CEO of Opioid Distributor Ordered to Testify in Bellwether Trial

AmerisourceBergen Drug Corp. CEO Steven H. Collis must give a deposition in the second bellwether trial in federal multidistrict litigation set to start in October.

Virginia Special Master Christopher C. Wilkes in the US District Court for the Southern District of West Virginia wrote a nine-page order, rejecting the drug maker’s argument that the testimony would be inconvenient and burdensome for Collis.

The opioid epidemic in West Virginia is documented in a Pulitzer Prize-winning newspaper series, triggered a Congressional investigation, spawned lawsuits brought by all 55 counties in West Virginia (including the Attorney General) in federal and state court.

The ruling came on June 29, 2020, in The City of Huntington and Cabell County Commission v. AmerisourceBergen Drug Corporation, Civil Action No. 3:17-01362. A bench trial before US District Judge David A. Faber starts October 19, and distributor Cardinal Health Inc. is also a defendant.

AmerisourceBergen (ABDC) is one of the big three opioid wholesalers and is facing 2,811 lawsuits before US District Judge Dan A. Polster in MDL 2804 IN RE: National Prescription Opiate Litigation in the Northern
District of Ohio

Wilkes said the importance of the issues in the case are “paramount and unparalleled,” and the amount of money at stake is potentially hundreds of millions of dollars and “unquestionably significant.” Therefore, the benefits of his testimony outweigh any burden.

“When the scales of justice are balanced, the tragic backdrop of this potentially momentous litigation justifies the deposition of ABDC’s chief executive officer,” the order says.

ABDC and Collins tried to hide behind the “apex doctrine,” which applies to a specific subset of deposition notices that demand the appearance of high-level executives or high-ranking government officials to prevent harassing or burdening top execs.

That argument went nowhere because the Fourth Circuit has not adopted the apex doctrine, nor commented on its validity.

Besides, Collis voluntarily testified before the Congressional Subcommittee on Oversight and Investigations of the US House of Representatives on May 8, 2018.

“It received sworn testimony from and posed written questions to ABDC Chairman, President, and CEO, Steven H. Collis. The purpose of the hearing was to “examine the role that [ABDC] may have played in contributing to the opioid epidemic as well as distribution practices specific to West Virginia,” the order states.

“Mr. Collis’ written and verbal answers to Congress which demonstrate core competence, personal involvement and direct knowledge of the factual issues the Court must decide during the bench trial,” says the order.
Further, “Collis has not submitted an affidavit indicating that he doesn’t have personal knowledge of the facts, or explained why sitting for the deposition would place “extraordinary demands on his time,” the order states.

The City of Huntington is represented by Anne McGinness Kearse, Joseph F. Rice, Linda Singer, and David I. Ackerman of Motley Rice LLP and by Charles R. “Rusty” Webb of The Webb Law Centre PLLC.
Attorneys for the Cabell County Commission include Paul T. Farrell Jr. of Farrell Law, Anthony J. Majestro of Powell & Majestro PLLC, and Michael A. Woelfel of Woelfel & Woelfel LLP.

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For “Outrageous Conduct” and “Evil Motive,” court Upholds $2.1 Billion in Verdict against J&J in Baby Powder Case

A Missouri appeals court upheld a jury verdict against Johnson & Johnson over cancer caused by its baby powder, but the court reduced the award from $4.7 billion to $2.1 billion.
“Plaintiffs proved with convincing clarity that defendants engaged in outrageous conduct because of an evil motive or reckless indifference,” the court said. “There was significant reprehensibility in defendants’ conduct.”

The court said in an 83-page opinion that the plaintiffs had proven that J&J concealed for decades that the talc products contained asbestos, “worked tirelessly” to ensure that testing protocols would not detect asbestos in all talc samples and, published articles downplaying the safety hazards of talc.

See Attacking and Lying, Johnson & Johnson is Battered by Talcum Powder – Cancer Litigation.

“The harm suffered by plaintiffs was physical, not just economic,” Judge Hess wrote. “Plaintiffs each developed and suffered from ovarian cancer. The plaintiffs underwent chemotherapy, hysterectomies, and countless other surgeries. These medical procedures caused them to experience symptoms such as hair loss, sleeplessness, mouth sores, loss of appetite, seizures, nausea, neuropathy, and other infections. Several plaintiffs died, and surviving plaintiffs experience recurrences of cancer and fear of relapse.”

22 plaintiffs

The unanimous decision by the Missouri Court of Appeals’ Eastern District came on June 22, 2020, in the case of 22 women who developed ovarian cancer from using J&J’s talc-based baby powder. The case is Robert Ingham v. Johnson & Johnson, Case No. No. ED107476, with Presiding Judge Philip M. Hess.

The court rejected Johnson & Johnson’s bid to throw out the 2018 jury verdict in favor of women. Facing 19,000 lawsuits, J&J stopped selling its cancer-causing baby powder in the US and Canada.

