Friday, October 17, 2014

Louisiana Liability For A Sales Representative's Sizing Error

            Those of us whose childhood had low tech play options and at least a touch of OCD recall playing with dominoes.  Not whatever the game is where the number of dots on a tile matters, which we understand exists from witnessing it in screen classics like “Boyz n the Hood.”  No, we mean the activity where you line up a series of dominoes in a sequence where tipping over the first one will cause a chain reaction where many or all fall over.  If you were really motivated or bored, then the arrangement of dominoes might have included the construction of elaborate stairs, towers, or catapults or tiles falling off of tables to start new chains.  There is probably some app for this now.

            The decision in Grabowski v. Smith & Nephew, Inc., No. 14-433, 2014 La. App. LEXIS 2367 (La. Ct. App. Oct. 1, 2014), reminds us of dominoes.  (We do try to have our non-legal introductions have something to do with our purported point.)  The case was really a detour from what looked like a medical malpractice action against a surgeon who performed a knee replacement with an insert that was too small for the tray he used.  The details of the two part implant system are not terribly important here, but the sizing of the insert and tray should match up.  The surgeon blamed the sizing error on the sales rep present at the implant after learning about it from another rep at a revision surgery three months later.  Skipping over some procedural parts and a whole section of the decision about a motion to recuse the judge—arrangements of dominoes sometimes have dead ends on purpose—plaintiff sued the original rep, the distributor with whom he had a contract at the time of the implant surgery, and the manufacturer of the implant with whom he used to have a contract.  The defendants eventually moved for and were granted summary judgment.  The basic idea was the rep was not liable for negligence because the duty of providing medical care to the patient—including using the right size of any medical device—rested solely with the surgeon.  In addition, the distributor was not liable for acts or omissions of someone who was its independent contractor and the manufacturer was not liable for someone with whom it had no direct contractual relationship.  On appeal, all the tiles fell to bring the deep pockets back into the case.  (We cannot tell what happened in terms of litigation between the plaintiff and the surgeon.)

            To impose any liability on the defendants in the absence of any allegation of failure to warn, mislabeling or product defect, first there had to be a duty owed by the rep to the plaintiff to “insure the proper implant was used in Mrs. Grabowki’s surgery.”  Id. at *18.  That sounds like part of practicing medicine to us and the evidence was that the surgeon “determined that Mrs. Grabowski required a size 5 implant . . . inserted the poly insert into the tray and tested it to verify that the dovetail mechanism of the implant held the tray and insert together in place [and] then completed the surgery.”  Id. at *3.  Regardless of what size insert the rep handed over to the nurse, it was the surgeon who did or did not perform the surgery correctly, including using the right devices.  Drawing largely on a distinguishable case where a physician’s answering service owed a duty to patients to promptly and accurately relay information from the patients to the physician, the appellate court found that the rep owed a duty “to provide the appropriate size poly insert for the size 5 implant that Dr. Collins determined Mrs. Grabowski required.”  Id. at *26.  That the duty was owed to the patient—with whom the rep never interacted—as opposed to the doctor or hospital staff—with whom the rep did have interaction—was glossed over.  The novel duty was rationalized largely on economic terms:

We do not see that imposition of this duty will result in an unmanageable flow of litigation . . . . [T]he nature of [the rep’s] activities, his experience, and his expected conduct in the OR made it clearly foreseeable that his failure to provide the proper size implant and corresponding poly insert would result in harm to the patient in whom it was being implanted.  Mrs. Grabowski was not at fault.  The economic impact is that all parties that contributed to Mrs. Grabowski’s harm share in the responsibility for her damages.  Surgeries, especially ones like Mrs. Grabowski’s, are becoming more and more technologically advance, requiring technological assistance from sales representatives who are specially educated and trained with respect to the medical devices they sell.  Accordingly, it is reasonable for these sales representatives to be responsible for their negligent acts.
Id. at **26-27.  Among other things, this rationale seems to ignore that the consequence of imposing potential liability for reps and entities that may be responsible for their acts or omissions is that it would deter the provision of this necessary technical assistance unless liability can be reallocated to the doctors and hospitals.  If we start with the assumption that “more technologically advance[d]” surgeries appeal to surgeons because they might improve the care provided to patients, then expansion of liability like this does not seem like a good idea, as we have said before. 

