Opening Salvo In New FDA Attack On Off-Label Use?

There aren’t too many other blogs that we’d characterize as “essential” to what we do, but the FDA Law Blog is one of them (SCOTUSblog is another).  Yesterday’s post (emailed this morning) on the FDA Law Blog about a new draft FDA guidance concerning certain investigational in vitro diagnostic devices may seem arcane at first glance, but it describes an FDA regulatory departure with potentially far reaching implications – maybe even a renewed attack upon off-label use on a scope not seen since the nadir of the Kessler commissionership in the mid-1990s.


Here’s what’s up.  The FDA determines what’s "on" and "off-label" on the basis of a product’s “intended use.”  An ancient FDA regulation, substantively unchanged since the 1950s, defines “intended use” in terms of “objective intent” of the manufacturer:

The words intended uses or words of similar import . . . refer to the objective intent of the persons legally responsible for the labeling of devices.  The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.  It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. . . . But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

21 C.F.R. §801.4 (“Meaning of ‘Intended Uses’”) (emphasis added).  There’s an essentially identical definition of “intended use” for prescription drugs.  See 21 C.F.R. §201.128. Since the FDA’s new draft guidance concerns devices (see n.1), we’ll discuss it in those terms.

The literal terms of §804.1 could be read to render “adulterated” or “misbranded” any device simply because the manufacturer knew (or even more extreme, should have known (“knowledge of facts that would give him notice”)) that the doctor/hospital/etc. to which the device was sold was going to use it off-label.  Under the last sentence of §801.4, such knowledge could trigger an “adequate labeling for use” obligation as to the off-label use.

But not having the required “adequate labeling” would make the device “adulterated,” “misbranded,” etc.  And to complete the regulatory Catch 22 – the manufacturer can’t add the required labeling because, by definition, an off-label use hasn’t been approved by the FDA as “safe and effective,” which is a prerequisite to putting anything on the labeling about any use.  That’s the import of the first paragraph of regulatory gobbledygook under §III(B)(2) of the draft guidance.

Notwithstanding the literal terms of §801.4 (and §201.128), the FDA has never chosen to enforce them in such a restrictive fashion. Rather, as the FDA Law Blog points out, the FDA has a “well-established practice of determining intended use based on the manufacturer’s conduct, rather than how a customer uses a product.”

There are a variety of more or less formal FDA statements to that effect over the years (which we’ll leave to the FDA Law Blog to collect if they’re interested), but one practical aspect of this longstanding agency policy is the emphasis on off-label “promotion.”  If the FDA were to interpret §801.4 as broadly as it’s written, there would be no need to worry about “promotion” – mere knowledge would be enough to trigger enforcement.

And this new draft guidance would do exactly that.  Check out the second paragraph of §III(B)(2) – right after the gobbledygook – which changes the well established rules of the game:

In addition to overt expressions by the manufacturer such as those present in labeling and advertising [that is to say, “promotion”], intended use may be shown by the circumstances surrounding the distribution of the product6 and the manufacturer’s knowledge that its product is offered and used for a purpose for which it is neither labeled nor advertised. For example, FDA may consider a manufacturer’s knowledge of the purposes for which its customers offer and use its IVD product, and the manufacturer’s provision of technical support for those activities, to be evidence that the IVD product is intended to be used for such purposes. The weight of this evidence will vary with the circumstances.

(Emphasis added).  The FDA is basing “objective’ manufacturer intent on the actions, not of the manufacturer, but of its customers.

We usually omit footnotes, but we left in the FDA’s footnote 6 for a reason.  Any guesses as to what that’s a reference to?  Why §804.1, of course: “6See, e.g., 21 CFR 801.4.”  What’s more, the FDA purports to impose the most extreme knowledge standard – that enforcement could be based upon “[s]ales to clinical laboratories [that is to say, customers] that the manufacturer knows, or has reason to know, use the . . . product [off-label] in clinical diagnostic use.”  Draft guidance §III(B)(2), third and seventh bullet points (emphasis added)

So what’s a manufacturer of these devices supposed to do if it merely learns of an off-label use?  The FDA wants to order manufacturers to “halt” sales anytime that they learn that their customers intend to use the product off-label:

Manufacturers . . . should not sell such products to laboratories that they know use the product [off-label] for clinical diagnostic use. If a manufacturer learns that a laboratory to which it sells its RUO-labeled IVD product is using it in clinical diagnosis, it should halt such sales. . . .

Draft guidance §III(b)(3) (emphasis added)

Make no mistake about it, this draft guidance is a major departure from the FDA’s longstanding policy of regulating labeling based upon what’s actually in the label.  Again, we’ll defer to the regulatory expertise of the FDA Law bloggers:

However, FDA’s stance that . . . manufacturers must “halt” sales to a customer because its use of [a device] for diagnosis [an off-label use] is a major departure.  Moreover, FDA’s reliance on customer conduct to define intended use has implications for other products beyond those [in the draft guidance], by determining intended use through customer behavior, not manufacturer’s conduct.

Fortunately, as the FDA Law Blog points out, the draft guidance is subject to comments until August 30, 2011.  We’d recommend that any regulated entity – device, drug, whatever – weigh in if it’s in a position simply to know about off-label uses of its products.  Under the regulatory interpretation in this draft guidance, mere knowledge, even imputed "should have known" knowledge, would be enough for the FDA to come knocking.

This draft guidance regulating a small group of medical devices could well be the tip of a very long and painful spear, since the FDA could invoke the same definition of “intended use” to demand that any manufacturer halt sales to customers known (or allegedly that “should be known”) to engage in off-label use.

