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

We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent Third Circuit opinion deciding plaintiff’s appeal isn’t the full affirmance we had been hoping for. But before you get the wrong idea, the Third Circuit got the most important issue right – when you have a multi-component medical device, PMA preemption is to be addressed on a component-by-component basis. After that, however, the appellate decision does some unraveling of the district’s dismissal of the claims that survived preemption and so the case is going back to the Eastern District.

Briefly, the facts are that plaintiff underwent a hip replacement surgery in which his surgeon opted to use a Smith & Nephew device that consisted of several component parts, one of which was the R3 metal liner. Shuker v. Smith & Nephew, PLC, 2018 U.S. App. LEXIS 5160, *11 (3d Cir. Mar. 1, 2018). Unlike the other components of the device, the liner had undergone FDA Pre-Market approval. Id. And, the parties are in agreement that the surgeon’s decision to use the R3 metal liner with this particular device was an off-label use. Id. at *12. Plaintiff suffered complications that required additional revision surgeries.

In its first decision, the district court tossed out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. When plaintiff filed an amended complaint attempting to correct the pleading deficiencies for the non-preempted claims, he again missed the mark and his remaining claims were dismissed with prejudice. The district court also entered a decision finding that it lacked personal jurisdiction over Smith & Nephew, PLC – a foreign parent company. Those three rulings are what the Third Circuit addressed in last week’s decision.

The question of how to apply PMA-preemption to a multi-component device was one of first impression in the Courts of Appeal. Id. at *2. And it is an important question because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds. The Third Circuit did a precise analysis that landed at the proper conclusion. However, the analysis does start up with a bit of a hiccup. Since we are talking about PMA-preemption, we are dealing with express preemption. Yet, in a footnote the court refused to follow the Supreme Court’s recent abolition of the presumption against preemption in the express preemption context set forth in Puerto Rico v. Franklin Cal. Tax-Free Tr., 136 S.Ct. 1938 (2016), because that decision wasn’t a products liability case and therefore did not directly concern the “historic police powers of the States.” Shuker, at *16n.9. We respectfully disagree with this conclusion for all the reasons we mention in our post discussing Franklin and simply point out that other courts have reached the opposite conclusion. Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).

Fortunately, that did not derail the Third Circuit from ultimately concluding that plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under Riegel. To do that, the court had to determine to what device it was applying the preemption analysis. Plaintiff argued that you have to look at the device that was implanted as a whole. Whereas defendant, bolstered by an amicus brief filed by the FDA at the court’s request, maintained that the proper focus is on the component of the device with which plaintiff takes issue. Shuker, at *18. Agreeing with the defense position, the court anchored its decision on three findings. First, the FDCA defines “device” to include “components, parts, and accessories.” Id. at *19. Second, the FDCA’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which the FDA approved use. Id. at *20. And despite the use to which the component is put, the FDA’s PMA-regulations for the component follow with it. In other words, “premarket approval requirements apply equally to the components, as manufacturers generally may not deviate from the requirements imposed through premarket approval regardless of how [a component] is used.” Id. (citation and quotation marks omitted). Third, the FDA’s position is that the device is not limited to the device as a whole but includes components. Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. Id. at *21-22.


[t]aken together, the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level. . . .. And the Riegel test is properly framed at Step One as “whether the Federal Government has established requirements applicable” to a component of the hybrid system.

Id. at *22-23. Because the part of the device plaintiff attacked was the R3 metal liner which was premarket-approved, any state tort claim that seeks to impose requirements that are different from or in addition to the FDA’s requirements for that component are preempted. That includes plaintiff’s negligence, strict liability, and implied warranty claims.

The appellate court next reviewed the dismissal of plaintiff’s claims that survived preemption – negligence and fraud claims based on alleged off-label promotion in violation of federal law – and found the negligence claim was adequately pleaded but that plaintiff failed again to satisfy Rule 9’s heightened standard for pleading fraud. As to negligence, the court found TwIqbal satisfied as to duty, breach, causation where plaintiff alleged:

  • the R3 metal liner was approved only for use with a different system and therefore under federal law defendant had a duty to refrain from false or misleading advertising;
  • in a press release, defendant misleadingly marketed the R3 metal liner as an option for the system used by plaintiff’s surgeon (one other than the one it was approved for); and
  • plaintiff’s surgeon “either read” or “was aware” of the press release.

