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Most of the controversy in the recent decision, Hill v. Bayer Corp., 2020 WL 5367334 (E.D. Mich. Sept. 8, 2020), revolved around whether the plaintiff could assert a cause of action for failure to report adverse product events to the FDA.  Like the great majority of decisions (particularly since Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. Dec. 18, 2018), exposed Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Jan. 10, 2013) (en banc), as an erroneous decision) Hill refused to allow such a claim.

Plaintiff’s chief problem in Hill was that the contraceptive device she was suing over was FDA pre-market approved, thus providing the defendant with a strong preemption defense.  As a purported “parallel” claim that could escape preemption, the plaintiff in Hill alleged failure-to-report as a “negligent failure-to-warn”:

Despite the heading “negligent failure-to-warn,” the Amended Complaint cites to a lengthy list of alleged federal regulatory violations, the vast majority of which do not involve warning requirements at all, but rather involve the alleged failure to make certain reports including adverse events to the FDA.

2020 WL 5367334, at *4.

Hill wasn’t buying what the plaintiff was selling.  “The law is well established that there is no parallel federal requirement that [defendant] had a duty to warn the general public or the medical community, and thus, those claims are expressly preempted because they are different from, or in addition to,’ the Medical Device Amendments (“MDA”) requirements.”  Id. (citations and quotation marks omitted).  Any duty to report was created solely by the Food, Drug & Cosmetic Act (“FDCA”):

[I]t is the Federal Government, not private litigants who are authorized to file suit for noncompliance with the medical device provisions. . . .  [A] state law tort claim that is “a disguised fraud on the FDA” claim is preempted. . . .  That is exactly what [plaintiff] seeks to do here: to hold [defendant] liable for alleged misrepresentations and withholding of information to the FDA.

Id. at *5 (citations and quotation marks omitted).

The learned intermediary rule is a traditional restriction on warning claims involving prescription medical products, and that rule means that the FDA is not a common-law learned intermediary.

Under the learned intermediary rule, the physician is the proper recipient of necessary information or warnings, not plaintiff.  Thus, under Michigan law, any duty in this case would be one owed to [plaintiff’s] physicians, not [plaintiff] herself, and not the FDA.

Id. at *7 (citations and quotation marks omitted).  Nice and simple – where the learned intermediary rule applies, there is no common-law duty to warn anyone else, including the FDA.  Because plaintiff “has not alleged any Michigan requirement that a manufacturer report adverse events to the FDA” but instead “relies solely on [defendant’s] alleged failure to warn the FDA of adverse events in support of her failure to warn claim,” the claim is preempted.  Id.

Hill is representative of most recent precedent (except for the case we discussed here).  Just since August, three other cases had held reporting-based warning claims preempted when asserted against manufacturers of PMA devices.  In Bayer Corp. v. Leach, ___ N.E.3d ___, 2020 WL 4811506 (Ind. App. Aug. 19, 2020) (discussed here), the court held:

[E]ven assuming that [defendant] failed to comply with federal reporting requirements, other federal law nevertheless required that [defendant] use the approved labeling and packaging.  Under the MDA, a state cannot impose a different or additional requirement.  Thus, the claims that [defendant] is liable for a failure to . . . are expressly preempted.

Id. at *10 (regulatory citations omitted).

Next, in Noel v. Bayer Corp., 2020 WL 5038782 (D. Mont. Aug. 26, 2020) (discussed here), failure-to-report claims failed under Montana law.  First, “no FDA requirement for Bayer to report consumer complaints directly to healthcare providers and consumers or to update its warnings and labeling.”  Id. at *4.  Second, “Montana law provides no such parallel duty” to the federal requirement that “device manufacturers must report any incident to the FDA where their device may have caused or contributed to a death or serious injury.”  Id. (citation and quotation marks omitted).  Under the learned intermediary rule:

A government regulator is not a foreseeable user or consumer of a product.  Nor is it a healthcare professional responsible for a patient’s care.  In neither case did the Montana Supreme Court hold that a manufacturer must warn the FDA (or government regulators generally) of known dangers.

Id. (emphasis original).

Likewise, Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020) (discussed here), joined the “[m]any courts [that] have found claims based on alleged reporting failures preempted.”  Id. at *7 (citations omitted).  Given the learned intermediary rule, Conley rejected the plaintiff’s argument and held that Pennsylvania common law imposed no “general[] . . . duty to warn third parties.”  Id. at *5-6 nn. 5-6.  Without any parallel common-law duty preemption could not be avoided.  Thus, the reporting claim in Conley “failed to state a parallel claim” and was “preempted.”  Id. at *7.

Depending on how a court chooses to view the issue, a failure-to-report claim against a PMA device manufacturer can be expressly preempted (Leach, Conley), impliedly preempted (Noel), or both (Hill).

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It’s been a while.  We have updated our cheat sheet devoted to ediscovery for defendants differently than most of our other cheat sheets and scorecards.  The topic of discovery of plaintiffs’ social media is broad – such cases arise in a wide variety of non-drug/device contexts – other personal injury, employment, civil rights, occasionally even criminal litigation.  So we can’t rely on our various automatic Westlaw/Lexis searches to bring the relevant cases to us.  Thus we must research this topic affirmatively to find what’s out there.

That means extra work for us, and recently we’ve been lax in this area.  But we finally got around to it.  So below (and also added to the cheat sheet itself) are our latest additions, all of which are:  (1) on point, and (2) favorable to our side of the “v.”  All of the new opinions below either allows access to a plaintiff’s social media activity or imposes sanctions (often for spoliation) on plaintiff for resisting such discovery.

We also provide our usual caution about social media ediscovery for defendants.  First and foremost, it’s not a good idea for a defendant to make a broad request for social media discovery at the very outset of the case – send a preservation letter (or get a court preservation order) instead.  Without more, courts are not impressed and are likely to treat the request as a “fishing expedition.”  The best time for a blanket social media discovery demand is after the defendant has caught the plaintiff in a lie – with contradictory public social media evidence − or the plaintiff has attempted to delete or otherwise hide social media activity.  The key word is “investigate.”  Once the tip of the spear penetrates a plaintiff’s shenanigans, the rest follows more easily.

Second, without hard evidence of the other side’s concealment, starting small, with less intrusive social media discovery is a good idea.  Rather than going after everything, consult an ediscovery specialist and consider proposing sampling – 5% or 10% of all posts – as something less intrusive, but statistically likely to find contradictory evidence if it exists.  An active social media user (who will most likely to generate useful information) usually has thousands of posts and other types of entries.  Thus, if anything exists, sampling is likely to bring it to light, and from there a defendant has grounds for seeking broader discovery.

Keeping those thoughts in mind, below are the latest favorable decisions allowing defendants to conduct ediscovery of plaintiff social media:

