In Re Bayer Corp. Combination Aspirin Products Marketing And Sales Practices Litigation.

• Decision Date: 30 March 2010
• Docket Number: No. 09 Md.2023(BMC)(JMA).,09 Md.2023(BMC)(JMA).
• Citation: In re Bayer Corp., 701 F.Supp.2d 356 (E.D. N.Y. 2010)
• Parties: In re BAYER CORP. COMBINATION ASPIRIN PRODUCTS MARKETING AND SALES PRACTICES LITIGATION.
• Court: U.S. District Court — Eastern District of New York

701 F.Supp.2d 356

In re BAYER CORP. COMBINATION ASPIRIN PRODUCTS MARKETING AND SALES PRACTICES LITIGATION.

No. 09 Md.2023(BMC)(JMA).

United States District Court E.D. New York.

March 30, 2010.

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Andres F. Alonso, David Bruce Krangle, Jerrold S. Parker, Parker & Waichman, Great Neck, NY, Daniel E. Becnel, Jr., Becnel Law Firm, LLC, Reserve, LA, Michael A. London, Virginia E. Anello, Douglas & London, New York, NY, Scott W. Weinstein, Morgan & Morgan, P.A., Fort Myers, FL, Daniel K. Touhy, Terrence Buehler, Touhy, Touhy, Buehler & Williams LLP, Chicago, IL, James G. Onder, Onder, Shelton et al., St. Louis, MO, Mark R. Niemeyer, Onder, Shelton et al., Webster Groves, MO, David J. Cohen, Saltz Mongeluzzi Barrett & Bendesky, Philadelphia, PA, Daniel J. Kurowski, Elizabeth A. Fegan, Hagens Berman Sobol Shapiro LLP, Oak Park, IL, Steve W. Berman, Hagens Berman Sobol Shapiro LLP, Seattle, WA, Barry B. Cepelewicz, Christine Mcateer Ford, Meiselman, Denlea, Packman, Carton & Eberz P.C., White Plains, NY, Alexander M. Schack, Law Offices of Alexander M. Schack, Daniel J. Mogin, Noah D. Sacks, The Mogin Law Firm, San Diego, CA, Kathleen Chavez, Chavez Law Firm, P.C., Matthew J. Herman, Robert Foote, Stephen William Fung, Foote, Meyers, Mielke & Flowers, LLC, Geneva, IL, Jeff D. Friedman, Shana E. Scarlett, Hagens Berman Sobol Shapiro LLP, Berkeley, CA, John Francis Ward, Ward & Olivo, Summit, NJ, for Plaintiffs.

Scott Michael Zimmerman, Adam L. Hoeflich, Heidell, Pittoni, Murphy & Bach, LLP, New York, NY, John E. Galvin, Jonathan H. Garside, Terry Lueckenhoff, Fox, Galvin LLC, St. Louis, MO, Lorna A. Dotro, Coughlin Duffy LLP, Morristown, NJ, Carolyn J. Frantz, Georgia N. Alexakis, Bartlit Beck Herman Palenchar & Scott LLP, Chicago, IL, Christopher Munro Young, DLA PiperUS, Shirli Fabbri Weiss, DLA Piper Rudnick Gray Cary San Diego, CA, for Defendants.

MEMORANDUM DECISION AND ORDER

COGAN, District Judge.

This case is before the Court on defendantBayer Healthcare LLC's (“Bayer” or “defendant”)motion to dismiss the Master Complaint(“Complaint”).The eleven above-captioned individual actions have been transferred to a multidistrict litigation docket established to consolidate, for purposes of coordinated pretrial proceedings, cases arising from claims that defendant misrepresented the virtues of Bayer Women's Low Dose Aspirin + Calcium (“Bayer Calcium”), which combines low-dose aspirin with calcium, and Bayer Aspirin with Heart Advantage (“Heart Advantage”) which combines low-dose aspirin with phytosterols.¹

Plaintiffs allege that Bayer marketed the combination products as if they had been approved by the Food and Drug Administration (“FDA”); as if they were appropriate for long-term use; and as if Bayer Calcium were a source of calcium and Heart Advantage provided cardiovascular benefits.However, the combination products were not FDA-approved and, plaintiffs claim, were inappropriate for long-term use and incapable of delivering the health benefits touted on their packaging.Plaintiffs argue that someone could not take either combination product as part of a daily low-dose aspirin regimen and get both the recommended daily dose of aspirin and the recommended daily dose of phytosterols or calcium.Someone taking Heart Advantage as part of low-dose aspirin regimen would get the recommended dose of aspirin, but only half the recommended amount of phytosterols.Similarly, someone taking Bayer Calcium as part of a low-dose aspirin regimen would get the recommended daily dose of aspirin, but only one-third of the recommended amount of calcium.Plaintiffs assert that Bayer's labeling was confusing because it commingled statements about the virtues of low-dose aspirin with those about the health benefits of calcium and phytosterols.In sum, rather than the whole being greater than the sum of its parts, the combination products, according to plaintiffs, were less.

