Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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J&J Was Alerted to Risk of Asbestos in Talc in ’70s, Files Show

J&J Was Alerted to Risk of Asbestos in Talc in ’70s, Files Show | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson trained its employees to reassure anyone concerned about whether the company’s talcum powder contained asbestos that the cancer-causing substance “has never been found and it never will’’ in its iconic baby powder, according to an undated memo unsealed in a lawsuit against the drugmaker.

 

But plaintiffs say other unsealed documents indicate that J&J has known for decades that its talc products include asbestos fibers and that the exposure to those fibers can cause ovarian cancer. The talc used by J&J to make its products “is not now, nor has it ever been, free from asbestos and asbestiform fibers,’’ according to the lawsuit filed on behalf of more than 50 women in St. Louis.

 

The unsealed documents add another dimension to the claims against J&J as it defends itself from more than 5,000 suits across the U.S. blaming its baby powder products for causing women to develop ovarian cancer. While five juries have ruled against J&J, the company has won one case and had some other claims thrown out.

 

 

One of the documents unsealed Sept. 6 indicates that in May 1974, an official at J&J’s Windsor mine in Vermont recommended “the use of citric acid in the depression of chrysotile asbestos’’ from talc extracted from the site.

 

“The use of these systems is strongly urged by this writer to provide protection against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time,’’ the mine’s director of research and development wrote then.

 

Documents provided by J&J show tests of its talc stretching back to at least 1972 found no traces of asbestos, though the two minerals often occur naturally near each other. In a 1983 worldwide study of its talc products, the drugmaker found “all talcs in this report were found to be free from asbestiform minerals and to conform to cosmetic talc requirements.”

 

Further Reading:

  • “J&J Bites the Talc-powder Dust in Another Trial - Ordered to Pay $110 Million”; http://sco.lt/6E8DnV
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J&J CEO Gorsky Is a Follower, Not a Leader: @JNJCares - NOT!

J&J CEO Gorsky Is a Follower, Not a Leader: @JNJCares - NOT! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson (JNJ) chief executive officer Alex Gorsky was initially chastised last week for deciding to stay on President Trump’s manufacturing advisory council, before reversing course just as Trump announced the panel would be dissolved after a series of defections.

 

A trio of internal memos sent to J&J employees, reviewed by STAT, offer some insight into Gorsky’s reasoning.

 

An exodus from the council began with Merck chief executive Ken Frazier, one of the most prominent African-American business leaders in the country, two days after Trump’s initial comments on Saturday, Aug. 12. Originally, Gorsky planned to sit tight. In a memo distributed on Monday, Aug. 14, Gorsky essentially argued that J&J had an opportunity to influence the Trump administration:

 

First Gorsky defended his decision to stay: “When we are a part of the conversation, we help ensure that healthcare remains the global priority it should be.”

 

Simply put, there are shareholders to consider and Gorsky was willing to wait it out.

 

Gorsky doubled down the next morning. In yet another memo on Tuesday, Aug. 15, he more explicitly reiterated his earlier argument that a seat at the table is better than no seat at all. And he did so even after acknowledging complaints from some employees and shareholders.

 

“In the end, I have concluded that Johnson & Johnson has a responsibility to remain engaged, not as a way to support any specific political agenda, but as a way to represent the values of Our Credo as crucial public policy is discussed and developed. …if we aren’t there standing up for our belief in diversity and inclusion, or if we fail to speak out when the situation demands it, then we have abdicated our Credo responsibility. We must engage if we hope to change the world and those who lead it.”

 

The Credo, for those unaware, is a long-standing mission statement etched on the J&J headquarters building in New Brunswick, N.J., that makes a commitment to act responsibly to health care providers, employees, communities, and shareholders. . (Some will argue J&J breached its Credo for episodes of illegal marketing that generated big fines or poorly handled product recalls, but that’s another story. For more on that, read “How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Fine”; http://bit.ly/1cjcp6s).

 

His Tuesday memo would have appeared to end the episode, but then, Trump struck again. Later that same day, the president outraged and upset many people once more with off-the-cuff remarks that indicated he assigned equal blame to those who attended the Charlottesville, Va., rally organized by white supremacists and neo-Nazis, and to those who protested the march.

 

On Wednesday, Aug. 16, Gorsky wrote a third memo to employees.

 

“…the president’s remarks at his press conference yesterday — equating those who are motivated by race-based hate with those who stand up against hatred — were completely unacceptable. Therefore, I decided to resign from the White House Manufacturing Advisory Council. By working with other members of the manufacturing council on a united withdrawal, I realized we would make the most significant impact.”

 

Trump showed his true colors with his initial remarks. Why wasn’t that enough to bail right then and there?

 

PharmaGuy’s comments:

In other words, Gorsky was a follower, not a leader!

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J&J Bites the Talc-powder Dust in Another Trial - Ordered to Pay $110 Million

J&J Bites the Talc-powder Dust in Another Trial - Ordered to Pay $110 Million | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson on Thursday was ordered by a Missouri jury to pay over $110 million to a Virginia woman who says she developed ovarian cancer after decades of using of its talc-based products for feminine hygiene.

 

The verdict in state court in St. Louis was the largest so far to arise out of about 2,400 lawsuits accusing J&J of not adequately warning consumers about the cancer risks of talc-based products including its well-known Johnson's Baby Powder.

 

Many of those lawsuits are pending in St. Louis, where the J&J has faced four prior trials, three of which resulted in $197 million verdicts against J&J and a talc supplier.

 

Thursday's verdict came in a lawsuit against J&J and talc supplier Imerys Talc by Lois Slemp, a resident of Virginia who is currently undergoing chemotherapy after her ovarian cancer initially diagnosed in 2012 returned and spread to her liver.