            From here, the analysis of whether there was a genuine issue of material fact as to whether the alleged breach of the new duty caused plaintiff’s injuries was brief.  The defendants went as far as introducing expert evidence that the implanting surgeon and hospital acted below the standard of care in connection with the implant.  Id. at *28.  Based on no evidence from plaintiff we see beyond that the rep did provide the implant after the surgeon specified the size, the court found a genuine issue of material fact.  We understand that joint tortfeasor law varies and not everywhere has the concept of last clear chance, but there should be some evidence that what the rep did caused the injury when the surgeon is the one who determined that the implant he received was the size he wanted to use in the surgery he performed.
            With potential liability for the rep established, the court turned to imposing liability on the distributor and manufacturer for the rep’s alleged breach of a novel duty.  To its credit, it rejected the argument that the basic reciprocal indemnity provisions in the contract between the rep and the distributor made plaintiff a third party beneficiary of the contract.  Id. at **29-32.  The handling of the argument that the rep acted with apparent authority for the manufacturer, with whom he had no direct relationship at the time of the implant surgery, is more problematic.  The court set out several “facts” that collectively established a genuine issue as to the existence of apparent authority.  While having a business card saying he was the representative of the manufacturer and the manufacturer’s name on a badge the hospital gave him to allow him to enter the operating room may be relevant facts, others were not “facts.”  The implanting surgeon offered that he “believed” the rep represented the manufacturer and “opined” that the manufacturer should be liable for failing to train the rep who no longer had any direct relationship with it.  That all sounds more like a justification for why the manufacturer should be liable than facts supporting apparent authority, but it was enough for the appellate court.  Id. at **35-37.

            Similarly, the last piece to fall was that the distributor’s contract with the rep created a “master-servant” relationship even though it purported to create an independent contractor relationship.  The basic question is whether the contract gave the distributor the right to supervise and control how the rep performed his contractual responsibilities.  The contractual provisions that were sufficient to deem the rep an employee of the distributor included “the payment of commissions for his sales, the number of causes for termination [of the rep], the lack of consequences in the event [the distributor] breaches the contract, and the ownership of the rep’s] product ideas without evidence of what training [the distributor] provided [the rep] that equipped him with special knowledge needed to formulate product ideas.”  Id. at *43.  We are not so sure how these all go to supervision or control, but what troubles us more is that provisions requiring the rep to be accurate and complete in communicating on the products, to use only written materials he was provided, and to comply with applicable laws were also seen as evidence of employment.  Id. at **40-41.  These provisions, of course, are necessary given various FDA requirements on the marketing of medical devices.  We suspect that absence of such requirements as to reps who market a medical device, regardless of whether the manufacturer, distributor, or nobody employs the rep, could be seen as a lack of appropriate marketing practices by the manufacturer.  In effect, manufacturers would need to have reps bound by such provisions, even when the reps are set up as independent contractors of distributors.  The presence of such provisions, in turn, makes reps employees of the distributors (or, of the manufacturer in instances where there is a similar independent contractor agreement with the manufacturer).  Combined with the potential liability of the rep for breach of a novel duty running to the patient, this, in turn, greatly decreases the chance of complete diversity in an ensuing injury lawsuit.  This, in turn, greatly increases the chance for bad rulings and new ways to impose liability.  Like a Mรถbius strip of perpetually falling dominoes. 

Thursday, October 16, 2014

A Colorado Federal Court Adopts Restatement (Third) of Torts Section 6(c)

A federal court recently placed Colorado amongst the states that apply Restatement (Third) of Torts §6(c) in design defect cases.  That’s a good place to be when you’re defending a medical device company.  Section 6(c) creates a tougher burden for design defect plaintiffs than does Restatement (Second) of Torts.  Showing a safer alternative design isn’t enough.  And that’s important, because there are often alternative designs for medical devices.  Section §6(c) instead focuses on prescribing doctors and their risk-benefit analysis:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.
Restatement (Third) of Torts § 6(c).  In short, if a reasonable doctor would choose to use the device for any class of patients, knowing the risks, it is not defectively designed – regardless of whether there might be an alternative design.  

