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The race to develop a Covid-19 vaccine comes at an awkward time for Johnson & Johnson

  • Public trust is critical for the success of any COVID vaccine
  • Johnson & Johnson faces 93,000 product liability claims
  • State governments accuse J&J of misleading the public and doctors in opioid litigation

The pharmaceutical giant recently acknowledged the importance of public trust in any future vaccine approved by the FDA to bring an end to the coronavirus pandemic.

“Johnson & Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles,” the company wrote in a Sept. 23, 2020, statement on the website.

Just days before the post, the company’s reputation suffered a body blow.

The state of New York on Sept. 17 filed insurance fraud charges against J&J for its role in the national opioid crisis which is killing 128 Americans a day. New York and other states contend J&J, to increase profits, misled the public and doctors about the dangers of the drugs, resulting in an epidemic of addiction and death. Just weeks later, J&J agreed to a massive $5 billion settlement with a group of lawyers representing local governments.

The opioid settlement is just the latest in a series of headlines in recent years eroding public faith in a company long marketed as the one you could trust. The company’s reputation in the global pharmaceutical industry “plummeted” to “nearly rock bottom” in the 2019 annual Reputational Case Studies released last October by Alva, according to PR Week. JNJ’s ranking dropped over five years from 9th place to 57th out of 58 companies, PR Week reported.

Reinforcing the Alva survey, Interbrand’s Best Global Brands concluded that JNJ lost half a billion dollars in brand value in 2019 over the previous year, according to according to a Sept. 29 editorial in Nature, the research journal.

To build public confidence in any vaccine produced through President Trump’s “warp speed” initiative, JNJ and 8 other pharmaceutical companies on September 8 signed a pledge to not submit vaccine candidates for FDA review until their safety and effectiveness has been demonstrated in large clinical trials.

However, none of the other 8 companies bring to the table JNJ’s product liability baggage of 93,000 consumer lawsuits, some ugly testimony and evidence on public display, and damning judgments from juries of ordinary Americans, upheld by experienced judges.

Here’s the story of JNJ’s operations emerging from inside the courtroom:

A "public nuisance" in Oklahoma

A judge in Oklahoma found Johnson & Johnson guilty as charged with creating a public nuisance.

District Judge Thad Balkman in Norman in 2019 ordered J&J to pay Oklahoma $465 million to cover one year’s worth of state expenses to clean up damages caused by the opioid epidemic.

The issue was what Balkman called J&J's “false, misleading and dangerous marketing campaigns” which “caused exponentially increased rates of addiction, overdose deaths” and babies exposed to opiates in the womb.

J&J had been the No. 1 provider in the U.S. of the active narcotic ingredient used to make opioid pills, the judge reported.

As for the company’s dealings with federal regulators, the judge found that JNJ was repeatedly warned over several years about its false and misleading marketing opioid campaign by both the U.S. Food and Drug Administration and the company’s own hired scientific advisory board.

The Oklahoma nonjury trial was the first to go to trial of more than 2,000 pending across the country against JNJ and other opioid drug makers.

Evil motive or reckless indifference in Missouri

A judge in Missouri found “substantial evidence” of “particularly reprehensible conduct” by JNJ involving its iconic baby powder.

An appellate court let stand a $2.1 billion award to 22 women who claim the talcum powder was tainted with asbestos and caused their ovarian cancer. Nearly 18,000 more talcum powder customers with ovarian or lung cancer are waiting in the wings for their turn in the courtroom.

Judge Rex Burlison in St. Louis wrote that JNJ “knew of the presence of asbestos in products that they knowingly targeted for sale to mothers and babies, knew of the damage their products caused, and misrepresented the safety of these products for decades,” according to the New York Times.

In upholding the verdict and award, an appellate court wrote that the women “showed clear and convincing evidence defendants engaged in conduct that was outrageous because of evil motive or reckless indifference,” according to the Times.

According to the court, J&J “discussed the presence of asbestos in their talc in internal memoranda for several decades; avoided adopting more accurate measures for detecting asbestos and influenced the industry to do the same; attempted to discredit those scientists publishing studies unfavorable to their products; and did not eliminate talc from the products and use cornstarch instead because it would be more costly to do so."

“There was significant reprehensibility in defendants’ conduct,” the court wrote.

Boys with female breasts in Pennsylvania

Johnson and Johnson, in the eyes of the U.S. Justice Department, falls into the category of companies that “put profits ahead of the public’s health.”

The quote from a DOJ press release in 2013 came as J&J agreed to what was then one of the largest healthcare fraud settlements in U.S. history. The charges involved illegal marketing of drugs and paying kickbacks to doctors and pharmacists.

The company’s anti-psychotic drug Risperdal figured prominently in the federal case. To achieve profit goals, J&J aggressively marketed to young boys a drug approved by the FDA only for adults. The company did so despite the FDA rejecting J&J’s requests for permission to market the drug to boys because it hadn’t been proven safe or effective for them.

