Ethicon TVT Mesh Lawsuits Consolidated In Federal Litigation All Allege That Women Suffered Serious Injuries, Such As Pain, Infection, Bleeding, Mesh Erosion, And Vaginal Scarring, Due To Having Pelvic Mesh Implants.

Birmingham, AL -- (ReleaseWire) -- 07/30/2015 -- The federal judge managing the vaginal mesh lawsuits in the U.S. District Court, Southern District of West Virginia, has scheduled a consolidated trial for 26 Ethicon vaginal mesh lawsuits that name Johnson & Johnson's Ethicon Inc. unit as defendant. Southern Med Law represents women in product liability lawsuits across the country and reports that U.S. District Judge Joseph Goodwin said the bladder mesh lawsuits selected were filed by 26 women from West Virginia who all had Ethicon's Gynecare TVT mesh implanted to treat stress urinary incontinence. The Gynecare complaints allege that the women suffered such injuries as mesh erosion, infection, scar tissue, organ perforation, chronic nerve damage, pain and urinary problems. Judge Goodwin said the cases had common issues of law and fact. The jury trial, scheduled for November 2, will focus only on the plaintiffs' identical claims of design defects with the TVT mesh, according to the order. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327)

"The firm has spoken with many women who have suffered injuries from bladder mesh products and will continue to follow the developments of this multi-district litigation for our clients." Southern Med Law continues to offer free legal consultations. To speak with one of the firms vaginal mesh attorneys you can call 205-547-5525 or visit www.southernmedlaw.com for more information on mesh lawsuits and other medical device injuries.

As stated in court documents and by the U.S. Food and Drug Administration (FDA), transvaginal mesh products are used to treat stress urinary incontinence and repair. The FDA announced that the number of complaints it has received regarding surgical mesh products prompted a proposal to reclassify transvaginal mesh from a moderate-risk device to a high-risk device. In making its announcement in April 2014, the federal regulatory agency said the reclassification would mean that mesh manufacturers would have to submit premarket approval applications that details the risks, safety and effectiveness of their products if they want to continue selling them on the U.S. market.

Court documents indicate that Ethicon is one of seven transvaginal mesh manufacturers included in the multidistrict litigation (MDL) in the Southern West Virginia federal court where nearly 72,000 mesh complaints are pending. According to a court docket maintained specifically for MDL's nationwide, Ethicon currently is facing 25,475 pelvic mesh complaints as of June 15. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327) In addition to Ethicon, other companies involved in the litigation and the number of lawsuits pending against them are:

In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325), 15,989
In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326), 16,755
In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2187), 10,956
In Re: Coloplast Corp. Pelvic Support System Products Liability Litigation (MDL No. 2387), 1,960
In Re: Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440), 300
In Re: Neomedic Pelvic Repair System Products Liability Litigation (MDL No. 2511), 94
jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-June-15-2015.pdf, June 15, 2015]

About Southern Med Law
Southern Med Law represents to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. Francois Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal representation that assures success.

Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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Southern Med Law Represent Women In Morcellator Cancer Lawsuits That Allege Power Morcellators Can Spread Undetected Uterine Cancer During Hysterectomies And Myomectomies.

Birmingham, AL -- (ReleaseWire) -- 07/29/2015 -- Morcellator cancer lawsuits contend laparoscopic power morcellators have the potential of spreading uterine cancer when used during a hysterectomy or myomectomy (removal of uterine fibroids) and hysterectomy cancer lawsuits continue to filed on behalf of women who have developed uterine cancer due to the morcellation device. Southern Med Law notes, most recent morcellator cancer lawsuits to be filed were on behalf two Philadelphia women who assert that morcellator manufacturers, Olympus Corporation and its subsidiary, Gyrus ACMI, misrepresented their products as being safe to use and failed to warn of the cancer risks associated with power morcellators. The claims were filed separately but both are alleging that Olympus' power morcellators spread undetected uterine cancer in their bodies and the companies failed to design its product to eliminate the cancer risks. The morcellation complaints further allege that Japan-based Olympus should have reasonably known of the dangers associated with their devices. (Case Nos. 150401310 and 150401312, Court of Common Pleas, Philadelphia County)