The facts of the Colorado case, Haffner v. Stryker Corp., No 2014 U.S. Dist. LEXIS 137214 (D. Col. Sep. 29, 2014), show how this can work.  The plaintiff had knee replacement surgery, but later needed revision surgery.  He was allergic to the cobalt and nickel contained in the knee replacement system.  So he sued, claiming, amongst other things, that the system was defectively designed.  Id. at *1, 2, 7.  

But the question under § 6(c) is not whether the device could have been designed without cobalt and nickel so that it is better suited for a particular patient or class of patients.  It’s whether the device, as designed, would be used by a reasonable doctor with “any” class of patients.  In other words, would it be prescribed for a class of patients without such allergies?  That question will often answer itself.  The Haffner court answered it for us:

Prescription medical devices are not the same as ordinary consumer products. A variety of similar devices made with different materials can be developed and manufactured to address the needs of different classes of patients. Simply because a product would not be compatible with a certain class of individuals--in this case, those with cobalt and nickel allergies--does not mean the medical device is defectively designed. The Restatement (Second) considered the possibility that certain drugs could be unavoidably unsafe while still remaining beneficial. The Restatement (Third) took this conclusion one step further, reasoning that medical devices can be safe for certain patient populations and not others without their risk outweighing their utility. It is for this reason that these devices can only be sold to doctors and administered by prescription. The plaintiff has failed to state a plausible claim that the Knee System is defectively designed. Therefore, this claim is dismissed.

Id. at *7-8.  That’s the crux of it.  Under § 6(c), the device need only be of a type that a reasonable doctor would prescribe to some patients.  That is almost always the case with a device approved or cleared by the FDA.  And therein lies the power of § 6(c).  

Now, § 6(c) is not all protective.  It does not necessarily protect against failure to warn claims, and so the Haffner court allowed plaintiff’s strict liability and negligent failure to warn claims to go forward.  

But the defendants are in a better place.  They no longer have to deal with, arguably, the most difficult claim to defend – design defect – particularly if they had to conduct that defense under law that allows consideration of alternative designs.  With that in mind, this was a very good result. 

Wednesday, October 15, 2014

A Juicy Little Decision

            This is actually a post from Reed Smith’s Rachel Weil.  While this is not her first post, she is still a mere "guest poster" at this point and takes sole responsibility for the content of her posts.  We have allowed her to use first person plural pronouns, though.

* * *
            On this unseasonably warm day where we are, as we lament the passage of another summer and the demise of its bounty of strawberries, blackberries and peaches, we rejoice that a recent trip to our local grocery uber-chain revealed a silver lining in the return of perfect clementines.  Clementines, those Lilliputian cousins of the tangerine, represent nature’s engineering at its best.  Easily accessible, their perfect sections are joined in a seamless whole, uniformly sweet and unmarred by “bad spots” or detritus. 

            Such are the attributes of a tidy little decision out of the Ortho Evra® MDL.  (We have blogged about other Ortho Evra® decisions, like here and here, for example, but this is the first that was postured in a fashion that facilitated total victory for the defendants in one shot.  Today’s breaking news post, also comes from the Ortho Evra® MDL.)   In Giffen v. Ortho McNeil Pharmaceutical, Inc., No. 3:12 oe 40001, 2014 U.S. Dist. LEXIS 136587 (N.D. Ohio. Sept. 26, 2014), Plaintiff was given samples of the Ortho Evra® birth control patch and used them for one month.  Alleging that the patch caused her to suffer a stroke, Plaintiff asserted the standard failure to warn, negligence, design defect, and warranty claims, along with a litany of fraud-based claims.  Defendants moved in the alternative (wisely, as you will see) for judgment on the pleadings or for summary judgment on all of the Plaintiff’s claims.  Id. at *1-2.  

