Thursday, July 10, 2008

Headcount II: The Learned Intermediary Rule And Medical Devices

Our post last month about Breen v. Synthes-Stratec, Inc., 947 A.2d 383 (Conn. App. 2008), got us thinking (always dangerous) about medical devices and the learned intermediary rule. Is there any valid reason why the learned intermediary rule shouldn’t apply to medical devices where it also applies to prescription drugs?

Well, we thought about that question for a while – maybe all of fifteen minutes – and we couldn’t think of any generally valid distinction. Perhaps a peculiar statute, but nothing grounded in the rationale of the rule came to mind. After all, as we discussed in our long post about the learned intermediary rule, there are really only two prerequisites for its application: (1) the product must be available only by a physician’s prescription, and (2) it must actually have been prescribed in the context of a physician/patient relationship.

Why? We’re not going to repeat ourselves, but once a doctor must be, and in fact is, involved in a prescription decision, that’s when it makes sense to require the manufacturer to direct its warnings to that learned intermediary. Some people get the application of the learned intermediary rule mixed up with whether the defendant actually wins or not. That’s not at all the same thing. Defendants can – and do – lose learned intermediary rule cases if their warnings to physicians are deemed inadequate for a variety of reasons. But whether to apply the rule, or not, turns on the presence of a prescribing physician, the presumed learned intermediary, and not on whether that physician was adequately warned in a particular case.

And as to the presence of the learned intermediary – and thus the applicability of the learned intermediary rule – there’s no difference whatever between a prescription drug and a prescription medical device.

But the very existence of cases like Breen mean that, for whatever reasons, plaintiffs are still contesting application of the learned intermediary rule in prescription medical device cases whenever they haven’t been foreclosed from doing so – even if their actual arguments have trouble passing the straight-face test. There’s simply no reason for the learned intermediary rule not to apply just because product happens to be a prescription medical device rather than a prescription drug.

For that reason, here’s our second learned intermediary rule head count – this time of jurisdictions where the learned intermediary rule has been applied in medical device cases.