While the regulations read this way, the FDA hasn’t ever enforced them as written.  That alone may be enough.  Another FDA power grab failed in the face of decades of non-use of purported agency authority in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).

Finally, specifically with respect to devices, we think it's apt to call upon a 1997 amendment to the FDCA:

Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

21 U.S.C. §397 (emphasis added).

With respect to “devices” (there’s no statutory drug equivalent) query whether this new draft guidance is simply ultra vires in light of §397.  The effect of this new interpretation of §801.4 would certainly “limit or interfere with” off-label use by making it impossible for doctors to obtain the necessary products.  It’s stated in a mere "draft guidance," not in a “regulation” nor is it part of a device approval/clearance.  Nor does this unprecedented departure involve “promotion” – only mere knowledge, which would make resort to "promotion" unnecessary.  Finally under FDA v. Brown & Williamson, it’s questionable whether there’s even any “existing” FDA authority.

The Closing Of The Learned Intermediary Frontier

It was the last blank space on the legal map – the only state with no precedent whatsoever.  As we mentioned earlier in the week, Rhode Island has now fallen.  There now remains no state in the country totally without precedent concerning the learned intermediary rule.  Granted, for now it’s only an oral ruling in a transcript, but a federal judge has predicted that Rhode Island would join the overwhelming consensus of jurisdictions and follow the learned intermediary rule:

First of all, after the learned intermediary doctrine, that has been adopted by over two dozen jurisdictions and, I think, Rhode Island would adopt it as well.

I see nothing in Rhode Island case law, including the Castrugnano [sic, should be Castrignano] case, to suggest that Rhode Island would require direct patient warning in pharmaceutical drug cases.  Just because 4024 A [sic, should be 402A] of the second restatement says nothing about the learned intermediary doctrine doesn’t bother me.  There are a lot of states that adopted both.

If Rhode Island doesn’t accept the doctrine in the way that most courts have, then it’s likely it's going to look to the third restatement, which requires direct warnings when the manufacturer has reason to know that the health care provider will not be in a position to reduce the risk to the patient.

Unlike the mass inoculation vaccine scenario that the restatement mention in one of its comments, Zometa is a very serious therapy that is commenced after consultation with doctors. . . . As intended there Zometa is a type of drug learned intermediary doctrine encourages a doctor-patient dialogue.

Zometa does not fall within the exception of the restatement and I, therefore, find a direct warning to Mr. Hogan was not required.

Hogan v. Novartis Pharmaceuticals Corp., 06 CV 260, Trial Tr. (5/23/11), at 387-88 (E.D.N.Y.).  The same court had discussed the learned intermediary rule with approval, but avoided a direct ruling, in Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9 (E.D.N.Y. April 24, 2011).

Given that there is no longer any untamed legal frontier (the effort now shifts to whether appellate courts might change existing precedent), this seems like a good time to review the positions and precedents of the various states with respect to the learned intermediary rule.  In doing this, we’ll be combining three prior lists. The main count, of course, will be the learned intermediary rule itself, but we’ll also add, because we have the data available, whether the state has:  (1) applied the learned intermediary rule in medical device cases, and (2) applied the rule to protect pharmacists from direct-to-consumer warning claims.

Here goes:

There are, by our count, thirty-four states and the District of Columbia, in which the learned intermediary rule has been adopted either by the jurisdiction’s highest court or by statute (which we consider equally authoritative). These are:

Alabama

Nail v. Publix Super Markets, Inc., ___ So.3d ___, 2011 WL 1820087, at *6-7 (Ala. May 13, 2011) (applied to pharmacists); Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513, 517-18 (Ala. 2008) (applied to pharmacists); Walls v. Alpharma USPD, 887 So.2d 881, 883 (Ala. 2004) (applied to pharmacists); Morguson v. 3M Corp., 857 So.2d 796. 801-02 (Ala. 2003) (applied to medical devices); Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1305 (Ala. 1984).

Alaska

Shanks v. Upjohn Co., 835 P.2d 1189, 1200 & n.17 (Alaska 1992). There’s no precedent in Alaska (that we know of) concerning medical devices or pharmacists and the learned intermediary rule.

Arkansas

Kowalski v. Rose Drugs of Dardanelle, Inc., ___ S.W.3d ___, 2011 WL 478601, at *?? (Ark. Feb. 9, 2011) (applied to pharmacists); West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991).  At one time, the Arkansas Supreme Court applied the rule to a medical device in Despain v. Bradburn, 2008 WL 324356 (Ark. Feb. 7, 2008), but rehearing was granted on other grounds (preemption), and the Despain opinion no longer exists. There’s no other Arkansas precedent that we know of that addresses the rule in medical device cases.

California

Carlin v. Superior Court, 920 P.2d 1347, 1354 (Cal. 1996); Brown v. Superior Court, 751 P.2d 470, 477 n.9 (Cal. 1988); Stevens v. Parke, Davis & Co., 507 P.2d 653, 660 (Cal. 1973).  In Murphy v. E.R. Squibb & Sons, Inc., 710 P.2d 247, 250-53 (Cal. 1985), the California Supreme Court exempted pharmacists from duty to warn liability, but without specifically mentioning the rule.  A raft of California intermediate appellate decisions applies the learned intermediary rule to medical devices.  Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 262 (Cal. App. 1999); Evraets v. Intermedics Intraocular, Inc., 34 Cal. Rptr.2d 852, 860 (Cal. App. 1994); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 818-19 (Cal. App. 1992); Hufft v. Horowitz, 5 Cal. Rptr.2d 377, 385 n.14 (Cal. App. 1992); Rosburg v. Minnesota Mining & Manufacturing Co., 226 Cal. Rptr. 299, 305 (Cal. App. 1986).

