Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today’s case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.  We were fresh off of a long flight home from Europe and were hesitant to take on a couple hundred miles of driving at each end of the day, so we investigated our options.  In the morning, direct flights from PHL to BDL abound.  But after 6 p.m., when our deposition was scheduled to end, there are no direct flights home. Nor are there Amtrak trains leaving Hartford after that hour.  So we threw up our hands and reserved a connecting flight home, reasoning that sleeping, reading, and eating Biscoff cookies would be more relaxing than driving.  This even though, to get from Hartford to Philadelphia, we had a totally illogical connection at Dulles, many miles out of the way.

Our originating flight landed at Dulles early.  And our 9:30 pm connection was showing “on time” on the board.  At 9:15 pm, the following announcement came over the loudspeaker: “We are very sorry, but your first officer is coming in on a flight that is delayed, so we need to delay your 9:30 pm flight until 11:30 pm.”  We were not pleased, but the new schedule would still get us home, crucial because we were leaving at noon on Saturday for an overnight trip.  At 11:20, the gate agent announced, “Your first officer’s flight has landed.  Give us a few minutes and we’ll get you boarded.”  At 11:30, we heard the following, dripping with contrition: “We are SO SORRY, but we are unable to put together a crew for your flight tonight, so we are delaying this flight until NOON TOMORROW.” [Emphasis added.]  Turns out that the long-awaited first officer had now exceeded his maximum hours for the day.

We did not react politely to this. We asked, “You mean to tell us that nothing in your computer could have told you this before we sat here for two hours and lost all other options??”  We did not receive a satisfactory response.  Ultimately, we took a 45-minute cab ride to Union Station (cavernous, pitch-black, and empty) and caught a 3:10 a.m. (!!) Amtrak train to Philadelphia.  When all was said and done, that was all that was left.

“Not much left” also describes (we warned you) today’s case, an excellent PMA and Buckman preemption decision out of the Northern District of Illinois.  In Gravitt v. Mentor Worldwide, 2018 WL 2933609 (N.D. Ill. June 12, 2008), the plaintiff alleged that she was injured by the defendant’s silicone breast implant.  Her complaint asserted claims under Illinois law, alleging design and manufacturing defects, failure to warn, and the defendant’s alleged failure to comply with the FDA’s pre-market approval (“PMA”) process for Class III medical devices, including numerous allegations of deficiencies in the defendant’s design and execution of post-PMA studies ordered by the FDA.

In earlier motion practice, the court dismissed most of the plaintiff’s claims without prejudice.  (We published a guest post on the first dismissals here.)  The plaintiff filed an amended complaint, which the court commented “strongly resemble[d] the original complaint.” Gravitt, 2018 WL 2933609 at *1.  The defendant again moved to dismiss, arguing that the plaintiff’s claims were expressly preempted under the Medical Device Amendments (“MDA”) to the FDCA or impliedly preempted under Buckman.

Express Preemption

The defendant argued that the plaintiff’s claims were expressly preempted to the extent that they were based on alleged methodological defects in the defendant’s post-PMA studies. The Court explained that under SCOTUS’s Lohr decision, as construed by the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), as well as SCOTUS’s Riegel decision, state law tort claims related to Class III medical devices granted PMA are allowed to proceed if they: 1) allege violations of common-law duties that parallel federal requirements; or 2) claim violations of federal law.  Conversely, state law claims that “would impose on [the defendant] a requirement that is in addition to federal requirements” – in other words, claims that the defendant “violated state tort law notwithstanding compliance with the relevant federal requirements” – are preempted. Gravitt, 2018 WL 2933609 at *4 (internal punctuation and citations omitted).

The court held that, while the complaint alleged numerous deficiencies in the defendant’s post-PMA studies and alleged that each deficiency amounted to an “independent failure to comply with the FDA’s post-approval requirements” and thus a ground for withdrawal of PMA, the plaintiffs “simply assume[d], without legal or other support, that those deficiencies amount[ed] to violations of the FDA’s conditions for PMA.” Id. at *6 (citations omitted).   The court concluded that “such an assumption may not ground a viable claim,” id., and held that certain categories of the plaintiff’s allegations were expressly preempted.

Implied Preemption

But the court held that other categories of the plaintiff’s allegations were not expressly preempted. Specifically, the court held that “the complaint plausibly alleged that [the defendant] violated federal law” by failing to satisfy several categories of requirements related to, inter alia, follow-up of study participants, collecting and reporting of data at required intervals and related updates to labeling, warning of newly-discovered risks of the device, and failing to comply with requirements for manufacturing facilities.  Because the plaintiff “plausibly alleged” that these “shortcomings in [the defendant]’s post-PMA testing and manufacturing processes violated federal law,” section 360(a) of the MDA did not preempt those claims. Id. But the court emphasized, “Plaintiffs may proceed with those claims, however, only if they pass through a second legal filter” – the “filter” of implied Buckman preemption of “fraud on the FDA claims.” Id. at *7.

The court explained that, under Buckman, “federal law preempts claims to the extent they seek to deploy state law in the service of policing fraud against federal agencies based on statements that federal  law required the defendant to make to the agency, id. (internal punctuation and citation omitted), but doesn’t preempt traditional tort law claims involving breach of a duty to the plaintiff.  The court held:

Here, several of the claims that survive express preemption – for example, claims that the defendant reported results of the core study for fewer than the required number of years and recruited fewer than the required number of patients for a large post-approval study – are impliedly preempted under Buckman because those shortcomings breached no . . .  [tort duty to the plaintiff].  Rather, as in Buckman, those claims are unconnected to any traditional state tort duty, meaning that the existence of the relevant federal enactments is a critical element of those claims.

Id. (internal punctuation and citation omitted).  The court noted that the plaintiff attempted to tie the defendant’s alleged misconduct to her state tort claims, alleging that, if the defendant had more fully complied with the PMA process, its “disclosures would have led to much wider knowledge of the risks associated with its product.” Id. (internal punctuation and citations omitted).  But, it emphasized, “the Buckman analysis centers on the nature of the asserted claim and the source of the violation, not on the violation’s effects . . . . A claim arising entirely out of a violation of [the defendant’s] compliance with the FDA’s requirements in granting PMA is . . . . preempted under Buckman. Id.

Two categories of claims remained. The court dismissed the plaintiff’s claims alleging that the defendant’s manufacturing facilities failed to comply with applicable law and regulations, holding that the complaint had not adequately alleged a true manufacturing defect claim.  In addition, the plaintiff had failed to respond to the defendant’s arguments against these claims.  The last claim alleged that the defendant learned, but did not disclose, that its device had a higher likelihood of rupture than had been reported.  The court acknowledged that these claims were not fully developed in the complaint, but held that Rule 9(b)’s particularity requirement did not apply to the claims.  Holding that the plaintiff’s pleading “cross[ed] the line from conceivable to plausible,” satisfying Twiqbal, the court allowed the claims to proceed.

But that was all that was left.  The claims that were preempted – expressly and impliedly – were dismissed with prejudice, in an infrequent and laudable turn of events.   We would wax on at greater length, but today’s flight is boarding in a few minutes.  At least that’s what the board says.  We’ll keep you posted.

 

On this date 46 years ago, President Nixon and his aides had a conversation about the Watergate break-in and cover-up.  What did they say?  We do not fully know, because the tape of the conversation has an 18 and ½ minute gap.  That gap was one of the more mysterious aspects of an ugly saga that culminated in Nixon’s resignation two years later.  There is a lot to the legacy of Watergate, including the insistence on appending “-gate” to every scandal (e.g., Billygate, Bountygate, Bridgegate, Debategate, Deflategate, Emailgate, Koreagate, Nannygate, Pizzagate, Travelgate, and Wienergate), but there is no doubt that the greatest impact of Watergate was on the public’s mistrust of government.  One manifestation of that growing mistrust was the 1974 enactment of the Privacy Act amendments to the Freedom of Information Act (FOIA).  Gerald Ford, the man who succeeded to the Presidency after Nixon’s fall (and the man who pardoned Nixon), initially wanted to sign the FOIA-strengthening amendments, but a couple of movers and shakers from whom we would later hear a lot — Chief of Staff Donald Rumsfeld and deputy Dick Cheney – opposed the amendments because of potential leaks.  Another guy who would become a bit more famous — Assistant Attorney General for the Office of Legal Counsel Antonin Scalia — advised that the bill was unconstitutional and even telephoned the CIA asking them to lobby the White House staff against it.  That lobbying worked.  President Ford vetoed the bill.  But Congress overrode President Ford’s veto, giving the United States the core Freedom of Information Act still in effect today, with judicial review of executive secrecy claims.  But Scalia was like a dog with a bone.  Years later, he called the 1974 amendments “the Taj Mahal of the Doctrine of Unanticipated Consequences, the Sistine Chapel of Cost-Benefit Analysis Ignored.”  Worst of all, in Scalia’s view, was the provision for judicial review:  “an agency denies a freedom of information request, shazam!—the full force of the Third Branch of the government is summoned to the wronged party’s assistance.”

 

But sometimes the agency wins.  That is what happened in Henson v. Department of Health and Human Services, 2018 WL 2994878 (7th Cir. June 15, 2018).  The plaintiff submitted a FOIA request to the Food and Drug Administration (FDA) seeking documents related to the premarket approval process for a glucose monitoring system. The agency produced many responsive documents, but not enough to suit the plaintiff.  He resorted to the judicial review provisions of FOIA – the ones Scalia decried — naming the agency and the two agency employees as defendants. On the defendants’ motion, district judge Herndon (someone we in the DDL world know well) dismissed the two agency employees from the case, concluding that FOIA “does not create a cause of action for a suit against an individual employee of a federal agency.” A magistrate judge then granted the agency’s request for a stay of discovery because cases under FOIA generally proceed to discovery only after a plaintiff’s case survives a motion for summary judgment.  The agency supplied the plaintiff with a Vaughn index—a list of each redacted or withheld document cross-referenced with the exemption that the agency asserts is applicable.  The FDA moved for summary judgment, arguing that it had conducted a reasonable search for all documents responsive to the FOIA requests and that it had properly withheld and redacted documents pursuant to FOIA exemptions for trade secrets, agency deliberative documents, and patient and employee private information.  Judge Herndon granted summary judgment for the defendants.

