Lawsuits alleging that Propecia causes persistent sexual side effects in men have been piling up over the past year. According to aboutlawsuits.com, about two dozen complaints have been filed in eight different federal district courts. More importantly, it is expected that in coming months the number of claims will turn into several hundred. In situations where there are more than 100 cases filed in federal court against the same pharmaceutical defendant, the solution is often the formation of an MDL, or Multidistrict Litigation. This may be happening very soon, according to aboutlawsuits.com.

On December 6^th, plaintiff Christopher Masefield filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to consolidate claims against Merck, manufacturer of finasteride drugs Propecia and Proscar. Masefield is asking that the litigation be centralized and consolidated in the U.S. District Court for the Eastern District of New York, or the Western District of Washington.

What is a Multidistrict Litigation?

For those of you who are not familiar with the term, a multidistrict litigation is a way of dealing with a large number of claims. Once an MDL is established, all claims of the nature are consolidated to one judge and centralized in one district of the United States. They are consolidated for efficiency purposes to avoid duplicative discovery and to ensure consistent pretrial rulings.

Multidistrict litigation is often confused with class action suits, as they both deal with a large number of claims. However, an important distinction is that a class action suit is structured so that an individual (or small group of individuals) sues on behalf of a large number of people. They also distribute the money more equally regardless of each plaintiff’s individual circumstances. In a multidistrict litigation, each plaintiff has their own claim and the claim has its own value.

More on Propecia

Recently, Men’s Health printed an article  on Propecia’s devastating effects on some men. They cite scientific studies, including one dating back as far as 2003 in the journal Urology. There were many men who dropped out of the study due to the intolerable nature of the sexual side effects. As Merck has always acknowledged that sexual side effects were possible while on the drug, the drop outs were not of concern. However, according to Dr. Wessells, lead investigator of the study, only half of the men who dropped out of the study saw full resolution of their symptoms 6 months after taking the pills. “It was always one of the strange things about that study, as to why these men didn’t get better” he recalled.

As more instances of persisting sexual side effects have been reported, more doctors have become interested in finding answers. Included is Dr. Michael Irwig, endocrinologist at George Washington University and lead researcher of March 2011 study on finasteride use- published in the Journal of Sexual Medicine.

Despite the compelling studies that have shown a correlation between finsateride and sexual side effects, there are still many pieces that doctors and researchers are trying to put together. Most importantly, patients and doctors alike are still desperately searching for an effective treatment for what some doctors are diagnosing as “PFS,” or “Post-Finasteride Syndrome.”

If you have taken Propecia or Proscar and are experiencing sexual side effects, please contact our office for a private and free consultation.

Additional Resources (besides those linked above):

Propeciahelp Website Men’s Journal November 2011

Although it may not work for everyone, there is not much dispute over whether or not Chantix can be an effective aid for quitting smoking. The safety of using the drug, however, has increasingly become a subject of controversy. Recent studies have come to very conflicting conclusions as to whether or not the risks outweigh the benefits. Pfizer, the manufacturer of Chantix, is siding with the FDA on this one.

When Chantix was approved for market in 2006, the patient information did not warn of any neuropsychiatric side effects. Users started to experience and report adverse events related to mood and behavioral change. The FDA put pressure on Pfizer to warn for the potential psychiatric effects that had been reported since the drug came on the market. While Pfizer slightly altered labeling to honor the FDA’s request, the added warning proved to be insufficient as more and more adverse events were reported in the next years.
Users and family members of users were reporting an increasing amount of suicidal behavior and depressed mood disorders. Finally, the FDA required Pfizer to add a black box warning on the label in 2009.

The FDA sponsored two post-market studies that measured the frequency of psychiatric episodes requiring hospitalization compared to other nicotine replacement therapy. They announced the results at the end of October, reporting that Chantix does not pose a substantially greater risk for neuropsychiatric adverse events than alternative drugs of its kind.

Meanwhile, researchers at Safe Medicine Practices, an independent drug safety research group, had been conducting similar studies. They released their findings last week, reporting that 90% of all reported suicides related to anti-smoking treatments from 1998 to 2010 involved Chantix, even though the drug was only on the market for 4 of these years. “We believe this drug is not suitable for use as a first choice for people who are trying to stop smoking,” researcher Thomas J. Moore told WebMD.

The Safe Medicine Practices study is published online and appears in the November issue of PLoS One. Researchers say that Chantix use was eight times more likely to result in suicidal behavior or depression than use of nicotine-replacement gums, patches, lozenges, and inhalers.

Because the FDA studies examined and relied on hospitalization records, Moore calls the studies “fatally flawed.”  “Suicide does not result in hospitalization” he says. They’ve asked the FDA to revise its labeling for Chantix to show the
increased risk found in their study. However, even though the FDA admits to significant limitations of the studies, it stands by its findings and insists the existing black box warning is sufficient.

Needless to say, Pfizer prefers the results of the FDA-sponsored studies over those of the independent research group. Pfizer now plans to conduct a new clinical trial examining psychiatric events in Chantix users compared to users of Zyban, nicotine replacement, and placebo in people with and without prior psychiatric problems. Results are expected to come out in 2017.

For now, the FDA is not adding any increased risk to the labeling of Chantix. However, it still carries the most serious warning the FDA gives, and for the same serious risks. Depression, suicidal ideation, suicide attempt, and completed suicide have all been reported in users taking Chantix, and none of these risks were published in early labeling.

If you believe you or a loved one has been adversely affected by Chantix, please contact an attorney immediately for a free consultation.