            Failure to Warn

            Defendants argued that the Ortho Evra® package insert was adequate as a matter of Missouri law.   The Court explained that, under Missouri’s learned intermediary doctrine, a warning is adequate if it “properly warns the doctor of the dangers involved in using the medication,” id. at *9-10, and that “Missouri courts have dismissed failure to warn claims where the manufacturer warns of the specific injury alleged.”  Id. at *10 (internal quotation marks and citations omitted).    The Court found that the Ortho Evra® package insert warned of the risk of stroke, and that the “detailed patient labeling document explicitly warned that the product could cause strokes;” Id. at *11, thus, the warning was “sufficient to meet the Defendants’ duty to provide adequate warning to physicians regarding the risks associated with the product.”  Id.  The Court also noted that “the record also establishes that [Plaintiff’s prescribing nurse-practitioner] “was aware that the Ortho Evra® birth control patch could cause a stroke [and] . . . was familiar with the language of Ortho Evra®’s FDA approved package insert and detailed patient labeling which warned about the risk of stroke.”  Id.   In addition, Plaintiff “acknowledged receiving a box sample of the Ortho Evra® birth control patch which included the package insert and detailed patient labeling.”  Id.

            The Court rejected Plaintiffs’ arguments that the Ortho Evra® package insert was “63 pages long;” thus, her prescriber “could not possibly go over every risk with every patient.” In a clear-eyed (and too rare) distillation of the essence of the learned intermediary doctrine, the Court emphasized that “Missouri law does not require a prescriber to go over every risk with every patient.  Rather, Missouri law requires manufacturers to provide adequate warnings to physicians regarding the risks associated with the product. . . . Thus, whether [the prescriber] directly warned Plaintiff is irrelevant.  Defendants have met their burden to [the prescriber], which is all Missouri law requires.”  Id. at *13.

            Remaining Claims

            The Court denied Defendants’ Motion for Judgment on the Pleadings as to Plaintiff’s remaining claims, holding that Rule 8(a) and Twiqbal were satisfied.  “Nevertheless,” it noted, “these claims fail pursuant to Defendants’ alternative request for summary judgment, which Plaintiff does not oppose.”  Id.  The Court held:

·                     Plaintiff could not prevail on a negligent failure to warn claim because, as explained, her failure to warn claim was without merit under Missouri’s learned intermediary doctrine.  Id. *14-15.

 ·                     While Plaintiff alleged a design defect, “she has put forth no facts to support her claim that the design was defective.  Plaintiff must set forth specific facts showing that there is a genuine issue for trial. . . . Because Plaintiff has not demonstrated a defect in Ortho Evra®’s FDA-approved design, she has not met this burden.”  Id. at *16.

·                     With respect to Plaintiff’s manufacturing defect claim, she “[a]gain . . . recites factual allegations but fails to put forth any facts creating a genuine issue that shows Defendants’ deviated from manufacturing specifications or otherwise identical units.  Without more, Plaintiff’s allegations fail as a matter of law.”  Id.

·                     To prevail on her negligent representation, fraudulent representation, fraudulent concealment, fraud and deceit, and breach of warranty claims, Plaintiff was required to prove “reliance on a false statement or that the goods were not of a certain kind or quality” fit for a particular purpose.  Id. at *16-17 (citations omitted)   Defendants argued that Plaintiff had failed to show that she relied on any statement.   The Court commented, “[T]he root of the issue is much simpler; namely, Plaintiff has failed to show Defendants’ alleged representation was false or that the goods were not fit for a particular purpose.” Id. at *17-18 (emphasis in original).  The Court concluded, “Because Plaintiff has failed to establish she relied on Defendant’s representations, or that such representations were false or unsuitable, these claims fail as a matter of law.”  Id. at *18.

            Thus, cutting to the heart of the burdens the Plaintiff was required to sustain and holding that she could not sustain them, the Court closed the door on her claims.   Compact, accessible, and uniformly sweet – a worthy model for courts facing these ubiquitous issues.