 

On appeal, the plaintiff raised three challenges: (1) that the district court should not have dismissed one of the agency employees as a defendant; (2) that entry of a stay pending summary judgment was improper, and (3) the district court erred on the merits.  The first two issues were easy.  First, the Seventh Circuit fell into line with the D.C., Fifth, and Ninth Circuits in holding that a plaintiff may not sue an individual agency employee for violating FOIA.  Second, entry of a stay pending summary judgment was well within the court’s “considerable discretion to manage the court’s docket to ensure the ‘just, speedy, and inexpensive’ resolution” of the case. 

On to the merits. 

The Seventh Circuit held that the undisputed facts showed that the FDA’s search for responsive documents was reasonable.  The agency searched its database.  The agency also had the recipients of the plaintiff’s letters and those representatives with whom the plaintiff had met search their files for responsive documents.  That was enough.  (We would be well-pleased if courts would follow Judge Herndon’s exquisite sense of reasonableness when assessing our client’s responses to discovery requests.)  The main issue in play was the applicability of the FOIA exemptions.  Here there was a procedural problem.  The plaintiff had the agency’s Vaughn indices yet did not point to specific claims of exemption with which he disagreed.  Nor did he file the Vaughn indices on appeal.  The Seventh Circuit was annoyed.  It advised future litigants to file such indices on appeal.  Meanwhile, the Henson appellate record was bereft of the sort of record that might permit the court to overturn the lower court’s decision.  In any event, the lower court’s decision seemed correct with respect to all applicable exemptions. There was certainly no clear error.

Exemption 4 under FOIA protects from disclosure “matters that are … trade secrets and commercial or financial information obtained from a person and privileged or confidential.”  That exemption, like the things defendants try to protect in standard confidentiality orders, applies when disclosing the contested information would cause “substantial competitive harm to the firm that owns the information.”  One of the document categories the FDA refused to produce was information regarding the raw materials used by the manufacturer of the glucose monitor.  That information was never publicly disclosed by the manufacturer, “nor is there evidence that the raw materials do not have economic value by virtue of remaining confidential.” 

Exemption 5 allows an agency to withhold “inter-agency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency.”  In withholding information pursuant to exemption 5, the FDA detailed “on an individual basis the topics discussed by the agency’s employees and the purposes for the communications.”  The plaintiff did not contradict any of the agency’s representations.  There was no showing of error, much less clear error.

Finally, exemption 6 excuses the disclosure of “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.”  The Seventh Circuit held that the “revelation of personal identifying information tips the scales in favor of non-disclosure.”  Hearkening back to the Watergate-era concerns animating the Privacy Act amendments, the Henson court observed that FOIA “requires transparency from the government – not the manufacturer’s patients and employees.”

 

 

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

You’re likely all familiar with the phrase, “don’t look a gift horse in the mouth.” Checking out a gift horse’s teeth is like looking for the price tag of the gift to see how much it’s worth. The expression is meant to convey that upon receiving a gift you should accept it gratefully. But what happens when you don’t accept the gift at all. In many instances, politely declining a gift is completely acceptable. When the gift actually comes in the form of help, passing it up may well be to your own detriment. Sure, it looks good to stand on your own two feet. To accomplish something on your own. But sometimes offers of help are extended because they are needed. A parent offers to help a child tie his shoe. A teacher offers to guide a student through a math lesson. A young man offers to cut the grass for an elderly neighbor. Or perhaps a judge offers plaintiff an opportunity to take discovery to save her case. And that plaintiff says: No thanks. I’ll stand “on the allegations contained in [my] original complaint.” That plaintiff shouldn’t be surprised that what wasn’t good enough the first time around, isn’t good enough the second.

The case is Benyak v. Medtronic, Inc., 2018 Ill. App. Unpub. LEXIS 998 (Ill. App. Jun. 14, 2018) and involves an implanted intrathecal pump that plaintiff alleges became inverted in her body causing her pain. Id. at *2. Plaintiff alleged only negligent design and manufacturing defect and negligent education of medical providers. Id. at *2-3. The medical device underwent pre-market approval by the FDA and so defendant moved to dismiss the claims as preempted. That motion was granted but the court granted plaintiff leave to serve written discovery on the manufacturer and then to file an amended complaint. Plaintiff opted to do neither and so the court dismissed her claims with prejudice. Id. at *2. Plaintiff then appealed that dismissal arguing that her original allegations should have survived defendant’s motion to dismiss.

The Illinois Appellate Court authored a nice accounting of PMA preemption, see id. at *5-15, which we won’t completely recount here because if you are even an infrequent reader of this blog, you’re likely well-versed in PMA preemption. And if not, check out this scorecard to start your PMA preemption education. We will point out the court’s proper conclusion that because of the MDA’s express preemption provision, there is no presumption against preemption. Id. at *10. Also that the court landed where most court’s do, finding that there is only “a small window in which a state-law claim may escape express or implied preemption.” Id. at *13. Finally, before turning to the case-specific details, the court notes that “the manner in which allegations are pled guides the analysis of whether a state-law claim involves requirements different from, or in addition to, the federal requirements.” Id. at *15.

Since it was undisputed that the device at issue was a PMA device, there was also no dispute that the FDA had established requirements applicable to it. Id. So the court moved on to the next part of the PMA-preemption analysis – did plaintiff’s state law claims involve requirements related to safety and effectiveness different from or in addition to federal requirements. Because safety was at the heart of plaintiff’s claims, the only real issue was the “different or in addition to” standard. In other words, did plaintiff’s claim parallel the federal requirements established by the FDA for this device.

As for design and manufacturing defect – plaintiff’s complaint was completely silent as to whether the device was designed or manufactured differently or out of compliance with the FDA’s approval and protocols. Id. at *16-17.

Absent such factual allegations, plaintiff, in essence, posits that the [device] should have been designed and manufactured differently than what the FDA approved during the premarket approval process, which necessarily would impose a requirement for the [device] that is different from, or in addition to, the requirements already imposed by the FDA.

Id. at *17.

On appeal, plaintiff argued that “the ability of the [device] to remain upright” was a premarket requirement that defendant failed to meet. However, the complaint “never specifically identified any specific requirement resulting from the premarket approval process.” Id. at *19. And this brings us back to that gift horse:

Understandably, at the time plaintiff filed her complaint, she might not have had enough facts to support her allegations, which is why the circuit court allowed her leave to serve written discovery on defendants and file an amended complaint. Had she taken the opportunity to conduct the discovery, she could have bolstered the allegations of her complaint and perhaps, her state-law claim would not have been expressly preempted by the MDA. But she chose not to conduct the discovery nor file an amended complaint, resulting in her design and manufacturing defect claim, as pled in her complaint, being expressly preempted.

Id. at *19-20. It jumped right up and bit her.

As for plaintiff’s other claim, negligent instruction, it is not a recognized claim under Illinois law. Id. Even if it were, plaintiff didn’t allege that the instructions defendant provided deviated from those approved by the FDA during the PMA process. Id. at *21. So, that’s two grounds to affirm the dismissal. Plaintiff attempted to turn the claim into a learned intermediary claim arguing it was really a failure to warn the doctor claim. But, that’s not what plaintiff alleged in the complaint. The complaint never mentions learned intermediary and the court was unwilling to construe it as such.

Finally, plaintiff asked for the case to be remanded with leave to amend her complaint. Wow. Once you refuse a gift it’s much less likely you’ll get offered it again. The appellate court found that because plaintiff had “intentionally” chose not to take discovery and amend her complaint when that opportunity was afforded to her, “she has waived any right to a remand with leave to amend.” Id. at *22.

We often talk about giving plaintiffs second bites at trying to plead their claims. But if you’re going to toss the apple away without so much as a nibble, don’t be surprised when the gift horse you decided to ignore gobbles it up and spits it out with nothing left for you to chomp on.

 

You’ll have to excuse us a bit today.  This post is about product liability – specifically Pennsylvania product liability.  However, it is not really focused on prescription medical products.  But what can we say?  We were provoked.

**********

“The dark side of the Force is a pathway to many abilities some consider to be unnatural.”   – Darth Sidious (a/k/a Sheev Palpatine).

Money and the dark side share many of the same attributes.

The first footnote of a new law review article, Wertheimer & Rahdert, “The Force Awakens:  Tincher, Section 402A, & the Third Restatement in Pennsylvania,” 27 Widener Com. L.R. 157 (2018), reveals that “[t]he preparation of this article was supported in part by a research grant from the Pennsylvania Association for Justice.”  Id. at 157 n.1.  So we were not surprised in the least that “Force Awakens” read like a plaintiff litigation expert’s opinion on Pennsylvania product liability law.  The scholarship was bought and paid for, after all.

Another conclusion we reached by the end of that article was more surprising.

The Pennsylvania Association for Justice wuz robbed.  Whatever they paid, they didn’t get what they paid for.

To explain. “Force Awakens” was an obvious response to our own Bexis’ 2017 91-page opus, J. Beck, “Rebooting Pennsylvania Product Liability Law: Tincher v. Omega Flex & the End of Azzarello Super-Strict Liability,” 26(2) Widener L.J. 91 (2017).  As the PAJ engagement no doubt required, Bexis article and the propositions it contains come in for criticism.  “Rebooting,” 26(2) Widener L.J. at 204-05.  Heck, “Force Awakens” was even published in the same law review (albeit with an intervening name change) as Bexis’ article.  The point-counterpoint can hardly be more obvious.

Except Bexis didn’t get any research grants.

The first way that “Force Awakens” doesn’t stack up is simply size.  Size matters if an article is going to cover all the bases.  If the 91 pages of Bexis’ article were kilos, it would weigh in as a heavyweight.  This 57-page counter-punch is, comparatively, a featherweight.

Of course, in scholarship, length is something, but not everything.

So what else?  We think “Force Awakens” wastes precious pages discussing non-Pennsylvania law.  Granted that, given Tincher’s discussion of California precedent, see “Rebooting,” 26(2) Widener L.J. at 144-45, 163-64, 169-70, reference to California law makes sense, but the extended discussion of New Jersey law, “Force Awakens,” 27 Widener Com. L.R. at 164-65, seems odd and tangential, at best.

