When we saw the first one we thought, that’s odd, but it’s mostly a malpractice claim pretty far from our sweet spot. When we saw the second one, we thought, maybe we should blog about this now…. But the result was mostly unfavorable, and other, more significant things were happening. But now that we’ve seen a third one, well we think we finally have to comment. We don’t want the odd facts that the plaintiff pleaded (we have some difficulty believing their truth) in Schiff v. Hurwitz to mess up Pennsylvania law − any worse than it already is, that is.
First, some legal propositions:
Proposition one − No separate duty to test theory exists under Pennsylvania product liability law − period. The relevant cases, all in our duty to test cheat sheet, are: Lance v. Wyeth, 4 A.3d 160, 168-69 (Pa. Super. 2010), appeal granted, 15 A.3d 429 (Pa. 2011); Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. 2003), aff’d, 881 A.2d 1262 (Pa. 2005) (per curiam); Oddi v. Ford Motor Co., 234 F.3d 136, 143-44 (3d Cir. 2000); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 570 (E.D. Pa. 2011); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 318 n.32 (E.D. Pa. 2007); Stitt v. Philip Morris, Inc., 245 F. Supp.2d 686, 694 (W.D. Pa. 2002).
Proposition two − The Food, Drug & Cosmetic Act (“FDCA”) does not give private persons a right of action to enforce it. Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001); In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 791 (3d Cir. 1999); Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3d Cir. 1994); Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990); Green v. Dolsky, 685 A.2d 110, 115 (Pa. 1996); 21 U.S.C. §337(a).
Proposition three − Strict liability does not lie against the maker of a prescription medical product under Pennsylvania law − not for any type of defect (except possibly manufacturing). Hahn v. Richter, 673 A.2d 888, 889-90 (Pa. 1996); Baldino v. Castagna, 478 A.2d 807, 810 (1984); Incollingo v. Ewing, 282 A.2d 206, 219-20 & n.8 (Pa. 1971), Lance, 4 A.3d at 164-65; Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006); Sykes, 484 F. Supp.2d at 318 & n.31; Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 750 (E.D. Pa. 2001).
Proposition four − Strict liability does not lie against health care providers in Pennsylvania. Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 537-38 (Pa. 1995); Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386 (Pa. 1991); Kelly v. St. Mary Hospital, 694 A.2d 355, 358 (Pa. Super. 1997); Podrat v. Codman-Shurtleff, Inc., 558 A.2d 895, 897 (Pa. Super. 1989); Makripodis v. Richardson-Merrell, Inc., 523 A.2d 374, 378 (Pa. Super. 1987); Flynn v. Langfitt, 710 F. Supp. 150, 152 (E.D. Pa. 1989); Eby v. Milton S. Hershey Medical Center, 31 Pa. D. & C.4th 121, 125 (Pa. C.P. 1996).
Proposition five − Strict liability cannot be reimported into prescription medical products/health care services under the guise of a consumer fraud claim brought under the Pennsylvania Unfair Trade Practices & Consumer Protection law (“UTPCPL”), because the act is inapplicable to medically-related activities. Walter v. Magee-Women’s Hospital, 876 A.2d 400, 407-08 (Pa. Super. 2005), aff’d, 906 A.2d 1194 (Pa. 2006); Foflygen v. Zemel, 615 A.2d 1345, 1354 (Pa. Super. 1992); Gatten v. Merzi, 579 A.2d 974, 976 (Pa. Super. 1990), Kee v. Zimmer, Inc., 2012 WL 1758618, at *4 (E.D. Pa. May 17, 2012); Zafarana v. Pfizer, Inc., 724 F. Supp.2d 545, 557 (E.D. Pa. 2010); Smith v. Bristol-Myers Squibb Co., 2009 WL 5216982, at *5-6 (D.N.J. Dec. 30, 2009) (applying Pennsylvania law); Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 374 (D.N.J. 2005) (applying Pennsylvania law); Kester v. Zimmer Holdings, Inc., 2010 WL 2696467, at *14 (W.D. Pa. June 16, 2010); Albertson v. Wyeth, Inc., 63 D. & C.4th 514, 538-39 (Pa. C.P. 2003); Crossen v. Peretz, 2002 WL 34576549 (Pa. C.P. Oct. 17, 2002); Luke v. American Home Products Corp., 1998 WL 1781624, at *8 (Pa. C.P. Nov. 18, 1998); see Beyers v. Richmond, 937 A.2d 1082, 1088 (Pa. 2007) (favorably citing and applying medical professional UTPCPL precedent to hold that lawyers were also not within the scope of the UTPCPL).