A side effect of Risperdal, which the company failed to adequately warn about, was that it could cause pre-pubescent boys to grow large feminine breasts.

A jury in 2019 awarded one victim $8 billion in punitive damages from JNJ. Although the dollar amount was reduced by the court to $6.8 million, the verdict expressed the jury’s outrage at the company’s behavior.

Another big blow to the company occurred Sept. 1 when the Supreme Court in Pennsylvania, where thousands of Risperdal cases are awaiting trial, refused to hear JNJ’s appeal of a $70 million losing Risperdal verdict from 2016.

A lower court had found that the seven-figure award was not excessive compensation for the psychological and emotional damage to the boy who was prescribed Risperdal at age 4. The court noted that the boy never knew life without gynecomastia, or large breasts, and spent his childhood being teased and bullied by other children.

Lawyers for the victim plan to return to court to seek additional punitive damages against JNJ.

J&J reports more than 13,000 Risperdal claims.


Mounting Verdicts Put Pressure on J&J’s Financial Position

  • Damning verdicts dent confidence in Johnson and Johnson
  • Analysts wary of billions in losses from consumer lawsuits
  • J&J Reports more than 90,000 unresolved product liability claims

Billion-dollar verdicts and scathing judicial rulings are taking a very public toll on pharmaceutical giant Johnson and Johnson. Notable financial writers have been raising alarms about JNJ as the company has been taking a beating in courts around the country over serious injuries claimed by consumers from the company’s baby powder, opioid sales, Risperdal and other prescription drugs and products.

“Will Legal Problems Bankrupt Johnson & Johnson?” a recent Motley Fool headline asked on July 2, 2020. “There's a real risk that as these fines pile up, they could end up bankrupting the company,” TMF writer David Jagielski warned in the article.

“Is JNJ Stock A Buy?” an Investor.com headline asked on July 24, 2020. “No, JNJ stock is not a buy right now,” writer Allison Gatlin answered.

“If you aren’t already long JNJ stock, you may want to remain on the sidelines and wait for the shares to drop,” wrote Tezcan Gecgil, contributor to InvestorPlace, on January 10, 2020.

Negative headlines about losing jury verdicts are having a “snowball effect,” Alastair Pickering, co-founder of Alva, a company which studies corporate reputations, told Beth Snyder Bulick for an article in October 2019 in FiercePharma.

“These are no longer things that can be seen as isolated one-off incidents and are now a pattern with a series now in close proximity to one another,” Pickering said.

FiercePharma, that same month, reported that investors already had factored in $50 billion in potential legal liability, leaving share prices at an historic low.

Despite legal difficulties, Johnson & Johnson is one of only two US companies, along with Microsoft, to maintain a top AAA credit rating with Moody’s Investor Service. On August 20, 2020, JNJ leveraged its high rating to borrow $7.5 billion, with most of the money going to buy out Momenta Pharmaceuticals of Cambridge, Massachusetts and gain a foothold into new treatments for autoimmune diseases.

Moody’s gave the debt financing a triple A rating but with a “negative outlook,” according to Joy Wiltermuth at Marketwatch. The negative outlook was due to “risks tied to ‘unresolved litigation involving opioids and talc,’ that could constrain free cash flow ‘over multiple years,’” Marketwatch reported.

The negative outlook also reflects “reduced capacity at the current rating level for additional acquisitions beyond Momenta while litigation remains unresolved,” according to Yahoo News.

In recent years, Johnson and Johnson has been working its way through more than 100,000 consumer lawsuits.

According to Forbes magazine, JNJ’s litigation expenses have been rising for several years, from $141 million in 2015 to around $2.0 billion in 2018, an average growth rate of 197%.

A recent decision in one of the talcum powder lawsuits raised speculation about how badly the litigation might hurt the company.

In June 2020, a Missouri judge let stand a reduced $2.1 billion verdict against J&J for 22 women who claimed the company’s talc powders were tainted with asbestos and caused their ovarian cancer. In a blistering opinion, an appellate court wrote that, "viewing the evidence in the light most favorable to the verdict, we find plaintiffs proved with convincing clarity that defendants engaged in outrageous conduct because of an evil motive or reckless indifference."

David Jagielski in The Motley Fool wrote that JNJ, with 2019 profits of $15 billion, can survive a $2.1 billion verdict.

“But that can change in a hurry, especially if the courts aren't convinced that J&J has been doing a good job of protecting its customers, as the recent Missouri ruling suggests. And there are many more cases that are likely to come forward, with more than 19,000 current lawsuits related to its talc products and their role in causing cancer,” Jagielski wrote.

“There's no formula or multiple that can help predict how much J&J will have to pay out over the years due to the lawsuits it's facing,” Jagielski wrote. “But one thing's for sure: The more lawsuits the company faces, the more likely its financials will take a big hit sooner or later.”