But most of “Force Awakens” was predictable – intended to provide something that plaintiffs could cite for arguments that Tincher didn’t change much, and (probably more importantly) in support of the embattled post-Tincher suggested jury instructions critiqued in “Rebooting.”  Thus, much of “Force Awakens” is an apologia for the SSJI and (like an expert report) reflects the position of those who purchased the scholarship:

  • “The Tincher court chose to maintain strict liability, and once again it crystallized that choice by reaffirming Section 402A, while at the same time refusing to adopt the directives of the Third Restatement.”  27 Widener Com. L.R. at 193.
  • “[P]roduct liability in Pennsylvania remains a form of strict liability.”  Id. at 194.
  • “Under Tincher the ‘blackletter’ principles of section 402A clearly remain the baseline for Pennsylvania product liability law.”  Id. at 196-97.
  • “[W]here a plaintiff succeeds in proving that a product’s dangers exceed ascertainable consumer expectations, social cost-benefit balancing of risks and utilities is not required.”  Id. at 198.
  • “Pennsylvania courts can and should utilize Barker’s fairly detailed discussion of the relevant evidentiary considerations as a guide.”  Id. at 200.
  • “Tincher’s explication of risk-utility analysis carefully avoids dependence on proof of a reasonable or feasible alternative design.”  Id. at 201.
  • “The [SSJI] Subcommittee sought to change instructions that were directly in conflict with Tincher, but to leave in place all other instructions. . . . This approach strikes us as essentially correct.”  Id. at 204.
  • “[T]hirteen of fifteen distinct charges or parts of [the PDI] charges employ the phrase “unreasonably dangerous” at least once”; “its ubiquity in the proposed PDI instructions strikes us as revealing overkill.”  Id. at 204 n.165.
  • “[W]e believe that the fundamental doctrinal assumption on which these [defense side] criticisms rest is incorrect.”  Id. at 206.
  • “By reaffirming Pennsylvania’s commitment to . . . Section 402A, [Tincher] clearly signaled that product liability is and should remain . . . a doctrine firmly founded on strict liability.”  Id.
  • “Because Tincher reaffirmed the strict liability character of product liability, it remains necessary to keep product liability separate from negligence.”  Id. at 206-07.
  • “As the [SSJI] properly recognized, courts must continue to draw that dividing line in their jury instructions.”  Id. at 207.
  • “For purposes of product liability under Section 402A, a product contains relevant dangers if it ‘lacks any element that is necessary to make it safe’ for an intended or foreseeable use, or if it ‘contains a condition that makes it unsafe’ for such use.”  Id. at 208.
  • “[W]e agree with the [SSJI] Subcommittee that it would be both premature and inconsistent with Tincher’s overarching perspective to draft new warning instructions based on dicta in the opinion regarding that subject.”  Id. at 208-09.
  • “The critics’ argument that the standard jury instructions should embrace a ‘state of the art’ defense is in our opinion entirely incorrect. . . .  This is a due care defense, pure and simple, and it sounds in negligence.”  Id. at 210.
  • “The Subcommittee used Barker’s revised list on the ground that it enabled more streamlined and efficient instructions.  As a practical matter we agree with this assessment. More importantly, we think the charge that the Subcommittee ignored the relevance of the Wade factors is incorrect.”  Id. at 211.

Overall, we found “Force Awakens” recitation of these (and other) pro-plaintiff talking points quite superficial.  To take just one example, the state-of-the-art discussion utterly ignores prior Pennsylvania appellate authority recognizing that such a defense exists as to risk/utility analysis, Hicks v. Dana Cos., 984 A.2d 943, 966 (Pa. Super. 2009), and never comes to grips with the black letter of the consumer expectation test requiring plaintiffs to prove that relevant product risks are “unknowable.  Bexis covered all that in some detail.  See “Rebooting,” 26(2) Widener L.J. at 164-72 (discussing state of the art issues).

Also inexplicably absent from “Force Awakens” is the Pennsylvania Supreme Court’s treatment of the “unreasonably dangerous” of Restatement §402A in Tincher.  “[T]he notion of ‘defective condition unreasonably dangerous’ is the normative principle of the strict liability cause of action.”  Tincher v. Omega Flex, Inc., 104 A.3d 328, 400 (Pa. 2014).

[I]n a jurisdiction following the Second Restatement formulation of strict liability in tort, the critical inquiry in affixing liability is whether a product is “defective”; in the context of a strict liability claim, whether a product is defective depends upon whether that product is “unreasonably dangerous.”

Id. at 380.  The “normative” nature of the unreasonably dangerous element is nowhere found in “Force Awakens” (the word never appears), and its status as “the critical inquiry” is buried in a footnote, 27 Widener Com. L.R. at 183 n.94, while the article describes other issues as “critical.”  Id. at 183 (“defective condition”), 193 (same), 194 (failure to satisfy defect tests).  Unreasonably dangerous as “overkill”?  We don’t think so.

Assuming that “Force Awakens” is used as intended to counter defense-side arguments about Tincher, we’ve found that, on a close read, the article includes some useful concessions, should defendants need to reply:

  • “Trial courts clearly may no longer rely on the jury instructions that had emanated from Azzarello.”  27 Widener Com. L.R. at 193.
  • “The fact that a product may be dangerous . . . does not automatically mean that it is also defective.”  Id. at 195.
  • “The Tincher court acknowledged that Third Restatement materials sometimes may be helpful.”  Id. at 197.
  • “Tincher recognized a negligence strand that contributed to product liability law’s formation and continues to play a role in its development.”  Id. at 206.
  • “[T]he ‘unreasonably dangerous’ language of Section 402A need not be excised in its entirety from product liability jury instructions,” id. at 207 − precisely what the pro-plaintiff SSJI did.
  • “[T]he general [SSJI] statement that ‘[a] product is defective’ if it lacks a necessary safety feature or contains an unsafe condition qualifies as an overstatement.”  Id. at 208.
  • Tincher “reaffirmed the default position that plaintiffs typically bear the burden of persuasion in civil matters.”  Id. at 212.
  • “The [SSJI] Subcommittee’s minimalist approach, while comporting with Tincher’s appeals to modesty and caution, ends up offering little by way of guidance on a range of potentially vexing product liability issues.”  Id. at 212-13.

We think that last quote is a particularly important point of departure. The SSJI subcommittee has always been slow, particularly when the law shifts in favor of defendants.  It took over 40 years, for example, for the Pennsylvania SSJIs to incorporate learned intermediary rule instructions.  As “Force Awakens” concedes, after Tincher the subcommittee’s tendency hardened to the point of Azzarello-based ossification “offering little by way of guidance.”  Id. at 213.

We on the defense side take the opposite view − recognizing the need of the bench and bar to fill in some of these post-Tincher blanks.  In sharp contrast to the retrograde approach endorsed by “Force Awakens,” the defense side’s jury instructions are being expanded and updated.  The 2018 second edition, which has just been released to the public, not only incorporates the most recent post-Tincher precedent – including the Superior Court’s 2018 holding that giving an Azzarello strict liability instruction is now “a paradigm example of fundamental error,” Tincher v. Omega Flex, Inc., 180 A.3d 386, 399 (Pa. Super. 2018) – but also has expanded beyond strictly Tincher issues to include instructions on causation (3 different situations), component parts, and post-sale duty to warn.  Suggested instructions are just that, suggestions; only the defense believes in more, not less.

Finally, our mention of post-Tincher precedent in the preceding paragraph is at the heart of why we believe that PAJ didn’t get value for whatever it paid.  Tincher was decided in late 2014.  “Force Awakens” came out halfway through 2018 – 3 ½ years later.  Bexis’ “Rebooting” article collected and reviewed every post-Tincher decision right up until that article couldn’t be edited any longer.  “Force Awakens” is just the opposite.  Remarkably, it doesn’t cite a single post-Tincher Pennsylvania decision.  Not one.  That omission, we’re pleased (but surprised) to say, leaves our opponents without any precedential support – just a law review article ex cathedra.

If we had to speculate on the reason why “Force Awakens” went radio silent on Pennsylvania precedent, we would again analogize to a litigation expert report. The available data – here post-Tincher precedent – was not supportive of the positions that the authors were being paid to advocate.  So they did what other paid experts do:  ignore it.

So, where the other side goes silent, that’s a signal for us to pour it on.  Here’s our support for our contention that almost all post-Tincher decisions disagree with the positions being asserted in “Force Awakens.”

Rejecting argument that Tincher was a narrow decision that did not change anything

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

Renninger v. A&R Machine Shop, 163 A.3d 988, 1000 (Pa. Super. 2017)

Plaxe v. Fiegura, 2018 WL 2010025, at *6 (E.D. Pa. April 27, 2018)

After Tincher an Azzarello-“any element”/”guarantor” jury charge is reversible error

Tincher v. Omega Flex, Inc., 180 A.3d 386, 399-400 (Pa. Super. 2018) (“Tincher II”)

After Tincher courts need not be bound by Azzarello-era decisions

Renninger v. A&R Machine Shop, 163 A.3d 988, 1000 (Pa. Super. 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *3 (W.D. Pa. July 14, 2016)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *7 (C.P. Clarion Co. Oct. 19, 2015)

Tincher requires that the product be “unreasonably dangerous”

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

High v. Pennsy Supply, Inc., 154 A.3d 341, 347 (Pa. Super. 2017)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 696 (M.D. Pa. 2017)

Roudabush v. Roundo, Inc., 2017 WL 3912370, at *2 (W.D. Pa. Sept. 5, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450 (E.D. Pa. 2016)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *6-7 (E.D. Pa. Sept. 8, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2 (W.D. Pa. July 14, 2016)

Stellar v. Allied Signal, Inc., 98 F. Supp.3d 790, 807 (E.D. Pa. 2015)

Nathan v. Techtronic Industries North America, Inc., 92 F. Supp.3d 264, 272 (M.D. Pa. 2015)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *3 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *8 (Pa. C.P. Mercer Co. April 14, 2015)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *2 & n.4 (Pa. C.P. Allegheny Co. April 4, 2016)

Explicitly applying Wade factors/cost-benefit balancing

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 695 (M.D. Pa. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 610 (W.D. Pa. 2017)

Punch v. Dollar Tree Stores, 2017 WL 752396, at *8 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 451 (E.D. Pa. 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2-3 (W.D. Pa. July 14, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 1019534, at *13-14 & n.16 (W.D. Pa. March 15, 2016)

Lewis v. Lycoming, 2015 WL 3444220, at *3 (E.D. Pa. May 29, 2015)

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798, at *3 n.2, 7 (M.D. Pa. March 20, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

High v. Pennsy Supply, Inc., 2016 WL 676409, at *2 (C.P. Dauphin Co. Feb. 18, 2016), rev’d on other grounds, 154 A.3d 341 (Pa. Super. 2017)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *9 (Pa. C.P. Mercer Co. April 14, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *5 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *4 (C.P. Clarion Co. Oct. 19, 2015)

Summary judgment for lack of viable alternative design in risk/utility case

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016)