Proposition six − Hospitals have no common-law obligation to obtain informed consent to medical procedures from patients. Valles v. Albert Einstein Medical Center, 805 A.2d 1232, 1239 (Pa. 2002); Watkins v. Hospital of the University of Pa., 737 A.2d 263, 268-69 (Pa. Super. 1999); Friter v. Iolab Corp., 607 A.2d 1111, 1114 (Pa. Super. 1992).
Proposition seven − In Pennsylvania the informed consent doctrine is not unlimited. It extends only to the risks and benefits of surgery, specifically not including any obligation to explain the FDA regulatory status of prescription medical products to patients. Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001). Nor does the informed consent doctrine require disclosure of a physician’s financial interests. Duttry v. Patterson, 771 A.2d 1255, 1259 n.2 (Pa. 2001); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 659 (E.D. Pa. 1995).
Proposition eight − and probably the most important for present purposes − federal judges exercising diversity jurisdiction have no business “predicting” novel expansions of state-law liability. They follow, and do not lead, state courts. Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975); Sheridan v. NGK Metals Corp., 609 F.3d 239, 253 (3d Cir. 2010); Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238, 253 (3d Cir. 2010); City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002) Camden County Board of Chosen Freeholders v. Beretta, 273 F.3d 536, 541 (3d Cir. 2001); Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994); City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993).
Second, we’ll take a look at the facts in Schiff v. Hurwitz, 2012 WL 1971320 (W.D. Pa. June 1, 2012) (hospital institutional review board’s (“IRB) motion) (“Schiff III”); Schiff v. Hurwitz, 2012 WL 1828035 (E.D. Pa. May 18, 2012) (medical device manufacturer’s motion) (“Schiff II”); and Schiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012) (doctor’s motion) (“Schiff I”), as they’re pleaded. That’s all we have to go on since all three Schiff opinions decide Rule 12 motions to dismiss. Maybe these weird allegations will become less beguiling when the pleadings can be pierced. Here’s hoping, anyway.
The plaintiff’s allegations in Schiff − which we have a hard time believing − are that the defendant medical device manufacturer sold a Class II device (that means no preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) called “Invasix” that the FDA had cleared for marketing and labeling for certain uses. The plaintiff, however, allegedly did not use the device for any of those labeled uses. Instead, the plaintiff alleges that she was provided the device in the context of some sort of underground, non-FDA authorized clinical trial of a new use. This underground trial purportedly was conducted like a clinical trial, in that her surgeon was an “investigator” and the trial was carried out under the auspices of the defendant hospital IRB. In accordance with the usual trappings of a clinical trial, the plaintiff signed a written agreement under which she was to receive money for participating in the trial and any medical expenses from adverse events suffered in what amounted to a medical experiment would be paid for. Plaintiff alleged that the manufacturer defendant, in order to avoid the FDA’s clinical trial requirements, falsely represented (it’s not clear to whom) that the new use had no safety issues. The plaintiff further claims that she was not informed of any safety risks by anyone − in particular that the defendant surgeon’s informed consent discussion omitted mention that she didn’t fit within the trial’s protocol and didn’t mention any safety risks. Then, of course (since this is a product liability action), plaintiff suffered injury from those risks. Plaintiff also claimed she wasn’t informed that the defendant surgeon “was a paid investigator.” Schiff I, 2012 WL 1355613, at *1-2; Schiff II, 2012 WL 1828035, at *1-2; Schiff III, 2012 WL 1971320, at *1-2. We’ve seen a lot of claims in several decades of practice, but we’ve never encountered allegations of an under-the-table or off-the-books clinical trial before. That’s the source of our skepticism about whether the pleaded facts in Schiff are true, or even could be true. But there’s always a first time….
On these purported facts, the plaintiff in Schiff alleged (at least) the following general theories: (1) against the treating surgeon: UTPCPL violations; (2) Against the manufacturer (Invasix): negligence, strict liability, breach of warranty, and misrepresentation; (3) against the hospital IRB: UTPCPL violations and intentional infliction of emotional distress. Plaintiff may well assert other claims − these are just what was discussed in the Schiff set of opinions.
Third, and the whole point of this post, here is why we’re bothered by what’s been going on in Schiff.
From our perspective, it appears that these weird FDA/clinical investigation allegations have mesmerized the court, at least as far as the pleadings are concerned. By that we mean that these allegations have induced a federal judge into permitting causes of action − for strict liability, for negligence, and under the UTPCPL − that have at best never been recognized under Pennsylvania law, and at worst are flatly rejected by controlling precedent.
It’s no isolated occasion. Precedentially unconstrained rulings typify the three Schiff opinions.