Breaking News – Branded Design Defect Preemption

     From the time that the Supreme Court handed down its decision in Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), we have been declaring that design defect claims against branded dugs should also be preempted.  See,, here, here, and here.  We now have a decision that has done just that.  Booker v. Johnson & Johnson, No. 3:12 oe 40000, slip op. (N.D. Ohio. Oct. 10, 2014).  Booker is from the Ortho Evra MDL, which has produced many good partial summary judgment decisions.  In some, we have noted that design defect claims were left standing after motions for judgment on the pleadings while other claims fell to summary judgment.  Booker got a second bite at the apple with a motion for summary judgment on design defect and some other lingering claims and raised directly the issue of whether a state law (Georgia, in this case) claim for design defect for a branded drug was preempted under Bartlett.  In the first such decision we know about, it was:  “The Court, having carefully read Mutual Pharmaceutical Co., concludes that it was impossible for Defendants to comply with both its state-law obligation to alter the drug’s composition, and its federal-law duty not to do so.”  This is so good that we will ignore the grammar glitches.  There is nothing about the basic fact pattern here that should limit the logic of this ruling to a minority of drugs or states.  It also should not be terribly surprising that the decision came from this judge, who issued the first published decision excluding evidence under Buckman, Bouchard v. American Home Prods. Corp., 213 F. Supp. 2d 802, 811 (N.D. Ohio 2002), and whose former Chief Judge held design defect claims for a branded drug preempted four years before Bartlett in Longs v. Wyeth, 621 F. Supp. 2d 504, 508-09 (N.D. Ohio 2009), reversed in part sub nom. Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010).  We are happy to spread the word on Booker, hope it gets published, and hope that other courts follow its path.

Tuesday, October 14, 2014

No, HIPAA Does Not Preempt Informal Treater Interviews

For over seven years, we’ve been following the odd little romance that the other side of the “v.” has been having with purported federal preemption of state litigation practices that allow our side to conduct voluntary, informal interviews with treating physicians – since our “HIPAA Does Not Preempt State Litigation Practice” post back in DDLaw’s formative Beck/Herrmann days.  To put our position in one sentence, since HIPAA has an explicit exception for litigation (45 C.F.R. §164.512(e)), HIPAA has no preemptive effect on state law that accords both sides the same right to talk to treating physicians informally.

We cheered when the New York Court of Appeals got it right and hissed when a Missouri intermediate appellate court got it wrong.  Well, we’re cheering again, and we like that better.

Last Friday the Eleventh Circuit decided Murphy v. Dulay, ___ F.3d ___, 2014 WL 5072710 (11th Cir. Oct 10, 2014), and rejected a HIPAA challenge to a Florida statute allowing – indeed effectively routinizing (if the doctor is willing) – informal treater interviews.  Murphy isn’t going to help our clients directly, since the statute in question applies only to medical malpractice cases, and general Florida law, according to our 50-state survey of informal interview law is adverse.  Still, precedent is precedent, and a federal appellate court rejecting bogus HIPAA preemption arguments should be rather persuasive, as well as fun to blog about.

Here’s what happened in Murphy.  In 2011, the Florida Legislature required that all medical malpractice plaintiffs jump through certain procedural hoops before filing suit.  One of those steps was to “execute a written authorization form for release of protected health information” that included authorization for defense side informal treater interviews.  Murphy, 2014 WL 5072710, at *1 (citing Fla. Stat. §766.1065(2)(a)).  As described in Murphy:

The authorization form must expressly allow ex parte interviews, stating:  “This authorization expressly allows the persons or class of persons listed . . . above to interview the health care providers listed . . . above, without the presence of the Patient or the Patient’s attorney.”  Id. §766.1065(3)(E).  Those “persons or class of persons” include the doctor defendant, his insurer, adjuster, experts or attorneys.  Id. §766.1065(3)(D)-(E).  Thus, the doctor defendant’s attorney would be able to interview ex parte the treating physician of a plaintiff.  However, the statute does not require the treating provider to submit to a request for an interview.  See id. §766.106(6)(b)(5).