High v. Pennsy Supply, Inc., 2016 WL 676409, at *4 (C.P. Dauphin Co. Feb. 18, 2016), rev’d on other grounds, 154 A.3d 341 (Pa. Super. 2017)

Tincher does not shift risk/utility burden of proof

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798, at *3 n.1 (M.D. Pa. March 20, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *1 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *2 n.4 (Pa. C.P. Allegheny Co. April 4, 2016)

Tincher rejects blanket exclusion of “negligence concepts” in strict liability

Roverano v. John Crane, 177 A.3d 892, 907 n.9 (Pa. Super. 2017)

Renninger v. A&R Machine Shop, 163 A.3d 988, 997 (Pa. Super. 2017)

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482-83 (Pa. Super. 2016)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Mercurio v. Louisville Ladder, Inc., 2018 WL 2465181, at *7 (M.D. Pa. May 31, 2018)

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *6 (Mag. M.D. Pa. Sept. 27, 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *6 (E.D. Pa. Sept. 8, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2-3 (W.D. Pa. July 14, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 1019534, at *13 n.15 (W.D. Pa. March 15, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *7 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *3-4 (C.P. Clarion Co. Oct. 19, 2015)

Risk/utility test is similar to, and derived from, negligence

Renninger v. A&R Machine Shop, 163 A.3d 988, 997 (Pa. Super. 2017)

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482 (Pa. Super. 2016)

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *6 (Mag. M.D. Pa. Sept. 27, 2017)

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 696 (M.D. Pa. 2017)

Punch v. Dollar Tree Stores, 2017 WL 752396, at *7 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *9 (E.D. Pa. Sept. 8, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *5 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *3-4 (C.P. Clarion Co. Oct. 19, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8 (Pa. C.P. Clarion Co. April 17, 2015)

Risk/utility test requires expert testimony

Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 724-25 (E.D. Pa. 2016)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016) (risks of alternative design)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *4 (Pa. C.P. Clarion Co. April 17, 2015)

Tincher requires jury instruction on “unreasonably dangerous”

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620-21 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Rejecting Azzarello guarantor/any element jury instruction

Tincher v. Omega Flex, Inc., 180 A.3d 386, 399-400 (Pa. Super. 2018) (“Tincher II”)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *3-4 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Consumer expectation test held inappropriate

Igwe v. Skaggs, 258 F. Supp.3d 596, 611 (W.D. Pa. 2017) (known risk)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452-53 (E.D. Pa. 2016) (complexity)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *8-9 (E.D. Pa. Sept. 8, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *5 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798 (M.D. Pa. March 20, 2015) (conceded inappropriate to mechanical equipment – concrete block maker)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017) (known risk)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *9 (Pa. C.P. Mercer Co. April 14, 2015) (obvious risk)

Consumer expectation test based on objective, reasonable consumer (not plaintiff)

High v. Pennsy Supply, Inc., 154 A.3d 341, 348-49 (Pa. Super. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 610 (W.D. Pa. 2017)

Yazdani v. BMW of North America, LLC, 188 F. Supp.3d 486, 493 (E.D. Pa. 2016)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450-52 (E.D. Pa. 2016)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *7 (E.D. Pa. Sept. 8, 2016)

Bailey v. B.S. Quarries, Inc., 2016 WL 1271381, at *15 (M.D. Pa. March 31, 2016), appeal dismissed, 674 F. Appx. 149 (3d Cir. 2017)

Lewis v. Lycoming, 2015 WL 3444220, at *3 (E.D. Pa. May 29, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Strict liability only applies to a manufacturer’s own products

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 712 (M.D. Pa. 2017)

McLaud v. Industrial Resources, Inc., 2016 WL 7048987, at *7 (M.D. Pa. Dec. 5, 2016), aff’d, 715 F. Appx. 115 (3d Cir. 2017)

Schwartz v. Abex Corp., 106 F. Supp.3d 626, 653-54 (E.D. Pa. 2015)

Tincher principles apply to warning claims

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Igwe v. Skaggs, 258 F. Supp.3d 596, 609-10 (W.D. Pa. 2017)

Bailey v. B.S. Quarries, Inc., 2016 WL 1271381, at *15 (M.D. Pa. March 31, 2016), appeal dismissed, 674 F. Appx. 149 (3d Cir. 2017)

Trask v. Olin Corp., 2016 WL 1255302, at *9 n.20 (W.D. Pa. March 31, 2016)

Williams v. U-Haul International, Inc., 2015 WL 171846, at *3 n.6 (E.D. Pa. Jan. 14, 2015) (subsequently vacated in part on other grounds having to do with negligence, 2015 WL 790142)

Horst v. Union Carbide Corp., 2016 WL 1670272, at *16 (Pa. C.P. Lackawanna Co. April 27, 2016)

Product must be “unreasonably dangerous” without a warning

High v. Pennsy Supply, Inc., 154 A.3d 341, 351 (Pa. Super. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 612, 614-15 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 453-54 (E.D. Pa. 2016)

Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 725, 727 (E.D. Pa. 2016)

Inman v. General Electric Co., 2016 WL 5106939, at *7 (W.D. Pa. Sept. 20, 2016)

Post-sale duty to warn continues to require defect at sale

Trask v. Olin Corp., 2016 WL 1255302, at *9 (W.D. Pa. March 31, 2016)

Evidence of product user’s negligent conduct admissible as relevant to risk/utility

Punch v. Dollar Tree Stores, 2017 WL 752396, at *11 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *4 (C.P. Clarion Co. Oct. 19, 2015)

Evidence of third-party’s negligent conduct admissible as relevant to risk/utility

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *5-6 (Mag. M.D. Pa. Sept. 27, 2017)

Evidence of product user’s knowledge admissible as relevant to consumer expectation

Igwe v. Skaggs, 258 F. Supp.3d 596, 611-12 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452 (E.D. Pa. 2016)

Evidence of product warnings relevant to consumer expectation

Igwe v. Skaggs, 258 F. Supp.3d 596, 610-11 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452-53 (E.D. Pa. 2016)

Evidence of product user’s negligent conduct admissible as relevant to causation

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *5 (Mag. M.D. Pa. Sept. 27, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450 (E.D. Pa. 2016)

Evidence of a product’s compliance with industry standards is relevant/admissible

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482-83 (Pa. Super. 2016) (maybe, but issue was not properly preserved)

Mercurio v. Louisville Ladder, Inc., 2018 WL 2465181, at *7 (M.D. Pa. May 31, 2018)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *1-2 (E.D. Pa. Jan. 26, 2017)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *3 (W.D. Pa. July 14, 2016)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *2 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *6-7 (C.P. Clarion Co. Oct. 19, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8-9 (Pa. C.P. Clarion Co. April 17, 2015)

Evidence of compliance with government standards is relevant/admissible

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *2 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017) (OSHA)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8-9 (Pa. C.P. Clarion Co. April 17, 2015)

Evidence of technological infeasibility under current state of the art is relevant/admissible

Igwe v. Skaggs, 258 F. Supp.3d 596, 611 (W.D. Pa. 2017) (on summary judgment)

And finally, to provide at least something that is specific to prescription medical products:

Existing exclusion of prescription medical products from strict liability applies after Tincher

Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 928237, at *3 (W.D. Pa. Feb. 15, 2018)

Krammes v. Zimmer, Inc., 2015 WL 4509021, at *4-5 (M.D. Pa. July 24, 2015)

In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2015 WL 3669933, at *35 (N.D. Ill. June 12, 2015)

*          *          *          *

Is there any contrary Pennsylvania product liability precedent?  Well, we’re a defense-side blog and we don’t do the other side’s research for them.  That’s what plaintiffs’ side presumably paid for with the “research grant” that produced “Force Awakens” – and they didn’t get it.  PAJ should demand its money back.

 

This post comes only from the Cozen O’Connor side of the blog.

The MDL court in the Testosterone Replacement Therapy (“TRT”) litigation recently entered summary judgment in favor of a non-US manufacturer that did not distribute in the US, along with its US subsidiary. The judgment ended efforts to hold those two defendants, Besins Healthcare, S.A. and Besins Healthcare Inc., liable under a series of product liability claims for injuries allegedly caused by the use of AndroGel, a TRT product. In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 2018 WL 2416239 (N.D. Ill. May 29, 2018).

The court knocked down each of the plaintiffs’ claims in rather short order. Plaintiff’s strict liability and negligent design defect claims fell because plaintiffs had no evidence of a defect. Plaintiffs tried to rely on allegations in the complaint. That doesn’t cut it on summary judgment. Allegations are not evidence:

As the non-moving party, it is plaintiffs’ burden to identify evidence to show why defendants are not entitled to judgment as a matter of law. Because plaintiffs have provided nothing more than quotations from their complaint and from this Court’s order denying the Besins defendants’ motion to dismiss, they have not met their burden.

Id. at *5. A lack of evidence also ended plaintiffs’ manufacturing defect claim: “Plaintiffs present no evidence or argument that AndroGel suffers from a manufacturing defect. Thus the Court considers plaintiffs to have forfeited that negligence theory.” Id. The court entered judgment against plaintiffs’ defect claims.

More interesting was the Court’s rejection of Plaintiffs’ failure to test claim. Plaintiffs relied on an email from an R&D employee at a Besins subsidiary reacting to publications suggesting an association between AndroGel and cardiovascular risks. The employee wrote that “the community should be calling for further study” and that Besins should be “very careful . . . about getting into this discussion” because it might have an “ethical obligation” to conduct such studies as a company that profited from the manufacture of AndroGel. Id. at *2. It’s not surprising that plaintiffs focused on this email.

But they did little else. In fact, plaintiffs’ evidence went no further than the email, which on its own does not establish a failure to test claim. On the other hand, the Besins defendants, who were not distributors of AndroGel in the US, presented actual evidence undermining plaintiffs’ claim. In particular, they relied on the R&D employee’s deposition testimony in which he clarified that Besins did not have the right to conduct testing in the United States. Id. This went unchallenged, and the court found it dispositive:

Plaintiffs have provided nothing to support a contention that the Besins defendants have a duty to conduct safety studies in the United States. To the contrary, the undisputed evidence shows that the Besins defendants cannot do so, and plaintiffs have not attempted to reconcile that evidence with their position.

Id.