Let’s dispel the haze, shall we?
We will assume for purposes of this argument − although the Pennsylvania Supreme Court has never spoken on the subject − that under some circumstances, Pennsylvania would allow a negligence per se-type cause of action for at least some violations of the FDCA.
But not these.
Start with legal Propositions 1 and 2 − Pennsylvania recognizes no duty to test, and there exists no private FDCA cause of action. A clinical trial, whether FDA approved or not, is simply a very formal a method of testing a product for safety and effectiveness. Pennsylvania courts have said over and over again, that unless a product is otherwise defective, it doesn’t matter whether it was properly tested, or indeed tested at all. If one assumes the rather fantastic allegations in Schiff that a surreptitious clinical trial of an experimental use was being conducted, that’s just an elaborate attack on the testing (or lack of same) of the product.
But plaintiff’s argument that the purported clinical trial should have been conducted under FDA auspices is simply an claim that the defendants violated the FDCA. As a private individual seeking damages, plaintiff simply can’t do that − not unless the claim resembles a recognized, pre-existing tort. That’s been looked at over and over again in medical device preemption cases (we’re not arguing preemption here because it’s a class II device), and the lack of an FDCA private right of action restricts plaintiffs to FDCA-related claims that “parallel” state law. We’ve done lots of posts on parallel claims, and most of our medical device preemption scorecard is devoted to what is or isn’t a “parallel” claim, so we won’t delve deeply into that here.
Since a duty to test doesn’t exist under Pennsylvania law, the FDCA violation claims in Schiff can’t possibly be parallel to any recognized Pennslyvania product liability claim. The defendant manufacturer might have violated the FDCA from here to kingdom come (or at least to Israel, where it’s based) but that’s for the FDA to sort out. As we’ve recently posted, private plaintiffs simply don’t have standing to raise FDCA violations that don’t also amount to traditional common-law claims − and the underground clinical trial allegations here aren’t even in the vicinity.
So the FDCA regulatory haze in Schiff is just that − a smokescreen of basically irrelevant allegations that do nothing but confuse and obfuscate the plaintiff’s common-law causes of action − or lack of same.
One of those other causes of action would seem to be informed consent. If, as plaintiff Schiff claims, she was not told the underlying medical risks and benefits of the surgery in question, then that would support a traditional informed consent action against the surgeon. Moreover, if the procedure in question was really “experimental” − in the sense that its risks and benefits were unknown − then the law requires patients to be told this fact. See Proposition 7. However, as the Pennsylvania Supreme Court has pointed out “the doctrine of informed consent is a limited one.” Valles, 805 A.2d at 1240 (quoting Duttry, 771 A.2d at 1258). Informed consent obligations are owed only by doctors, not by hospitals, and certainly not by manufacturers. See Proposition 6. The learned intermediary rule, at the heart of most of the cases in Proposition 3, limits a manufacturer’s informational obligations to warning the treating physicians. If those choose not to pass along information, that’s both their prerogative and their responsibility.
Thus, the apparent holding in Schiff III, 2012 WL 1971320, at *3, that some sort of “negligence” based warning claim (exactly what is never articulated) exists against the hospital IRB is simply contrary to Pennsylvania law governing the informed consent obligations of hospitals. The only negligence theory (we’ll put aside that “informed consent” in Pennsylvania sounds in battery, not negligence) that might even arguably exist to impose liability on a hospital for inadequate patient information would be under Friter, supra − that a hospital voluntarily agreeing to participate in an FDA-regulated clinical trial voluntarily assumes, and must perform reasonably, the informed consent obligations stated in FDA regulations. But the allegations in Schiff are antithetical to any Friter-based cause of action, since plaintiff asserts that the defendants sought to circumvent FDA clinical trial regulations, not follow them. Again, we’re left with a bare allegation that the hospital (and its IRB) should have complied with the FDCA, which must fail since it’s not “parallel” to any liability Pennsylvania law has ever recognized against a hospital.
Could there be a claim against the hospital in Schiff? It’s hard to tell, and we don’t have a lot of experience in this area, but IRBs are supposed to supervise clinical trials. To the extent plaintiff claims that she fell outside of the alleged study’s alleged protocol, well, at least compliance with protocol sounds like something that’s within the scope of an IRB’s supervisory duty. So maybe.