2014 WL 5072710, at *3.

Almost immediately, some Florida would-be plaintiff went running to federal court with a declaratory judgment action whining that this Florida law – which specified that the form release must be HIPAA compliant – was nevertheless preempted by HIPAA.  2014 WL 5072710, at *2 (citing Fla. Stat. §766.1065(3)).  Some pro-plaintiff district judge agreed, holding that despite exempting litigation, HIPAA required that informal interviews be “voluntary,” and the statute wasn’t because plaintiffs couldn’t file medical malpractice actions without signing the release.  2014 WL 5072710, at *4.  The Court of Appeals unanimously reversed.  Nobody has to sue anybody.

Interestingly, plaintiffs fell afoul of their own favorite canard, the presumption against preemption.  Id. at *5 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)).  Murphy found that two express exceptions to preemption (which could be called “savings clauses”) potentially applied:  “First, disclosure may be made through the judicial process.  2014 WL 5072710, at *5 (citing §164.512(e)).  Second, disclosure is permitted if an individual expressly authorizes release of his or her medical information in a valid authorization form.  See id. §164.502(a)(1)(iv).”  The litigation exception – the one we like to cite here at DDLaw – provides:

[E]ven without a written authorization, “[a] covered entity may disclose protected health information in the course of any judicial or administrative proceeding.”  Id. §164.512(e)(1).  But certain procedures must be followed.  Information may be released only in response to:  (1) an “order of a court or administrative tribunal,” or (2) a “subpoena, discovery request, or other lawful process, that is not accompanied by an order of a court or administrative tribunal,” when certain conditions are met.  Id. §164.512(e)(1)(i)-(ii).

2014 WL 5072710, at *7.  Those conditions are either notice to the other side, or entry of a “a qualified protective order” involving protection against further dissemination.  Id. (citing §164.512(e)(1)(ii)).
HIPAA also allows disclosure via a “valid” written authorization.  Id. (citing §164.508).  That avenue has a bunch of its own exceptions and requirements, which we discuss below.  Id. (citing §164.508(b)(2)).  We’re being uncharacteristically punctillous with the citations because HIPAA is complex and we want our readers to know how to navigate this.

Put more than one exception together and one has a “compound authorization,” whereby “an authorization for the use and disclosure of protected health information is combined with any other legal permission.”  2014 WL 5072710, at *8 (citing 78 Fed. Reg. 5565, 5609 (Jan. 25, 2013)).  Even that has exceptions, including that medical treatment may not be “conditioned” upon such an authorization.  Id. (citing §164.508(b)(3)(iii)).

So much for the gobbledygook.  The ruling in Murphy is much more straight-forward.  First, Florida is allowed to require an authorization because the authorization complies with everything HIPAA can throw at it.  The statute “ensur[es] that the form meets each of the required elements set forth in the HIPAA regulations.”  Murphy, 2014 WL 5072710, at *10.  The authorizations are explicitly revocable.  That revocation comes with ancillary consequences – “that the presuit notice is deemed retroactively void” and “a plaintiff’s medical negligence claim may be barred by the statute of limitations” – doesn’t matter.  “HIPAA regulations do not require that a person be able to revoke an authorization free of any consequences.”  Id.

Second, there is a “legitimate purpose” – additional privacy protection – to require a plaintiff to list treaters who (a plaintiff claims) has no relevant information.  Id. at *11.  We note that it also keeps plaintiffs from hiding relevant treaters, which they routinely do.  Further, even if there were no HIPAA-related purpose, there doesn’t have to be.  “HIPAA regulations do not require that the scope of an authorization be commensurate to a specific, legitimate purpose.”  Id.

Third, the statutory authorization is quite “specific,” specifying access to “all” information.  That the scope of material released is “broad” doesn’t mean it isn’t “specific.”  “[Plaintiff] may not like the breadth of the authorization . . . but the HIPAA regulations do not require that authorizations be narrow, simply that they be specific.”  Id.  The purpose of the release is crystal clear, to defend a malpractice action.  Id.  Stop whining.

Fourth, and finally, there’s no improper “compound authorization.”  The statute conditions litigation, not medical treatment, on its execution.  Id. at *12.  “The presuit notice is merely a condition precedent for filing a medical negligence suit in Florida state court.”  Id.

