Imerys Settles 14,000 Talc Cancer Lawsuits for Up to $102.5 Million

Imerys SA agreed to sell off its North American talc mines to pay for a settlement of up to $102.5 million, working with representatives of 14,000 existing and potential future claimants who got cancer from asbestos-laden talcum powder products.

Imerys is the primary supplier of talc to Johnson & Johnson, whose Baby Powder and Shower to Shower products are the target of 17,058 lawsuits consolidated before US District Chief Judge Freda L. Wolfson in MDL 2738, IN RE: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation.

The Imerys settlement does not affect the Johnson & Johnson cases in the MDL because, on February 13, 2019, Imerys Talc America, Inc., Imerys Talc Vermont, and Imerys Talc Canada filed a voluntary petition under Chapter 11 in the US Bankruptcy Court for the District of Delaware. The automatic stay in Bankruptcy Court halted the lawsuits against Imerys, which have been in Bankruptcy Court since then.

Approval possible in June

The Imerys bankruptcy cases are pending before the Judge Laurie Selber Silverstein, and are jointly administered under Case No. 19-10289. Judge Silverstein may approve the settlement as early as June 2020. The French-based J&J talc supplier is expecting to receive confirmation of the plan and emerge from bankruptcy protection by the end of 2020.

Assets of the 3 Imerys companies will be sold at auction with the proceeds going into an independent trust to compensate talc victims, the company said in a statement. In return, plaintiffs will drop their suits, allowing the businesses to emerge from Chapter 11.

The deal aims to end six years of litigation over Imerys’s role as the sole talc supplier for J&J. Imerys agreed to make a minimum $75 million payment. An additional amount of up to $102.5 million, subject to a reduction mechanism proportionate to the sale price of the assets.

An April 2018 verdict by a New Jersey jury ordered Imerys to pay a $25 million in punitive damages award to Stephen Lanzo and his wife. Then in June 2018 Imerys agreed to pay $5.5 million before trial to settle claims from 22 women, who alleged that its asbestos-contaminated talc caused them to develop ovarian cancer.

In the same case, J&J was ordered to pay $4.7 billion in damages to the plaintiffs. For more details, read Johnson & Johnson is Battered by Talcum Powder – Cancer Litigation.

Talc and Asbestos

“It is unlikely that any naturally occurring talc deposit would not also contain some asbestos. Combine the foregoing with the fact that there are no practicable and economical means by which to separate asbestos from talc, it is reasonable to conclude that, it is more likely than not, that all talc contains asbestos,” writes John Ray, who has been a leading consultant to the Mass Tort industry for more than a decade.

Talc and asbestos often occur in the same geological formations together. Before the dangers of asbestos were publicly revealed, many companies neglected to check for asbestos in talcum powder products.

Imerys said the bankruptcy settlement was a “Significant step for Imerys towards a permanent and final resolution of historic talc-related liabilities.” It will produce a “favorable outcome for the Group allowing to move forward and focus on its current operations, free of historic talc-related liabilities.

Imerys operates hundreds of industrial sites across 50 countries around the world, supplying about 15% of the world’s talc. It operates mines and processing facilities in Europe, North America, Asia, and Australia. Its open-cast mine in Three Forks, Montana, is the largest talc operation in the United States.

The company did not play a major role in the asbestos industry during the 20th century. Rather, Imerys’ liability for asbestos exposure came with its acquisition of the Luzenac Group, a major talc supplier.

Imerys Talc America is liable for diseases caused by asbestos-contaminated talc mined by the Luzenac Group during the 20th century. Imerys disputes its talc has ever caused cancer, but recent lawsuits involving the company have been successful for plaintiffs.

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Zantac Setting the Record Straight

THERE IS NO ACCEPTABLE LEVEL OF NDMA

MTN has reviewed numerous complaints filed against the makers of Zantac/Ranitidine products. Many complaints have referenced the FDA having determined the “safe level” of NDMA. These statements make it appear that the FDA has determined that it is “ok” for a drug to contain a certain level of NDMA.

It is important that plaintiffs attorneys do not give the various Courts the impression that the FDA has established a level of NDMA that can be found in a drug and that drug not be considered adulterated and misbranded. If plaintiff counsel opens this door, the defendants are surely to walk through it, or at least attempt to do so.