The departures from established Pennsylvania law are even worse in Schiff II, with its holding that the alleged FDCA violations somehow provide an informational claim that can bypass the learned intermediary rule, see 2012 WL 1828035 at *6 (“defendant was negligent for failing to follow FDA regulations regarding investigative devices and failing to properly test the . . . device”). We’ve already dealt with the non-existent “duty to test.” As for the rest, let’s be blunt. Once a physician/patient relationship is in place, for forty years Pennsylvania has not recognized any exception to the learned intermediary rule, not for pharmacists, not for contraceptives, and certainly not for clinical trials. Once again, there is no “parallel” direct-to-patient warning duty in Pennsylvania. It’s a bare FDCA violation claim that the plaintiff in Schiff has no standing to pursue.
What could conceivably be pursued, buried beneath all the FDA-related dross in the Schiff complaint, is a claim that the manufacturer withheld information about safety and effectiveness (or the lack of data supporting same) from the prescribing surgeon. That would state a claim under Pennsylvania law, but Schiff II wanders so far afield from anything recognizable as a Pennsylvania cause of action, that its hard to tell if a normal claim is even being alleged. Also, the plaintiff in Schiff asserts a breach of contract claim, that the manufacturer agreed to pay for certain things, and then didn’t. That could also be a viable claim, assuming the accuracy of the pleading (which is questionable).
Likewise, Schiff II purports to tease some sort of “strict liability” claim from the plaintiff’s FDCA-related allegations:
Plaintiff argues that, because the strict liability claim is based on more than a failure to warn theory, the claim is permitted to go forward. Plaintiff argues that the “risk of thermal injury rendered the device unsafe, defective and dangerous as well as [defendant manufacturer’s] failure to consider the factors set forth in the FDA Guidance Document on RF medical devices” also permits for recovery for strict liability. At the Motion to Dismiss phase, this Court finds that plaintiff has adequately pled a claim for strict liability.
2012 WL 1828035, at *5. We’ve read this quote several times, and it’s still so vague and garbled that we can’t even figure out what kind of strict liability (design, warning, manufacturing?) is at issue. Schiff II doesn’t mention design. It doesn’t mention manufacturing. But it nevertheless states that there’s something “more than a failure to warn.” But the only thing mentioned aside from an inherent risk (which can only be warned about – see Viguers, supra, for the proposition that inherent risks aren’t design defects), is the purported FDCA violation.
We do know this − Propositions 3 and 4. Strict liability does not exist in Pennsylvania in the context of medical procedures involving prescription medical products. That’s been the law, without exception (where the bar to strict liability has been asserted; we know a couple of cases where it wasn’t) in Pennsylvania since Incollingo in 1971. The absence of strict liability has been reaffirmed regularly by appellate courts applying Pennsylvania law. Indeed, the most significant pending controversy in prescription medical product liability litigation in Pennsylvania is whether a negligence claim exists for design defect. Even the very pro-plaintiff Lance decision (now before the Pennsylvania Supreme Court) agreed that no strict liability claim of any sort exists. The fight in Lance is solely over negligence.
And then there’s fraud/UTPCPL. As the abundant precedent cited in support of Proposition 5 holds, the Pennsylvania consumer fraud statute doesn’t apply to medical procedures of any sort or in product liability actions involving prescription medical products that physicians use in such procedures. But in all three Schiff decisions allow novel UTPCPL or fraud causes of action to proceed against persons against whom that such claims have never before been allowed − and once again, the bizarre FDCA violation claims are at the heart of the allegations. In Schiff I:
Here, [plaintiff] avers that confusion and deceptive conduct surrounded the affiliation, connection, and association [defendant surgeon] had with the [defendant manufacturer] and the “BodyTite Procedure” as well as Plaintiff’s lack of knowledge of the clinical trial involving the Invasix device. Furthermore . . . [the surgeon] allegedly failed to warn [plaintiff] of the potential dangers of the Invasix Device and, critically, allegedly misrepresented that the FDA approved, or was at least involved in the clinical trial, of the Invasix Device.
2012 WL 1355613, at *4 (emphasis added). The “critical” UTPCPL allegations − indeed the only facts actually cited − all have to do with the purported non-FDA clinical trial.
In Schiff II, instead of the UTPCPL, plaintiff alleged, and the opinion allowed, a “misrepresentation” claim where “some of the alleged misrepresentations were made regarding the classification of the device.” 2012 WL 1828035, at *7. There’s the FDA again. Once again, however, this claim is completely incompatible with controlling Pennsylvania law − our supreme court’s unanimous Southard decision cited in Proposition 7 above. There the court held:
[T]he FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery. The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results. The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure. It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed.
781 A.2d at 107 (emphasis added).
Need not be disclosed to the patient….
