Judge dismisses J&J request to toss out lawsuit over opioids crisis

Pharmaceutical giant Johnson & Johnson has a legal case to answer over accusations that it drove the US opioid epidemic now claiming 130 lives a day, an Oklahoma judge has ruled.

After a fiery hearing on Monday, with accusations of lying, Judge Thad Balkmandismissed a motion by the company to toss out a multi-billion dollar lawsuit by Oklahoma’s attorney general. He said the state has presented sufficient evidence for the trial to continue.

The state has spent the past month laying out evidence alleging that Johnson & Johnson played a leading role in creating the epidemic with marketing strategies that dangerously misrepresented the risk of opioid addiction to doctors, manipulated medical research and drove prescribing of high strength narcotics to patients who didn’t need them.

The Oklahoma ruling will bolster hundreds of other lawsuits in the pipeline against leading opioid makers, drug distributors and pharmacy chains by counties, cities and states across the US blighted by an epidemic estimated to have claimed more than 400,000 lives over the past two decades.

On Monday, Johnson & Johnson argued that Oklahoma’s attempt to sue it under a public nuisance statute was wrong because the law was intended to address problems such as property disputes. The company’s lawyer, Stephen Brody, argued that if the state were to prevail then public nuisance laws could be used to make McDonald’s pay for the obesity crisis, gun manufacturers for shootings, and the oil industry for climate change.

Brody also said Johnson & Johnson’s promotion of opioids was protected by the First Amendment and the supreme court’s landmark Citizens United ruling, which prevents the government from restricting corporate spending on political advertising.

Brody added that the state failed to prove that Johnson & Johnson’s opioid subsidiary, Janssen, played any role in causing the epidemic because its drugs were only a fraction of the market.

The state’s lawyer, Brad Beckworth, was visibly angry as he repeatedly accused the company of lying.

“That may be the most recalcitrant, strident and offensive argument I’ve ever heard. And that’s saying something because me and my firm have prosecuted the tobacco industry to the tune of $17.2bn. We represented the state of Florida against British Petroleum for the worst environmental disaster this country has ever known to the tune of $3bn,” Beckworth told the court. “I have never seen conduct as reprehensible and as offensive as I have seen at the hands of Johnson & Johnson.”

Beckworth derided the free speech argument.

“No man or woman has ever laid down their life for this country so that a pharmaceutical company could come out and lie or hook kids on opioids,” he said.

He challenged Johnson & Johnson’s claim it was selling its drugs within the guidelines set by the federal regulator, the US Food and Drug Administration. The FDA, he said, had sent it an order to desist from marketing one of its opioid for all types of chronic pain when it had only been approved for a much smaller group of patients.

Beckworth went on to say “this company is perpetuating the opioid crisis as we sit here today”.

Johnson & Johnson challenged accusations that its marketing helped cause the opioid epidemic by saying that while ice cream sales and crime went up in the summer “that does not mean that ice cream causes homicides”. Beckworth said he was astonished by the parallel, calling it “offensive”.

“This company has literally compared the opioid epidemic to ice cream sales,” he said.

Beckworth said Johnson & Johnson’s attempt to dismiss the case was mostly a PR stunt because the company’s share price dropped sharply after the state laid out damning evidence about the part it played in league with other opioid makers to drive up prescribing of their drugs with an intense campaign targeting doctors with false claims about their safety and effectiveness.

“It’s a PR stunt. That’s all it is,” he said. “It was fear these TV cameras were going to show the public the truth about Johnson & Johnson.”

Brody responded by saying he was caught off guard by the intensity of Beckworth’s presentation.

