[Drug and Device Law] No Prescription For Consumer Protection
Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very appetizing. FDA regulated manufacturers of prescription medical products aren’t snakeoil salesmen, payday lenders, reverse mortgage peddlers, or participants in some other “relatively common cash and credit transactions in which [consumers] engage on a regular basis.” West Virginia ex rel. McGraw v. Bear, Stearns & Co., 618 S.E.2d 582, 587 (W. Va. 2005). These statutes almost universally exempt government regulated activity, and instead of personal injuries consumer protection statutes typically allow recovery of non-tort damages such as monetary loss, attorney fees and multiple damages.
That’s one reason we were particularly pleased with the non-preemption part of the recent decision in Otis-Wisher v. Medtronic, Inc., ___ F. Appx. ___, 2015 WL 3557011 (2d Cir. June 9, 2015) (blogged about here), that dismissed the Vermont consumer protection act claims:
[T]he Vermont Consumer Protection Act . . . defines a “consumer” as a “person who purchases, leases, contracts for, or otherwise agrees to pay consideration for goods or services . . . for his or her use or benefit or the use or benefit of a member of his or her household.” Plaintiff did not constitute a “consumer” under the statute because she did not, for her personal use, purchase [the product], which in any event is not available for consumer purchase, but rather was prescribed the medical device by her doctor. Though Vermont has apparently not addressed this issue in the specific context of medical devices, the District Court’s ruling here is consistent with that of courts in other jurisdictions interpreting similar consumer protection laws.
Id. at *2 (emphasis added).
Otis-Wisher, being non-precedential, simply cited to the cases in the defendant-appellee’s brief. Id. That isn’t good enough for us, so we decided to see what was out there. Probably the most far-reaching opinion along these lines is White v. Wyeth, 705 S.E.2d 828 (W. Va. 2010), in which West Virginia’s highest court (not usually particularly friendly to our clients) held that prescription medical products were not subject to that state’s consumer fraud act because of the restricted way in which they were distributed. “Prescription drug cases are not the type of private causes of action contemplated under the terms and purposes of the [statute] because the consumer can not and does not decide what product to purchase.” Id. at 838.
[T]he high degree of federal regulation of prescriptive drug products attenuates the effect product marketing has on a consumer's prescriptive drug purchasing decision. . . . There is a strong argument that the scope of consumer protection acts was never meant to include FDA-approved drugs. The clear public policy behind these provisions is that consumer protection laws were meant to fill a gap by protecting consumers where product safety was not already closely monitored and regulated by the government.
Id. (citations and quotation marks omitted).
In part, White relied on a New Jersey intermediate appellate court decision which reached a similar conclusion:
[T]he intervention by a physician in the decision-making process necessitated by his or her exercise of judgment whether or not to prescribe a particular medication protects consumers in ways . . . that are lacking in advertising campaigns for other products. . . . [W]ithin a highly regulated industry in which the ultimate consumer is not in fact free to act on claims made in advertising in any event, the relationship between words used in the advertising and purchase of the product is at best an attenuated one.
New Jersey Citizen Action v. Schering-Plough Corp., 842 A.2d 174, 177-78 (N.J. Super. App. Div. 2003). Since then, the New Jersey Supreme Court more broadly ruled that consumer fraud claims were simply subsumed by that state’s product liability statute. See Runner v. Bard, ___ F. Supp.3d ___, 2015 WL 3513424, at *13 (E.D. Pa. June 3, 2015) (discussing Sinclair v. Merck & Co., 948 A.2d 587 (N.J. 2008) (blogged here)). Nonetheless, the reasoning in NJCA remains relevant to similar statutes in other states – as White demonstrates – or in other New Jersey situations beyond the reach of product liability. See In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *32 (D.N.J. July 10, 2009) (third party payers are not “consumers” under New Jersey consumer fraud statute because they “do not use or consume the drugs they purchase”) (we note that there is other similar TPP precedent; it is beyond the scope of this post).
