We have a guest post today, from Luther Munford of Butler Snow.  He’s been doing some thinking about how something analogous to the “two schools of thought” medical malpractice doctrine should apply to medical product liability cases.  As always with out guest posts, our posters deserve 100% of the credit, and any blame, for their posts.


When the law addresses medical judgment directly, it allows room for reasonable physician choice.  It is ironic then, that a product liability suit over design defect may not allow any such room.  In order to protect physician choice, courts need to resist the temptation to turn product liability disputes into a contest in which reasonable physician choice has no place.

In medical malpractice litigation, where the standard of care is directly in issue, there is room for diversity of opinion.  The jury focuses on the doctor’s choices.  And if, in the light of a diversity of medical opinion, the doctor’s conduct was reasonable, there is no liability.  Steven. E. Pegalis, 1 Am. Law Med. Malp. § 3:3 (2017) (“reasonably applicable alternative methods of diagnosis or treatment” allowed).  As it is phrased in Pennsylvania, if there are “two schools of thought,” the doctor is free to pick one over the other.  Jones v. Chidester, 610 A.2d 964, 969 (Pa. 1992) (“school of thought” means “a considerable number of recognized and respected professionals”).  See also Velazquez ex rel. Velazquez v. Portadin, 751 A.2d 102, 107-108 (N.J. 2000) (allowing practice with “substantial support as proper practice by the medical profession”) (quoting Schueler v. Strelinger, 204 A.2d 577, 585 (N.J. 1964)).

But in a product liability case over defective design, there may be no room for reasonable choice.  Design defect law may ask a jury whether there is any “safer alternative” to a defendant’s device, and, if the jury believes there is, the defendant’s device may be found defective and presumably unsuitable for sale to anyone.  In fact, this question can arise whether or not there is a specific “safer alternative design” requirement in state law because the plaintiff may simply offer such a design as evidence of unreasonable risk. In answering the question, the jury will be asked to choose which expert witness is “most credible” without any allowance for reasonable differences of opinion.

If the law is going to protect a doctor’s ability to exercise reasonable medical judgment in choosing among available devices and surgeries, the question is what needs to be done to keep the unsuitable instrument of design defect litigation – where the doctor may not even be a witness and there is no pre-suit screening panel — from taking away those choices.  Only if the doctor has a choice can the doctor have the ability to determine the best method of treating the patient.

There are at least five ways design defect law can be shaped to protect doctor choice.

First, there is the question of actual doctor choice.  Where the surgeon has chosen not to employ an alternative, perhaps because of the surgeon’s education, training and experience, the jury should not be allowed to find the manufacturer liable because a choice the surgeon rejected might be deemed by the jury to be  “safer.”  See Anderson v. PA Radocy & Sons, Inc., 865 F. Supp. 522, 531 (N.D. Ind. 1994) (manufacturer not liable for employer’s decision to purchase uninsulated fiberglass bucket rather than insulated one); James. A. Henderson & Aaron. D. Twerski, Optional Safety Devices: Delegating Product Design Responsibility to the Market, 45 Ariz. St. L.J. 1399, 1417 (2013) (delegation to learned intermediary defeats design liability).

Second, a court should apply established product liability law principles and exclude from any list of “safer alternatives” those alternatives that present different advantages and disadvantages that require doctor choice, such as a different treatment or different surgery.

This is consistent with the way product liability generally protects consumer choice.  It is generally accepted that, to be a “safer alternative design,” the design must be for the same product, not a different one.  A different product may be safer in one respect, but if it serves different distinct purposes, it cannot provide a basis for finding the less safe product defective.  Informed consumers remain free to choose, and manufacturers are allowed to innovate.  The issue comes up in a variety of product liability contexts.

For example, the Fourth Circuit held in an early negligence case that, given the “peculiar purposes of [the] design” of a Volkswagen bus to provide room for passengers and cargo by placing the driver in front of the engine, a plaintiff could not argue that the design was unsafe because it was not as crashworthy as that of a passenger sedan.  The court granted judgment as a matter of law for the defendant.  Dreisonstok v. Volkswagenwerk, A.G., 489 F.2d 1066, 1074 (4th Cir. 1974), followed in Restatement (Third) of Torts: Product Liability § 2, cmt. f, illus. 9 (1998).  Similarly, a safer bullet proof vest does not make a bullet proof vest with less coverage unreasonably dangerous when the vest allows a greater range of motion.  Linegar v. Armour of Am., Inc., 909 F.2d 1150, 1154 (8th Cir. 1990); see also Hosford v. BRK Brands, Inc., 223 So.3d 199, 208 (Ala. 2016) (smoke alarm not defective just because a more expensive dual-sensor alarm was sold).

