The Associated Press
ST. LOUIS – A Missouri jury has awarded $72 million to the family of an Alabama woman who died from ovarian cancer, which she said was caused by using Johnson & Johnson’s well-known baby powder and other products containing talcum.
The civil lawsuit by Jackie Fox of Birmingham, Alabama, was part of a broader claim in the city of St. Louis Circuit Court involving nearly 60 people.
Her son took over as plaintiff following his mother’s October 2015 death at 62, more than two years after her diagnosis.
Marvin Salter of Jacksonville, Florida, said his late mother, who was a foster parent, used the iconic talcum powder as a bathroom staple for decades.

“It just became second nature, like brushing your teeth,” he said. “It’s a household name. “
A Fox attorney said the jury verdict Monday night, which came after nearly five hours of deliberations at the conclusion of a three-week trial, was the first such case among more than 1,000 nationally to result in a jury’s monetary award.
The jury said that Fox was entitled to $10 million in actual damages and $62 million in punitive damages. Attorney James Onder said he “absolutely” expects Johnson & Johnson – the world’s biggest maker of health care products – to appeal the verdict.

The New Jersey-based company previously has been targeted by health and consumer groups over possibly harmful ingredients in items including its iconic Johnson’s No More Tears baby shampoo.
In May 2009, a coalition of groups called the Campaign for Safe Cosmetics began pushing Johnson & Johnson to eliminate questionable ingredients from its baby and adult personal care products.


After three years of petitions, negative publicity and a boycott threat, the company agreed in 2012 to eliminate the ingredients 1,4-dioxane and formaldehyde, both considered probable human carcinogens, from all products by 2015.
Spokeswoman Carol Goodrich said Tuesday that the New Jersey-based company was considering its next legal move.
In a written statement, she said the verdict “goes against decades of sound science proving the safety of talc as a cosmetic ingredient in multiple products,” citing supportive research by the U.S. Food and Drug Administration and National Cancer Institute.

At trial, Fox’s attorneys introduced into evidence a September 1997 internal memo from a Johnson & Johnson medical consultant suggesting that “anybody who denies (the) risks” between “hygenic” talc use and ovarian cancer will be publicly perceived in the same light as those who denied a link between smoking cigarettes and cancer: “denying the obvious in the face of all evidence to the contrary.”

Talc is naturally occurring, mined from the soil and composed of magnesium, silicon, oxygen, and hydrogen. It’s widely used in cosmetics and personal care products, such as talcum powder, to absorb moisture, prevent caking and improve the product’s feel.

Nora Freeman Engstrom, a Stanford University law professor not involved in the Missouri case, said it’s unlikely the $72 million award will survive, noting that the U.S. Supreme Court, in a recent series of rulings, has maintained that appellate courts clamp down on punitive damages.

“Big jury verdicts do tend to be reined in during the course of the appellate process, and I expect that to be the case here,” she told The Associated Press.

The verdict Monday “doesn’t bode well for Johnson & Johnson” as it faces at least 1,200 still-pending lawsuits and possibly thousands more, she said.
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“This case clearly was a bellwether, and clearly the jury has seen the evidence and found it compelling,” she said, concluding “the jury was distressed by the company’s conduct.”

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Medscape surveyed almost 4000 primary care physicians and selected specialists to find out if and why they were sued and how the lawsuit affected their career and patient care decisions. Fifty-nine percent of respondents to the Medscape survey have been named in at least one malpractice suit. Nearly half (47%) were among others named in the suit, and 12% were the only parties sued. While among the specialties surveyed, some were sued more than other, no physicians are immune. According to a 2010 American Medical Association (AMA) survey on all physicians, on average 42.2% are sued, with 22.4% sued twice or more, and by late career the risk increases to 61%. [1]

The Most and Least Vulnerable SpecialtiesAccording to recent studies, among all physicians, obstetricians/gynecologists (ob/gyns) and surgeons are most likely to be sued, psychiatrists and pediatricians are least likely to be sued, and primary care physicians fall somewhere in between. [1,2] Of the specialties surveyed this year by Medscape, 85% of ob/gyns, 83% of general surgeons, and 79% of orthopedists reported having been sued. In addition, at 23% and 26%, respectively, general surgeons and orthopedists had the highest percentage among specialties surveyed of being the only parties named; ob/gyns came in third at 18%.

A 2015 analysis found that male doctors were nearly two and a half times more likely to have legal claims made against them than women doctors. [3] These findings were similar across a number of countries. The current Medscape survey also reflected this disparity: two thirds (64%) of male respondents reported being sued compared with slightly less than half of women (49%). Women are also far less likely to be the only named defendant in a suit (8% vs 14%). Women are sued less than men regardless of specialty (see Figure).