In November of 2019, a Philadelphia jury slammed J&J with a massive $8 billion punitive damages award in the ongoing Risperdal litigation. A judge later reduced that award to $6.8 million, which is ten times the $680,000 compensatory award granted to the plaintiff in an earlier trial. On September 1, 2020, however, the Supreme Court of Pennsylvania shot down J&J’s last appeal to vacate a much larger $76 million compensatory verdict, setting the stage for a new trial on punitive damages. The case is just one of more than 13,000 Risperdal claims J&J reported in it’s 2020 10-K filing.


Johnson & Johnson Accused of “targeting Black and Brown communities with toxic products”

  • National Women's Health Network says “J&J must address its own racist practices”
  • Internal marketing documents show J&J targeted, “curvy Southern women 18-49 skewing African American”
  • 170 nonprofit groups from 51 countries call for the end of talc sales world-wide

Advocates for black women’s health are calling out Johnson & Johnson for failing to “walk the talk” when it comes to the company’s professed stand for racial justice. At issue is Johnson & Johnson’s decision to withdraw Johnson’s Baby Powder from North American markets while continuing to sell the talcum powder in third-world countries.

J&J’s decision in May to pull its talcum powder out of the U.S. and Canadian markets followed a $4.7 billion jury verdict in Missouri against the company over claims that its talcum powder causes ovarian cancer. The company said it would continue to sell the talcum powder in other parts of the world.

Black Women for Wellness, a health advocacy group, called the decision to continue international sales an assault on black and brown women in Africa, Asia and Latin America. They referenced a statement supporting racial equality issued by Johnson & Johnson CEO Alex Gorsky in June at the height of the U.S. Black Lives Matter protests.

“If ‘racism in any form is unacceptable’ and ‘Black lives matter,’ as its CEO Alex Gorsky states, then J&J must address its own racist practices,” M. Isabelle Chaudry, Esq, senior policy manager, National Women's Health Network, said in the Black Women for Wellness press release.

More than 170 nonprofit groups from 51 countries in July joined Black Women for Wellness in calling for Johnson & Johnson to stop selling its talc-based powder world-wide.

“Now is the time for Johnson & Johnson to demonstrate its commitment to health equity beyond public statements. This means stopping the targeting Black and Brown communities with toxic products,” Monica Unseld, Ph. D, MPH, founder of Data for Justice, said in the press release.

Anger over J&J’s plans was further stoked by reports in national media that the company earlier had targeted its baby powder marketing to black and brown communities in the U.S. and overweight women in the South after overall sales began to drop off.

“The ‘right place’ to focus, according to a 2006 internal J&J marketing presentation, was ‘under developed geographical areas with hot weather, and higher AA population,’ the ‘AA’ referring to African-Americans,” according to a report by Reuters.

To implement the strategy, the company gave away samples of baby powder “through churches and beauty salons in African-American and Hispanic neighborhoods, ran digital and print promotions with weight-loss and wellness company Weight Watchers and launched a $300,000 radio advertising campaign in a half-dozen markets aiming to reach ‘curvy Southern women 18-49 skewing African American,’” according to the Reuters investigation.

In a statement issued to Reuters, the company said, “Suggesting that Johnson & Johnson targeted a particular group with a potentially harmful product is incredibly offensive and patently false.”

But Janette Robinson Flint, Executive Director of Black Women for Wellness disagrees:

Africa plays a big role in J&J’s future growth plans. In 2016, the company announced the launch of a new global public health strategy and the opening of operations in Cape Town, South Africa. J&J’s operations on the continent were the subject of protests even before the recent talc controversy.

Doctors Without Borders began staging protests against J&J in October 2019 over what it considered overcharging for Bedaquiline, a game-changer treatment for people with drug-resistant tuberculosis. The medical organization, which calls itself the largest nongovernmental provider of TB treatment worldwide, reported that J&J priced Bedaquiline beyond the ability of most patients in poorer countries to pay. Although the drug came on the market in 2012, only a small fraction of the people who needed the drug were able to get it.

“Bedaquiline was developed with considerable taxpayer, non-profit and philanthropic support. Much of the critical work to inform the use of the drug and demonstrate its therapeutic value was conducted by the TB research community, health ministries, and treatment providers including MSF, and was financed by taxpayers and other donors,” according to an article posted Jan. 20, 2020 on the website of doctorswithoutborders.org.

The doctors staged months of public protests in front of Johnson & Johnson offices around the world, at the J&J shareholders meeting and at the New York Stock Exchange. Finally in July, with the Covid pandemic in full swing, the company dropped the price.