Connecticut

Hurley v. Heart Physicians, P.C., 3 A.3d 892, 899-900 (Conn. 2010) (applied to medical device); Hurley v. Heart Physicians, P.C., 898 A.2d 777, 783-84 (Conn. 2006) (applied to medical device); Vitanza v. Upjohn Co., 778 A.2d 829, 836-38 (Conn. 2001).  A combination of state and federal trial courts has applied the learned intermediary rule to pharmacists.  Levesque v. Cluett, 2007 WL 4305676, at *3 (Conn. Super. Oct. 16, 2007); Deed v. Walgreen Co., 927 A.2d 1001, 1003-04 (Conn. Super. 2007); Plante v. Lomibiao, 2005 WL 1090180, at *3-4 (Conn. Super. Mar. 31, 2005); Deed v. Walgreen Co., 2004 WL 2943271, at *5 (Conn. Super. Nov. 15, 2004); White v. Stop & Shop Cos., 1998 WL 559730, at *2 (D. Conn. Aug. 17, 1998).

Delaware

Lacy v. G.D. Searle & Co., 567 A.2d 398, 400-01 (Del. 1989) (applied to medical device). We don’t know of Delaware law concerning the rule and pharmacists.

District of Columbia

Mampe v. Ayerst Laboratories, 548 A.2d 798, 801 & n.6 (D.C. 1988).  In Raynor v. Richardson-Merrell, Inc., 643 F. Supp. 238, 246-47 (D.D.C. 1986), and Ealy v. Richardson-Merrell, Inc., 1987 WL 159970, at *2-3 (D.D.C. Jan. 12, 1987), federal district courts held that the rule precluded pharmacist liability. We don’t think there’s been a medical device/learned intermediary rule case in DC yet.

Florida

E.R. Squibb & Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997); Upjohn Co. v. MacMurdo, 562 So.2d 680, 683 (Fla. 1990); Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla. 1989).  In McLeod v. M.S. Merrell Co., 174 So.2d 736, 738-39 (Fla. 1965), the Florida Supreme Court exempted pharmacists from duty to warn liability, but without specifically mentioning the rule.  A bunch of federal district courts have applied the learned intermediary rule to medical devices under Florida law – these are just the published ones.  Wolicki-Gables v. Arrow International, Inc., 641 F. Supp.2d 1270, 1286-87 (M.D. Fla. 2009), aff’d on other grounds, 634 F.3d 1296 (11th Cir. 2011); Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1367-68 (S.D. Fla. 2007); Alexander v. Danek Medical, Inc., 37 F. Supp.2d 1346, 1350 (M.D. Fla. 1999); Baker v. Danek Medical, Inc., 35 F. Supp.2d 875, 881 (N.D. Fla. 1998); Savage v. Danek Medical, Inc., 31 F. Supp.2d 980, 984 (M.D. Fla.), aff’d mem., 202 F.3d 288 (11th Cir. 1999); Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511, 1517-18 (S.D. Fla. 1990); Amore v. G.D. Searle & Co., 748 F. Supp. 845, 849-50 (S.D. Fla. 1990).

Georgia

McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003) (applied to medical device).  Georgia appellate courts have also barred claims against pharmacists.  Nail v. State, 686 S.E.2d 483, 485-86 (Ga. App. 2009); Chamblin v. K-Mart Corp., 612 S.E.2d 25, 28-29 (Ga. App. 2005); Walker v. Jack Eckerd Corp., 434 S.E.2d 63, 67-69 (Ga. App. 1993).

Hawaii

Craft v. Peebles, 893 P.2d 138, 155 (Hawaii 1995) (applied to medical device).  We haven’t seen any pharmacy liability cases out of Hawaii.

Illinois

Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118, 1127 (Ill. 2002) (applied to pharmacists); Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35, 42 (Ill. 2002) (applied to medical device); Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 354 (Ill. 1996); Frye v. Medicare-Glaser Corp., 605 N.E.2d 557, 559-61 (Ill. 1992) (applied to pharmacists); Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387, 393 (Ill. 1987).  The Seventh Circuit recently ordered federal courts to respect Illinois’ application of the learned intermediary rule to pharmacists.  Walton v. Bayer Corp., ___ F.3d ___, 2011 WL 1938428, at *5-6 (7th Cir. May 23, 2011).

Kansas

Savina v. Sterling Drug, Inc., 795 P.2d 915, 928 (Kan. 1990); Humes v. Clinton, 792 P.2d 1032, 1039-40 (Kan. 1990) (applied to medical device); Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1227-28 (Kan. 1987) (applied to medical device); Johnson v. American Cyanamid Co., 718 P.2d 1318, 1324 (Kan. 1986); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1052 (Kan. 1984).  In Nichols v. Central Merchandise, 817 P.2d 1131, 1133 (Kan. App. 1991), the court barred pharmacist claims.

Kentucky

Hyman & Armstrong, P.S.C. v. Gunderson, 279 S.W.3d 93, 109-110, 112 (Ky. 2008); Larkin v. Pfizer, Inc., 153 S.W.3d 758, 761 (Ky. 2004) (dictum also extends rule to medical devices).  Several Kentucky federal courts have barred pharmacist claims under the rule.  Flint v. Target Corp., 2009 WL 87469, at *3-4 (W.D. Ky. Jan. 13, 2009), aff’d, 362 Fed. Appx. 446 (6th Cir. 2010); Smith v. Wyeth Inc., 488 F. Supp.2d 625, 628-29 (W.D. Ky. 2007); Foister v. Purdue Pharma, L.P., 295 F. Supp.2d 693, 706 (E.D. Ky. 2003).