  • Dewidar v. National Railroad Passenger Corp., 2018 WL 280023 (S.D. Cal. Jan. 3, 2018). Plaintiff’s social media data was directly relevant to the claimed incident and injuries.  Boilerplate objections, including privacy, disregarded.
  • Stokes v. City of Visalia, 2018 WL 1116548 (E.D. Cal. Feb. 26, 2018). Postings made by Plaintiff and third parties on any social media device or social media program are permissible discovery in this action.
  • Castelino v. Rose-Hulman Institute of Technology, 2018 WL 1140389 (S.D. Ind. March 2, 2018). Plaintiff ordered to produce a downloaded copy of his Facebook account.  The demand is proportionate.  Plaintiff put his emotional state at issue.  Use of a third-party vendor to extract the data is proper.
  • Thompson v. Coleman, 544 S.W.3d 635 (Ky. April 26, 2018). Proper to allow a specialist selected by defendants to inspect plaintiff’s decedent’s cell phone, computer, and social-media account for one year before the decedent’s suicide.  Defendant is entitled to discover alternative causes, and should not be limited to the period the decedent used its product.  Proper to order simultaneous production.  There is no privilege against discovery, and a confidentiality order has been entered.  Review of irrelevant material does not preclude discovery.
  • Hinostroza v. Denny’s, Inc., 2018 WL 3212014 (D. Nev. June 29, 2018). Plaintiff must identify all social media platform she uses.  Defendant is entitled to social media discovery from one year before the plaintiff’s accident.  Text messages close to the accident are also discoverable.  Social networking is neither privileged nor protected by any privacy right.
  • C v. Metro. Government of Nashville & Davidson County., 2018 WL 3348728 (M.D. Tenn. July 9, 2018). Plaintiffs ordered to identify all their social media platforms.  Plaintiffs also ordered to produce all non-public social media content regarding the alleged incidents and for two months on either side of them.
  • Bossenbroek v. HHS, 2018 WL 4790383 (Fed. Cl. Sept. 4, 2018). Production of social media is ordered to substantiate of plaintiff’s injuries and their severity.  No expectation of privacy in social media since, even if “private,” it is shared with others.
  • Connolly v. Alderman, 2018 WL 4462368 (D. Vt. Sept. 18, 2018). Plaintiff ordered to produce social photographs, videos, or documents addressing or reflecting plaintiff’s ability to engage in relevant activities from the beginning of the claimed incidents to the present.  Failure to comply will result in an order to produce passwords.  Any privacy issues can be resolved with a confidentiality order.
  • Peterson v. City of Minot, 2018 WL 5045194 (D.N.D. Oct. 17, 2018). Defendant entitled to have its expert search plaintiff’s computer for relevant social media.  Material will be sent to plaintiff’s counsel first.  If plaintiff objects, the material will be reviewed in camera by the judge to determine discoverability.
  • Hayes v. HHS, 2018 WL 7049378 (Fed. Cl. Dec. 4, 2018). Plaintiff required to produce all social media postings concerning alleged pain and suffering, activities, physical capabilities, and any alternative causes. social media posts and videos are reasonably and directly relevant to establishing the severity of the ongoing injury.  There is no right to privacy in social media.  Social media is not similar to medical records.
  • Walker v. Corizon Health, Inc., 2018 WL 6602229 (D. Kan. Dec. 17, 2018). Plaintiff’s social media is relevant and discoverable.  If plaintiff’s social media accounts have privacy settings limiting public access, plaintiff must provide defendant with copies of any social media postings, public or private, which in any way relate to the matters involved in this lawsuit.
  • Robinson v. MGM Grand Detroit, LLC, 2019 WL 244787, at *1 (E.D. Mich. Jan. 17, 2019). Plaintiff must comply with social media discovery, including from his cell phone, concerning his alleged disability, emotional damages, mitigation of wage loss.  Defendant supported request with evidence that plaintiff was working out while allegedly disabled.  Discovery is both relevant and proportional.
  • Vasquez-Santos v. Mathew, 92 N.Y.S.3d 243 (N.Y.A.D. Jan. 23, 2019). Denial of social media discovery reversed.  Where plaintiff posted photographs and other evidence of his engaging in sports and similar activities on devices, emails accounts, and social media, this material was discoverable.  Private social media is discoverable where it contradicts or conflicts with a plaintiff’s alleged restrictions, disabilities, losses, and other claims.
  • Walmart, Inc. v. Ohler, 2019 WL 644936 (La. App. Feb. 15, 2019). Denial of social media discovery reversed.  Information on social media accounts is generally discoverable.  In camera review ordered to determine if information posted since the date of the accident concerns the accident or plaintiff’s alleged injuries and treatment, or reflects physical capabilities that are inconsistent with the injuries allegedly suffered.
  • Matter of Parks, 2019 WL 8955113 (S.D. Fla. March 22, 2019). Defendant entitled to six months of plaintiffs’ social media posts, including videos and photographs, prior to the date plaintiffs first filed their claims.  There is  no general bar against the production of social media.  The information is relevant  to the injuries and damages and not burdensome to produce.
  • In re Ford Motor Co. DPS6 PowerShift Transmission Products Liability Litigation, 2019 WL 3815721 (C.D. Cal. May 13, 2019). Plaintiff’s counsel sanctioned for obstructing discovery into plaintiff’s Twitter account on privacy grounds.  A social media account, which by its nature is intended to be shared, cannot be shielded from discovery on privacy grounds.
  • Herzog v. Sacko Delivery & Trucking, 115 N.Y.S.3d 616 (N.Y. Sup. May 17, 2019). Defendant entitled to plaintiff’s post-accident statements and representations on social media that bear on the extent of the injured plaintiff’s damages.
  • Mercado Cordova v. Walmart Puerto Rico, Inc., 2019 WL 3226893 (D.P.R. July 16, 2019). Plaintiff sanctioned with an adverse spoliation inference for deleting a social media account.
  • McLaughlin v. Bayer Essure Inc., 2019 WL 3483177 (Mag. E.D. Pa. July 24, 2019). Plaintiffs must produce responsive social media.  They may do so either by reviewing and gathering social media themselves, or by providing access authorizations to defendants, subject to the right to claw back any privileged material.  Adopted 2019 WL 3811907 (E.D. Pa. Aug. 13, 2019).
  • Trevino v. Golden State FC LLC, 2019 WL 3892356 (E.D. Cal. Aug. 19, 2019). Plaintiffs ordered to produce records of their email, text messaging, social media activity, and phone calls made on their personal phones during the workday when they were supposed to be working.
  • Soderstrom v. Skagit Valley Food Co-op, 2019 WL 3944327 (W.D. Wash. Aug. 21, 2019). Social media discovery compelled from the date the alleged events began.  By filing suit plaintiffs put their mental and emotional states at issue.  Social media activity is not protected from discovery by any right of privacy.
  • LaJeunesse v. BNSF Railway Co., 333 F.R.D. 649 (D.N.M. Aug. 30, 2019). Sanction of dismissal granted for plaintiff knowingly, intentionally, and willfully misrepresenting his social media use and for knowingly and willfully refusing to produce social media material.
  • O’Hern v. Meech Lake General Partner LLC, 2019 WL 4410319 (Ill. App. Sept. 12, 2019). Sanction of dismissal for repeated and defiant refusal to turn over social media activity in discovery affirmed.
  • Dickerson v. Barancik, 2019 WL 9903813 (M.D. Fla. Oct. 22, 2019). Social media content is generally discoverable, particularly when the plaintiff’s physical condition is at issue.  Plaintiff must produce all non-privileged content shared on her Facebook account from two years prior to the date of the accident to the present.
  • Bruner v. City of Phoenix, 2020 WL 554387 (D. Ariz. Feb. 4, 2020). Plaintiffs sanctioned for deleting social media entries and an entire account.  Ignorance of how to go about downloading accounts is no excuse for nonproduction.
  • Caserta v. Triborough Bridge & Tunnel Authority, 115 N.Y.S.3d 895 (N.Y.A.D. Feb. 18, 2020). Restrictions on defendant’s discovery of plaintiff’s social media vacated as unnecessarily restrictive.  Discovery of photographs, videos, and other social media postings regarding plaintiff’s social and recreational activities that might contradict his claims of disability, is relevant, useful, and reasonable.
  • Rodriguez-Ruiz v. Microsoft Operations Puerto Rico, L.L.C., 2020 WL 1675708 (D.P.R. March 5, 2020). Discovery of plaintiff’s social media profile(s) is appropriate.  Plaintiff lacks a right to privacy in the content of his social media profiles.  Social media activity is relevant to assertions of emotional distress.
  • Aspin v. Allstate Property & Casualty Insurance Co., 2020 WL 1523250 (W.D. Wash. March 30, 2020). Plaintiff must provide access to his social media accounts or to the devices through which the requested information can be found.  If plaintiff cannot download and produce the requested emails, text messages, social media posts, photos, and/or videos himself, he shall provide whatever access is necessary so that defendant can locate and copy the relevant information.
  • Crossman v. Carrington Mortgage Services, LLC, 2020 WL 2114639 (M.D. Fla. May 4, 2020). Plaintiff’s social media, including her Facebook and Instagram accounts, relates to her contemporaneous mental and emotional states and therefore relates to the injuries she claims she suffered.  A confidentiality order eliminates any privacy concern.
  • Tate v. Zaleski, 2020 WL 3404739 (S.D. Miss. June 19, 2020). Plaintiffs ordered to produce a downloaded copy of their Facebook accounts.  Plaintiffs also ordered to allow a qualified, neutral expert to search their personal cell phones for communications responsive to defendants’ discovery.
  • Denson v. Corp. of President of Church of Jesus Christ of Latter-Day Saints, 2020 WL 3507410 (Mag. D. Utah June 29, 2020). Given that some relevant evidence in plaintiff’s possession has gone missing, defendant is entitled to access to plaintiff’s electronic devices and cloud based accounts to create a mirrored image.  Access shall be by an independent third-party expert to ensure that irrelevant materials remain private.  Plaintiff ordered to turn over the necessary passwords.
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This is from the non-Reed Smith side of the blog.

Sometimes a protective order just isn’t enough.  As product liability defense attorneys, we are often faced with discovery requests for highly sensitive trade secret information.  Plaintiffs’ counsel tend to think that a confidentiality or protective order is a cure-all that should allow companies to throw wide their doors, drawers, disks and anything else.  After all, there’s this court order, agreed to by the parties, signed by the judge, that carries penalties for failure to comply.  But all that means is that the receiving party, in our case plaintiffs, has an obligation to not make confidential documents and information public.  But what if making the information public is something unintentional or not within their control.  Just by way of example, in October 2013 hackers stole nearly 3 million encrypted credit card records from Adobe; in 2017 Equifax had a data breach that exposed about 147.9 million consumers; in 2012 LinkedIn had 6.5 million user passwords stolen and posted onto a Russian hacker forum; and in 2014 Yahoo was the victim of a data breach that compromised the names, email addresses, dates of birth and phone numbers of 500 million users.  And, while this is just a guess, we think the cyber security at these companies might just be a little more sophisticated than that used by most plaintiffs’ counsel.  We don’t say that to belittle their security efforts.  They’re just not Yahoo.  So, that little piece of paper signed by a judge isn’t protection against potential leaks as unintentional as they may be.

That was an important consideration in Schmidt v. Navistar, Inc., 2020 WL 5548837 (D.N.M. Sep. 16, 2020).  This is not a drug or device decision, but we thought the message was worth sharing.  It is a product liability case brought against the manufacturer of a commercial truck that rolled over causing the driver fatal injuries.  Id. at *1.  At issue was plaintiff’s request that defendant produce is computer assisted design (“CAD”) and finite element analysis (“FEA”) models for the subject vehicle and similar models.  Plaintiff claimed the CAD and FEA files were needed for their expert to address alternative safer designs and to “evaluate the structural integrity and design” of the vehicle.

Instead of the CAD and FEA files, defendant produced its testing files, drawings and corporate engineering specifications.  Id. at *2.  Both sides submitted affidavits from experts explaining why the CAD/FEA files were necessary (plaintiff) and why they were not (defendant).  Defendant’s employees and experts also detailed that these files were “Defendant’s most highly valued trade secrets” that even few of defendant’s employees had access to.  Id.  Further, the CAD/FEA files had never been produced outside of the company.  Id. at *3.  Defendant’s engineers explained that if leaked, CAD models (unlike the drawings/specs produced) could be entered into computers to create counterfeit parts.  Id. at *4.

