TAXOTERE MDL TIPPING THE SCALES OF JUSTICE

The Taxotere MDL Court continues to grant Defense motions to dismiss (on a case-by-case basis), allowing Defendants to raise matters outside of the pleadings (not previously pled in the Master Answer), without seeking leave to amend prior to filing the motions, to address the matters not previously pled, while generally limiting Plaintiffs leave to amend in anticipation of such motions (which is not required in the first instance), or to counter such motions once filed.

THE NEXUS OF THE ISSUE

The Master Complaint refers to permanent chemotherapy-induced alopecia, as an absence of incomplete hair regrowth six months after completion of chemotherapy.

The Taxotere MDL Court has construed the above as admission of fact by individual Plaintiffs adopting the Master Complaint, as an admittance on the record that that specific Plaintiff possessed this knowledge six months after completion of chemotherapy.

One might pose the question to Her Honor, prior to appointment to the Taxotere MDL, “Did you know that the failure of hair to regrow within six months after completion of chemotherapy was conclusive of the condition being permanent?”

How can it be said that the aforementioned “admission of fact” by any given Plaintiff is any more than admission that the Plaintiff was aware (knew/discovered) of this fact at any time prior to the filing of the complaint, specific to that Plaintiff. The Taxotere MDL Court has somehow reached such a conclusion.

More simply stated, admitting that a Plaintiff knew a fact on the day she filed her complaint, is not an admittance that she possessed, discovered nor reasonable would have been expected to discover, that same fact, at an earlier point in time, and thus should have filed her complaint at some earlier point in time, based on the knowledge (discovery) to avoid the complaint being SOL barred.

It is also important to note that Plaintiffs are not required to plead matters in their complaint in anticipation of any affirmative defense.
Additionally, it is important to note that Fed. R. Civ. Pro. 12 applies not only to Plaintiff pleadings, Rule 12 also applies to affirmative defenses raised by Defendants.

DEFENDANTS’ MOTIONS TO DISMISS BASED ON SOL

Defense motions to dismiss individual Plaintiffs’ cases in MDLs, based on SOL are generally brought under Rule 12(b)(6) (Failure to State a Claim Upon Which Relief Can be Granted) or Rule 12(c) Motion for Judgment on the Pleadings (see citations at the end of this article).

If a Defendant wishes to raise SOL matters under 12(b)(6), they must do so by the filing of a motion.

In the MDL context, this means that the “Master Answer” would need to adequately plead the SOL Statutes and Jurisprudence of all 50 States, as well as every possible set of Plaintiff facts that might later arise (on a case-by-case basis) relevant to those SOL Statutes and Jurisprudence of all 50 States. If the Master Answer was not plead as above, the Defendant would need to file for leave to amend, and file said amendment to the answer of the given specific Plaintiff’s case.

In that it would be impossible for a Defendant to accomplish the above in the “Master Answer”, a Defendant should be required to file a motion for leave to amend (to plead facts, law, and other matters not pled in the Master Answer) specific to the given Plaintiff against whom they move).

In this scenario, a Plaintiff Motion to Strike pursuant to Rule 12(f) should be considered, based on Defendant’s failure to adequately plead the defense in the answer. Additionally, the Defendant having raised matters (like specific state law) in the motion to dismiss, not raised in the answer (matters outside the pleadings).

If the Defendant Motion for Judgment on the Pleadings Fed R. Civ. Pro. 12(c), and raises any matter (case law citation, statute, or fact) not cited and raised in the Master Answer, the Court must treat this motion as a Motion for Summary Judgement and apply Fed. R. Civ. Pro. 56, pursuant to Fed. R. Civ. Pro. 12 (d).