This principle is particularly apt in the field of medical devices where different products offer different sets of benefits and complications and whose “safety” depends on professional judgment and, in the case of devices, surgical skill.  Like the learned intermediary doctrine, device defect law should recognize that the doctor relies not only on what the manufacturer has supplied, but also “other medical literature, and any other source available to him, and … the personal medical history of his patient.”  Lebowitz v. Ortho Pharmaceutical Corp, 307 A.2d 449, 457 (Pa. Super. 1973).  The Texas Court of Appeals so held in a hormone therapy case:

[A] plaintiff cannot prove that a safer alternative design exists by pointing to a substantially different product, even when the other product has the same general purpose as the allegedly defective product . . .  Thus, a safer alternative design must be one for the product at issue . . . [Plaintiff] does not explain how [the drug] could have been modified or improved . . .  In essence, [plaintiff] argues that the [drug] should have been a different product . . .  But, as the supreme court has explained, Texas law does not recognize this sort of categorical attack on a product.

Brockert v. Wyeth Pharm., Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009). See also In re Propulsid Prod. Liab. Litig., No. MDL 1355, 2003 WL 367739, at *3-4 (E.D. La. Feb. 18, 2003) (alternative or different methods of treatment insufficient to prove alternative design).

In medical device cases, courts have held that different devices which perform in different ways cannot be treated as safer alternatives. The principal authorities come from the pedicle screw cases where the courts refused to accept other fixation devices, such as those involving hooks and wires, as presenting safer alternative designs.  The Fifth Circuit explicitly gave doctor choice as a primary reason for its holding.  It said:

[Plaintiff] therefore argues that other products that do not use pedicle screws should be considered as alternative designs . . .  Underlying this argument is the assumption that all pedicle screws are defective and there can be no system using pedicle screws that would be an acceptable product.  The problem with this argument is that it really takes issue with the choice of treatment made by [plaintiff’s] physician, not with a specific fault of the pedicle screw sold by [defendant].

Theriot v. Danek Med., Inc., 168 F.3d 253, 255 (5th Cir. 1999).

Similarly, in other device cases it has been held that a treatment that uses no device at all cannot be considered as a safer alternative.  As the United States District Court for the District of Nevada explained:

Neither is the Court swayed by Plaintiff’s argument that the testimony of [the expert] to the effect that Plaintiff’s [surgery] could have been accomplished without use of [the product].  The fact that an alternative method of [surgery] was potentially available does not support Plaintiff’s design defect claim.  As argued by Defendants, non-mesh repair is not an alternative design and does not meet Plaintiff’s burden to support this particular claim.

Schmidt v. C.R. Bard, Inc., No. 2:11-CV-00978-PMP, 2013 WL 3802804, at *2 (D. Nev. July 22, 2013).

While this rule would have its most direct application in states with a safer alternative design requirement, it would not be limited to those states.  It should apply wherever alternative design is used as a basis for declaring a device unreasonably dangerous.  In Driesenstock, the Fourth Circuit’s Volkswagen bus case, the issue was whether the alternative could be used to prove the defendant’s negligence.  And in Linegar, the Eighth Circuit’s bullet-proof vest case, the question was whether the vest was unreasonably dangerous.  In neither case was there a specific safer alternative design requirement.  See James Beck (“Bexis”), On Alternative Design, Take Two – Negligence, Drug and Device Law Blog (Feb. 27, 2017) (use of alternative design in negligence cases).

[Editorial note:  The Massachusetts Niedner decision (discussed here) is also an excellent example of this application]

Third, even where the products might be very similar, the jury should not be asked to choose between two products where either one is supported by a “school of thought” or “substantial medical opinion.”  From the “doctor’s choice” perspective, it is error for a court to intervene in the diagnosis and treatment of a patient in order to dictate the treatment of a patient when reasonable medical professionals could disagree.  For example, one court recognized the “same product” requirement but nevertheless said a jury could find that an alternative was safer if it did not alter “a fundamental and necessary characteristic of the product.”  Hines v. Wyeth, No. CIV. A. 2:04-0690, 2011 WL 1990496, at *8 (S.D.W. Va. May 23, 2011) (citing Torkie-Tork v. Wyeth, 739 F. Supp. 2d 895, 900 (E.D. Va. 2010)).  In that case the court said it was for the jury to decide whether natural progestin and synthetic progestin were different products. Id. at *9.  But if either choice would be within the doctor’s standard of care, that difference should not matter.

Fourth, the principle of reasonable doctor choice could also be used to interpret comment k to the Restatement (Second) of Torts §402A.  That comment rules out design defect liability for medical products if a proper warning is given and the device is “unavoidably unsafe.”  This has sometimes been incorrectly said to simply import a risk-utility test.  Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810, 818-819 (S.D.W. Va. 2015).  But a better reading would be to say that a medical product is “unavoidably unsafe” and so qualifies for comment k protection if its use, within the professional standard of care, presents a risk of injury to the patient.  That would, for example, be true of nearly all implantable medical devices. See James Beck (Bexis), Unavoidably Unsafe PMA Medical Devices, Drug and Device Law Blog (Nov. 30, 2017).