Id. at *28-29. Like the district court, the Third Circuit considered and relied upon the press release cited in plaintiff’s complaint. Unlike the district court, the Third Circuit appears to only focus on the portions of the press release upon which plaintiff relied (see prior post for more details) and concludes that’s enough to get plaintiff to the discovery stage. Id. at *29n.18. Although we wonder if the court’s calling plaintiff’s allegations enough to “nudge” the claim over the threshold is a veiled acknowledgement of just how narrowly the complaint squeaked by. See id. at *30.

Meanwhile, plaintiff’s fraud claim needed more than a nudge and it didn’t get even that. The court focused on plaintiff’s failure to plead justifiable reliance on the alleged misrepresentation. The “read” or “was aware” of allegation that sufficed for negligence lacked the requisite details regarding how the press release “induced or influenced” plaintiff’s surgeon for a fraud claim. Id. at *33-34. Plaintiff has to allege the “circumstances of the alleged [influence on Mr. Shuker’s surgeon] with sufficient particularity to place [defendant] on notice of the precise misconduct with which it is charged.” Id. at *34. Despite this having been plaintiff’s second failed attempt at meeting the pleading standard on fraud, the Third Circuit decided to give plaintiff another chance and found the claim should only be dismissed without prejudice.

Finally, there was a separate finding by the district court that it did not have personal jurisdiction over Smith & Nephew, PLC, a foreign parent company. The Third Circuit agreed with the district court that specific personal jurisdiction was not conferred on a stream-of-commerce theory. Id. at *36-37. We’ve talked about this before and more recently in light of BMS v. Superior Court, and like the Third Circuit “we have no cause to revisit” the precedent on the issue (but you should feel free to). But the court did think plaintiff alleged enough in his complaint to allow some limited jurisdictional discovery on possible alter ego based personal jurisdiction. Id. at *38-40. Emphasis on the limited part. See id. at *40n.20 (“District Court should take care to circumscribe the scope of discovery . . . to only the factual questions necessary to determine its jurisdiction;” further referencing proportionality amendment to Rule 26(b)(1)).

So, on the third pass plaintiff got a little life breathed back into this case which is unfortunate, but as the first appellate decision on component preemption – we’ll put it in the win column.

Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.”  All of our flights were delayed, although we were luckier than many.  When we landed at Dulles for our connecting flight home, the queue at the customer service booth comprised hundreds of stranded passengers looping around and around like the approach to Space Mountain, hoping, with varying degrees of impatience and panic, to reschedule canceled flights.  But our connecting flight was only late – very late.  We sat at our gate for almost three hours, then were finally allowed to board.  We buckled in, we watched a taciturn flight attendant demonstrate the seat belts we were already wearing, and then we sat.  For forty more minutes.  (By now, it was 12:30 a.m.)  Finally, the “flight deck” made an announcement:  we were sitting still because the trash can in the galley lacked a lid, and this was a “safety hazard” that had to be rectified before we could take off.  And so we were waiting for the “caterer,” a contractor, to bring a new trash can.  Eventually, a truck pulled up, but it was carrying the wrong type of trash can.  Ultimately, someone went next door to a plane that was done flying for the night — as all sane people were, by that point – and stole a trash can.  And we were on our way.

So who was at fault?   Was it the contractor, which (twice) provided the wrong trash can? Or was it the airline, which shall remain nameless because (trust me) it doesn’t need any more bad publicity and which specified and installed the trash can?  Depends on the nature of the claim, under a (very very) loose interpretation of today’s decision from the Eastern District of Wisconsin.

In Janusz v. Symmetry Medical, Inc., 2017 U.S. Dist. LEXIS 88895 (E.D. Wis. June 9, 2017), the plaintiffs alleged that the femoral neck of their artificial hips systems broke, requiring additional surgeries to replace the hip system.  The femoral neck was a component, manufactured by the defendant according to specifications and instructions provided by the hip system’s fabricator (which was bankrupt by the time of suit).  The plaintiffs asserted claims sounding in negligence and strict liability against both companies, and the component manufacturer moved for summary judgment, asserting the so-called “contract specification defense” to the plaintiffs’ claims.  This is a component part manufacturer’s defense, and not one we have ever discussed here.  Hence, our interest in Janusz.