Resources referenced in this article:

Johnson & Johnson Consumer Health Announces Discontinuation of Talc-based Johnson’s Baby Powder in U.S. and Canada

Johnson & Johnson to End Talc-Based Baby Powder Sales in North America

Johnson & Johnson Press Release, July 6th 2020

A Message from Johnson & Johnson Chairman and CEO Alex Gorsky About Recent Events in the United States

Nonprofits urge Johnson & Johnson to halt sales of Baby Powder globally

Pressure mounts on Johnson & Johnson to halt global talc sales

Special Report: As Baby Powder concerns mounted, J&J focused marketing on minority, overweight women

Johnson & Johnson Announces Launch of New Global Public Health Strategy at Opening of New Operations in Africa


"Evil Motive": What Judges Write About Johnson & Johnson

  • Juries have issued multi-billion dollar punitive damage awards
  • Scathing rebukes from judges reinforce the need for substantial punitive deterrents
  • Series of judicial rulings illustrate a broken corporate culture that elevates profits above people 

After a Missouri jury in 2018 slammed Johnson & Johnson with a $4.7 billion verdict in a case over tainted baby powder, the company appealed. It would be hard to imagine a worse outcome for the company’s reputation than the appellate court decision.

“Viewing the evidence in the light most favorable to the verdict, we find Plaintiffs proved with convincing clarity that Defendants engaged in outrageous conduct because of an evil motive or reckless indifference,” Judge Philip Hess wrote in an opinion dated June 23, 2020.

In an 83-page decision filed in the Missouri Court of Appeals, Hess found that Johnson & Johnson, which built a reputation as a trusted friend of mothers and babies, had instead an “evil motive” or “reckless indifference” to its loyal customers.

At least as far back as 1969, Johnson & Johnson knew that its iconic Johnson’s Baby Powder contained cancer-causing asbestos, according to the opinion.

The 22 women who won the verdict claimed their ovarian cancer was caused by regular use of the baby powder or another J&J talcum powder.

To the company, baby powder was its “company trust mark,” “golden egg” and “sacred cow,” according to the opinion.

The opinion cites multiple internal company letters, reports, test results and warnings over five decades about the presence of asbestos in the powder. Yet, J&J fought to hide evidence of asbestos contamination. Among the “outrageous conduct” cited by the judge was the company secretly paying for publication of articles downplaying the risk, pressuring independent agencies to withdraw findings of asbestos in Johnson’s Baby Powder and attempting to discredit scientists who discovered the truth.

“Defendants worked tirelessly to ensure the industry adopted testing protocols not sensitive enough to detect asbestos in every talc sample,” Hess wrote. “…A reasonable inference from all this evidence is that, motivated by profits, Defendants disregarded the safety of consumers despite their knowledge the talc in their Products caused ovarian cancer.”

Wile the appellate court reduced the jury verdict by half, the order justified the final multi-billion dollar judgement by quoting case law that reads: "High-ratio punitive damage awards are sometimes necessary in order to have a sufficient deterrent effect."

The appellate decision followed equally scathing findings by the trial judge Rex Burlison in St. Louis, Missouri, in upholding the jury’s verdict.

Burlison wrote that “substantial evidence was adduced at trial of particularly reprehensible conduct” by Johnson & Johnson, including that the company “knew of the presence of asbestos in products that they knowingly targeted for sale to mothers and babies, knew of the damage their products caused, and misrepresented the safety of these products for decades,” according to the New York Times.

Johnson & Johnson's Declining Reputation

The judicial opinions in the talc case are the latest of several court findings that have blistered Johnson & Johnson’s reputation in recent years for a range of litigation involving other products including opioids, Risperdal, and vaginal mesh. Taken all together, these massive verdicts and scathing judgments allude to a systematic problem within Johnson & Johnson -- a culture that prioritizes making money, even when it means hurting people. 

In a global reputational survey of pharmaceutical companies, Johnson & Johnson dropped from 9th place out of 58 companies in 2014 to 57th out of 58 in 2019, according to PR Week.

"So far, we have seen clear evidence that J&J’s reputation has been negatively affected by the issues it is facing. The key risk beyond the lawsuits and settlement costs is clearly the erosion of the company's brand promise," Alastair Pickering, chief strategy officer at alva, told PR Week.

Johnson & Johnson's Role in the Opioid Crisis

The alva Reputation Case Study followed Johnson & Johnson’s losses in litigation related to company’s role in the the deadly national opioid epidemic.

In a 2019 trial in Norman, Oklahoma, District Judge Thad Balkman found J&J guilty as charged of creating a public nuisance. The trial exposed the company’s role as the No. 1 provider in the U.S. of the active narcotic ingredient used to make opioid pills, according to Balkman’s report.

Balkman found that Johnson & Johnson and other drug companies encouraged doctors to prescribe excessive quantities of opioid drugs.

“Defendants’ opioid marketing, in its multitude of forms, was false, deceptive and misleading,” the judge found, leading to “exponentially increased rates of addiction, overdose deaths” and babies exposed to opiates in the womb.

Risperdal Rulings

In January 2020, Philadelphia Court of Common Pleas Judge Kenneth Powell Jr. defended his rulings following a jury’s decision to award $8 billion to a young Maryland man. Nicholas Murray grew large female breasts as a result of taking Risperdal as a boy. It was a side effect that Johnson & Johnson knew was a problem but went to great lengths to hide.