 

Slemp claimed she developed cancer after four decades of using talc-containing products produced by J&J, including J&J's Baby Powder and Shower to Shower Powder.

 

The jury awarded $5.4 million in compensatory damages and said J&J was 99 percent at fault while Imerys was just 1 percent. It awarded punitive damages of $105 million against J&J and $50,000 against Imerys.

 

Reuters watched the verdict through Courtroom View Network, which broadcast it online.

 

"Once again we've shown that these companies ignored the scientific evidence and continue to deny their responsibilities to the women of America," Ted Meadows, a lawyer for Slemp and other plaintiffs, said in a statement.

 

J&J in a statement said it sympathized with women impacted by ovarian cancer but planned to appeal.

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Giving J&J an Ethics Prize is Like Giving Strom Thurmond a Civil Rights Award

Giving J&J an Ethics Prize is Like Giving Strom Thurmond a Civil Rights Award | Pharmaguy's Insights Into Drug Industry News | Scoop.it

"Should a drug company that’s agreed to pay billions in criminal and civil fines for illegally marketing its drugs to children and dementia patients be honored with an ethics prize?"

 

Um, no.

 

The company is Johnson & Johnson, which has of course paid out a lot of cash in federal penalties for fraudulent marketing. That's not a problem for an organization called Fellowships at Auschwitz for the Study of Professional Ethics, or FASPE, which is honoring the company next month with an award for "ethical leadership." Art Caplan of NYU will be presenting the award. If you'd like to attend, you can get prime seating for your entire group for a mere $50,000.

 

Sheila Kaplan of Stat News has the story, but sadly, it's behind a paywall. Here is an excerpt:

 

FASPE Chairman David Goldman, an attorney in New York, said he was aware of the pharma giant’s various ethical tangles, but believes the company has moved beyond them. “We do think they’ve acknowledged their failures and taken the appropriate steps to resolve them,” he said. “They know what they’ve done; we talked to them about it and they’ve taken the right action.”

 

The award will be accepted by Dr. Joanne Waldstreicher, J & J’s chief medical officer. Goldman said she was “as committed to the ethics program and ethical behavior as anybody who we’ve seen.” He added: “We think we’ve got this right.”

 

Others disagree, noting that in 2013, J&J and its subsidiaries agreed to pay $2.2 billion to resolve criminal and civil allegations of improperly promoting several prescription drugs, including paying kickbacks to physicians. That was one of the largest health care fraud settlements in US history. The company has also lost recent product liability cases involving allegations of its talcum powder causing ovarian cancer.

 

“It’s like giving Strom Thurmond a civil rights prize, or Wells Fargo an award for business ethics,” said Dr. Carl Elliott, a bioethicist at the University of Minnesota. “Of all the potential people or organizations to honor with an ethics award, why pick a company that has just paid a $2.2 billion federal penalty for fraud?”

Pharma Guy's insight:

Further reading:

  • “Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year”; http://sco.lt/5l207V 
  • “The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts”; http://sco.lt/8FrB5t 
  • “America’s Most Admired Lawbreaker”; http://sco.lt/7Gz2q9
  • "How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use"; http://sco.lt/7gkFl3 
  • “J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability”; http://sco.lt/70aVsn 
  • “J&J #Pharma Earnings Up 18.7% Despite Being Top Fined Drug Company!”; http://sco.lt/5ycMZF 
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Johnson & Johnson Soon to Become a Real #Pharma Company. Are You Surprised?

Johnson & Johnson Soon to Become a Real #Pharma Company. Are You Surprised? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It surprises many investors to discover that the consumer products division of Johnson & Johnson isn't its most important business segment. Indeed, recently, consumer products have been the laggard for the healthcare conglomerate, and strength in the pharmaceutical business has been the key driver of overall growth for J&J. Coming into Tuesday's third-quarter financial report, J&J investors fully expected that those trends would continue, creating modest sales growth that would translate into bottom-line success. Johnson & Johnson's results were even stronger than anticipated, giving shareholders comfort that the healthcare giant is still moving forward. Let's take a closer look at Johnson & Johnson's latest results and what lies ahead for the company.

 

Johnson & Johnson's third-quarter financials continued to build positive momentum for the healthcare conglomerate. Revenue climbed 4.3% to $17.82 billion, accelerating from last quarter's growth pace and topping the consensus forecast among investors. Adjusted net income rose 12% to $4.68 billion, and that produced adjusted earnings of $1.68 per share, beating what those following the stock had expected by $0.03 per share.

 

As we've seen in several past quarters, the strength of Johnson & Johnson's overall business was concentrated in the pharmaceutical division. Pharma sales jumped 9% to $8.4 billion, rapidly approaching the 50% mark in terms of its total contribution to J&J's top line. Gains for medical devices were much smaller, rising 1.1% from year-ago levels, and the consumer division actually lost ground on the sales front with a 1.6% decline.

Pharma Guy's insight:

Related article: “Johnson & Johnson Should Split Up, Say Investors”; http://sco.lt/7X7i5J

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The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts

The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a blow to Johnson & Johnson, the company was ordered last Friday to pay $70 million to a male Tennessee teenager who claimed its Risperdal antipsychotic pill caused him to grow enlarged breasts. The finding by a Pennsylvania state court jury was not only the latest, but it is the biggest defeat to date in what has become another sprawling litigation over the drug.

In reaching its decision, the jury found that J&J failed to properly warn Risperdal could cause gynecomastia, which is the abnormal development of large mammary glands in males. Moreover, the jury also determined that the company “intentionally falsified, destroyed, or concealed records” that Risperdal could cause boys to develop breasts.

Last week’s verdict, which only included compensatory damages, dwarfs the $2.5 million that was awarded last year to an Alabama man, who sued J&J after he developed size 46 DD breasts. The latest case was brought by Andrew Yount, who was born in 1998, and was given Risperdal in 2003 to treat a psychiatric problem, according to one of his attorneys.

