Here’s another guest post this time by Clem C. Trischler and Jason M. Reefer, of Pietragallo Gordon, about a recent litigation involving the Michigan immunity statute and when a “drug” (according to plaintiffs) isn’t a “drug.” You’ll like it – the plaintiff lost.
As always our intrepid contributors deserve all the credit, and any blame, although there’s not likely to be any this time around.
We cheer them again
We cheer and cheer again
For Michigan, we cheer for Michigan
We cheer with might and main
We cheer, cheer, cheer
With might and main we cheer!
Those words were written in 1898 by Louis Ebel after the University of Michigan’s football team defeated the heavily-favored Maroons by one point. But if you didn’t know the history of “The Victors,” you might have thought the lyrics were written by Bexis. That is because “[i]n 1995, the [Michigan] Legislature amended M.C.L. 600.2946 to provide immunity for products-liability claims against a manufacturer or seller of a drug that was approved for safety and efficacy by the FDA and labeled in compliance with FDA standards.” Attorney Gen. v. Merck Sharp & Dohme Corp., 807 N.W.2d 343, 347 (Mich. Ct. App.), appeal denied, 803 N.W.2d 696 (2011).
Quite simply, “the Michigan Legislature made a policy judgment intending to shield drug manufacturers from liability.” Devore v. Pfizer Inc., 58 A.D.3d 138, 141 (N.Y. App. Div. 2008). Accord Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 131 (Mich. 2003) (“[T]he Legislature has determined that a drug manufacturer or seller that has properly obtained FDA approval of a drug product has acted sufficiently prudently so that no tort liability may lie.”). As such, unless a plaintiff alleges and proves an exception, “MCL 600.2946(5) now establishes an absolute defense for drug manufacturers and sellers in a product liability action . . . .” Duronio v. Merck & Co.,, No. 267003, 2006 WL 1628516, at *3 (Mich. Ct. App. June 13, 2006).
Those exceptions are (1) selling the drug after the FDA withdraws it from the market; (2) bribing an FDA official; and (3) committing fraud on the FDA. See M.C.L. §600.2946(5)(a)-(b). The first two should rarely arise, and the third is preempted by federal law. See Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) (holding that a drug manufacturer is immune from suit unless “the FDA itself determines that a fraud has been committed on the agency during the regulatory-approval process”) citing Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001) (emphasis in original).
The Western District of Michigan aptly summarized what remains the current state of Michigan law:
As a result of [M.C.L. § 600.2946(5)] and [Garcia], most [product liability claims] in Michigan against drug manufacturers are functionally foreclosed. In order to maintain a product liability suit against a drug manufacturer under Michigan law, a plaintiff need allege more than the elements of the common law tort. A plaintiff must also allege the federal government has established that the drug manufacturer either committed fraud against the FDA or bribed an FDA official.
White v. SmithKline Beecham Corp., 538 F. Supp. 2d 1023, 1029 (W.D. Mich. 2008) (dismissing all claims and denying motion to amend as “futile”) (emphasis supplied).
(For those interested, there’s a string cite of additional cases at the conclusion of this post applying Michigan’s absolute immunity and dismissing all claims.)
Against this avalanche of authority, you’d expect pharmaceutical litigation in Michigan to have disappeared. You’d be wrong.
In a last-gasp effort to salvage their claims, it appears that Michigan plaintiffs have only two options: (1) argue that Michigan law doesn’t apply; or (2) argue that the claims do not involve a drug. But as Bexis has observed, forum-shopping plaintiffs have been almost-universally unsuccessful in arguing Michigan law does not apply.
That leaves only the question of whether the product at issue is a “drug.” In cases involving noninvasive peroral formulations (e.g., pills, capsules, tablets), this question won’t even arise, as those products fit squarely into a layperson’s understanding of the term. But there are many less traditional formulations that nonetheless meet the definition – intramuscular, transmucosal (nasal), and topical products, to name a few. Fentanyl transdermal delivery systems – i.e. patches – are another example.