Also detrimental to plaintiff’s need-based argument was testimony by her expert that in prior cases involving the same defendant, the expert had not been provided  CAD or FEA files and that they were not necessary for the expert to conduct his analysis.  Id. at *5.

It was against this factual background that the court conducted its analysis.  It was undisputed that the CAD and FEA files were trade secrets.  This is precisely the type of data if it fell into the wrong hands could cause defendant serious economic harm.  Id. at *8.  Therefore, “the burden shifts to Plaintiff to show that the information sought is relevant to the subject matter of the lawsuit and is necessary to prepare the case for trial.”  Id.  While relevance may be difficult to dispute in this context, necessity was not proven.  Given all of the data defendant did produce, the court was persuaded that defendant produced the “substantial equivalent” of what plaintiff sought without risking its trade secret information. Id. at *9.  Just because the CAD or FEA files may have made the expert’s job easier that did not justify disclosure of these highly-guarded trade secrets.

We are unaware of this type of material previously being held discoverable in other product liability litigation and we hope it stays that way because the same issue could easily arise in medical device litigation.  We haven’t had to blog about the issue before and as long as the law stays this way, we won’t have to again.

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Here is another post by our blogger in training, Dean Balaes.  This time he explores an interesting decision that applied the “sham affidavit” doctrine to defeat an all-too-common P-side deposition tactic, last minute leading questions (often when the defense has no time for re-cross) designed to generate self-serving answers that contradict prior damaging testimony.

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The great philosopher Dolly Parton once remarked, “If you want the rainbow, you gotta put up with the rain.”  All attorneys want the rainbow.  That is to say, attorneys want to win unequivocally for their clients, but great expectations often meet humbling realities.  Any lawyer who has taken a deposition knows that clients sometimes say the most darndest, case-destroying things.  As advocates, attorneys may feel called to stave off the rain for the rainbow by soliciting self-serving testimony after the fact in the hope of salvaging their clients’ cases.  In these moments, the best advocacy may well be knowing when to do nothing at all.  Enter yet another post on the sham affidavit doctrine:

[A] party may not create a material issue of fact to defeat summary judgment by filing an affidavit disputing his or her own sworn testimony without demonstrating a plausible explanation for the conflict.

Jiminez v. All American Rathskeller, Inc., 503 F.3d 247, 251 (3d Cir. 2007) (quoting Baer v. Chase, 392 F.3d 609, 624 (3d Cir. 2004)).

To use yet another idiom, this doctrine can be summed up as “pulling the rabbit out of the hat.”

This is exactly what the plaintiff tried to do in Kennedy v. Ethicon, Inc., 2020 WL 4050459 (E.D. Pa. July 20, 2020), a pelvic mesh case.  The issues in Kennedy revolved around both parties’ realizing that the case suffered from glaring statute of limitations problems – but where there is a rule, there is an exception.  The “discovery rule” was one such loophole.  Id. at *7.  This exception “is premised on the concept that where the existence of an injury is not apparent or where the existence of an injury cannot be reasonably ascertained, the statute of limitations does not begin to run until such time as the injury’s existence is known or discoverable by the exercise of reasonable diligence.”  Id.

With this background, one can understand why, at deposition, both parties were trying to identify when exactly the plaintiff/witness “gained knowledge of the relationship between her injuries and the pelvic mesh.”  Id. at *14.  The witness originally stated “in no uncertain terms” that she knew her injuries arose because of the pelvic mesh implant in “March, April and May 2011[.]”  Id.  On this point, it cannot be understated how certain the witness was; for example, she testified that: (1) “she observed first hand the damage her mesh implant was causing…;” (2) “as a result of this observation, she attributed her injuries to the pelvic mesh;” and (3) “more specifically, she attributed her injuries to a defect in the mesh.”  Id. at *13.  Why, one might ask?  The witness further testified that she was able to make these observations (and judgments) at the doctor’s office because “they had a camera” above her head that let her see for herself.  Id.

At this point, blog readers have probably figured out that, regardless of whether the witness learned of her injuries in “March, April and May 2011” or not, the defendants had the case won on statute of limitations grounds.  The Court’s opinion does not address it, but one can reasonably assume that the plaintiff’s counsel knew they were caught in the rain without an umbrella, so to speak, but still wanted to rely on the “discovery rule” exception.

Thus, at the “tail end” of her deposition, the witness’s own attorneys questioned her, posing “self-serving” questions to their client and obtaining statements that directly contradicted her previous testimony.  Id.  Contrary to the witness’s original statement that she knew of her injuries in “March, April and May 2011,” the other side adduced self-serving testimony from the witness that she only became aware of her injuries in September 2011 or “early 2012.”  Id.

In a vacuum it might seem that, based on the plaintiff’s two contradictory lines of testimony, there was a material fact in dispute.  Fast-forwarding to the defendant’s motion for summary judgment, however, the Court declined to look at the deposition in a vacuum and, therefore, did not buy the witness’s “self-serving” testimony.  Id.  Relying on the “logic of the sham affidavit doctrine” for guidance, the Court stated that “Plaintiffs must, at a minimum, make some attempt to explain the apparent contradiction in [the witness’s] testimony for the Court to consider the latter, contradictory portions of it.”  Id. at *15.

This is why Kennedy is of interest – the sham affidavit doctrine is not often applied to oral deposition testimony.  Our readers should make note of that, because testimonial u-turns by plaintiffs at the “tail end” of depositions, induced by counsel, are hardly unknown, and as Kennedy demonstrates, the “sham affidavit” rationale is one way of curtailing such questionable tactics.

In Kennedy, the best “attempt” offered by counsel at explaining their client’s contradictions was not very good, being a vague set of assertions that the defendants were “cherry picking” portions of the deposition transcript and “[t]o the extent there is contradiction in the evidence regarding timeliness, Pennsylvania law makes clear that this issue should be decided by a jury[.]”  Id.

At the core of plaintiff’s argument in Kennedy is failure to come to grips with Justice Souter’s recommendation that lawyers understand “confession and avoidance.”  Here is an example of confession and avoidance:  Counsel could have said, “Yes, your honor, there is a contradiction, but I will tell you why it does not make a bit of difference in this case.”  Notice, however, that in Kennedy counsel did not confess to the specific contradiction at issue.  They went straight to the avoidance portion of Justice Souter’s recommendation.  One could hazard a guess that use of the adjective “some” indicates that the Court in Kennedy set a relatively low bar for counsel to hurdle.  Id.  But for lack of a “meaningful explanation,” the Court declined “to credit or consider” the plaintiff’s tail-end contradictory statements.  Id.  Summary judgment granted.  Id.

Putting aside Kennedy, it is difficult to discuss the sham affidavit doctrine without acknowledging that doctrine is invoked when there is an appearance of legal hanky-panky.  A lawyer’s job is to know more than the client.  During depositions, it is common (and expected) for witnesses to feel scared, fumble their words, make contradictions, and be confused.  A witness often does not know how the deposition testimony will be used.  Attorneys, however, should maintain a higher standard of conscientiousness at depositions.  This means, among other things, preparing their witnesses so that their answers do not counter their overall legal strategy, or else developing some other strategy consistent with what the witnesses believe to be true.

In those situations, it is incumbent on attorneys to avoid muddying the waters (and destroying a witness’s credibility) by encouraging the witness to directly contradict him/herself under oath.  Arguing an “issue of fact” from the irreconcilable testimony of the same witness is rarely a winning strategy, and could even be sanctionable.  In other words, an attorney’s questions should not attempt to gin up a dispute, especially when prior testimony blatantly contradicts the latter statement.

In sum, one can read Kennedy’s expansion of the sham affidavit doctrine to oral testimony as a shot across the bow to combat attorneys seeking to manufacture material facts in dispute from a single witness’s contradictions.  Sometimes, a likely story is exactly that.

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Not too long ago we researched and posted about how preemption precludes private plaintiffs from second-guessing FDA decisions on the marketing and classification of the products the Agency regulates.  Looking through that post again, we note that quite a few of those decisions (although well less than half) involved commercial disputes of one sort or another.  See Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990); Hi-Tech Pharmaceuticals, Inc. v. Hodges Consulting, Inc., 230 F. Supp.3d 1323 (N.D. Ga. 2016); JHP Pharmaceuticals, LLC v. Hospira, Inc., 52 F. Supp. 3d 992 (C.D. Cal. 2014); Catheter Connections, Inc. v. Ivera Medical Corp., 2014 WL 3536573 (D. Utah July 17, 2014); Imagenetix, Inc. v. Frutarom USA, Inc., 2013 WL 6419674, at *4 (S.D. Cal. Dec. 9, 2013); Midlothian Laboratories, L.L.C. v. Pamlab, L.L.C., 509 F. Supp.2d 1065 (M.D. Ala. 2007), vacated in part other grounds, 509 F. Supp.2d 1095 (M.D. Ala. 2007); Healthpoint, Ltd. v. Stratus Pharmaceuticals, Inc., 273 F. Supp.2d 769 (W.D. Tex. 2001); Braintree Laboratories, Inc. v. Nephro-Tech, Inc., 1997 WL 94237 (D. Kan. Feb. 26, 1997).