Pharma Guy's insight:

Speaking of films, Two "Unbroke Girls" & George Clooney Aim to Give J&J Its Comeuppance in New Film “America’s Most Admired Lawbreaker”; http://sco.lt/7Gz2q9 The film should depict "How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use"; http://sco.lt/7gkFl3 

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Board Overhaul at Crooked Valeant #Pharma - Some Old J&J Cronies Gone

Board Overhaul at Crooked Valeant #Pharma - Some Old J&J Cronies Gone | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After weeks of delay, Valeant Pharmaceuticals on Friday filed its 2015 annual report with regulators, a significant move that will help the beleaguered drug maker avoid default on more than $30 billion in debt. At the same time, the company overhauled its board, shrinking it to 11 members from 14.

 

[And among the independent directors stepping down is Colleen Goggins, a former worldwide chair at Johnson & Johnson, where she first worked with Pearson, who was a consultant to the health care giant at the time.]


The steps come following withering scrutiny during a Senate hearing earlier this week in which both Michael Pearson, the outgoing Valeant chief executive, and Bill Ackman, the hedge fund investor and Valeant board member, admitted that jacking up the prices of drugs to sky-high amounts was a mistake. And during that session, Ackman promised that leadership, as well as pricing changes, are planned.

As expected, Pearson is stepping down from the board. His replacement, former Perrigo Chief Executive Joe Papa, begins work next week and was nominated to join the board, along with seven existing board members. This group includes Ackman, who heads Pershing Square Capital Management. The company also plans to bulk up its governance committee by adding three independent board members.

The filing, which contains some revisions to financial results for different portions of 2014 and 2015, will be picked through in coming days. But what was already a voluminous section devoted to “government and regulatory inquiries,” a euphemism for investigations, is rapidly expanding.

Pharma Guy's insight:

This is reminiscent of the time that Colleen A. Goggins, at the time Worldwide Chairman, Consumer Group, Johnson & Johnson, was sent to testify in place of Bill Weldon, JNJ's CEO at the time, who declined to attend due to medical problems (see "JNJ's CEO Weldon May Send Underling to Congress. The Aching Back Excuse"). Afterward, Goggins left J&J, probably with a nice severance package. Now we know where she and her pal Pearson ended up!

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Johnson & Johnson Should Split Up, Say Investors

Johnson & Johnson Should Split Up, Say Investors | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Activists call upon Johnson & Johnson to consider splitting itself up.


The behemoth drug maker is split into three main divisions – consumer care, pharmaceuticals and medical devices. According to consensus data compiled by Bloomberg and comparative valuations, enterprise value (EV) of these three segments separately would total up to $295 billion. The figure could go even higher if the drug maker discloses more information regarding its pipeline, and reports improved operating margins for consumer health division. In this case, the EV can be expected to lie in range of $252.4-$365.7 billion.

Pharma Guy's insight:

JNJ may position itself as a "consumer" products company, but its  main business is pharmaceutical drugs and medical devices. Back in 2012 consumer product sales accounted for 23% of WW sales. See here: http://bit.ly/JNJ2012 Now consumer sales are only 19% of the total.

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Is Direct-to-Consumer TV Advertising a Losing Proposition?

Is Direct-to-Consumer TV Advertising a Losing Proposition? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

2014 was a banner year for TV direct-to-consumer (DTC) advertising in that it saw the highest percentage spent on TV since at least 2001 (see chart and read "Pharma Ups Its Investment in TV DTC Advertising").

A few weeks ago I said "Forgettaboutit! The numbers are not yet in for 2015, but if it's anything like 2014 -- and judging by personal experience -- the drug industry will be spending even MORE money on TV DTC ads."

The Top 10 TV DTC Rx advertisers spent $876.3 million in 2015 (see insert below). The question is: Is it worth it?

My answer: No! 

 

How do I know? Click here for my analysis of TV DTC ROI (return on investment).

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J&J Executive Defends High Drug Prices as “Very Responsible”

J&J Executive Defends High Drug Prices as “Very Responsible” | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A top official at Johnson & Johnson dismissed questions about drug price reform debate, saying that the company is “responsible” in pricing its drugs.


Johnson & Johnson has gained notoriety for the high cost of its drugs. For example, it produces and markets the cancer drug Imbruvica, which retails at around $9,550 for one bottle of 90 capsules. Dosage is four capsules a day, meaning one bottle will be a 22-and-a-half day supply.


At this average price, a full-year supply would cost $154,922.

Johnson & Johnson Chief Financial Officer Dominic Caruso, in response to a question about the industry voluntarily restraining the prices of its own drugs, explained that he would rather focus on justifying the current prices of drugs. “I think, we’re very responsible in our drug pricing. And we tend to support the price of our drugs with strong economic data,” he said. “So rather than pledge to a particular number I think it’s important that we continue to develop robust data that provides a solid foundation for the value that our products provide the health care system.”


Listen to Caruso’s full remarks here.

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J&J: America’s Most Admired #Pharma Lawbreaker - Chapter One

J&J: America’s Most Admired #Pharma Lawbreaker - Chapter One | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A shocking story about the biggest company in the US's most profitable industry.


The Food and Drug Administration had prohibited Johnson & Johnson salespeople from trying to promote Risperdal to doctors to treat children because of its feared side effects, including hormonal disorders. The company was also not allowed to promote it to treat the elderly except for the most serious psychotic disorders; it was thought to cause strokes, diabetes and other ailments in that population. But by the time young Austin started growing breasts, Johnson & Johnson was reaping more than half of its Risperdal sales from prescriptions written for children to alleviate all kinds of behavior disorders, and for the elderly, who were given the drug for simple symptoms of dementia or restlessness.


