relevant factor, then there would be impossibility, because the FDA said "yes" to marketing.  But, due largely to the presumption, the court kicks the process back a step and puts state law in the position of supervising a defendant’s submission of a product for FDA approval:

Simply because tort liability “parallel[s] federal safety requirements” does not mean that liability is preempted.  Allowing a state tort claim under the instant circumstances would not “interfere[] with the methods by which the federal statute was designed to reach its goal.”
2010 WL 3256029, at *10.

With all due respect, we find that quite hard to believe.  How does a claim that a defendant was “negligent” in the “process leading up to placing a drug on the market” play out”?  Is it that the defendant should have done another study or analyzed an existing study differently?  But the FDA’s approval means that it did not think any additional studies or analysis was required.  So the “process” claim is really an attack on the end result, that being the FDA’s application of its criteria for approval.  It’s also a blatant second-guessing of the adequacy of the information made available to the FDA – which brings into play the same policy factors that undergird the Buckman decision:

Conversely, [the] claims would also cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court. Applicants would then have an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA's evaluation of an application.
531 U.S. at 351.  No two ways about it, the "process" claim in Wimbush has to involve some allegation that the submission, and therefore the FDA's approval decision, was based upon "insufficient" information a la Buckman.

Oddly, the Wimbush opinion doesn’t even cite Buckman (we can't believe that the defendant would have failed to argue it).  Instead, the court goes on to distinguish Geier v. American Honda Motor Co., 529 U.S. 861 (2000), which didn’t involve any challenge to the validity of the government’s decision that the automobiles in question met federal standards and could be sold, and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), which was an express preemption case and thus quite different.  See 2010 WL 3256029, at *10.  In a footnote of all things, Wimbush asserts that there’s no difference between “complementary” warning claims as in Levine and a claim that an FDA approved drug should never have been marketed:

Both the district court, and [the defendant] seek to distinguish Levine . . . on the basis that Levine involved a state law inadequate warning claim whereas the instant case involves a state law negligent-bringing-to-market claim.  [This] is indeed true. . . .  However, we find this to be a distinction without a difference, as the rationale in Levine applies with equal force to this claim as it did to the inadequate warning claim.  Just as state tort law on adequacy of warnings can be seen as “complementary,” to the FDA’s labeling regulation, so too can state law duties regarding the decision to bring a product to market be seen as complementary to the FDA’s function of approving a drug for market.  This makes sense, as whether the FDA approves a drug for market depends, in very large part, upon the results of the manufacturer's investigation and testing prior to seeking FDA approval.  If the manufacturer is negligent in this investigation, then the entire FDA approval process is tainted from the outset.
2010 WL 3256029, at *11 n.7 (various citations omitted) (emphasis added).

Tainted?  Does that mean that a plaintiff gets to ask a jury to ignore the FDA approval?  That's a pretty raw conflict.  Maybe it somehow got lost due to the fact that in this case (but probably not the next) the drug in question was removed from the market.  There's no conceivable analogy to Levine there.  It is, however, exactly the conflict underlying preemption of fraud on the FDA claims.

There are any number of other ways in which this strained analogy also fails.  First, allowing a claim that a label should have been updated sooner than it was doesn’t implicate the FDA’s original approval of the label.  Second, the manufacturer’s reaction to new information in the labeling context doesn’t implicate the adequacy of information previously sent to the FDA, and thus doesn’t implicate the Buckman factors.  Third, “categorical liability” – that a legal product should never have been sold at all – is not a traditional tort claim, whereas an inadequate warning claim is.  E.g., Restatement (Third) of Torts, Products Liability §2, reporter’s notes to comment d, part IV(D)) (1998).  Fourth, the contention that “the entire FDA approval process is tainted from the outset” is identical to the allegation underlying a preempted fraud on the FDA claim.  Fifth, causation is much different.  A warning claim is subject to the usual strictures and limits imposed on drug claims by the learned intermediary rule.  Causation in a claim that a drug should never have been marketed at all, like a fraud on the FDA claim, skips the prescriber entirely, and can be argued to turn on the mere fact that the drug was available for sale.

And most fundamentally, for the precise reason that the majority in Levine stayed away from the failure-to-contraindicate claim in that case, the claim that Wimbush waved through the preemption gate is a direct second-guess of the FDA.  Indeed, the claim in Wimbush is worse than the claim Levine avoided because, while the Levine claim challenged only one approved use of the drug (administration by IV push), the claim in Wimbush is that the FDA should never have approved that drug for any purpose at all (the use in question being off-label).  That type of claim strikes at the core purpose of the FDA, which is to determine what drugs can and can't be sold in this country.

If the Sixth Circuit in Wimbush said “bring ‘em on” to tort claims second-guessing FDA decisions, Judge Posner said “no way” to another claim of the same nature.  In Robinson v. McNeil Consumer Healthcare, slip op., 2010 WL 3156548 (7th Cir. Aug. 11, 2010) (previously discussed here and here), the plaintiff claimed that the drug in question, which the FDA allowed to be sold over the counter without a prescription, should have been a prescription-only drug. Again, as with the Levine failure-to-contrainticate non-claim, and the Wimbush should-never-be sold-at-all claim, the claim in Robinson amounted to state law saying “no” to something (over the counter sale) about which the FDA had said “yes.”

Judge Posner, at least, was having none of it.  Deciding whether a drug should be generally available OTC or restrictively available by prescription only was the job of the FDA, not a common-law jury:

Although the plaintiff contends that it's unreasonably dangerous, or defective in design, either contention implying (if accepted) that the drug should be taken off the market, at the oral argument of the appeal her lawyer said “we’re not saying take it off the market . . . we’re not saying it should be banned.”  So maybe the plaintiff just wants it sold by prescription only.  But this would increase the drug’s cost (because of the prescribing physician's fee and the time required by the patient to obtain and fill the prescription) and thus reduce its availability . . . .