"The risk of developing leiomyosarcoma is very real when a woman has a hysterectomy or myomectomy and the women who are filing morcellation lawsuits know all too well about the dangers involved in using power morcellators during these surgeries," says Dr. Francois Blaudeau, who recently settled the first morcellator cancer lawsuit against morcellator makers, LiNA Medical APS, Kebomed AG & LiNA Medical US. The complaint was filed on behalf of Pennsylvania resident, Scott Burkhart, whose 53-year-old wife, Donna Burkhart, died of metastatic leiomyosarcoma cancer in 2013, one year after having a robot-assisted hysterectomy with uterine morcellation. (Case No. 5:14-cv-1557, U.S. District Court, District of Pennsylvania)

Southern Med Law notes that laparoscopic power morcellators are used to grind uterine tissue into small fragments during a hysterectomy or myomectomy for removal through small incisions in the abdomen. The morcellator can spread the uterine tissue fragments containing the unsuspected cancer cells into the abdominal and pelvic cavity where the cancer cells may be dispersed throughout a woman's body. The U.S. Food and Drug Administration (FDA) conducted an analysis and found that the prevalence of unsuspected uterine sarcoma in women undergoing a hysterectomy or myomectomy to remove benign fibroids is 1 in 352 and the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. The FDA defines leiomyosarcoma as a rare and aggressive form of soft tissue cancer involving smooth muscle cells in the uterine and gastrointestinal areas.

[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014]

Due to the cancer risks surrounding laparoscopic power morcellators, the FDA issued a strong warning in November 2014 against using the devices for the majority of women who require a hysterectomy or myomectomy, including those who are going through menopause, about to enter menopause, or those who are good candidates for minimally invasive procedures that do not require the use of power morcellators. The FDA directed doctors to share this warning with their patients. The agency also directed power morcellator manufacturers to include a black box warning on their product labels about the cancer risks associated with their devices.

Court documents indicate that the growing number of morcellator cancer lawsuits has prompted a petition to the U.S. Judicial Panel on Multidistrict Litigation (JPML) for consolidating morcellation complaints. Six plaintiffs involved in power morcellation lawsuits have asked the JPML to transfer 22 morcellator complaints filed in 16 different federal courts across the country, as well as all other subsequently filed morcellator complaints, to the U.S. District Court, District of Kansas for coordinated pretrial proceedings. Court records show that the 22 morcellator cancer lawsuits name Johnson & Johnson's Ethicon unit as defendants. The JPML has scheduled oral arguments on the petition for October 1. (In Re: Power Morcellator Litigation, MDL Case No. 78)

About Southern Med Law
Southern Med Law representsto the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. Francois Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal representation that assures success.

Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

With Essure Lawsuits Pending, FDA Invites Public Comments At Meeting Of Its Advisory Panel On The Essure Birth Control System After Multiple Reports of Perforation Of The Uterus, Pelvic Pain, Ectopic Pregnancy, And Fetal And Adult Deaths.

Birmingham, AL -- (ReleaseWire) -- 07/28/2015 -- The U.S. Food & Drug Administration (FDA) is inviting interested members of the public to present data, information or oral or written views on Essure permanent birth control device at the FDA's meeting on September 24th. Southern Med Law notes that after Essure lawsuit filings and complaints surrounding Essure, the FDA has called for a meeting of its Obstetrics and Gynecology Devices Panel to seek expert scientific and clinical opinion on the Essure birth control implant after numerous reports of Essure side-effects including perforation of the uterus, pelvic pain, ectopic pregnancy, and even fetal and adult deaths. The FDA has opened a docket so that anyone interested in speaking at the meeting can submit electronic or written comments prior to the event.

[federalregister.gov/articles/2015/07/22/2015-17985/obstetrics-and-gynecology-devices-panel-of-the-medical-devices-advisory-committee-notice-of-meeting">federalregister.gov/articles/2015/07/22/2015-17985/obstetrics-and-gynecology-devices-panel-of-the-medical-devices-advisory-committee-notice-of-meeting, July 22, 2015]

"A citizen's petition was filed earlier this year with the FDA containing complaints about Essure. Now, women who have been injured by the birth-control product and other members of the public will have an opportunity to relay their own personal experiences about Essure. We encourage interested individuals to submit their comments or attend the meeting, if possible," says Dr. Francois Blaudeau, a founding partner of Southern Med Law, who is also a practicing obstetrician/ gynecologist.

