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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