Because the statutory procedure meets HIPAA’s authorization exception for release of information, it doesn’t matter that Florida doesn’t require that any notice be given of the informal interviews, as the litigation exception requires:

Because [the statute] is consistent with HIPAA’s requirements for disclosure by written authorization, it is also irrelevant whether [it] calls for procedures that satisfy the requirements of another HIPAA disclosure exception − including the exception for disclosure by judicial process. . . .  [W]hen an individual executes a valid HIPAA authorization, he waives all HIPAA protection as to the health information covered by the authorization, including the protections against litigation-related disclosures. Accordingly, no other HIPAA exception for disclosure needs to be satisfied once an individual signs a valid written authorization.

2014 WL 5072710, at *12 (citations and footnote omitted).  We don’t mind giving notice under the litigation exception, as long as plaintiffs aren’t permitted to threaten their treaters, but we have to say that this Florida statute is ingenious in creating a way around that litigation-related requirement.

In the end the plaintiff in Murphy was left trying to create something that wasn’t there – a “voluntariness” gloss on HIPAA that would prevent any state from conditioning anything on the release of information otherwise considered confidential under HIPAA.  That “Hail Mary” pass didn’t work either.  HIPAA itself allows for “coercive” release of medical information to qualify for federal health insurance benefits.  Id. at *14.  [A]s plaintiff’s decision whether to file suit is still a voluntary one,’ once a plaintiff chooses to sue, s/he can’t hide information from the other side.  Id.  “[I]t was their choice to file the suit in the first instance.”  Id. at *13-14 (citations and quotation marks omitted).  Thus, there is no preemptive conflict with HIPAA:

The HIPAA regulations allow authorizations to be based on conditions − such as employment, Medicaid benefits, and other incentives − and prohibit only one type of condition.  Even that condition is not absolute but has exceptions.  Further, an individual’s decision to sign an authorization prior to bringing a medical negligence claim in state court is not an involuntary one.  If an individual does not wish to execute such an authorization, he does not have to.  He is, however, precluded from using the Florida courts to obtain relief through a medical negligence lawsuit against a health care provider.

2014 WL 5072710, at *15.  In the end, the result in Murphy is the same as it was under the common law physician-patient privilege, as we discussed here, the volutary decision to file suit legitimately works a waiver of privacy concerns that might otherwise inhibit the other side’s access to the information necessary to defend that suit.  Anybody who doesn’t like it shouldn’t sue.

Monday, October 13, 2014

The Scylla and Charybdis of PMA Preemption

This post is from the non-Reed Smith side of the blog only.

            It’s been a while since we’ve seen a legal reference to Scylla and Charybdis, the sea monsters of Greek myth who posed an intractable dilemma to all sailors who attempted to navigate between the two.  It is a tried and true metaphor, like its modern English counterpart -- between a rock and a hard place.  But it is particularly fitting in products cases dealing with pre-market approved medical devices.  So, even though it is another favorable InFuse decision and we probably would have blogged about it anyway, the court’s clever turn of phrase was enough to reel us in:

In light of Riegel and Buckman, a plaintiff can survive a preemption challenge to a state-law tort claim concerning an allegedly defective medical device only by steering between the Scylla of express preemption under § 360k(a) and the Charybdis of the implied Buckman preemption of claims that exist solely by virtue of the FDCA. It is a challenge to avoid one obstacle without colliding with the other, because the plaintiffs must show that a manufacturer has violated federal law if they are to defeat express preemption, but the plaintiffs must also show that their legal theories predated the federal enactment or would exist independently of federal law if they are to defeat implied preemption.

McCormick v. Medtronic, Inc., 2014 Md. App. LEXIS 117 (Md. App. Ct. Oct. 6, 2014).  Well said!  And, as has been the case in most InFuse matters – plaintiffs crashed into both obstacles leaving only small bits of their vessel (complaint) intact. 