Johnson & Johnson emails, sales training manuals and business plans produced as evidence in the case revealed that the company organized special sales units illegally targeting doctors who treated the elderly and children. State mental institutions treating children, whose drugs would be paid for by Medicaid, were targeted, too.


When it came time to explain their conduct at trials and to federal investigators, Johnson & Johnson executives and salespeople have unwaveringly, even indignantly, defended themselves. One salesman, who otherwise fit the salt-of-the-earth mold that R.W. Johnson had envisioned for his company’s employees, gave thousands of Risperdal samples in child-sized doses to Austin Pledger’s doctor in Birmingham, Alabama. Yet he insisted under oath in February he didn’t recall stepping around kiddie furniture and toys as he walked into an office with a sign that said “pediatric neurologist,” and that he had no way of knowing that the doctor wasn’t treating adults.

Pharma Guy's insight:

Meanwhile, you might want to read this: How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Finehttp://bit.ly/1cjcp6s 

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IBM Creates Watson Health to Analyze Medical Data: Focus is on Hips & Diabetes

IBM Creates Watson Health to Analyze Medical Data: Focus is on Hips & Diabetes | Pharmaguy's Insights Into Drug Industry News | Scoop.it

IBM is taking its Watson artificial-intelligence technology into health care in a big way with industry partners, a pair of acquisitions and an ambitious agenda.


The initial three industry partners are Apple, Johnson & Johnson and Medtronic. On Monday afternoon, after the close of stock trading, IBM also announced it would buy two start-ups: Explorys, a spin-off from the Cleveland Clinic whose data on 50 million patients is used to spot patterns in diseases, treatments and outcomes; and Phytel, a Dallas maker of software to manage patient care and reduce readmission rates to hospitals.


The IBM plan, put simply, is that its Watson technology will be a cloud-based service that taps vast stores of health data and delivers tailored insights to hospitals, physicians, insurers, researchers and potentially even individual patients.


“We’re going to enable personalized health care on a huge scale,” said John E. Kelly, a senior vice president who oversees IBM’s research labs and new initiatives.


IBM’s broad vision of combining and analyzing health data from varied sources to improve care has been around for decades. But the company and its partners say that technology, economics and policy changes are coming together to improve the odds of making the IBM venture a workable reality. They point to improvements in artificial intelligence, low-cost cloud computing and health policy that will reward keeping patients healthy instead of the fee-for-service model in which more treatments and procedures mean more revenue.


“Forces in health care are aligning as never before,” said Sandra E. Peterson, a group worldwide chairman at Johnson & Johnson in charge of information technology and new wellness programs. “It could be a unique moment and something like this could have real legs.”


A focus of the Johnson & Johnson partnership with IBM will be improving patient care before and after knee and hip replacements. The company will apply Watson technology to data sources ranging from patient records to digital fitness devices and smartphone applications, which can monitor movement and vital signs. “It will allow us to do much more integrated, personalized care,” Ms. Peterson said.


Medtronic, a large medical equipment maker, wants to use data intelligently to treat diabetes patients beyond providing them with its glucose monitors and insulin pumps. Medtronic devices are already digital and produce a lot of data, but the company plans to use the Watson software to spot patients trending toward trouble and automatically adjust insulin doses and send alerts to care providers and the patients themselves.


“The goal is dynamic, personalized care plans so you can delay or stop the progression of diabetes,” said Hooman Hakami, executive vice president in charge of Medtronic’s diabetes group.

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J&J Slams Ex-FDA Chief David Kessler in Risperdal Male Breast-Growth Case

J&J Slams Ex-FDA Chief David Kessler in Risperdal Male Breast-Growth Case | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson’s lawyers, in a trial over whether the antipsychotic drug Risperdal caused boys to develop abnormal breasts, attacked a former government health regulator as a biased witness with a penchant for finding that drugmakers hide their medicines’ risks.


David Kessler, the former head of the U.S. Food and Drug Administration, has become a “hired gun” for consumers suing drugmakers since he left government service in 1997 and now routinely finds companies fail to adequately warn the public about their products’ risks, Diane Sullivan, one of J&J’s lawyers, said Friday in state court in Philadelphia.


During cross-examination, Sullivan accused Kessler of “cutting and pasting” findings from other cases into his conclusion that officials of J&J’s Janssen unit knew Risperdal caused some boys to develop female breasts and failed to alert patients, doctors and regulators about it. Kessler testified on behalf of the parents of a 20-year-old autistic man suing over the side effect.

“Each case is complex and there is an enormous amount of details associated with them,” Kessler countered. “To say I’ve testified each and every time the same way would be incorrect.”


J&J, based in New Brunswick, New Jersey, faces more than 1,000 cases over the Risperdal side effect in state court in Philadelphia. The current case may be the first in which a jury decides whether J&J and Janssen are liable for mishandling the antipsychotic medicine.

Pharma Guy's insight:


The Department of Justice (DOJ) just updated its commemorative poster highlighting the now seven highest multi-million/billion dollar settlements that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs.

The latest addition to the poster is Johnson and Johnson, which will pay $2.2 billion to the U.S. government to end civil and criminal investigations into kickbacks to pharmacists and the marketing of pharmaceuticals for off-label uses. According to an NBC News story (here), "The settlement with the company and its subsidiaries covers the marketing of schizophrenia treatment Risperdal and of heart drug Natrecor, said the source, who spoke on condition of anonymity."

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J&J Speaks Out as Florida Plans to Use an Old Drug in a Lethal Injection Execution @JNJCares

J&J Speaks Out as Florida Plans to Use an Old Drug in a Lethal Injection Execution @JNJCares | Pharmaguy's Insights Into Drug Industry News | Scoop.it

J&J no longer manufactures etomidate, although it discovered the drug back in the 1960s, but an untried three-drug concoction including the anaesthetic is set to be used in the execution of Mark Asay tomorrow.