“The record clearly indicates that Defendants had actual knowledge of Risperdal’s defect,” Powell wrote. “…This evidence is clear and convincing that Defendants acted with conscious or deliberate disregard for the known defects with Risperdal.”

In an earlier Risperdal case, trial judge Paula Patrick wrote that the verdict and a $70 million monetary award against Johnson & Johnson were not excessive based on the evidence and the young man’s injuries.

Vaginal Mesh

In Australia, a judge overseeing a class action lawsuit over injuries caused to women by Johnson & Johson’s vaginal mesh found that the company and its subsidiary Ethicon failed to warn women about the “gravity of the risks” and rushed the mesh to market without adequate testing, according to Reuters.

“The risks were known, not insignificant and on Ethicon’s own admission, serious harm could ensue if they eventuated,” the judge said in her ruling, according to Reuters.

According to alva’s work on reputational surveys, terms such as ‘danger’, ‘harm’, ‘unsafe’, ‘unethical’, and ‘mislead’ have more than doubled in news stories and social media posts regarding Johnson & Johnson since 2016.


 

Government to Fund J&J COVID Vaccine Trials Despite Company's Late Start and Lagging Progress

  • J&J lags behind other drug makers in race for vaccine
  • Nonetheless, government slates more funds for testing J&J's vaccine candidate
  • On the WHO list of top 16 vaccine contenders, J&J didn't make the cut

On the same day that the World Health organization published a draft report which left J&J's COVID-19 vaccine candidate off of list of the top 16 contenders, the Wall Street Journal reported that the U.S. government would be funding and conducting this summer three final-stage Phase III studies of three vaccine candidates with 30,000 participants each. Two of the vaccine candidates to be tested were those from Moderna and AstraZeneca which had completed Phase 1 trials and either started or completed Phase 2. The third vaccine candidate selected was Johnson & Johnson’s which has yet to begin a Phase 1 human trial.

Consider the various company timelines to produce a Covid 19 vaccine:

Moderna

American biotech company Moderna near Boston began working on a vaccine as early as January 2020. Moderna, working with the US National Institute of Allergy and Infectious Diseases (NIAID), began the first Phase I human trial on March 16th with 45 participants to determine the optimal dose of its vaccine candidate, mRNA-1273. The company released the first data from the trial in May.

Moderna began the Phase II trial with 600 participants on June 1, and expects to launch a randomized, placebo-controlled Phase III trial in July with 30,000 participants with the goal of determining whether the vaccine can prevent symptoms of Covid 19.

AstraZeneca

In the U.K., Oxford University teamed up with AstraZeneca in mid-April to begin the Phase 1 human trial of their recombinant adenovirus vaccine candidate, called AZD1222, with 1,000 participants. In mid-May, the AstraZeneca/Oxford partnership began enrolling 10,260 participants for the Phase 2/3 human trial.

Considered a global front-runner in the race to produce a Covid-19 vaccine, AstraZeneca/Oxford’s candidate was the only one to have reached Phase III testing as of June 20, according to the World Health Organization as reported in the Washington Post.

Johnson & Johnson Lags Behind

Johnson & Johnson didn’t announce the selection of a lead vaccine candidate until March 30. J&J issued a press release which stated that it expected to be ready for a Phase 1 trial by September at the latest.

On June 10, with Operation Warp Speed in effect, J&J announced it was accelerating its first human trial of its vaccine candidate, Ad26.COV2-S, recombinant, to late July. The company called it a randomized, double-blind placebo-controlled Phase 1/2a trial with 1,045 adult participants in the U.S. and Belgium. 

A dynamic list of the 5 most promising Covid 19 vaccines, updated by the Cornell Alliance for Science as developments in the lab dictate, includes both Moderna’s and AstraZeneca’s candidates as of June 24. Johnson & Johnson didn’t make the cut. The rest of the Cornell list is made up of two Chinese companies and Inovio from Pennsylvania.

A June 24 report from the World Health Organization (WHO) lists 16 vaccine candidates in clinical trial. Those by University of Oxford/AstraZeneca, Moderna/NIAID and one from China topped the list. Johnson & Johnson fell into a second list of 125 vaccine candidates in pre-clinical stage.

READ MORE: Did J&J CEO Alex Gorsky's Ties to White House Influence COVID-19 Vaccine Funding? 

J&J's Troubled Litigation History

Confidence in Johnson & Johnson has taken a hit in recent years. In more than 100,000 lawsuits against J&J, consumers have alleged that the company cut corners and failed to publicly disclose problems with its products that lead to severe injuries. Billion-dollar jury verdicts against the company in Johnson’s Baby Powder and Risperdal anti-psychotic drug lawsuits are signs that juries are trying to send a message to the company to change its ways.