Under this defense, a manufacturer that “makes a product strictly in accordance with the design specifications of another is not liable in negligence unless the specifications are so obviously defective and dangerous that a contractor of reasonable prudence would have been put on notice that the product was dangerous and likely to cause injury.” Januscz, 2017 U.S. Dist. LEXIS 88895, at *11 (citation omitted).  And, while this defense is not among the five defenses listed in Wisconsin’s product liability statute, the court held that the statute supplemented but did not supersede common-law doctrines that weren’t inconsistent with it.  While Wisconsin common law had not adopted the contract specification defense, either, it had adopted the “government contractor defense,” the underlying principles of which — declining to hold a contractor liable when it manufactured a product according  to the specifications of another – overlap those of the contract specification defense.  Under the government contractor defense, a contractor that “makes a product strictly in accordance with the design specifications of another is not liable in negligence unless the specifications are so obviously defective and dangerous that a contractor  of reasonable prudence would have been put on notice that the product was dangerous and likely to cause injury.” Id. at *12 (citation omitted).  This is essentially the same test used in the contract specification defense generally. See Restatement (Third) of Torts: Products Liability §5, Reporters’ Note to Comment a (1998) (a “majority of courts” hold “that a manufacturer of a component part . . . cannot be held strictly liable . . . so long as the specifications provided are not so obviously dangerous that it would be unreasonable to follow them”) (citation and quotation marks omitted).

In Januscz, however,  the court drew a distinction between negligence and strict liability that does not exist generally.  It held that, “[i]ntuitively,” it made sense that “an entity that has no role in designing a product should bear no liability if the product is defectively designed.” Id. at *12.  But “that intuitive  reaction follows only when plaintiff’s theory of recovery is negligence.” Id. (citations omitted).  And, “in Wisconsin, product liability was and is a matter of strict liability.” Id. at *13 (citations omitted).  In the strict liability context, unlike in negligence, “the focus is on the dangerousness of the product regardless of the defendant’s conduct.  Thus, a defendant may be blameless but strictly liable.” Id. (internal punctuation and citations omitted).  The court concluded that, given  the  “recent codification of product liability law reaffirming Wisconsin’s commitment to  the principles of  strict liability, if  presented with a question of whether the contract specification defense applies to a question of strict liability under Wisconsin law, the Wisconsin Supreme  Court would hold  that it does not.” Id. at *24. Januscz declared that “strict liability means strict liability.   It exists to shift costs associated with unsafe products to those  who are in the best position to disperse  those costs (be it through insurance, indemnification,  or some other means.” Id. at *25.  And, the court held, the “contract specification defense significantly undermines the policies underlying strict liability.  Therefore, the court concludes that the defense does not exist  under Wisconsin law.” Id. at *26.

This result is simply wrong under Wisconsin law. The Januscz court completely failed to cite the most relevant case, Schreiner v. Wieser Concrete Prod., Inc., 720 N.W.2d 525 (Wis. 2006), in which the Wisconsin Supreme Court expressly adopted Restatement Third §5 as “consistent with Wisconsin law.” Id. at 530.  Thus, Wisconsin law does not distinguish between negligence and strict liability, particularly in the context of product specifications and component parts. See also Spychalla v. Boeing Aerospace Operations Inc., 2015 WL 3504927, at *3 n.2 (E.D. Wis. June 3, 2015) (recognizing Wisconsin’s adoption of §5 after enacting of tort reform statute).  Indeed, after correctly holding that the Wisconsin tort reform statute only “supplements” the common law Januscz failed even to cite Restatement Third §5 – the relevant Wisconsin common law for component parts under Schreiner.  If anything, the statute reinforces use of the Third Restatement in Wisconsin, since the statute generally adopted that Restatement alternative design defect test and its “not reasonably safe” defect terminology. See Wis. Stat. §895.047(1)(a) (“A product is defective in design if the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the manufacturer and the omission of the alternative design renders the product not reasonably safe.”).