 

Now off-patent, several generic drugmakers manufacture the drug and J&J seems unable to intervene directly to stop its use on death row.

 

J&J’s pharmaceutical division, Janssen, said in a statement: “We do not condone the use of our medicines in lethal injections for capital punishment.”

 

“Janssen discovers and develops medical innovations to save and enhance lives. We do not support the use of our medicines for indications that have not been approved by regulatory authorities.”

 

Maya Foa, director of Reprieve, the international rights organisation, said: “The world’s largest drug manufacturer has added its voice to the industry-wide consensus that opposes the misuse of medical products in lethal injection executions.”

 

“Pharmaceutical companies are clear that their drugs are for saving the lives of patients, not ending the lives of prisoners. In Florida particularly, Governor Scott should listen to clear and unequivocal statements from Johnson & Johnson and others calling time on this dangerous misuse of medicines, and stay the execution of Mark Asay on Thursday”

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Johnson & Johnson’s Legal Woes Continue to Escalate as DOJ Targets Its Rx Drug Marketing Practices

Johnson & Johnson’s Legal Woes Continue to Escalate as DOJ Targets Its Rx Drug Marketing Practices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As if Johnson & Johnson didn’t have enough legal woes already, with the mounting number of cases claiming a link between its talcum powder and ovarian cancer (read “J&J Bites the Talc-powder Dust in Another Trial - Ordered to Pay $110 Million”; http://sco.lt/6E8DnV), the pharma giant now faces a fresh round of investigations into its marketing practices.

 

In a quarterly filing with the Securities and Exchange Commission, J&J disclosed new investigations by the U.S. Justice Department and the U.S. Attorney's Office in Massachusetts. The probes target arthritis drugs Remicade and Simponi, hepatitis C treatment Olysio and psoriasis drug Stelara.

 

Most recently, in April, J&J was subpoenaed by the Massachusetts district court, which is seeking documents related to copayment-support programs the company is offering for Olysio, Simponi and Stelara, according to the SEC filing. Investigators are seeking information about how J&J reports the prices of those products to the Centers for Medicare & Medicaid Services and how it discloses rebate payments to the state’s Medicaid agencies.

 

J&J had previously been pulled into a separate Massachusetts investigation that involves several pharmaceutical companies. The district attorney’s office has been collecting information about ties between drug companies and nonprofits that help fund prescription purchases for Medicare patients. The office has been doling out subpoenas over the last two years, targeting Biogen, Celgene, Regeneron, Gilead and others.

 

In February, Pfizer disclosed in its annual SEC filing that it received two subpoenas seeking information about its relationship with Patient Access Network Foundation and other nonprofit groups that provide copay assistance to underinsured patients.

 

J&J hasn’t disclosed which charitable organizations the district attorney’s office asked about, but all such relationships have come under fire recently. That’s because it’s against the law for pharmaceutical companies to link their products with charitable organizations and to offer direct copay subsidies to patients covered by government-run insurance plans.

 

Further Reading:

  • “Giving J&J an Ethics Prize is Like Giving Strom Thurmond a Civil Rights Award”; http://sco.lt/6RqBRB
  • “Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year”; http://sco.lt/5l207V
  • “The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts”; http://sco.lt/8FrB5t
  • “America’s Most Admired Lawbreaker”; http://sco.lt/7Gz2q9
  • "How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use"; http://sco.lt/7gkFl3
  • “J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability”; http://sco.lt/70aVsn
  • “J&J #Pharma Earnings Up 18.7% Despite Being Top Fined Drug Company!”; http://sco.lt/5ycMZF
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Johnson & Johnson Innovation Launches QuickFire Challenge to Improve Safe Use of Drugs

Johnson & Johnson Innovation Launches QuickFire Challenge to Improve Safe Use of Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Challenge awards up to $200,000 to novel solutions that advance safety by informing patients and consumers, simulating surgical procedures or ensuring proper storage and use of prescription, over-the-counter and cosmetic products

 

NEW BRUNSWICK, N.J., March 29, 2017 - Johnson & Johnson Innovation LLC today announced the launch of the newest QuickFire Challenge: Advancing the Safe Use of Healthcare Products. The challenge seeks to identify entrepreneurs, academics, scientists, engineers or startup companies who are advancing potentially game-changing, early stage, innovative solutions to advance safety in healthcare products that help inform patients and consumers, simulate surgical procedures, and ensure proper storage and use of prescription, over-the-counter and cosmetic products.

 

"Dedicated to scientific excellence, bioethics and values-based decision-making, the Johnson & Johnson Office of the Chief Medical Officer has a history of collaborating externally to create innovative solutions for patients and consumers," said Joanne Waldstreicher, M.D., Chief Medical Officer, Johnson & Johnson.  "Through our collaboration with Johnson & Johnson Innovation on this challenge, we hope to identify scientifically sound, breakthrough ideas that will advance both the safe use and a greater understanding of the safety of healthcare products to positively impact outcomes."

 

This initiative represents the Johnson & Johnson Family of Companies' ongoing commitment to patient and consumer safety and independent safety assessments. It is open globally to applicants with solutions across the pharmaceuticals, medical devices and consumer products sectors. QuickFire Challenge winners will receive research grants totaling up to USD 200,000, entrance to a Johnson & Johnson Innovation – JLABS facility and / or mentoring from Johnson & Johnson Innovation.