The recent decision Exela Pharma Sciences, LLC v. Sandoz, Inc., ___ F. Supp.3d ___, 2020 WL 5535026 (W.D.N.C. Sept. 15, 2020), is another one along these lines, and it’s a doozy.  In the course of dismissing the claims, Exela rules on several issues that also arise in our product liability sandbox.

The facts that created the dispute in Exela were somewhat unusual.  The defendant was minding its own business, selling a drug overseas for which it had not sought FDA approval.  A drug shortage arose in the United States, which “led the FDA to approach the Defendant about importing and selling its unapproved . . . product in the United States under the FDA’s ‘shortage program’ without requiring the drug to obtain FDA approval.”  Id. at *2.  The defendant did so under an FDA “memorandum of discretion” (with a fixed end date that the FDA extended several times) that it would not be prosecuted for doing so.  Id. at *2-3.  One condition of the FDA memorandum (which becomes important) was that the defendant include a “dear healthcare provider” (“DHCP”) letter with each unit of product sold, explaining the situation.  Id. at *2.

While defendant was selling its drug under its arrangement with the FDA, the plaintiff developed and obtained FDA approval for a competing product that was arguably better and safer (Exela was decided on a motion to dismiss, so plaintiff’s alleged facts were taken as true).  Id. at *3.  However, the plaintiff had trouble selling its product with the defendant’s product still on the market, leading it to lobby the FDA to remove the unapproved competitor from the market:

After the FDA approved the Plaintiff’s product, the Plaintiff made numerous efforts to get the Defendant to stop selling its unapproved product. . . .  [T]he Plaintiff repeatedly asked the FDA to remove [defendant’s drug] from its drug shortage list and prohibit any further importation and distribution of the Defendant’s unapproved product.

Id.  Plaintiff also sent nasty letters to the defendant complaining about “allegedly improper and unethical conduct” and demanding that the FDA-authorized imports stop.  Id.  Eventually, the FDA did declare an end to the shortage and told defendant to stop importing its product, and defendant “immediately complied.”  Id. at *3-4.  However, the FDA allowed defendant to sell the rest of its “existing inventory.” Id.  During this time, plaintiff still had trouble competing with defendant’s product, allegedly obtaining only 20% market share.  Id. at *4.

The lawsuit – brought under state law (primarily North Carolina deceptive trade practices) and the federal Lanham Act − made a variety of claims that second-guessed the FDA’s decision to allow defendant’s product on the market and to keep it there for as long as the Agency did.  That led to one of our favorite results:  implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and its progeny.

Finding all the state-law claims preempted, Exela invoked not only the FDCA’s no-private-right-of-action provision, 21 U.S.C. §337a, which Buckman construed, but also the FDA’s “complete discretion” to decide whether, and when, to “bring an enforcement action under the FDCA.”  2020 WL 5535026, at *5 (quoting in part Heckler v. Chaney, 470 U.S. 821, 835 (1985)).  Exela held:

The FDCA’s prohibition on private actions, however, would be thwarted if savvy plaintiffs can label as arising under a state law for which there exists a private enforcement mechanism a claim that in substance seeks to enforce the FDCA.  As such, private litigants may not bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA.  Likewise, there can be no state law cause of action if a plaintiff’s true goal is to privately enforce alleged violations of the FDCA.

2020 WL 5535026, at *5 (citations and quotation marks omitted).

“The test for determining whether a state law claim is impliedly preempted is whether or not the claim would exist in the absence of the FDCA.”  Id. (citation and quotation marks omitted).  “[A]ny claim that relies on the FDCA or its implementing regulations as a critical element is barred by §337(a).”  Id. (citation and quotation marks omitted).  Such “implied preemption applies to claims like breach of warranty, negligence per se, design defect, and failure to warn.”  Id. (citations omitted).

Plaintiff’s first claim was that, notwithstanding the FDA’s memorandum of discretion, the defendant was liable under North Carolina law for the “deceptive practice” of marketing an “illegal” product, and that “the FDA acted unlawfully by letting the Defendant import and sell that product.”  2020 WL 5535026, at *6.  That claim “challenges the FDA’s decision not to bring enforcement proceedings against the Defendant under the FDCA.”  Id.  FDA prosecutorial discretion barred those allegations.  Once again, the discussion in the Exela opinion is so favorable to preemption that we’ll simply quote it organically, removing the various citations:

The Plaintiff’s [trade practices] claim related to the Defendant’s sale and importation of the . . . product is preempted.  The FDCA contains no private right of action and gives the FDA complete discretion to decide whether to bring enforcement proceedings.  As such, the FDA has power to determine whether particular drugs require an approved NDA [New Drug Application] in order to be sold to the public.  The Plaintiff does not have the authority to stand in the shoes of the FDA to determine whether the Defendant’s sale of the products at issue amounts to the sale of an unapproved drug under the FDCA.  This enforcement authority lies exclusively with the FDA. . . .  [I]t is the sole responsibility and privilege of the federal government, and not private plaintiffs, to bring a suit to enforce those violations.  The crux of the Plaintiff’s [trade practices] claim is a challenge to whether the importation and sale of the Defendant’s [drug] product are lawful under the FDCA.  As such, the Plaintiff is preempted from making that claim.

Id. at *7 (citations and quotation marks omitted).  As in Buckman, “the FDA engaged in a prolonged effort to balance . . . the risks inherent in a drug shortage with the safety risks of allowing the importation and sale of an unapproved product.”  2020 WL 5535026, at *7.  State-law claims attacking the FDA’s actions “would disrupt the delicate and considered balance that the FDA struck.”  Id.  “For the Plaintiff to now second guess the FDA’s decision in a civil action based on state law would render the FDA’s authority to be a nullity.”  Id.

Exela further analogized the claim attacking the defendant’s importation of its product to a “stop-selling” claim of type held preempted in the product liability context.

[T]he FDA issued a Memorandum . . . allowing the Defendant temporary permission to import and sell its [drug] product. Notwithstanding the Defendant’s permission from the FDA, a viable [trade practices] claim related to the import and sale of [that] product would have nonetheless forced the Defendant “to leave the market or accept tort liability.”  This is precisely the type of claim that . . . must be preempted.

Id. at *8 (quoting Drager v. PLIVA USA, Inc., 741 F.3d 470, 479 (4th Cir. 2014)).  Any claim “assert[ing] that the only way to comply with state law would have been for the Defendant to leave the market” is preempted.  Id.  Thus Exela illustrates one of the strengths of implied preemption – its principles apply to all cases, and are not limited to the same statutory sections.  Such “distinction[s] matter[] little for preemption purposes.”  Id. at *9 (also finding persuasive the stop-selling rationale of Zogenix, Inc. v. Patrick, 2014 WL 1454696 (D. Mass. April 15, 2014)).

Plaintiff’s second claim was that, by seeking renewal of the FDA’s memorandum of discretion, the defendant committed a state-law unfair trade practice.  Exela saw through that claim right away.  It wasn’t the defendant’s request to the FDA that the plaintiff challenged, but “Plaintiff’s true quarrel is with the FDA granting the . . . request.”  Id. at *10.  In that respect Exela is akin to the bogus “pre-approval design defect” claims that have sometimes bamboozled courts in product liability cases by purporting to attack a defendant’s FDA submission, when what the plaintiff really seeks to nullify is the FDA’s approval.  That claim also failed as a matter of law:

The Plaintiff does not allege that the FDA’s . . . decisions were a result of any false or misleading actions on the part of the Defendant.  The Plaintiff only alleges that the Defendant committed an unfair or deceptive act by merely seeking renewal.  That is insufficient. . . .

Id. at *11.  The FDA was “fully aware” of the defendant’s request, the “approval status and production status” of the plaintiff’s competing product, and the “state of the . . . market” when it allowed these renewals.  Id. at *10.

Plaintiff’s third claim is one we see fairly frequently in product liability litigation.  Plaintiff alleged that the defendant had an obligation to send another DHCP letter to “update” statements in the original FDA-required DHCP letter with new information – the existence of the plaintiff’s FDA-approved, competing product.  That claim raised the issue whether state law can require a defendant to send a DHCP/“Dear Doctor” letter where the FDA has not.  Exela answered “no,” to that question.

Only the FDA can require a regulated manufacturer to send out DHCP letters.  The FDA “mandate[s] and oversee[s] the distribution of Dear Healthcare Provider letters.”  2020 WL 5535026, at *11.  Thus, again, the plaintiff was attacking FDA-imposed requirements:

[T]he Defendant distributed the Dear Healthcare Provider letters at the FDA’s direction and with the FDA’s approval.  The distribution of those letters was one of the FDA’s conditions for not exercising its enforcement authority. . . .  Under those conditions, the FDA explicitly approved the language contained in the Defendant’s Dear Healthcare Provider letters and any revisions of those letters required FDA approval.

Id. at *12 (citations omitted).  Since the FDA would have to review any alterations to the DHCP letter it had previously approved, preemption was also required under what we call the “Mensing independence principle”:

[the FDA] prohibited the Defendant from unilaterally changing the statements contained in the letter, including the statement about which the Plaintiff complains.  The Supreme Court has held that “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”  That is because “[t]he only action the [Defendant] could independently take − asking for the FDA’s help − is not a matter of state-law concern.”

Id. (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 623-24 (2011)).  “[T]he FDA’s scheme for controlling the risks . . . would have been undermined if the Defendant sent other communications to customers contradicting the contents of the FDA-approved [DHCP] letters.”  Id.