Finally, the principle of doctor choice might be a basis for excluding from evidence actions of the federal Food and Drug Administration based on a comparison of one treatment to another if both treatments were considered to be within the doctors’ standard of care.  Congress has told the FDA that it is not to “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient….”  21 U.S.C. § 396 (2009).  Nevertheless, the FDA does take regulatory actions based not on independent judgments about safety and effectiveness but rather upon comparisons among methods of treatment.  A negative comparison that failed to recognize reasonable doctor choice should be just as inadmissible as expert testimony that failed to apply the correct liability standard.  See, e.g., United States v. Wintermute, 443 F.3d 993, 1001 (8th Cir. 2006).

If the principle of doctor choice were applied in design defect law, it would be necessary to decide what theories of design defect liability would survive.  Certainly a device not considered to be within the standard of care would face liability if it were so egregiously dangerous as not to have any justifiable therapeutic use.  Or if scientific testing proved a way to design the same product so that it was both safer and equally effective, that might be considered in some jurisdictions.

And none of this would directly affect liability for failure to warn, because any rule that rests on doctor’s choice has to assume that doctors are aware of the complications that may arise out of use of the device.

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that “off-label use is generally accepted” and that under the law, “[p]hysicians may prescribe drugs and devices for off-label uses,” 531 U.S. 341, 351 & n.5 (2001), was one of our Bone Screw cases.  Thus, we follow medical malpractice decisions, like Doctors Co. v. Plummer, ___ So.3d___, 2017 WL 242577 (Fla. App. Jan. 20, 2017), which we discussed recently, for what they have to say about off-label use.  In malpractice cases, the dark side often attempts to equate “intended uses” listed in FDA-approved drug/device labeling with the medical standard of care.  As we mentioned in that post, arguments that FDA-approved product labeling equals the medical standard of care are really  attempts to turn off-label use itself into a tort.

The Doctors Co. decision prompted us to look back over our 9+ years of blogging output for where we addressed this issue previously.  Surprisingly, there was only one, a 2007 Bexis piece that (even more surprisingly) didn’t cite any caselaw.  We also found a 2009 law review article by our erstwhile co-founder, Mark Herrmann, which might have been prompted by the earlier blogpost.  But nothing was on the blog itself that could qualify as useful research.

We rectify that today.

Continue Reading FDA-Approved Labeling ≠ Medical Standard Of Care

Sometimes it takes us a while to catch on to things. This is more than a little embarrassing for a Jersey guy to admit, but while many of our high school classmates were devout Springsteen fans after his first two albums, Greetings from Asbury Park and The Wild, The Innocent, and The E Street Shuffle, we would not commit until after the release of Born to Run, by which time Bruuuuuuuce had become a national phenomenon. For years we saw shaved kale salad on menus and passed it by, thinking that we probably did not like kale and definitely did not like shaving, so why bother? Now it is our go-to appetizer for when we want to feel vaguely virtuous. We were late adopters of on-line banking, Apple Pay, and Twitter. Our garage will surely be the last in the neighborhood with a hybrid powered car, a self-driving car, or a flying car. On the way back from visiting the Drug And Device Law Son in Moscow, the British Airways entertainment offerings included season 2 of Catastrophe, an Anglo-American miracle of fun and filthy television comedy. Now we are queuing up season one on Amazon Prime. We are complete-ists, even backwards, if nothing else. Better late than never, right?

Today we are taking a look at an old case (two and a half-years old, but turning up in our topic searches just now). The case is called Meredith v. Nuvasive, Inc., 2013 U.S. 190130 (W.D. Texas Dec. 9, 2013). The plaintiff in Meredith alleged injuries from malfunction of a neuromonitoring device during spinal surgery. Her claims were for manufacturing defect, breach of implied warranties, negligence, gross negligence, and res ipsa loquitur. There is nothing especially unusual in any of that. But here is the man-bites-dog aspect of the case: the product liability plaintiff moved for summary judgment against two relatively unusual defenses, the manufacturer defendant as a “health care provider” under the Texas malpractice statute, and lack of any sale of a medical device precluding warranty claims.

For those of you in need of an executive summary, know this: The plaintiff in Meredith went one for two. (1) The court held that a device manufacturer was not a health care provider under the relevant medical malpractice statute. (2) Because the device was simply used in the hospital, and not sold to the plaintiff or anyone else, the defendant had a real shot at picking off the warranty claims.

Continue Reading Texas Federal Court Says Device Manufacturer is not a Health Care Provider, but also not a Seller

We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a “health care provider” within the meaning of that state’s pretty restrictive laws regarding medical malpractice.  While rejecting the manufacturer’s appeal on the record before it, the court in Verticor didn’t flatly say “no.”  Instead, it held:

As the issue is framed here, [[manufacturer’s] license authorizes it “to provide” (at least in the sense of manufacturing and selling) the [device] − and nothing more.  Consequently, [manufacturer] can be “licensed . . . by the State of Texas to provide health care” only if the [device] is, in itself, “health care” as the [statute] defines that term. . . .  Under it, “health care” is distinguished by either of two nouns − “act” or “treatment” − that is “performed or furnished,” or should have been, “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.”  The first alternative, an “act,” denotes some sort of deed or activity.  As an inanimate object, [the device], in itself, could not be an “act,” although it might be utilized in acts that qualify as “health care,” such as surgery.  Similarly, the other alternative, “treatment” also denotes some form of activity that is performed or furnished for or to a patient. Consequently, the [device] would not, in itself, be a “treatment,” although it might be utilized in a “treatment.”