 

Prescription medication errors cause at least one death every day and injure approximately 1.3 million people each year.1 Moreover, with increased dissemination and sharing of health information via social media and online, there is a greater need than ever before for bioethical, transparent and evidence-based information sources that help patients and consumers make more informed healthcare decisions. To help make this possible, the challenge aims to improve safety in healthcare through improving the provision of balanced and factual information – and development of solutions – to ensure safety across the spectrum of medical devices, pharmaceutical and consumer products.

 

QuickFire Challenge entries that reflect the overall mission of improving the safety of and safe use of healthcare products will be evaluated by a juried panel comprising senior scientific and medical research staff as well as medical safety experts within Johnson & Johnson who have expertise across pharmaceuticals, medical device and consumer sectors. Participants can enter innovative ideas, methods or technologies that will help improve safety and healthcare outcomes for patients and consumers.

 

The QuickFire Challenge innovation focus areas are:

 

  • Empowering patients and consumers to make more informed healthcare decisions by providing better information and education about the safety of healthcare products (pharmaceuticals, medical devices and consumer products).

This challenge focus area seeks ways to maximize consumer and patient education and understanding of healthcare products and their safety and efficacy, including medical devices, pharmaceuticals and consumer products. The objective is to empower patients, consumers and healthcare providers to make more informed decisions and obtain maximum benefit from product use through greater understanding of safety data and by ensuring more effective communication and enhancing education.

 

  • Improving training and development for surgeons by identifying new models that simulate the operating room environment.

This focus area seeks new and robust models and methods to evaluate medical devices used by surgeons in a simulated environment representative of operating room procedures, with the goal of helping the surgeon understand how to safely and effectively use a medical device and understand variability in device and performance/outcome. Entries should focus on soft tissue models that anatomically represent organ-specific anatomic features and biological properties, such as tissue injury, bleeding and clotting responses.

 

  • Empowering patients and consumers to more safely administer and handle healthcare products.

The third focus area seeks ways to address the challenge of prescription medication errors. Entries should identify patient- and consumer-focused devices, solutions or platforms that will prevent errors and solutions to promote safe storage and administration or extend the shelf life of prescription, over-the-counter or cosmetic products.

 

"Entrants can submit ideas in one of three focus areas that are critical for ensuring that we make the safest possible products on behalf of patients and consumers," said Melinda Richter, Head of Johnson & Johnson Innovation, JLABS. "In addition to funding, Advancing the Safe Use of Healthcare Products QuickFire Challenge winners will be awarded JLABS support that includes infrastructure, services, educational programs and networks in global hotspots."

 

Information about entering the challenge and entry guidelines can be found online at jlabs.tv/safetyquickfirechallenge. Participants must indicate whether they have a team in place that can bring their idea to life. Entries must be submitted by May 24, 2017. Winning entries will be evaluated and winners in each category selected in fall 2017.

 

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Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year

Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson was ordered by a Texas jury to pay more than $1 billion to patients who claimed the company hid flaws in its Pinnacle artificial hips that had to be surgically removed, in J&J’s second loss linked to the implants.

 

Officials of J&J’s DePuy unit, which makes the Pinnacle hips, knew the devices were defective, but failed to properly warn doctors and patients about the risk they would fail, the federal jury in Dallas concluded Thursday. The verdict includes more than $30 million in actual damages for the six plaintiffs and more than $1 billion in punitive damages, according to court filings.

 

J&J still faces almost 9,000 lawsuits accusing the company of mishandling the metal-on-metal hips. J&J stopped selling the devices in 2013 after the U.S. Food and Drug Administration toughened artificial-hip regulations.

 

At $1.04 billion in damages, it’s the third-largest overall jury award of 2016, according to data compiled by Bloomberg. The largest, for $3 billion, came in June in a breach of contract case brought by Hewlett-Packard Co. against Oracle Corp. The punitive award against J&J was the largest against a company this year, according to Bloomberg data. Such punishment damages are intended to dissuade defendants from continuing sanctioned practices.

 

“The jury is telling J&J that they better settle these cases soon,” said Mark Lanier, who represented the group of six hip patients who sued J&J and DePuy. “All they are doing by trying more of these cases is driving up their costs and driving the company’s reputation into the mud.”

 

J&J’s DePuy unit acted appropriately in designing and testing the product, spokeswoman Mindy Tinsley said in a statement. The companies have strong grounds for appeal and remain committed to the long-term defense of the lawsuit allegations, according to the statement.

 

The verdict continues a losing stretch for J&J before U.S. juries. Six of the seven largest product-defect verdicts in the U.S. this year have been against J&J units, including three in lawsuits claiming its talc products cause ovarian cancer.

Pharma Guy's insight:

Related Stories:

  • “The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts”; http://sco.lt/8FrB5t
  • “America’s Most Admired Lawbreaker”; http://sco.lt/7Gz2q9
  • "How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use"; http://sco.lt/7gkFl3
  • “J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability”; http://sco.lt/70aVsn
  • “J&J #Pharma Earnings Up 18.7% Despite Being Top Fined Drug Company!”; http://sco.lt/5ycMZF
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Want a $500 K Grant? Enter J&J's World Without Disease QuickFire Challenge

At Johnson & Johnson Innovation and Janssen Research & Development, our goal is to improve the health and wellness of people around the world. To that end, we have a passionate and engaged workforce across our consumer, medical device and pharmaceutical units who are interested in finding and deploying comprehensive, end to end, integrated solutions which take into account the world in which we live today. Johnson & Johnson Innovation and Janssen Research & Development are bringing together the consumer, medical device and pharmaceutical sectors to award a prize or a series of prizes to the person or team(s) who submits the best idea, technology, or solution that will address a critical health need for the world's population.

Pharma Guy's insight:

Laudable. I know this is marketing speak, but a world without disease is as realistic as a world without war, IMHO.

