Hail! Hail! To Michigan

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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.

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We cheer themagain
We cheer andcheer again
For Michigan, wecheer for Michigan
We cheer withmight and main
We cheer, cheer,cheer
With might andmain we cheer!
 Those words were written in 1898by Louis Ebel after the University of Michigan’s football team defeated theheavily-favored Maroons by one point. But if you didn’t know the history of “The Victors,” you might havethought 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-liabilityclaims against a manufacturer or seller of a drug that was approved for safetyand efficacy by the FDA and labeled in compliance with FDA standards.”  Attorney Gen. v. Merck Sharp & DohmeCorp., 807 N.W.2d 343, 347 (Mich. Ct. App.), appeal denied, 803N.W.2d 696 (2011). 
 Quite simply, “the MichiganLegislature made a policy judgment intending to shield drug manufacturers fromliability.”  Devore v. Pfizer Inc.,58 A.D.3d 138, 141 (N.Y. App. Div. 2008). Accord Taylor v. Smithkline BeechamCorp., 658 N.W.2d 127, 131 (Mich. 2003) (“[T]heLegislature has determined that a drug manufacturer or seller that has properlyobtained FDA approval of a drug product has acted sufficiently prudently sothat no tort liability may lie.”).  As such, unless a plaintiff allegesand proves an exception, “MCL 600.2946(5) now establishes an absolute defensefor 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) sellingthe drug after the FDA withdraws it from the market; (2) bribing an FDAofficial; 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 federallaw.  See Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) (holding that a drugmanufacturer is immune from suit unless “the FDA itself determines thata fraud has been committed on the agency during the regulatory-approvalprocess”) citing Buckman Co.v. Plaintiffs’ Legal Committee,531 U.S. 341, 350 (2001) (emphasis in original). 

The Western District ofMichigan 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 suitagainst a drug manufacturer under Michigan law, a plaintiff need allege morethan the elements of the common law tort. A plaintiff must also allegethe federal government has established that the drug manufacturer eithercommitted fraud against the FDA or bribed an FDA official.
White v. SmithKline BeechamCorp., 538 F. Supp. 2d 1023, 1029 (W.D. Mich. 2008) (dismissing all claimsand denying motion to amend as “futile”) (emphasis supplied). 

(For those interested, there’s astring cite of additional cases at the conclusion of this post applyingMichigan’s absolute immunity and dismissing all claims.)
 Against this avalanche ofauthority, you’d expect pharmaceutical litigation in Michigan to havedisappeared.  You’d be wrong. 
 In a last-gasp effort to salvagetheir 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 notinvolve a drug.  But as Bexis hasobserved, forum-shopping plaintiffs have been almost-universally unsuccessfulin arguing Michigan law does not apply. 
 That leaves only the question ofwhether 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 fitsquarely into a layperson’s understanding of the term.  But there are many less traditionalformulations that nonetheless meet the definition – intramuscular, transmucosal(nasal), and topical products, to name a few. Fentanyl transdermal delivery systems – i.e. patches – are anotherexample. 
 Yet because the common conceptionof “drug” might not include these products, some have suggested that they arenot drugs at all, but rather “acombination drug and device – the drug is the opioid fentanyl and thedevice is the delivery system that time releases the drug for absorption intothe body.”  (A similar observation couldbe made about any controlled-release formulation.)
 But this is not true, at least asfar as the FDCA is concerned.  SeeMiller 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 fentanylpatch, because the product is a “drug” under the FDCA and, therefore, entitledto the benefit of Michigan’s statutory immunity).
 Under Michigan law, thedistinction between a drug and a device is significant.  That is because, while drug manufacturers areafforded absolute immunity, device manufacturers are not.  See M.C.L. § 600.2945(b).  (Of course, that says nothing about the broadpreemption afforded by the Medical Device Amendments.  See Riegel v. Medtronic, Inc.,552 U.S. 312, 317 (2008).)
 Miller was a wrongful deathaction involving alleged defects in Mylan’s fentanyl patch, a generic versionof Duragesic®.  As a preliminary matter,the plaintiff conceded that her failure-to-warn claims failed under Mensing.  Miller, 2012 WL 5300721, at *1n.1.  She also did not contest thedismissal of her Michigan Consumer Protection Act claim based on the“authorized conduct” exception thereto.  Id.  See, also MCL445.904(1)(a); Duronio, 2006 WL 1628516, at *7 (holding that theauthorized conduct exception applies to claims involving FDA-approvedproducts); Merck Sharp & Dohme Corp., 807 N.W.2d at 349 n.7 (holdingthat the appellate court in Duronio “correctly dismissed the plaintiff’sMCPA claim because an exemption within the MCPA statute applied, MCL445.904(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 previouslyheld that where the FDAspecifically authorizes the conduct at issue, the MCPA is inapplicable.”).
 Mylan moved to dismiss theremaining design and manufacturing defect claims pursuant to Michigan’sstatutory immunity.  The plaintiff agreedthat Michigan law provides an “absolute defense” in claims involving drugs andthat none of the exceptions to M.C.L. § 600.2946(5)applied, Miller, 2012 WL 5300721, at *5,but argued
 that her productliability claim is not premised on defects of the pharmacologically activeingredient of the [Mylan patch], i.e. fentanyl, but on defects in the deliverysystem, i.e. the surrounding “film” or “adhesive” layers, that arepharmacologically inactive components of the patch.  Plaintiff claims that these “layers” are nota “drug,” but are more akin to a medical device, and therefore her claims arenot subject to Michigan’s drug immunity law.
 Id. at *1.  Thus, the “sole remaining issue before theCourt [was] whether the [Mylan patch] is a ‘drug’ as that term is defined forpurposes of the immunity afforded by Mich. Comp. Laws § 600.2946(5).”  Id. 
 By analogizing a patch to asyringe, id. at *6, the plaintiff maintained that her claims were notbased on the active pharmaceutical ingredient (“API”) itself, but rather on thestructure of the patch that delivered the API. The plaintiff in Miller, therefore, tried to distinguish the casefrom those involving oral-dose formulations, which really just take issue withinherent risks associated with the API. 
 