Verticor, slip op. at 10 (footnotes omitted).  All this manufacturer submitted was that it was licensed to manufacture medical
devices.  That wasn’t enough.  Texas medical malpractice tort reform was separate from that state’s product liability tort reform.  Id. at 11-12.  Further, the “common usage” (how such statutes are construed) of the term “health care” denoted something different from manufacturing:

In common usage, one associates “health care” with medical intervention, assistance, or other acts − e.g., one’s family doctor performing an annual physical or a nurse administering a flu shot − as opposed to the mere making or selling of a product used in providing such services.  Focusing as it does on acts and treatment provided to patients, the [statute’s] definition of “health care” does not clearly depart from this basic notion.

Id. at 13.

Continue Reading Medical Device Manufacturers as “Health Care Providers”

Maybe our motto here at DDLaw should be “we read law review articles so you don’t have to.”  Here are a couple of recent ones that looked interesting to us.

Tort Liability and Medical Innovation

The first one is Anna B. Laakmann, “When Should Physicians Be Liable For Innovation?,” 36 Cardozo L. Rev. 913 (Feb. 2015).  The title caught our eye because of our interest in off-label use, which is sometimes (when not yet the recognized standard of care) considered medical “innovation.”  Since Bexis’ 1998 law review article popularized the now-overwhelmingly adopted position that informed consent includes medical risks, not regulatory matters such as off-label use, we are particularly interested in patrolling that boundary.  If a treatment is so new that its risks and benefits cannot accurately be assessed, then a warning about its experimental nature is appropriate, but that kind of warning is a small subset of “off-label use” as an FDA regulatory status.

Here is the article’s thesis:

This Article proposes a fiduciary framework to regulate physician innovation under conditions of endogenous [we think that means “inherent” in this context] uncertainty.  The proposed approach could be described as a “libertarian paternalism” model of medical decisionmaking.  It mandates close scrutiny of the decisionmaking process but deference to the substance of medical decisions.  Under this framework, the physician should be held liable for failing to act in the patient’s best interests, taking into account the patient’s unique clinical condition and value preferences.  Within these constraints, however, patients should have the freedom to choose − and assume the associated risks and uncertainties − from among a range of clinically acceptable alternatives.  Properly applied, fiduciary principles can strike a desirable balance that respects patient autonomy, deters unreasonable risks, and encourages beneficial innovation.

Id. at 914.  Okay, let’s see what this is all about.

Continue Reading Law Review Articles That Caught Our Eye

Here’s another guest post by Reed Smith’s own Kevin Hara, this time about a recent Texas case holding that health care providers involved in clinical trials are still protected by a state medical malpractice statute, and thus were fraudulently joined.  While we are of two minds about such statutes (making it harder to sue HCPs increases litigation against our clients), since HCPs are our clients’ clients, and thus the heart of their businesses – and we’re defense lawyers by temperament – in the end we come out in favor of less liability generally.  This is an interesting use of fraudulent joinder that could well apply to the definition of “health care provider” under similar statutes in other states.

As always, our guest posters deserve all the credit and any blame for the contents of their posts.


When it comes to Texas, one might never know based on its jurisprudence that the state motto, and indeed the state’s moniker, is derived from “Tejas,” a Native American term for Friendship.  At least from a defense perspective, the Lone Star State at times seemed mighty inhospitable; after all, Texas invented that awful “heeding presumption” back in 1972, touching off a Reign of Fire, as states followed suit, adopting a variety of feeding presumptions.  It also allowed personal injury recovery under its consumer protection statute, made a big deal of Restatement Second §402B, and was the last of the large states to adopt the learned intermediary rule.  While we’re at it, let’s not forget the decision that would never die, the Murthy case, making the worst decisions list in consecutive years in 2011 and 2012, giving us not just one opinion to lament, but Two for the Money.

But we’re forgiving, and won’t “mess with Texas” too much.  Although it took until 2012, with some help from Bexis, for the Texas Supreme Court to finally adopt the learned intermediary doctrine, deciding that it was A Time to Kill an awful decision from 2010 whose name should have been Mud.  Texas adopted the Third Restatement, which should kill the heeding presumption, and even if it doesn’t, that presumption now excludes prescription drugs and medical devices, at least forcing it into Submission.  The Legislature amended the DTPA to eliminate personal injury damages, and we haven’t heard a peep from §402B in a while, and this section’s Failure To Launch into widespread acceptance is a good thing.  Texas Daubert decisions have been outstanding.  Not only that, a lot of excellent Reed Smith practitioners are based in our Houston office.

