Medical Device Preemption Developments

Boring title, but accurate.  Here’s the latest.


First, Medtronic won another one the other day.  Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503 (D. Mass. Jan. 10, 2012), involved an insulin delivery system.  It had a number of components, including the pump, which physically moved the insulin from where it’s stored into the body.  Plaintiffs alleged that the pump malfunctioned and caused undisclosed injuries.

The insulin system was a PMA device, so the defendants moved for summary judgment on grounds of preemption.  Plaintiffs targeted the pump, rather than any other aspect of the system, because the pump had originally been §510k cleared (unpreempted under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) – by itself – in 2004.  The insulin delivery system predated the pump, and was PMA approved.  By PMA supplement in 2006, the FDA approved incorporation of the pump into the system.  The plaintiff was prescribed that system.  Duggan, 2012 WL 45503, at *3-4.

Plaintiffs’ primary argument for avoiding preemption was that the components in the system should be parsed, the 2006 PMA supplement ignored, and the pump treated as a “mere” §510k device.  They got nowhere.  The same argument had been made, and rejected, in other device system litigation (mostly knee implants, if we recall):

Many courts have held that once premarket approval is granted, all claims relating to all components of the device are preempted. This analysis applies even where a component of a PMA-approved device had previously been approved through the § 510(k) process.

Id. at *4 (citations omitted).

Plaintiffs then tried component part argument 2.0, claiming that the data in the defendant’s supplement was insufficient to support PMA approval of the pump.  Id. at *5.  The opinion doesn’t detail the basis of that argument, but we assume that some malleable FDA “expert” was involved.  The court refused to allow PMA preemption turn on a litigant’s after-the-fact deconstruction of the approval submission.  What the FDA decided, not what a litigant claimed that the FDA should have decided, controlled:

[T]he sufficiency of the data submitted to the FDA with respect to the safety and efficacy of a device does not govern the scope of the premarket approval.  Whether a product is FDA-approved is determined by the language in the approval letter, not by the application documents submitted to it for review.  The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval.

Duggan, 2012 WL 45503, at *5 (citing our old pal, Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)).  We view this holding as the most important takeaway from Duggan.

Interestingly, plaintiffs also tried to intervene with the FDA itself, attempting to depose Agency personnel and filing an FDA citizen’s petition challenging the scope of the PMA.  2012 WL 45503, at *3.  Both moves backfired.  It’s really difficult to depose government personnel when the government doesn’t want it.  E.g., United States ex rel. Touhy v. Regan, 340 U.S. 462 (1951).  That goes double for the FDA in the First Circuit.  See Giza v. Secretary of HEW, 628 F.2d 748 (1st Cir. 1980).  Oops.  Duggan, 2012 WL 45503, at *5 (plaintiffs forced to drop subpoena).  On top of that, the FDA denied the petition, reaffirming that the PMA covered the entire system.  Really oops.  Id. (“[t]o the extent there was any ambiguity about the scope of the approval letter, this rejection of the Citizen Petition is the cherry on the icing”).  Observing that plaintiffs had thusly shot themselves in the foot, the court granted summary judgment.  Id.

Second, Boston Scientific won a preemption motion in a rather unusual case in Erickson v. Boston Scientific Corp., No. SACV 10-698 AG (ANx), slip op. (C.D. Cal. Dec. 12, 2011).  We’re only just finding out about it, though.  The unusual nature of the case is the general attack on the life expectancy of several of the defendant’s products (pacemakers powered by batteries).  The plaintiff claimed that he had been told that four different pacemakers “would last ten years” but that none of them (except the last, which hadn't been implanted very long) came close to that lifespan.  Slip op. at 2.

Erickson was dismissed via judgment on the pleadings.  So, initially, it is a valuable judicial notice decision, as the court took judicial notice of the FDA approvals of all four pacemakers (six total FDA documents) – a PMA, two PMA supplements, and several supplemental product development protocols (“PDPs”).  Slip op. at 3-4.  Judicial notice, of course, allows for dismissal on the pleadings, thereby saving considerable discovery expense and reducing the nuisance value of plainly preempted litigation.

Erickson held that both of these regulatory avenues – the PMA supplements and supplemental PDPs – were equivalent to pre-market approval, and thus preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), barred the action.   Slip op. at 7.  The decision discussed supplemental PDPs at some length:

Some of Defendants’ pacemakers were not subject to the FDA’s PMA process, but were instead approved through the FDA’s supplemental Product Development Protocol (“PDP”).  In Reigel, the Supreme Court stated that an application for supplemental premarket approval is “evaluated under largely the same criteria as an initial application.”  Riegel v. Medtronic, Inc., 552 U.S. 312, 319.  Courts have interpreted Reigel to mean that preemption applies equally to both the PMA and PDP processes.