READ MORE: J&J's Credo Versus A Mountain of Product Liability Lawsuits


 

Celebrity Luster Overlooks J&J Product Liability Problems

  • Celebrities lend their reputations to Johnson & Johnson for cash
  • Arnold Palmer, Jennifer Aniston, Chris Bosh, Lisa Ling, Kevin Nealon, Brian Vickers, Angela Lansbury, and more
  • Fans pay the price

Golf legend Arnold Palmer, in his signature pink sweater, meets celebrity buddies on the golf course in television commercials for Xarelto, Johnson & Johnson’s new generation blood thinner. In ads that aired over a period of two years, the foursome with NBA player Chris Bosh, comedian Kevin Nealon and NASCAR driver Brian Vickers promote treatment with Xarelto as “the right move for us.”

Nearly 30,000 consumers decided Xarelto was not the right move for them. In lawsuits, they claimed the public wasn’t adequately warned that Xarelto could cause uncontrolled and potentially fatal bleeding.

Just one month before his death in 2016 and two years before an antidote to Xarelto was developed, Palmer had to undergo surgery to stop internal bleeding in his colon, according to Golf Digest. If the colon bleeding episode was linked to Xarelto, it doesn’t appear Palmer ever said so publicly. Those watching the Xarelto lawsuits wonder if there was a connection.

The U.S. Food and Drug Administration (FDA) is investigating the use of celebrity endorsements of pharmaceuticals. The agency is examining the influence of celebrities and how consumers would react if the ads disclosed payments to the celebrities.

“Brand-name pharmaceutical companies use celebrity endorsements because they hope such endorsements will cause patients to blindly pressure their doctor to prescribe the companies’ products, regardless of the merits of using those drugs,” Dr. Michael Carome, the director of nonprofit Public Citizen’s Health Research Group, told Drugwatch.

Johnson & Johnson spends more on marketing than other big-name pharmaceutical firms, according to Drugwatch. Although pharmaceutical companies like to blame the high price of prescriptions drugs on the cost research and development, J&J spends more than twice as much money on marketing as on R&D. In 2013, the company spent $8.2 billion on R&D but $17.5 billion on marketing.

Recent celebrities who have endorsed J&J products or lent their reputations to the company include Friends star Jennifer Aniston who began pitching Aveeno over-the-counter skin care products in 2013.

Before the company’s DePuy hip replacements were hit with thousands of consumer lawsuits and removed from the market, J&J hired actress Angela Lansbury and Chicago Cubs Hall of Fame shortstop Ernie Banks to promote the joint replacements.

“Literally this reached millions of people and it was a very educational message — ‘Don’t wait. Go see an orthopedic surgeon,’” Mindy Tinsley, Group Manager, Communications, DePuy Orthopaedics Inc., told Orthopedics Today in 2007.

The latest celebrity to sign on with Johnson & Johnson is journalist Lisa Ling. Ling fronts a series of infomercials on the company website and YouTube channel about the search for a vaccine for Covid-19. The series coincides with a $456 million federal grant received by the company in March for a “new vaccine asset” for Covid 19.

Johnson & Johnson has leveraged family-friendly stars to boost the image as a good corporate citizen. Starting in 1999, J&J created a series of public service-like ads about caring for children featuring actors Ray Romano and Christopher Reeve, author Toni Morrison and singer/composer Randy Newman.

Another corporate feel-good ad series, J&J’s iconic “Having a baby changes everything” campaign, in 2005 began to feature celebrities talking directly into the camera about how children changed their lives. Actor Stephen Collins from The WB’s 7th Heaven, actress Holly Robinson Peete from UPN’s Love Inc. and writer Nicholas Sparks from publisher Warner Books, were seen in three versions of the ad, according to Adweek.

Published reports indicate that celebrities a decade ago were earning from $20,000 to $2 million just to raise awareness about a particular disease, let alone endorse a specific drug or product, although the public typically was unaware of the payment.

Left unsaid in TV commercials are problems that arise with company products: the hip joints that failed and needed to be replaced a second time. Or, the tens of thousands of people a year who died from Xarelto and similar anti-coagulants before an antidote was found, according to a 2019 article in Georgetown Medical Review.

In the case of Xarelto, the J&J drug and other similar new anticoagulants had become “one of the highest priority drug safety problems in 2016 by several measures” and a leading factor in drug-related emergency room visits, according to QuarterWatch.

The Georgetown Medical Review found that “more than 84,000 patients taking (Xarelto and similar drugs) are hospitalized every year in the United States due to major bleeds. After the bleeding begins, the risk of death or disability can be high.” Xarelto was marketed an alternative to warfarin, a widely prescribed 66-year-old anti-coagulant that was thousands of dollars cheaper than Xarelto and could be quickly reversed with a dose of Vitamin K. By comparison, when an antidote for Xarelto was approved by the FDA in 2018, the price for a single dose ranged from $25,000 to $50,000 per patient, according to the medical review.