The Illinois Supreme Court likewise found the “mere sale” of prescription medical products beyond the scope of that state’s consumer protection statute:
The risks associated with pharmaceuticals are a large part of the reason why a doctor’s prescription is required for these medications. A drug often can affect different patients differently, causing adverse side effects in one but not another. [This] approach reflects the reality that even in their intended and ordinary use, prescription drugs may nonetheless cause harmful side effects in some patients. A drug manufacturer cannot say with complete certainty that its product, when used as intended, will be reasonably safe for all patients. As a result, the mere sale of a prescription medication cannot be a representation which serves as the basis for a consumer fraud claim.
De Bouse v. Bayer, 922 N.E.2d 309, 318 (Ill. 2009).
For similar reasons – the “learned intermediary rule” − the Pennsylvania Unfair Trade Practices & Consumer Protection law (“UTPCPL”) was interpreted as excluding prescription medical products in In re Avandia Marketing, Sales & Products Liability Litigation, 2013 WL 3486907 (E.D. Pa. July 10, 2013):
Media dissemination of information concerning the existence of these drugs does not enhance the public’s ability to acquire them, as the skill and knowledge of the physician still must be brought to bear in a determination of whether the pharmaceutical is appropriate for the patient. Because Plaintiff could not obtain Avandia without a physician’s prescription, and the allegations with regard to the prescribing physician’s exposure to, and justified reliance on, misleading information from Defendant are insufficient to state a cause of action, the learned intermediary doctrine bars Plaintiffs claim.
Id. at *2. Accord Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 374 (D.N.J. 2004) (UTPCPL claims barred under Pennsylvania law because there is “no duty to disclose any information directly to Plaintiff”).
California courts did pretty much the same thing in Kanter v. Warner-Lambert Co., 122 Cal. Rptr.2d 72 (Cal. App. 2002), holding that FDA-regulated products were not “consumer product[s],” under a statutory definition reading “any tangible personal property which is distributed in commerce and which is normally used for personal, family, or household purposes.” Id. at 86. Neither prescription drugs nor medical devices were considered “consumer products” because “the FDCA and its implementing regulations govern the labeling at issue here.” Id. See Stein v. Sonus USA, Inc., 2005 WL 6198234, at ??? (Ariz. Super. Sept. 8, 2005) (“medical devices are not consumer products because they are not available directly to the general public and they are already protected by the Food, Drug, and Cosmetic Act”) (following Kanter), aff’d, 150 P.3d 773 (Ariz. App. 2007). Cf. Forcellati v. Hyland’s, Inc., 876 F. Supp. 2d 1155, 1165-66 (C.D. Cal. 2012) (homeopathic products, as opposed to prescription products, insufficiently regulated to fall within Kanter rule).
In Maryland, dental fillings installed by a professional dentist were not “consumer” products within the meaning of that state’s consumer fraud statute because they were “selected and used” by a required “professional” health care provider, and thus fell within a statutory exception:
Consumer goods are defined by the Act as goods “which are primarily for personal, household, family, or agricultural purposes.” Dental fillings are not purchased by consumers as a good but are selected and used by a practitioner as part of a professional service. The Consumer Protection Act expressly exempts professional services.
Hogan v. Md. State Dental Ass’n, 843 A.2d 902, 906 (Md. Spec. App.2004); Accord Pease v. Abbott Labs., Inc., 2013 WL 174478, at *2 (D. Md. 2013) (“prescription drugs are not ‘consumer goods’” under Maryland statute; drug “was selected by her physician and prescribed for her, not as a consumer good, but as part of her course of medical treatment”).