            We’ve blogged about dozens of InFuse cases at this point and you can peruse those posts at your leisure here.   And, if you are defending off-label promotion claims, we recommend a less leisurely stroll – there is a lot of good stuff in these cases.  All of the InFuse plaintiffs have attempted to sail between Riegel and Buckman preemption by tethering their claims to allegations of off-label promotion – and usually not much else.  Overwhelmingly, courts have seen through the gambit and the claims have either been wrecked on the rocks or swallowed by the whirlpool.  This case is really no different, but it does make some good points that we wanted to bring to your attention.    

            First and foremost, this is a Maryland appellate court decision explicitly rejecting an awful Maryland trial court decision in another case that held that express preemption doesn’t apply at all where off-label promotion is alleged.  That decision was more a parting of the Red Sea for plaintiffs, giving them a wide berth right through preemption.  But, the McCormick court found that the reasoning of that trial court was correctly “almost universally rejected elsewhere.”  Id. at *33 n. 13.

            Maintaining that plaintiffs were still required to maneuver between both express and implied preemption, the court found all claims preempted except those premised on false off-label promotion, including breach of express warranty.  Misrepresentation claims, whether sounding in fraud or negligence, parallel FDCA prohibitions on untruthful off-label promotion and therefore are not expressly preempted.  Further, because fraud and misrepresentation are “traditional state common law” claims, they exist independently of the FDCA and are not impliedly preempted.  Id. at *34-37.  Importantly, the court is adamant that the non-preempted claims are only those involving allegations of misstatements or misrepresentations:

The claims are also impliedly preempted to the extent that they may concern the act of off-label promotion itself, divorced from any misrepresentations that Medtronic may have made in the course of off-label promotion. Such a claim exists solely by virtue of the federal statutes and regulations that concern misbranding, and the claim has no independent existence in Maryland law.

Id. at *40.  We would expand that last part to include any state law, but we see where that would be overreaching by the court.

            Traditional failure to warn claims were also preempted:

These claims are preempted insofar as they attack the accuracy or adequacy of the statements that Medtronic made in the FDA-mandated and FDA-approved labeling.   To fault Medtronic for making the statements that the FDA required it to make, or to impose liability on Medtronic for not making statements that the FDA required it not to make, would be to impose state-law requirements that are "different from, or in addition to," those imposed by the FDCA.  

Id. at *34-35; *41 (preempted negligent failure to warn as well).

            Finally, plaintiffs’ strict liability claim was vague at best, alleging only that “off-label use of the product . . . was defective, unsafe, and ineffective.”  Id. at *42 (emphasis in original).  In so far as plaintiff framed his claim around use, he sailed right into both express and implied preemption:

To the extent that the complaint would impose liability on the basis of the risk-utility or consumer-expectation tests, it is expressly preempted under § 360k(a). The FDA has approved the Infuse product, and the agency neither has prohibited nor can prohibit its off-label use by members of the medical profession. Because Maryland cannot impose different or additional requirements, the risk-utility and consumer-expectation allegations fail to state a claim.
The complaint also fails to state a claim insofar as it attempts to premise a products liability claim on off-label use: products liability law concerns products, not the uses of products. In any event, to the extent that the [plaintiff’s] products liability claim is a stand-in for a complaint about the off-label use of the Infuse product, it is impliedly preempted under Buckman, because the concept of illegal off-label use or promotion of a medical device would not exist but for the FDCA.

Id. at *43.  And while the court concluded that plaintiff wasn’t alleging a design defect claim, the opinion notes that such a claim would have been expressly preempted because “FDA has carried out the only permissible risk-benefit analysis as to the appropriate product design.”  Id. at *44 n. 17.     

            As has also been the situation in many of the InFuse cases – while fraud and misrepresentation claims aren’t preempted, they also aren’t pleaded sufficiently.  In this case, the complaint lacked specificity as to when and how the alleged false statements were made.  Vague references aren’t enough to meet the heightened standard of particularity for fraud and therefore the claims were dismissed, but plaintiff is being afforded a chance to correct the defects.

            The InFuse litigation continues to offer defendants calm seas and smooth sailing.  We’ll take that every time.