Prescribing doctors – in our business you have to love them. Almost all of the cases we handle are governed by the learned intermediary rule, meaning that there’s no duty to warn a patient directly, and all warnings about prescription medical products are directed to the prescribers. When the prescribing doctor says “I knew all that already,” or “I never read your warning but relied upon my experience instead,” we win. If the extra warning our clients supposedly should have given wouldn’t have changed how the prescriber treated his or her patient, there’s no causation. No causation = summary judgment.
Thus we really like to talk to the prescribers – as early in the case as possibly and as informally as possible – to find our just how defensible our cases really are. We also like to talk to them to prevent the various abusive tactics that plaintiffs’ counsel employ when they’re allowed sole and unrestricted access to prescribers except through depositions. These tactics have included threats to sue the prescriber for malpractice unless s/he gives favorable testimony for the plaintiff, payment of “expert fees” if s/he gives favorable testimony for the plaintiff, providing the prescriber with collections of one-sided “information” about the product, and inducing prescribers to sign form affidavits that they later disavow when deposed, among other things.
The plaintiffs’ bar is pretty smart. They know how valuable informal prescriber interviews are to defendants in personal injury cases. They have waged a fairly successful decade-long fight to prevent defense counsel from having equal access to these critical witnesses. Their latest tactic, however, is just plain wrong. In places where they have been unsuccessful in changing state-law practices, they now claim that state law allowing defense counsel to talk to prescribers informally is preempted by the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§1320-d, et seq. (“HIPAA”). That’s just not so. HIPPA always intended to leave state civil procedure to the states.
There’s simply no basis for preemption. HIPAA enacted to ensure the security of electronic health information while it was stored and when it was exchanged between entities health-care providers, insurers, and the like during routine business. It was not intended to restrict anything that occurred during litigation. HIPAA says so explicitly.
The problem is that HIPAA’s preemption clause is quite broad and easy to find, while the exceptions are less apparent. When these preemption arguments have been made in mass tort litigation – where defense counsel have the resources to rebut them – they have been rightly rejected. However, these same arguments have been pressed in “one-off” malpractice cases and the like where defense counsel are not so well prepared. In that situation, some courts have been deceived by what is a statutorily fatuous argument.
HIPAA is not a substitute for the physician-patient privilege; it created no federally enforced privilege of any sort. Northwestern Memorial Hospital v. Ashcroft, 362 F.3d 923, 926 (7th Cir. 2004). Nor does HIPAA create any private cause of action – so litigants aggrieved by purported HIPAA violations have no federal right to sue. Poli v. Mountain Valleys Health Centers, Inc., 2006 WL 83378, at *2 (E.D. Cal. Jan. 11, 2006); Runkle v. Gonzales, 391 F. Supp.2d 210, 237 (February 2, 2006 D.D.C. 2005); Bradford v. Semar, 2005 WL 1806344, at *3 (E.D. Mo. July 28, 2005); Gaul v. Hughes Pharmacy Services, Inc., 2005 WL 1491216, at *3 (N.D. Iowa Jun. 23, 2005); Rigaud v. Garofalo, 2005 WL 1030196, at *3 (E.D. Pa. May 2, 2005); Johnson v. Quander, 370 F.Supp.2d 79, 99-100 (D.D.C. 2005). Rather, HIPAA provides its own administrative remedies. See 145 C.F.R. §160.306.
The physician-patient privilege was “unknown to the common law,” and where created by statute “is subject to many exceptions and to waiver for many reasons.” Whalen v. Rose, 429 U.S.589, 602 n.28 (1977). Almost everywhere, once somebody files suit over some sort of medical condition, all privileges are waived as to that condition. Alcon v. Spicer, 113 P.3d 735, 740 (Colo. 2005); Henricksen v. State, 84 P.3d 38, 48-49 (Mont. 2004); Willoya v. State Dept. of Corrections, 53 P.3d 1115, 1124 n.38 (Alaska 2002); Laznovsky v. Laznovsky, 745 A.2d 1054, 1067 (Md. 2000); Doe v. Orangeburg County School Dist. No. 2, 518 S.E.2d 259, 261 n.7 (S.C. 1999); Rodriguez v. Suzuki Motor Corp., 996 S.W.2d 47, 63 (Mo. 1999); Marsh v. Wenzel, 732 So. 2d 985, 990 (Ala. 1998); Donovan v. Bowling, 706 A.2d 937, 940 (R.I. 1998); Maynard v. Heeren, 563 N.W.2d 830, 837 (S.D. 1997); Steinberg v. Jensen, 534 N.W.2d 361, 368 (Wis. 1995); Stigliano v. Connaught Laboratories, Inc., 658 A2d 715, 718 (N.J. 1995); Nelson v. United States, 649 A.2d 301, 308 (D.C. 1994); Carson v. Fine, 867 P.2d 610, 618 (Wash. 1994); Vredeveld v. Clark, 504 N.W.2d 292, 300 (Neb. 1993); Pearce v. Ollie, 826 P.2d 888, 903 (Idaho 1992); Owen v. Owen, 563 N.E.2d 605, 608; State v. Valley, 571 A.2d 579, 586 (Vt. 1989); Dillenbeck v. Hess, 536 N.E.2d 1126, 1135 (N.Y. 1989); Nelson v. Lewis, 534 A.2d 720, 722 (N.H. 1987); State v. Berry, 324 So. 2d 822, 827 (La. 1976); State v. Campbell, 500 P.2d 21, 33-34 (Kan. 1972); City & County of San Francisco v. Superior Court, 231 P.2d 26, 28 (Cal. 1951); Wright v. Wasudev, 1994 WL 642785 at *5 (Tenn. Ct. App. Nov. 16, 1994); Moses v. McWilliams, 549 A.2d 950, 956 (Pa. Super. 1988); Orr v. Sievert, 292 S.E.2d 548, 550 (Ga. App. 1982).