Chief US District Court Judge Freda L. Wolfson in New Jersey is overseeing 17,609 cases MDL 2738, IN RE: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation.

Slashing the jury award down from $4.69 billion, the court revised it to $500 million in actual damages and $1.62 billion in punitive damages.

J&J said it would appeal to the Missouri Supreme Court.

Mark Lanier, the lead lawyer for plaintiffs, called the decision “a clarion call for J&J to try and find a good way to resolve the cases for the people who have been hurt.”

Plaintiffs’ attorney Eric Holland added, “I’m pleased that all three judges agreed. I’m also pleased that they so carefully looked at the evidence, and I was so impressed with how they were able to dive into what amounted to a 6,000-page record in what was a six-week trial and come up with what happened here. Very impressive work.”

J&J a bad actor for 50 years

J&J has faced intense scrutiny of its baby powder’s safety following a 2018 Reuters investigation that found it knew for decades that asbestos lurked in its talc.

• Internal company records, trial testimony, and other evidence show that from at least 1971 to the early 2000s, J&J’s raw talc and finished powders tested positive for asbestos.

• Its talc supplier Rio Tinto Minerals warned that there was no safe level of asbestos exposure

• J&J has been the target of a federal criminal investigation into the safety of its talc products, as well as an investigation by 41 states of its baby powder sales.

• The company has also faced an investigation by a congressional subcommittee on the health risks of asbestos in consumer products containing talc.

11 of the 22 women plaintiffs did not live to see the ruling.

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Emerging Mass Tort: Women Sue After the Bladder Pain Drug Elmiron Causes Eye Damage

Litigation is building against three major drug companies that make Elmiron, which treats painful bladder syndrome. Studies show it damages the retina in the eye and causes severe vision loss, particularly in women.

Shockingly, the drug label contains no warning about eye damage.

A major study released on October 12, 2019, found that about 25 percent of patients taking the drug show signs of retinal damage. As a result, plaintiffs have filed vision loss lawsuits against Janssen Pharmaceuticals, Teva Branded Pharmaceuticals, and Ortho-McNeil Pharmaceuticals. The lawsuits focus only on brand-name drugs and charge that the manufacturers failed to warn the public about the risk of vision problems properly.

For many years, pentosan polysulfate, known by its brand name Elmiron, is the most commonly prescribed drugs for patients suffering from interstitial cystitis (IC), a rare and extremely painful bladder condition. Currently, it’s the only oral drug approved to treat bladder pain and discomfort associated with IC, and it’s not available in generic.

Elmiron causes pigmentary maculopathy, or macular degeneration, affecting the retina, resulting in:

● Blurry Vision
● Night blindness
● Difficulty Reading
● Dark Spots in Vision
● Loss of Detailed Vision
● Blurred vision
● Seeing dark spots
● Color blindness
● A change in eye color
● Blindness

Elmiron was approved in 1996 by the FDA to treat IC, a chronic, progressive, and debilitating urinary bladder disease. The sickness causes severe bladder and pelvic pain and the urge to urinate constantly. According to the Mayo Clinic, IC can cause complications, including reduced bladder capacity, lower quality of life, sexual intimacy problems, and emotional troubles.

Toxic to retina

Research presented in October 2019 to the American Academy of Ophthalmology linked Elmiron to retinal damage. Researchers concluded that Elmiron “appears to be toxic to the retina,” which is a thin layer of tissue at the back of the eye that receives light and allows us to see. The study, conducted by three ophthalmologists at Kaiser Permanente in California, reviewed 140 patients who had taken an average of 5,000 pills each for 15 years. They found that the rate of toxicity rose with the amount of drug consumed.

The first to raise the alarm about Elmiron eye damage was Dr. Nieraj Jain of the Emory Eye Center in Atlanta, GA. In 2018, he reported that six patients who had been taking Elmiron for about 15 years had developed unusual changes in their macula, the central part of the retina responsible for delivering clear, crisp, central vision. Because nothing in the patients’ medical history or diagnostic tests explained the subtle, but striking pattern of abnormalities, Dr. Jain and his colleagues raised a warning flag that long-term use of Elmiron may damage the retina

Health Canada announced in October 2019 that that pigmentary maculopathy would be added to the warnings and precautions on the drug label. However, the FDA did not add this change to the label.

Multiple lawsuits

Plaintiff demographics involve mostly women between the ages of 37 to 79 years. Common presenting symptoms include blurred vision, prolonged dark adaptation, and metamorphopsia (which is a type of distorted vision in which a grid of straight lines appears wavy and parts of the grid may appear blank).

Levy Konigsberg LLP and Napoli Shkolnik PLLC filed a product liability lawsuit against the manufacturers for failing to warn plaintiff Valerie Hull of the serious eye and vision injuries. Plaintiff Valerie Hull, a South Carolina resident, was documented as “patient zero” in the 2018 study by Emory Eye Center. The complaint, case No. MID-L-003646-20, was filed on June 9, 2020, in the Superior Court of New Jersey, Middlesex County, naming Janssen Pharmaceuticals and Teva Branded Pharmaceutical Products R&D as defendants.