J&J is a client of the Amy Doner Group which specializes in finding celebrity endorsers for pharmaceutical companies, according to Doner’s website. Emblazoned across the home page is a quote from Variety.com calling Doner "a modern-day matchmaker for pharmaceutical companies.”

According to Forbes magazine, Palmer earned $3.6 million in prize money as a golfer but an estimated $875 million through endorsements, appearances, licensing and golf course design – a little more than Johnson & Johnson agreed to pay in 2019 to settle 25,000 Xarelto lawsuits.

 


 

Fall of Talc Reveals Pattern of Problems at J&J

  • Johnson & Johnson discontinues sales of it's iconic talcum powder in US
  • Company faces thousands of consumer lawsuits over cancer claims
  • J&J faces nearly 100,000 product liability claims

Many American consumers will be shocked to find Johnson’s Baby Powder disappear soon from store shelves. The iconic product in familiar white canisters has been a trusted staple of parents’ baby care arsenal for more than 125 years.

In an announcement May 19, buried beneath the crush of Covid-19 news, Johnson & Johnson said it would discontinue sales of its baby talcum powder in North America as soon as current supplies run out. Mentions of baby powder have been scrubbed from the company’s website.

The decision comes as the company faces thousands of consumer lawsuits alleging the powder caused deadly ovarian and lung cancers and a U.S. Department of Justice criminal investigation into whether and when the company knew or suspected the product was dangerous.

While many consumers will be taken by surprise, people who closely follow business and legal news are wondering whether they are seeing the emergence of a pattern.

J&J in recent years has been the target of more consumer product liability lawsuits than the other top 10 largest pharmaceutical companies combined.

In the course of lawsuits, companies typically are required by the court to make public relevant internal documents. During this process, J&J corporate documents have come to light which reveal apparent knowledge by J&J executives of problems with various products that subsequently injured consumers. Those who have been winning lawsuits against J&J claim that the company failed to adequately warn the public -- or even hid information from the public -- about the potential for harm.

Here’s a look at revelations from lawsuits that may show a pattern:

Johnson’s Baby Powder

About 20,000 consumers have sued J&J, claiming its talcum powder caused one of two very deadly cancers: mesothelioma, an incurable cancer of the lining of the lung believed to be caused almost exclusively by exposure to asbestos, or ovarian cancer which usually isn’t detected until it has spread.

Talc and asbestos are naturally occurring minerals often found in the ground in close proximity to each other.

J&J vehemently denies that its talcum powder was contaminated with asbestos. But internal corporate documents and other evidence emerged in the course of consumer lawsuits that conflict with the company’s public statements.

Reuters news service dug into those documents and court testimony and reported that “from at least 1971 to the early 2000s, the company’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public.”

A jury in St. Louis, Missouri, which heard the evidence in 2018 awarded $4.7 billion to 22 women with ovarian cancer or their survivors.

Judge Rex Burlison upheld the verdict.

“First, substantial evidence was adduced at the trial of particularly reprehensible conduct on the part of defendants, including that defendants knew of the presence of asbestos in products that they knowingly targeted for sale to mothers and babies, knew of the damage their products caused, and misrepresented the safety of these products for decades. Second, defendants’ actions caused significant physical harm and potential physical harm, including causing ovarian cancer in plaintiffs or plaintiffs’ decedents,” Burlison wrote.

“The evidence presented at trial includes the testimony of plaintiffs’ expert witnesses, evidence of the testing of the products at issue, including defendants’ own testing, defendants’ correspondence and the testimony of defendants’ corporate representative and chief medical officer. This evidence satisfies the standards for causation under all applicable state law.”

Following the verdict, the DOJ opened an investigation into whether J&J lied about cancer risks of its baby powder.

And U.S. Sen. Edward Markey called on the U.S. Food & Drug Administration to investigate.

“Johnson & Johnson’s baby powder is an iconic consumer product, used by countless American families…That the company may have concealed a potentially serious health and safety risk associated with the use of its baby powder is deeply troubling,” Markey wrote.

Anti-psychotic Risperdal

More than 13,000 boys and young men have sued Johnson & Johnson for failing to adequately warn the public that Risperdal could cause pre-adolescent boys to grow large and permanent female breasts. The deformity socially and psychologically devastated the boys during childhood and requires major surgery to fix.

As more evidence and company documents have emerged in the course of individual lawsuits, verdicts against J&J have grown dramatically.

Risperdal was approved by the FDA in 1993 for adult schizophrenics. In defiance of the FDA and to increase profits, the company marketed the drug as a treatment for a wide variety of behavioral issues with children.

Evidence has shown that the company knew that Risperdal could cause breast growth in young boys and tried to hide the problem from public view.

The company paid $2.2 billion to the DOJ in 2013 to end a federal criminal investigation into fraudulent marketing of Risperdal.