Rather than actually follow Wisconsin law, the court simply repeated the truism that “strict liability does not mean absolute liability.”  2017 U.S. Dist. LEXIS 88895, at *26 (emphasis in original).  To wit, a component manufacturer could escape liability if its component part underwent substantial change when it was included in the assembled device.  But, the court held, the defendant’s femoral neck component did not undergo such change.  And so the court denied summary judgment on the plaintiffs’ strict liability claims, though it granted summary judgment for the component manufacturer on the plaintiffs’ negligence claims.

While this interesting decision appears thorough at first glance, in fact it completely omits essential Wisconsin law, Schreiner and Restatement Third §5, and thus its discussion of the philosophical underpinnings of strict liability, based on Restatement Second §402A, which Wisconsin no longer follows, is (to be polite) open to question.  We hope that the defendant eventually convinces the court of the error of its ways.


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

Today’s case is no “mixed bag,” no cautionary tale. We don’t have to look for a silver lining or a rose among the thorns.  Rather, Shuker v. Smith & Nephew, PLC, 2015 U.S. Dist. LEXIS 43141 (E.D. Pa. Mar. 31, 2015) is one of those cases that just keeps giving and giving and giving.  We’ve got component parts, preemption, off-label use, failure to report, pleading deficiencies, and plenty of other small but delightful nuggets. So we’ll get straight to it.

In April 2009, plaintiff underwent a total hip replacement. Id. at *12.  Plaintiff eventually had to have multiple revision surgeries to correct and alleviate complications from the original hip replacement.  The lawsuit ensued alleging claims for  (1) negligence/negligence per
se, (2) negligence based on violations of FDA regulations and FDCA provisions, (3) strict products liability, (4) breach of express warranty, (5) breach of implied warranties of merchantability, (6) fraud, and (7) loss of consortium.  Id. at *39-40.

Continue Reading A Jam Packed Hip Implant Case From the Eastern District of Pennsylvania

Last week we wrote about body part transplants.  In legal terms, we asked whether body parts could be the basis of a product liability action.  No, they cannot.  In cinematic terms, we asked whether grafting a killer’s body part onto an otherwise good person can lead to mayhem.  Yes, it can.  At least that scenario is plausible enough to pass TwIqbal muster as that standard is applied by the less fussy courts. We’re not joking.  It is an interesting thought-experiment to ask whether there are some courts that would wave such a claim through, permitting discovery as to whether a transplant could turn the poor plaintiff into a killer.  The crazily-lenient court would sniff at our arguments, telling us that any weaknesses in plaintiff’s theory could be explored on cross-examination and pondered by a jury of someone’s peers.

We admit that our standard of plausibility is a tad tougher.  It still drives us crazy that Steve Austin, The Six Million Dollar Man, supposedly could lift several tons with his bionic arm.  The bionic arm was attached, of course, to a not-so-bionic torso, waist, and leg – wouldn’t those ordinary body parts be crushed by the load?  Then there’s the metaphysical question as to whether transplants could be so extensive or fundamental as to render the recipient a different person.   We’re pretty sure we encountered this issue in a story by Poe and a movie on Lifetime.  We read one tale of a man who removed his artificial parts one-by-one (eye, nose, arm, leg, etc.) until there was virtually nothing left.  We have seen something very like that during expert depositions.

The ancients puzzled over when a change in parts produced a different whole.  In Plutarch’s Life of Theseus, Plutarch asked whether a ship that was restored by replacing each and every one of its wooden parts remained the same ship.  In more modern times, there is the example of George Washington’s axe, which three times had its handle replaced and twice had its head replaced.  Was it really the same axe? In his Essay on Human Understanding, Locke discussed the Principium Individuationis.  If atoms are taken away or added, an object is no longer the same mass or body. And yet, living creatures are different.  For them, identity depends not on a mass of the same particles, but on something else.  An oak growing from a plant to a great tree and then lopped is still the same tree.  Man is different still.  Locke thought that for man self depends on consciousness, not substance.   By that reasoning, when lawyers drone on at trial and render some of the jurors unconscious, they have effectively created a new jury.  It might be intentional. Somehow, all of this made us think of the old Wendy’s “Parts is parts” commercial.  And then we got hungry.