Pursuant to 21 U.S. Code § 351. (Adulterated drugs and devices) a drug is considered adulterated if it contains any substance not listed on its “ingredients” label, as approved by the FDA. Drugs are commonly recalled due to the presence of significant amounts of harmless substances or particles simply because those harmless substances and/or particles render the lot or batch in which they were found, adulterated.

A drug is mislabeled pursuant to 21 U.S. Code § 352.(Misbranded drugs and devices) if (a)(1) If its labeling is false or misleading in any particular.

Pursuant to Title 21-§331. (Prohibited acts) the introduction of any drug into interstate commerce, as well as receiving any such drug (relevant to those entities in the distribution chain, including retailers) that is adulterated, misbranded or both, a criminal offense.

A drug could be misbranded but not adulterated however, all adulterated drugs are also misbranded.

No “statement or finding” by the FDA can change any aspect of a law enacted by Congress. The Safe Levels of NDMA mentioned by the FDA, prior to the FDA’s request that all makers of Zantac/Ranitidine (OTC and RX) remove all of these products from the market, were intended to prevent consumers who had taken these drugs from panicking. The “save levels of NDMA” the FDA was referring to were those established by the EPA and other agencies relevant to drinking water. The FDA changed course on April 1, of 2020 relevant to their focus on keeping consumers calm and converted to the position inter alia: Stop taking these drugs, the contaminant found in these drugs is a probable carcinogen.

As of April 1, 2020, the FDA, after an investigation that lasted over 7 months, the FDA, in addition to “requesting” (the limit of the FDAs unilateral power) that all makers of Zantac/Ranitidine products remove (recall) their products from the market. The April 1, 2020 Statement.

NDMA is not approved by the FDA as an active or inactive ingredient (excipient) for use in any drug product. The FDA would not approve a drug that listed NDMA has an ingredient.

No product for which the FDA has determined contains NDMA can be held to have been approved by the FDA. The FDA does not approve adulterated and misbranded drugs.

The April 1, 2020 Statement by the FDA also expressed the following finding by the FDA.

“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions,

MTN Note: This is a reference to storage temperatures or temperatures at which NDMA conversion begins relevant to Zantac/Ranitidine. Prior to the FDAs determination made public in the April 1, 2020 statement, all prior FDA statements had indicated that the FDA believed Zantac/Ranitidine was subject to converting to NDMA at temperatures significantly higher than normal “room temperatures”.

It is worth nothing that the FDA investigation relevant to certain batches and lots of blood pressure drugs found to contain N-Nitroso Compounds, that has been ongoing far longer than the Zantac/Ranitidine products investigation and the FDA has not requested a total recall of these products nor has the FDA found that NDMA begins to form at room temperature, relevant to the blood pressure drugs.

The EPA determined that NDMA was an “extremely hazardous substance” as early as the 1980s. “Extremely hazardous substance” is technical EPA speak for poison. Based on the findings of the FDA, it does not appear that defendants simply sold Plaintiffs a defective and harmful product, they “poisoned” plaintiffs.

NDMA IS A POISION! We are not being hyperbolic, NDMA has been successfully used as a murder weapon in at least 4 documented cases, three of which resulted in murder convictions and the forth resulting in the perpetrators on death prior to trial, as he poisoned himself with NDMA while trying (successfully) to murder his wife.

DESIGN IS A BROAD TERM UNDER THE LAW

The packing as well as the temperature at which a product is manufactured and held (stored) by the manufacturer are all included as part of the design of the drug. If other entities in the supply chain, such as shippers, distributors and retailers need to maintain a drug at below normal temperatures (refrigeration) then it is the legal duty of the manufacturer to instruct these other members of the supply chain as to the necessity to “hold” the drug at temperatures that assures that the drug will remain in the same condition (including contain the same ingredients and only those ingredients) that were present when it left the hands of the drug makers.

If the consumer needs to maintain a drug at a certain temperature so as to prevent the drug from “deteriorating” or any portion of the drug from converting to a substance not listed on the label (ingredients) it is the duty of the manufacturer to provide the appropriate instructions on the label. Many drugs carry a “refrigeration instruction” but not Zantac/Ranitidine.