Texas has other positive attributes as well, including being the birthplace and home of Matthew McConaughey, and of baseball standout Nolan Ryan, who we believe, despite numerous accolades, remains underrated because of his somewhat pedestrian won loss record (which for pitchers reveals more about the team and much less about the individual).  Seriously, seven no-hitters?  Ryan pitched in an era where starters routinely went the distance, and they were their own closers; we urge you to check out his career innings pitched, hits allowed, complete games, and well, the strikeouts speak for themselves. No disrespect to Madison Bumgarner, who was otherworldly in the 2014 World Series, but who has 6 complete games in his career.  Ryan had an incredible 222, including several years where he had more than 20.  We realize that people smarter and more knowledgeable than we are will correctly we might add, mention that Ryan also walked many hitters and never won the Cy Young. That’s the beauty of sports.

And then there’s ZZ Top and Janis Joplin and Beyonce.

But we digress.  Back to the legal issues.  It would be remiss not to note that Texas also has some very favorable statutes, including Civil Practice and Remedies Code 82.007, which provides a rebuttable presumption of nonliability for manufacturers and prescribers in pharmaceutical product liability actions involving failure to warn for FDA approved warnings, and 82.008, which provides a presumption of nonliability for compliance with government standards.  See Tex. Civ. Prac. & Rem. Code §§ 82.007(a)(1) and 82.008.  We were concerned that a recent Southern District of Texas decision would a la Murthy, run roughshod over state law like the TCU Horned Frogs in an 82-27 rout of Texas Tech this year or UCLA in a 66-3 drubbing of Texas in 1997 (the Longhorns’ worst loss ever).  Fortunately, we were pleasantly surprised.

Continue Reading Guest Post – When It Comes To Fraudulent Joinder In Texas, Let’s Hail The Glory Daze And Just Keep Winning

Things are often done differently down in Louisiana.  For one thing, Louisiana is the nation’s only civil law state.  It’s also the only state not to have enacted the Uniform Commercial Code.  We blogged about one such difference before – the state’s unique claim for “redhibition.”  Today we’re examining another Louisiana legal peculiarity.  This peculiarity makes it easier to remove Louisiana cases to federal court.

It involves the Louisiana medical malpractice statute, and is exemplified by two recent cases we ran across – although we’ve been aware of this quirk since our Bone Screw days.  The new cases are Arnold v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. Lexis 56519 (N.D. Ohio April 23, 2014), and Scales v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. Lexis 56490 (N.D. Ohio April 23, 2014).  Both of these cases involved Louisiana plaintiffs claiming injury from the defendant’s hip implant.  In both cases they had joined medical malpractice claims against local Louisiana physicians and/or hospitals with their product liability claim against the out-of-state manufacturer.

Both Arnold and Scales were removed to federal court.  The plaintiffs apparently did not move to remand, given the definitive trend in the law discussed below, and both cases were transferred to the relevant MDL.  In the MDL the medical malpractice defendants moved to dismiss.

Ordinarily, if a product liability plaintiff wants to run the risk of antagonizing the same medical providers whose testimony is likely to be critical on issues like the learned intermediary rule and causation, s/he can defeat diversity by asserting medical malpractice claims, as was done in Arnold and Scales.  As long as such claims assert medical malpractice – and not some bogus supplier strict liability theory – in most states they will meet the rather minimal fraudulent joinder standards for pleading a “colorable” cause of action, and thereby prevent successful removal.

Not in Louisiana – at least recently − so defense counsel need to be attuned to this possibility.

Medical malpractice actions in Louisiana are governed by statute, La. Rev. Stat. §§1299.41, et seq.  The relevant part of the statute for this discussion is §40:1299.47, concerning medical review panels.  Subsection 40:1299.47(B)(1)(a)(I) provides:

No action against a health care provider covered by this Part, or his insurer, may be commenced in any court before the claimant’s proposed complaint has been presented to a medical review panel established pursuant to this Section.

Louisiana courts have interpreted “may not be commenced in any court” to mean that, unless and until a medical review panel has completed its review in a given case, it is not possible under Louisiana law to sue a health care provider for medical malpractice.  LeBreton v. Rabito, 714 So. 2d 1226, 1230 (La. 1998) (“this provision requires that a patient ‘must provoke a medical review panel and receive an opinion from it before he can file suit in a court of law’”) (quoting Everett v. Goldman, 359 So.2d 1256, 1263 (La. 1978)).  See Todd v. Angelloz, 844 So. 2d 316, 318-20 (La. App. 2003) (if a “claimant’s proposed complaint has not been first presented to a medical review panel, an exception of prematurity must be sustained, and claimant’s district court claim must be dismissed”).

Thus, the medical malpractice statute precludes any action against any healthcare provider to which it applies until the condition precedent (panel review) is complied with.  The MDL court in Arnold and Scales therefore considered the joinder of the physician and hospitals in those actions to be “premature.”  Accordingly, the actions against the malpractice defendants were dismissed without prejudice:

Following a decision by the review panel, [plaintiff] will then decide whether or not to file a malpractice action. . . .  Because Plaintiff has failed to comply with the administrative requirements of the Louisiana Medical Malpractice Act, Defendants. motions to dismiss are granted without prejudice.