Jurisdictions In Which the Legislatures or Highest Courts Have Applied the Rule in Prescription Medical Device Cases (14):
  • Alabama: Morguson v. 3M Corp., 857 So.2d 796. 801-02 (Ala. 2003).
  • Arkansas: Despain v. Bradburn, ___ S.W.3d ___, 2008 WL 324356, at *_ (Ark. 2008), rehearing granted on other grounds, 2008 WL 1067202 (Ark. April 10, 2008).
  • Connecticut: Hurley v. Heart Physicians, P.C., 898 A.2d 777, 783-84 (Conn. 2006).
  • Delaware: Lacy v. G.D. Searle & Co., 567 A.2d 398, 400-01 (Del. 1989).
  • Georgia: McCombs v. Synthes, 587 S.E.2d 594, 595 (Ga. 2003).
  • Hawaii: Craft v. Peebles, 893 P.2d 138, 155 (Hawaii 1995).
  • Illinois: Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35, 42 (Ill. 2002).
  • Kansas: Humes v. Clinton, 792 P.2d 1032, 1039-40 (Kan. 1990); Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1227-28 (Kan. 1987).
  • Mississippi: Miss. Code §11-1-63(c)(ii).
  • New Jersey: N.J. Stat. §2A:58C-4.
  • Ohio: Ohio Rev. Code §2307.76(c); Vaccariello v. Smith & Nephew Richards, Inc., 763 N.E.2d 160, 164 (Ohio 2002); Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875, 878-79 (Ohio 1991).
  • Oklahoma: Edwards v Basel Pharmaceuticals, 933 P.2d 298, 300-01 (Okla. 1997); Tansy v. Dacomed Corp., 890 P.2d 881, 886 (Okla. 1994).
  • Washington: Terhune v. A.H. Robbins Co., 577 P.2d 975, 978 (Wash. 1978).
  • Wyoming: Rohde v. Smiths Medical, 165 P.3d 433, 436 n.5 (Wyo. 2007).
Jurisdictions In Which Intermediate Appellate Courts Have Applied the Rule in Prescription Medical Device Cases (10):
  • Arizona: Piper v. Bear Medical Systems, Inc., 883 P.2d 407, 415 (Ariz. App. 1993); Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978).
  • California: Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 262 (Cal. App. 1999), review denied (Cal. April 14, 1999); Evraets v. Intermedics Intraocular, Inc., 34 Cal. Rptr.2d 852, 860 (Cal. App. 1994), review denied (Cal. Feb. 16, 1995); 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).
  • Colorado:  O'Connell v. Biomet, Inc., No. 09CA0224, slip op. at 5-7 (Colo. App. March 18, 2010).
  • Louisiana: Marks v. Ohmeda, Inc., 871 So.2d 1148, 1157 (La. App.), writ denied, 883 So.2d 1019, 1020 (La. 2004).
  • Michigan: Brown v. Drake-Willock International, Ltd., 530 N.W.2d 510, 516 (Mich. App. 1995), app. denied, 562 N.W.2d 198 (Mich. 1997).
  • New Mexico: Jones v. Minnesota Mining & Manufacturing Co., 669 P.2d 744, 748 (N.M. App. 1983); Perfetti v. McGahn Medical, 662 P.2d 646, 650 (N.M. App.), cert. denied, 662 P.2d 645 (N.M. 1983).
  • New York: 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).
  • Pennsylvania: Creazzo v. Medtronic, Inc., 903 A.2d 24, 31-32 (Pa. Super. 2006).
  • Tennessee: King v. Danek Medical, Inc., 37 S.W.3d 429, 452-53 (Tenn. App. 2000), appeals denied (Tenn. Nov. 6, 2000 & July 9, 2001).
  • Texas: Ethicon Endo-Surgery, Inc. v. Meyer, 249 S.W.3d 513, 516 (Tex. App. 2007); Guzman v. Synthes (USA), 20 S.W.3d 717, 720 n.2 (Tex. App. 1999); Bean v. Baxter Healthcare Corp., 965 S.W.2d 656, 662 (Tex. App. 1998).
Jurisdictions In Which State Trial Courts Have Applied the Rule in Prescription Medical Device Cases (2):
  • Massachusetts: Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569, at *6-7 (Mass. Super. Sept. 24, 2004).
  • Virginia: Hart v. Savage, 2006 WL 3021110, at *2 (Va. Cir. Oct. 19, 2006); Hamlett v. Virginia Vascular Associates, 2003 WL 22382792, at *4-5 (Va. Cir. April 21, 2003).
Jurisdictions In Which Federal Courts Have Predicted Adoption of the Rule in Prescription Medical Device Cases Where State Courts Are Silent (16):
  • Florida: 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); Wilson v. Danek Medical, Inc., 1999 WL 1062129, at *3 (M.D. Fla. March 29, 1999); Bogle v. Sofamor Danek Group, Inc., 1999 WL 1132313, at *4 (S.D. Fla. April 9, 1999); Broderick v. Danek Medical, Inc., 1999 WL 1062135, at *5 (S.D. Fla. April 9, 1999); McDaniel v. Sofamor Danek Group, Inc., 1999 WL 1062136, at *4-5 (S.D. Fla. April 9, 1999); Edgar v. Danek Medical, Inc., 1999 WL 1054864, at *6 (M.D. Fla. March 31, 1999); Duncan v. Iolab Corp., 1991 WL 544617, at *1 (M.D. Fla. Nov. 18, 1991), aff’d per curiam, 12 F.3d 194 (11th Cir. 1994); 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).
  • Indiana: Phelps v. Sherwood Medical Industries, 836 F.2d 296, 303 (7th Cir. 1987); Minisan v. Danek Medical, Inc., 79 F. Supp.2d 970, 978 (N.D. Ind. 1999); Parks v. Danek Medical, Inc., 1999 WL 1129706, at *6 (N.D. Ind. June 17, 1999).
  • Maine: Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 (1st Cir. 1995); Herzog v. Arthrocare Corp., 2003 WL 1785795, at *8 (D. Me. Mar. 21, 2003).
  • Maryland: 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: Lareau v. Page, 840 F. Supp. 920, 933 (D. Mass. 1993), aff’d, 39 F.3d 384 (1st Cir. 1994).
  • Minnesota: 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).
  • Missouri: Kirsch v. Picker International, Inc., 753 F.2d 670, 67 (8th Cir. 1985).
  • Nebraska: Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *13-14 (D. Neb. Aug. 16, 1999).
  • Nevada: Moses v. Danek Medical, Inc., 1998 WL 1041279, at *5 (D. Nev. Dec. 11, 1998).
  • New Hampshire: Nelson v. Dalkon Shield Claimants Trust, 1994 WL 255392, at *4 (D.N.H. June 8, 1994); Dupre v. G.D. Searle & Co., 1987 WL 158107, at *4 (D.N.H. April 28, 1987).
  • North Carolina: Baraukas v. Danek Medical, Inc., 2000 WL 223508, at *4 (M.D.N.C. Jan. 13, 2000).
  • Oregon: Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1147-48 (D. Or. 1989).
  • South Carolina: Odom v. G.D. Searle & Co., 979 F.2d 1001, 1004 (4th Cir. 1992); Brooks v. Medtronic Inc., 750 F.2d 1227, 1231 (4th Cir. 1984).
  • Utah: Tingey v. Radionics, 193 Fed. Appx. 747, 757 (10th Cir Aug. 8, 2006).
  • Virginia: Talley v. Danek Medical, Inc., 179 F.3d 154, 162-63 (4th Cir. 1999).
  • Wisconsin: Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830 (N.D. Ind. 1999); Monson v. AcroMed Corp., 1999 WL 1133273, at *20 (E.D. Wis. May 12, 1999).
There’s not really any precedent going the other way. The only decision we know of that distinguishes between drugs and devices in applying the learned intermediary rule – that is, holding that, despite the applicability of the learned intermediary rule in drug cases, the rule shouldn’t apply in a medical device case – is unpublished and non-precedential. Kinzer v. Landon, 1996 WL 354880, at *5 (Tex. App. June 27, 1996), writ denied (Tex. Dec. 13, 1996).

