Mark O’Mara to Speak on Civil Rights vs. Police Brutality at Mass Tort Nexus Course on June 13th

Mark O’Mara will be speaking on the topic of “Civil Rights vs. Police Brutality” litigation at the Mass Tort Nexus course on Saturday, June 13th in Ft. Lauderdale. Mark will speak on cases involving violations of individuals’ civil rights under the color of authority, committed by Law Enforcement Officers or Correctional Officers, leading to the injury and often death of the victims of these acts.

The George Zimmerman case thrust Mark into the national consciousness, where he remains today due to his frequent appearance on CNN, HLN, Court TV and all the major networks. A fact not as well known to the non-legal community is that Mark, prior to the Zimmerman case and after, has been the “go to attorney” for many individuals, often African Americans and other people of color, who have been victims of civil rights violations.

Mark’s experience in MDL leadership, from his work on the Benicar MDL to his co-lead position in the CenturyLink MDL, combined with his broad experience in civil litigation in the representation of those who had their civil rights violated by law enforcement, are accolades on Mark’s resume which the public and the legal community at large are often not aware. Mark represented the estate of Sam DuBose, an African American man stopped for a tag violation by an off-campus University of Cincinnati police officer, Ray Tensing. As can be seen in a widely published body cam video, Sam was executed by Tensing, who then created a story of self-defense, even though it was belied by all the evidence. Mark also represented the estate of Mathew Ajibade, a 20-year old black college student beat up, held in a restraint chair and tased in the crotch by officers at the Chatham County Jail. Mathew succumbed to his abuse and died while still in the restraint chair.

He is presently representing the estate of 17-year old Adrein Green, shot in the back and killed from 20 feet away by a homeowner who was already in his home and on the phone with police. This shooting occurred about two miles from the shooting of Trayvon Martin, in Sanford, Florida. While the investigation is still underway, no charges have been filed.

Given the sea change in public attitude towards police brutality, we offer the unique opportunity to learn from an expert on the front lines, and get his insight on the recent cases of Ahmaud Arbery, George Floyd, and the now infamous Central Park dog walker, Amy Cooper.

We would like to believe that the “sea change in public attitude towards police brutality” and the increase in cell phone videos and body cams might alter the behavior of those police officers with a tendency towards excessive and unnecessary use of force, but the Floyd homicide tells us we have a long way to go.

Unfortunately, while these horrific acts could lay the foundation for some positive change in the way we police each other, recent reactions to the protests have already demonstrated a willingness to use tear gas and force against those peacefully protesting, are troubling.

In order to rebuild the tattered trust that our minorities have for the criminal justice system, we must be willing to tear down the Blue Wall code of silence, and hold those that are silent as accountable as those who act. Only when we accomplish that can we bring about a day when a young man of color can walk or drive down the street, see a police officer and not automatically feel fear.

Politicians, as well as Local, State and Federal Governments have clearly failed to stem the tide of excessive police violence. Plaintiff civil rights lawyers are the country’s last and best hope to bring about the change that will maintain the viability of our justice system.

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Litigation Starts over Diet Drug Belviq, Yanked from Market Because of Cancer Risk

After being on the market for 8 years, the marginally-effective diet Drug Belviq, made by the Japanese drug company Eisai, has been pulled off the market because it may cause cancer.

Eisai, based in Woodcliff Lake, New Jersey, voluntarily withdrew Belviq from the market in February 13, 2020, at the behest of the U.S. Food and Drug Administration.

Earlier, in January 2020, the FDA had alerted the public about a possible risk of cancer associated with lorcaserin, the active ingredient in Belviq, based on preliminary analysis of the data.

A range of cancer types were reported, including pancreatic, colorectal, and lung. The FDA instructs patients to stop taking the drug.

Litigation underway

Plaintiff law firms are actively marketing to Belviq patients now. Lawsuits against Eisai began to be filed in March 2020, considering it may have a high average case value litigation.