The decision whether to permit a drug to be sold over the counter rather than just by prescription is for the FDA to make.  The agency bases its decision on whether the drug is safe and effective for use without a doctor’s permission, and it has decided not to require that drugs containing [the active ingredient] be sold by prescription only.

Granted, that doesn’t bar a court from holding that state law requires warnings on the label of an over-the-counter drug beyond what the FDA has required.  [But] the FDA stated: “We believe that the overall benefit versus risk profile for [the drug] remains very favorable when they are used according to the labeled instructions. It is in the interest of the public health to maintain . . . a range of therapeutic options for the short-term relief of pain.
2010 WL 3156548, at *5-7 (lots of citations omitted – it’s Posner, after all).

So that’s two claims second-guessing the FDA addressed by appellate courts barely a week apart.  Clearly, the other side’s feeling emboldened to bring the very types of claims that the Supreme Court ran away from in Levine.  Here's a third.  In the Bartlett litigation that we’ve been following (here and here), there’s a “design defect” claim being litigated.  The defendant in Bartlett doesn’t seem to have raised preemption specifically against that claim – only making the stock generic preemption argument (and getting its head handed to it, see Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp.2d 279 (D.N.H. Sept. 30, 2009), reconsideration denied, 2010 WL 2765358 (D.N.H. July 12, 2010).  We commented before on the potential for such claims to devolve into second-guessing the grounds for an FDA’s approval decision that a drug was safe and effective and should be marketed:

It will be interesting to see what Judge Laplante ultimately makes of a purely “design defect” trial involving a prescription drug.  Will he allow the plaintiff to argue that – contrary to the FDA’s decision not to force NSAIDs off the market due to the SJS risk – a civil jury can conclude that the drug’s risks outweigh its benefits and the drug should not be sold for an approved indication?  Most “design defect” claims involving drugs devolve either into:  (1) “FDA was wrong” claims; or (2) “failure to recall” claims that, as we’ve discussed before aren’t recognized in any state.  Maybe we’ll have a Bartlett III to look forward to where Judge Laplante delves characteristically deeply into these questions.
It turns out, there have been a bunch of Bartlett decisions in the mean time, and – sure enough – this “design defect” claim is shaping up as a common-law second-guessing of the FDA’s weighing of the risks and benefits of the drug.  See Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3210724, at *1 (D.N.H. Aug. 10, 2010) (“a product’s risks and benefits must be evaluated with reference to the public as a whole, not [plaintiff] in particular”); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3092649, at *6 n.7 (D.N.H. Aug . 2, 2010) (discussing “risk-utility analysis” in the context of “various alternative drugs”); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3239247, at *2-4 (D.N.H. July 30, 2010) (“a product is defective if its risks outweigh its benefits so as to make it unreasonably dangerous”; “proof of an alternative design” is not “an essential element”); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2889114, at *8 (D.N.H. July 22, 2010) (“other NSAID side effects that [plaintiff] never suffered . . .[are] is highly relevant to determining whether [the drug’s] safety risks outweigh its medical benefits”).

Since weighing the risks and benefits of drugs is precisely what the FDA does during its approval process, a common-law cause of action predicated on “risk/benefit” analysis as the basis for finding a drug defective also amounts to second-guessing the FDA’s approval decision. While the defendant in Bartlett doesn’t seem to have put that proposition squarely before the court, if the case goes in that direction, it’s another example of plaintiffs ignoring Levine and arguing that the jury can say “no” where the FDA said “yes.”

Finally, there’s the recent decision in Lance v. Wyeth, slip op., 2010 WL 2991597 (Pa. Super Aug. 2, 2010), (discussed here), which permitted a “negligent design” claim in a prescription drug case under Pennsylvania law.  That’s a variant of the claim that was held not preempted in Wimbush (they’re both fen-phen cases), but Lance addressed state law issues that Wimbush let slide (and, conversely, didn't have preemption before it).

This, too, could turn into a second-guessing of the FDA (plaintiff can be relied upon to try), but fortunately it’s less likely in Pennsylvania than in Wimbush or Bartlett, for a number of reasons.  First, and foremost, Lance specifically held that Pennsylvania law “defers” to the FDA in decisions whether a prescription drug should be on the market.  2010 WL 2991597, at *7 (“we defer to the federal regulatory scheme and the FDA's decision as to whether a drug should lawfully remain on the market”).  Second, the plaintiff (unlike in Bartlett) in Pennsylvania darn well better have an alternative design – pure risk/utility balancing isn’t allowed.  “The determination of whether a product was negligently designed turns on whether an alternative, feasible, safer design would have lessened or eliminated the injury plaintiff suffered.”  Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38, 64 (3d Cir. 2009); see Aaron v. Wyeth, 2010 WL 653984, at *11 (W.D. Pa. Feb. 19, 2010) (dismissing negligent design claim in prescription drug case for lack of alternative design).  Third, defendants can argue that compliance with governmental regulations – that is, obtaining FDA approval, establishes due care.  Brogley v. Chambersburg Engineering Co., 452 A.2d 743, 745 (Pa. Super. 1982).

However, the mere fact that claims second-guessing the FDA are proliferating is in itself troublesome, since there’s no basis in Levine (whatever Wimbush might assert) for allowing them.  The other side won Levine only by kicking to the curb claims like failure-to-contraindicate that would have said “no” to uses – and modes of distribution, and products, and designs – to which the FDA has said “yes.”  In that respect, we’d like to see Wimbush appealed, but with the Supreme Court having heard four FDA-related preemption cases over the past three years, who knows?  Either they're extremely interested in the subject or just about sick of it.  But we won't know until someone tries.