PHILADELPHIA – In continuing testimony taken during the first punitive damages trial surrounding anti-psychotic drug Risperdal in Philadelphia, a Johnson & Johnson senior director said that the company and its subsidiary Janssen Pharmaceuticals were not responsible for attempting to “spin” information provided to the media about the medication.
The trial is significant as Philadelphia’s Complex Litigation Center is home to thousands of similar claims from out-of-state plaintiffs, and the city has a reputation for high-dollar verdicts. It's the first time in Philadelphia that a jury can consider assessing punitive damages in a Risperdal case and also another front the company must fight as it litigates opioid, talcum powder and other mass tort cases elsewhere.
In Murray v. Janssen Pharmaceuticals, involving Maryland plaintiff Nicholas Murray, a jury decided the case in Murray’s favor in November 2015 and awarded him $1.75 million. The $1.75 million jury verdict represented damages for “disfigurement and mental anguish," though it was later cut down to $680,000.
For the second trial, plaintiff counsel will attempt to prove that the companies deliberately disregarded evidence that Risperdal could lead to gynecomastia in young males, and nonetheless released the drug into the open market for prescription and use by patients without disclosing the side effects.
Murray was prescribed Risperdal at the age of nine in 2003, for off-label treatment of symptoms associated with his Asperger’s Syndrome. Like other plaintiffs who stepped forward, Murray also developed gynecomastia.
The Cross-Examination of Dr. Gahan Pandina Continues
Monday morning opened with plaintiff counsel Jason Itkin’s further cross-examination of Dr. Gahan Pandina, a Senior Director of Clinical Research at Johnson & Johnson since 2001.
Itkin’s questioning surrounded points from business-planning sessions and internal company email correspondence, discussing the formation of relationships between the company and key opinion leaders (KOLs) in the field of pediatric psychology, meaning doctors who were specialists in the field.
It was suggested by plaintiff counsel that the purpose of these relationships was for the company to share its own crafted message of information about Risperdal to those doctors.
In one email message, a company higher-up, Dr. Remy Mahmoud, called the move “a great way to get out to the child and adolescent prescribing community.”
One heading from a subsequent company planning document said it was key to “train KOL’s to handle the media” and that the company “needed to make a proactive media plan.”
“Why do they need a media plan [in regards to Risperdal] if it wasn’t approved for kids?” Itkin asked.
Pandina replied that the company received a number of media requests and inquiries on its products from the press, and it was important for the company to be able to handle those requests properly.
Citing an alleged conflict of interest, Itkin asked Pandina if it was inappropriate that scientists presenting themselves as independent researchers were paid by the drug company to talk to the media.
“I wouldn’t know,” Pandina replied.
Another exhibit presented was an internal pharmacovigilance, or drug safety, report on Risperdal from the year 2000.
Under the heading “Summary & Conclusions”, the document read: “Not yet approved or recommended for use in children and adolescents.”
After the exhibit was entered into evidence, Itkin returned to the issue of marketing.
“Was it improper to market a drug that Johnson & Johnson’s safety department said wasn’t recommended for use in children and adolescents?” Itkin inquired.
Pandina responded, “I can’t answer that.”
In another email exchange, a Dr. Georges Gharabawi, Pandina’s supervisor, said in response to a question about weight gain experienced by pediatric subjects in clinical trials, in part: “The brand team will need to meet and agree on how to spin the message before we put together any manuscripts.”
Itkin asked Pandina if it was true that a company shouldn’t “spin” scientific data, and Pandina replied that he “wouldn’t use the word spin” in this instance.
In an email to the company’s Pediatric Publication Team later published to the jury, clinical studies supervisor Carin Binder mentioned a “nauseating amount of info” on “SHAP” (Side Effects Hypothetically Associated with Prolactin) across every age group and related gynecomastia, in one draft of an article credited to Dr. Robert Findling.
Plaintiff counsel argues that a table in that article showed a statistically-significant relationship between prolactin levels and gynecomastia.
Another email was entered into evidence from Pandina to Gharabawi from December 2002, one that read, in part: “We may need to address this at the global level, as this could potentially negatively impact risperidone across all segments.”
A 2005 letter from the company sent to the Food & Drug Administration said there was “no correlation between prolactin levels and adverse events that are potentially attributable to prolactin” – a determination plaintiff counsel said was contrary to a finding from the deposition testimony of a Johnson & Johnson scientist, Dr. Ivo Caers.
Caers claimed there was in fact a statistically-significant correlation between SHAP-related adverse events and prolactin levels during weeks 8 to 12 of a clinical trial.
“Have you seen any conduct by the drug company that needs punishment?” Itkin asked.
“No,” Pandina said.
Johnson & Johnson Counsel Conducts Direct Examination
Defense counsel John Winter began his direct examination by asking Pandina about his background, before turning to a number of different internal company emails Pandina wrote.
In one, Pandina said: “Prolactin levels do not correlate with adverse events, nor does prolactin level predict who might develop an adverse event.”
Pandina emphasized that significant research was done on the subject of prolactin levels and adverse events in those who participated in clinical trials.
Pandina was further asked by defense counsel about a number of emails he had written or was copied on.
In one email that was discussing a Jan. 24, 2002, meeting in Toronto, it read that “expert endocrinologists agreed that the pediatric trial date shows no relationship to prolactin elevation, and prolactin levels decrease to within normal ranges by Weeks 48-54 [of the study].”
Winter asked Pandina about his remarks regarding negative impact to risperidone and addressing trial results on the global level.
Pandina said he meant that “the inclusion of a recommendation for prolactin monitoring would be a departure from past studies, and should be reviewed by our global team internally.”
“Was there anything in the label that says to monitor prolactin?” Winter asked.
“No,” Pandina said.
When it came to the matter of the company’s business plan published in 2001 for Risperdal, Winter asked if the positioning statement related to what company sales representatives told physicians or if it was used in calls to physicians.
Plaintiff counsel Tom Kline objected to both questions, asking how the witness would know the answer to those questions.
“It was used for internal marketing purposes, not for sales. But I’m not a sales expert,” Pandina said.
Pandina was also asked if a section titled “Clinical Data Key Messages” was used by company sales representatives.
“Not to my knowledge,” according to Pandina.
It was mentioned that Pandina was part of a team who conducted 18 different studies on Risperdal, and was asked why such a number were completed.
“We were looking to pursue development of indications for irritability of symptoms associated with autism, pediatric bipolar disorder and adolescent schizophrenia,” Pandina said, along with “possible indications for treatment of children and adolescents.”
In response to a question of why he worked on Risperdal, Pandina said his intent was to provide information on treatment of devastating disorders.
On the subject of LEGO blocks stamped with “Risperdal” on them, referred to by the defense as “squeeze balls”, Pandina was asked when they were made available.
“Right around the time we made our determination for irritability for symptoms associated with autism and Risperdal,” Pandina said, explaining they were produced for doctors.
Previously, plaintiff counsel attempted to link the LEGO blocks with an alleged move by the company to market the drug toward children.
During a brief re-direct examination, Kline picked up one of the LEGO blocks and rhetorically asked Pandina, “These were for doctors?”
Philadelphia County Court of Common Pleas case 130401990
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com