But once we receive good new cases, it becomes our responsibility to get the word out, and that’s what we’re doing today, even if we feel we’ve been a mite slow about it.
Eckhardt v. Qualitest
Two readers (Quinton Urquhart of Irwin, Fritchie, and Rachel Passaretti-Wu of Skadden) both sent us, in response to our “Conte Rejected Again” post, Eckhardt v. Qualitest Pharmaceuticals, Inc., C.A. No. M-11-235, slip op. (S.D. Tex. Aug. 9, 2012). Eckhardt − guess what? − also rejected the notorious Conte theory that brand-name manufacturers could be liable for allegedly inadequate warnings accompanying competing generic drug products that they never sold.
Eckhardt is the latest of a number of cases to reject brand-name liability under Texas law. As indicated in our Branded/Generic liability scorecard, Eckhardt builds on Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. 2010); Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009); Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. Mar. 29, 2010); Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009); Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008), aff’d on other grounds, 623 F.3d 271 (5th Cir. 2010); Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003) and Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, slip op. at 1-2 (Tex. Dist. Dallas Co. May 7, 2010), in hewing to the traditional product liability axiom that manufacturers are the only ones that can be liable for their products.
We make that point because we were somewhat disturbed to read the Eckhardt court expressing “disappointment” with the quality of the briefing on both sides. Slip op. at 2-3. While we expect the other side to do things like throw in “two several-hundred-page depositions” without page citations, id., we’re not accustomed to seeing our side criticized for citing “cases that have no nexus with” relevant law. Id.
That’s precisely what we try to avoid with our branded/generic scorecard. If as is the case in Eckhardt, the jurisdiction in question has a statutory product liability scheme (like Texas, or Tennessee, Kentucky, and New Jersey to name a few), we try to note in our case summary. That way we try to make it easy for defense counsel everywhere to cite to the most relevant cases, whether inside or outside any particular jurisdiction.
Anyway, the rest of Eckhardt is good. It’s a “one-two punch” case − by that we mean (as is apparent from our Generic Preemption scorecard) that the generic defendants have also been dismissed on preemption grounds. Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 1511817 (S.D. Tex. April 30, 2012). Thus, the one-two punch of preemption and product identification has effectively ended the case.
Eckhardt makes the following holdings that might be useful in future cases:
- The tenuous relationship of branded products to generic labeling was not sufficient to justify liability under any Texas product liability theory. Slip op. at 4-5.
- Fraud and similar claims satisfy the statutory definition of “products liability” claims. Id. at 6-7.
- Breach of warranty and consumer protection claims fail where the defendant did not make the product. Id. at 8-9.
- Negligence and negligent misrepresentation fail because a non-manufacturer owes no recognized duty to persons using competing products. Id. at 10-11.
Baker v. APP Pharmaceuticals
We thank old colleague Will Sachse of Dechert for sending along Baker v. APP Pharmaceuticals LLP, C.A. No. 09-05725 (JAP), slip op. (D.N.J. Aug. 21, 2012). Baker contains an excellent description of the New Jersey presumption of adequacy of FDA-approved warnings:
In failure to warn cases involving prescription drugs, “[i]f the warning or instruction given in connection with a drug . . . has been approved or prescribed by the federal Food and Drug Administration under the ‘Federal Food, Drug, and Cosmetic Act,’” there is a rebuttable presumption that the warning is adequate. This is no ordinary rebuttable presumption. “Compliance with FDA regulations” gives rise to “what can be denominated as a super-presumption[.]” “[C]ompliance with FDA standards should be virtually dispositive of such claims.” Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced in [New Jersey Rule of Evidence] 301.”
Baker, slip op. at 12-13 (citations, but not quotation marks, omitted).
The New Jersey presumption suffers from ill-advised, judicially-created exceptions to the broad legislative mandate, but Baker held that neither of those applied. There can’t be “deliberate concealment” of information that’s “publicly available in published scientific and medical literature.” Slip op. at 9-10. Moreover, the plaintiffs weren’t being honest with the court. The information in question was, in fact, disclosed to the FDA. Id. at 10-11. (The concealment claim was also a preempted fraud on the FDA claim, but the court didn’t have to discuss that.) Also, for case-specific reasons (after-the-fact timing, and the information involving a different drug), the court found no manipulation, “intentional” or otherwise, of FDA post-marketing regulatory processes. Id. at 12-14. Thus the FDA-approved warning was as a matter of law.
Of equal interest, the court in Baker held that, even if the warning had been inadequate, it couldn’t have caused any injury. This is important, because there hasn’t been all that much New Jersey law on warning causation. There’s Strumph v. Schering Corp., 606 A.2d 1140, 1148-49 (N.J. Super. App. Div. 1993) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (adopting dissenting opinion below), which establishes the warning causation principle in New Jersey. There’s also Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005). These are both cases where the prescribing physician already knew the information and didn’t read the warning. Two favorable opinions for a jurisdiction with as much learned intermediary rule litigation as New Jersey strikes us as a little thin.
Baker’s now a third case in that category. First of all the court took out the lamentable “heeding presumption.” “The heeding presumption is rebutted, however, if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted.” Slip op. at 14-15 (citation and quotation marks omitted):
Moreover, a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and considered the risk in prescribing the product. In that case, the physician’s conduct is the superseding or intervening cause that breaks the chain of liability between the manufacturer and the plaintiff.
Id. at 15 (citations, quotation marks, and footnote omitted). That happened in Baker. Not only did the prescriber know of the alleged heparin-related risk, but he “stood by his decision to administer heparin” under the facts of the case. Id. at 15-16. Further blocking any causal inference was the physician’s failure to read labels for “frequently” prescribed drugs with which he was familiar:
[The prescriber] testified in his deposition that he does not read the label of drugs he prescribes often, which includes heparin. Moreover, Plaintiffs concede that [the prescriber] never testified that he would have consulted a black box warning or “Dear Doctor” letter, or that he ever reviewed the Physician’s Desk Reference when prescribing heparin. Therefore, a different warning would not have made a difference in [plaintiff’s] treatment or outcome because [the prescriber] would not have reviewed it.
Baker, slip op. at 16 (citation omitted).
There was also a case-specific superseding cause − the “fail[ure]” of the nursing staff “to follow its own heparin treatment protocol” and monitor the drug level in the plaintiff’s blood. Id. at 16-17.
Therefore, Plaintiffs have failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the failure of the hospital to follow its treatment protocol, that was a substantial factor in causing or exacerbating [plaintiff’s] injuries.
Baker, slip op. at 17.
Thus, Baker is a nice causation triple play (prior knowledge, failure to read, and third-party superseding cause) in a jurisdiction where such precedent is most welcome.
Thanks to everyone who sends us cases − and keep them coming.