The National Trial Lawyers
  • Home
    • Meet Our Team
    • Contact Us
    • Mission & Goals
    • FAQ
  • Webinars
  • News
  • Membership Directory
    • Top 100 Map – Civil Plaintiff
    • Top 100 Map – Criminal Defense
    • Top 40 Under 40 Map – Civil Plaintiff
    • Top 40 Under 40 Map – Criminal Defense
  • Top 100
    • Civil Plaintiff Officers / Executive Committee
    • Criminal Defense Officers / Executive Committee
    • Benefits
    • About
    • Top 100 President’s Message
    • Diplomat
    • Membership Renewal
    • Member Profile Updates
    • Top 100 Badge
    • Media
  • Top 40
    • Civil Plaintiff Officers / Executive Committee
    • Criminal Defense Officers / Executive Committee
    • Top 40 Under 40 Trial Academy Bootcamp
    • Benefits
    • About
    • Top 40 President’s Message
    • Membership Renewal
    • Member Profile Updates
    • Top 40 Badge
    • Media
  • Specialty Assoc
    • About
    • Shop
    • Officers
    • Membership Renewal
    • Member Profile Updates
    • Media
  • Nominate
    • Top 100
    • Top 40
    • Specialty Association
    • Trial Lawyer Hall of Fame
    • Trial Lawyer of the Year
    • Trial Team of the Year
    • America’s Most Influential Trial Lawyer
    • America’s Most Influential Law Firm
    • Lifetime Achievement Award
  • Shop
  • Magazine
    • A-List
  • Education and Networking Agenda
    • Trial Lawyers Summit
      • Summit Sponsors
    • Top 40 Under 40 Trial Academy Boot Camp
    • Mass Torts Made Perfect
    • The Lanier Master Class 5.0 Trial Academy 2021
    • Webinars
  • Hall of Fame
    • Trial Lawyer Hall of Fame

Risperdal Behind Massive Spike in Mass Tort Litigation

Posted on February 22, 2017 by Larry Bodine

Risperdal-V2-headerBy Anjelica Cappellino. This article is reprinted from The Expert Institute.

There has been a huge spike in mass tort litigation due to the Johnson & Johnson medication, Risperdal, an anti-psychotic drug used to treat schizophrenia and other psychiatric disorders. Risperdal has been the center of litigation for years due to allegations that the drug causes breast tissue growth in young men, a condition called gynecomastia. This past year, however, Risperdal has accounted for over a third of all mass tort lawsuits pending in the Philadelphia Complex Litigation Center. Mostly comprised of individual suits rather than class actions, the verdicts may differ greatly, depending upon the evidence presented in each case. Due to the scientific and medical nature of the drug’s effects, experts in the field may strongly impact the verdict.

Risperdal’s Litigation History and Current Lawsuits

Risperdal has received a significant amount of attention dating back to 1994, when the drug first went on the market and Johnson & Johnson was accused of illegal marketing activities. In one of the largest health care fraud settlements in United States history, Johnson & Johnson was forced to pay more than $2 billion in penalties and settlements to state and government entities as a result of lawsuits relating to Risperdal and two other drugs, as well as civil and criminal complaints about their use. The Department of Justice stated Risperdal and two other Johnson & Johnson drugs were promoted for dementia patients, when Risperdal was approved only to treat schizophrenia. The Food and Drug Administration did not approve this use as safe and effective.

Deceptive marking actions are not the only claims against Risperdal.  The largest cause of action against the drug is that it causes men to develop gynecomastia. This breast development can have devastating and long-term effects on young men. At least 13,000 product liability claims involving Risperdal have been filed in courts around the United States, alleging that Johnson & Johnson was aware that the medication could cause gynecomastia, but concealed that information to the public.

Most of the current litigation is pending in the Los Angeles Superior Court and the Philadelphia Court of Common Pleas in Pennsylvania, where a small group of cases went to trial as part of a bellwether trial process. In February 2015, in one of the first cases to go to trial, a Pennsylvania jury awarded $2.5 million in damages to a 20-year old male plaintiff who had been using Risperdal since he was eight years old. A month later at the second trial, the plaintiff was not awarded any damages after a jury concluded that there was insufficient evidence that Risperdal caused his breast growth. However, the jury did find that the company provided inadequate safety warnings. In November of that same year, a separate jury in the same court awarded $1.75 million to another Risperdal user who developed breasts after taking the drug since age five. In July 2016, the largest award in Philadelphia Risperdal litigation was reached. A jury awarded a Tennessee teenager $70 million in damages after finding that Johnson & Johnson officials failed to warn the young man and his family that the drug could cause him to grow breasts. Most recently, in January 2017, Johnson & Johnson entered into a pre-trial settlement days before another Philadelphia trial, a case which would have been the seventh trial about Risperdal’s link to gynecomastia.