Barbara Zottola of White Plains, NY, filed a class action complaint in March 2020 against Eisai Inc. in U.S. District Court in White Plains, accusing the drug maker of pushing the product to market, despite evidence that it was defective. Zottola is represented by Manhattan attorneys Andrew J. Obergfell and Joseph I. Marchese and Miami attorney Sarah N. Westcot.

The lawsuit also names Arena Pharmaceuticals Inc., the San Diego company that developed and licensed lorcaserin, the active ingredient, and CVS Health Co., the pharmacy chain from which Zottola purportedly bought the drug.

In April 2020, Barbara Zottola of New York filed a class-action lawsuit against Eisai, Inc., claiming it knew about Belviq’s cancer-causing potential for years, yet kept pushing it to market.

The complaint by Saunders & Walker of Pinellas Park, Florida, asks the federal court to certify a class of hundreds of thousands of people across the country who purchased Belviq. The suit seeks damages for alleged breach of an implied warranty, deceptive acts, false advertising, unjust enrichment, fraud, and conversion.

Risk of cancer

Eisai Co., Ltd. is a Japanese pharmaceutical company headquartered in Tokyo, Japan. It has offices in New Jersey, Massachusetts, and Pennsylvania. Eisai, originally a marketing partner on Belviq, acquired the sole rights to the drug from Arena Pharmaceuticals for only $23 million in cash in January 2017.

Belviq revenues for 2017 totaled $21.3 million. The company promoted prescriptions for the weigh-loss drug for $40 with savings cards for commercial-insured patients. Ordinarily, it costs approximately $300 a month and is not covered by most insurance companies.

Belviq was approved by FDA on June 27, 2012, for use with a reduced-calorie diet and increased physical activity to help weight loss in adults who are obese or are overweight and have weight-related medical problems. Belviq is a serotonin 2C receptor antagonist indicated for chronic weight management in adults who are obese, or overweight, and who have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol. It is supposed to work by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and an extended-release tablet (Belviq XR).

A four-year study, requested after Belviq’s approval in 2012, showed a possible link to increased cancer risks in patients with either an established cardiovascular disease or multiple risk factors.

In December 2012, the US Drug Enforcement Administration proposed classifying lorcaserin as a Schedule IV drug because it has hallucinogenic properties at higher than approved doses and users could develop psychiatric dependencies on the drug. On May 7, 2013, the US Drug Enforcement Administration classified lorcaserin as a Schedule IV drug under the Controlled Substances Act.

Interestingly, back on September 16, 2010, an FDA advisory panel had voted 9–5 against approval of the drug based on concerns over both efficacy and safety, particularly the findings of tumors in rats. On October 23, 2010, the FDA at first decided not to approve the drug. This was not only because cancer-promoting properties could not be ruled out, but also because the weight loss efficacy was considered “marginal.”

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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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In a Big Win, Plaintiffs’ Experts can Testify in Talc-Ovarian Cancer Litigation

A federal judge in New Jersey has ruled that scientific and medical experts proposed by the plaintiffs’ experts are qualified to testify about how genital talc use causes ovarian cancer. The ruling has major implications for ongoing state and federal litigation against Johnson & Johnson.

The ruling paves the way for future bellwether trials that could establish compensatory and punitive damage guidelines for the more than 16,000 cases pending in the MDL.

The ruling is a big win for plaintiffs’ attorneys, who for years have faced accusations from Johnson & Johnson about allowing “junk science” into the courtroom. J&J sought to bar all of the plaintiffs’ experts from testifying, which would have effectively wiped out all the cases before Wolfson.

“These experts report on the growing amount of peer-reviewed medical literature regarding talcum powder and ovarian cancer and represent the increasing number of highly respected researchers and doctors who are standing up to tell the world about the dangers of talcum powder,” said Leigh O’Dell, co-chair of the plaintiffs’ steering committee. “These respected and qualified experts will now testify in trials about the risk factors and causes of ovarian cancer, and the biological links of talcum powder use to this deadly disease.”