“I’m somewhat surprised by the invective,” he said.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Judge-dismisses-Johnson-Johnson-s-request-to-toss-out-lawsuit-over-opioids-cri-28867929/

J&J Darzalex shows treatment effect in mid-stage study in certain myelomas

Genmab A/S (OTCPK:GNMSF -2.3%) announces that a Phase 2 clinical trial, GRIFFIN, evaluating licensee Johnson & Johnson (JNJ +0.3%) unit Janssen Biotech’s Darzalex (daratumumab), combined with Celgene’s Revlimid (lenalidomide), Takeda’s Velcade (bortezomib) and dexamethasone (VRd), in newly diagnosed multiple myeloma patients eligible for high-dose chemo and autologous stem cell transplantation met the primary endpoint.

Patients receiving Darzalex + VRd showed a 42.4% rate of stringent complete responses compared to 32.0% for VRd alone.

No new safety signals were reported.

Darzalex is currently approved in the U.S. for multiple myeloma patients ineligible for autologous stem cell transplantation.

https://seekingalpha.com/news/3476311-j-and-js-darzalex-shows-treatment-effect-mid-stage-study-certain-mm-patients

Juror urges U.S. judge to uphold $80 million Roundup verdict against Bayer

A juror who was part of a panel that delivered an $80 million award against Bayer AG (BAYGn.DE) after finding that its glyphosate-based weed killer Roundup caused a man’s cancer has urged the presiding judge to uphold the decision.

A letter from the juror written on July 4 was posted to the court docket on Monday as part of legal filings by Bayer. The company accused the juror of bias and called on the judge to disregard the letter in his decision making.

In the letter, the unidentified juror told U.S. District Judge Vince Chhabria in San Francisco that the $80 million in awards “were no accident” and the result of “meticulous planning” by the jury.

The letter was a response to statements by Chhabria during a court hearing last week, when the judge said he would have to reduce the $75 million punitive damages portion of the award on constitutional grounds.

Following a four-week trial, a federal jury on March 27 awarded $5 million in compensatory and $75 million in punitive damages to Edwin Hardeman, who was diagnosed with non-Hodgkin’s lymphoma in 2014.

U.S. Supreme Court rulings limit the ratio of punitive to compensatory damages to 9 to 1, which in this case would put the maximum for punitive damages at $45 million.

In the letter, the juror said higher damages ratios were allowed in extraordinary cases, echoing arguments Hardeman’s lawyers made during Tuesday’s hearing, when they urged Chhabria to affirm the total award.

“Based on the evidence provided, ‘reprehensible’ is much too kind a word to describe the actions of the Monsanto employees,” the juror wrote.

Bayer, which bought Roundup maker Monsanto for $63 billion last year, says Roundup and its active ingredient glyphosate are safe for human use and not carcinogenic. It faces Roundup cancer lawsuits by more than 13,400 plaintiffs.

The company in filings on Monday only identified the writer as “juror #5.”

A lawyer for the company said he had observed the juror attending Tuesday’s hearing, talking to Hardeman’s lawyers and hugging Hardeman and his wife. Bayer said the juror had also displayed bias against the company during jury selection.

Last week’s letter marks the second time jurors in the Roundup litigation called on judges to uphold their verdicts.

In October, several jurors who delivered a $289 million verdict against Monsanto, finding Roundup caused a man’s terminal cancer, wrote to the San Francisco trial court judge, asking her to “respect and honor the verdict.”

The judge ultimately upheld the jury’s finding but reduced the award to $78 million. The case is on appeal.

Legal experts at the time said the letters were unusual, as jurors generally do not engage with post-trial proceedings following a verdict.

Bayer on Monday said the letters deprived it of fair trials.

“The fact that jurors from both trials wrote letters in support of constitutionally impermissible verdicts is highly unusual, and generates further anti-Monsanto bias in the Bay Area that will infect future Roundup trials,” the company said.

https://www.reuters.com/article/us-bayer-glyphosate-lawsuit/juror-urges-u-s-judge-to-uphold-80-million-roundup-verdict-against-bayer-idUSKCN1U3263

LightStrike Robot Destroys Deadly Superbug Candida auris in Study

Candida auris (C.auris) is an emerging, often multi-drug resistant, fungus that causes serious and often deadly infections in healthcare settings. The Centers for Disease Control & Prevention (CDC) recently issued a warning about C.auris, terming it a “serious global health threat.”