Under either scenario, it would be arguably prejudicial and an abuse of discretion for a Court to allow a Defendant leave to amend their answer, for the purpose of filing a motion under 12(b)(6), and then deny the Plaintiff the same leave (to amend the complaint), once the Defendant’s motion was filed.
According to Fed R. Civ. Pro. 12(c) (which invokes Fed. R. Civ. Pro. 56), it would arguably be an abuse of discretion for the Court to deny a Plaintiff’s motion to amend, in the face of a motion under these rules. In fact, the widely held (the term “black letter case law” is apt) that leave to amend is to be freely granted, is not merely a concept, as the premise behind the concept is rooted in the right to due process granted under the U.S. Constitution.
The Taxotere Court seems to be willing to allow Defendants to file dismissal motions, raising matter (case law, statute etc.) not previously raised (matters outside the [prior] pleadings) at the late stages of the litigation, while denying Plaintiffs leave to amend, holding that it would be prejudicial (to Defendants) for the Court to allow Plaintiffs to amend their complaints at “this late stage”.

“You can’t amend your answer at this late stage, to counter a motion brought by Defendants at this late stage.” One wonders how a court of equity justifies such an inequitable holding.

AUTHORITIES

Rule 15 (a) declares that leave to amend, “shall be freely given when justice so requires”; this mandate is to be heeded. Foman v. Davis, 371 US 178 – Supreme Court 1962 id at 182.

We review the decision to deny a party leave to amend its complaint for abuse of discretion. United States ex rel. Willard v. Humana Health Plan of Tex., Inc., 336 F.3d 375, 387 (5th Cir.2003). Leave to amend should be freely given, FED. R. CIV. P. 15(a), and outright refusal to grant leave to amend without a justification such as, “undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed undue prejudice to the opposing party by virtue of allowance of the amendment, futility of amendment, etc.” is considered an abuse of discretion. Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962); see also Humana Health Plan, 336 F.3d at 386 (citing Foman for examples of permitted reasons to deny leave to amend). US ex rel. Adrian v. Regents of Univ. of Calif., 363 F. 3d 398 – Court of Appeals, 5th Circuit 2004.

It is too late in the day and entirely contrary to the spirit of the Federal Rules of Civil Procedure for decisions on the merits to be avoided on the basis of such mere technicalities. “The Federal Rules reject the approach that pleading is a game of skill in which one misstep by counsel may be decisive to the outcome and accept the principle that the purpose of pleading is to facilitate a proper decision on the merits.” Conley v. Gibson, 355 U. S. 41, 48. Foman v. Davis, 371 US 178 – Supreme Court 1962 id at 182.

Every defense to a claim for relief in any pleading must be asserted in the responsive pleading if one is required. But a party may assert the following defenses by motion: (6) failure to state a claim upon which relief can be granted; (Fed. R. Civ. Pro. 12(b)(6)
Motion for Judgment on the Pleadings. After the pleadings are closed—but early enough not to delay trial—a party may move for judgment on the pleadings. Fed R. Civ. Pro. 12(c)

Result of Presenting Matters Outside the Pleadings. If, on a motion under Rule 12(b)(6) or 12(c), matters outside the pleadings are presented to, and not excluded by, the Court, the motion must be treated as one for summary judgment under Rule 56. All parties must be given a reasonable opportunity to present all the material that is pertinent to the motion. Fed. R. Civ. Pro. 12 (d)

Disclaimer:

This article was written by John Ray. John Ray is not an attorney. No word, statement, utterance nor implication herein, should be construed as legal advice. The expressions in this article are the thoughts and opinions of the author and should not be attributed to any third party. The Statutes, Rules and Case Law cited herein, speak for themselves.

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Zantac / Ranitidine Litigation Common Misconceptions By John Ray

The topic below will be discussed in depth in the Mass Tort Nexus (MTN) Whiteboard Wednesday (January 20, 2021), if you have not registered for the session, you can do so here: https://www.masstortnexus.com/Whiteboard

Common Misconception: Sales of prescription versions of Zantac/Ranitidine were insignificant after the OTC versions were approved.

Fact: Sales of prescription versions of Zantac/Ranitidine remained strong even after the OTC versions were approved. Between 18 million and 20 million prescriptions were written for Zantac/Ranitidine, each year, over the last decade. Zantac/Ranitidine made the list of “Top 50 Most Prescribed Drugs” every single year over the last decade.

Why is this important?