Maryland

Rite Aid Corp. v. Levy-Gray, 894 A.2d 563, 577 (Md. 2006); Nolan v. Dillon, 276 A.2d 36, 40 (Md. 1971).  Under Maryland law, a federal court of appeals applied the rule to pharmacists, Hofherr v. Dart Industries, Inc., 853 F.2d 259, 263 (4th Cir. 1988), and a couple of federal courts apply the rule to medical devices.  Miller v. Bristol-Myers Squibb Co., 121 F. Supp.2d 831, 838 (D. Md. 2000); Lee v. Baxter Healthcare Corp., 721 F. Supp. 89, 95 (D. Md. 1989), aff’d, 898 F.2d 146 (4th Cir. 1990).

Massachusetts

Coombes v. Florio, 877 N.E.2d 567, 577 n.1 (Mass. 2007); Cottam v. CVS Pharmacy, 764 N.E.2d 814, 820 (Mass. 2002) (applied to pharmacists); MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65, 68 (Mass. 1985).  A federal court applied the rule to a medical device in Lareau v. Page, 840 F. Supp. 920, 933 (D. Mass. 1993), aff’d, 39 F.3d 384 (1st Cir. 1994), as has a state trial court.  Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569, at *6-7 (Mass. Super. Sept. 24, 2004).

Michigan

In Smith v. E.R. Squibb & Sons, Inc., 273 N.W.2d 476, 479 (Mich. 1979), the Michigan Supreme Court relied on the learned intermediary rule, but a later decision called that “dictum.”   In re Certified Questions, 358 N.W.2d 873, 877 (Mich. 1984).  We count it, because the Smith rule has been followed by appellate courts applying Michigan law.  Mowery v. Crittenton Hospital, 400 N.W.2d 633, 637 (Mich. App. 1986); King-Washington v. Eli Lilly & Co., 394 Fed. Appx. 827, 828-29 (2d Cir. 2010) (applying Michigan law).  The rule was applied to medical devices in Brown v. Drake-Willock International, Ltd., 530 N.W.2d 510, 516 (Mich. App. 1995), and to pharmacists in several cases.  Adkins v. Mong, 425 N.W.2d 151, 152-54 (Mich. App. 1988); Stebbins v. Concord Wrigley Drugs, Inc., 416 N.W.2d 381, 386-88 (Mich. App. 1987); Lemire v. Garrard Drugs, 291 N.W.2d 103, 105 (Mich. App. 1980).

Minnesota

Mulder v. Parke Davis & Co., 181 N.W.2d 882, 885 n.1 (Minn. 1970).  Lots of federal courts apply the rule to medical devices.  Wehner v. Linvatech Corp., 2008 WL 495525, at *4 (D. Minn. Feb. 20, 2008); Johnson v. Zimmer, Inc., 2004 WL 742038, at *9 (D. Minn. March 31, 2004); In re Orthopedic Bone Screw Litigation, 1999 WL 628688, at *14 (D. Minn. March 8, 1999), aff’d mem., 221 F.3d 1343 (8th Cir. 2000); Bruzer v. Danek Medical, Inc., 1999 WL 613329, at *6 (D. Minn. March 8, 1999); Greiner v. Sofamor, S.N.C., 1999 WL 716891, at *5 (D. Minn. March 8, 1999); Mozes v. Medtronic, Inc., 14 F. Supp.2d 1124, 1130 (D. Minn. 1998); Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1305-06 (D. Minn. 1988).  We don’t know of any Minnesota pharmacy cases involving the rule.

Mississippi

The Mississippi Supreme Court has consistently followed the rule.  Janssen Pharmaceutica, Inc. v. Bailey, 878 So.2d 31, 57 (Miss. 2004); Moore v. Memorial Hospital, 825 So.2d 658, 664 (Miss. 2002) (applied to pharmacist); Bennett v. Madakasira, 821 So.2d 794, 804 (Miss. 2002); Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 691-92 (Miss. 1988).  The legislature has also imposed the rule by statute to both drugs and medical devices. Miss. Code §11-1-63(c)(ii).

Missouri

Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 146-47 (Mo. 1967).  A federal appellate court applied the rule to medical devices.  Kirsch v. Picker International, Inc., 753 F.2d 670, 67 (8th Cir. 1985).  An intermediate appellate court allowed pharmacy liability despite the rule.  Horner v. Spalitto, 1 S.W.3d 519, 522 (Mo. App, 1999).

Montana

Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244, 257-60 (Mont. 2010); Hill v. Squibb & Sons, 592 P.2d 1383, 1387-88 (Mont. 1979).  We don’t know of any Montana cases involving the rule and either medical devices or pharmacists.

Nebraska

Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 841-42 (Neb. 2000).  In Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *13-14 (D. Neb. Aug. 16, 1999), the rule was applied to a medical device.  We don’t know of any Nebraska learned intermediary cases involving pharmacists.

Nevada

Nevada’s a little strange.  In Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994), both the plurality (2 justices) and the dissent (2 more justices) followed the learned intermediary rule.  The plurality held that the “mass immunization” exception to the rule applied to the case.

[W]e do not believe that [the prescriber’s] advice . . . that “it was time” for [plaintiff] to receive his MMR II vaccine is the type of individualized medical judgment contemplated by the learned intermediary defense. . . . Accordingly, the mass immunization exception does apply to this case.