Slip op. at 8 (other citations omitted).  We’ve seen supplemental PMA and PDP preemption decisions before (see our device preemption scorecard for details), but Erickson is the first case we can recall specifically discussing a supplement to a PDP in the context of preemption.  That’s probably the most important takeaway from Erickson.

In Erickson the plaintiff also trotted out the “parallel violation” exception.  Slip op. at 9-10.  The defendant made mincemeat of it – aided significantly by the plaintiff's failure to plead anything resembling an adequate parallel claim.  Plaintiff did not allege what was violated or how that related to his claim.  Id. at 9-10. That didn’t cut it:

[A] plaintiff cannot simply incant the magic words “[defendant] violated FDA regulations” in order to avoid preemption.  Rather, a plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue, or identify specific PMA requirements that have been violated.

Slip op. at 9 (citations and quotation marks omitted).

The only thing specific that the plaintiff in Erickson alleged was that some of the pacemakers had been recalled.  A bare allegation of a recall, however, wasn’t nearly enough.  First, “[m]any courts have recognized that product recalls do not create a presumption that FDA requirements have been violated.” Slip op. at 10 (citations omitted).  Second, recalls do not amount to withdrawal of approval.  Id. Third, the recall wasn't even relevant, since there was no allegation “that the recall was prompted by defects relating to the pacemakers’ longevity.”  Id.

The treatment of the recall is a second very usable takeaway from Erickson. Finally, for the record, Erickson also dismissed fraud claims as insufficiently pleaded, slip op. at 10-11, and throws out several of the claims (the older pacemakers) under the statute of limitations.  Id. at 13-15.

Mensing and TwIqbal Team Up To Deliver a Knockout

            We know sports-courtroom analogies are overused, hackneyed, timeworn, trite (you get the idea).  But, nevertheless they can be useful and provide a little color to what might otherwise be viewed by some (of course, not us) as dull legal goings on.  For instance, we could simply report that the District of Maryland tossed out another case against a generic prescription drug manufacturer.  Grinage v. Mylan Pharmaceuticals, Inc., 2011 U.S. Dist. Lexis 149667 (D. Md. Dec. 30, 2011).  Or we could say –

A four-round hard glove fight took place in at 101 W. Lombard Street, Baltimore in the final days of 2011.  The fight pitted local Beatrice “the Plaintiff” Grinage against West Virginia’s own Mylan “the Defendant” Pharmaceuticals.  Catherine C. Blake, United States District Judge acted as referee.  The stakes were Grinage’s claim for the wrongful death of her husband allegedly caused by his ingestion of generic Allopurinal.  From the minute the bell rang, it was evident that the Defendant, with the law on its side, had the reach advantage.  In the first round, the Defendant had Grinage reeling from a right uppercut.  In the second, the Defendant’s left jab, right cross combination almost finished the Plaintiff off.  The Plaintiff hung in for two more rounds, but the devastating blows from the prior rounds had taken the wind from the Plaintiff’s sails.  With one last hook, the Plaintiff went down; the bell rang and Mylan emerged victorious.   And the crowd went crazy!!

OK, back to reality.  The punches were really Mensing and TwIqbal and they were as effective as any roundhouse and equally impervious to all plaintiff’s bobbing and weaving.

Round One – Failure to Warn:  Plaintiff tried to dodge Mensing by arguing efficacy over substance.  If claims regarding the substance of the generic drug warning are preempted, plaintiff claimed that generic drug manufacturers should have tried to harder to provide the warning they were allowed to give.  Grinage, 2011 U.S. Dist. Lexis 149667, *10.  Plaintiff argued that the defendant should have “employed more effective communication to healthcare providers and consumers” through things like Dear Doctor letters, training programs and public notifications.  Id.  To be clear, plaintiff’s contention was that the defendant could have met its duty to warn by using these methods of communication “without including substantial new warning information.”  Id. at *12.  However, even if Mensing leaves open for consideration a claim for “effective communication,” you still have to plead causation: 

Here, there is no allegation that [plaintiff] and his doctor did not see the labeling as it was approved and take into consideration the information included therein . . . . Nor has [plaintiff] alleged any other facts sufficient to support a reasonable inference that further communications consistent with the approved label would have affected the choices made by [plaintiff] or his doctor.