The court found other unfixable problems with plaintiffs’ failure to test claim. Plaintiffs presented no evidence that Besins actually failed to test. The R&D employee’s email certainly doesn’t prove that. Plaintiffs also provided no evidence of a proximate causation, making no evidentiary connection between the alleged failure to test and their injuries:

[P]laintiffs have provided no evidence that the Besins defendants’ alleged failure to test proximately caused plaintiffs’ injuries. Plaintiffs’ theory is that the Besins defendants’ failure to adequately test AndroGel caused AbbVie [the company to whom Besins licensed the exclusive right to market and distribute AndroGel in the US] to lack sufficient information about AndroGel’s risks. The alleged failure to test, plaintiffs say, thus “directly contributed to AbbVie’s failure to provide an adequate warning to healthcare providers in the United States.” Plaintiffs, however, do not cite any evidence to support this theory. Their conclusory argument is insufficient to withstand summary judgment.

Id.

The court also rejected plaintiffs’ failure to report adverse reports claim. Plaintiffs described this claim as a failure to report adverse events to other manufacturers, industry experts and the FDA. Having so constructed their claim, however, plaintiffs presented no evidence or argument to establish that the Besins defendants had an enforceable duty to report adverse events to other manufacturers or industry experts. Id. at *6. For their part, the Besins defendants presented evidence that they had no duty to report AndroGel adverse events to the FDA. That responsibility instead fell solely to AbbVie, the company to whom the Besins defendants licensed the exclusive right to market and distribute AndroGel in the US. Id. With no duty, plaintiffs had no claim. Setting that aside, plaintiffs nonetheless presented no evidence that the Besins defendants failed to report any adverse event or that such failure proximately caused their injuries. Id. For all these reasons, the court entered judgment against plaintiffs’ failure to report claim.

The upshot of this opinion appears to be that the non-distributor Besins defendants are our of the Hormone Replacement Therapy MDL.

Researchers at Temple University here in Philly recently published a scientific article, “Learning Impairments, Memory Deficits, and Neuropathology in Aged Tau Transgenic Mice Are Dependent on Leukotrienes Biosynthesis: Role of the cdk5 Kinase Pathway,” in the scientific journal Molecular Neurobiology.  That sounds pretty dense, but what the article concludes is that the generic drug zileuton (branded name Zyflo) has been shown – in a transgenic mouse study – to reduce both physical evidence of Alzheimer’s disease, and its mental symptoms.  To whit:

[A]ged tau transgenic mice were randomized to receive zileuton . . . starting at 12 months of age for 16 weeks and then assessed in their functional and pathological phenotype.  Compared with baseline, we observed that untreated tau mice had a worsening of their memory and spatial learning.  By contrast, tau mice treated with zileuton had a reversal of these deficits and behaved in an undistinguishable manner from wild-type mice.

“Learning Impairments” Article, at Abstract (emphasis added).  In lay terms, it might just successfully treat (we hesitate to throw the “c” word around) Alzheimer’s disease.

Nothing else works very well at treating Alzheimer’s disease.

Zileuton/Zyflo has been on the market since 1996, indicated for treatment of asthma, and is thus available for generic production under Hatch-Waxman.

Since this drug has already been FDA approved, it may also be used off-label, right now, to treat Alzheimer’s patients under the therapeutic rationale explained in the “Learning Impairments” article.  With the drug’s basic safety profile already established by FDA approval and twenty-something years of clinical use, the primary issue in any such off-label use is effectiveness – does it actually benefit Alzheimer’s patients – rather than safety.

Let’s assume, for the moment, that zileuton/Zyflo actually has therapeutic value for treating Alzheimer’s in humans.  This is a drug that can be produced generically, so who is going to finance the Phase III human studies necessary to provide the “substantial evidence” that the FDA requires for a label change adding a new indication?  If any generic manufacturer can take a “free ride” on studies sponsored – at great expense – by someone else, then there is not much incentive for anyone to spend that money.  Thus, this extremely consequential new indication may become a regulatory orphan.  Of course, if the drug shows sufficient promise, other sources of funding could become available – third party payers who pay for the medical needs of Alzheimer’s patients, or even the research fund that is supported by the recently issued Alzheimer’s semipostal stamp.

If this off-label use is truly beneficial, then it would (in the absence of any better treatment option) likely become the medical standard of care despite being off-label.  Eventually, the FDA would be forced to engage in some ad hoc, retrospective approach in order to reconcile the label with clinical practice.  That’s how the FDA finally resolved the regulatory conundrum of so-called “pedicle screws,” where regulation fell behind clinical practice – a retrospective study supported the safety and effectiveness of off-label spinal use, but only after manufacturers endured a decade of meritless product liability litigation.  See 63 Fed. Reg. 40025-41 (FDA Jul. 27, 1998).

While further studies are being performed, however, what happens to scientific communication?  This could be (or it could not be – too early to tell for sure) an historic breakthrough in treatment of Alzheimer’s.  If it is, does the FDA continue to prohibit any manufacturer of zileuton/Zyflo from informing the medical community of information on the effectiveness of the off-label treatment, such as optimal dosage and administration practices?  We’ve frequently decried the unconstitutionality of such speaker- and topic-based restrictions on manufacturer scientific communications under the First Amendment.  However, for the most part the FDA’s refusal to conform to current First Amendment norms has flown under the public’s radar, allowing the agency to get away with dilatoriness, and the rest of the government to monetize the FDA’s unconstitutional stance with through “false” claims litigation that isn’t really about falsity.

Alzheimer’s, however, is the elephant in the room.  Without some sort of effective treatment, our health care system cannot indefinitely support the cost of palliative Alzheimer’s care.  Almost everybody knows somebody suffering from dementia, or else someone suffering through the heartbreak of caring for someone with dementia.  The FDA will run into a political and medical buzz saw if its retrograde attitude towards truthful off-label promotion gets in the way of making information about an effective (we hope) treatment for Alzheimer’s available to the public.

And now – but probably not coincidentally – it looks like the FDA is finally getting off the regulatory schneid.  A couple of days ago, the agency issued a “statement” from the commissioner about what was billed as a “new effort” “to advance medical product communications to support drug competition and value-based health care.”  The big news in the statement is rather buried in regulatory-speak, but it is legitimate big news:

Additionally, it’s our [FDA’s] belief that giving companies clear guidelines for providing payors with truthful and non-misleading information about unapproved products and unapproved uses of approved or cleared products will help facilitate communications that can allow payors to provide coverage for these new products and new uses more quickly after FDA approval or clearance.  And our hope is that these communications can also help companies and payors establish pricing structures that benefit patients as well as health plans.

(Emphasis added).  That’s a reference to (among other things) off-label use.  Specifically, the FDA is now approving “truthful and non-misleading” off-label promotion when directed to an audience of third party payors.

The details of this regulatory retreat from Moscow are found in the FDA’s new final guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, & Similar Entities − Questions & Answers, available here.  That’s another mouthful, so we’ll call it the “Off-Label Promotion (OLP) Guidance,” since that’s really what it is.

The FDA is now allowing those who market prescription drugs and medical devices (see id. at 16 explaining the identical treatment of all classes of medical devices) to provide information about off-label uses of these products to “payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis.”  OLP Guidance at 1 (footnote omitted)

This audience includes public and private sector payors, formulary committees (e.g., pharmacy and therapeutics committees), drug information centers, technology assessment committees, pharmacy benefit managers, third party administrators, and other multidisciplinary entities that, on behalf of health care organizations, review scientific and/or technology assessments to make drug or device selection or acquisition, formulary management, and/or coverage and reimbursement decisions on a population basis.

OLP Guidance at 5 (footnotes omitted).

That’s the who.

The “what” is just about everything.  The kind of information that regulated drug and device manufacturers can now provide to third-party payors about off-label uses is defined as:

“any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug.  Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention. . . .  [Off-label promotion] may include comparative analyses of the economic consequences of a drug’s clinical outcomes to alternative options (including the use of another drug) or to no intervention.

[The information] can be presented in a variety of ways that can include, but are not limited to, an evidence dossier, a reprint of a publication from a peer-reviewed journal, a software package comprising a model with a user manual, a budget-impact model, a slide presentation, or a payor brochure.

OLP Guidance at 4-5.

The “when” varies a bit depending on whether what kind of off-label use is at issue.  The FDA has drawn what we believe to be a new distinction between “material differences” from the labeling that “relate[] to an approved indication” and so-called “unapproved indications.”  Id. at 7.  In our experience, the FDA has always considered any variance from labeling limitations to be off-label use.  But now, as to approved indications, “material differences from the FDA-approved labeling (e.g., new or increased risks, different dosing/use regimens, different endpoints, more-limited/targeted patient populations)” are treated differently, and somewhat less stringently.  Id. at 6.  A presentation “should include an accurate overview of the design of the economic analysis, including a statement of the study objectives.”  Id. at 11 (going into considerable detail).

As to promotion of uses involving such “material differences” from labeling, a basis in “competent and reliable scientific evidence” is sufficient.  Id. at 10.  In determining the sufficiency of the scientific basis, the FDA will be deferring to “existing current good research practices for substantiation developed by authoritative bodies.”  Id.  The prior FDA requirements of “substantial evidence” is nowhere mentioned.  It appears to be gone as a restriction on off-label promotion under the OLP Guidance.  Promotion of “material differences” must include a “conspicuous and prominent statement describing” those differences.  Id. at 14.

However, off-label promotion “regarding unapproved products and unapproved uses of approved/cleared products” is also now allowed by the FDA.  Id. at 18-20.  As to this type of what might be considered “true” off-label uses, distribution of the following information to third-party payers is now OK with the FDA:

  • “Product information (e.g., drug class, device description and features).”
  • “Information about the indication(s) sought, such as information from the clinical study protocol(s) about endpoint(s) being studied and the patient population under investigation (e.g., number of subjects enrolled, subject enrollment criteria, subject demographics).”
  • “Anticipated timeline for possible FDA approval/clearance/licensure of the product or of the new use.”
  • “Product pricing information.”
  • “Patient utilization projections (e.g., epidemiological data projection on incidence and prevalence).”
  • “Product-related programs or services (e.g., patient support programs).”
  • “Factual presentations of results from studies, including clinical studies of drugs or devices or bench tests that describe device performance (i.e., no characterizations or conclusions should be made regarding the safety or effectiveness of the unapproved product or the unapproved use).”

Id. at 18-19.