Nearly 700 C.auris cases have been reported in the U.S. thus far, but hospitals overseas have been battling the deadly pathogen for quite some time. The Netcare Hospital Group, which operates the largest private hospital network in South Africa, was the first and is the only hospital group in South Africa to utilize Xenex high intensity, broad spectrum mobile disinfection robots that have been proven effective against viruses and bacteria that can threaten patient safety. Dr. Caroline Maslo is Senior Clinical Advisor and Head of Infection Control for Netcare’s Hospital Division, and the lead author of a new peer-reviewed study “The efficacy of pulsed-xenon ultraviolet light technology on Candida auris” that validates the efficacy of LightStrike™ pulsed xenon ultraviolet (UV) disinfection technology in destroying C.auris.

In the BMC Infectious Diseases study, researchers reported a 99.6% reduction in C.auris after a 10-minute treatment with pulsed xenon UV disinfection, stating, “The PX-UV mobile device is easy to use and has significantly shorter cycle times that makes it easier to disinfect all areas outside the room where the patient received care, as recommended by the CDC.”

Dr. Mark Stibich, co-founder and Chief Scientific Officer of Xenex, said, “As an evidence based company, seeing this research documenting the efficacy of pulsed xenon UV disinfection technology against C.auris is very exciting. We began hearing reports of C.auris some time ago and began testing in government laboratories to create protocols for how our technology should be utilized to combat it. This data from Dr. Maslo’s group further validates our best practices. Adding LightStrike robot disinfection to your hospital’s infection prevention bundle can help combat the spread of C.auris in the hospital environment, and our team is prepared to help healthcare facilities integrate the technology into their infection prevention strategy.”

Xenex LightStrike robots quickly destroy bacteria, viruses, mold, fungus and spores on hospital surfaces. The portable disinfection robots are effective against the most common as well as the most dangerous pathogens, including Clostridium difficile (C.diff), norovirus, influenza, Ebola, carbapenem-resistant Enterobacteriaceae (CRE), Vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). Trained hospital cleaning teams operate the robot, which is brought in after the patient has left the room as part of a hospital’s comprehensive infection prevention strategy. The intense pulsed xenon UV light quickly destroys invisible pathogens lurking on surfaces (bedrails, tray tables, door knobs, wheelchairs, etc.).

More than 400 healthcare facilities worldwide are using LightStrike Germ-Zapping Robots™ daily to disinfect rooms against a full spectrum of agents, including C.auris. Several hospitals in the northeastern U.S. utilized their Xenex robots after treating C.auris patients, and no additional infections were reported. The robots can be used in any department and in any unit within a healthcare facility, including isolation rooms, operating rooms, general patient care rooms, contact precaution areas, emergency rooms, bathrooms and public spaces.

LightStrike robots have been studied extensively in the hospital environment and credited in numerous peer-reviewed, published studies with helping hospitals decrease their C.diff, MRSA and Surgical Site Infection (SSI) rates from 46% – 100%.

Netcare purchased and implemented LightStrike devices in hospitals across South Africa from Kiara Healthcare, Xenex’s authorized reseller in Africa.

Xenex’s patented Full Spectrum^TM pulsed xenon UV room disinfection system is used for the advanced disinfection of healthcare facilities. Due to its speed and ease of use, the Xenex system has proven to integrate smoothly into hospital cleaning operations. Xenex’s mission is to save lives and reduce suffering by destroying the deadly microorganisms that cause healthcare associated infections (HAIs). The company is backed by well-known investors that include EW Healthcare Partners, Piper Jaffray Merchant Services, Malin Corporation, Battery Ventures, Tectonic Ventures, Targeted Technology Fund II and RK Ventures. For more information, visit Xenex.com.

https://www.biospace.com/article/releases/lightstrike-robot-proven-effective-at-destroying-deadly-superbug-candida-auris-in-new-published-study/

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Trump Plans ‘Favored Nations Clause’ to Tie Drug Prices to Cost Other Nations Pay

In his latest move to drive down the costs of prescription drugs in the United States, President Donald Trump is planning to issue an executive order that will tie the costs of prescription drugs paid for by the federal government to the lowest price paid in other countries.