  1. There will be a potentially far greater number of potential Zantac/Ranitidine “prescription use” plaintiffs.
  2. Due to the significant number of arguably counterfeit Zantac/Ranitidine finished drugs, placed into the stream of commerce by “repacking entities,” combined with the fact that the FDA has discovered these products and deactivated the NDC codes for many of these products, it is highly unlikely that your firm has a complete list of Zantac/Ranitidine NDC codes.

Why does this matter?

1. When the FDA deactivates an NDC code, it is removed from the public database of active NDC codes. MTN has uncovered and compiled these deactivated NDC codes.
2. Firms accepting Zantac/Ranitidine clients may believe they have a full list of all Zantac/Ranitidine NDC codes; however, it is improbable that any firm is working from a complete list of codes (it took MTN over 9 months to locate all Zantac/Ranitidine NDC codes, including those that have been deactivated by the FDA, or removed from the public view for other reasons).

Why is having a complete list of NDC codes critical?

  1. Your firm has a prospective client that claims to have taken prescription Zantac/Ranitidine, you sign the client and order their pharmacy records.
  2. Your record review department or company reviews the pharmacy and/or insurance records, looking for Zantac/Ranitidine NDC codes; the proof that your client did, in fact, consume a prescription Zantac/Ranitidine product.
  3. If you are not working from a complete list of Zantac/Ranitidine NDC codes (which is likely), then your record review may conclude that your client who claims to have taken prescription Zantac/Ranitidine, did not, because the NDC code for the product they consumed is not on the “incomplete” list of NDC codes in your possession.

Additionally, once you have access to a comprehensive list of NDC codes, you are likely to discover that many of your clients consumed one of the repackaged (arguably counterfeit) versions of prescription Zantac/Ranitidine.

In addition to the reasons previously stated, identifying all of your clients who took repackaged (arguably counterfeit) versions of Zantac/Ranitidine, is also crucial for the following reasons:

  1. Overcoming PLIVA v Mensing (in addition to the other facts that make Mensing inapt).
  2. A majority of the repacking entities are located in California, were the JCCP has already established an MDL-like consolidation for these cases.
  3. Given the ever-growing appearance, that the Zantac/Ranitidine MDL has landed in the hands of a defense-friendly Judge, the ability to establish jurisdiction and file cases in various State Court Consolidation, is now of paramount importance.

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ROUND UP SETTLEMENT REDUX – ARE THEY FOR REAL THIS TIME?

BACKGROUND

On June 24, 2020, Bayer announced agreements to resolve major legacy Monsanto litigation. The press release, issued primarily for the benefit of nervous Bayer investors, implied that Bayer had reached settlement to resolve the majority of Plaintiff cases. Bayer claimed that the settlement would range between $10.1 billion to S10.9 billion U.S.

Although Mass Tort Nexus (MTN) had serious doubts that Bayer would accomplish substantial resolution of the litigation at a cost of $10.1 billion to S10.9 billion U.S., we waited several months before publishing our article titled, Dear Bayer, the number is $22 Billion.

It appears that Bayer has given up any hope of a global settlement of Plaintiff cases, at significantly subpar settlement values.
The latest information received from MTN sources leads us to believe that Bayer is now attempting to settle for more reasonable values, with firms considered to be a “litigation threat”, while offering firms they do not consider to be a trial threat, far lower average case values.

WILL THIS NEW STRATEGY WORK?

It is probable that Bayer will reach settlement with firms that have already scored big trial wins, by offering reasonable average case values. As is generally the case, settlement agreements with these firms are likely to include “gentlemen’s agreements”, precluding these firms bringing new cases post settlement of their existing dockets.

It is also probable that Bayer will succeed in reaching settlement, at significantly subpar values, with a number of those firms Bayer does not consider a litigation or trial threat.

The wild card for Bayer in this strategy arises from any assumption that they have correctly identified all firms that might pose serious litigation/trial threat. Even if a given firm or attorney has never brought down a jury award in excess of $100 million or $1 billion, does not mean they are incapable of such an achievement. It is important to note, among those firms that are members of this very small club, prior to their having acquired their first earth shattering (and stock price impacting) jury award, they might have been included in the group Bayer does not consider to be a threat. There is a first time for everything.