Id. at *13.  Down goes failure to warn.

            Round Two – Defective Design:  This is where Mensing and TwIqbal work a really effective combo.  Maryland state courts are divided over whether the proper test for determining if a prescription drug is defectively designed is risk-utility or consumer expectation.  The latter fails under Mensing:

An ordinary consumer forms her expectations regarding the safety of drugs from her doctor or from the drug's label. Thus, if [a drug] is dangerous beyond the expectations of the ordinary consumer, that can only be a symptom of [the manufacturer’s] failure to update its label or communicate effectively with doctors. For reasons articulated above, any state law defective design claim predicated on this theory is pre-empted by FDA labeling regulations.

Id. at *18.   But plaintiff’s design defect claim couldn’t be helped by application of the risk-utility test because she failed to plead any facts regarding the utility of the drug or the availability of less dangerous alternatives.  In steps TwIqbal.  “Here, no factual allegations are included that raise the right to relief on a risk-utility design defect theory above the speculative level.”  Id. at *19.  Down goes design defect.

            Round Three – Breach of Implied Warranty:  With the plaintiff on the ropes, the breach of warranty claims topple over with very little resistance.  First, a breach of warranty of merchantability requires proof of the existence of a defect.  Id. at *20-21.  See rounds one and two.  Second, a breach of warranty of fitness for a particular purpose requires an allegation of a particular purpose “as distinguished from the ordinary or general use to which the goods would be put by the ordinary buyer.”  Id. at *21.  No such allegation means no such claim.  Down goes breach of warranty.

            Round Four – Fraud:  Plaintiff is staggering and it doesn’t take much to secure the knockout.  Fraudulent representations allegedly made to the plaintiff or his doctor – preempted under Mensing. Id. at *22-23.  Fraudulent representations allegedly made to the FDA – insufficiently pled to meet the heightened requirements of Rule 9(b):

The complaint contains no reference to any specific communication to the FDA that constituted a misrepresentation, or to any specific studies or other information improperly omitted from filings or other communications with the FDA.

Id. at *23-24.  And, we would argue this fraud claim is also preempted by Buckman, but we’ll settle for a Rule 9 dismissal.  Down goes fraud.

            Another bout goes in the books in favor of generic drug manufacturers.  Thanks to Adam S. Ennis  at
Jackson Kelly PLLC for passing this one along. 

Shameless Plug - Free Webinar on Duty to Warn in the Digital Era

On January 25, 2012 (Bexis’ birthday), between 12:00-1:00 p.m. (EST), our friends who publish the Physicians Desk Reference are putting on a free webinar entitled "‘Duty-To-Warn’ in the Digital Era: Emerging Issues."  You can register for it online here.

And did we mention, it's free?

Here’s a brief description of the subject matter:

Manufacturers have a legal responsibility to communicate the known risks associated with their medications and ‘duty-to-warn’ responsibilities have traditionally been fulfilled by publishing labeling information online or in reference texts.

However, as physician workflow consolidates around electronic health record systems, manufacturers may increasingly find themselves under scrutiny regarding their ‘duty-to-warn’ efforts – how and where they provide safety messaging will make the difference.

Hear industry experts share the latest developments in:

• ‘Duty-to-warn’ relating to medical malpractice litigation and product liability management, including an update on the Supreme Court’s recent cases and the impact on generics.
• The increasing role of technology in the evolution of ‘duty-to-warn’ benchmarking.
• The growing responsibility on regulatory and marketing operations regarding ‘duty-to-warn’ in healthcare IT systems.
• The importance of labeling information in the physician’s electronic workflow.

Why do we care?

Well, Steve McConnell of our blog (the guy who mostly writes the funny Monday posts) is one of the panelists, and he’s going to be presenting much of the legal framework for the webinar.  Other panelists include Christopher L. Gaenzle, Assistant General Counsel for litigation at Pfizer; Richard E. Hinson, and former senior marketing executive at Roche; Jay H. Stone, M.D., an interventional cardiologist at the Shore Cardiac Institute in Toms River, N.J.  The moderator is Brian McDonough, .M.D., a syndicated medical correspondent.

So if you’d like to interact with Steve, and learn something about the interface between technology and defending litigation involving prescription drugs and medical devices, drop in on this webinar.  For additional information, contact Jason Willett at (415) 644-3926 or by email at jason.willett@pdr.net.