 

Also read: "Johnson & Johnson Expands Its Membership in the Digital Innovation Club"; http://sco.lt/65ScEr 

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Two "Unbroke Girls" & George Clooney Aim to Give J&J Its Comeuppance in New Film

Two "Unbroke Girls" & George Clooney Aim to Give J&J Its Comeuppance in New Film | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“Making a Murderer” filmmakers Laura Ricciardi and Moira Demos are set adapt the serialized Huffington Post article “America’s Most Admired Lawbreaker” for TV. The project is the first under a new first-look deal between Sonar Entertainment and George Clooney and Grant Heslov’s Smokehouse Pictures.

Written by journalist Steven Brill, “America’s Most Admired Lawbreaker” tells the story of a a division of pharmaceutical giant Johnson & Johnson that created a powerful antipsychotic drug and marketed it aggressively to children and the elderly, while allegedly withholding data about its terrible side effects. Johnson & Johnson agreed to pay more than $2 billion in penalties and settlements, but sold a reported $30 billion worth of the drug worldwide.

Nicki Paluga will adapt the article to series with Ricciardi and Demos, with the latter two directing. The scripted event series does not yet have an episode count.

The project and the deal with Sonar are part of a continued effort by Smokehouse to push into television. The company is already developing “Ms,” a miniseries about Gloria Steinem and the founding of Ms Magazine, at HBO, and “The Studio,” about a movie studio in the 1990’s,  Showtime.

“We couldn’t be more excited to be in business with George and Grant and their talented team at Smokehouse,” said Sonar CEO Thomas Lesinski. “Smokehouse has a stellar track record of delivering commercial and critically acclaimed content. Smokehouse will be a great partner for Sonar Entertainment, as the two companies align perfectly in our approaches to premium TV programming.”

Pharma Guy's insight:

Johnson and Johnson, agreed to pay $2.2 billion to the U.S. government to end civil and criminal investigations into kickbacks to pharmacists and the marketing of pharmaceuticals for off-label uses. According to an NBC News story (here), "The settlement with the company and its subsidiaries covers the marketing of schizophrenia treatment Risperdal and of heart drug Natrecor, said the source, who spoke on condition of anonymity." Also read: “Money Doesn't Make Big Pharma Accountable: Why Suing Isn't Working”; http://sco.lt/6XbVHl 

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Johnson & Johnson Tops List of #Pharma Companies Delivering Innovative Drugs

Johnson & Johnson Tops List of #Pharma Companies Delivering Innovative Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The sixth annual Productive Innovation Index released by IDEA Pharma today, which ranks biopharmaceutical companies by their ability to successfully bring innovations to market, sees Johnson & Johnson top the industry for the fourth year running. 


The Productive Innovation Index measures, scores and celebrates a company’s ability to deliver innovation to patients, by objectively evaluating performance data based on a rolling five year period (2010-2015), and operates on the premise: if you gave the same molecule to two different companies in early phase, which would make the best of it?

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Diabetes Drugs Dominate Pharma TV DTC Advertising

Diabetes Drugs Dominate Pharma TV DTC Advertising | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Type 2 diabetes is on the rise in the U.S.--and so is TV adspending for drugs to treat the condition. New medicines, along with increased marketing budgets on older meds, more than doubled diabetes category spending on TV advertising in 2015 to $468 million, up from $194 million in 2014, according to data collected by real-time TV tracker iSpot.tv.


The four new diabetes drug entrants to TV advertising last year were Sanofi's ($SNY) Toujeo, Boehringer Ingelheim and Eli Lilly's ($LLY) Jardiance, Eli Lilly's Trulicity, and GlaxoSmithKline's ($GSK) Tanzeum.


However, it was Johnson & Johnson's Invokana, already on the airwaves, that made the biggest splash, spending $101.2 million on TV ads in 2015, up from $35.2 million in 2014. iSpot noted that just one Invokana ad, "You're Not Alone," accounted for an estimated $75 million additional spending, or 16% of the category total for the year.

Pharma Guy's insight:

Was all the TV ad spending for Invoking worth it? Find out here: http://bit.ly/1Kbh0NV 

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J&J is Largest Contributor to #Pharma Lobbying Group Opposing Drug Pricing Relief Ballot Measure

J&J is Largest Contributor to #Pharma Lobbying Group Opposing Drug Pricing Relief Ballot Measure | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson (J&J) recently contributed $5.86 million to the “Pharmaceutical Research and Manufacturers of America California Initiative Fund” to help head off lower drug prices, according to a California Secretary of State filing on October 2.


The "Late Contribution Report" document shows that J&J is the largest contributor, and one three founding drug makers to commit funds in opposition of the “California Drug Pricing Relief Ballot Measure.”


On September 22, J&J’s “Contributor Code” listed on California Form 497 was “Other,” as the company initially donated only $160,000 to the fund.


By comparison, Bristol-Myers Squibb, a pharmaceutical company that also has a major location in New Brunswick donated $2.88 million on the same date.


However, J&J kicked in another $5.7 million just seven days later, raising its total contribution to the newly opened fund to $5.86 million.

“We were shocked when we put forth the California Drug Price Relief Act,” Ged Kenslea, Senior Director Communications, AIDS Healthcare Foundation, told New Brunswick Today.

Pharma Guy's insight:

This fits with statements from Johnson & Johnson Chief Financial Officer Dominic Caruso who said “I think, we’re very responsible in our drug pricing. And we tend to support the price of our drugs with strong economic data.”; http://sco.lt/7gEGDx 

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J&J: Less About Consumer Products and More About Medical Devices & Rx Drugs

J&J: Less About Consumer Products and More About Medical Devices & Rx Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

JNJ has always positioned itself as a "consumer" products company, but its main business is pharmaceutical drugs and medical devices. According to a Q2 2015 financial statement (here), Rx products account for 45% of the company's sales, medical devices 36%, and consumer products - for which the company is loved - only 19% (see chart on left).