This kind of off-label promotion should be accompanied by a variety of disclaimers and other information to ensure that the off-label nature of the uses involved is understood:

  • “A clear statement that the product or use is not approved/cleared/licensed, and that the safety or effectiveness of the product or use has not been established.”
  • “Information related to the stage of product development” and “whether a marketing application for the product or new use has been submitted to FDA or when such a submission is planned.”
  • “[M]aterial aspects of study design and methodology and . . . material limitations related to the study design, methodology, and results. Firms should also ensure that results are not selectively presented.”
  • “A prominent statement disclosing the indication(s) for which FDA has approved, cleared, or licensed the product and a copy of the most current FDA-required labeling.”

Id. at 19.  Significantly, there is no prerequisite that an FDA application for marketing be either pending or contemplated, although if this is the case, it should be disclosed.

As to off-label promotion of these so-called “unapproved uses” (and also drugs and devices that have not yet received any FDA regulatory OK), the FDA tries to salvage what it can of the justifications it used to advance in opposition to our side’s First Amendment arguments about truthful off-label promotion:

FDA believes that the categories of information . . . are, on the one hand, broad enough to encompass the information that payors may need to make informed coverage and reimbursement decisions and, on the other hand, limited enough to maintain appropriate incentives for firms to conduct robust studies to evaluate the safety and efficacy of unapproved products and unapproved uses of approved/cleared/licensed medical products. . . .  FDA believes that the risk that payors will be misled is relatively low.  Payors are a sophisticated audience with established procedures to carefully consider the full range of relevant evidence about new uses of medical products.

OLP Guidance 21-22.

Finally, the OLP Guidance reminds us that “[f]irms’ communications to other audiences about unapproved products or unapproved uses of approved/cleared/licensed products could raise additional or different considerations and are beyond the scope of this guidance.” Id. at 22.

In conclusion, let’s look at that last point a bit. The OLP Guidance punches another huge hole in the FDA’s previous attempts to ban regulated entities from distributing truthful information about off-label uses to anybody.  As discussed at some length in Greater New Orleans Broadcasting Ass’n, Inc. v. United States, 527 U.S. 173, 192-94 (1999), the number and nature of exceptions to a speech prohibition adversely affect both the prohibition’s rationality and its ability to advance the governmental interest that motivates it.  We fail to see how any constitutionally valid distinction can exist between providing the identical information, with identical disclaimers and limitations, to one “sophisticated” audience (third-party payors) while prohibiting that information’s distribution to another “sophisticated” audience – that being medical doctors that directly prescribe these drugs and devices.

And that’s just within the rubric of commercial speech.  Greater New Orleans also cautioned, “decisions that select among speakers conveying virtually identical messages are in serious tension with the principles undergirding the First Amendment.”  Id. at 194.  We now have Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011), for the proposition that, with respect to pharmaceutical detailing, we’re not just dealing with commercial speech.

Thus, we believe that, as a practical matter, the OLP Guidance effectively dooms any First Amendment defensibility of an FDA ban on the same truthful information being distributed, in the same fashion, to the rest of the medical community beyond third-party payors.  Conversely, to those regulated entities that seek to inform physicians of truthful scientific information about their products, we believe that the OLP Guidance can serve as a roadmap to success in an Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), situation by establishing that off-label promotion is “truthful,” “not misleading,” and therefore protected against governmental enforcement activity.  After all, just as third-party payers are sophisticated professionals interested in possible effective treatments for Alzheimer’s disease, so are the doctors directly involved in treating Alzheimer’s patients.

Not so long ago the Philadelphia Court of Common Pleas emitted a malodorous opinion exercising personal jurisdiction over a foreign corporation because one of its materials suppliers was in Pennsylvania, even though the quality of that supplied material seemed to have nothing much to do with the injury, which occurred outside Pennsylvania.   That opinion seems to have mislearned the teaching of the SCOTUS BMS opinion.  Beyond that, the less said about it, the better.  But it was interesting to us how that rotten opinion did not address the plaintiff’s alternative argument that the corporate defendant’s registration to do business in Pennsylvania constituted consent to general personal jurisdiction.   Perhaps the court realized it had done enough damage by stretching specific personal jurisdiction beyond the bounds of reason.

Or perhaps the Philly court did not buy the consent argument.  And now we know that is the case because the same court and same judge issued an opinion rejecting the consent via corporate registration argument.  Mallory v. Norfolk So. Ry. Co., No. 1961 8-2 EDA, slip op. (Phila. C.C.P May 30, 2018), is actually a very good personal jurisdiction opinion.  Let’s pause, rub our eyes, take that in, and celebrate.

The plaintiff in Mallory was a railway carman in Virginia. He sued his railway employer, which was incorporated and had its principal place of business in Virginia, alleging that exposure to carcinogen caused him to suffer colon cancer.  The defendant was definitely not “at home” in Pennsylvania.  The exposure and injury did not occur in Pennsylvania.  So why was the case in Philadelphia?  Could it be the reputation Philadelphia juries enjoy for flipping million dollar verdicts around like nickels?  Yes, Virginia plaintiffs, there is a Santa Claus, and he sits on a jury in Philadelphia’s City Hall.  Virginia courts and juries, of course, have a very different reputation.

But even putting aside mere predilection, what could possibly be the basis for a Virginia plaintiff to sue a Virginia defendant in Philadelphia for injuries having nothing to do with Philadelphia?  The plaintiff hung jurisdiction on the defendant’s registration to do business in Pennsylvania.  The plaintiff was not merely engaged in wish fulfillment.  Section 5301 of the Pennsylvania Judiciary Act does, unfortunately, provide that qualification as a foreign corporation in Pennsylvania constitutes a sufficient basis for general personal jurisdiction.

The question, then, is whether exercising personal jurisdiction over a corporation that registered to do business in Pennsylvania, without more, comports with due process.  Put another way, whatever the statute says, does foreign corporate registration equal true consent – the kind of consent that can waive constitutional rights?

The Mallory court’s answer seems altogether obvious but, at the same time, remarkable given the court that is doing the answering.  It is actually a rather brave, as well as wise, decision.  The court reviews the Pennsylvania statutory scheme and concludes that the “Defendant’s consent to jurisdiction was not voluntary.”  If a foreign corporation does not register with the Commonwealth, it cannot do business in Pennsylvania.  Moreover, it would be prohibited from seeking any redress with the Commonwealth’s courts (you know – in cases where Pennsylvania jurisdiction actually made sense).  As the Mallory court reasons, “the Legislature imposed a punitive sanction upon those foreign corporations; it matters not if such a sanction is characterized as a carrot rather than a stick, the punitive result is the same.”  Put simply, foreign corporations have no choice but to register in Pennsylvania.  Having no choice is the antithesis of giving consent.  The Mallory court held that a state’s securing of general personal jurisdiction over a foreign corporation via what is essentially mandatory registration is an exercise of coercive power at odds with the SCOTUS BMS decision and due process.

To be sure, there are some old legal chestnuts out there that permitted “state courts to obtain personal jurisdiction over  foreign corporations via mandatory registration statutes” (e.g., Pennsylvania Fire Ins. Co. (1917)), but those cases “are relics of the Pennoyer era, in which a bright-line rule prohibited courts from exercising personal jurisdiction over persons or corporations outside the geographic boundary of the court.”  They have been effectively overruled.  And good thing, too.

By contrast to the Philadelphia court’s crabbed reading of the recent SCOTUS BMS case when it came to specific personal jurisdiction, the Mallory court’s reading of recent SCOTUS precedents on general jurisdiction is insightful and on the mark.  The Mallory court interprets recent SCOTUS cases as teaching that “federalism prevents this Court from exercising general jurisdiction over Defendant simply because Defendant does business in Pennsylvania.”  Thus, “[b]y requiring foreign corporations to submit to general jurisdiction as a condition of doing business here, Pennsylvania’s statutory scheme infringes upon our sister states’ ability to try cases against their corporate citizens.”  Yes, hurray for those sister states, with damages caps and parsimonious jurors.

The reasoning of Mallory in rejecting the consent argument is sound, it should apply to all Pennsylvania cases and, for that matter, cases anywhere.  Indeed, Mallory’s reasoning on the issue far exceeds that of several federal district courts in Pennsylvania, which have fallen for arguments that the Pennsylvania statute could somehow overcome constitutional restraints on general personal jurisdiction.

Now if only the courts here could screw their heads on right about specific jurisdiction.

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

What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a motion to dismiss based on preemption? In recent years, as the law has developed and become increasingly favorable for defendants, most of our posts about PMA preemption are at the motion to dismiss stage. That’s because usually not much survives beyond that point. So when we happened upon Delfino v. Medtronic, Inc., 2018 WL 2688420 (Minn. Dist. May 18, 2018), we decided it warranted more than just a notch on our PMA preemption scorecard.

It looks like all the claims in this case were originally tossed back in 2012 but plaintiff was given an opportunity to amend her complaint to properly allege parallel violation claims. Now, almost 6 years since that decision – during which time we assume significant discovery was conducted – all of plaintiff’s claims are being dismissed again. Plaintiff’s negligence and strict liability claims are preempted for lack of evidence of a violation of a federal requirement and plaintiff’s warranty claims are barred by the express terms of the limited warranty of the device.

The device at issue is an implantable cardioverter defibrillator (“ICD”) and there is no dispute that it is a Class III, PMA medical device and therefore subject to preemption under Riegel v. Medtronic, 552 U.S. 312 (2008). Any state law tort claim must therefore parallel, rather than add to, federal requirements. Id. at *3. In other words plaintiff has to prove the violation of a federal requirement applicable to the device, violation of an identical state-law duty, and causation. Id. It is also not disputed that the device’s battery prematurely depleted and required replacement earlier than anticipated. Id. at *1.

We won’t walk through all the nitty-gritty, but section I.C of the opinion documents how Medtronic went about introducing manufacturing and testing records to refute plaintiff’s manufacturing defect claim. Via records, deposition testimony, and affidavits Medtronic was able to demonstrate “the manufacturing and inspection history” of the device which in turn proved that the device “passed all quality control inspections, and complied with the FDA-imposed requirements.” Id. at *4. Defendant also established that they learned that a subset of the ICD’s were suffering from premature battery depletion due to the copper used in certain of the electrodes in the device’s capacitors. It was found that copper from one supplier was at the root of the problem and defendant stopped using that copper going forward. Id.

Against that history, the question for the court was whether there was any violation of a federal requirement. Plaintiff first argued that by using copper in it capacitors, defendant was violating a federal manufacturing specification that the end terminations of the capacitors consist of plated tin over nickel. Putting aside that the copper was not used in the end terminations and that defendant’s end terminations were plated tin over nickel – there was nothing in the requirement that barred the use of copper. Id. at *5-6. As the court more fully explains, PMA silence doesn’t mean PMA forbiddance. The court points first to the language of the requirement at issue to show that when the FDA wanted to impose a prohibition it did so expressly. Id. at *6. And, if plaintiff’s theory were correct, no PMA would ever have to include prohibitory language because everything not expressly allowed would in fact be prohibited. If silence is going to be so all-encompassing, the result would be an even greater review burden on the FDA. Id. Otherwise the silence would almost assuredly be deafening.