Plaintiff’s fourth claim is another one we see fairly frequently in product liability litigation – whether state law can force a defendant to include information about other, competing products.  Plaintiff alleged that the defendant committed an unfair trade practice “by failing to warn its customers that [defendant’s] product had a higher [allegedly harmful impurity] content than the standard that the FDA required [plaintiff] to meet and by failing to tell its customers about the difference in [impurity] content between the two products.”  Again Exela held “no.”

Initially, Exela found that the plaintiff’s purported “FDA standards” were “not standards at all.”  The plaintiff exaggerated their import.  2020 WL 5535026, at *13.  All plaintiff offered was a “letter” the FDA had sent during the approval process for its competing product.  Not good enough.  That “letter . . . does not constitute an official agency determination.”  Id.  “[T]hat the FDA required the Plaintiff’s . . . product to meet a certain . . . level to receive FDA approval did not create a binding limitation on other drugs.”  Id.  In any event “regulatory letters do not constitute final agency action.”  Id. (quoting Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 563 (9th Cir. 1992)).

Further, Exela could find no state-law duty obligating the defendant to provide customers with derogatory information about how its product compared with the plaintiff’s competing product.

The Plaintiff has cited no authority for the proposition that a merchant’s failure to inform its customers as to how its product compares unfavorably to a competitor’s product constitutes a deceptive trade practice.  There is no basis to conclude that the law imposes such obligation.

2020 WL 5535026, at *13.  The FDA was free to set different standards for full drug approval, as opposed to temporary importation permission.  “The Plaintiff cannot, however, use a state-law claim . . . to countermand the FDA’s determinations and [to] substitute its own requirements.”  Id. (citation and quotation marks omitted).

Fifth and Sixth, the plaintiff asserted claims that the defendant had “oversupplied” the market and “misused” its “incumbent status” while selling its product when, and in the amount, the FDA allowed.  Id. at *14.  Both of these claims met the same preempted fate.  The allegations were simply that the defendant sold its product in accordance with FDA requirements.  Such claims were preempted “because there is no private right of action in the FDCA and the FDA is the sole entity that can bring enforcement actions to halt the sale and importation of drugs.”  Id. (citation and quotation marks omitted).

Seventh, the plaintiff also brought a common-law tort claim for “interference with prospective economic advantage.”  That claim likewise had as its “cornerstone” the allegations that “it is illegal to introduce an unapproved drug into interstate commerce.”  Id. at *15.  Since the tort claim alleged essentially the same thing, it was likewise dismissed.

Plaintiff’s claim is . . . that it is somehow “illegal” for the Defendant to do precisely what the FDA gave the Defendant permission to do.  As such, this claim again attempts to enforce the FDCA against the Defendant for importing and selling an illegal drug.  The FDA, however, is the only entity that can bring a claim against the Defendant for its alleged introduction of an illegal drug into interstate commerce.  The Plaintiff is preempted from bringing [this] claim.

Id. (citation omitted).  How many times must this self-evident proposition be repeated?  Not that we’re complaining.

Plaintiff also asserted many of the same claims under the guise of Lanham Act violations.  As we’ve discussed a number of times before, because the Lanham Act is a federal statute, it is not subject to preemption, per se.  However, courts have reached much the same result employing “comity,” “deference,” and similar principles.  So it was in Exela.  Lanham Act claims are “precluded” if they:  (1) “turn[] on the content of something that has been previously preapproved by the FDA”; (2) “conflict[] with an affirmative policy judgment by the FDA”; or (3) “involve an issue on which the FDA has taken positive regulatory action.”  2020 WL 5535026, at *16 (citations and quotation marks omitted).

On these bases all of plaintiff’s equivalent Lanham Act claims were precluded.  They involved communications preapproved by the FDA, FDA policy judgments, and matters where FDA had taken positive action.  Id.  at *16-17.

We recommend that our defense-side colleagues take a close look at Exela.  It’s chock full of useful preemption nuggets, and draws together citations to many cases from different areas of the law that have prevented private plaintiffs from second-guessing the FDA – product liability, to be sure, but also administrative and commercial litigation.

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We slipped our summer vacation in just before summer slipped away. Last week, we walked the rocky shores of Cape Cod, ate lobstah rolls the size of trolley cars, and navigated our way through the traffic catastrophes charmingly known in New England as “rotaries.” On our last day in the Bay State, the temperature plunged. Many fellow strollers on the sand donned down jackets. Summer in Massachusetts has a way of vanishing suddenly.

On our six and half hour drive back home, we dreamed up an outline for a short story entitled “Thoreau in the Passenger Seat.” Odds are we’ll never follow through, so here’s a sketch.

While we ogled the beautiful red-and-white Nauset Lighthouse in Eastham, a scruffy, bearded guy sidled up close to us (not much social distancing) and described the lighthouse’s history. Then he held forth about the power and majesty of the surf below. Many waves were 20 feet high. They crashed with fury. His words climbed above the din, and were poetic and precise. This shore saw scores of shipwrecks. Sharks had been spotted throughout the season. According to this strangely intense guy, who told us his name was Henry, the only comparable beach in the northeastern quadrant of the country was said to be the vast expanse on Long Beach Island in New Jersey, which he had never actually laid eyes on, but fervently hoped to someday.

It so happened that we would be driving down in that direction the next morning, and we said we’d be happy to give our new friend a lift. Deal. So at 10 am sharp on Saturday, we picked Henry up at the Dunkin’ Donuts in Mashpee, drove across the Bourne Bridge, and proceeded southwest. Through New Bedford and Fall River, Henry’s conversation was interesting enough, though his pro-whaling and pro-Lizzy Borden positions struck us as a bit off-key. We also noticed a hygiene deficiency; he gave off a slight whiff of pond scum. Then he started fiddling with the radio stations. Our usual rule is that the driver calls the tune. If Casey Kasem’s America Top 40 keeps us calm and steady in the middle lane, that should suffice. Yes, the time period of this particular Top 40 show, September 1978, was a particularly putrid moment for popular music. The Grease soundtrack dominated the charts. The number one song was “Boogie Oogie Oogie.” But Henry wanted to play the Hair Nation station. We demurred. A dose of Great White, Ratt, and Poison would prompt us to drive into a pylon. After we slapped Henry’s hand away from the dial, he stewed sullenly for a half hour.

The silence was tense, but was preferable to the way it ended – Henry started jibbering about the local flora and fauna, and none of what he said seemed remotely plausible. We’re pretty sure that the trees outside Providence, Rhode Island do not leak jello, and we doubt that salmon sing in the streets of Stamford, Connecticut. By the time we crossed the George Washington Bridge, we had grown quietly desperate to get away from this guy. If there was an ejection seat button, we’d have pushed it. The gas gauge was nearing the E, so we pulled into the first service station in New Jersey. Filling the tank cost almost $50. We eyed Henry expectantly. He never once reached for his wallet. Instead, he acidly observed that the namesake for the Turnpike Plaza, Vince Lombardi, couldn’t hold a Yankee candle to Bill Belichick’s record with the New England Patriots. We seethed. Then Henry said he needed to visit the men’s room and the Popeye’s chicken stand. Why couldn’t he have done that while we gassed up, especially since he wasn’t going to chip in at all? We sighed, pulled around, dropped him off, and waited. We waited about sixty seconds. That was just enough time to wrestle with our conscience, accelerate onto the ramp, and get back into the highway.

In his book on Cape Cod, Thoreau wrote that a man could stand on the great beach on Eastham and “put all America behind him.” At the Vince Lombardi rest stop on the New Jersey Turnpike, we decided to put Henry behind us. All the way down to the Philly suburbs, we didn’t look at our rearview mirror once.

***************

Today we will look at our rearview mirror. It is worthwhile to reflect upon Webb v. Mentor Worldwide LLC et al., 2020 WL 1685323 (N.D.N.Y. April 7. 2020), because it adds to the consensus that breast implant litigation is severely circumscribed by express preemption. Breast implants are class III medical devices. They go through the Premarket Approval (PMA) process and are subject to the Medical Device Amendments (MDA) of 1976 provision, 21 USC section 360k, which preempts any safety-related state rule regarding medical devices that is different from or in addition to federal requirements.

In Webb, the plaintiff claimed that her breast implants caused her to suffer many serious physical ailments. Her lawsuit included the usual panoply of causes of action for manufacturing defect, design defect, failure to warn, and breach of warranty. The court held that all were preempted.

The failure to warn, design defect, and warranty claims were clearly preempted. Any additional warning or different design would necessarily be different from or in addition to the federal scheme. Why do plaintiff lawyers even bother to include these claims anymore?

As usual, the real action resided in the manufacturing defect claim. As usual, the plaintiff argued for the narrow parallel claim exception, meaning that the claims were premised on violations that implicated both federal and state law. Also as usual, all the plaintiff could cite in the way of federal law were generic Quality System Regulations and Current Good Manufacturing Practices (CGMP). The plaintiff never specified how the defendant violated those regulations. The Webb court correctly held that any action premised on vague, overboard violations of general regulations would necessarily subject a defendant to standards different from or in addition to the MDA provisions.

There are some courts out there that permitted manufacturing defect claims based on vague CGMP violations to elude preemption. Those decisions are in the minority and are poorly reasoned. With the Webb decision in the books, that minority rule is even more in the minority, and the poor reasoning behind it is now even more obviously poor.

There are two other aspects of the Webb decision that the defense bar might find an opportunity to employ. First, the court rejected the plaintiff’s effort to include the manufacturer’s parent company as a defendant. The conclusory allegations of alter ego status could not survive a motion to dismiss. Second, the court denied the plaintiff’s request to amend her complaint. The plaintiff had not offered to amend her complaint after being served with the defendant’s pre-motion letter, and did not include a proposed amendment when she ultimately did seek permission to amend.