There’s a little overlap – we’ve included federal cases when there’s no state appellate authority, so Massachusetts and Virginia appear twice. We haven’t included federal authority where there’s state appellate authority. Taking out the overlap, the current tally shows: that a total of 40 states have applied the learned intermediary rule in medical device product liability cases, consisting of: fourteen jurisdictions by either the legislature or the state’s highest court; an additional nine states by the state’s intermediate appellate court; and an additional sixteen jurisdictions in which federal courts have made Erie predictions. As mentioned, two of those sixteen have consistent trial court authority, but no appellate precedent.

That means that ten states have not had occasion to apply the learned intermediary rule to medical devices. One of those is West Virginia, which, of course, now refuses to apply the learned intermediary rule at all. The other ten are: Alaska, Idaho, Iowa, Kentucky, Montana, North Dakota, Rhode Island, South Dakota, and Vermont. Of those, seven have applied the learned intermediary rule in prescription drug cases, one (Idaho) has applied the learned intermediary rule in a non-drug context, and two, Rhode Island and Vermont, have not considered the learned intermediary rule at all.

7 comments:

Ted Heise said...

Proper use of devices frequently requires more learning than does the use of drugs, so perhaps the learned intermediary rule should be even more applicable in their case.

Beck/Herrmann said...

It's not really a matter of "more" or "less" applicable. Either the LIR applies or it doesn't - that's the point. We don't think it turns on the doctor's actual skill, or upon how much medical skill is in fact required. That's too factual to make for a workable rule. Once there's in fact a doctor prescribing a prescription-only product, the rule applies.

Beyond that, it's a question of whether the defendant adequately warned the doctor.

Ted Heise said...

Guess I've made it pretty clear I'm no lawyer--just a B flat scientist. Thanks for the clarification!

Anonymous said...

The major difference between Drugs and devices is that devices have changed so fast and grown so complicated that Doctors cannot keep up with technology. Many absolutely depend on Device reps in the OR's to assist with the surgeries. Thus we now have 2 learned intermediaries, the doctor who fully understands the biology and the device rep who fully understands the hardware. When both of these parties fail and harm the patient both must be held liable.

Anonymous said...

Do you mean "Medical Product" or "Medical Device" in the following header?:

"Jurisdictions In Which Federal Courts Have Predicted Adoption of the Rule in Prescription Medical Product Cases Where State Courts Are Silent (16):"

Beck, et al. said...

You got us. For two years nobody caught that typo. Fixed it.

Thanks.

Anonymous said...

Thanks for your response. One follow up comment: It looks like Massachusetts and Virginia can't be included in that particular category if the rule has been adopted by their state trial courts as your post indicates. The two categories are mutually exclusive.