The Essure birth-control system was approved by the FDA in November 2002 as a permanent birth control implant. During the outpatient procedure, a doctor inserts small, bendable coils through the vagina, cervix and uterus and into the fallopian tubes. Scar tissue forms around the coils over several months, which blocks the tubes to prevent insemination, the FDA explained. In June, the FDA posted a new page titled, "Essure Benefits and Risk" on its website and contains a list of long-term Essure side-effects, such as:

- Migration of Essure inserts through the fallopian tubes into the lower abdomen and pelvis
- Perforation of the uterus
- Pelvic pain
- Rash and itching associated with possible nickel allergy
- Unintended pregnancy, including ectopic pregnancy (apregnancy outside of the uterus)

The FDA's website says the agency has received 5,093 adverse event reports regarding Essure from November 2002, when the device was first approved, to May 31, 2015. The reports include mental irregularities, headache, fatigue, and weight fluctuations. There were also five reports of fetal deaths occurring in women who became pregnant after having an Essure implant. There were also four adult deaths reported, one reportedly due to uterine perforation during device placement and one death related to an air embolism during device removal surgery, according to the FDA.

[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452250.htm, June 24, 2015]

Court documents indicate that five Essure lawsuit claims have been filed in the U.S. District Court, Eastern District of Pennsylvania, seeking to remove a shield of protection from Bayer against liability lawsuits that allege such Essure side effects as pelvic pain, organ perforation and unintended pregnancies. According to the Essure lawsuit filings, Bayer purchased Conceptus, the original manufacturer of Essure which received approval from the FDA for the birth control implant. The FDA approved Essure with a list of conditions, one of which was a requirement for Essure's manufacturer to report adverse events resulting from the device. The complaints allege that Bayer concealed adverse events and the company's action invalidates Essure's conditional approval. According to the plaintiffs, Bayer's action opens the company up to product liability lawsuits over its Essure birth control devices. Bayer maintains that the company should continue to be shielded from Essure lawsuits because there is "no document which says the Essure PMA (premarket approval) is invalid." The federal judges presiding over the cases have not yet ruled on the plaintiffs' request. (Case No. 2:14-07315, 2:14-07316, 2:14-07317, 2:14-07318, 2:15-00384, U.S. District Court, Eastern District of Pennsylvania)

About Southern Med Law And Filing An Essure Lawsuit
Southern Med Law is an experienced law firm providing legal representation to the men and women across the country who have been victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. Francois Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Contact:
Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Bair Hugger Lawsuits Purport That Patients Developed Post-Op Infections After Knee And Hip Replacement Surgeries From Forced Air Warming Blankets.

Birmingham, AL -- (ReleaseWire) -- 07/27/2015 -- A conference will be held Monday to discuss 3M Bair Hugger lawsuits and post-operative infections sustained by hip and knee replacement patients from the Bair Hugger forced air warming blanket. Southern Med Law, an experienced law firm representing men and women in product liability lawsuits reports the warning blanket injury conference is geared to provide more information for a deeper understanding on how to proceed with 3M Bair Hugger lawsuits that purport 3M's Bair Hugger warming blankets have caused patients to develop prosthetic joint infections (PJI) following hip and knee implants after the Bair Hugger warming blanket disrupted the airflow in operating rooms and contaminate the sterile field in the rooms. This contaminated purportedly caused surgical patients to develop infections that required repeat surgeries replacement of their artificial joint and in some cases amputation. A strong connection has been shown between Bair Hugger and patients developing prosthetic joint infections (PJI) following hip and knee implants.

"Currently filed lawsuits contend there is a strong connection between the Bair Hugger forced air warmer blanket and patients developing prosthetic joint infections (PJI) following hip and knee implants. The teleseminar will be of great benefit to those who want more information on Forced Air Warming technology and how Biar Hugger, specifically, has affected the lives of many patients," says Dr. Francois Blaudeau, a founder of Southern Med Law.