Thoreau ended Walden by announcing that “There is more day to dawn.” Not for the Webb complaint. Not for breast implant claims.

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We’ll be very clear – as we have before:  We don’t like most class actions.  Indeed, if given our druthers, we would abolish Rule 23, as it applies to class actions for damages, altogether.  But that’s not in the offing anytime soon.  Today, we offer a class action decision that we think both sides, us on the defense and those on the plaintiffs side, can agree on, excluding only those responsible for the problem.

In Pearson v. Target Corp., 968 F.3d 827 (7th Cir. 2020), the court came up with one possible solution to the class action “objector problem.”

What’s that?

Well, once a class action settles (as most do), all too often “objectors” come out of the woodwork.  While these objectors purport to assert the interests of the class, usually, all they want is money to make them go away.  Or, as described in Pearson:

We address here a recurring problem in class-action litigation known colloquially as “objector blackmail.”  The scenario is familiar to class-action litigators on both offense and defense.  A plaintiff class and a defendant submit a proposed settlement for approval by the district court.  A few class members object to the settlement but the court approves it. . . .  The objectors then file appeals.  As it turns out, though, they are willing to abandon their appeals in return for sizable side payments that do not benefit the plaintiff class: a figurative “blackmail” by selfish holdouts threatening to disrupt collective action unless they are paid off.

968 F.3d at 829.

Since the motive of these “selfish” objectors is strictly pecuniary, removing their ability to collect (and keep) the money they get simply for getting out of the way would effectively end this problem.  That’s what happened here.

In Pearson the original class action settlement had been successfully opposed as “a ‘selfish deal’” by virtually the only class action objector we think gives them a good name − Ted Frank.  Id. at 830 (describing Pearson v. NBTY, Inc., 772 F.3d 778, 787 (7th Cir. 2014)).  The settlement was then reworked and reapproved.  Id.  Up popped three new objectors, and the following occurred:  “All three objectors appealed.  All three dismissed their appeals before briefing began.  The dismissals struck Frank as suspicious and possibly in bad faith.”  Id. at 830-31.

Frank filed “a motion for disgorgement of any payments made to objectors in exchange for dismissing their appeals.”  Id. at 831.  The district court didn’t think it had jurisdiction to do that.  Another appeal ensued, and the Seventh Circuit determined that it did.  See id. at 829 (describing  Pearson v. Target Corp., 893 F.3d 980, 983 (7th Cir. 2018)).

Back in the district court again, and discovery revealed that, sure enough, the objectors had been paid off.  “[T]he three objectors had indeed all received side payments in exchange for dismissing their appeals—$60,000 each to [two of them] and $10,000 to [the third] . . . while the class had received nothing.”  968 F.3d at 831.  Nonetheless, they were allowed to keep the money because the side deals did not “harm” the class “by taking money that had been earmarked for it.”  Id.  By this time, none of the original litigants was party to the appeal – leaving Frank and the settling objectors to duke it out.  Id.

Ted Frank – winner by a knockout.

And a knockout the third Seventh Circuit Pearson opinion indeed is.  It was an abuse of discretion not to order disgorgement of the objector’s side deals:

[I]n finding that the money defendants paid to objectors had not been earmarked for the class, the district court failed to address a critical piece of evidence.  More fundamental, though, that factual question appeared relevant only because the district legally erred by requiring some positive statutory violation as a predicate for disgorgement.

968 F.3d at 831.  The same principle that motivates the in pari delicto defense applied – “[i]t has long been axiomatic “that no person shall profit by his own wrong.”  Id. (citation and quotation marks omitted).  The role that objectors are supposed to play in class action litigation, justifies treating them as fiduciaries.  “As a general rule, wherever confidence is reposed, and one party has it in his power, in a secret manner, for his own advantage, to sacrifice those interests, which he is bound to protect, he shall not be permitted to hold any such advantage.”  Id. at 832.  These “ancient principles” apply to class action litigation.  Id. at 834.  Objectors thus “ha[ve] a duty to object only in good faith.”  Id. (citation and quotation marks omitted).

The Seventh Circuit thus ordered the objectors to pay back their side deal proceeds to the class:

These objectors made sweeping claims of general defects in the . . . settlement.  Either those objections had enough merit to stand a genuine chance of improving the entire class’s recovery, or they did not.  If they did, the objectors sold off that genuine chance, which was the property of the entire class, for their own, strictly private, advantage.  If they did not, the objectors’ settlements of meritless claims traded only on the strength of the underlying litigation, also the property of the entire class, to leverage defendants’ and class counsel’s desire to bring it to a close.  Either way, the money the objectors received in excess of their interests as class members “was not paid for anything they owned,” and thus belongs in equity to the class.

968 F.3d at 834 (quoting Young v. Higbee Co., 324 U.S. 204, 214 (1945)).

So blackmailing objectors can be ordered to disgorge the proceeds of their side deals, which will go a long ways – perhaps all the way – to eliminating the incentive for this kind of legalized extortion.  But what to do with the money?  The “best remedy, to give it to the class, “is no longer possible or would be self-defeating because the administration costs would swallow the benefits.”  Id. at 837 (citation omitted).  What the court came up with, we don’t much like, a cy pres “constructive trust.”  Id.  In our opinion, the money should be returned to whomever the bogus objectors extorted those funds from (which is not clear from the opinion), but we’d rather just about anybody get it other than the blackmailing objectors who received it.

We agree that “reasonable and good-faith objections” should not be deterred by the Pearson court’s treatment of objectors as fiduciaries.  Id. at 838.  Just don’t take secret payoffs as a quid pro quo to abandon purportedly valid appeals:

We do not expect any good-faith objector will fail to bring her objection because she is prohibited from selling out the class in exchange for private payment, where she may choose instead not to sell out the class and still receive payment if she brings the class a real benefit.

Id.  Let’s see if other courts follow the Seventh Circuit’s lead in cutting through the Gordian Knot of objector blackmail.

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Stop us if you have heard this before.  A group of plaintiffs bring a purported class action under a range of California consumer protection laws seeking damages related to the purchase of a medical product (or collection of somewhat related medical products) that they claimed failed to comply with FDA requirements.  The defendants raise preemption and/or primary jurisdiction in a motion to dismiss.  We blog about the resulting decision.  While the problem may be with the last step, our blogging, it does seem like these economic injury classes have to get by a number of legal hurdles that should trip them up.  We suspect—gasp—that the lawyers who bring these cases look for things to sue over first and then find their putative class representatives later, suggesting a business model for imposing costs on the manufacturers of medical products.

This applies to supplements too.  While we do think there is something fundamentally different about prescription medical products from the brightly-packaged products on the counter at convenience stores or sold over the television or internet with vague claims of what the products actually do, the class actions brought against the manufacturers of the latter group of products often seem contrived.  We do not offer this from the vantage point of having defended those cases or as prelude to offering a detailed recap of the treatment of dietary supplements under the FDCA.  Rather, we surmise that many purchasers of such products buy them—the ones who buy them to use them, not buy them to serve as class reps—because they have not been evaluated by FDA, because they can take them without prescriptions or required monitoring, because they are curious about trying something, and/or because shiny packaging catches their eye at the check-out counter.  We doubt these purchaser care much about whether sound scientific evidence and regulatory evaluation were required before the supplement entered the stream of commerce.  We could be wrong.  There is a rumor than we have been before.

Rosas v. Hi-Tech Pharms., No CV 20-00433-DOC-DFM, 202 U.S. Dist. LEXIS 164565 (C.D. Cal. July 29, 2020), involves a proposed class under an alphabet soup of California consumer statutes and common law misrepresentation for four supplements made by defendant that contain combinations of three chemicals—two old decongestants/stimulants denoted as DMAA and DMHA and an amphetamine called methylsynephrine.  The supplements have names suggesting they might help someone work out and/or lose weight.  The gravamen of the complaint was that it was not legal to sell supplements in the U.S. containing any of these chemicals, particularly after FDA issued a warning letter to the defendant in April 2019 about its use of DMHA and to other manufacturers over the last eight years or so about the use of DMAA and methylsynephrine.  (It takes a few seconds to find various statements from FDA about these chemicals and their use in supplements.)  Defendant moved to dismiss on primary jurisdiction, preemption, standing, pleadings, and judicial abstention, but the court only reached the first one.

Swap in CBD for these stimulants and adjust the regulatory facts a bit, but keep the basic claims, defenses, applicable law, and the court the say, and you might experience a little déjà vu for a post from over the summer on the Colette case.  In that post, we harkened back to prior posts on the origin of the primary jurisdiction doctrine and whether FDA warning letters count as final agency actions.  In Colette, the non-final nature of what FDA had done to that point on CBD-containing supplements was what made the primary jurisdiction doctrine require putting the case on ice.  A mere two months later, the Rosas court did not cite Colette in deciding very similar primary jurisdiction issues.

In some ways, Rosas was an even easier application.  The defendant had sued FDA over its actions with regard to DMHA and, a month before Rosas was decided, the D.D.C. had dismissed the case because there was not yet a final agency action to review, presumably under the Administrative Procedure Act.  Given the way primary jurisdiction works, that dismissal provided a little foreshadowing for the result in Rosas.  The Ninth Circuit spelled out the factors for primary jurisdiction as follows:

(1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory scheme that (4) requires expertise or uniformity in administration.

Id. at *6 (citation omitted).  The middle two factors were conceded, but the plaintiffs offered creative opposition to the other two.