Additionally, it is never wise to insult (directly or indirectly) any Plaintiff’s attorney if you are trying to reach settlement. Many Plaintiffs’ attorneys would consider being thought of as “no threat” at trial, an insult to be addressed by disproving the assumption.

Bayer stockholders have long ago lost patience with the company’s handling of the Round Up litigation. Bayer stock would not likely fair well if another $100 million or $1 billion dollar verdict was handed down.

Twenty-nine years ago, Mark Lanier was just another attorney, (as far as anyone knew) fast forward to 2021, and over $20 billion(ish) in jury verdicts later, Mark Lanier, is now “that Mark Lanier” . Twenty-nine years ago Bayer would not likely have considered Mark a serious threat and would have likely paid the price for their underestimation.

Jim Onder was just a down to earth unassuming fellow raised in the mid-west, and although Jim is still a down to earth unassuming fellow however, Jim Onder is now “that Jim Onder.”

Atticus Finch was not, ‘that Atticus Finch”, until he was.

THE BOTTOM LINE

Bayer plays a risky game, at very high stakes, if they fail to recognize any attorney they do not consider a serious threat, might not be the next Atticus Finch, just waiting to become “that Atticus Finch.”

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Paragard IUD: Low Numerosity and Late Consolidation Present Obstacles

In December of 2020, the Paragard IUD device was consolidated in the Northern District of Georgia under Judge Leigh Martin May. Defendants include: Teva Pharmaceuticals USA, Inc., Teva Women’s Health, Inc., Teva Women’s Health, LLC, Teva Branded Pharmaceutical Products R&D, Inc., The Cooper Companies, Inc., and CooperSurgical, Inc.

The intake is very conservative for this case and consists of the following:

1.) Breakage in the T-arm (only)
2.) AND surgical removal, or otherwise egregious type of injury, such as a hysterectomy

It is the opinion of this office that the PPN is very low. Possibly less than 5,000. The SOL on this case will be the biggest hurdle due to Statute of Limitations issues.

That said, this action may lend itself to fighting the Learned Intermediary Doctrine against the Doctrine of Informed Consent, when deposing treating physicians. Most states require written (express) informed consent, when exposing a patient to potentially life-threatening risk. Failure to acquire Informed Consent is, at worst, battery under most state laws.

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YOUR FIRM SHOULD BE MARKETING FOR ELIMIRON CASES NOW

Mass Tort Nexus (MTN) is adding the emerging Elmiron litigation to our January 20, 2021, Whiteboard Wednesday session. If your firm does not have an immediate plan to market for and acquire clients in this litigation, you will likely be kicking yourself later. If you sat on the sidelines for, “Invokana Amputation Cases,” you probably still have bruises from kicking yourself. Avoid future self-recrimination by gaining the “why” and “how” knowledge required to start retaining Elmiron clients now.

MTN will continue our discussions related to State Court Consolidation filing strategies in the Zantac/Ranitidine litigation following the MDL Court’s recent preemption rulings (and why your firm should continue marketing for these cases). The MDL is not “dead” by any means, and concurrent State Court Consolidations simply make sense, especially while the MDL PSC works out the “bumps in the road,” for which they are not to blame, but must deal with, nonetheless.

While many of you may have been taking time off for Christmas and New Year’s, The Judicial Panel on Multidistrict Litigation granted a petition to Transfer and Consolidate cases involving the drug Elmiron to the District of New Jersey, forming MDL 2973.

The following statements may be confusing if you have not attended the Mass Tort Nexus “Four Days to Mass Tort Success Course”. If you have not taken the course, register for the upcoming March course today. You need the fundamental “tool kit” of knowledge and skills provided in the course, if you plan to talk the talk, much less walk the walk (be) a successful Mass Tort firm.
If your firm has been following the emerging Elmiron litigation and have concluded that the litigation does not meet the Potential Average Case Value/Potential Plaintiff Numerosity required ratio to justify your firm marketing for these cases, you erred. YOUR FIRM SHOULD BE MARKETING FOR ELMIRON CASES! The PPN is higher than you might think, and the PACV justifies a significant average cost per case acquired figure. We apologize to those who have not taken “the course,” as we teach the language of Mass Tort.