HIPAA doesn’t change any of this. It was not enacted to address how state-law litigation impacts upon state-law privileges. Rather HIPAA was primarily enacted to require the government to create national standards for the routine electronic transmission of health care information. See 42 U.S.C. §1320d-2; In re Diet Drug Litigation, 895 A.2d 493, 497 n.11 (N.J. Super. 2005) (“[t]he Act’s first objective was not to protect privacy”). Congress wanted to promote the efficiencies that came with increased use of electronic data management technology in the medical area while preserving patient privacy. As a consequence, Congress mandate the adoption of federal privacy protections for individual health information. See Pub.L. 104-191 §264(a, c) (uncodified).
The administrative response was the so-called HIPAA Privacy Rule (“Privacy Rule”), effective April 14, 2003. 68 Fed. Reg. 8334 (Feb. 20, 2003). As a general proposition, the Privacy Rule requires covered entities, (health care providers, health plans and health care clearinghouses) to follow specified procedures to prevent improper or inappropriate disclosure of a patient’s individually identifiable health information. There are exceptions to these procedures – and one of these exceptions concerns litigation.
The HIPAA Privacy Rule does not confer federal privacy rights on state-law personal injury plaintiffs. Instead health care providers “may disclose protected health information in the course of any judicial. . .proceeding.” 45 C.F.R. §164.512(e). This regulation states, in pertinent part:
(e) Standard: Disclosures for judicial. . .proceedings.(1) Permitted disclosures. A covered entity may disclose protected health
information in the course of any judicial. . .proceeding:. . .(i) In response to an order of a court. . .provided that the covered entity discloses only the protected health information expressly authorized by such order; or(ii) In response to a subpoena, discovery request, or other lawful process, that is not accompanied by an order of a court. . .if:(A) The covered entity receives satisfactory assurance. . .from the party seeking the information that reasonable efforts have been made by such party to ensure that the individual who is the subject of the protected health information that has been requested has been given notice of the request. . .(iii) . . .[A] covered entity receives satisfactory assurances. . .if the covered entity receives from such party a written statement. . .that:(A) The party requesting such information has made a good faith attempt to provide written notice to the individual. . .(B) The notice included sufficient information about the litigation. . .to permit the individual to raise an objection to the court. . ., and. . .(1) No objections were filed;or(2) All objections filed by the individual have been resolved by the court…(Emphasis added).
That’s the only protection HIPAA provides in the litigation context – any “lawful process that is not accompanied by an order of a court” simply requires “notice” and “satisfactory assurance” prior to production of individual medical information Id. §164.512(e)(ii)(A). Whatever state-law litigation procedure that was legal before HIPAA remains legal afterwards. Thus the governing federal regulation under HIPAA neither prohibits informal physician interviews nor requires them – and the same is true as to any other form of litigation-related information gathering permitted by state law. The regulation simply provides for resolution of “objections. . .by the court.” Id. §164.512(e)(iii)(C)(2).In light of the applicable HIPAA regulation, a claim that the Act preempts state civil practice makes no sense. Nothing in HIPAA purports to prohibit any method of gathering personal medical information about a personal injury plaintiff in the context of litigation initiated by that plaintiff. To the contrary, the language of §164.512(e) demonstrates that the HIPAA Privacy Rule contemplated and specifically addressed the issue of discovery in civil litigation – and preserved state law practice, whatever that practice might be. See E.E.O.C. v. Boston Mkt. Corp., 2004 WL 3327264, at *5 (E.D.N.Y. Dec. 16, 2004) (HIPAA “does not expressly prohibit ex parte communications with health providers for an adverse party, but neither does it authorize such communications”; declining to find preemption).In promulgating the Privacy Rule, the government confirmed that HIPAA was not intended to interfere with litigation discovery as permitted by state law. The Final Rule promulgating the Rule directly addressed the issue of state litigation practice.