Defendant presents several alternative grounds for dismissing plaintiffs' claims, the essence of which is that plaintiffs have alleged nothing more than a violation of the Food, Drug, and Cosmetic Act (“FDCA”)21 U.S.C. § 301 et seq.(2009), which does not provide a private cause of action.In the alternative, defendant argues that plaintiffs' claims allege insufficient theories of injury and damages.

For the reasons set forth below, defendant's motion is denied.

BACKGROUND

Bayer is a major pharmaceutical company that has “been associated with aspirin” for over 100 years and describes itself as the “worldwide leader in the field of non-prescription drugs.”One of its marquee products is low-dose aspirin.Bayer markets its aspirin products at the website www. wonderdrug. com and has long touted the benefits of a daily regimen of low-does aspirin.Aspirin is an analgesic, one of a class of drugs that act in various ways on the nervous system to decrease pain.Low-dose aspirin may be sold over-the-counter (“OTC”) subject to an FDA monograph, which specifies what claims a manufacturer can make about the drug.21 C.F.R. § 330.13(2009).An aspirin manufacturer making approved claims does not need to go through the new drug approval (“NDA”) process and can rely on the FDA monograph.In other words, any manufacturer can sell aspirin under the FDA monograph for aspirin as long as that manufacturer makes only claims permitted by the monograph.²All such a manufacturer need do is include standard directions and warnings, including that a long-term aspirin regimen should be pursued only under a doctor's supervision.Bayer sells its low-dose aspirin under the FDA monograph.

The FDA has approved unqualified health claims for calcium, for reducing the risk of osteoporosis, and phytosterols, for lowering cholesterol and reducing the risk of heart disease.Id. at §§ 101.72,101.83.The FDA only permits unqualified health claims to be made after a “significant scientific agreement, among experts qualified by scientific training and experience ... that the claim is supported by such evidence.”Twelve nutrients have won this approval.Once awarded an unqualified health claim, the product's label is entitled to vaunt the nutrient's health benefits.21 U.S.C. § 343(r)(2006).Calcium, the FDA found, reduces the risk of osteoporosis by contributing to peak bone mass.Accordingly, certain food and dietary supplements that provide at least 20 percent of the recommended daily amount of calcium may take advantage of the unqualified health claim and advertise the benefits of calcium.21 C.F.R. § 101.72.Likewise, certain food and dietary supplements with the requisite levels of phytosterols can place “[a] health claim associating diets that include plant sterol/stanol esters with reduced risk of heart disease” on their labels.Id. at § 101.83.

Defendant has extolled Bayer Calcium and Heart Advantage as the sum of their respective parts.In addition to the qualified health claims about low-dose aspirin, Bayer Calcium employs the health benefit claim authorized for high-calcium foods and Heart Advantage employs the health benefit claim authorized for foods high in phytosterols.Each tablet of Bayer Calcium contains 81 mg of aspirin, the amount recommended for a daily aspirin regimen, and provides 300 mg of elemental calcium.It is labeled as a “PAIN RELIEVER/CALCIUM SUPPLEMENT” and for “ASPIRIN REGIMEN” use.The package labeling states that Bayer Calcium “Provides 300 mg of Calcium Which Helps Strengthen Bones To Help Fight Osteoporosis.”There is a glass of milk next to the health benefit statements on the label and the product's name, which plaintiffs contend “represents that, like milk, Bayer Calcium is a source of dietary calcium.”Although one tablet of Bayer Calcium is the recommended (and advertised) dose for someone on a low-dose aspirin regimen, that would provide only 300 mg of calcium, a fraction of the recommended daily dose.³

Bayer Calcium's label employs the health claims approved for calcium, including which groups are at an increased risk of developing osteoporosis (menopausal women and those with a family history of the disease) and that “[a]dequate calcium intake” is one factor that “may reduce the risk of osteoporosis.”21 C.F.R. § 101.72.The packaging also advertises Bayer Calcium as a source of aspirin and recites the health claims used on Bayer Low-Dose Aspirin: “Aspirin Protects Your Heart by Keeping Your Blood Flowing Freely.”Additionally, identical to the packaging of Bayer Low-Dose Aspirin, the insert recites aspirin's cardiovascular benefits, including reducing the risk of stroke and heart attacks.According to plaintiffs, there is nothing to alert a consumer that the aspirin benefits recited in the insert were FDA-approved for use in low-dose aspirin, but not Bayer Calcium.⁴

On October 27, 2008, the FDA sent a letter warning that, because of Bayer Calcium's combined active ingredients and their combined labeled uses, it was a new drug that could not be sold OTC.Although each of Bayer Calcium's component parts could be sold OTC, the FDA's letter stated that the combination product would be subject to NDA because no other product with those ingredients and marketed for those uses had previously been commercially marketed.Current marketing, the FDA advised Bayer, misbranded the combination product because it lacked “directions under which the layman can use a drug safely for the purposes for which it is intended.”

Bayer introduced Heart Advantage in early 2008.Each tablet contains 81 mg of aspirin, the standard daily dose, and 400 mg of phytosterols, half the recommended daily dose.Heart Advantage's packaging implies, plaintiffs contend falsely, that the combination product has all the virtues of its component parts.⁵The label advertises Heart Advantage as Bayer Aspirin “Plus Cholesterol Lowering Phytosterols,” and describes the product as an ...