It’s safe to say that, as a matter of controlling Pennsylvania law, the supposed FDA “classification” of a regulated product “does not constitute a material risk” and “need not [be] disclose[d].” It’s hard to get clearer than Southard that “misrepresentations . . . regarding the classification of the device” are immaterial and cannot possibly be the subject of any viable fraud claim, since such information doesn’t have to be disclosed in the first place.
In Schiff III, once again, the UTPCPL allegations deemed most important are those involving the purported FDCA violations:
The Complaint further avers that [the IRB] engaged in unfair trade practices because the FDA had not given prior approval for [these] devices in . . . plastic surgery procedures. These facts, in addition to others in the Complaint, are sufficient to state a claim for unfair trade practices and negligence.
2012 WL 1971320, at *4.
But yet these FDCA violation allegation have no analogy in any legal claim recognized in Pennsylvania, given Proposition 5 − that the UTPCPL simply doesn’t apply to medical providers. Here, in a slightly different guise, we have the same bare FDCA regulatory violation (that private plaintiffs can’t pursue, Proposition 2) being passed off as something else, this time the violation of another statute. Plaintiff can’t do that either − it’s been tried. As the Third Circuit has held:
[Plaintiff’s] position would require us to usurp administrative agencies’ responsibility for interpreting and enforcing potentially ambiguous regulations. Jurisdiction for the regulation of OTC drug marketing is vested jointly and exhaustively in the FDA and the FTC. . . . and what the FD & C Act and the FTC Act do not create directly, the Lanham Act [a federal statute] does not create indirectly.
Sandoz Pharmaceuticals, 902 F.2d at 231 (cited in Proposition 2). In this respect, the UTPCPL as alleged in Schiff is no different than the Lanham Act claim alleged in Sandoz − both try to create forbidden private FDCA violation claims “indirectly” under cover of another statute.
So as we see it the FDCA-related allegations in the Schiff litigation about the purported surreptitious conduct of a clinical trial are both, (1) irrelevant, since there’s no FDCA-based cause of action paralleling any recognized claim under Pennsylvania law, and (2) immaterial, since the Pennsylvania Supreme Court has already held that FDA regulatory status is not information that need be disclosed to patients at all.
More fundamentally we believe that the repeated allowance of novel and often already-rejected supposed “Pennsylvania law” causes of action in Schiff needs to stop. That’s Proposition 8. Schiff is merely diversity-jurisdiction-based state-law litigation. The Supreme Court and the Third Circuit have repeatedly and vehemently held that federal courts just cannot do what’s been going on in Schiff − allowing novel theories of liability that state courts have not recognized.
[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.
Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).
A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.
Day & Zimmerman, 423 U.S. at 4 (1975).
Sheridan , 609 F.3d at 253.
As a federal court sitting in diversity, we are charged with predicting how another court – in this case, the [relevant state] Supreme Court – would rule on the record presented to us. . . . [I]n reaching our conclusion we have exercised restraint in accordance with the well-established principle that “where two competing yet sensible interpretations” of state law exist, “we should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the state] decides differently.” To hold here, as [plaintiff] urges. . . would undoubtedly subject manufacturers and dealers to greater liability. . . . Given the muddled state of [state] law on this point, we must decline [plaintiff’s] invitation.
Travelers Indemnity, 594 F.3d 238, 253 (3d Cir. 2010) (quoting Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002)).
[I]t is not the role of a federal court to expand state law in ways not foreshadowed by state precedent. Instead, a federal court follows the precedents of the state’s highest court and predicts how that court would decide the issue presented.
City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002).
In a diversity case . . . federal courts may not engage in judicial activism. Federalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law. . . . Our role is to apply the current law of the jurisdiction, and leave it undisturbed.
Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994) (quoting City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993)).
At bottom, Schiff doesn’t strike us as that hard or complicated of a case. There’s a question of whether the defendant adequately warned the prescribing surgeon of the risk (or perhaps of it’s unknown nature) that the plaintiff encountered. If not, did the surgeon already know the risk from his own clinical experience or elsewhere? Did the surgeon adequately pass along the relevant risks to the plaintiff as part of his informed consent discussion? If some sort of experimental surgery was involved, was plaintiff adequately informed by the surgeon that the relevant risks could not be accurately estimated on the basis of what was known? And if there was some sort of protocol-based investigation going on (whether FDA-authorized or not), did the defendant surgeon follow the protocol and inform the patient that she was being enrolled in such a study − and did the defendant IRB adequately ensure that study protocols were being followed? That’s it. That sounds like what Schiff was (or should be) about. The rest, all the regulatory brouhaha, is a smokescreen at best and an invitation to error at worst. Right now, it unfortunately appears that the invitation is being accepted. We hope that changes.