Although FDA makes clear that its warning letters are not final as far as it is concerned—which the court noted—plaintiffs argued that an outlier Ninth Circuit case rejecting primary jurisdiction had concluded that FDA warning letters could be final actions.  Id. at **8-10.  The court noted that the warning letters in that case had built on an interim rule, but no such rule existed as to the supplements at issue here.  Accordingly, the court followed the general rule and concluded that no final agency action had occurred, despite the issuance of warning letters.  Id. at **10-11.  (If you want more musings on warning letters in cases like this, then try here.)

The last factor—that the regulatory scheme requires expertise or uniformity in administration—might have seemed like a walkover, but the plaintiffs claimed the Dietary Supplement Health and Education Act (“DHSEA”) was not so complicated that the court could not decide the issues plaintiffs would need to win.  Plaintiffs relied on an Eleventh Circuit seizure case, which decided on the application of the DHSEA to supplements containing DMAA.  Id. at *12.  The Rosas court declined, finding the issues presented in the case under the DHSEA were “‘technical and scientific questions’ best left to the FDA.”  Id. at *13 (citation omitted).  The court also noted the risk of differing interpretations that would undermine the regulatory scheme, something we know many courts do not think twice about.  Id.

With that, primary jurisdiction required that the complaint be dismissed.  The dismissal, of course, was without prejudice until there is a final agency action.  Once that happens, if the state law claims are based solely on FDA violations, then they may run into the preemption issue the court punted on here.

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Not quite two months ago, the Dept. of HHS published a notice of proposed rulemaking that would make a significant change in the National Vaccine Injury Compensation program.  See 85 Fed. Reg. 43,791 (HHS July 20, 2020).  If this becomes a final rule, it could affect the prevalence of civil litigation involving vaccines.

HHS seeks to undo an Obama-era change that added two conditions to the table of compensable vaccine-related injuries:

On January 19, 2017, the Department issued a final rule amending the Table (Final Rule) that, among other things, added SIRVA [Shoulder Injury Related to Vaccine Administration] and vasovagal syncope [injection-triggered fainting] to the Table. . . .  The Final Rule followed a 2012 Institute of Medicine (IOM) report, . . . the work of nine HHS workgroups that reviewed the IOM findings; and consideration of the Advisory Commission on Childhood Vaccines (ACCV) recommendations.

The Department now proposes to remove SIRVA and vasovagal syncope from the Table. . . .

85 Fed. Reg. at 43,795 (citations and footnotes omitted).

Interestingly, the notice indicates that, to the extent they were consulted at all, the IOM, the HHS workgroups or the AACV oppose HHS’ reversal.  See Id. at 43802-03 (proposal “do[es] not meet the tenets of the . . . Guiding Principles” because it is not “made to the benefit of petitioners”).  We find the HHS proposal concerning because it explicitly seeks to create more tort litigation, supposedly as an attempt to “incentivize” proper vaccine administration.  Having lived through the DTP wars that brought about the Vaccine Act in the first place, we don’t think that vaccination and litigation – any litigation – are a good match.

The HHS proposal distinguishes SIRVA and, to a lesser extent, vasovagal syncope from the other vaccine-related injuries in the table because they relate to “administration” of vaccines by health-care providers, as opposed to the inherent risks of the vaccines themselves.  “SIRVA is, of course, not a vaccine, and it is not an injury caused by a vaccine antigen, but by administration of the vaccine by the health care provider.”  Id. at 43,796.

There is nearly uniform agreement in the scientific community that SIRVA is caused by improper vaccine administration, rather than by the vaccine itself. . . . [S]houlder lesions are more likely to be the consequence of a poor injection technique . . . rather than antigens or adjuvants contained in the vaccines.

85 Fed. Reg. at 43,795 (citations and footnotes omitted).  The proposal devotes less attention to vasovagal syncope, but asserts the same general conclusion.  “[V]asovagal syncope results from the act of injection, rather than the vaccine or its components.”  Id. at 43,796.

HHS is thus now taking the position that SIRVA occurs primarily because health care providers are “negligent” in how they inject vaccines – we kid you not.  “The scientific literature indicates that SIRVA likely results from poor vaccination technique, rather than the vaccine or its components alone.”  Id. at 43,795.

First, the Department has concluded that the Vaccine Act should be read as not applying to cover injuries, like SIRVA and vasovagal syncope, which involve negligence by the vaccine administrator.

85 Fed. Reg. at 43,796 (emphasis added).  “[N]egligent administration . . . can encompass anything from negligent needle placement to ‘the doctor’s negligent dropping of an infant patient.’”  Id. (quoting Amendola v. Secretary, Dept. of HHS, 989 F.2d 1180, 1186-87 (Fed. Cir. 1993)).  “[T]hat Congress asked the Secretary to ‘make or assure improvements’ in the ‘administration’ of vaccines . . . does not imply that the compensation program covers negligent administration.”  Id. (citation omitted).  So HHS now wants people to sue doctors and other health care providers instead.

However, what actually drove the Vaccine Act was a desire to decrease the transaction costs of compensation for vaccine-related injuries generally, because fear of injury was leading to resistance to vaccination:

[T]here were many complaints that obtaining compensation for legitimate vaccine-inflicted injuries was too costly and difficult.  A significant number of parents were already declining vaccination for their children, and concerns about compensation threatened to depress vaccination rates even further.

Bruesewitz v. Wyeth LLC, 562 U.S. 223, 227 (2011) (footnotes omitted).  These concerns would not seem to be limited to the subset of vaccine-related injuries acknowledged in the HHS proposal, but would exist regardless of who was responsible for the injury.

We also looked at the case HHS cited, and Amendola does not stand for exclusion of alleged negligent administration from Vaccine Act compensation.  If anything, it stands for the opposite proposition:

[Plaintiffs] conclude that the Act does not cover mere negligence, either by the manufacturer or the administrator.  However this is too broad a reading. . . .  There is no reference to merely negligent contamination, or to an occasion of negligence in deciding, for example, whether to administer an otherwise satisfactory vaccine. . . .  We see no basis for drawing a bright line that excludes erroneous judgment calls by the administrator. . . .

989 F.2d at 1186.

HHS also asserts that the Vaccine Act’s operative term, “vaccine-related injury or death,” 42 U.S.C. §300aa-11(a)(1), should not be interpreted as requiring something more than “but for,” causation, but should be construed as incorporating, sub silentio, the notion of administrator negligence as a superseding cause.  However, the Vaccine Act itself limits compensation by excluding only injuries “due to factors unrelated to the administration of the vaccine.”  42 U.S.C. §300aa-13(a)(1)(B).  And that’s defined, too:

(2) For purposes of paragraph (1), the term “factors unrelated to the administration of the vaccine”−

(A) does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition, and

(B) may . . . include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner’s illness, disability, injury, condition, or death.

Id. §300aa-13(a)(2).  Nowhere are “causes,” “factors,” “injuries,” or “conditions” associated with the physical administration of a vaccine statutorily excluded from compensation.  HHS’ superseding cause-based proposal also seems at odds with the nature of the Congressionally intended “no-fault compensation program” itself, in which “[n]o showing of causation is necessary.”  Bruesewitz, 562 U.S. at 228.  The proposal’s attempt to account for this language seems rather forced:

To be sure, the Vaccine Act does in certain places refer to “administration of” or the “administrator” of the vaccine.  But we think that those usages were not meant to suggest the Program covers negligence in the administration of the vaccine, but served other purposes.  At most, these usages render the statute ambiguous with respect to needle injuries.

85 Fed. Reg. at 43,797.  We don’t think so − the statute actually defined the term “factors unrelated to the administration of the vaccine” : − and expressly limited the exclusion to pre-existing conditions.

Thus, to “incentivize” health care providers to administer vaccines more safely, HHS is thus proposing that they should get sued more often.  “Congress wanted to preserve a state tort remedy for certain avoidable injuries, such as those caused by negligent vaccine administration.”  85 Fed. Reg. at 43,797.  “[A]warding no-fault compensation . . . to those with SIRVA and vasovagal syncope claims lessens the incentive to take appropriate precautions.”  Id. at 43,798.  HHS prefers that the public sue negligent vaccine administrators than having to seek contribution itself:

[The Vaccine Act’s] subrogation provision does not properly incentivize the vaccine administrator, since it is unlikely that the Federal government would assert many claims against administrators, given the burden and expense compared to the relatively small potential recovery for the Federal government. Individuals would have a greater incentive to assert such claims if the administrator were negligent.

Id. at 43,801 (emphasis added).  So we are not exaggerating here.  An express purpose of the HHS proposal is to encourage litigation against health care professionals who administer vaccines, and thus to impose “the burden and expense” of litigation on others.

Digging a little deeper, we believe that is possible, even probable, that HHS’ entire discussion of incentives and negligent administration is pretextual.  Another aspect of HHS’ “review” is “the Department’s experience since SIRVA and vasovagal syncope were added.  85 Fed. Reg. at 43,795.  The driving force behind this proposal appears to be to save money, since SIRVA claims in particular now make up more than half of the Vaccine Act docket.  Id. at 43,798.

From FY 2016 through FY 2019, approximately $119,154,985 has been paid out of the Vaccine Injury Compensation Trust Fund (Trust Fund) to compensate SIRVA petitioners, who are overwhelmingly adults. The sheer prevalence of shoulder injuries in the country’s adult population and the low burden of proof placed on petitioners have made it attractive to file SIRVA petitions, even when such claims are dubious.  Petitioners in such cases often prevail because of the low burden of proof and because it is not necessary to prove causation.

