Judge Owen Lee Kwong, JD, RPH

IMS Health Inc. and Verispan, LLC v Kelly A. Ayotte et al

; No. 07-1945; United States Court of Appeals for the First Circuit; November 18, 2008.     




  The Federal Court of Appeals for the First Circuit in a 2 to 1 decision held that New Hampshire’s Prescription Information Law “that among other things prohibited certain transfer of physicians’ prescribing histories for use in detailing” regulates conduct, not speech, thereby removing “the challenged portions of the statute from the proscriptions of the First Amendment.” The appellate court further found that the act when construed narrowly is sufficiently clear to withstand plaintiffs’ vagueness challenge and concluded that plaintiffs’ Commerce Clause challenge fails, as the law affects only domestic transactions. The appellate court reversed the decision of the district court, which found the relevant portions of the Prescription Information Law an unconstitutional abridgement of free speech and vacated the injunction against enforcement of the Prescription Information Law.    



  
  Plaintiffs’ “complaint alleged that the statutory ban on transfer and use of prescriber-identifiable information transgressed the Free Speech Clause of the First Amendment, was void for vagueness, and offended the Commerce Clause.” Plaintiffs IMS Health Inc. and Verispan, LLC, are in the business of data mining and “purchase data of the type and kind [‘when a prescription is filled . . . such as the name of the patient, the identity of the prescribing physician, the drug, its dosage, and quantity dispensed’], aggregate the entries, group them by prescriber, and cross-reference each physician’s prescribing history with physician-specific information available through the American Medical Association. The final product enumerates the prescriber’s identity and specialty, the drug prescribed, and kindred information.” Plaintiffs “record, group, and organize several billion prescriptions each year. To protect patient privacy, prescribees’ names are encrypted . . . .” “New Hampshire’s concern . . . is . . . commercial use: the exploitation of the mined data by pharmaceutical companies, whose detailers [pharmaceutical sales representatives] use it in marketing [brand-name] drugs to physicians.” “That information enables the detailer to zero in on physicians who regularly prescribe competitors’ drugs, physicians who are prescribing large quantities of drug for particular conditions, and ‘early adopters’ (physicians with a demonstrated openness to prescribing drugs that have just come onto the market). The information also allows the detailer to tailor her promotional message in light of the physician’s prescribing history.”   

  The Prescription Information Law made the “goals of the . . . statute pellucid: the protection of privacy interests, the safeguarding of patient health, and cost containment.” “Pharmaceutical detailing has pushed the art of marketing into uncharted waters. In the service of maximizing drug sales, detailers use prescribing histories as means of targeting potential customers more precisely and as a tool for tipping the balance of bargaining power in their favor. As such, detailing affects physician behavior and increases the likelihood that physicians will prescribe the detailers’ (more expensive) drugs. The New Hampshire legislature found this advantage in bargaining power invidious (chiefly because of its inflationary impact on drug prices) and determined that it compromised the integrity of physician decision-making. Consequently, the legislature sought to level the playing field not by eliminating speech but, rather, by eliminating the detailers’ ability to use a particular informational asset-prescribing histories-in a particular way.”     



  
  “In our view, the portions of the law at issue here regulate conduct, not speech. Unlike stereotypical commercial speech, new information is not filtered into the marketplace with the possibility of stimulating better informed consumer choices (after all, physicians already know their own prescribing histories) and the societal benefits flowing from the prohibited transactions pale in comparison to the negative externalities produced. This unusual combination of features removes the challenged portions of the statute from the proscriptions of the First Amendment.”  

  “Even if the Prescription Information Law amounts to a regulation of protected speech-a proposition with which we disagree-it passes constitutional muster. In combating this novel threat to the cost-effective delivery of health care, New Hampshire has acted with as much forethought and precision as the circumstances and the Constitution demands.”    



  
  State legislation similar to New Hampshire Prescription Information Law is pending in Arizona, the District of Columbia, Illinois, Kansas, Maine, Maryland, Massachusetts, New York, North Carolina, Rhode Island, Vermont, Washington, and West Virginia. On March 5, 2008, Vermont postponed the effective date of its prescription information law until July 1, 2009.  