Fortunately, the Court made quickwork of this flawed argument.

First, the Court rejected theproposition 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, itthereby falls within Michigan’s absolute defense.  The FDCA, in turn, defines “drug” as:


(A) articlesrecognized in the official United States Pharmacopœia, official HomœopathicPharmacopœia of the United States, or official National Formulary, or anysupplement 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 anyfunction of the body of man or other animals; and (D) articles intended for use as a component of any article specified inclause (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 FDAapproved 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 theFDCA.  Id. at *6–7. 

The Court, therefore, rejectedthe plaintiff’s comparison of a fentanyl patch to a syringe, stating insteadthat the argument is “more analogous to separating the non-pharmacologicallyactive components of a gel cap in a time-release capsule . . . from the activepharmacologic ingredient it encapsulates, anobvious absurdity.”  Id.at *7 (emphasis supplied).

Finally, the Court noted thatprior attempts to draw a distinction between claims based on active andinactive ingredients were roundly rejected. Id. at *7–8.  For example,courts had previously applied Michigan’s statutory immunity to cases involvingthe Ortho-Evra® patch.  See, e.g. Bowerv. Johnson & Johnson, 795 F. Supp. 2d 672, 677 (N.D. Ohio 2011)(dismissing all claims). 

More to the point, the precise argumentraised by the plaintiff in Miller had been discarded by the UnitedStates 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 bloghere).  The plaintiff in Lake-Allenalleged defects in the brand-name, Duragesic® fentanyl patch.  The defendant-manufacturer moved to dismissplaintiff’s design defect claims based on, interalia, comment k.  Utah is anacross-the-board comment k state, such that all strict liability design claimsinvolving “prescription drugs” must be dismissed.  See Grundberg v. Upjohn Co.,813 P.2d 89 (Utah 1991).  To avoid thisresult, the Lake-Allen plaintiff suggested that a fentanyl patch is nota drug, but rather is “more akin to a drug container.”  Lake-Allen, 2009 WL 2252198, at*2.  The plaintiff, therefore, assertedthat her lawsuit was not based on the fentanyl itself, but rather the structureof the patch, thereby avoiding comment k’s sweep.  The federal court rejected this “nonsensical”argument:

Plaintiffs’ argumentthat the patch is more akin to a container is unpersuasive.  The Duragesic® patch was approved by the FDAas a drug and to categorize it as a container is akin to categorizing anysubstance available in a time release capsule as a container.  In the case of prescription pharmaceuticalpatches, it is nonsensical toseparate the liability of the overall product and the substance that itreleases.

Id. at *3 (emphasissupplied).

The Miller Court agreed,concluding that the plaintiff “offered no basis, legal or otherwise, on whichthe 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 ofthis product liability claim.”  Miller,2012 WL 5300721, at *8.  Thus, Michigan’sstatutory immunity applied and all remaining claims were dismissed withprejudice.  Id.
 In the end, Millerreinforces the proposition that the Michigan legislature meant what it said: ifthe FDA approved the product as a drug, all claims based thereon aremeritless.   

And that’s music to all defenseattorneys’ ears.
 
 
As promised, and because this isa full-service blog, here’s a string cite of additional cases to help with yourresearch: Marsh v. Genentech, Inc., 693 F.3d 546, 555 (6th Cir. 2012)(affirming dismissal of all claims under Michigan’s statutory immunity andrejecting 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 findingof fraud by the federal government, all claims fail under Michigan law); Blairv. 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 pharmaceuticalmanufacturer); Muniz v. Genentech, Inc., No. 1:11-CV-683, 2011 WL5089289, 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); Tiefenthalv. 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. 2d878, 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. OhioJune 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 forsummary judgment on all claims, including (1) strict liability – failure towarn; (2) strict liability – design defect; (3) negligent failure to warn; (4)negligence per se; (5) implied warranty; (6) unjust enrichment; (7) medicalmonitoring; and (8) punitive damages); Devore v. Pfizer Inc., 58 A.D.3d138, 139, 867 N.Y.S.2d 425, 426 (2008) (interpreting Michigan law and affirminggrant of motion to dismiss all claims, including (1) fraud, (2) negligentrepresentation, (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 forsummary 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 drugmanufacturer); Griffus v. Novartis PharmaceuticalsCorp., 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 liabilityclaims”); Ammend v. BioPort, Inc., No. 5:03-CV-31, 2006 WL 1050509 (W.D.Mich. April 19, 2006) (granting motion for summary judgment, because theplaintiff did not show “the FDA has made its own determination of fraud orbribery”); 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) productsliability-failure to warn; (4) breach of express warranty; (5) fraudulentmisrepresentation; (6) fraud; and (7) negligent misrepresentation); Norrisv. 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 Hohendorfv. Pfizer Inc., No. 109845/06, 2007 WL 7628983 (N.Y. Sup. Ct. March 22,2007) (same).