Attendees of the MTN January 20, 2021, Whiteboard Wednesday session, will receive an “Elmiron Litigation Package” after the session. The package will include sample complaints, as well as MTN suggested client qualifying questions. In this litigation, firms that do not have a thorough understanding of all of the relevant facts are more likely to disqualify potential clients that they should retain, than the inverse.

HIGH POINTS ON ELMIRON

Elmiron is the only drug approved by the FDA to treat Interstitial Cystitis. The primary symptoms of Interstitial Cystitis are chronic pain in the bladder and pelvic area.
The primary adverse event in the Elmiron litigation is Pigmentary Maculopathy. Pigmentary Maculopathy induced by Elmiron is latent (important to SOL), progressive, and irreversible. If diagnosed early, treatment may slow the progression of the disease; however, there is no cure. Pigmentary Maculopathy often leads to complete blindness, or near blindness, over time.

WHAT YOUR FIRM SHOULD DO TODAY

If your firm, (or lead generation company) was involved in the Transvaginal Mesh Litigation, have your staff begin compiling a list of every woman that contacted your organization (without regard to whether they qualified for retention as a TVM client). After attending the January 20, 2021 Whiteboard Wednesday session (and receiving our Elmiron Litigation Package with the suggested qualifying criteria), you will want to reach out to all TVM plaintiffs (including those you rejected) and ask if they were prescribed Elmiron. If they answer is yes, you should then proceed to asking the qualifying questions relevant to Elmiron (see recent label changes at the end of this article).

If you have attended the MTN Four Days to Mass Tort Success Course, you already know that “past clients” (including those that contacted your firm, but were not retained) are your best, first source of new clients in any mass tort litigation.

You are very likely to find that many of the women who contacted your firm about a potential Transvaginal Mesh Litigation, were also prescribed Elmiron, before, during, or after their TVM surgeries.

Given the extremely high rate of progressive maculopathy apparently associated with long term consumption of Elmiron, you are likely to find a significant number of Elmiron potential plaintiffs, in your firms TVM files. Do you really want another firm to sign a client that your firm has already contacted or represented, simply because you did not take the time to reach out to the one group of people your firm can initiate direct contact with?

As a primer, the relevant changes to the Elimiron label are below. Keep in mind, this adverse event is latent, progressive, and irreversible. Do not assume that the 06/16/2020 label change date will have begun the SOL running on the majority of potential plaintiff cases.

ELMIRON (NDA-020193)

(PENTOSAN POLYSULFATE SODIUM)

06/16/2020 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

Retinal Pigmentary Changes

(Newly added subsection)

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.

Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.

6 Adverse Reactions
Post-Marketing Experience

(Newly added information)

The following adverse reactions have been identified during post approval use of pentosan polysulfate sodium; because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

  • pigmentary changes in the retina (see WARNINGS).

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

(Newly added information)
Patients should be informed that changes in vision should be reported and evaluated. Retinal examinations including optical coherence tomography (OCT) and auto-fluorescence imaging are suggested for all patients within six months of starting ELMIRON® and periodically during long-term treatment (see WARNINGS).

Other

Patient Leaflet

(Extensive changes; please refer to label)

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Cook Medical Recalls Two Devices

Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Products

Flexor Check-Flo Introducers

• Catalog and Lot numbers: See Full List
• Manufacturing Dates: February 17, 2020 to September 29, 2020
• Distribution Dates: May 23, 2020 to November 17, 2020
• Devices Recalled in the U.S.: 37,326
• Date Initiated by Firm: November 24, 2020

Device Use

The Cook Medical Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) are catheters that have a coated shaft, a valve, a dilator, and markers that show up on an x-ray. The catheters help insert other medical devices used for therapy or diagnosis into the vessels, except those of the heart and brain, during surgery or other procedures.

Fig. 1: Pictures of the Flexor Check-Flo Introducer and the Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) with a red arrow showing where separation usually happens (proximal bond site).