With more than 2,000 cases pending in the Complex Litigation Center of the Philadelphia Court of Common Pleas, and another 300 cases pending in Los Angeles Superior Court, litigation is far from over. The total number of mass tort cases pending in Philadelphia’s Complex Litigation Center at the beginning of 2017 has risen to its highest level in more than five years. Risperdal accounts for the second largest percentage of cases, making up more than 31 percent of Philadelphia’s mass tort docket. In 2016, there were 550 pending Risperdal cases, a 40 percent increase from the previous year.

How Have the Experts Weighed in?

Since the inception of the first lawsuit, expert witnesses were vital to the outcome of the case. David Kessler, a pediatrician and former Food and Drug Administration Commissioner, has been a vocal expert witness in the Risperdal litigation. Since 2012, Kessler has offered his expert services to plaintiffs as both a pediatrician and failure-to-warn expert, writing detailed reports about Johnson & Johnson’s promotion of Risperdal for non-approved uses in children. In 2015, Kessler testified in a Philadelphia trial that Johnson & Johnson knew as early as 2001 that Risperdal could cause gynecomastia in boys, five years before the company adding a warning about such a side effect on its label. The crux of most Risperdal cases is whether the company adequately warned the plaintiff of the drug’s side effects. Therefore, expert testimony like Kessler’s is indispensable in establishing that Risperdal did not contain adequate warnings of its possible side effects.

As plaintiffs often begin taking Risperdal in their youth, pediatricians have served as vital expert witnesses in explaining the effects of the drug on young males. Pediatric neurologists and endocrinologists have testified to explain how the drug affects the hormone levels and nervous system. Specifically, the drug stimulates the pituitary gland and elevates levels of prolactin, a hormone that is related to female breast development and lactation in nursing mothers.

In addition to Risperdal’s long-term effects on young men, the causal link between Risperdal and gynecomastia must also be established. As David Kessler previously testified in January 2015, he concludes that there is a connection. Kessler has pointed to a clinical trial, funded by Johnson & Johnson, that showed 3.8% of young males using Risperdal developed breasts. Kessler testified that the medication “probably or very likely” triggered the condition. Because gynecomastia is caused by elevated amounts of prolactin, experts have testified that if children’s levels of prolactin are monitored while on the medication, the development of gynecomastia can be more easily recognized, opposed to incorrectly attributing the side effects to weight gain.

In light of the growing mass tort litigation, the Philadelphia Court of Common Pleas is scheduled to convene a meeting on March 9, 2017 concerning its centralized docket of Risperdal claims. Although several plaintiffs have reached confidential settlements prior to trial thus far, there are thousands of cases that are still pending and there are no signs that litigation will slow down in 2017.

Posted in Blog, Product Liability

Comments are closed.

News Categories

Subscribe to Blog and VFJ via Email

Enter your email address to subscribe to this blog, the Voice for Justice and receive notifications of new posts by email.

Read about other Top Jury Verdicts

Toyota Will Pay $180M to Settle Violations of the Clean-Air Act

Toyota Will Pay $180M to Settle Violations of the Clean-Air Act

The U.S. Department of Justice and U.S. Environmental Protection Agency (EPA) announced today that the United States has[Read More...]
Boeing's Insitu Will Pay $25M to Settle a Whistleblower Complaint About Used Drone Parts

Boeing's Insitu Will Pay $25M to Settle a Whistleblower Complaint About Used Drone Parts

Bingen, Wash.-based Insitu, a Boeing subsidiary, has agreed to pay $25 million to settle allegations that it used recycl[Read More...]
Deutsche Bank Agrees to Settle Criminal and Civil Charges for $130M

Deutsche Bank Agrees to Settle Criminal and Civil Charges for $130M

DEUTSCHE Bank AG agreed to pay US$130 million to settle criminal and civil charges that it bribed foreign officials and manip[Read More...]
Boeing Pays $2.5B to Settle Charges Tied to the 737 MAX Crashes

Boeing Pays $2.5B to Settle Charges Tied to the 737 MAX Crashes

Boeing has agreed to pay just over $2.5 billion to resolve a federal charge of “criminal misconduct” for how its [Read More...]
Texas Attorney General Seeks $43M in Google Antitrust Lawsuit

Texas Attorney General Seeks $43M in Google Antitrust Lawsuit

The mass exodus of Texas Attorney General Ken Paxton's top staff over accusations of bribery against their former boss has le[Read More...]

#LegalNews

@@TheNTLtop100

Contact Us | Terms of Use | Privacy Policy

Attorney information and content provided on this website is provided for the benefit of members of The National Trial Lawyers and as a public service by Legal Associations Management, Inc. The website and all data are the property of Legal Associations Management, Inc. Data, including without limitation attorney information and content, on the site may not be mined, sold, or used commercially for any purpose without the explicit written consent of Legal Associations Management, Inc. This site may not be accessed by any automated program for extracting data for any use. By accessing and using the site you agree that you will not develop, support or use software, devices, scripts, robots, or any other means or processes (including crawlers, browser plug-ins and add-ons, or any other technology) to scrape data or otherwise copy profiles and other data. Unauthorized use or attempted unauthorized use of this system may subject you to both civil and criminal penalties.