Moreover, if plaintiff wants to rely on a “prohibited-unless-expressly-authorized” theory, she’s walking herself away from a parallel violation claim. “If the federal requirements are silent on a particular matter, than any state-law requirement as to that matter is necessarily ‘in addition to’ federal requirements.” Id.  That means plaintiff’s attempt to circumvent preemption actually ran her head first into it.

Finally, in opining that the ICD should have been made without copper, plaintiff’s expert neglects to explain how the capacitors could function without it. It’s a technical argument about electrodes (and that’s not this blogger’s area of expertise) but the more general takeaway is that you can’t argue a design that is non-functional. “State tort law that requires a manufacturer’s [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than a state regulatory law to the same effect.” Id. at *7 (citation omitted).

Plaintiff’s next argument centered on device longevity. In its PMA submission, defendant included a projection that the ICD would generally perform for 5.1 years. Plaintiff argued that that projection became a requirement when the PMA was approved. But while the FDA could have established a performance standard for the ICD, it did not. Id. “Indeed, the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement. Id. at *8 (with a lengthy list of citations to demonstrate the point). PMA approval is a “reasonable assurance” of safety, not a guarantee. In fact, PMA devices are by definition those with higher risks. That’s why they go through the heightened scrutiny and a risk/benefit analysis for approval. “If premature device failure were enough to withstand preemption, then few if any medical device claims would be preempted.” Id. The MDA and Riegel would be “dead letters.” Id.

Plaintiff’s final argument to try to establish a parallel violation claim was that at the time the ICD was returned to defendant, three years after manufacture, the capacitor leakage current measured higher than allowed. Id. But that’s an irrelevant fact. “For her claim to survive preemption, Plaintiff must offer evidence that [defendant] violated a federal manufacturing requirement during the device’s manufacture.” Id. To which we point you back to the really nice way Medtronic confirmed that its manufacturing process was fully compliant.

That left only plaintiff’s warranty claims. First, they were barred by the terms of defendant’s limited warranty, which defendant honored and under which plaintiff made no claim. Id. at *10. But, they were also impliedly preempted. To prevail on a warranty claim that implicates safety or effectiveness, plaintiff must convince the jury that the device was not safe and effective – directly contrary to the FDA’s conclusions. Juries can’t be allowed to “substitute their own cost-benefit analysis in place of that applied by the experts at the FDA.” Id. at *10-11.

Would we prefer an early out on a motion to dismiss? Sure. But, sometimes a few claims squeak by and when they do, as we’ve always opined, plaintiffs still face a daunting uphill battle to survive summary judgment scrutiny.

The federal right-to-try (“RTT”) adventure, which we chronicled here, and here, concluded not long ago with the final passage of S. 204, signed into law on May 30.  The final bill is not materially different from the house draft we analyzed earlier.  The final bill cleaned up some of the previous hastily-drafted language, such as tying the definition of “life threatening” to prior regulations dealing with that subject.  The two provisions of most interest to us – concerning RTT adverse events and immunity from civil suits – had been pretty good before, and stayed that way.  Reporting requirements became slightly less onerous.  A “sense of the Senate” section at the end ensures no resurrection of the Abigail Alliance foolishness regarding a constitutional right to medications.  So it’s done, but our basic skepticism remains unchanged – we don’t think that the entire exercise was worth the candle, given existing FDA compassionate use regulations, and we strongly doubt that many people, if anyone, will be helped.  Right to try was a right-wing shiny object, a distraction from the serious problems stemming from our chaotic approach to health care.

According to something we read recently on the FDA Law Blog, a “New Vermont Law Seeks to Allow Wholesale Importation of Drugs from Canada.”  We view that legislation similarly to RTT.  Canadian drug importation is a left-wing shiny object, also distracting politicians from the country’s serious health care problems.  Think about it.  California alone has a greater population than Canada.  Any large-scale importation of cheaper Canadian drugs to the United States would almost immediately cause shortages in Canada.  Given the current tit for tat, we would expect Canada to react by slapping an export tariff on prescription drugs to force United States consumers to continue paying for the inefficiencies in our health care delivery system.

But putting stupid, unnecessary trade wars to one side, let’s focus on our sandbox – product liability.  What would the product liability effects of the Vermont program, as created by the new legislation, be?

The legislation authorizes the state to design a program whereby, “a State agency that shall either become a licensed drug wholesaler or contract with a licensed drug wholesaler” in order to import prescription drugs from Canada to Vermont – all in supposed compliance with federal law. 18 Vt. S.A. §4651(a)(1).  The arrangement is to “use Canadian prescription drug suppliers regulated under the laws of Canada.”  Id. §4651(a)(2).  While the imported Canadian drugs are supposed to meet FDA “safety, effectiveness, and other” standards, id. §4651(a)(3), there is no requirement that their Canadian labeling be altered.  The Vermont state agency:

Shall . . . (1) become licensed as a wholesaler or enter into a contract with a Vermont-licensed wholesaler; (2) contract with one or more Vermont-licensed distributors; (3) contract with one or more licensed and regulated Canadian suppliers; [and] (4) engage with health insurance plans, employers, pharmacies, health care providers, and consumers. . . .

Id. §4655(1-4).  Nowhere in the statute are the ultimate manufacturers of the Canadian drugs even mentioned.  The statute does not envision any contact between the drug companies and the state importing agency.  How does Vermont expect to handle drug recalls?  Controlled substances?

The statute also raises interesting product liability questions.  This being Vermont, the statute has no provisions creating any sort of immunity from suit.  So it appears to us that, by inserting one of its agencies into the chain of drug distribution, Vermont has exposed itself to product liability suits should any of the drugs it sells cause injury.  Equally important, the statutory scheme probably makes the state the prime target of any such litigation.  In all likelihood, none of the drug manufacturers will be subject to personal jurisdiction in Vermont.  They will not be selling any drugs in Vermont.  They will have labeled their drugs in accordance with Canadian, not American, regulations.  They will have no notice of their drugs being diverted from Canada to Vermont.  In terms of Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), and Daimler AG v. Bauman, 571 U.S. 117 (2014), the drugs will enter Vermont solely by virtue of the conduct of unrelated third persons.

Just as we pointed out flaws with the immunity provisions of various versions of right-to-try statutes, the immunity issues here also implicate the viability of the Vermont program, albeit in a different fashion. With no statutory immunity, and no ability to obtain jurisdiction over drug manufacturers for the Canadian market, the statute paints a great, big target on the back of the state importing agency, as the deepest pocketed potential defendant available to all potential plaintiffs who might take the drugs thereby imported into the state.  Sovereign immunity won’t help, since the Vermont scheme has the state engaging in commerce, not in any traditional governmental role.

Both sides of the political spectrum unfortunately share an affinity for largely meaningless, feel-good prescription drug-related schemes.  Importing drugs from the Great White North, like the Vermont program envisions, would be rife with problems, including saddling states with product liability.  Maybe that is inevitable where states seek to act as commercial entities.

This guest post is by Tom Hurney at Jackson Kelly, a genuine West Virginia lawyer who leaped at the opportunity to write about a recent favorable decision of his home state’s highest court and to give you a taste of what West Virginia is like.  We were happy to oblige.  So here’s a discussion of why plaintiffs really need expert witnesses in their West Virginia cases.  As always, our guest posters are 100% responsible for what they say – they deserve all the credit (and any blame) for their analysis.

[Sadly, on the day this Post was published, Mr. Bourdain passed away.  West Virginia was glad to host him.

**********

West Virginia is a great state. If you come to West Virginia, you, like Anthony Bourdain, will meet gracious and kind people, see nature’s beauty and have some great meals. In his “Parts Unknown” field notes on West Virginia, here, Bourdain said he was “intensely grateful for the kindness, hospitality, and patience the people of West Virginia showed to this ignorant rube from New York City who arrived with so many of the usual preconceptions, only to have them turned on their head.”  Bourdain tried squirrel, learning how to skin, gut and quarter, here, and had mortgage lifter tomatoes on salt-rising bread, salt trout, chow chow and vinegar pie, here.  We were glad to have him, although we would have included on his culinary tour some West Virginia hot dogs (with mustard and cole slaw and onions if you want them), beans and cornbread, pepperoni rolls and perhaps a few of our superior craft beers like Devil Anse IPA, Wild Trail Pale Ale, and Bridge Brew Ale.  We would have suggested pizza at Pies & Pints in Charleston, Morgantown or Fayetteville or DiCarlo’s in Wheeling or Lola’s in Charleston; sandwiches at the Secret Sandwich Society in Fayetteville; lunch or dinner at Stardust Café or Jim’s Drive In (great burgers) in Lewisburg; Italian at Oliverio’s in Morgantown or Bridgeport, Muriales in Fairmont, Fazio’s or Soho’s in Charleston; great steaks at the Char in Beckley or Boyd’s in Martinsburg or Chop House in Charleston; and Seafood at Tidewater Grill in Charleston, unless you just want a big fish sandwich, then go to the Fresh Seafood Co. at Capitol Market.  There are a bunch of other great places we don’t have room to mention.

We tell you all this because if you aren’t from here or haven’t visited (and many D&D Blog readers have) you might have the wrong impression of West Virginia. You should rethink that stereotype, like Anthony Bourdain, because in West Virginia it is now clear that plaintiffs need experts to prove warning cases in West Virginia.

On the heels of its 3-2 opinion rejecting “innovator liability” in McNair v. Johnson & Johnson, the Supreme Court of Appeals of West Virginia issued J.C. v. Pfizer, Inc., 2018 WL 2293297 (W. Va. May 15,
2018), where the plaintiffs appealed a summary judgment ruling from the West Virginia Mass Litigation Panel (, arguing that “the Panel’s decision was erroneously based on the absence of expert testimony to support their claims that Pfizer failed to adequately warn of the risks of a prescription medication.  The petitioners further assert that even if expert testimony were required, summary judgment was erroneous because Pfizer’s experts could supply the necessary testimony.”

