America's Most Admired Lawbreaker: Chapter 15, The Verdict...And 'Moving On'
'Very Full, Pendulous Women's Breasts' The following are excerpts from Tom Kline’s closing argument for the plaintiff: Ivo Caers confirmed for us Table 21 was never reported to the FDA. … We know now what’s behind the tables: The little girls with the lactating breasts … and the little boys even under ten who have gynecomastia. My word. And when Dr. Kessler told us, ‘Red flag. This isn’t cherry picking.’ When a pharmaceutical company acting reasonably and prudently has this k
America's Most Admired Lawbreaker: Chapter 13, "Hardball"
A 'Hired Bazooka' Question: Mrs. Pledger, I think you told our jurors that during the time that you're taking Mr. Pledger to doctors while he was on Risperdal, none of his doctors ever diagnosed gynecomastia? Benita Pledger: I never heard of gynecomastia. And, no, they did not. Question: At some point … you saw a commercial on TV for a Plaintiff’s law firm about Risperdal and lawsuits running?
… And it had a phone number 1-800, call if you have taken Risperdal? Pledger: It ha
America's Most Admired Lawbreaker: Chapter 10, "Chess at $1,000 An Hour"
The New CEO On February 21, 2012, five weeks after Johnson & Johnson paid $158 million to Texas and made Allen Jones a multimillionaire, the company announced that the board had appointed Alex Gorsky to succeed William Weldon as the new chief executive officer. The press release noted that Gorsky had begun at J&J in 1988 as a salesman for Janssen and then worked his way up to president of the unit. Although he had left in 2004 to run rival Novartis' North American division, h
America's Most Admired Lawbreaker: Chapter 8, "Firing Blanks, Hunting for Smoking Guns"
A Weak First Case On December 14, 2006, Stephen Sheller filed his first case against Johnson & Johnson. The client was a New Jersey boy who had taken Risperdal beginning in 2001. When he had met the boy and his mother, Sheller thought the case would be about diabetes and weight gain. But then she and her son became traumatized by his growing breasts, and in August 2004, he had radical surgery to remove them. Still, the suit focused on diabetes, and the complaint Sheller wrote
America's Most Admired Lawbreaker: Chapter 7, "A Multi-Front War"
Heavy Up Top Since he had begun taking Risperdal, Austin Pledger was having fewer tantrums. The reports Benita Pledger read from her son's school reflected what she was seeing at home: "His frustration behavior has greatly," his special education teacher wrote in April 2004. But it was far from a complete turnaround. Austin would still erupt in volatile behavior, biting himself or suddenly dropping to the floor and pounding his head. Benita and Phillip continued to dote on hi
America's Most Admired Lawbreaker: Chapter 5, "Three Card Monte"
A Convenient Re-Analysis Six days before Austin Pledger swallowed his first Risperdal, Janssen scientists and marketing executives met with an advisory board of doctors in a luxury hotel suite in New York. The group wrestled with problems concerning the prolactin and gynecomastia data that had come in from the clinical study Gorsky and his team had ordered up, hoping to put the issue to rest. This new study was actually a study of studies. It pooled the one study called “INT-
America's Most Admired Lawbreaker: Chapter 3, Sales Over Science
Putting The Risks in 'Tiny Font' By the beginning of 1999, Johnson & Johnson had expanded the ElderCare unit to 136 salespeople from 83, and the materials they were using to pitch doctors had caught the FDA’s eye. On January 5, Lisa Stockbridge of the FDA’s Division of Drug Marketing, Advertising and Communications wrote to Janssen’s director of regulatory affairs complaining that “presentations that focus on this population are misleading in that they imply that the drug has
America's Most Admired Lawbreaker: Chapter 2, Blowing Past the Label
'Otherwise The Sky Would Be The Limit' In 1961, newspapers around the world ran stories (accompanied by horrific images) of deformed babies whose mothers had taken a drug to curb nausea during pregnancy called thalidomide. A vigilant FDA inspector had refused to approve thalidomide for sale in the United States because she was worried about its safety. But the thalidomide story, along with persistent new reports about other drug company abuses, were highlighted in hearings co
Getting your Kid to Talk about School
As the first day of school quickly approaches, parents are asking me how to get their kids to talk to them more about school. We parents want information! We feel that in exchange for our nurturance and worry and everything we did to get them ready for school, we should at least get to know what's happening there! StartFragment So how can you get more than a "fine" out of your kids when you ask them "How was school?" Drawing on techniques from some of the most brilliant peopl
10 Do's & Don't's for a Successful Start to Kindergarten
My "big girl" is starting school next week. We have gone to her school and met some of the teachers, the principal, and done a little tour. Despite being told multiple times we were just there to finalize paperwork, she insisted on packing her backpack, bringing a snack, and was disappointed when we left her school after a half hour. While my sweet, eager little girl is only attending preschool for the first time, it got me thinking of how actual school isn't that far off. He