In Q1 of 2012 the percentages were 37%, 40%, and 23% (see here).

I am interested in this because of data regarding J&J's PROFITS that I came across in a article by journalist Steven Brill today in The Huffington Post Highline titled "America’s Most Admired Law Breaker.

That article is part of a 15-part "DocuSerial" detailing how Johnson & Johnson took an anti-psychotic drug, Risperdal, initially intended only for the treatment of psychotic disorders, and put it in the hands of children and the elderly in violation of FDA restrictions. Of course, I've written about J&J's illegal activities many time now here on Pharma Marketing Blog (read, for example, "How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Fine").

But what about J&J's profits? Where do they come from? What's the impact on the company's reputation?


Read more here...

Pharma Guy's insight:

How long can J&J lean on its consumer products division for bolstering its reputation - even though not too long ago the McNeil Consumer division had a big problem reputation-wise: http://bit.ly/Id0vLk 

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One Step Closer to Universal Flu Vaccine. Yay! I was there!

One Step Closer to Universal Flu Vaccine. Yay! I was there! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Researchers in the US have started testing what they believe could be a universal vaccine against influenza, tackling both seasonal and pandemic strains such as bird flu.


The team - from the Scripps Research Institute (TSRI) in the US and Johnson & Johnson's Janssen Pharma unit - say the vaccine could provide long-acting protection against seasonal flu, potentially doing away with the need to develop new vaccine cocktails every year to address the prevailing strains.


The ultimate aim is to have a vaccine that only has to be given every five to 10 years to protect against flu, and would also provide some protection against emerging pandemic strains.


That would include those that jump the species barrier from animals to humans, such as the swine flu epidemic that killed hundreds of thousands of people worldwide in 2009.


The work is still in animal studies but focuses on using a different part of the flu virus as the basis for the antigen used in the vaccine. 


At the moment, scientists analyse the flu surface protein hemagglutinin (HA) in circulating flu strains to guess which will be causing infections during the flu season and setting in motion a manufacturing scramble to make combination vaccines that can take several months.


If the virus changes in the interim, the vaccine will be less effective. That happened last year, where the engineered vaccines only cut the chance of developing flu by around 23%. To compensate, pharma companies are developing vaccines that increase the number of strains included in the cocktail from three to four.


In a bid to sidestep that arms race, the TSRI and Janssen researchers are working with the stem of the HA protein, rather than the top end which is variable.

Pharma Guy's insight:

Regarding my involvement: I once made a living building molecular models of complex proteins for life science researchers. One such model was of the influenza flu coat protein, which I built for  Dr. Ian Wilson, who is now Chairman of the Department of Integrative Structural and Computational Biology at The Skaggs Institute for Chemical Biology, which is part of the Scripps Research Institute. The model is still on display in the lobby of the Scripps Research Institute! Below is a recent photograph that was sent to me by Mika Elizabeth Ono, Scripps Research Institute Director of Communications.


Back in the 80s, when I built this model, computer graphics were not good enough to help scientists like Wilson visualize the detailed structure of proteins. Here's how Dr. Wilson describes my tiny contribution to his research:


"We decided we would have a go at building a trimer so we co-opted John Mack from New York who was a model builder. He came up to Harvard [I built a model there first] and we constructed a dimer as one unit. This was a three-dimensional plastic model, 1 angstrom per cm. We could actually look at this thing to see what it really looked like and we could obviously trace it out. There were some limited computer-graphics programs that you could use to trace out the molecule, but it was really hard to get a feel for what it was all like without seeing everything at once. So that (three-dimensional) model turned out to be extraordinarily useful for trying to understand the structure. The third monomer was also built and we thought we would be able to assemble and disassemble the trimer, but they were so intertwined that it was impossible" (see "A Discussion with Ian Wilson").


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J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability

J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The maker of Children’s Tylenol agreed to plead guilty to a federal criminal charge of knowingly selling adulterated bottles of its painkillers for children and infants. The drugs were recalled in 2010 because they contained metal particles.


Prosecutors accused the company of continuing to sell the tainted products for nearly a year after discovering the problem, also claiming that McNeil failed to take immediate steps to fix the cause of the adulteration.


The Johnson & Johnson subsidiary first learned of the particle problem in May 2009, when a consumer complained about black specks inside a bottle of Infants' Tylenol, according to court documents.

McNeil subsequently found metal particles during production but continued making the liquid medicines for several more months. The company and prosecutors said Tuesday that no one was injured due to the tainted drugs.


However, Shawn Arndt, whose 4-year-old son Joshua died after taking one dose of Infant’s Tylenol, sued the company in 2012. The US District Court for Eastern Pennsylvania dismissed his suit in December 2014, in part because Joshua died in November 2009, several months after the recall went into effect.

Pharma Guy's insight:


The New York Times reports that "Johnson & Johnson appeared to abandon its own template [ie, the gold standard in brand crisis management], stunning a few business school professors. Its conduct also drew harsh criticism from federal officials" (see "In Recall, a Role Model Stumbles").

At issue was the slow response to reports of contamination of popular over-the-counter medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.

In a letter to Peter Luther, President, NA OTC, McNeil Consumer Healthcare (see end of this post), FDA said "We are aware of the complaint information available to your company, the sequence of events, and the extent of your firm's follow up measures during this period. We have concluded that your company did not conduct a timely, comprehensive investigation."

The New York Times took J&J to task for not covering this in its coporate blog: "Johnson & Johnson’s conduct is all the more out of step, analysts said, because the drug maker had been one of the first in the pharmaceutical industry to set up its own blog, jnjbtw.com ...as of Sunday at 6 p.m., on the issue of the current recall, the blog so far has had no comment from the company."

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