And now for the segue from what the DDL Daughter calls the Interesting Pause to what she calls the Boring Law Bits.  The question of when or whether the whole becomes different because of a new sum of its parts applies to device components.  Different devices are subject to different regulatory regimes and, consequently, to different legal standards.  A class III device goes through the PMA process and enjoys preemption.  A class II device goes through 510(k) clearance and enjoys quality time in a Parisian report and an MDL file.  Preemption, sadly, will seldom extend its sweet embrace to a 510(k) device, no matter how much Bexis and logic and policy suggest otherwise.  What if a device’s components are partly PMA and partly 510(k)?   A Franken-device?!  Something approximating that issue came up recently in Smith v. DePuy Orthopaedics Inc., 2014 U.S. App. LEXIS 718 (3d Cir. Jan. 7, 2014).  Smith is an unpublished opinion, so you will likely have a problem wringing any precedential value out of it.  But that doesn’t stop us from discussing it.  It contains sound reasoning and ample cites, and you should hasten to transplant them into your briefs.

The plaintiff, Smith, sued for what he claimed was a knee replacement gone wrong.  The Magistrate Judge asked for summary judgment motions from both parties on preemption, and then dismissed the case on the ground that the claims were preempted because the product went through the PMA process.  That sounds like a proactive Magistrate Judge.  We would be remiss not to acknowledge the heroic work being done by Magistrate Judges all over the place.  It is a thankless job; or at least it was until right now:  thank you.  We say that even though some Magistrate Judges have put us through Discovery Hell and even though one ultra-soft Magistrate Judge vexed us in our prosecutorial salad days by granting bail to every criminal defendant who avowed that he or she was “honorable.”  Apparently several of those defendants preferred to live out their honorable lives in other jurisdictions, in other countries, or in the wind – anywhere but the dark-paneled courtrooms where 12 citizens solid and true would scrutinize the peripatetic defendant’s crimes.

Back to Smith v. DePuy.  There is also a procedural component to that case that is a wee bit interesting.  The court stayed most discovery during the pendency of the motions.  The plaintiff served additional discovery requests, sought a continuance, and submitted a declaration with its summary judgment cross-motion describing what discovery he sought and why it had not previously been obtained.  But he failed to discuss how the discovery sought, if provided, would preclude summary judgment.   That is, he failed to submit a declaration that complied with all the requirements of Fed.R. Civ.P. 56(d).  Oops.  No continuance.  No additional discovery.   No case.  We have written about the requirement of Rule 56(d) before.

The key is the regulatory history of the device at issue.  In 1985, the RP Knee went through the PMA process, which “provide[s] reasonable assurance of its safety and effectiveness.”  In 1996, the defendant introduced the P.F.C. Sigma Knee, which was a fixed-bearing system containing: (1) a femoral piece; (2) a patella; (3) a tibial tray; and (4) a tibial insert.  The FDA approved the P.F.C. Sigma Knee through the 510(k) Pre-Market Notification process. In February 2000, Defendants submitted a PMA application to the FDA to supplement the existing RP Knee with a new rotating platform, which was designed to be used with the 510(k)-cleared femoral and patella components of the P.F.C. Sigma Knee.  Things are starting to get mixed up.  Or are they?  The FDA approved this application in March 2000, as a supplement to the LCS Total Knee System PMA. Soon after, in May 2000, the defendants submitted a PMA application to supplement the RP Knee to include the 510(k)-cleared rotating platform tibial trays and bearings from the P.F.C. Sigma Knee, thereby incorporating all components of the P.F.C. Sigma Knee into the RP Knee.  The FDA approved that application in June 2000 as another supplement to the LCS Total Knee System PMA.  In February 2006, Defendants submitted another PMA application to supplement the RP Knee, this time to notify the FDA that an inspection was being added to the manufacturing process for certain tibial trays.  The FDA approved this application in February 2006.