  In 

 (D.Me. 2008) 532 F.Supp. 2d 183, the United States District Court for the District of Maine concluded that “the provisions of the Maine law [An Act to Amend the Prescription Privacy Law] that seeks to restrict the use and disclosure of commercial information violates the free speech guarantee of the First Amendment” and granted, in part, a motion for a preliminary injunction and enjoined the enforcement of portions of the Prescription Privacy Law. As Maine lies within the federal jurisdiction of the First Circuit, 

’s pronouncements are now constrained by the more recent decision of the First Circuit in 

 is a Judge for the State of California and a Pharmacist for Kaiser Permanente, Los Angeles, California. He is a graduate of University of Utah, School of Pharmacy, and University of California at Los Angeles, School of Law. 

 is a Pharmacist for Kaiser Permanente, Los Angeles, California, and is a graduate of University of Southern California, School of Pharmacy. 

Articles

The Federal Court of Appeals for the First Circuit in a 2 to 1 decision held that New Hampshire's Prescription Information Law "that among other things prohibited certain transfer of physicians' prescribing histories for use in detailing" regulates conduct, not speech, thereby removing "the challenged portions of the statute from the proscriptions of the First Amendment."

IMS v Ayotte: NH's Prescription Information Law is constitutional

; Nos. A116707, A117353; Filed November 7, 2008.

On November 7, 2008, a California Intermediate Appellate Court in San Francisco held that the name-brand drug manufacturer Wyeth’s “common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan [the brand name] or its generic equivalent. The risk of harm to such a patient is foreseeable to Wyeth.” The appellate court reversed the previous judgment in favor of Wyeth.

Plaintiff Conte “developed tardive dyskinesia, a debilitating and incurable neurological disorder . . . [allegedly] as a result of taking [generic] metoclopramide for almost four years . . . ”

Conte “claims that defendants [Wyeth and generic manufacturers Pliva, Purepac, and Teva] knew or should have known of a widespread tendency among physicians to misprescribe Reglan and generic metoclopramide for periods of 12 months or longer, even though the medication is only approved for 12 weeks of use, because the drug’s labeling substantially understates the risks of serious side-effects from extended use.”

The court states, “The crux of Conte’s claims against all of the drug company defendants is that she was injuriously overexposed to metoclopramide due to their dissemination of false, misleading and/or incomplete warnings about the drug’s side effects.”

The plaintiff’s claims against Wyeth “are premised on misrepresentation in Wyeth’s labeling of Reglan and in a monograph on Reglan it provided for the Physician’s Desk Reference (PDR).”

The court states that “it is undisputed that Conte took only the generic version of the medication, not Reglan.”

Conte’s prescribing physician stated in his declaration that “[a]t no time did [he] rely in any way on representations made in the PDR monograph, package insert, labeling materials or other information from Wyeth regarding the medication Reglan in order to formulate [his] course of care and treatment for Ms. Conte.” The prescribing doctor’s deposition testimony is that he “‘probably’ read Wyeth’s monograph on Reglan in the PDR during his residency training . . . ”

The court’s duty analysis looked primarily to the foreseeability of physical harm. As “[i]t is . . . highly likely that a prescription for Reglan written in reliance on Wyeth’s product information will be filled with generic metoclopramide . . . it is also eminently foreseeable that a physician might prescribe generic metoclopramide in reliance on Wyeth’s representation about Reglan. In this context we have no difficulty concluding that Wyeth should reasonably perceive that there could be injurious reliance on its product information by a patient taking generic metoclopramide.”

The California court departed from the majority of courts that have considered this issue and rejected the reasoning of Foster v American Home Products Corp. (4th Cir. 1994) 29 F.3d 165, 171, which stated that for the court to impose a duty upon a manufacturer for damages caused by the generic bioequivalent would stretch the concept of foreseeability too far because a manufacturer “cannot reasonably expect that the consumer will rely on information they provide when actually ingesting another company’s drug.” When a manufacturer of a generic drug blindly accepts the name-brand manufacturer’s representation, it does so at its own risk.

 is a judge for the state of California and a pharmacist for Kaiser Permanente, Los Angeles, California. He is a graduate of University of Utah, School of Pharmacy, and University of California at Los Angeles, School of Law. 

 is a pharmacist for Kaiser Permanente, Los Angeles, California, and is a graduate of University of Southern California, School of Pharmacy.

On November 7, 2008, a California Intermediate Appellate Court in San Francisco held that the "common-law duty [of Wyeth] to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent."

Judge Owen Lee Kwong, JD, RPH

Articles

IMS v Ayotte: NH's Prescription Information Law is constitutional

Conte v Wyeth: Name-brand drug maker accountable for alleged harm caused by generic drug