Why is the fact that the FDA has found that NDMA begins to develop in Zantac/Ranitidine at room temperature so important?

  1. The products were presumably (discovery will tell) manufactured at refrigerated temperatures. It is quite possible that many of the outsource overseas manufacturing facilities that made Zantac/Ranitidine are not even air conditioned.
  2. Once any given Zantac/Ranitidine rolled of the line, it was not held pre nor post packing by the manufacturer (packing and warehousing) at refrigerated temperatures.Presumption/Conclusion: NDMA began to form before the product left the original manufacturers hands.
  3. The shippers (including overseas container shippers) were not instructed to, nor did they maintain the product at refrigerated temperatures.
  4. The various land base shippers (trucking companies) that handled the product, were not instructed to, nor did they maintain the product at refrigerated temperatures.
  5. The retailers were not were not instructed to, nor did they maintain the product at refrigerated temperatures.
  6. The retailers were not were not instructed to, nor did they maintain the product at refrigerated temperatures.

Final Presumption/Conclusion: Every Zantac/Ranitidine tablet that ever rolled off any drug makers line, from the first tablet ever made, began converting in part, to NDMA and continued to do so, throughout the supply chain and in the consumers hands. More simply stated, all Zantac/Ranitidine per the FDAs statements are presumed by the agency, to be and to always, and at all times, been contaminated with NDMA.

Takeaway’s

  1. The acceptable level of NDMA that can be found in a drug and that drug is not adulterated and misbranded is zero, nada, zip, none.
  2. The FDA has established that every Zantac/Ranitidine tablet ever made (unless refrigerated though out its entire lifecycle) is and or was prior to consumption, contaminated with NDMA and thus misbranded and adulterated.
  3. The products consumed by Plaintiffs were not approved by the FDA in that the FDA does not approve misbranded and adulterated drugs. In fact, misbranded and adulterated drugs are specifically not approved by the FDA and Federal as well as every States law makes the introduction of such products into the stream of commerce an offense (generally criminal). Federal Law (Our State Survey on this matter is not completed however, Federal Law will suffice) as well as State laws, make the receiving and further distributions (by those in the supply chain) an offense equal to that of the original manufacturer.
  4. Generic Drug makers, whether OTC or RX, for these reasons as well as others, can not claim protection under Pliva v. Mensing in that any restriction under the law relevant to a generic drug makers ability to unilaterally make changes to their warning label, is irrelevant to drugs that were not approved by the FDA in the first instance. The FDA does not approve adulterated and misbranded drugs nor does the FDA approve nor place restrictions relevant to the labels of these products. The law restricts these products from being sold, hard stop.

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Good News For Talcum Powder Plaintiffs, Maybe…

On May 19, 2020 Johnson & Johnson stated that the company would stop marketing Johnson’s Baby Powder containing Talc, in the U.S. and Canada. The pharmaceutical giant cited a decline in customer demand amid publicity about safety concerns as their reason for deciding to pull their talc-containing products from the market.

Johnson & Johnson also stated that it will continue to sell a cornstarch-based version of Johnson’s Baby Powder in the U.S. and Canada. Talcum Powder Lawsuit Plaintiffs have long held that the cornstarch-based version was a safer alternative to talc as the active ingredient in baby powder and other similar products.

The maker of Shower to Shower powder, Bausch Health Cos. Inc. made the switch from Talc to Corn Starch in November of 2019. Bausch Health Cos. Inc. also faced product liability suits over its Talc products; however, the number of cases filed against Bausch pale in comparison to the number filed against Johnson and Johnson and Imerys (as co-defendants).

It is likely not mere coincidence that Johnson and Johnson announced its decision to make the switch of talc to corn starch on the heels of their Co-Defendant, Imerys, announcing that it would relinquish certain assets to the Bankruptcy Trustee in the companies’ Chapter 11 proceeding, for the purpose of paying plaintiffs’ claims in exchange for ending the hard-fought litigation against Imerys. The Imerys settlement would not relieve Johnson and Johnson of liability from Plaintiffs’ Talc claims unless the Imerys Bankruptcy Court allows Johnson and Johnson to contribute to the Imerys bankruptcy trust under a third party channeling injunction.