On October 15, 2007, Smith underwent right knee replacement surgery and had the RP Knee—including the P.F.C. Sigma tibial insert, tibial tray, patella, and femoral component- implanted.  In mid-2008, Smith allegedly experienced “chronic pain with swelling and locking of the joint.”  In mid-2009, Smith underwent a revision of his loose knee implant.  In 2010, Smith allegedly developed a “snapping behind the patella-femoral joint.”  The cure for that sensation was apparently the filing of a legal complaint.  The claims mostly fell under New Jersey’s Products Liability Act, alleging manufacturing defect, design defect, and failure to warn, as well as negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraudulent concealment, fraud and deceit.  There was also a claim under the Virginia Consumer Protection Act.  Why is that?  We do not know.  Nor does it matter.

After the district court dismissed his case, the plaintiff appealed, arguing that the district court abused its discretion by proceeding with summary judgment before the plaintiff received discovery on the components implanted during his second surgery.  The plaintiff wanted to employ the discovery to determine which components went through the PMA process and which did not.  Smith expected newly discovered documents to show only a 510(k) clearance for the components at issue, which would contradict the defendants’ declaration that these components were included in the PMA process.

The Third Circuit did not buy the plaintiff’s argument.  As the court read the regulatory history, the PMA supplements to the LCS Total Knee System incorporated the components of the P.F.C. Sigma Knee that had previously been cleared through the 510(k) process, and thus those components were subject to the same PMA federal preemption. Moreover, because the components implanted during the second surgery all related to the P.F.C. Sigma femoral piece, tibial tray, and tibial tray bearings, which were approved by the FDA through the PMA process, and because those components are components of the PMA-approved RP Knee, no discovery was necessary to determine that these components were also subject to PMA preemption.  That is double-barreled reasoning by the court.  The parts are part of a whole that was covered by the PMA process, and that’s enough.  But even if it isn’t, the particular parts at issue went through the PMA process.  New discovery wouldn’t change any of that.

The Third Circuit observed that PMA preemption motions are often decided without discovery.  The court also expressed annoyance that the plaintiff’s request for additional regulatory documents occurred just one day before his opposition brief was due and a month and a half after he received the defendant’s production.  According to the Third Circuit, that delay, together with the failure to explain why the discovery was needed, provided the district court with sufficient grounds to deny the continuance motion. The summary judgment, therefore, was affirmed.

For those of you who read through this blogpost all the way, we congratulate you.  You are the same person as when you started. Or maybe just an ounce smarter.

Yesterday we blogged about Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS (E.D.N.Y. July 15, 2013) – a hip implant case that was dismissed because the court found the complaint woefully deficient.  Keeping with the same subject matter, today we have another hip implant case, from a neighboring court, with another insufficient complaint, plus a positive preemption ruling.  Sort of a variation on a theme.

In Simon v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 170413 (S.D.N.Y. Dec. 3, 2013), plaintiff also alleged that she was injured by implantation of the R3 Acetabular System.  It’s important to the preemption discussion to know a little bit more about the device.  The R3 System includes a liner component made of cross-linked polyethylene (non-metal). Id. at *6.  The R3 System, with its non-metal liner, received §510(k) approval (“substantial equivalence”) from the FDA.  Id.  Defendant also manufacturers the Birmingham Hip Resurfacing (“BHR”) System — a separate PMA-approved device.  The BHR System was designed to be used with a metal liner. As part of the BHR System, the metal liner also received PMA approval.  Id. at *7.  Plaintiff’s surgeon opted to implant the R3 System with the metal liner from the BHR System.  Id. at *2.

Plaintiff alleged three causes of action:  negligence, strict liability design defect, and breach of implied warranty.  The court dismissed all three for roughly the same reasons.  If the crux of plaintiff’s allegations are that her injury was caused by the R3 System as a whole – her complaint fails to state a claim.  If she is alleging injury from the metal liner component alone – her claims are preempted.

Continue Reading Hip Implant Litigation Part II – TwIqbal Plus Preemption

Every now and then, an administrative law decision – usually involving the FDA – contains something that’s useful to our product liability defense practices.  In that light we offer Cytori Therapeutics, Inc. v. FDA, ___ F.3d ___, 2013 WL 1164775 (D.C. Cir. March 22, 2013).  The device in Cytori was a §510k “substantial equivalent” device (for extracting stem cells from
fat), except that the FDA held that it wasn’t.  And that was the whole point of the decision, as the aggrieved manufacturer appealed the FDA’s not substantially equivalent (“NSE”) letter in the courts.