3M Bair Hugger Warming Blanket
3M's Bair Hugger forced air warmer blanket uses FAW technology to maintain patients' normal body temperature during surgery to prevent hypothermia. According to 3M, Bair Hugger forced air warmer blanket is the first ever FAW system and has been used by 180 million patients around the world, a "number that increases by more than 50,000 patients each day." According to 3M's advertisement for the product, over 80 percent of U.S. hospitals use Bair Huggar therapy. The problems with the forced air warmer blanket comes in connection with PJIs. The number of PJI's following hip and knee implants has been on the rise since 1999, from less than 5 percent in 1990 to its current number of 3.5 percent, according to the presentation materials for teleseminar. Simultaneously, the medical field has taken steps, such as antibiotic protocols, cleaner operating rooms, body evacuation suits, and better sterilization procedures to prevent PJIs from occurring. However, FAW has not changed since that time and has been associated with contaminating sterile areas which leads to infections, according to the presentation materials.

[solutions.3m.com/wps/portal/3M/en_US/IPD-NA/3M-Infection-Prevention/products/catalog/~?N=7570550&rt=c3]

Bair Hugger Warming Blanket Lawsuit
Court documents indicate that 3M is facing multiple Bair Hugger warming blanket lawsuits. One lawsuit, filed in the U.S. District Court, District of Kansas, alleges that Bair Hugger caused the plaintiff to develop a Methicillin-resistant Staphylococcus aureus (MRSA) infection after undergoing a knee replacement surgery in September 2010. The plaintiff contends he had to have his leg amputated due to the infection. According to the forced air warming blanket lawsuit, the hot air accumulates under the surgical drape and escapes below the level of the surgical table. The complaint maintains that the escaped air creates warm, rising airflow currents that deposit bacteria from the floor of the surgical room into the surgical site. The Bair warming blanket lawsuit purports that 3M knew about the risks associated with its Bair Hugger system, but did not redesign the blanket or warn healthcare professionals about the risk.(Case No. Case 2:14-cv-02044). In another warming blanket lawsuit a 70-year-old man developed a deep-joint infection after hip replacement surgery purportedly due to the Bair Hugger. The infection caused the plaintiff to undergo 15 additional surgeries, including a revision surgery for his artificial hip. (Case No. 4:13-cv-01164, U.S. District Court, Southern District of Texas)

About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. Francois Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Southern Med Law Represents Women In Morcellator Lawsuits Who Have Undergone Robotic Hysterectomies Using Laparoscopic Power Morcellators And Have Purportedly Developed Uterine Sarcoma And Leiomyosarcoma Cancer Cells

Birmingham, AL -- (ReleaseWire) -- 07/22/2015 -- Morcellator Lawsuit News: While robotic surgeries are being used more frequently in both men and women in minimally invasive surgeries, a new study has found that more than 100 patients have died over the past 14 years after robotic surgeries. The attorneys at Southern Med Law are highly aware of the risks of robotic surgeries after they have represented men and women in robotic surgeries lawsuits and are currently representing numerous women in morcellator lawsuits who have developed uterine cancer and even death after robot assisted hysterectomies involving uterince morcellation.

Southern Med Law has recently settled the first morcellator cancer lawsuit in the country involving a 53-year-old Pennsylvania woman who died after undergoing a robot-assisted hysterectomy with uterine morcellation. Researchers from MIT, Rush University Medical Center, and University of Illinois at Urbana-Champaign, reviewed over 10,000 adverse events reports filed with the U.S. Food and Drug Administration (FDA) regarding robotic surgery from 2000 to 2013. According to the study, there were 144 patient deaths, 1,391 patient injuries and 8,061 device malfunctions reported to the FDA. Researchers said little or no information was provided in the reports for the majority of death events. Researchers concluded that "despite widespread adoption of robotic systems for minimally invasive surgery, a non-negligible number of technical difficulties and complications are still being experienced during procedures."

[arxiv.org/ftp/arxiv/papers/1507/1507.03518.pdf, 2015]

"This study supports the power morcellation claims in power morcellator lawsuits filed on behalf of women who either developed cancer or died as a result of undergoing a robot-assisted gynecological surgery in which a power morcellator was used," said Dr. Francois Blaudeau, a founder of Southern Med Law.

As stated by the law firm and the FDA, laparoscopic power morcellators are used in minimally invasive and robot-assisted hysterectomies and these devices have the potential to spread cancer during the surgery. When used to remove the uterus or uterine fibroids, power morcellators grind the uterine tissue into small fragments so that they can be removed through small incisions in the abdomen. However, when uterine tissue may have undetected cancer cells, the power morcellator can disseminate the cancer cells into the abdominal or pelvic cavity where they can be spread throughout a woman's body.