Id. at 958 n.16.  As the plurality indicates, the Allison dissent believed that no exception to the rule applied.  Id. at 969 (a manufacturer “should not be held liable simply because the learned intermediary failed to perform his duty to warn his patient”).  No justice in Allison rejected the rule itself.  Without mentioning the rule, the Nevada Supreme Court barred pharmacist liability in Sanchez v. Wal-Mart Stores, Inc., 221 P.3d 1276, 1280-84 (Nev. 2009).  The rule was applied to a medical device in Moses v. Danek Medical, Inc., 1998 WL 1041279, at *5 (D. Nev. Dec. 11, 1998).  In light of Allison, we think the trial order in Chanin v. Teva Parenteral Medicines, Inc., 2010 WL 1846579 (Nev. Dist. April 6, 2010), is simply wrong.

New Jersey

The learned intermediary rule is required by statute in New Jersey.  N.J. Stat. §2A:58C-4.  The Supreme Court also follows the rule.  Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245, 1257 (N.J. 1999) (addressing rule where the product “exhibit[ed] characteristics both of a medical device implanted in the body and of a drug”); Niemiera v. Schneider, 555 A.2d 1112, 1117 (N.J. 1989).  We don’t know of any New Jersey pharmacist/learned intermediary rule cases.

New York

Spensieri v. Lasky, 723 N.E.2d 544, 549 (N.Y. 1999); Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993).  Several New York intermediate courts have applied the rule to medical devices, Mulhall v. Hannafin, 841 N.Y.S.2d 282, 285 (N.Y.A.D. 2007); Banker v. Hoehn, 718 N.Y.S.2d 438, 440-41 (N.Y.A.D. 2000); Bukowski v. CooperVision Inc., 592 N.Y.S.2d 807, 809 (N.Y.A.D. 1993), and to pharmacies.  In re New York County Diet Drug Litigation, 691 N.Y.S.2d 501, 502 (N.Y.A.D. 1999); Bichler v. Willing, 397 N.Y.S.2d 57, 58-59 (N.Y.A.D. 1977).  Federal appellate authority also applies the rule to medical devices.  Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75 (2d Cir. 1993); Fane v. Zimmer, Inc., 927 F.2d 124, 129-30 (2d. Cir. 1991).

North Carolina

A statute applies the learned intermediary rule to drugs and medical devices.  N.C. Gen. Stat. §99B-5(c).  A North Carolina appellate court rejected pharmacist liability in Batiste v. American Home Products Corp., 231 S.E.2d 269, 274-76 (N.C. App. 1977).

Ohio

A statute applies the learned intermediary rule to drugs.  Ohio Rev. Code §2307.76(c); accord Howland v. Purdue Pharma, L.P., 821 N.E.2d 141, 146 (Ohio 2004); Wagner v. Roche Laboratories, 671 N.E.2d 252, 256 (Ohio 1996); Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875, 876, 878 (Ohio 1991); White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 755 (Ohio 1988); Seley v. G.D. Searle & Co., 423 N.E.2d 831, 834, 836-37 (Ohio 1981).  The Ohio Supreme Court held that the rule also applies to medical devices.  Vaccariello v. Smith & Nephew Richards, Inc., 763 N.E.2d 160, 164 (Ohio 2002).  We don’t know of any Ohio law on pharmacists and the learned intermediary rule.

Oklahoma

Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300-01 (Okla. 1997) (applied to medical device); Tansy v. Dacomed Corp., 890 P.2d 881, 886 (Okla. 1994) (applied to medical device); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla. 1974). We haven’t seen any Oklahoma law on pharmacists and the learned intermediary rule.

Oregon

Oksenholt v. Lederle Laboratories, 656 P.2d 293, 296-97 (Or. 1982); Vaughn v. G.D. Searle & Co., 536 P.2d 1247, 1247-48 (Or. 1975); McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974).  In Griffith v. Blatt, 51 P.3d 1256, 1262 (Or. 2002), the court indicated that the rule may be statutorily limited in strict liability actions.  In Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1147-48 (D. Or. 1989), the court applied the rule to a medical device.

Pennsylvania

Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385 (Pa. 1991) (applied to pharmacist); Baldino v. Castagna, 478 A.2d 807, 812 (Pa. 1984); Incollingo v. Ewing, 282 A.2d 206, 220 & n.8 (Pa. 1971).  Creazzo v. Medtronic, Inc., 903 A.2d 24, 31-32 (Pa. Super. 2006), applied the rule to medical devices, as have several federal district courts.  Parkinson v. Guidant Corp., 315 F. Supp.2d 741, 749 (W.D. Pa. 2004); Burton v. Danek Medical, Inc., 1999 WL 118020, at *7 (E.D. Pa. March 1, 1999); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *8-9 (E.D. Pa. Dec. 29, 1998).

South Carolina

Madison v. American Home Products Corp., 595 S.E.2d 493, 496 (S.C. 2004) (applied to pharmacist).  Federal appellate courts applied the rule to medical devices in Odom v. G.D. Searle & Co., 979 F.2d 1001, 1004 (4th Cir. 1992), and Brooks v. Medtronic Inc., 750 F.2d 1227, 1231 (4th Cir. 1984).

Tennessee

Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994).  A federal appellate court applied the rule to a medical device in Jacobs v. E.I. Du Pont Nemours & Co., 67 F.3d 1219, 1238-1239 (6th Cir. 1995), as did an intermediate appellate court in King v. Danek Medical, Inc., 37 S.W.3d 429, 452-53 (Tenn. App. 2000).  We don’t know of any Tennessee learned intermediary law concerning pharmacists.

Utah

Downing v. Hyland Pharmacy, 194 P.3d 944, 946-47 (Utah 2008) (applied to pharmacist); Schaerrer v Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 928-29 (Utah 2003) (applied to pharmacist); Barson v. E.R. Squibb & Sons, Inc., 682 P.2d 832, 835 (Utah 1984).  A federal appellate court applied the rule to a medical device in Tingey v. Radionics, 193 Fed. Appx. 747, 757 n.4 (10th Cir. 2006).