Arnold, 2014 U.S. Dist. Lexis 56519, at *5-6; accord Scales, 2014 U.S. Dist. Lexis 56490, at *5.

We mentioned “bogus” strict liability theories against healthcare providers above.  Well, the plaintiffs in Arnold and Scales asserted those, too.  It didn’t help them avoid the statute.  Arnold, 2014 U.S. Dist. Lexis 56519, at *6; accord Scales, 2014 U.S. Dist. Lexis 56490, at *5.  That’s been tried before and failed − plaintiffs can’t avoid the statute by asserting claims against healthcare providers that purportedly sound in strict liability.  “Malpractice includes a health care provider’s strict liability for some defective items used during the course of a patient’s treatment; i.e., defective blood, tissues, transplants, drugs, medicine, and prosthetic devices.”  Rogers v. Synthes, Ltd., 626 So. 2d 775, 777 (La. App. 1993) (emphasis added).  Cf. Silvestrini v. Intuitive Surgical, Inc., 2012 WL 380283, at *6-7 (E.D. La. Feb. 6, 2012) (same result with respect to claim for “ordinary negligence”; any claim related to the plaintiff’s medical treatment is covered by the statute).

Critical for our interest in the details of Louisiana medical malpractice law, under several fact patterns premature joinder of medical malpractice defendants protected by the review panel provisions of the Louisiana statute has been held to be “fraudulent,” thereby establishing diversity jurisdiction in federal court, notwithstanding the presence of non-diverse healthcare provider defendants.  Historically, the easiest pattern for defendants to obtain this result (a finding of fraudulent joinder) is where the plaintiff sues only the diverse product liability defendants – as the express terms of the statute demand − but asserts, after removal, that s/he also intends to join non-diverse medical malpractice defendants at some unclear later time.  That doesn’t work.

[T]he fact is, in this case, the only defendants named are diverse.  Complete diversity exists, the petition for removal was timely filed, the jurisdictional threshold is met, and this court has subject matter jurisdiction.  Diversity is considered between the parties to the action only, not unnamed parties. That those unnamed parties may someday be named as defendants is speculative.

Harris v. Brecher, 2007 WL 1296349, at *1 (W.D. La Apr. 13, 2007).  “A possible future destruction of diversity, even by the promised later addition of an indispensable party, is not a proper ground for remand.”  McQuistin v. Boston Scientific Corp., 2008 WL 104210, at *1 (W.D. La Jan. 9, 2008); accord Marcel v. Rehabcare Group, Inc., 2008 WL 4657258, at *3 (E.D. La. Oct. 20, 2008); Oiler v. Biomet Orthopedics, Inc., 2003 WL 22174285, at *5-6 (E.D. La. Sept. 17, 2003); Donaldson v. Spinal Concepts, Inc., 2003 WL 21913704, at *3 (E.D. La. Aug. 6, 2003), reconsideration denied, 2003 WL 22175986 (E.D. La. Sept. 19, 2003); Audrisch v. Ethicon, 2002 WL 32151749, at *2 (W.D. La. April 11, 2002); Lillie v. Wyeth-Ayerst Laboratories, 1994 WL 532091, at *1 (E.D. La. Sept. 26, 1994); Maquar v. Synthes Ltd. (U.S.A.), 1992 WL 111199, at *1 (E.D. La. May 14, 1992).

Another fact pattern favorable to removal (but a lot less common) is where the plaintiff settles with the medical malpractice defendants during the pendency of a review panel’s activity under §40:1299.47.  Erdey v. American Honda Co., Inc., 96 F.R.D. 593, 598 (M.D. La. 1983).  Settlements, unlike contested dismissals, are “voluntary” acts by plaintiffs that eliminate nondiverse parties from consideration.  Id. at 598-99.  The same is true of voluntary dismissals made under threat of a motion to dismiss for prematurity.  Denton v. Critikon, Inc., 781 F. Supp. 459, 460-61 (M.D. La. 1991).

The most common pattern, and the one over which there was – used to be, anyway – the most controversy, involved cases where the plaintiff violated the Louisiana medical malpractice statute and sued healthcare reporters in the initial complaint.  Some Louisiana courts, prior to 2006, used to remand such cases.  That happened to us in Bone Screw.  We always viewed that as a questionable result, since it effectively rewarded plaintiffs for breaking the state’s rules.