The controversy surrounding laparoscopic power morcellators was instrumental in prompting U.S. House Rep. Mike Fitzpatrick, R-Pa. to offer an amendment to a bipartisan bill regarding approval of drugs and medical devices. According to a Wall Street Journal report, Rep. Fitzpatrick's amendment is designed to improve safety monitoring of medical devices by requiring patients' medical records to include the make and model number of medical devices that were used in the event that patients are harmed by the devices during treatment. The 21st Century Cures Act, which was passed earlier this month, proposes to speed up the federal government's process for approving drugs and medical devices.

[wsj.com/articles/house-passes-bill-to-improve-safety-monitoring-of-medical-devices-1436736213, July 12, 2015]

The law firm comments that the injuries alleged in complaints regarding power morcellators have lead the FBI to launch an investigation into power morcellators. According to a Wall Street Journal report, the FBI is investigating whether Johnson & Johnson, the largest power morcellator manufacturer, and its Ethicon division hid the potential cancer risks associated with their power morcellators from U.S. health regulators and the medical community, and how long they knew that their Ethicon power morcellator surgical devices purportedly carried a cancer risk. Johnson & Johnson suspended sales and distribution of power morcellators after the FDA warned in April 2014 against using the devices in hysterectomies and for removing uterine fibroids.

[wsj.com/articles/fbi-is-investigating-surgical-device-1432746641, May 27, 2015]

Dr. Blaudeau was recently involved in settling a power morcellator lawsuit that was filed on behalf of Scott Burkhart, a Pennsylvania widower whose wife died of disseminated leiomyosarcoma in February 2013, after having a power morcellator hysterectomy. According to the power morcellator lawsuit, there was no evidence of disseminated cancer in Donna Burkhart prior to her robot-assisted hysterectomy that occurred March 6, 2012. Donna Burkhart was diagnosed with the aggressive leiomyosarcoma just 9 days after having surgery. The morcellator lawsuit contends that power morcellator manufacturers, LiNA Medical APS, Kebomed AG & LiNA Medical US, failed to adequately warn about the cancer risk associated with power morcellators. The terms of the settlement were not disclosed. (Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania)

About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. Francois Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam
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For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

AndroGel And Other Pending Low Testostserone Treatment Lawsuits Allege That Men Who Use Testosterone Medication Have Suffered Such Cardiovascular Injuries As Heart Attacks And Strokes As Well As Blood Clots.

Birmingham, AL -- (ReleaseWire) -- 07/22/2015 -- As filings of testosterone treatment lawsuits involving such Low-T drugs as AndroGel, Androderm, Axiron and Testim continue to mount, the makers of AndroGel are seeking to have potential bellwether cases dismissed. The majority of the 2,000 low testosterone lawsuits pending in the U.S. District Court, Northern District of Illinois are filed against AbbVie and Abbott Laboratories and the first round of bellwether trials will only involve AndroGel lawsuits, court records show. AbbVie filed a motion on July 6 stating that 169 Plaintiffs Fact Sheets had missing information, such as names of prescribing physicians and dispensing pharmacies, and authorizations to allow AbbVie to collect additional medical records were not completed. AbbVie warned that if plaintiffs do not provide the information by the time of the bellwether hearing on August 14, AbbVie said in its motion that the Court should dismiss those Low-T cases with prejudice. Plaintiffs responded in a joint status report filed on the same day as AbbVie's motion, that they are concerned that AbbVie is attempting to use this issue as "a tactical sword in the testosterone bellwether process, rather than as a fact finding and discovery tool to gather information and collect the plaintiffs' medical records with authorizations." (In re: Testosterone Replacement Therapy Product Liability Litigation – MDL No. 2545

"Southern Med Law anticipates this matter will soon be resolved and the pretrial proceedings will continue with case selections for bellwether trials," says Dr. Francois Blaudeau, the law firm's founder.

Southern Med Law is an aggressive and effective advocate for people who have been injured due to dangerous and defective drugs. Dr. Blaudeau, has a unique understanding of the medical and legal questions at issue in testosterone therapy lawsuits. If you or someone you love have been harmed by prescription testosterone products, please call Dr. Blaudeau at Southern Med Law to learn more about your legal rights today. Call the office directly at 205-547-5525 for a free, no obligation testosterone therapy lawsuit review or by filling out our online form on this site.