On Friday, Trump announced a “favored nations clause” which will instruct government agencies buying prescription drugs to only pay the lowest price paid for by foreign countries. “As you know, for years and years, other nations paid less for drugs than we do, sometimes by 60, 70%,” Trump told reporters on Friday, according to a video posted by CNBC.

Last fall, Trump initially announced a price-negotiation plan for Medicare-supported infused and injected drugs that the administration claimed could save $17 billion over five years. Part of that plan also included a “benchmark” for Medicare costs against the pricing of drugs in 16 other nations as part of an international pricing index. Trump made drug pricing a central point of his 2016 presidential campaign, which included the infamous claim that pharmaceutical companies are “getting away with murder” when it comes to the prices the companies charge for medication.

In his latest comments concerning pricing, Trump queried why other nations should pay less than the United States, a criticism long aimed at the pricing of prescription drugs. The U.S. is the top market for drugmakers, in part due to the lack of pricing controls. The U.S. pays more per capita for prescription drugs than any other country in the world. Trump said the new pricing policy will be dictated through an executive order. In his remarks though, he did not specify when that order would be issued, only said that his administration was currently working on it. From the president’s remarks, it is unclear what the total breadth of the executive order would be when it comes to pricing. The Wall Street Journal speculated that the executive order would only cover some drugs, possibly the more expensive ones that treat rare diseases.

The latest action for pricing is only part of a series of programs implemented by the White House aimed at lowering drug costs. Other policies put in place include the requirement that prescription drugs advertised on television must include the list price, which is the price negotiated between manufacturers and pharmacy benefits managers. The list price is typically not the price paid by consumers at their retail pharmacy. The inclusion of list prices on television advertisements is part of the White House’s blueprint for lowering healthcare costs, called American Patients First. The White House plan includes four primary strategies to bring down costs — boosting competition, enhancing negotiation, creating incentives for lower list prices and bringing down out-of-pocket costs. Requiring the inclusion of the list price is seen by the White House as a means of making drug prices more transparent and as a way of giving patients some leverage with their prescribers over medication they may require.

Last month, Trump issued an executive order that requires insurers, doctors, hospitals and others in the healthcare industry to provide information about the negotiated and often discounted cost of care. At the time the order was signed, the administration said the goal of the executive order is to arm patients with pricing data so they will have the necessary information to provide them with greater control over health care costs.

https://www.biospace.com/article/trump-plans-new-favored-nations-clause-to-tie-drug-prices-to-the-costs-other-nations-pay/

ChromaDex Shares Nicotinamide Riboside Study Results

ChromaDex Corp CDXC 0.57% announced the results of its latest clinical study were published in the journal Scientific Reports. The study further validates the safety and efficacy of ChromaDex’s proprietary form of NR, Niagen.

Niagen is the patented and only known FDA safety-notified form of a naturally occurring vitamin B3 known as nicotinamide riboside. ChromaDex says its Niagen is the only commercially available nicotinamide riboside which has twice been reviewed under FDA’s new dietary ingredient notification program.

“The results of this large human trial directly support the efficacy and safety of our NAD-boosting consumer product Tru Niagen,” said ChromaDex CEO Rob Fried in a statement. “The study also provides key data points for regulatory submissions as we continue our global expansion.”

https://www.benzinga.com/general/biotech/19/07/14038795/chromadex-shares-nicotinamide-riboside-study-results

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