Yet because the common conception of “drug” might not include these products, some have suggested that they are not drugs at all, but rather “a combination drug and device – the drug is the opioid fentanyl and the device is the delivery system that time releases the drug for absorption into the body.” (A similar observation could be made about any controlled-release formulation.)
But this is not true, at least as far as the FDCA is concerned. See Miller v. Mylan Inc., No. 12-11684, 2012 WL 5300721, at *8 (E.D. Mich. Oct. 25, 2012) (dismissing all claims against the manufacturer of a fentanyl patch, because the product is a “drug” under the FDCA and, therefore, entitled to the benefit of Michigan’s statutory immunity).
Under Michigan law, the distinction between a drug and a device is significant. That is because, while drug manufacturers are afforded absolute immunity, device manufacturers are not. See M.C.L. § 600.2945(b). (Of course, that says nothing about the broad preemption afforded by the Medical Device Amendments. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008).)
Miller was a wrongful death action involving alleged defects in Mylan’s fentanyl patch, a generic version of Duragesic®. As a preliminary matter, the plaintiff conceded that her failure-to-warn claims failed under Mensing. Miller, 2012 WL 5300721, at *1 n.1. She also did not contest the dismissal of her Michigan Consumer Protection Act claim based on the “authorized conduct” exception thereto. Id. See, also MCL 445.904(1)(a); Duronio, 2006 WL 1628516, at *7 (holding that the authorized conduct exception applies to claims involving FDA-approved products); Merck Sharp & Dohme Corp., 807 N.W.2d at 349 n.7 (holding that the appellate court in Duronio “correctly dismissed the plaintiff’s MCPA claim because an exemption within the MCPA statute applied, MCL
445.904(1)(a)”); and Alexander v. Del Monte Corp., No. 09-12303, 2011 WL 87286, at *2–3 (E.D. Mich. Jan. 11, 2011) (“This Court has previously held that where the FDA specifically authorizes the conduct at issue, the MCPA is inapplicable.”).
Mylan moved to dismiss the remaining design and manufacturing defect claims pursuant to Michigan’s statutory immunity. The plaintiff agreed that Michigan law provides an “absolute defense” in claims involving drugs and that none of the exceptions to M.C.L. § 600.2946(5) applied, Miller, 2012 WL 5300721, at *5, but argued
that her product liability claim is not premised on defects of the pharmacologically active ingredient of the [Mylan patch], i.e. fentanyl, but on defects in the delivery system, i.e. the surrounding “film” or “adhesive” layers, that are pharmacologically inactive components of the patch. Plaintiff claims that these “layers” are not a “drug,” but are more akin to a medical device, and therefore her claims are not subject to Michigan’s drug immunity law.
Id. at *1. Thus, the “sole remaining issue before the Court [was] whether the [Mylan patch] is a ‘drug’ as that term is defined for purposes of the immunity afforded by Mich. Comp. Laws § 600.2946(5).” Id.
By analogizing a patch to a syringe, id. at *6, the plaintiff maintained that her claims were not based on the active pharmaceutical ingredient (“API”) itself, but rather on the structure of the patch that delivered the API. The plaintiff in Miller, therefore, tried to distinguish the case from those involving oral-dose formulations, which really just take issue with inherent risks associated with the API.
Fortunately, the Court made quick work of this flawed argument.
First, the Court rejected the proposition that the definition of drug is limited to the API of a product. Pursuant to M.C.L. § 600.2945(d), if a product is considered a drug under federal law, it thereby falls within Michigan’s absolute defense. The FDCA, in turn, defines “drug” as:
(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).
21 U.S.C. § 321(g)(1) (emphasis supplied). Accordingly, “drug” is not synonymous with API, but also includes any and all “components” thereof.