Reason for Recall

Cook Medical is recalling the Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) because of an increased chance of separation at a specific point (proximal bond site) shown in Figure 1. If the device separates during use, this may lead to life-threatening adverse events.

Use of the affected product may cause serious adverse events, including longer procedure time, another procedure to take out a separated piece, blocking blood flow to vital organs, vessel injury, and bleeding.

Not All Recalls Lead to Litigation

MTNs review of the FDA Maude Adverse Event reporting database and found less than 57 total adverse events reported, related to these recalled devices. In the reported adverse events, the Surgeon was generally able to mitigate the impact of the device defect. There were no reports of death however, there were 14 reports of serious injuries.

These devices are primarily used by Interventional Radiologist. The devices are used in procedures under imaging. Any device failure that might otherwise have caused injury absent real time imaging during the procedure, would generally allow the Surgeon to take immediate corrective action.
MTN does not expect the number of individuals injured by this device will be sufficient to justify a consolidated mass litigation. If your firm receives an inquiry from any individual injured by the defect in these devices, contact our office for more information if you are considering filing an individual plaintiff action.

MTN will keep our readers abreast of any changes in our initial impressions related to this matter.

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ZANTAC MDL COURT RULES AGAINST PLAINTIFFS by John Ray

As the clock ran down on 2020, the Zantac/Ranitidine MDL Court handed down two rulings on defendant’s preemption motions (see copies of the Courts rulings at these links (link) (link). If these rulings stand, 80%-90% of potential Zantac/Ranitidine cases could ultimately face dismissal (if filed in the MDL).

The Court, in ruling for Defense on numerous matters raised, is allowing Plaintiff Leadership the opportunity to amend the various complaints on which Defense motions were based. Although the Court’s grant of leave to amend is a positive for Plaintiffs, firms not within the loop of Plaintiff Leadership face the uncertainty of knowing whether any amendments made, will change the Court’s current position. Therefore, filing certain Plaintiff cases in the MDL is a risk many firms no longer consider wise.

Fortunately, the MDL is not the only possible consolidated venue for your Zantac/Ranitidine cases. The remainder of this article will address efforts MTN is assisting in, to form State Consolidations, in venues where proper jurisdiction should exist for 80%-85% of the Plaintiff cases firms are likely to retain.
We will also discuss why we believe Plaintiffs will likely fare better in the State Consolidations, related to the preemption issues, which thus far have not gone well for Plaintiffs in the MDL.

We will start with a review of authorities relevant to the substance of this article. We will conclude with steps you can take now and in the near future, to protect your existing clients as well as factor into your decision to continue or discontinue marketing for these cases.

CITATION OF AUTHORITIES

The FFDCA comprehensively regulates the manufacture, importation, and sale of prescription drugs. Before a new drug may be introduced into interstate commerce, the FDA must approve the manufacturing process, labeling, and packaging. 21 U.S.C. § 355(b)(1). The approval process addresses the chemical composition of the drug, id. § 355(b)(1)(B), (C), the drug’s safety and effectiveness, id. § 355(b)(1)(A), and elements of the drug’s distribution, such as “the methods used in, and the facilities and controls used for, the manufacture, processing, and packing” of the drug, id. § 355(b)(1)(D), and the “labeling proposed to be used” for the drug. Id. § 355(b)(1)(F). The approval process is specific to each manufacturer and each product. See 21 C.F.R. § 314.50. In re Canadian Import Antitrust Litigation, 470 F. 3d 785 – Court of Appeals, 8th Circuit 2006 ID at 789

“No person shall introduce or deliver for introduction into interstate commerce any new drug” unless the drug is the subject of an approved application. [21 U.S.C. § 355(a)]

There are exceptions to 21 U.S.C. § 355(a)], which include OTC products subject to a Final OTC Monograph, Drugs Compounded by licensed pharmacy pursuant to a prescription from a licensed physician for a specific patient and repackaged products for use institutions, including unit dose packing. None of these exceptions apply to our current analysis.

The term “label” means a display of written, printed, or graphic matter upon any article or the immediate container (not including packaged liners) of any article; and the term “labeling” means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. 21 U.S. Code § 321(k) § 321 (m), 201(k) and 21 USC § 453(s).