The U.S. Bankruptcy 11 U.S. Code § 524 (g)(2)(I) provides an opportunity for Johnson and Johnson to attempt to invoke the Bankruptcy Court to issue a “channeling injunction” which, if granted, would allow Johnson and Johnson to contribute to the Imerys bankruptcy trust and dispose of their portion of the liability arising from existing plaintiff cases as well as future cases.

The Plain Language of the Code pursuant to 11 under U.S. Code § 524 (g)(2)(IV)(bb) also requires that any third-party channeling injunction be approved by a 75% vote of the Plaintiffs addressed in § 524 (g)(2)(I).

11 U.S. Code § 524 (g) was passed by Congress in order to protect asbestos claimants who were exposed to asbestos, but had not yet manifested an asbestos related disease (future claimants), The Statute was enacted due to the number of asbestos defendants who sought bankruptcy protection. The primary purpose of the Statute was to protect “future claimants” in the various asbestos litigations.

Although 11 U.S. Code § 524 (g) arose from the asbestos litigation, there is nothing in the Statute that indicates that Congress intended to limit the applicability of the Statute to asbestos cases.

Notwithstanding the plain language of the Statute, there is a Federal Circuit split on numerous issues relevant to the applicability 11 U.S. Code § 524 (g) under a variety of scenarios, including whether the applicability of the Statute is limited to “asbestos defendants”.

The good news for Talcum Powder Plaintiffs is that we can now see light at the end of the tunnel however; if Johnson and Johnson tries to settle “on the cheap” via the Bankruptcy Court, we could be facing a new and different long and hard-fought battle in yet another court.

It is our hope that the Judge in the Imerys Bankruptcy Court will not ignore 11 U.S. Code § 524 (g)(2)(IV)(bb) and attempt to enforce a settlement agreement that includes a release of liability for Johnson and Johnson, absent Johnson and Johnson making a large enough contribution to the Imerys trust that at least 75% of the existing Talcum Powder Litigation Plaintiffs would find acceptable and agree to.

Stay tuned, the light at the end of the tunnel could show us the way to a satisfactory end to this litigation, or burn Plaintiffs, giving rise to appeals that might prolong the matter indefinitely.

One thing that is certain, Johnson and Johnson not only wants to end this litigation, the decision makers, being those executives with titles starting with a “C” and the Board Members need to see an end to this litigation, as another multi-billion dollar jury verdict could render these well-compensated executives out of a job. Most of Mass Tort Litigations have little impact on the stock value of the defendant, both the Talcum Powder Litigation and the Roundup litigation have been an exception to this general rule. Bayer and Johnson and Johnson stockholders and the market, in general, has reacted quickly and negatively to the large verdicts handed down by juries, thus far. There is nothing that causes more fear in Stockholders and the market than uncertainty, and both defendants are saddled with an elephantine uncertainty until such time as they can inform their Stockholders that these litigations are substantially behind them.

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Zantac Judge Appoints Plaintiff Leaders Even As Defendants Deny Cancer Connection

A federal judge appointed 26 lawyers to spearhead the Zantac litigation in Florida, even as the drug company defendants claimed the antacid does not cause cancer.

District Judge Robin Rosenberg, of the U.S. District Court for the Southern District of Florida, is presiding over 230 cases in MDL 2924, IN RE: Zantac (Ranitidine) Products Liability Litigation.

The suits accuse Sanofi, Pfizer Inc., Boehringer Ingelheim Pharmaceuticals Inc., and GlaxoSmithKline LLC, as well as generic drug makers, retailers, distributors, and pharmaceutical ingredient makers, of false advertising, and failure to warn.

Zantac/Ranitidine is an antacid and antihistamine that was commonly used to treat and prevent heartburn, as well as stomach ulcers, gastroesophageal reflux disease (GERD), and conditions that cause too much stomach acid.

The FDA issued a recall on April 1, 2020, requesting that all manufacturers immediately withdraw prescription and over-the-counter (OTC) Zantac/Ranitidine products due to excess levels of NDMA, a probable human carcinogen in the drug that has also been found in rocket fuel.