Johnson // Becker, PLLC filed Pelczar v. Teva Branded Pharmaceuticals R&D, et al. was filed in the United States District Court for the District of Connecticut on March 26, 2020. Defendants include Teva Branded Pharmaceuticals and Janssen Pharmaceuticals.

The firm also filed the case Allen v. Janssen Pharmaceuticals, Inc. et al. in the US District Court for the Eastern District of Pennsylvania on May 6, 2020. It seeks class certification to establish a fund to be used for medical monitoring of patients using Elmiron to monitor the status of their vision.

Plaintiff Tina Pisco filed an Elmiron lawsuit on May 4, 2020, against Janssen and Johnson & Johnson, charging the medication caused her to develop maculopathy. Pisco started taking Elmiron in 2012 to treat interstitial cystitis. In 2018 she noticed that her vision was rapidly deteriorating. By March 2019, she was diagnosed with permanent retinal injury in both eyes, according to her lawsuit.

Pisco claims that the “dangerously defective prescription drug” was “designed, marketed, and distributed . . . while knowing significant risks that were never disclosed to the medical and healthcare community.” Pisco alleges that Janssen “withheld material adverse events” and “failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy.”

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9th Circuit Kicks Dicamba Weed Killer Off the Market

Three kinds of Dicamba weed killer, embroiled in litigation for drifting to neighboring farms and killing crops, have been kicked off the market. The 9th US Circuit Court of Appeal revoked the Environmental Protection Agency’s (EPA) approval of the herbicides made by Bayer AG and its German rival BASF.

“American farmers have been using Dicamba, a chemical herbicide, to combat weeds for more than 50 years. Dicamba is an effective weed killer, but its toxicity is not limited to weeds. It can kill many desirable broadleaf plants, bushes, and trees. It also has a well-known drawback. Dicamba is volatile, moving easily off a field onto which it has been sprayed,” the court said.

The ruling cost Bayer $34 million in lost earnings.

BASF has filed an emergency motion to intervene in the decision blocking the sale of three Dicamba-based herbicides, including BASF’s Engenia herbicide. The June 3 ruling also bans herbicides XtendiMax and FeXapan.

BASF said, “The Ninth Circuit’s decision has caused immediate chaos among the agricultural community and threatens the livelihood of countless US farmers.” Ironically, US farmers are the plaintiffs against BASF.

Bayer settles

Instead, Bayer announced a mass tort settlement of the dicamba drift litigation on June 24, 2020. Bayer will pay up to $400 million to resolve the litigation in MDL 2820 pending before US District Judge Stephen N. Limbaugh, Jr., in the US District Court for the Eastern District of Missouri and claims for the 2015-2020 crop years.

Bayer said it expects a contribution from its co-defendant, BASF, towards this settlement.

Bayer did not include the Bader Farms verdict in its settlement. In the first bellwether trial, the jury awarded $15 million in compensatory damages on February 14, 2020, to Missouri peach farmer, Bill Bader and his family-owned Bader Farms. The following day, they added another $250 million in punitive damages against Bayer and BASF.

A three-judge panel of the 9th Circuit ruled that the US Environmental Protection Agency (EPA) substantially understated the risks related to the use of Dicamba, a chemical in herbicides used on genetically engineered soybeans and cotton. The herbicides are known to drift away and damage other crops that are not resistant.

Environmental groups – including the National Family Farm Coalition, Center for Food Safety, Center for Biological Diversity and Pesticide Action Network North America — have long sought cancellation of the EPA’s approval of Bayer’s Dicamba herbicide and BASF’s Engenia and Corteva.

EPA follow-up action

The EPA issued a cancellation order that says growers and commercial applicators may use existing stocks of Dicamba that were in their possession on June 3, 2020, the effective date of the 9th Circuit decision. This use may not continue after July 31, 2020.

EPA Administrator Andrew Wheeler said, “the cancellation and existing stocks order is consistent with EPA’s standard practice following registration invalidation and is designed to advance compliance, ensure regulatory certainty, and to prevent the misuse of existing stocks.”

The 9th Circuit ruling concerned the agency’s 2018 registration decision to approve Dicamba. Bayer had been seeking a new EPA registration for the herbicide for 2021 and beyond.

Arkansas farmer Reed Storey told Reuters he was encouraged by the ruling after his soybeans suffered damage from Dicamba sprayed on neighboring fields from 2016 to 2018.

“It’s a move in the right direction in getting the in-crop use of it stopped,” he said.

Some farmers and seed dealers said the ruling could drive a shift away from Bayer’s dicamba-resistant Xtend soybean seeds to Enlist E3 soybeans sold by Corteva.

Xtend soybeans account for more than half of US soy plantings. Farmers turned to the product to protect themselves from Dicamba sprayed by neighbors and after some weeds developed resistance to glyphosate.

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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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