Quite a few other federal district court cases also hold that FDA-regulated, prescription-only products are not “consumer” products in one consumer protection context or another. The most recent of these is Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164 (E.D.N.Y. 2014), which we previously discussed here. Under the New York consumer fraud statute, information about prescription medical products is not a “consumer oriented” act, for many of the reasons discussed above:
It is uncontroverted that Section 349 of the New York General Business Law prohibits deceptive practices that are directed to consumers. . . . It is further uncontroverted that under New York law, drug manufactures do not owe consumers a duty to warn of a drug’s risks, but instead owe such a duty to the prescribers of that drug. This is because unlike other consumer products that may be freely purchased by consumers, prescription drugs may only be purchased by pursuant to a prescription issued by a medical doctor. . . . Accordingly, because the defendants’ alleged deceptive practice of failing to provide adequate warnings by concealing information is not, as a matter of law, a practice directed at consumers, plaintiff has failed to allege a consumer-oriented practice cognizable under [the statute].
Id. at 173-74 (citations omitted). Accord Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 552, (E.D. Pa. 2006) (“securities and prescription drug labeling are highly regulated by the federal government . . ., like securities, prescription drugs are not available in the same manner as usual consumer products”) (applying New York law), aff’d on other grounds, 521 F.3d 253 (3d Cir. 2008) (preemption), vacated on other grounds, 556 U.S. 1101 (2009) (preemption).
Several courts have also reached this result under Ohio law. Smith v. Smith & Nephew, Inc., 5 F. Supp.3d 930, 932 (S.D. Ohio 2014) (the prescription medical product “was purchased by the hospital, not Plaintiffs, and therefore it was not a part of a consumer transaction within the [statutory] definition”); Reeves v. PharmaJet, Inc., 846 F. Supp.2d 791, 798 n.2 (N.D. Ohio 2012) (a “prescription medical device is not a good for personal, family or household use and thus is not a consumer good as defined by the OCSPA.”); Williams v. Boston Scientific Corp., 2013 WL 1284185, at *6 (N.D. Ohio Mar. 27, 2013) (“the device was not a ‘consumer good’”; individual plaintiff was not a “consumer participating in a consumer transaction”).
Other decisions along the same lines include: Collins v. Davol, Inc., 56 F. Supp.3d 1222, 1232 n.9 (N.D. Ala. 2014) (medical “device is clearly inconsistent with the [Alabama statute’s] definition of ‘consumer good,’ i.e. ‘goods that are used or bought for use primarily for personal, family, or household purposes’”); Herzog v. Arthrocare Corp., 2003 WL 1785795, at *10 (D. Me. 2003); (“the [Maine] Act does not extend protection to individuals who pay the bill for a medical service provider’s acquisition of a medical device, even though that device is ‘used’ on them”); In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863, 876 (D. Minn. 1998) (“Plaintiffs’ [products] do not constitute ‘consumer products’ under the Act because these implants are not readily accessible to all consumers”); Goldsmith v. Mentor Corp., 913 F. Supp. 56, 63 (D.N.H. 1995) (“the prosthesis, a medical device regulated under the MDA, is not a consumer product”; “it is not ‘tangible personal property . . . normally used for personal, family, or household purposes’”); Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1024-25 (E.D. Mich. 1993) (“prescription drugs and medical devices are not listed among the examples of consumer products”; “Medical devices that are surgically implanted are not consumer products. The ordinary consumer has no access to such devices.”); see also Williams v. Purdue Pharma Co., 297 F. Supp.2d 171, 174-75 (D.D.C. 2003) (“difficult to discern a consumer-merchant relationship” if defendants had “promoted [the drug] only to physicians and other non-patients”; claim might be stated based on allegations concerning “brochures and a videotape directed to consumer-patients”).
In light of what we’ve found, we have to agree with Otis-Wisher. Widespread precedent exists to challenge statutory consumer protection/fraud claims asserted against prescription medical products. While there might be adverse precedent out there, we repeat: we do not do our opponents’ research for them. Given these products’ restricted distribution, heavy regulation, and lack of direct seller/patient contact, they shouldn’t qualify as “consumer” oriented within the meaning of most state statutory schemes.
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Posted By Bexis to Drug and Device Law at 6/25/2015 08:00:00 AM --
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