The FDA noted that its ongoing investigation of Zantac/Ranitidine determined that levels of NDMA increase over time and when the drug is stored at higher-than-normal temperatures. Consumers have been advised to stop taking any Zantac/Ranitidine tablets or liquid medications.

In light of the continuing Coronavirus pandemic, the Court conducted two days of leadership applicant interviews via a Zoom hearing attended by almost 100 attorneys. U.S. District Judge Robin L. Rosenberg heard from more than 60 applicants before making her appointments.

Judge Rosenberg created a Plaintiffs’ Steering Committee composed of 10 men and 10 women in Pretrial Order # 20. The Court went even further in creating a Leadership Development Committee, a novel, and innovative idea to allow younger attorneys in the mass tort world to gain leadership experience.

“The Court also sought to appoint a diverse leadership team that is representative of the inevitable diversity of the Plaintiffs in this case, and a team that affords younger and slightly less experienced attorneys an opportunity to participate in a leadership role in an MDL. The Court sought to create a team that would collectively bring to bear both wisdom and judgment, and also new approaches and ideas,” Judge Rosenberg wrote.

Plaintiff’s Dream Team

Co-Lead Counsel are:
• Mike McGlamry of Pope McGlamry P.C.
• Bobby Gilbert of Kopelowitz Ostrow Ferguson Weiselberg Gilbert.
• Tracy Finken of Anapol Weiss.
• Adam Pulaski of Pulaski Kherkher.

Additionally, 15 members were appointed to the Steering Committee: Rosemarie Riddell Bogdan (Martin, Harding & Mazzotti), Mark J. Dearman (Robbins Geller Rudman & Dowd LLP), Elizabeth A. Fegan (Fegan Scott LLC), Marlene J. Goldenberg (Goldenberglaw, PLLC), Roopal P. Luhana (Chaffin Luhana LLP), Ricardo M. Martinez-Cid (Podhurst Orseck, P.A.), Lauren S. Miller (Cory Watson, P.C.), Melanie H. Muhlstock (Parker Waichman LLP), Daniel A. Nigh (Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.), Carmen S. Scott (Motley Rice, LLC), Mikal C. Watts (Watts Guerra LLP), Sarah N. Westcot (Bursor & Fisher, P.A.), Conlee S. Whiteley (Kanner & Whiteley, L.L.C.), R. Brent Wisner (Baum Hedlund Aristei & Goldman, P.C.), and Frank Woodson (Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.).

Judge Rosenberg made the following appointments to the Leadership Development Committee: Paige Boldt (Watts Guerra LLP), Je Yon Jung (May Lightfoot, PLLC), Adam William Krause (Krause and Kinsman, LLC), Nicola Larmond-Harvey (Saunders & Walker, P.A.), and Bradford B. Lear (Lear Werts LLP).

Other appointments included:

• Ashley Keller (Keller Lenkner) as chairman, and Fred Longer (Levin, Sedran & Berman) as co-chairman, of the Law & Briefing Committee,        and Daniel Nigh (Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor) as chairman of the Science & Experts Committee.
• Mikal Watts (Watts Guerra) and Brent Wisner (Baum, Hedlund, Aristei & Goldman), were appointed as co-chairs of the Bellwether & Trial         Team.

Whining from the Corporate Defendants

In a Zoom meeting five days later, a rogue’s gallery of drug makers who are defendants in the Zantac litigation said the lawsuits are “based on a series of mights and maybes,” claiming there is no causal link between the drug and cancer.

“The law is supposed to lag science,” said Anand Agneshwar, who represents Sanofi SA and laid out the case for the defendants. “It’s not supposed to lead it.”

Paige Sharpe, who also represents Sanofi, said, “Even if they can show that Zantac can cause one type of cancer, plaintiffs will have to show it caused their individual cancer. That’s a very high hurdle.”

The defense team pointed to statements made by both the FDA and the European Medicines Agency when they pulled the drug from shelves saying that there was no proven link between the drug and cancer.

Sanofi is represented by Arnold & Porter Kaye Scholer LLP, DLA Piper, Jones Foster Johnston & Stubbs, and Stearns Weaver Miller Weissler Alhadeff & Sitterson PA.

GlaxoSmithKline is represented by Dechert LLP, Nelson Mullins Broad and Cassel, and Shook Hardy & Bacon LLP.