For a discussion of the administrative law impact of Cytori, we refer you to the FDA Law Blog.  We’re only interested in the case because an NSE letter is essentially the FDA’s administrative decision that, in order to be marketed, a medical device is required to go through the PMA process rather than through §510k clearance.  As we all know, the PMA process is preemptive (Riegel), whereas the §510k clearance process is not (Lohr).

Plaintiffs in product liability cases often argue that this or that piece of a PMA-approved device system was already/should be treated as a §510k device, and thus preemption should not be recognized.  That’s where Cytori can come in handy.  Why?  Because the DC Circuit holds that deference is to be afforded to FDA decisions determining whether medical devices require either PMA or §510k clearance.

Continue Reading Interesting FDA Administrative Law Holding

The Biomaterials Access Assurance Act of 1998?

Why the heck are we writing about that now?

Well, first, it’s our blog; if we entertain no one else, at least we can entertain ourselves.

And, second, one of us recently received a call from a sophisticated in-house lawyer at a sophisticated drug or device company for whom this act may do a great deal of good — but the lawyer was unaware that the act existed. We figure it’s time to spread the word.

If you provide the raw material or a component part that is used in manufacturing an implantable medical device, then the BAAA could be a friend indeed. (The full cite is The Biomaterials Access Assurance Act of 1998, 21 U.S.C. Secs. 1601-1606.)

In 1998, Congress was concerned that suppliers of raw materials were being unfairly targeted in litigation. DuPont, for example, supplied less than $100 worth of a resin, Teflon, to a jaw implant manufacturer, and ended up being named in 651 lawsuits against the implant manufacturer and paying millions to defend itself. Although the law in most jurisdictions recognizes a “raw material supplier” or “bulk supplier” defense, the supplier must nonetheless endure expensive discovery before being able to extricate itself from the litigation. Suppliers of surgical stainless steel, resins, and nickel and titanium memory metals withdrew from the medical device supply market because of the threat of litigation.

Congress responded. The BAAA creates immunity for companies that provide biomaterials that are used to manufacture implantable medical devices. The manufacturer of the device itself may be liable, of course, but the company that provided raw materials or component parts generally is not.

The following description is very general and omits what may, in certain cases, be important elements of the act. But the description at least alerts you to the existence of the act and gives a general description of its operation.

The BAAA creates a procedural device to let the biomaterial provider escape at reasonable cost from litigation aimed primarily at the implant manufacturer. The supplier may file a “motion to dismiss,” which can be supported by “affidavits” (21 U.S.C. Sec. 1604(b)), showing that the supplier is not a “manufacturer” of the final implant, is not a “seller” of the final implant, and did not fail “to meet applicable contractual requirements” relating to the raw material. Id. at Sec. 1605(a)(1)-(3). Discovery is then limited to the issues raised by the supplier’s motion, and the court must rule based on the resulting record. Id. at Sec. 1605(c)(1)(A). “Thus, the BAAA allows trial courts to dismiss biomaterials suppliers from lawsuits prior to discovery.” Whaley v. Morgan Advanced Ceramics, Ltd., No. 07-cv-00912-REB-CBS, 2008 U.S. Dist. LEXIS 29918 (D. Colo. Mar. 31, 2008).

There’s not much extant authority interpreting the BAAA. The FDA issued a draft guidance to implement the BAAA in 2001, but a couple of minutes of research didn’t reveal whatever became of that. A decade ago, a federal trial court denied a motion to amend a complaint to add four raw material or component part suppliers to a hip implant case, reasoning that amendment would have been futile in light of the BAAA. See Marshall v. Zimmer, Inc., 1999 WL 34996711, slip op. (S.D. Cal. Nov. 5, 1999). And, earlier this year, another federal trial court granted a motion to dismiss brought under the BAAA by the supplier of a femoral hip component to a Total Hip System. Whaley, 2008 U.S. Dist. LEXIS 29918.

We’re not trying to describe this law in detail here; we’re just reminding you that it exists. If you represent the supplier of a raw material or component part, the BAAA may be a quick and relatively inexpensive way to have your client dismissed from litigation.

Don’t overlook it.