Here is the new syllabus point from the case, which as West Virginia lawyers (or our National Big Law friends who come down to visit frequently) know, is the binding precedent from the opinion:

The determination of whether expert testimony is necessary to sustain the burden of proof in complex cases involving matters of science, medicine, engineering, technology and the like is made on a case-by-case basis.  When the issues involved are beyond the common knowledge and experience of the average juror, expert testimony shall be required.

This isn’t a Daubert deal (or in West Virginia, a Wilt deal) – it doesn’t analyze the admissibility of expert testimony because there wasn’t any.  That’s right.  Basically, after losing their designated expert (detail on that below) Plaintiffs argued they could proceed without an expert in a case where they alleged “the children had suffered birth defects that were proximately caused by their mothers’ ingestion of the drug sertraline hydrochloride (brand-name ‘Zoloft’) while they were pregnant.”  Plaintiffs “alleged that Pfizer failed to adequately warn of the risks of birth defects from the use of Zoloft while pregnant and that adequate warnings would have prevented their injuries.  The petitioners do not dispute that the federal Food & Drug Administration (‘FDA’) has evaluated the safety of Zoloft for decades and that it remains approved as safe and effective.”  In furtherance of that claim, plaintiffs “designated Adam C. Urato, M.D., as their expert on the adequacy of the Zoloft label in 2003, specifically as it related to the use of Zoloft during pregnancy.”  They disclosed that “Dr. Urato would offer opinions concerning the label to a reasonable degree of medical and scientific certainty, as an expert in Maternal-Fetal Medicine and based on his education, training, experience, review of the relevant literature, and specialized knowledge[.].”  So far, so good, right?

We digress for a moment to point out that before you go off on West Virginia and the rejection of learned intermediary in State ex rel Johnson & Johnson v Karl, let’s take a moment and note the
action by the Legislature in 2016 to adopt the doctrine, as noted in footnote 9 of the opinion:

In 2016, the Legislature enacted West Virginia Code § 55-7-30, which provides, in part, that it is the “intention of the Legislature in enacting this section to adopt and allow the development of a learned intermediary doctrine as a defense in cases based upon claims of inadequate warning or instruction for prescription drugs or medical devices.”  This Court had previously declined to adopt the doctrine. See Syl. Pt. 3, State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 647 S.E.2d 899 (2007) (“Under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers. We decline to adopt the learned intermediary exception to this general rule.”).  Because the case at bar was filed in 2012, the doctrine has no application here.

So, consistent with the separation of powers in the Mountain State, the Legislature stepped in to change a substantive opinion of the Court, which is how checks and balances are supposed to work.
Anywhoo, back to our discussion of J.C. v. Pfizer, which includes the Supreme Court’s careful recitation of the thorough analyses of the case by the Mass Litigation Panel.

Plaintiffs’ first expert, Dr. Urato was unable to appear for deposition “due to unspecified health reasons.”  With Urato a no-show, Pfizer moved to exclude him.  Plaintiffs’ opposition (which would come back to haunt them) “their labeling expert was a critical witness and their ‘key liability expert’ without whom they would be severely prejudiced.”  After noting the “great deal of work” he had done, plaintiffs “advised the Panel that should Dr. Urato’s medical situation prevent him from testifying, they would ‘seek to designate a new expert in his place, considering the importance of the liability topics on which he is designated to opine.’”  They argued at the hearing on the motion, ““Doctor Urato is a key liability expert of ours . . . We also want a trial to go forward with our key liability expert.  We shouldn’t be hamstrung and not have our key liability expert.”  Although the MLP ordered the deposition to proceed by a date certain, the plaintiffs “remained unable to produce him,” and instead moved for leave to designate a replacement again describing Dr. Urato as their “key” liability expert without whom the plaintiffs would be prejudiced.  The MLP directed plaintiffs to provide an affidavit under seal containing “a medical diagnosis for Dr. Urato and an affirmation that he was not medically able to sit for deposition.”  But, plaintiffs advised the Panel “we have had very limited contact with Dr. Urato and he has not supplied us with the affidavit from his treating doctor.”

Even though the MLP found plaintiffs, knew by June 9 the expert could not be deposed, did not provide an affidavit and did not timely determine Dr. Urato’s medical condition, whether he was able to testify in these cases, or request a replacement in a timely manner[,]” the MLP found good cause to name a new expert finding it “would be unfair to punish the litigants for their counsel’s lack of diligence.”  Plaintiffs named their new expert, David A. Kessler, M.D., purportedly “a nationally known expert and former Commissioner of the FDA.”  They then moved to limit Dr. Kessler’s deposition “to no more than three hours” arguing that Pfizer was already “well aware of his opinions,” because he issued a “116-page report detailing his opinions [gave a] deposition … in 2015 in a federal Zoloft multi-district litigation case….”  The Panel denied the motion to limit the length of the deposition and ordered plaintiffs to produce him.  “Two days before the deposition was to be taken, the petitioners filed a supplemental expert disclosure in which they withdrew Dr. Kessler.”

Pfizer moved for summary judgment “arguing that the petitioners could not meet their evidentiary burden on the alleged inadequacy of the 2003 Zoloft label.”  Plaintiffs responded that they could meet their evidentiary burden with Pfizer documents and, if expert testimony was necessary, they could get it from Pfizer’s witnesses.  The MLP granted summary judgment.

The MLP observed that whether the failure to adequately warn claim is based in strict liability or negligence, “the question is whether [Pfizer] acted reasonably under the circumstances.”  Relying on West Virginia precedent, the MLP noted the importance of having an expert witness in failure to warn cases, particularly when there are “complex technical, scientific, and medical issues beyond the common knowledge and experience of the average person.”  The MLP found that “[w]hether Pfizer behaved as a reasonably prudent manufacturer would when warning about the use of Zoloft during pregnancy involves complex issues of science and medicine”; that “this is not a case where the label is silent regarding the alleged risk” because the label during the relevant time carried the Category C pregnancy warning; that “the FDA has repeatedly approved Zoloft’s label”; that “numerous independent organizations have concluded that the evidence does not support a causal link between Zoloft and birth defects”; that the “inclusion of warnings that are not supported by the science can lead to unintended and adverse consequences for the patient”; and that the petitioners’ “prior statements regarding the importance of their labeling expert and the prejudice to their case without such an expert are inconsistent with any assertion that they do not need such an expert because the alleged inadequacy of the Zoloft label is “obvious.”

The MLP also found that the documents plaintiffs claimed proved their warning case – “animal studies, epidemiology, adverse event reports, Core Data Sheets, and FDA regulations” – were “not within the common knowledge and experience of the average juror…[and that] such evidence cannot substitute for expert testimony on the adequacy of the Zoloft label.  Further, “[n]either the interpretation of such studies nor the appropriate method for distilling such lengthy and complex information into a prescription drug label is within the ordinary knowledge and experience of the average juror.”  The MLP concluded “the adequacy of Zoloft’s label required expert testimony.  Because the petitioners had withdrawn their warning/label expert, the Panel concluded they could not meet the burden of proof on an essential element of their claim.”

After detailing plaintiffs’ argument – essentially, they didn’t need an expert because evaluation of the warning was an issue within its common knowledge of the jury – and Pfizer’s argument – you need an expert to prove a warning claim – the Supreme Court of Appeals of West Virginia stated it was plaintiffs’ burden to prove an inadequate warning or “to prove that Pfizer acted unreasonably regarding the pregnancy warning on its 2003 Zoloft label, i.e., the Category C warning mandated by the FDA, as well as the additional warning that patients should ‘notify their physician if they become pregnant or intend to become pregnant during therapy[,]’ and that the failure to adequately warn proximately caused their alleged injuries.”  Recognizing that the FDA approval of the label was evidence of reasonableness, the Court stated “our precedent reflects that expert testimony will be necessary to sustain an evidentiary burden when the matters involved are beyond the common knowledge and experience of the average juror.”

The Court noted particularly that plaintiffs resisted Pfizer’s motion to disqualify their first expert, arguing that his testimony “was critical to their claim,” and explaining in detail why.  The Court expressed some amazement at the withdrawal of the second expert and stated “[n]otwithstanding the petitioners’ u-turn after they voluntarily withdrew their key liability expert, evaluating whether the language in the 2003 Zoloft label was adequate based upon the scientific and medical information that was available at that time, including the science related to the risks of untreated depression during pregnancy, is well beyond the ken and experience of the average juror.”  After a detailed discussion of West Virginia precedent on the need for expert testimony and the common knowledge exception, the Court concluded “[o]ur consideration of the complex issues in the case at bar concerning what should and should not be included in a drug label demonstrates that this is a case where expert testimony is necessary…,” and “[t]o find otherwise, following our consideration of the facts, claims, and circumstances of this case, would be to invite an unsound, unintelligent, and speculative verdict based upon matters beyond the cognition and experience of the average juror.”  (Here, we just have to interject Justice Neely’s separate opinion in Totten v. Adongay, 337 S.E.2d 2 (1985) (Neely, J., concurring), West Virginia’s seminal case on the “common knowledge” exception to the requirement of expert testimony:  “The reason that I have taken the time to concur in part and dissent in part in a case that appears to be of little moment is simply to point out that it is stupid to try any malpractice case, no matter how outrageous, without the help of an expert witness.”).

The Court further rejected plaintiffs’ argument that the warning case could be proven with Pfizer documents and testimony.  After a detailed review of the documents and Pfizer witness testimony, the Court concluded “[t]he foregoing deposition testimony shows that the petitioners cannot sustain their evidentiary burden with Pfizer’s witnesses…,” because “rather than supporting the petitioners’ claim, these witnesses each testified that the U.S. Zoloft label adequately conveyed the essential information in the Core Data Sheet, including the benefit/risk assessment to be conducted by the prescribing physician and the patient for use during pregnancy.”  Again, the Court recounted the plaintiffs fought to keep their expert even though they had “‘significant material evidence’ that would obviate the need for expert testimony….  As the petitioners previously represented, the advanced education, experience, and expertise of Dr. Urato, and later Dr. Kessler, were necessary for an intelligent consideration and analysis of this “significant material evidence” and the myriad of factors involved in the formulation of the Zoloft label.  The petitioners’ argument that they do not need their key liability expert but can sustain their failure to adequately warn claim with Pfizer witnesses is plainly untenable.”

Last, the Court rejected plaintiffs’ argument that requiring expert testimony would be “unfair”:  “Importantly, requiring a party to meet his or her evidentiary burden with expert testimony – where necessary – ensures that a jury’s verdict has a sound evidentiary basis and has been intelligently rendered.”

The Court therefore affirmed the MLP’s order granting summary judgment.