Southern Med Law notes that AndroGel is by far the most popular of the available prescription testosterone treatment drugs, making up at least 75 percent of the market at one time. According to the AndroGel complaints, the defendants' advertising campaign paid off in a return of $1.4 billion in sales in 2013, making AndroGel the "biggest selling androgen drug in the United States." As stated in court documents, AndroGel was approved by the U.S. Food and Drug Administration (FDA) in 2000 to treat hypogonadism, which is low testosterone that occurs due to some underlying medical condition that is not associated with age. (In re: Testosterone Replacement Therapy Product Liability Litigation – MDL No. 2545)

[fda.gov/Drugs/DrugSafety/ucm436259.htm]

Testosterone Treatment Lawsuits

Court documents indicate that a multidistrict litigation was established for testosterone treatment lawsuits in June 2014 for complaints alleging that men who use prescription testosterone drugs are at risk for adverse cardiovascular events such as heart attacks, stroke and cardiac death, and testosterone makers failed to disclose the risks associated with their testosterone products. (In re: Testosterone Replacement Therapy Product Liability Litigation – MDL No. 2545)

As stated in court documents, the testosterone lawsuits were filed in wake of the U.S. Food and Drug Administration (FDA) launching an investigation in January 2014 into all FDA-approved prescription testosterone gels, patches, creams, and injections. After its investigation, the regulatory agency issued a safety announcement in March 2015 stating testosterone products should be approved only for men who have low testosterone levels caused by certain medical conditions. According to the FDA, the benefit and safety of testosterone medications have not been established for treating low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone. The FDA also required testosterone manufacturers to update the labels of their products to warn of the potential increase in the risk of heart attack or stroke in patients who use testosterone replacement medication.

About Southern Med Law And Filing An AndroGel Lawsuit
Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation through Southern Med Law. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective legal advocate for those who were harmed due to dangerous and defective drugs. If you believe that you or a loved one was injured by testosterone products, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation testosterone therapy lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.

Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

As Southern Med Law Settles The First Federally Filed Power Morcellator Lawsuit, The House Passes Medical Research Legislation That Tracks Safety Of Medical Devices Such As Laparoscopic Power Morcellators That Can Potentially Spread Uterine Cancer.

Birmingham, AL -- (ReleaseWire) -- 07/21/2015 -- In a move to reduce injuries and the spread of cancer after power morcellation hysterectomies and fibroid removal, the U.S. House passed a bipartisan bill that speeds up the government's process for approving drugs and medical devices, as well as improving the safety monitoring of medical devices that includes power morcellators, Southern Med Law reports. The new medical research legislation comes as Southern Med Law recently settled the first morcellator cancer lawsuits against morcellator makers, LiNA Medical APS, Kebomed AB & LiNA Medical US. According to the Wall Street Journal, the provision to improve the monitoring of medical devices was an amendment added to the "21st Century Cures Act" by Rep. Mike Fitzpatrick, R-Pa. The provision requires "unique device identifiers," such as the make and model number of medical devices, to be included in patients' medical records in the event that patients are harmed by the devices, the Wall Street Journal reported. While the U.S. Food and Drug Administration (FDA) in 2013 ordered labels of medical devices to include "unique device identifiers," Rep. Fitzpatrick's office said the amendment "adds pressure" to the FDA's ruling, according to the Wall Street Journal.

[wsj.com/articles/house-passes-bill-to-improve-safety-monitoring-of-medical-devices-1436736213, July 12, 2015]

"We are pleased that the House passed this legislation and accepted Rep. Fitzpatrick's amendment which appears to be very beneficial to patient safety," says Dr. Francois Blaudeau, founder of Southern Med Law. The firm is currently representing women in morcellator lawsuits and other medical device lawsuits involving Mirena, Essure, Bladder Mesh and IVC filters. To speak with one of our attorneys for a free legal evaluation please call 205-547-5525 or 205-515-6166.

You can also visit http://www.southernmedlaw.com for more information.

According to Dr. Blaudeau, who is also an attorney and obstetrician-gynecologist, power morcellators are used in about 10 percent of the 600,000 hysterectomies that are performed each year in the United States. As stated in court records, power morcellators grind uterine tissue into fragments so that they can be removed through small incisions in the abdomen. As the uterine tissue is removed, the undiagnosed cancer cells contained in the tissue spreads into the peritoneal cavity, according to court documents. Power morcellators have the potential to not only spread cancer, but upstage the disease as well.