The clinical experts initially challenged by the defense but now cleared to testify about the dangers of talcum powder use include:

  • Anne McTiernan, MD, Ph.D. – Research Professor at the University of Washington School of Public Health’s Department of Epidemiology and the University of Washington School of Medicine, and a cancer prevention researcher at the Fred Hutchinson Cancer Research Center.
  • Arch “Chip” Carson, MD, Ph.D. – Associate Professor and Program Director for the Southwest Center for Occupational and Environmental Health at the University of Texas School of Public Health in Houston.
  • Daniel Clarke-Pearson, MD – Professor and recent Chairman in the Department of Obstetrics and Gynecology at the University of North Carolina-Chapel Hill, specializing in gynecologic oncology.
    Judge Wolfson’s ruling allows additional testimony from the following experts:
  • Ghassan Saed MD, Ph.D. – Research Professor in the Departments of Obstetric Gynecology and Oncology at Wayne State University and the Karmanos Cancer Center in Detroit. Dr. Saed will testify about his clinical research demonstrating that talcum powder can cause inflammation and oxidative stress in cells.
  • William Longo, Ph.D. – Material scientist/electron microscopist and founder of Georgia’s Micro Analytical Laboratories, specializing in the analysis of asbestos and mineral fiber-containing materials. Dr. Longo will testify that J&J talcum powder products contain asbestos and fibrous talc, based on his analysis using transmission electron microscopy.

“We are obviously pleased with the court’s ruling and are eager to move forward, said Michelle Parfitt, co-chair of the plaintiffs’ steering committee. “Epidemiologists and gynecologic oncologists will be allowed to testify that talcum powder causes ovarian cancer, including their opinions regarding the contribution of asbestos, fibrous talc, and metals to its carcinogenicity.”

The ruling by Wolfson will allow plaintiffs to present expert testimony that J&J’s talc products can cause cancer-based on epidemiological studies. They will be allowed to testify that the link could be caused by contamination with asbestos and heavy metals.

Wolfson also ruled that the plaintiffs’ experts cannot testify that inhaling talc can travel to the ovaries if inhaled, though they may say that it can reach the ovaries when used vaginally.

The case is In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation (MDL No. 2738). There are 16,594 cases consolidated before Chief US District Judge Freda L. Wolfson.

In 2018 J&J finally complied with discovery requests, which disclosed damning revelations that its own tests have found asbestos in its talc for 60 years and that the company lied to the FDA about it.

Since then plaintiff lawyers have introduced the internal documents into evidence with devastating results at trial. Most of the verdicts have involved plaintiffs with mesothelioma.

  • $4.7 billion awarded in December 2018 to 22 women with ovarian cancer. A Missouri state jury made the award after it heard that Johnson & Johnson has known for decades about the risk of asbestos contamination in its talc.
  • $325 million awarded in May 2019 in New York to Donna Olson, whose mesothelioma was caused asbestos-laced Johnson & Johnson baby powder. The company’s damning internal documents were used as evidence.
  • $117 million awarded by a New Jersey jury in April 2018 to Steven Alonzo, who has mesothelioma.
  • $40.3 million awarded by a California jury in October 2019 to Nancy and Phil Cabibi because the company’s baby powder was tainted with asbestos. In 2017, Nancy was diagnosed with mesothelioma.
  • $37.3 million awarded by a New Jersey jury in September 2019 to four plaintiffs claiming they developed mesothelioma from inhaling asbestos allegedly present in Johnson & Johnson’s cosmetic talc products. The judge actually struck the closing argument by defense lawyer Diane Sullivan for accusing the plaintiffs’ attorneys of creating evidence and being sinister.

The talc litigation may eventually cost the company as much as $10 billion, according to Bloomberg Intelligence.

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Lawsuits Rise Against Allergan for Breast Implant-Caused Cancer

Since Allergan recalled its Biocell textured breast implants in July 2019 for causing a rare form of cancer, hundreds of women who underwent breast implant surgery are finding their cancer were caused by defective Allergan breast implants.

Five months later the Judicial Panel on Multidistrict Litigation consolidated four pending class actions involving Allergan to Federal Court in New Jersey. Since December 2019, some 66 cases are pending before US District Judge Brian R. Martinotti in MDL 2921, IN RE: Allergan Biocell Textured Breast Implant Products Liability Litigation.