That’s now changed.  More recent decisions, following analogous Fifth Circuit precedent from 2005 and later, have since then virtually unanimously found fraudulent joinder because:  (1) the defendant simply can’t legally be sued at the time of removal, and (2) that is the only time at which removal is supposed to be judged:

Although [plaintiff] cites a long line of cases in the Eastern District of Louisiana which have held that a remand is not premature, recent 5th Circuit cases hold that where a plaintiff has failed to satisfy statutory administrative requirements before bringing suit against certain defendants, those defendants are improperly joined.  See Holder v. Abbott Labs, Inc., 444 F.3d 383, 387-88 (5th Cir. 2006), and Melder v. Allstate Corp., 404 F.3d 328, 332 (5th Cir. 2005).  Thus, [plaintiff] may eventually have a viable claim against [the physician], but at this time [he] is improperly joined.

Jones v. Centocor, Inc., 2007 WL 4119054, at *1 (E.D. La. Nov. 15, 2007).  See Butler v. Louisiana State University Health Sciences Center, 2012 WL 7784402, at *4 (Mag. W.D. La. Nov. 19, 2012) (relying on Holder and Melder), adopted, 2013 WL 1180873 (W.D. La. March 20, 2013); Voorhies v. Administrators of Tulane Educational Fund, 2012 WL 1672748, at *6 (E.D. La. May 14, 2012) (same); Taylor v. Ochsner Clinic Foundation, 2011 WL 6140885, at *4 (E.D.La. Dec. 9, 2011) (same); Garcia v. Covidien, Inc., 2011 WL 4550809, at *2 (E.D. La. Sept. 28, 2011) (repudiating prior opinion in Ohler v. Purdue Pharma, L.P., 2002 WL 88945 (E.D. La. Jan. 22, 2002), in light of Holder and Melder); Pardo v. Medtronic, Inc., 2010 WL 4340821, at *2 (E.D. La. Oct. 26, 2010) (relying on Holder and Melder); Fontenot v. Johnson & Johnson, 2010 WL 2541187, at *9 (Mag. W.D. La. Apr. 30, 2010), adopted, 2010 WL 2541178 (W.D. La. June 17, 2010) (same); Senia v. Pfizer, Inc., 2006 WL 1560747, at *2-3 (E.D. La. May 23, 2006) (same).  See also Harden v. Field Memorial Community Hospital, 265 F. Appx 405, 409 (5th Cir. 2008) (also affirming fraudulent joinder where administrative requirement not followed).

Other courts have denied remand in this situation (plaintiff improperly naming healthcare providers) by refusing to speculate on what might happen in the future, given that the validity of removal is to be determined as of the date of removal:

At the present time, the plaintiffs do not have a right to pursue a claim in any court against [the physician], and this action may well be concluded before such a right accrues.  In addition, if a medical review board finds no wrongdoing on the part of the physician, the plaintiff may choose not to pursue the physician in litigation.  On the other hand, if the medical review panel finds wrongdoing on the part of the physician, the physician may well choose to enter into a settlement with a plaintiff without the necessity of further litigation.  Thus, it is speculative to assume that the physician, who is not presently subject to suit, will later be joined as a defendant in this action.  Finally, the propriety of removal is to be judged as of the time of the removal, not as of some future time.

Bourne v. Eli Lilly & Co., 2005 WL 2998914, at *2-3 (Mag. W.D. La. Nov. 8, 2005), adopted, 2006 WL 273614, at *2 (W.D. La. Jan. 31, 2006).

The cases which hold that a premature medical malpractice claim against a non-diverse, in-state defendant does not deprive the court of diversity jurisdiction are persuasive because they correctly apply the plain language of the [Louisiana statute].  Whether a plaintiff who is currently proceeding before medical review panel pursuant to the [statute] may later allege and prove a medical malpractice claim in a state or federal court case is not relevant to the determination of diversity jurisdiction at the time of removal.  Rather, what is critical is whether, at the time of removal, the plaintiff can commence an action against the health care provider under state law.

Ellis v. Ethicon, Inc., 2010 WL 1251640, at *3 (M.D. La. 2010).

If the rule were such that defendants are not improperly joined and the suit is remanded, then a plaintiff who has joined such defendants in violation of Louisiana’s procedural rules is rewarded with his choice of forum.  To the contrary, under existing jurisprudence and reasoning, if a plaintiff properly follows Louisiana’s procedural rules under the [statute], and does not immediately join the resident medical providers in the state court suit, the lawsuit is subject to removal and a federal court forum as only diverse defendants are present.