[T]he provisions in this paragraph are not intended to disrupt current practice whereby an individual who is a party to a proceeding and has put his or her medical condition at issue will not prevail without consenting to the production of his or her protected health information. In such cases, we presume that parties will have ample notice and an opportunity to object in the context of the proceeding in which the individual is a party.
65 Fed. Reg. 82462, 82530 (emphasis added). Where a plaintiff-patient has voluntarily placed his or her medical condition at issue by filing suit, informal physician interviews thus remain proper whenever allowed by state law. The Federal Register and the Final Rule confirm that the government took particular care to ensure that, in the context of civil litigation, health care providers such as treating physicians could continue to disclose patient-plaintiffs’ health care information as a matter of course. For this reason, in the litigation context, notice is “presumed” for purposes of §164.512(e)(ii) based upon “ample notice and the opportunity to object” in the lawsuit “in which the individual is a party.” See 65 Fed. Reg. 82462, 82530. Thus the government made clear that the HIPAA Privacy Rule was not intended to affect current state-law litigation practice in any way.
Because HIPAA does not even purport to reach state-law litigation practices, there is no real reason to reach preemption as such. But even if express HIPAA preemption is considered, the preemption claim fails because preemption under HIPAA is expressly limited to “contrary” state law. HIPAA contains an express preemption clause that limits preemption to situations involving direct conflict between the Act and state law. Any federal standard resulting from HIPAA’s implementation “shall supersede any contrary provision of State law.” 42 U.S.C. §1320d-7(a)(1) (emphasis added). A “contrary” state law is defined as one that would make it “impossible [for a covered entity] to comply with both the State and federal requirements,” or that would stand “as an obstacle to the accomplishment and execution of the full purposes and objectives of [the Act].” 45 C.F.R. §160.202.Unless prohibited by statute, administrative agencies may delineate the preemptive scope of the statutes they administer. Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996). As already discussed, under HIPAA state practice concerning informal treater interviews is preserved in 45 C.F.R. §164.512(e), and HHS has explicitly stated its intention “not. . .to disrupt current practice” concerning “a party to a proceeding [who] has put his or her medical condition at issue.” 65 Fed. Reg. at 82530. That defeats any claim of statutory preemption because, compliance with both state law and the Privacy Rule is not impossible, nor do informal interviews stand as an obstacle to the accomplishment of HIPAA’s objectives. The Privacy Rule itself expressly carved out an exception to maintain the free flow of information in judicial settings. Congress provided three exceptions to the HIPAA’s conflict-based preemption clause – where the state law: (1) is designed to prevent fraud and abuse in insurance; (2) concerns controlled substances; or (3) more stringently protects patient privacy than HIPAA. See 42 U.S.C. §1320d-7(a)(1). The preemption claim raised against informal interviews is that they do not fall under these three exceptions. That puts the cart before the horse, because it assumes a conflict when in fact there is none – since preemption is expressly limited only to “contrary” state law. The exceptions become irrelevant because there is nothing “contrary” to state law allowing informal physician interviews. HIPAA simply doesn’t purport to restrict state-law litigation practice in personal injury litigation in any way. Even if some argument could be made that there was some sort of conflict, the “presumption against preemption” would apply to a preemption claim involving construction of an express preemption clause. See Our Post on “Heedless Use of Heeding Presumptions” of December 8, 2006. In construing a federal preemption clause, courts “start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act.” Medtronic v. Lohr, 518 U.S. at 485. Well, physician/patient questions are squarely within the states’ historic powers. Not only is there is no federal physician/patient privilege. Whalen, supra, but even in federal litigation, privileges are governed by state law. Fed. R. Evid. 501. The presumption against preemption thus applies with full force in this case. The HIPAA preemption clause does not permit – let alone mandate – preemption here. On its face, §1320d-7 demands that state law be “contrary” to the Act. Since the Privacy Rule contains a specific exemption for litigation-related discovery, informal treater interviews permitted under state practice cannot possibly be contrary to the terms of HIPAA. “All that [the Privacy Rule] should be understood to do, therefore, is to create a procedure for obtaining authority to use medical records in litigation.” Northwestern Memorial Hospital, 362 F.3d at 925-25 (disapproving lower court preemption analysis). Accord Harris v. Whittington, 2007 WL 164031, at *2 (D. Kan. Jan. 19, 2007) (“plaintiff objects to the “ex parte” nature of interviews based on the enactment of HIPAA. . . . HIPAA rules and regulations contemplate the disclosure and use of medical information in a judicial proceeding”).Thus, in Hawes v. Golden, 2004 WL 2244448 (Ohio App. Sep. 22, 2004), appeal denied, 822 N.E.2d 811 (Ohio 2005), the appellate court disagreed with the contention that a state statute waiving the physician-patient privilege upon the filing of certain personal injury litigation was preempted by HIPAA. The exceptions in 45 C.F.R. §164.512(e), preserving state discovery procedures, precluded the existence of any preemptive “conflict”:
Whether [the state statute] is preempted by HIPAA depends on whether it is “contrary” to federal law. “Contrary” is defined. . .as the impossibility of complying with both state and federal requirements. In this case, it is not impossible for the medical provider/covered entity to comply with both federal and state law. Under state law, the patient/physician privilege is waived upon filing a wrongful death action such that medical evidence is discoverable from a medical provider/covered entity. . . . HIPAA likewise permits disclosure of medical evidence either pursuant to a court order, discovery request or subpoena. Consequently, there is no conflict. Appellant claims that HIPAA does not contain any provisions. . .regarding waiver of her decedent’s privacy rights. . .[but] does not, however, cite 45 C.F.R. §164.512(e), regarding judicial and administrative proceedings, discussed above, which clearly apply to this case. These provisions specifically authorize release of medical records pursuant to a court order, subpoena, or discovery request. This Court finds that these provisions permit discovery of medical evidence relevant to wrongful death cases. They are not superseded or preempted by HIPAA.
