The analysis published in the New England Journal of Medicine, reveals the FDA is concerned that the use of bisphosphonates actually contributes to rare but serious adverse events associated with bisphosphonates, such as atypical femur fractures, osteonecrosis of the jaw, and esophageal cancer.  The FDA is urging new labeling to properly reflect the serious nature of these potential injuries.

According to the FDA analysis of the FLEX trial, “the rates of vertebral and nonvertebral osteoporotic fractures were similar whether participants continued to receive alendronate (Fosamax) for up to 10 years (a rate of 17.7%) or were switched to placebo for the extension period (16.9%). In the time-to-fracture analyses, fracture rates were consistent across treatment groups (Fosamax 5 mg, Fosamax 10 mg, and placebo) and all subgroups of bone mineral density through year 3 (approximately 8 years of continuous treatment, including the registration period).” Thus, there is a question of the efficacy of these drugs after 3 to 5 years.

Helpful links.

http://www.nejm.org/doi/full/10.1056/NEJMp1202619?query=featured_home&

http://www.bloomberg.com/news/2012-05-10/bone-drugs-may-not-help-women-long-term-fda-review-says.html

Proscar was approved in 1992 for treatment of in men with benign prostatic hyperplasia (also referred to as BPH or an enlarged prostate).

Propecia was approved in 1997 for the treatment of men with male pattern hair loss.

Helpful links:

FDA: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=propecia&utm_content=6

Bloomberg Article:

http://www.bloomberg.com/news/2012-04-12/merck-s-baldness-drug-linked-to-sex-concerns-after-use.html

Both women developed breast cancer after taking combination estrogen and progesterone products manufactured by the defendants.

The decision comes on the heels of a $76.4 million dollar verdict against Pfizer’s units Wyeth and Phamacia & Upjohn in favor of three women who developed breast cancer after Pfizer’s menopausal drugs, Premarin, Prempro and Provera.

Connie J. Barton v. Wyeth Pharmaceuticals Inc., 694 EDA 2010, Superior Court of Pennsylvania; Donna Kendall v. Wyeth Inc., 936 EDA 2010, Superior Court of Pennsylvania.

Helpful Links.

http://www.bloomberg.com/news/2012-01-04/pfizer-must-pay-45-million-in-prempro-cases-pennsylvania-court-rules.html

http://www.businessweek.com/news/2012-01-05/pfizer-must-pay-45-million-in-prempro-cases-court-rules.html

The latest revelation comes after a $72.6 million dollar jury verdict against Pfizer and its units Wyeth and Pharmacia & Upjohn in Philadelphia in early December, 2011. Before the Philadephia jury could consider punitive damages, Pfizer settled the case.

Pfizer also announced that it has set aside additional funds for settlement purposes. However, many plaintiff attorneys are doubtful the slugfest will resolve any time soon.

Helpful link:

http://www.bloomberg.com/news/2011-12-15/pfizer-has-settled-about-half-of-prempro-cases-adds-to-reserve.html

Plaintiff Judy Mulderig used Premarin and Provera for more than 11 years and was awarded $24.75. Plaintiff Bernadette Kalenkoski used Prempro for 4 years and was awarded $27.85 million while Susan Elfont was awarded $20 million.

It is estimated that jury verdicts to date against Pfizer and its units exceed $121 million dollars.  Further, it is estimated that more than $243 million in punitive damages have been awarded by juries in the Prempro litigation.

Pfizer faces numerous jury trials in federal district courts throughout the United States in calendar year 2012.

Helpful link:

http://www.bloomberg.com/news/2011-12-06/pfizer-prempro-drug-caused-women-s-breast-cancer-jury-rules.html

Besides Johnson & Johnson, C.R. Bard, Inc., and Endo Pharmaceutical Holdings, Inc. also manufacture vaginal mesh. At this juncture, it is unclear what the FDA will do with vaginal mesh products.

But what should the recipient of a vaginal mesh product do?  If you are experiencing problems associated with a vaginal mesh product, talk to your doctor.

Protect Your Legal Rights

If you or a loved one has been injured from a vaginal mesh product, call our office for a confidential consultation.  The James Esparza Law Firm has helped thousands of individuals and families who have been injured from medical devices and pharmaceutical products. We would like to help you too.

Helpful Links:

Bloomberg:

http://www.bloomberg.com/news/2011-09-07/j-j-s-vaginal-mesh-to-be-weighed-by-fda-advisory-panel-as-lawsuits-climb.html

This ruling is the exact opposite of how Judge William R. Wilson ruled in MDL 1506, In re Prempro Products Liability Litigation. Judge Wilson ruled that there exists no commonality of interest among the claimants.

http://www.vancouversun.com/health/Judge+certifies+class+action+lawsuit+involving+hormone+therapy+drug/5213703/story.html

Mrs. Hine’s lawyer, Harry F. Bell Jr. of The Bell Law Firm, said “the verdict is not surprising given the defense’s resources and how restricted the evidence in the case was.”  Mr. Bell went on to state:

The defense’s resources also were considerable.

“I wish people could understand the time and resources they put into this case,” he said.

Bell said the company’s attorneys set up a temporary office in downtown Charleston and brought in jury consultants and focus groups.

Then they bombarded the court with motions, he said.

“They just pounded us on every single argument, every single point,” Bell said. “They slammed the court and us with a lot of motions. And I’d say the vast majority of those motions, the defendants won.”

Helpful Links

http://www.wvrecord.com/news/237265-hormone-therapy-drugs-didnt-cause-cancer-jury-rules

http://www.bloomberg.com/news/2011-07-28/pfizer-s-prempro-didn-t-cause-woman-s-cancer-jury-concludes.html

http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2011/07/28/bloomberg1376-LP2C9F6JTSE901-640J3CSH2UJ0DR543FHO5K4EN0.DTL

The report calls for and integrated premarket and post-market approach to insure that a device is safe and effective for the life of a device.

As expected the medical device industry rejected the report, saying it did not deserve “serious consideration” from Congress or the Obama administration.

Helpful Links

http://www.nytimes.com/2011/07/30/business/study-calls-approval-process-for-medical-devices-flawed.html?_r=1&hp

http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/Report-Brief.aspx

”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”

TVM is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), conditions that may occur after childbirth and pregnancy. In 2010, more than 75,000 women had vaginal mesh surgery to repair POP.

Recent research shows that at least 10% of women who have received TVM implants suffer from mesh erosion within 12 months of surgery and more than half of these patients require additional surgery to remove the mesh following complications.

The advisory also noted that the FDA will be meeting on September 8-9, 2011 to discuss a potential ban on the mesh. The FDA was prompted to issue this warning after receiving more than 3,875 injury reports associated with the mesh, three of which involved fatalities, from 2005 to 2010.

What Patients Should Do?

• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

If you or a loved one has been harmed by a transvaginal mesh, call the James Esparza Law Firm for a confidential discussion of your legal rights. Our law firm has helped thousand who have been harmed by faulty medical devices.  We would like to help you too.

Call Now 1-800-745-4050

Helpful Links:

FDA

Press Release 07/13/2011

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm

Urogynecologic Surgical Mesh

http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

Los Angeles Times

Revaluating Vaginal Mesh Implants

http://www.latimes.com/news/nationworld/nation/sc-dc-0714-fda-mesh-20110714,0,6030373.story

Washington Post

FDA: Complications From Mesh For Pelvic Organ Prolapse ‘Not Rare’

‘http://www.washingtonpost.com/blogs/the-checkup/post/fda-complications-from-mesh-for-pelvic-organ-prolapse-not-rare/2010/12/20/gIQADWtwCI_blog.html