In a 2015 lawsuit against Johnson & Johnson, a jury awarded $2.5 million to Austin Pledger of Alabama whose breasts grew as a result of Risperdal to size 46DD. His story was featured in People magazine.

In 2016, a jury awarded plaintiff Andrew Yount of Tennessee what was then a record $70 million. Yount’s jury was the first to hear evidence that J&J arranged for an article about Risperdal in a medical journal that omitted the problem of breast growth in boys. When questions were raised about the article, evidence showed the company tried to cover its tracks.

Trial judge Paula Patrick urged the Superior Court of Pennsylvania to uphold the verdict and $70 million monetary award against Johnson & Johnson, finding the jury’s decisions were reasonable based on the evidence and Yount’s injuries.

In the latest verdict against J&J in October 2019, a jury awarded a single Risperdal victim $8 billion in punitive damages. Although the award was reduced by a judge without explanation to $6.8 million, the jury’s outrage at the company’s conduct was clear.

Vaginal Mesh

Johnson & Johnson in 2005 launched and aggressively marketed a plastic mesh vaginal implant that company executives knew could fail and cause internal pain for its female customers, according to the Guardian newspaper and a consortium of European and British investigative journalists.

“Internal emails between executives, shared with the Guardian, show staff at Johnson & Johnson (J&J) were concerned that the plastic material the mesh was made from had the potential to turn ‘hard as a rock’ and roll up like a ‘folded potato chip’ inside patients… In one exchange, staff discussed how ‘shrinkage of the mesh may lead to pain,’” the newspaper reported.

Vaginal mesh was marketed as an alternative treatment to surgery to treat organ prolapse.

Women around the world have complained of severe vaginal pain, inability to have sexual relations, sexual partners who have been injured by protruding bits of hard plastic, and incontinence.

More than 1,000 Australian women in November 2019 won a landmark class action lawsuit against J&J after describing their pain as “so bad she struggles to breathe,” “excruciating,” and like “there was a blade in her vagina,” the Guardian reported.

The court found J&J didn’t warn women about the “gravity of the risks” and rushed the mesh to market without adequate testing, according to Reuters. The court is still deciding how much J&J and its subsidiary Ethicon will pay to the more than 1,350 women who sued.

“The risks were known, not insignificant and on Ethicon’s own admission, serious harm could ensue if they eventuated,” the judge said in her ruling, according to Reuters.

J&J sold vaginal mesh under the brand name Prolift for seven years until thousands of lawsuits and international investigations of vaginal mesh products by several manufacturers led J&J to pull the mesh from the market in 2012.

As of the end of 2019, there were 3,300 mesh lawsuits still pending against J&J, according to the company’s annual report.

Hip Implants

Johnson & Johnson is responsible for what the British Medical Journal called “one of the biggest disasters in orthopaedic history.”

In 2005, the company, through its DePuy orthopedic division, began selling a new metal-on-metal hip replacement system called the ASL-XR. The new hip made of metal balls and metal sockets was promoted as a technological advancement over plastic joints which could wear out over time.

Within a few years, surgeons were finding an unusually high failure rate of the hip replacements and high levels of chromium and cobalt in patients’ blood from metal erosion. Upon surgically re-opening the patient, surgeons found a pus-like fluid and saw that muscle, bone and soft tissue had been destroyed.

Some patients also reported constant pain, disturbed sleep, mood swings, anxiety, hearing loss, vision trouble, and tinnitus, according to Consumer Reports magazine.

Still, the company kept marketing the device.

“DePuy used a range of techniques and arguments to try to assuage fears arising from the evidence,” according to the BMJ. “…(one U.K. surgeon) was even told by a DePuy sales representative that good sources had told them that an illegal chromium ship unloaded its cargo in the river Tees a couple of years earlier and that was the reason for the raised chromium and cobalt levels he was finding in patients’ blood. DePuy declined to comment on this allegation.”

Facing thousands of lawsuits and complaints, DePuy in 2010 recalled the ASL-XR after it had been implanted in almost 100,000 people worldwide. At the same time, the company promoted another prosthetic, the Pinnacle, as a replacement even though it had the same metal-on-metal design, according to Consumer Reports magazine.

In 2016, a federal jury in Texas jury ordered J&J to pay six patients $30 million in actual damages and $1 billion in punitive damages after finding that J&J knew the Pinnacle product was defective and failed to adequately warn the public about the risks, according to BloombergA judge later reduced punitive damages by half.

In 2019, J&J reached settlements totaling $1 billion to settle almost all of the outstanding lawsuits over Pinnacle hip replacements, according to the L.A. Times.

At the end of 2019, there were 11,400 hip replacement lawsuits pending against J&J, according to the company’s annual report.

 


 

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 Credo Watch asks the question: With more than 90,000 product liability claims, does Johnson & Johnson still deserve the reputation it earned in the mid-twentieth century? And does Johnson & Johnson still adhere to its famous Credo established in 1943?

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