Virginia

Pfizer, Inc. v. Jones, 272 S.E.2d 43, 44 (Va. 1980).  A federal appellate court applied the rule to a medical device in Talley v. Danek Medical, Inc., 179 F.3d 154, 162-63 (4th Cir. 1999).  A Virginia trial court rejected pharmacy liability in Gressman v. Peoples Service Drug Stores, Inc., 1988 WL 619115, at *6-8 (Va. Cir. 1988).

Washington

Washington State Physicians Insurance Exchange & Ass’n v. Fisons Corp., 858 P.2d 1054, 1061 (Wash. 1993); Rogers v. Miles Laboratories, Inc., 802 P.2d 1346, 1353 (Wash. 1991); McKee v. American Home Products Corp., 782 P.2d 1045, 1149-50 (Wash. 1989); Terhune v. A.H. Robbins Co., 577 P.2d 975, 978 (Wash. 1978) (applied to medical device).  We don’t know of any Washington pharmacist cases.

Wyoming

Rohde v. Smiths Medical, 165 P.3d 433, 438 (Wyo. 2007) (applied to medical device).  Federal appellate courts have applied the rule to drugs.  Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 851-53 (10th Cir. 2003); Haste v. American Home Products Corp., 577 F.2d 1122, 1125 (10th Cir.1978).  There aren’t any Wyoming pharmacist cases that we know of.

* * * *

There are two other states where the state’s highest court has adopted the learned intermediary rule in a non-prescription medical product context.  That raises the total of high court/statutory states to 36 (plus DC).  One of them has lots of other precedent, the other none.  These are:

Idaho

Sliman v. Aluminum Company of America, 731 P.2d 1267, 1270 (Idaho 1986).  There are no other learned intermediary rule cases under Idaho law.

Texas

The Texas Supreme Court has applied the learned intermediary rule twice in non-prescription medical product cases.  Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 190-91 (Tex. 2004); Alm v. Aluminum Company of America, 717 S.W.2d 588, 591-92 (Tex. 1986).  Texas intermediate appellate courts have repeatedly applied the learned intermediary rule.  Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 502-03 (Tex. App. 2010); Ethicon Endo-Surgery, Inc. v. Meyer, 249 S.W.3d 513, 516 (Tex. App. 2007) (applied to medical device); Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 461-462 (Tex. App. 2000) (applied to pharmacist); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App. 2000); Guzman v. Synthes (USA), 20 S.W.3d 717, 720 n.2 (Tex. App. 1999) (applied to medical device); Bean v. Baxter Healthcare Corp., 965 S.W.2d 656, 662 (Tex. App. 1998) (applied to medical device); Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 609 (Tex. App. 1993); Stewart v. Janssen Pharmaceutica, Inc., 780 S.W.2d 910, 911 (Tex. App. 1989); Cooper v. Bowser, 610 S.W.2d 825, 831 (Tex. Civ. App. 1980); Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex. Civ. App. 1973).  So have the federal appellate courts.  Pustejovsky v. Pliva, Inc., 623 F.3d 271, 276 (5th Cir. 2010); Ebel v. Eli Lilly & Co., 321 Fed. Appx. 350, 355-56 (5th Cir. 2009); Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 207-08 (5th Cir. 2008); McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006); Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999) (applied to medical device); Wimm v. Jack Eckerd Corp., 3 F.3d 137, 142 (5th Cir. 1993) (applied to pharmacist); Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 (5th Cir. 1992); Hurley v. Lederle Laboratories, 863 F.2d 1173, 1178 (5th Cir. 1988); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974).   We’re also watching two current appeals pending in the Texas Supreme Court that raise learned intermediary issues.

* * * *

One state’s highest court has rejected the learned intermediary rule.

West Virginia

Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 913-14 (W. Va. 2007).  West Virginia has a statute that, regardless of learned intermediary rule issues, bars claims against pharmacists.  W. Va. Code §30-5-2; see Vagenos v. Alza Corp., 2010 WL 2944683, at *3-5 (S.D.W. Va. July 23, 2010).

* * * *

Another five states have intermediate (but not highest) appellate authority following the learned intermediary rule.

Arizona

Piper v. Bear Medical Systems, Inc., 883 P.2d 407, 415 (Ariz. App. 1993) (applied to medical device); Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978) (applied to medical device); Dyer v. Best Pharmacal, 577 P.2d 1084, 1087 (Ariz. App. 1978).  Federal appellate decisions have also applied the rule. King-Washington v. Eli Lilly & Co., 394 Fed. Appx. 827, 828-29 (2d Cir. 2010) (applying Arizona law); Head v. Eli Lilly & Co., 394 Fed. Appx. 819, 820 (2d Cir. 2010) (applying Arizona law); Gove v. Eli Lilly & Co., 394 Fed. Appx. 817, 818 (2d Cir. 2010) (applying Arizona law). We don’t know of any pharmacist cases in Arizona.

Colorado

O’Connell v. Biomet, Inc., ___ P.3d ___, 2010 WL 963234, at *2-4 (Colo. App. March 18, 2010) (applied to medical device); Hamilton v. Hardy, 549 P.2d 1099, 1110 (Colo. App. 1976). Nor do we know of any pharmacist cases in Colorado.