Allergan’s textured implants are linked to women developing anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is not breast cancer. The cancerous cells develop in scar tissue and fluid near the implant, and in some cases, it can spread and lead to death. Some symptoms of ALCL include persistent swelling or pain near the breast implant, and development seromas, or fluid pockets.

“We cannot allow women to be unnecessarily harmed while we collect data,” Dr. Eric Swanson wrote in a February 2019 article in the Annals of Plastic Surgery. “The cost of medications and the emotional and financial impact of BIA-ALCL take a heavy toll on affected women, even if the disease is seldom fatal.”

Implants and Cancer

Plaintiffs seek to force Allergan to pay for the costs of surgery, diagnostic testing, and medical monitoring in people who have Biocell implants. For those who choose not to replace their Biocell implants, Allergan has refused to cover the costs of invasive diagnostic testing and medical monitoring.

The FDA has not linked smooth Allergan breast implants to cancer, and these are not involved in the recall.

At the time of the recall, the FDA also indicated that the breast implant cancer problems have resulted in:

  • 573 Breast Implant BIA-ALCL cases reported worldwide.
  • 84% (481) of the cancer cases involved Allergan Breast Implants.
  • 33 deaths from BIA-ALCL have been identified.
  • More than 90% of breast implant cancer deaths where the model is known to involve Allergan devices.

According to the FDA, the following products have been removed from the market:

  • Natrelle Saline-Filled breast implants (Styles 168, 163, 363 & 468)
  • Natrelle Silicone-Filled breast implants (Styles 110, 115 & 120)
  • Natrelle Inspira Silicone-Filled breast implants (multiple “T” Styles)
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
  • McGhan Bidimensional Silicone-Filled breast implants (Style 153)
  • McGhan Croissant Shaped Tissue Expander (Style 134)
  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

The textured implants carried a greater risk of performance failure, pain, rupture, and scar tissue around implant.

The FDA first identified a connection between breast implants and anaplastic large cell lymphoma in 2011. But the agency said there were too few cases at the time to properly gauge the risk. In 2016, the World Health Organization classified the disease as a type of T-cell lymphoma that developed after receiving breast implants.

By 2017, the FDA announced BIA-ALCL was primarily associated with textured implants, which led to the recall.

In an early case, plaintiff Misty Riportella of Santa Clarita, California filed suit against Allergan on November 1, 2019, Case 8:19-cv-02103, in federal court.

Unbeknownst to Ms. Riportella, the FDA released a report on January 26, 2011 finding “[b]ased on the published case studies and epidemiological research, the FDA believes that there is a possible association between breast implants and ALCL.”

Back in March 2000 Riportella was implanted with a Textured Saline Filled 270 cc McGhan® Style 168 breast implant on the left (No. 27-168271 Lot MR7826) and Textured Saline-Filled 270 cc McGhan®Style 168 breast implant on the right (No. 27-168271 Lot MA4827).

At the time the implants were placed into Riportella’s body, she was not advised, nor did she have any independent knowledge, that they were anything other than safe, life-long products. Nor was she advised that the product was associated and/or known to cause BIA-ALCL.

Throughout the years, different physicians discussed diagnoses such as congestive heart failure, COPD, blood flow issues, and numerous other “causes” for how Riportella was feeling. She had multiple imaging studies, x-rays, ultrasounds, CTs, blood work-ups, heart monitoring to name a few of the battery of tests she underwent.

In February 2019, Riportella’s daughter noticed a significant swelling in one of her breasts. She went to the ER and several other doctors until she was diagnosed with BIA-ALCL in June 2019. The implants and one lymph node were removed on July 17, 2019.

“Had the medical community been made aware of the existence of the true frequency, severity and significance of BIA-ALCL caused by the products, medical professionals and providers, including those who advised and served Plaintiff, would not have advised patients, including Plaintiff, to proceed with implantation of the products,” the complaint says.

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