Figure 1. Physicians sued by gender and specialty.

Male physicians did have a slight edge (47%) over women (41%) in cases resolved in favor of the defendant either from dismissal or by verdict. Sex appeared to play no role in the percentage of cases that reached a settlement before or during trial (38% of men and 37% of women).
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According to the question on the experience of being sued, men and women seemed to differ on the intensity of its negative effect. Fifty-seven percent of women chose the most negative options: very bad (20%) or horrible—the worse experience of their lives (37%). Forty-five percent of men had these extreme responses (20% and 26%, respectively). About half of men (51%) said that it was merely unpleasant and irritating or upsetting, but they could function. Fewer women (41%) chose these less extreme options. Four percent of men and 2% of women were either neutral or thought it wasn't as bad as they thought it would be.

A 2011 analysis in the New England Journal of Medicine projected that 36% of physicians in low-risk specialties and 88% of those in high-risk specialties would experience a first claim by age 45 years; this would increase to 75% of low-risk specialists and 99% of high-risk specialists by age 65 years. [2] In the current Medscape survey, by age 54 years, 64% of the physicians who responded had experienced at least one malpractice suit over the course of their careers. After age 60 years, the percentage rose to about 80%. As one respondent wrote, "The older you get, the more you have to lose."

A JAMA study published in 2011 reported that 48% of paid claims were for events in inpatient settings, 43% in outpatient setting, and 9% in both. [4] In this year's Medscape survey, the largest percentages of those who faced lawsuits were in office-based solo practices (70%) or single-specialty groups (64%). Of interest, the second lowest percentage (53%) reported was from physicians in office-based multispecialty groups. Ownership may play a role in the higher risk in solo practices and single-specialty groups. In the 2010 AMA survey, physicians who had an ownership interest in a practice were at greater risk than those in other settings, with 47.5% of them reporting being sued compared with a third of those without ownership interest. [1] In the Medscape survey, the settings least likely to produce lawsuits (47%) were outpatient clinics. Continue Reading

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Megan Brooks

In response to the ongoing opioid abuse epidemic, top officials at the US Food and Drug Administration (FDA) today announced plans to reassess the agency's approach to opioid medications.

"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Robert Califf, MD, the FDA's Deputy Commissioner for Medical Products and Tobacco, said in a news release. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."

The plan is further outlined in an article published online today in the New England Journal of Medicine.

"Nationally, the annual number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents," write Dr Califf and coauthors Janet Woodcock, MD, and Stephen Ostroff, MD, also from the FDA. "Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable. As the public health agency responsible for over-sight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions. We are committed to action, and we urge others to join us."

The multicomponent plan will focus on policies aimed at reversing the epidemic, while still providing pain patients access to effective medication. Specifically, the FDA plans to:

* Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public-health effects;

* Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;

* Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;

* Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to those of the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;

* Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;

* Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;

* Improve access to naloxone and medication-assisted treatment options for patients with opioid-use disorders; and

* Support better pain-management options, including alternative treatments.

The FDA says they will seek guidance from outside experts in the fields of pain management and drug abuse. The agency has already asked the National Academy of Medicine to assist in developing a framework for opioid review, approval, and monitoring that balances an individual's need for pain control with considerations of the broader public-health consequences of opioid misuse and abuse.

The FDA says it will convene independent advisory committees made up of physicians and other experts when considering approval of any new opioid drug that does not contain abuse-deterrent properties. The agency will also convene a meeting of its standing Pediatric Advisory Committee to provide advice on a framework for pediatric opioid labeling and use of opioid pain medications in children.

The FDA also plans to tighten requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids, an action, they say, that will generate the "most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose and death."

Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States.

"Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence," Dr Califf said in the FDA statement. "It's time we all took a step back to look at what is working and what we need to change to impact this crisis."

"Agencies from across the Department of Health and Human Services and throughout the federal government are united in aggressively addressing this public health crisis," US Health and Human Services (HHS) Secretary Sylvia M. Burwell, said in the news release. "The FDA is a vital component to combating this epidemic, and the innovation and modernization they have committed to undertaking is an important part of the overall efforts at HHS."

Last spring, HHS announced a major initiative to address the opioid abuse epidemic in the US. The initiative focuses on informing opioid prescribing practices, increasing the use of naloxone, and using medication-assisted treatment to move people out of opioid addiction.

The FDA says it will provide updates on progress with the goal of sharing timely, transparent information on a regular basis.
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NEJM. Published online February 4, 2016. Abstract

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