Indiana

Allberry v. Parkmor Drug, Inc., 834 N.E.2d 199, 202-03 (Ind. App. 2005) (applied to pharmacist); Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992) (applied to pharmacist); Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881, 886-87 (Ind. App. 1985) (applied to pharmacist); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548-59 (Ind. App. 1979).  Federal appellate decisions also apply the rule. Ziliak v. Astra Zeneca, 324 F.3d 518, 521 (7th Cir. 2003); Phelps v. Sherwood Medical Industries, 836 F.2d 296, 301-303 (7th Cir. 1987) (applied to medical device).

Louisiana

There is lot of Louisiana intermediate appellate authority applying the rule.  Kampmann v. Mason, 921 So.2d 1093, 1094 (La. App. 2006); Marks v. Ohmeda, Inc., 871 So.2d 1148, 1157 (La. App. 2004) (applied to medical device); David v. Our Lady of Lake Hospital, Inc., 857 So. 2d 529, 532 (La. App. 2003); Brown v. Glaxo, Inc., 790 So.2d 35, 38 (La. App. 2000); Calhoun v. Hoffman-LaRoche, Inc., 768 So.2d 57, 61 (La. App. 2000); Guillory v. Doctor X, 679 So.2d 1004, 1010 (La. App. 1996) (applied to pharmacist); Mikell v. Hoffman-LaRoche, Inc., 649 So.2d 75, 79-80 (La. App. 1994); Gassen v. East Jefferson General Hospital, 628 So.2d 256, 258-59 (La. App. 1993) (applied to pharmacist); Rhoto v. Ribando, 504 So.2d 1119, 1123 (La. App. 1987); Kinney v. Hutchinson, 468 So.2d 714, 717 (La. App. 1985) (applied to pharmacist); Cobb v. Syntex Laboratories, Inc., 444 So.2d 203, 205-06 (La. App. 1983).  Ditto for federal appellate courts.  Hall v. Elkins Sinn, Inc., 102 Fed. Appx. 846, 849-50 (5th Cir. 2004); Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 265-266 (5th Cir. 2002); Grenier v. Medical Engineering Corp., 243 F.3d 200, 205 n.14 (5th Cir. 2001) (applied to medical device); Theriot v. Danek Medical, Inc., 168 F.3d 253, 255 (5th Cir. 1999) (applied to medical device); Willett v. Baxter International, Inc., 929 F.2d 1094, 1098-1099 (5th Cir. 1991) (applied to medical device).

New Mexico

Serna v. Roche Laboratories, Division of Hoffman-LaRoche, Inc., 684 P.2d 1187, 1189 (N.M. App. 1984); Jones v. Minnesota Mining & Manufacturing Co., 669 P.2d 744, 748 (N.M. App. 1983) (applied to medical device); Perfetti v. McGahn Medical, 662 P.2d 646, 650 (N.M. App. 1983) (applied to medical device); Richards v. Upjohn Co., 625 P.2d 1192, 1195 (N.M. App. 1980); Hines v. St. Joseph’s Hospital, 527 P.2d 1075, 1077 (N.M. App. 1974).  We don’t know of any New Mexico pharmacist cases.

* * * *

In addition to the 41 states where there is state appellate authority supporting the learned intermediary rule, federal courts predicting state law have forecast the adoption of the learned intermediary rule in seven more states – and Puerto Rico.  Four of these states (and PR) involve court of appeals authority.

Iowa

Petty v. United States, 740 F.2d 1428, 1440 (8th Cir. 1984); Madsen v. American Home Products Corp., 477 F. Supp.2d 1025, 1033-34 (E.D. Mo. 2007) (applying Iowa law).  We don’t know of any pharmacist or medical device cases from Iowa.

Maine

Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 (1st Cir. 1995) (applied to medical device); Doe v. Solvay Pharmaceuticals, Inc., 350 F. Supp.2d 257, 270-71 (D. Me. 2004), aff’d, 153 Fed. Appx. 1 (1st Cir. 2005); Herzog v. Arthrocare Corp., 2003 WL 1785795, at *8 (D. Me. March 21, 2003) (applied to medical device).  In Tardy v. Eli Lilly & Co., 2004 WL 1925536, at *2-3), a state trial court applied the rule to bar claims against a pharmacist.

New Hampshire

Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 656 (1st Cir. 1981); McCue v. Norwich Pharmacal Co., 453 F.2d 1033, 1035 (1st Cir. 1972); Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 135, 145-46 (D. N.H. 2010); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *5-6 (D.N.H. Sept. 14, 2010); Nelson v. Dalkon Shield Claimants Trust, 1994 WL 255392, at *4 (D.N.H. June 8, 1994) (applied to medical device); Dupre v. G.D. Searle & Co., 1987 WL 158107, at *4 (D.N.H. April 28, 1987) (applied to medical device). We’re unaware of pharmacist cases from New Hampshire.

North Dakota

Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1017 (8th Cir. 2004); Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *4 n.4 (D.N.D. Sept. 5, 2000).  We don’ t now of any medical device or pharmacist cases from North Dakota.

Puerto Rico

Guevara v. Dorsey Laboratories, Division of Sandoz, Inc., 845 F.2d 364, 366 (1st Cir. 1988); Rivera-Adams v. Wyeth, 2010 WL 5072541, at *3 (D.P.R. Dec. 8, 2010); Pierluisi v. E.R. Squibb & Sons, Inc., 440 F. Supp. 691, 694-95 (D.P.R. 1977). We’re not aware of medical device or pharmacy cases from Puerto Rico.

Rhode Island

Hogan v. Novartis Pharmaceuticals Corp., 06 CV 260, Trial Tr. (5/23/11), at 387-88 (E.D.N.Y.) (applying Rhode Island law); see Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9 (E.D.N.Y. April 24, 2011) (discussing rule with approval) (applying Rhode Island law). Obviously, we don’t know of any pharmacist or medical device cases from Rhode Island.