Pfizer is represented by Williams & Connolly LLP and Walsh Pizzi O’Reilly Falanga LLP.

Boehringer is represented by King & Spalding LLP, Carlton Fields, Wicker Smith O’Hara McCoy & Ford, Shipman & Goodwin LLP, and Covington & Burling LLP.

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Litigation is Emerging Against an Asthma Drug that Causes Suicide, Mental Side Effect

Up to 24 million asthma and allergy patients, including children as young as 12 months, are potentially risking serious mental health side effects from taking Singulair tablets and granule packets manufactured by Merck & Co.

Montelukast, the active ingredient in Singulair, blocks substances in the body called leukotrienes to help improve symptoms of asthma and allergic rhinitis. According to the FDA, side effects of Montelukast, include suicidal thoughts and actions, as well as behavior or mood-related changes like:

• Agitation, including aggressive behavior or hostility
• Attention problems
• Bad or vivid dreams
• Depression
• Disorientation or confusion
• Feeling anxious
• Hallucinations (seeing or hearing things that are not really there)
• Irritability
• Memory problems
• Obsessive-compulsive symptoms
• Restlessness
• Sleepwalking
• Stuttering
• Tremor or shakiness
• Trouble sleeping
• Uncontrolled muscle movements

The FDA identified cases of completed suicides associated with Montelukast, with many reporting the development of neuropsychiatric symptoms prior to the suicide. The side effects can happen to people with and without mental disorders. Some patients had the effects continue even after they stopped taking the drug.

The FDA required a black box warning – the agency’s most prominent warning – in March 2020 to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug. The FDA said that many health care professionals and patients are not aware of the risk.

“We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions. The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” said Sally Seymour, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

“The FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions. Importantly, there are many other safe and effective medications to treat allergies with an extensive history of use and safety, such that many products are available over the counter without a prescription.”

Immediate Adverse Events

The prescription drug generated $698 million in sales for Merck in 2019. In 2018, approximately 9.3 million patients of any age received a prescription for Montelukast from US retail pharmacies. Of these, approximately 2.3 million were children younger than 17 years.

Mass tort law firms are actively reviewing potential claims on behalf of patients who used Singulair and suffered an unwarned adverse event. No MDL has been created yet.

The FDA approved prescription Montelukast in 1998 to treat asthma for children and adults, for seasonal allergic rhinitis in 2002, for perennial rhinitis in 2005, and for exercise-induced bronchoconstriction in 2007.

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness and coughing caused by asthma, and also to treat sneezing and stuffy, runny or itchy nose from hay fever.

However, the FDA started getting adverse event reports for in 2008, primarily for depression, aggression, irritability, nightmares, insomnia, and suicidality. The suicide of a 15-year-old boy taking Montelukast in 2007 was one event prompting the FDA review.

The FDA updated its Singulair labeling include a precaution against neuropsychiatric events in 2008.

The market for Singulair is huge. Allergies and hay fever affect as much as 30% of US adults – between 30 million and 60 million people, according to Public Citizen.

In 2014, Merck asked for FDA approval for over-the-counter sales for adults and only for the treatment of allergy symptoms. Public Citizen successfully asserted that Singulair was too dangerous to be sold over the counter because it has minimal benefits but posed potentially serious health risks. The FDA banned the proposed Singulair OTC sales on May 2, 2014.

The FDA reevaluated the risks and benefits of Montelukast and determined it should not be the first choice treatment particularly when allergic rhinitis symptoms.

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Emerging Imodium Litigation Over Heart Damage

Imodium, though not an opioid, may increase the effect of opioids when consumed at the same time. Imodium, along with its generic forms, are intended to act on the digestive system and are the #1 best-selling drug to treat diarrhea. However, taking too much can cause serious cardiac problems, and the effects are worsened with the interaction of other common drugs like Zantac.

Heroin-like High

Opioid addicts and many young people are turning to Imodium A-D and similar over-the-counter medications to get a heroin-like high.

Imodium was approved by the FDA in 1976 has been available over-the-counter in the US since 1988. The FDA started getting reports of serious adverse events in 2010. The active ingredient — Loperamide Hydrochloride — has euphoric effects and information on how to facilitate such effects is easily available.