ANDA applicants are required to submit (for approval), in electronic format, the content of labeling for the proposed drug (§ 314.94(a)(4)(ii) and (d). Once the FDA issues a final approval letter for an ANDA, no major changes to the labeling, including the labeling that appears on the outside the container, can be altered without prior approval from the FDA.

Assignment of an NDC number does not in any way denote FDA approval of the product. (21 CFR 207.37 (a)(2)).

The appearance on a drug product label of a person’s name, without qualification, is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section. 21 U.S. Code § 201.1 (h)(2)The term “counterfeit drug” means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who, in fact, manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor. 21 U.S. Code § 321 (g)(2).

Was Walgreens the sole manufacturer, the only entity involved in all acts required to enter the product below into the stream of commerce? Does Walgreens hold a single ANDA or NDA approval for a Ranitidine product? Were any of the Store Branded generic OTC products, manufactured solely by the retailer? Did any of these retailers hold a single NDA or ANDA approval for a Ranitidine product?

Both of the labels below were uploaded in two NDC code applications. Both listed ANDA 077824 as the FDA approval for the respective products. Anneal is the holder of this ANDA. Given the significant differences in these two labels and the fact that Aidarex is not the owner of ANDA 077824, how can Airadex legally market a product under the label below? Given the fact that the FDA delisted the NDC code for the Aidarex product, the answer seems to be Aidarex could not legally market their product as labeled. As labeled, the Aidarex product arguably needed to apply for a unique ANDA prior to marketing this product. The below is just one example of a significant number of entities that listed ANDA 077824, in their NDC applications, only to have the FDA delist the NDC codes, once the agency discovered the NDC code applicant was not the holder of the ANDA listed. It is important to note that it takes the FDA as long as three years, on average, to discover and deactivate the NDC codes for these products, and in many cases, the entity that had a given NDC code delisted, simply applied for another NDC code. Rinse and repeat.

RECALL vs NDC CODE DEACTIVATION

The MDL Court made mention of the fact that the FDA had not taken action against the various generic manufacturers relevant to claims made by Plaintiffs. Although the Court was not made aware of the significant number of actions the FDA has taken, to-date, against these defendants. These FDA actions would have been highly relevant to the Court’s considerations, had the Court been made aware.

It is important to note (regarding NDA and ANDA products), the FDA only recalls or recommends recall for products that have been approved by the FDA.
When the FDA discovers that NDC codes were obtained, (via the automated NDC code assignment system) for products that have not been approved by the FDA (unapproved drugs), The FDA deactivates the NDC codes associated with the given unapproved product.

A recall is not withdrawal of FDA approval, however; the FDA’s deactivation of an NDC code assigned to an unapproved drug product can only be interpreted as the agency’s determination that the product was never approved for entry into interstate commerce in the first instance.

When the various Master Complaints were filed in the Zantac/Ranitidine MDL, Plaintiffs’ Leadership had no reason to suspect that certain defendants (both named and unnamed) had apparently engaged in an ongoing conspiracy to enter counterfeit Ranitidine products into the stream of commerce. Plaintiffs’ Leadership had no reason to suspect that the FDA had discovered NDC codes had been assigned to a significant number of these unapproved drug products and then deactivated the NDC codes for these products. Furthermore, Plaintiffs’ Leadership had no reason to suspect that the conspiracy was so successful, that competition from legitimate products (approved products) was substantially eliminated. Having no reason to suspect any of the foregoing, these facts and evidence were not made known to the Court prior to the rulings on the various “Mensing” preemption motions. The defendants certainly possessed all this knowledge, however, obviously did not reveal to the Court and opposing parties these facts in their motions and arguments seeking preemption under Mensing.

The Court granted Plaintiff Leadership leave to amend the various complaints, allowing a short time frame for these amendments to be filed. Mass Tort Nexus (MTN) does not know whether Plaintiff Leadership will be able discover all the facts and evidence necessary, within the Court’s timeframe, to change the Court’s position relevant to the existing preemption rulings.