South Dakota

Schilf v. Eli Lilly & Co., 2010 WL 4024922 (D.S.D. Oct. 13, 2010); McElhaney v. Eli Lilly & Co., 575 F. Supp. 228, 231 (D.S.D. 1983), aff’d, 739 F.2d 340 (8th Cir. 1984); Yarrow v. Sterling Drug, Inc., 263 F. Supp. 159, 162 (D.S.D. 1967), aff’d, 408 F.2d 978 (8th Cir. 1969).  They’re all drug cases. We’re not aware of any South Dakota medical device or pharmacist cases.

Wisconsin

Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830 (N.D. Ind. 1999) (applied to medical device) (applying Wisconsin law); Monson v. AcroMed Corp., 1999 WL 1133273, at *20 (E.D. Wis. May 12, 1999) (applied to medical device); Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 963 (D. Wis. 1981), modified on other grounds, 523 F. Supp. 206 (D. Wis. 1981).  We don’t know of any Wisconsin pharmacist cases.

* * * *

That’s 48 states, plus DC and PR, following the learned intermediary rule.  The one remaining state has a trial court case, and nothing else (that we know) applying the rule.

Vermont

Estate of Baker v. University of Vermont, 2005 WL 6280644 (Vt. Super. May 5, 2005) (applied to pharmacist).

* * * *

That’s 49 (+DC/PR) up and one down as of now – aside from the occasional trial court decision attempting to deny appellate reality.  The learned intermediary frontier has closed.

While Plaintiff Slept, Learned Intermediary Got a Re-affirming Wake Up

For my first venture in blogging, I bring you a sweet learned intermediary victory made all the sweeter by the opposition’s falling asleep at the switch – Dykes v. Johnson & Johnson, 2011 U.S. Dist. LEXIS 55138 (E.D. La. May 20, 2011) – a win/win in our book. 

First, a little background:  plaintiff underwent a hysterectomy during which her surgeon used a medical product (an absorbable hemostat) to help control bleeding.  A few days later plaintiff claimed she suffered an inflammatory response wherever the hemostat had touched her body (described as a poison ivy type reaction in the bowel area).  Clearly not a pleasant experience for plaintiff, but a risk both known in the medical community (her surgeon learned about foreign body reactions in medical school) and warned about by the manufacturer in the package insert:

PRECAUTIONS:  Use only as much SURGICEL Hemostat as is necessary. . . .  Remove any excess before surgical closure in order to . . . minimize the possibility of foreign body reaction.

ADVERSE REACTIONS:  Encapsulation of fluid and foreign body reactions have been reported. 

Id. at 4.  Can’t get much plainer than that.

But, I’m getting ahead of myself.

The devil was in the procedure.  After the case had sat around for seven months, the court entered a scheduling order allowing nine more months for discovery.  So, what did plaintiff’s counsel do for those 9 months – nothing!  No interrogatories.  No document requests.  No noticing depositions.  Not even hiring an expert to opine on the adequacy of the warning.  Id. at 14-15.

Finally, when the defendant deposed the surgeon who performed plaintiff’s hysterectomy – the key deposition of the whole case – plaintiff’s counsel failed to ask THE question:  whether the manufacturer’s warning would have been adequate to inform her of the risk.  See fn. 1.

It gets worse.  Three months before the close of discovery, plaintiff’s counsel told the judge that discovery was proceeding without problem.  Id. at 5.  That’s probably true, since if nothing’s happening, then there probably aren’t any problems.  We should all be so lucky to get this much help from opposing counsel.

Then, the inevitable happened.  Defendants filed a motion for summary judgment.  At that point plaintiff woke up, and sought a trial continuance on the grounds that more (any?) discovery was needed.  Win #1 – Kudos to the court for denying the continuance request, holding: 

The fact that the motion to continue was denied should not have come as any surprise to plaintiff; counsel will not be rewarded for such dilatory trial preparation with a fishing expedition as this juncture.

Id. at 15. 

Win # 2 – summary judgment granted because plaintiff could not satisfy either prong of Louisiana’s two-prong test for proving an inadequate warning claim in a learned intermediary case.  First, was the physician inadequately warned? If so, second, was that inadequacy both the cause in fact and the proximate cause of plaintiff’s injury?  Id. at 10.  As to adequacy, Louisiana (like most places) looks to the testimony of the prescribing physician, who here acknowledged that she was aware of the risk since medical school and that the package insert did include a warning.

Q:  “Certainly the package insert does indicate a warning of foreign body reactions, right?”

A:  “Right, yeah.”

Plaintiff had not bothered to probe this testimony at the deposition.  She also failed to offer any expert testimony to the contrary.  Nothing plus nothing equals nothing.  The court found the defendant’s warning adequate as a matter of law and plaintiff’s failure to warn claim ended there.  Id. at 12.

To make the rubble bounce, the court went on to find that even if the warning had been inadequate, plaintiff’s claim still would have failed because plaintiff could not establish causation:  “Dr. Williams never read the warning, and thus the warning played no role in the events leading up to plaintiff’s injury.”  Id. at 13.  So, don’t wince when a physician says they’ve never seen the package insert for your client’s product.  Whenever a treater says that, it means there was nothing different your client could have done that would have changed the physician’s decision to use the product or prescribe the drug.  That’s like not asking for directions.  Or worse, it’s like warning your husband that eating the large Italian hoagie with extra hot peppers is going to give him heartburn – something he’s known the risk of since the day he turned 30 – it simply won’t change his mind.  [Note, as the first woman blogger on this site, expect to see more of a female perspective.  Get used to it, guys!]