Based on this definition, the FDA approved the Mylan fentanyl patch as a drug. Miller, 2012 WL 5300721, at *6. Moreover, the label for the Mylan fentanyl patch “expressly defines the [layers of the patch], which Plaintiff claims were defective, as components of the . . . system,” such that the patch itself falls squarely within the definition of drug in the FDCA. Id. at *6–7.
The Court, therefore, rejected the plaintiff’s comparison of a fentanyl patch to a syringe, stating instead that the argument is “more analogous to separating the non-pharmacologically active components of a gel cap in a time-release capsule . . . from the active pharmacologic ingredient it encapsulates, an
obvious absurdity.” Id. at *7 (emphasis supplied).
Finally, the Court noted that prior attempts to draw a distinction between claims based on active and inactive ingredients were roundly rejected. Id. at *7–8. For example, courts had previously applied Michigan’s statutory immunity to cases involving the Ortho-Evra® patch. See, e.g. Bower v. Johnson & Johnson, 795 F. Supp. 2d 672, 677 (N.D. Ohio 2011) (dismissing all claims).
More to the point, the precise argument raised by the plaintiff in Miller had been discarded by the United States District Court for the District of Utah. See Lake-Allen v. Johnson & Johnson, L.P., No. 2:08CV00930DAK, 2009 WL 2252198 (D. Utah July 27, 2009) (discussed by the blog here). The plaintiff in Lake-Allen alleged defects in the brand-name, Duragesic® fentanyl patch. The defendant-manufacturer moved to dismiss plaintiff’s design defect claims based on, inter alia, comment k. Utah is an across-the-board comment k state, such that all strict liability design claims involving “prescription drugs” must be dismissed. See Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991). To avoid this result, the Lake-Allen plaintiff suggested that a fentanyl patch is not
a drug, but rather is “more akin to a drug container.” Lake-Allen, 2009 WL 2252198, at *2. The plaintiff, therefore, asserted that her lawsuit was not based on the fentanyl itself, but rather the structure of the patch, thereby avoiding comment k’s sweep. The federal court rejected this “nonsensical” argument:
Plaintiffs’ argument that the patch is more akin to a container is unpersuasive. The Duragesic® patch was approved by the FDA as a drug and to categorize it as a container is akin to categorizing any substance available in a time release capsule as a container. In the case of prescription pharmaceutical patches, it is nonsensical to separate the liability of the overall product and the substance that it releases.
Id. at *3 (emphasis supplied).
The Miller Court agreed, concluding that the plaintiff “offered no basis, legal or otherwise, on which the Court can embrace the suggestion that the ‘non-pharmacologic’ ‘film’ or ‘adhesive’ layers of the patch can be viewed as a separate ‘medical device,’ distinct from the pharmacologically active ingredient fentanyl, for purposes of this product liability claim.” Miller, 2012 WL 5300721, at *8. Thus, Michigan’s statutory immunity applied and all remaining claims were dismissed with prejudice. Id.
In the end, Miller reinforces the proposition that the Michigan legislature meant what it said: if the FDA approved the product as a drug, all claims based thereon are meritless.
And that’s music to all defense attorneys’ ears.