Fontenot, 2010 WL 2541187, at *9.  Accord Sons v. Medtronic Inc., 2012 WL 6628871, at *1 (W.D. La. Dec. 18, 2012) (“because a claim filed against a physician defendant prior to the completion of the medical review panel procedure was premature and subject to dismissal, the physician defendant’s presence must be disregarded for the purposes of determining diversity jurisdiction”); Silvestrini, 2012 WL 380283, at *5; Daniels v. Touro Infirmary, 2011 WL 6140869, at *2 (E.D. La. Dec. 9, 2011); Dyson v. Advanced Bionics, L.L.C., 2011 WL 6294314, at *3 (Mag. M.D. La. Nov. 22, 2011), adopted, 2011 WL 6259937 (M.D. La. Dec. 15, 2011); Bush v. Thoratec Corp., 2011 WL 5038842, at *6 (E.D. La. Oct. 24, 2011); Esposito v. Ethicon, Inc., 2011 WL 2883067, at *3-4 (Mag. M.D. La. June 13, 2011), adopted, 2011 WL 2883342 (M.D. La. July 15, 2011); Malbroux v. American Medical Systems, Inc., 2011 WL 2148417, at *3-5 (W.D. La. May 31, 2011); Owens v. Ethicon, Inc., 2010 WL 3172737, at *1 (M.D. La. Aug. 11, 2010); Valence v. Jefferson Parish Hospital Service No. 2, 2008 WL 1930524, at *2 (E.D. La. May 1, 2008); In re Baycol, 2003 WL 24232801, at *2 (D. Minn. Aug. 29, 2003) (“there is no dispute that at the time of removal, proceedings before the Louisiana Medical Review Panel had arguably just commenced.  Thus, it is clear that at the time of removal, defendants’ exception of prematurity would have to be sustained, and the cases against the physicians dismissed.”); Carter v. Warner-Lambert, 2001 U.S. Dist. Lexis 23993 at *5 (W.D. La. June 29, 2001) (remand denied as plaintiff had failed to present claim to medical review panel); Boxie v. Gate Pharmaceuticals, 1999 U.S. Dist. Lexis 23150 at *8 (W.D. La 1999) (same).

As we’ve noted, other, a number of older decisions are contrary.  As is our practice, we aren’t doing the other side’s research for them, so we’re not citing those cases, which appear to be superseded anyway.  Just know that the current vitality of these older cases is extremely questionable, even if they don’t yet bear red flags.

Another problematic fact pattern is where medical malpractice defendants were improperly sued, but were dismissed in state court via a “dilatory exception of prematurity” (such a charming phrase) in state court and thereafter removed.  See Touriac v. Chenevert, 2012 WL 4471143. At *3 (W.D. La. Sept. 26, 2012) (denying remand where defendant’s dismissed in state court); Cooper v. Sofamor, Inc., 1993 WL 17634, at *1 (E.D. La. Jan. 15, 1993) (same).  Again, however, the law is not uniformly favorable, but the same issues of failure to exhaust mandatory state administrative requirements would likewise seem to apply.

Back when we were removing Bone Screw cases, we were just as likely to lose as win.  Now, however, the law has taken a decidedly more favorable turn, so we recommend removing Louisiana cases whenever the only non-diverse defendants are improperly joined medical malpractice defendants.

One of us had a conversation yesterday with a lawyer (who will remain nameless because we haven’t asked otherwise) about off-label use issues in a malpractice case against a doctor who used something called a Nidek Laser in eye surgery.  We haven’t looked at any facts of any case or about the device.  We know only what our correspondent told us.

He said doctors are being sued on theories that they did something “illegal” in using an approved device with a supposedly unapproved computer program.  We offered some quick thoughts to our correspondent, whose last words were that these “interesting” issues are “popping up across the country” in similar malpractice cases involving Nidek lasers and lasik surgery.

That got us thinking.  If the plaintiff side is actually coordinating this kind of attack, maybe there are other defense side malpractice lawyers who would like to know what we had to say, since FDA-related issues of this sort (thankfully) aren’t something that’s particularly common in malpractices cases.  So here goes:

(1)  As for the purported expert claiming “illegal” activity by the doctor, move to exclude him.  Expert testimony that something was “illegal” under the Food Drug & Cosmetic Act (“FDCA”) is improper expert testimony on issues of law.  We’ve blogged about this expert issue a number of times.  See here.

(2) As for a plaintiff claiming that a doctor “illegally” violated the FDCA by using an unapproved device, that plaintiff doesn’t have standing to make that claim.  Move for summary judgment, or to dismiss.  As we’ve commented on many times previously, see here, there is no private right of action under the FDCA.  21 U.S.C. §337(a); Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).  Plaintiffs have no business claiming anything is “illegal” under the FDCA, and most states do not allow negligence per se actions based upon supposed violations of statutes that forbid private rights of action.  Our posts on negligence per se issues, found here, discuss this interplay.

(3) As for claims that off-label use is “illegal,” or “investigational” or “experimental,” it simply ain’t so.  Plaintiffs saying that are just plain hooey.  Off-label use is legal and common.  The Supreme Court confirmed that in Buckman as well.  For that proposition the court cited Bexis – really.  He wrote the earliest definitive law review article on off label use more than ten years ago, and his article also discusses the “investigational” and “experimental” points.  Here’s a link to that article.  You’ll find it cited in Buckman and almost a score of other cases for the same proposition.  The article’s somewhat dated on the legal citations (looking for what cites it is probably now more useful for case citations), but the discussion of the FDA and medical ethical issues is still pretty valuable.

We don’t generally get involved in medical malpractice cases since it’s outside our expertise, but if malpractice plaintiffs are making a concerted effort to confuse courts in such cases with bogus FDCA-related issues, such as these, then it becomes our business.  So we’ll try to help where we can.