MTN spent over 9 months and several thousand hours researching and gathering evidence unraveling the apparent conspiracy, resulting in the following:

1. MTN has complied, what we believe to be, the only complete list of NDC codes ever assigned to a Ranitidine product. This task was particularly difficult because the FDA removes NDC codes from the public NDC code list, after the FDA has deactivated a code or the labeler has taken action to cause the given NDC code to be archived. This list will be vital for firms reviewing potential prescription use cases as without a complete list of Ranitidine NDC codes, upon review of pharmacy of insurance records, firms will incorrectly conclude that a potential client claiming to have been prescribed Ranitidine, were not.
2. MTN has compiled a list (with evidence) of all Ranitidine NDC codes deactivated by the FDA.
3. MTN has complied a list (with evidence) of all Ranitidine unapproved products, not discovered and deactivated (NDC codes) by the FDA.
4. MTN has compiled a list of all Ranitidine NDC codes which have been archived and no longer appear on the public list.
5. MTN has reviewed every label for every Ranitidine for comparison to the Reference Listed Drug (RLD) label (patient insert and physician label) and discovered that a plurality of the OTC and Rx generics patient insert and physician labels did not conform to the RLD (brand Zantac). This fact alone should be sufficient to overcome a Mensing defense.
6. There will be far more prescription Ranitidine cases than one might expect. In the last decade, Ranitidine has never failed to make the “Top 50 Most Prescribed Drugs” list with 18 to 20 million prescriptions written per year.
7. The primary defendant in most of the prescription cases will not be one of the NDA or ANDA holders, but instead will be a repacking company.
8. Approximately 80%-85% of client cases firms are likely to sign will be cases in which proper jurisdiction in these States: California, Pennsylvania, New York, New Jersey, and Connecticut.

FILING IN STATE CONSOLIDATIONS vs THE MDL

Why is it so important that proper jurisdiction will arguably exist in California, Pennsylvania, New York, New Jersey, and Connecticut for a significant percentage of Plaintiff cases? All these States’ laws allow for MDL like State Consolidation of Mass Tort cases.

WHY FILE IN STATE CONSOLIDATIONS

It is difficult to consider the MDL a safe venue for filing many, if not most, Plaintiff cases given the recent preemption rulings. Once Plaintiff Leadership files the amended complaint(s), Defense is likely to file preemption motions based on the amended complaints. It is impossible to know how long the MDL Court will take to rule on any new defense motions. If the existing preemption rulings hold, you will have filed your cases at risk of mass dismissal.

It is important to note, that as of January 01/05/2021; less than 1000 individual complaints have been filed or transferred to the MDL, almost exclusively against the brand makers.

While less than 1000 complaints have been filed in the MDL, MTN believes approximately 30,000 have been entered into the “Census” and benefit from the various tolling agreements, regardless of whether the given censused case is filed in the MDL or in another venue.

CAN PREEMPTION BE AVOIDED IN STATE CONSOLIDATIONS?

It is important to understand that MDL Plaintiff Leadership was not in possession of the facts and evidence discovered by MTN over the past 9 months, when the original complaints were filed.

The litigation firms will be working with to cause the various State Consolidations to become available will have all MTN’s research and evidence that will enable them to plead facts and present evidence, never considered by the MDL Court.

The first, and most obvious, argument these firms will be able to put forth is simple:
The fact that FDA prohibits a generic manufacturer (ANDA) from unilaterally making changes to their label and labeling, is irrelevant if the product in question was not approved by the FDA in the first instance.

STAY TUNED

MTN will be reaching out to all our network members soon. Once the litigation teams have been assembled for the various State Consolidations, MTN will provide our network members with an online portal that can be used to correctly identify all possible defendants in your prescription and OTC cases, so you can identify which of your Plaintiff cases may be proper for filing in State Consolidations.
For now, if you are barred in California, Pennsylvania, New York, New Jersey, or Connecticut and are interested in being part of the “State Consolidation” team, email John Ray or Barbara Capasso.

John Ray: john@masstortnexus.com
Barbara Capasso: barbara@masstortnexus.com

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