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From Health Law Daily, March 24, 2014

Drug rep’s claims of illegal marketing by employer lack critical components

By Harold M. Bishop, JD

The Second Amended Complaint of a qui tam relator was dismissed without prejudice for failure to plead his allegations with sufficient particularity. The relator alleged that his employer illegally marketed a prescription drug product and that, as a consequence, illegal prescriptions were billed to the Medicare and Medicaid programs. The court found that the relator failed to identify the actual recipients of the allegedly illegal prescriptions, the actual amount of any claim for reimbursement, the identity of any individual who submitted a claim, the date on which any request for reimbursement was made, and most importantly, that corresponding claims for reimbursement were submitted to the government (U.S. ex rel. Palmieri v Alpharma, Inc., March 21, 2014, Hollander, E).

Background. The qui tam relator, Jerome Palmieri (Palmieri), filed an action against his employers, Alpharma, Inc. and Alpharma Pharmaceuticals, LLC (collectively, “Alpharma”); King Pharmaceuticals, Inc.; and Pfizer, Inc. (collectively “Defendants”), pursuant to the False Claims Act, 31 U.S.C. secs. 3729 et seq. and analogous state qui tam statutes. The suit concerns Defendants’ marketing of Flector Patch (diclofenac epolamine), a topical pain medication delivered by a transdermal patch, approved by the FDA for treatment of acute pain due to minor strains, sprains, and contusions. Diclofenac epolamine is a non-steroidal anti-inflammatory drug (NSAID) in the same family as ibuprofen and naproxen. The U.S. and state governments chose not to intervene.

Palmieri has been employed as a sales representative by Alpharma since 2001, and later by King and Pfizer. Palmieri alleged that Defendants engaged in a program of aggressive and illegal marketing of the Flector Patch to physicians and encouraged these physicians, sometimes by way of unlawful kickbacks, to prescribe Flector Patch to their patients, including prescriptions for off-label use and at excessive dosage. Palmieri alleged that some of these off-label, excessive, or unlawfully-induced prescriptions were submitted to federal and state health care reimbursement programs, such as Medicare and Medicaid.

The court previously dismissed Palmieri’s First Amended Complaint for failure to plead with sufficient particularity. Palmieri’s Second Amended Complaint contained new allegations regarding prescriptions written for nine patients by two Pennsylvania physicians. The Defendants again moved for dismissal.

Pleading false claims with particularity. Defendants maintain that the Second Amended Complaint fails to meet the Rule 9(b) standard of pleading with particularity because Palmieri still does not adequately allege details of any false claims allegedly submitted to the government. (Fed. R. Civ. P. 9(b). While they acknowledge that Palmieri has added allegations that nine patients of two Pennsylvania doctors received off-label prescriptions, they contend that he failed to adequately to allege that claims for reimbursement for those prescriptions were submitted to federally-funded health care programs.

The court agreed that Palmieri’s new allegations still fell short of alleging that false claims were actually presented to the government for reimbursement. According to the court, by citing four patients’ requests for refills, Palmieri plausibly alleged that those patients did fill prior prescriptions. However, the court found that Palmieri does not know the actual identity of those individuals, and his allegations are plainly lacking in details such as the actual amount of any claim for reimbursement, the identity of any individual who submitted a claim, or the date on which any request for reimbursement was made. Moreover, the court found that his allegations were still devoid of the most critical component, which cannot be inferred: that corresponding claims for reimbursement were submitted to the government. The claims were dismissed without prejudice.

The case number is ELH-10-1601.

Attorneys: Anna C. Dover (Milberg LLP) for Jerome Palmieri. Jamie M. Bennett, Office of the US Attorney, for the USA. Brigham Cannon (Kirkland and Ellis) for Alpharma, Inc., Alpharma Pharmaceuticals, LLC, King Pharmaceuticals, Inc. and Pfizer, Inc.

Companies: USA; Alpharma, Inc.; Alpharma Pharmaceuticals, LLC; King Pharmaceuticals, Inc.; Pfizer, Inc.

MainStory: TopStory CaseDecisions QuiTamNews CMSNews AdvertisingNews DrugBiologicalNews FCANews FraudNews MedicaidNews MedicaidPaymentNews PaymentNews PartDNews PrescriptionDrugNews MarylandNews

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