“Loperamide’s accessibility, low cost, over-the-counter legal status, and lack of social stigma all contribute to its potential for abuse,” said lead study author William Eggleston, PharmD, of the Upstate New York Poison Center at Upstate Medical University.

“The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria,” the agency said.

People abusing the drug took 50 to 300 milligrams to induce a high. Litigation is gradually building against the manufacturer. All products sold under the Imodium brand name are manufactured by Janssen Pharmaceuticals Inc. and Johnson and Johnson Consumer Inc.

About 2.1 million people addicted to opioid painkillers, and there is widespread fear the seemingly harmless medication could contribute to the epidemic. One in five Americans has a family member addicted to painkillers, according to a Kaiser Family Foundation survey.

“Abuse of loperamide continues in the United States, and taking higher than recommended doses can cause serious heart problems that can lead to death,” said Acting FDA Commissioner Ned Sharpless, M.D.

FDA Action

In 2016, the FDA issued a safety announcement that it had received numerous reports of serious heart issues and medication reactions in patients taking prescription loperamide and over-the-counter Imodium products. The FDA also warned that taking higher than recommended doses of medicine Imodium, including through abuse or misuse of the product, can cause serious heart problems that can lead to death.

A Heart Alert warning was added to loperamide Drug Facts labels in the spring of 2017 to warn consumers that taking more than directed can cause deadly heart problems.

Even so, Amazon sells a 192-pack of generic Loperamide for $13.48 or 7 cents per tablet. Tablets contain 2 mg of Loperamide, and the maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use.

Like Morphine

Imodium is a synthetic anti-diarrheal indicated for the control of the symptoms of diarrhea, including Travelers’ Diarrhea (consumption of contaminated foods or beverages). The medication is designed to manage periodic episodes of diarrhea, not chronic diarrhea, which can be an indication of a more complicated and serious medical condition.

Like morphine, Imodium works by binding to opioid receptors in the digestive tract, which has the effect of slowing digestion. When food moves slowly through the intestines and colon, patients’ stools will be more solid, which is one of the reasons many patients experience constipation when taking prescription opioids.

Imodium, therefore, mimics the effects of opioids on the digestive system in addition to increasing tone of the anal sphincter. Patients usually find relief from their diarrhea symptoms within a short amount of time.

It is sold under these brand names:

  • Imodium
  • Imodium A-D
  • Imodium A-D EZ Chews
  • Imodium Multi-Symptom Relief

When taken in high doses, Imodium can cause the following cardiac issues:

  • Arrhythmias (irregular beating of the heart)
  • QT Interval Prolongation (rapid or chaotic heartbeats)
  • Torsades de Pointes (ventricular tachycardia or rapid beating of the lower heart chambers)
  • Syncope (temporary loss of consciousness or fainting spell)
  • Cardiac Arrest

“These are serious heart complications that can lead to patient death. Cardiac arrest is a particularly frightening potential side effect for these drugs, which can often lead to death in patients,” according to the Parker Waichman law firm.

Drug Interactions

Cardiac complications and cardiac arrest can be amplified when patients take loperamide or Imodium in combination with certain other medications:

• Tagamet HB (cimetidine)
• Zantac (ranitidine)
• Prevpac (lansoprazole)
• Biaxin (clarithromycin)
• Lopid (gemfibrozil)
• Omnel/Sporanox (itraconazole)
• Ketoconazole
• Nuedextra (quinidine)
• Qualaquin (quinine)
• Kaletra/Norvir/Technivie (ritonavir)

Loperamide and Imodium can also cause severe allergic, which will often occur shortly after taking a dose of the medications. Some patients can experience anaphylaxis and anaphylactic shock, as well as other hypersensitivity reactions.

“The propensity for these drugs to cause dependence and cardiac events is exceptionally alarming,” says the Parker Waichman law firm.

Dan Gale, an ER doctor in Wisconsin, said “The biggest safety issue is what happens to the heart. It disrupts our electrical pathways in our heart. When it happens, it’s like flipping a switch. It’s not like you feel a little bit worse and a little bit worse and then you die. You just collapse.”

People overdosing on loperamide may suffer sudden, repeated losses of consciousness caused by a fall in blood pressure.

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