Id.  HHS claims that “excessive awards . . . in SIRVA cases threaten the integrity of the [compensation program].”  Id.

But if the Vaccine Act’s statutory compensation program doesn’t pay, who will?  Maybe nobody.  HHS also seems to anticipate that returning SIRVA and vasovagal syncope cases to the tort system would increase transaction costs and thereby make it too expensive for moderately injured people to seek any compensation from anyone.  HHS undertook a study and determined that SIRVA claims have a “median award” of $22,530 in the tort system.  Id.  HHS also “conducted a search in the WestLaw legal database for cases in state court that contained both the terms ‘SIRVA’ and ‘vaccine,’ and found only 20 hits.”  Id. at 43804.  So the preferred course seems to be that nobody recover anything from anyone.

While that might be OK, from our DTP (and thimerosal) experience, we don’t like to see anyone – including health care providers (who are the customers of our clients) – deliberately being left open to suit over injuries allegedly inflicted on people getting vaccinated.  That only encourages lawyers on the other side of the “v.” to attack everyone involved in the vaccination process.  If health care providers are sued, some number of them will inevitably file third-party actions against vaccine manufacturers as alternative causes (which the HHS proposal doesn’t consider at all), leading to what could well be unpreempted civil litigation over vaccines.  See 85 Fed. Reg. at 437,97 (relying on cases holding that “negligent administration” of vaccines is not preempted by the Vaccine Act).

Thus, we think it is preferable that these claims remain under the auspices of the Vaccine Act, as we think the plain language of the statute demonstrates that Congress so intended.  If there are proof problems specific to claims arising from “vaccine administration” as opposed to inherent characteristics of a vaccine, a targeted approach directed at ensuring that alternative causes are ruled out could be undertaken consistently with the statute’s requirements.

The availability of compensation is one less disincentive to vaccination, and with so many hopes currently resting on the rapid development and roll-out of a safe and effective COVID-19 vaccine, we need to be removing disincentives to vaccination, not increasing them.

*          *          *          *

Finally, after we’d put together the above post, we learned of yet another vaccine-related development.  On August 20, 2020 HHS published a notice in the federal register, extending PREP Act immunity to certain pharmacy personnel (“certain State-licensed pharmacists to order and administer, and pharmacy interns”) who administer childhood vaccines by changing the definition of “covered persons.”  This expansion of immunity encompasses all childhood vaccines – including those already covered by the Vaccine Act − not just any as-yet unreleased vaccines against COVID-19.  As to Vaccine Act compensation, this declaration states:

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program.  Covered countermeasures that are subject to the National Vaccine Injury Compensation Program . . . are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.  All other terms and conditions of the Declaration apply to such covered countermeasures.

Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, at 12th page (unnumbered) (emphasis added).

Given the sweeping scope of PREP Act immunity (see our prior post), the combined effect of these two actions appears to create a bizarre disparity – if childhood vaccines are administered by less trained pharmacists and pharmacy interns, those persons are immune from all injury claims (subject only to the PREP Act’s largely undefined immunity program under 42 U.S.C. §247d-6e(a)).  But if the same vaccines are administered by other health care providers, those providers remain subject to negligence liability under the Vaccine Act for SIRVA and vasovagal syncope, as described above.  To us this disparity, disadvantaging doctors and nurses (covered only by the Vaccine Act) as compared to pharmacists (covered only by the PREP Act), makes no sense.  We question whether HHS’ right hand knows what HHS’ left hand is doing.

This latest development also raises a broader question as to which we admit we do not know the answer:  As to any eventual COVID-19 vaccine, will compensation for (almost certainly inevitable) vaccine-related injuries be governed by the Vaccine Act’s compensation system – which 85 Fed. Reg. 43,791 treats as primarily concerned with “childhood” vaccines – or will such compensation be provided under the heretofore largely undefined standards of the PREP Act’s compensation system?

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Defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions, as our PMA Preemption Score Card (now with well over 500 decisions) demonstrates.  Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020), is one of these, but some aspects of Conley make it more interesting than most PMA preemption decisions – presumably why West chose it for publication in F. Supp.

The principal plaintiff in Conley was an amputee implanted with a pain-fighting stimulator.  He had lost the limb to cancer, and thus needed frequent MRIs to look for possible recurrence.  The device was designed with an “MRI mode” to accommodate that situation.  However, that MRI mode allegedly malfunctioned, and he had the device explanted.  Id. at *1.  In an attempt to avoid preemption, plaintiffs also tried to involve the defendant’s representative, alleging that the rep “regularly tested” the device, and when the problem arose, “informed . . . that the stimulator ‘was not reading properly’ when it was last tested.”  Id.

Only one of plaintiffs’ attempts to avoid preemption was successful, and even that claim failed as a matter of Pennsylvania law.

Plaintiffs’ negligence claim “related to the conduct of Defendant’s employee” failed because, “to state a valid parallel claim for negligence, the ‘duty’ element must arise from federal requirements applicable to a medical device.”  Id. at *5 (citation and quotation marks omitted).  As to the manufacturer’s representative, “Plaintiffs here have failed to identify any duty arising from the federal requirements applicable to the [device].”  Id.

Aside from the sales representative, the only claimed negligence duty concerned purported violations of FDA GMPs (also called “CGMPs”).  Significantly, since the Third Circuit has not decided the issue, Conley came down on the “specific” side of the split over how GMP violations must be pleaded.  “[I]nsofar as Plaintiffs attempt to use the GMPs as the basis for a parallel claim, courts have regularly found that general citations to the GMPs or federal regulations are not specific enough to sustain a parallel claim.”  Id. (citations and footnote omitted).  Conley cites a useful selection of favorable Third Circuit district court opinions on this issue, and distinguishes the major adverse decision.  Id.

The same reasoning applied to plaintiffs’ strict liability claim for manufacturing defect.  Vague claims of “recalls” and that the device was “adulterated could not avoid preemption:

Once again, the Court notes that Plaintiffs have failed to allege any specific violations of federal law that might establish a parallel state duty.  The amended complaint neither identifies a specific manufacturing defect, nor specifically alleges how Defendant’s practices ran afoul of FDA requirements.  Insofar as Plaintiffs argue this claim can survive preemption due to their reliance on the GMPs, once again, the Court notes that the GMPs are too vague to satisfy the requirements of a parallel claim.

2020 WL 5087889, at *7 (citations omitted).

Plaintiffs’ warning claim in Conley was also preempted.  Since “Pennsylvania’s duty to warn for medical devices runs to the physician,” there was no analogous state-law duty to report adverse events to the FDA.  2020 WL 5087889, at *6 & n.6.  Thus, the plaintiffs’ failure-to-report claim predicated on such a non-existent duty was both expressly and impliedly preempted.  Id. at *7 & n.7.  Nor did plaintiffs in Conley plead that “actual” unreported incidents or how any failure to report caused the alleged injuries.  Id. at *7.

Only express warranty escaped preemption, based on what we consider to be the archaic and simplistic rationale that such claims “do[] not involve a state requirement.”  Id. at *6.  This reasoning dates to the pre-Riegel decision, Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir. 1995), and most other courts, including several in the Third Circuit, hold at least some express warranty claims – those arising from FDA-approved language – to be preempted.  See Hart v. Medtronic, Inc., 2017 WL 5951698, at *6 & n.6 (D.N.J. Nov. 30, 2017) (only express warranty claims “beyond those appearing in the FDA-approved instructions and warnings” escape preemption); Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp.3d 586, 602 (D.N.J. 2015) (“an express warranty claim is not necessarily preempted under the MDA”; no preemption “if the plaintiff can show that the defendant-manufacturer made voluntary statements that were not approved by the FDA or mandated by the FDA”) (citation and quotation marks omitted); Becker v. Smith & Nephew, Inc., 2015 WL 4647982, at *4 (D.N.J. Aug. 5, 2015) (“If a claim is based on the information contained in FDA approved product labels and packaging inserts, it is barred.”) (citation and quotation marks omitted); Morton v. Allergan, Inc., 2015 WL 12839493, at *4 (D.N.J. April 2, 2015) (plaintiff “does not factually allege that [defendant] made any voluntary statement . . . that was not approved by the FDA”; express warranty “is therefore preempted”); see also Bexis’ book, at §5.01[3][c][iv], at n.226.

Nonetheless, the express warranty claim in Conley was dismissed because plaintiffs’ claim failed to plead reliance, as required by the statute’s “basis of the bargain” element:

[Plaintiffs] appear to acknowledge that they were unaware that any warranty may have existed at all until after [the] explant surgery, a year after the device was originally implanted.

2020 WL 5087889, at *6.  An unknown “warranty” simply cannot be part of the “basis of the bargain” on which a product was sold.

Leave to amend was also denied.  Id. at *8.  Conley applied (as it should have) the rule from Albrecht that “[p]reemption is a matter of law.”  2020 WL 5087889, at *8 (citing Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1680 (U.S. 2019)).  Conley is the first medical device decision in the Third Circuit explicitly applying Albrecht to medical device preemption, but it surely won’t be the last.  Plaintiffs’ request for discovery on this legal question amounted to a “fishing expedition”:

In medical device cases, courts have regularly rejected the argument that plaintiffs are entitled to discovery prior to dismissal on preemption grounds.  As the Court is disinclined to allow Plaintiffs to undertake a discovery fishing expedition . . ., the Court finds that allowing further amendment in this case would be futile.

Id. at *8 (citation omitted).

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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