Hawes, 2004 WL 2244448, at *2-3 ¶¶12-13 (citations omitted).The HIPAA preemption issue has also been extensively litigated in New Jersey. There, the courts have concluded that “[n]owhere in HIPAA does the issue of ex parte interviews with treating physicians, as an informal discovery device, come into view. The court is aware of no intent by Congress to displace any specific state court rule, statute or case law on ex parte interviews.” Smith v. American Home Products Corp., 855 A.2d 608, 622 (N.J. Super. 2003). “HIPAA, by its own terms, does not exclusively dominate the field of protecting individual privacy interests in health information.” Diet Drug, 895 A.2d at 502 n.26. Concerning judicial proceedings generally:
As for this state’s informal discovery practices, congressional intent seems not to intrude on New Jersey’s general authority over its judicial and administrative proceedings. HIPAA. . .allows a covered entity to disclose protected health information without written authorization of the patient or an opportunity for the patient to agree or object to the disclosure during judicial proceedings under certain circumstances such as a court order, discovery request, or subpoena.
Smith, 855 A.2d at 622. Thus “[b]ecause informal discovery is not expressly addressed under HIPAA, the courts should be governed by state law. . . . Because the disclosure is limited in scope, the [informal] interviews do not conflict with the general principles of HIPAA.” Id. at 623.
[P]rivacy protection, while of national importance, is being balanced with discovery issues, which would suggest that it is an area of traditional tort litigation, and therefore within the State’s control.
Diet Drug, 895 A.2d at 502 n.26 (invoking the “presumption” in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 347 (2001), “against finding federal preemption where the field is one traditionally occupied by the states”).Likewise, a court in New York ruled that HIPAA does not preempt that state’s discovery practices permitting informal treater interviews:
HIPAA is not a barrier to the relief sought by defendants. . . . Contrary to plaintiff’s assertions, HIPAA itself provides no impediment to the relief sought by defendants. The regulations promulgated under HIPAA provide that under certain conditions, “A covered entity may disclose protected health information in the course of any judicial or administrative proceeding”. . . . [I]n order to foster the truth seeking function of a trial and in order to ensure fundamental fairness and a level playing field, a plaintiff should not be allowed to simply refuse to provide an appropriate authorization to defendants yet seek to interview these same health care providers for potential trial testimony.
Steele v. Clifton Springs Hospital & Clinic, 788 N.Y.S.2d 587, 589-90 (N.Y. Sup. 2005) (citing 45 C.F.R. §164.512(e)). See Anderson v. City of New York, 2006 WL 1134117, at *1 (Mag. E.D.N.Y. April 28, 2006) (applying New York law).Contrary cases are not persuasive. Law v. Zuckerman, 307 F. Supp.2d 705 (D. Md. 2004), for example, stated “[i]f a state law can force disclosure without a court order, or the patient’s consent, it is not ‘more stringent’ than the HIPAA regulations.” Id. at 711. Law thus ignored (or the parties did not bring to the court’s attention) 45 C.F.R. §164.512(e)(1)(ii), which expressly exempts from preemption state-law discovery without a court order as long a there is “notice” and an opportunity to be heard. Further Law, 307 F. Supp. 2d at 710, and Croskey v. BMW of North America, Inc., 2005 WL 1959452, at *5 (E.D. Mich. Feb. 16, 2005), both relied on the district court opinion in National Abortion Federation v. Ashcroft, 2004 WL 292079 (N.D. Ill. Feb. 6, 2004), which was disapproved on this precise point by the Seventh Circuit in Northwestern Memorial Hospital, 362 F.3d at 925-26.