As promised, and because this is a full-service blog, here’s a string cite of additional cases to help with your research: Marsh v. Genentech, Inc., 693 F.3d 546, 555 (6th Cir. 2012) (affirming dismissal of all claims under Michigan’s statutory immunity and rejecting plaintiff’s attempt to distinguish Garcia); In re Aredia & Zometa Products Liab. Litig., 352 F. App’x 994, 995 (6th Cir. 2009) (holding that Garcia is “binding precedent” such that, absent a finding of fraud by the federal government, all claims fail under Michigan law); Blair v. Genentech, Inc., No. 1:11-CV-482, 2011 WL 5088969, at *4 (W.D. Mich. Oct. 26, 2011) (granting motion to dismiss all claims against a pharmaceutical manufacturer); Muniz v. Genentech, Inc., No. 1:11-CV-683, 2011 WL 5089289, at *5 (W.D. Mich. Oct. 26, 2011) (same); Marsh v. Genentech, Inc., No. 1:11-CV-688, 2011 WL 5089467, at *6 (W.D. Mich. Oct. 26, 2011) (same); Tiefenthal v. Genentech, Inc., No. 1:11-CV-689, 2011 WL 5089468, at *5 (W.D. Mich. Oct. 26, 2011) (same); Borycz v. Johnson & Johnson, 796 F. Supp. 2d 878, 883 (N.D. Ohio 2011) (interpreting Michigan law and dismissing claims for (1) failure to warn; (2) breach of express and implied warranties; (3) negligence; (4) fraud, misrepresentation, suppression and concealment; and (5) wantonness, because the product “was subject to and successfully completed the FDA approval process”); Shannon v. Johnson & Johnson, No. 1:09 OE 40043, 2011 WL 2471921, at *5 (N.D. Ohio June 21, 2011) (same); In re Trasylol Products Liab. Litig., 763 F. Supp. 2d 1312, 1324 n.14 (S.D. Fla. 2010) (referring to the “general immunity” provided by Michigan law); In re Baycol Products Litig., MDL NO.1431, No. 04–3667 (MJD/SRN), 2009 WL 7836091, at *3–4 (D. Minn. Feb. 13, 2009) (interpreting Michigan law and granting manufacturer-defendant’s motion for summary judgment on all claims, including (1) strict liability – failure to warn; (2) strict liability – design defect; (3) negligent failure to warn; (4) negligence per se; (5) implied warranty; (6) unjust enrichment; (7) medical monitoring; and (8) punitive damages); Devore v. Pfizer Inc., 58 A.D.3d
138, 139, 867 N.Y.S.2d 425, 426 (2008) (interpreting Michigan law and affirming grant of motion to dismiss all claims, including (1) fraud, (2) negligent
representation, (3) strict liability – failure to warn, strict liability – design defect, (5) breach of the implied warranty of merchantability, and (6) fraudulent concealment); In re Aredia & Zometa Products Liab. Litig., No. 3:06-MD-1760, 2008 WL 913087, at *1–2 (M.D. Tenn. Apr. 2, 2008) (granting motion for summary judgment on all claims and denying request for additional discovery as “futile”) aff’d, 352 F. App’x 994 (6th Cir. 2009); Zammit v. Shire US, Inc.,
415 F. Supp. 2d 760, 769 (E.D. Mich. 2006) (dismissing all claims against drug manufacturer); Griffus v. Novartis Pharmaceuticals Corp., No. 06-10891, 2006 WL 2583129, at *2 (E.D. Mich. Sept. 6, 2006) (dismissing claims for (1) negligence, (2) implied warranty, and (3) express warranty, pointing out that plaintiff’s “negligence and warranty claims are simply disguised product liability claims”); Ammend v. BioPort, Inc., No. 5:03-CV-31, 2006 WL 1050509 (W.D.
Mich. April 19, 2006) (granting motion for summary judgment, because the plaintiff did not show “the FDA has made its own determination of fraud or
bribery”); Henderson v. Merck & Co., Inc., No. 04-CV-05987-LDD, 2005 WL 2600220, at *8–12 (E.D. Pa. Oct. 11, 2005) (granting motion for judgment on pleadings on claims for (1) negligence; (2) products liability-defective design; (3) products liability-failure to warn; (4) breach of express warranty; (5) fraudulent misrepresentation; (6) fraud; and (7) negligent misrepresentation); Norris v. Pfizer Inc., No. 109847/06, 15 Misc.3d 1114(A), at *1, 839 N.Y.S.2d 434 (N.Y. Sup. Ct. 2007) (dismissing all claims with prejudice); and Hohendorf v. Pfizer Inc., No. 109845/06, 2007 WL 7628983 (N.Y. Sup. Ct. March 22,