The law firm notes that the FDA issued a safety alert in April 2014 that discouraged surgeons from using power morcellators to perform a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids) because of the medical device's potential to spread undiagnosed cancer which greatly reduces a woman's chances for long-term survival. The FDA issued a stronger warning in November stating that power morcellators should be avoided in the vast majority of women who require a hysterectomy or myomectomy.

[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014].

The law firm further comments that the FBI has launched an investigation into power morcellators and the probe includes whether Johnson & Johnson, the largest morcellator manufacturer, knew about the cancer risks linked with power morcellators before pulling the devices off the market. According to a Wall Street Journal report, Johnson & Johnson suspended sales of power morcellators in wake of the FDA's warning about the devices in April 2014. The FBI has already interviewed a retired pathologist who notified Johnson & Johnson about the potential cancer risks connected to power morcellators, the Wall Street Journal stated.

[wsj.com/articles/fbi-is-investigating-surgical-device-1432746641, May 27, 2015]

As morcellation cancer lawsuit filings continue to mount, six plaintiffs have filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally filed power morcellator lawsuits alleging that power morcellators spread undiagnosed cancer cells during gynecological surgeries. In their petition, the plaintiffs asked the judicial panel to transfer 22 morcellator complaints pending in 16 different courts nationwide, to the U.S. District Court, District of Kansas for coordinated pretrial proceedings. Court records show that all of the complaints are filed against Johnson & Johnson's Ethicon unit. The JPML has scheduled oral arguments on the request for October 1. (In Re: Power Morcellator Litigation, MDL Case No. 78)

Southern Med Law reports that Dr. Blaudeau settled the first federally filed morcellator cancer lawsuit earlier this month. The lawsuit was filed on behalf of Pennsylvania resident, Scott Burkhart, whose 53-year-old wife, Donna Burkhart, died of disseminated leiomyosarcoma in February 2013, which she developed after undergoing a power morcellator hysterectomy. According to the lawsuit, Donna Burkhart had no evidence of cancer prior to having a robot-assisted hysterectomy on March 6, 2012. She was diagnosed with the aggressive uterine cancer just 9 days after having surgery. The lawsuit, which was settled for an undisclosed amount, was filed in March 2014 in the U.S. District Court, Eastern District of Pennsylvania. (No. 5:14-cv-1557)

About Southern Med Law
Southern Med Law and Dr. Francois Blaudeau possess a unique understanding of the medical and legal questions at issue in power morcellator cancer lawsuit claims. It is this in-depth knowledge that is tantamount to a successful legal representation that protects the rights of the injured. The staff at Southern Med Law is not only trained in successfully handling your legal needs but also understand the pain and suffering and treatment from a medical point of view, and is committed to protecting the rights of all individuals.

Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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Five Essure Lawsuits Allege Bayer Concealed Adverse Event Information Associated With Essure, Including Organ Perforation And Spontaneous Migration Of The Birth Control Device, Reports Southern Med Law

Birmingham, AL -- (ReleaseWire) -- 07/21/2015 -- Federal judges are set to rule on whether Bayer can continue to be shielded from Essure product liability lawsuits that allege such side effects as pelvic pain, organ perforation and unintended pregnancies due to the birth control implant. Court records indicate that Bayer Healthcare Pharmaceuticals has asked for a dismissal of five Essure birth control lawsuits filed in the U.S. District Court, Eastern District of Pennsylvania. The birth control lawsuits contend the U.S. Food and Drug Administration's (FDA) premarket approval for Essure is invalid because Bayer failed to report adverse events caused by the contraceptive to the FDA, and Bayer's protection from product liability lawsuits over the birth control devices should be removed.

Bayer stated in its July 2 omnibus motion that Essure was approved through the FDA's premarket approval (PMA) process in November 2002 and plaintiffs "can point to no document which says the Essure PMA is invalid. That is because none exists." Bayer also contends in its brief that the FDA has not required "a recall or additional warnings on the device, and has certainly not concluded that the PMA for Essure should be withdrawn as Plaintiffs argue should occur here." (Case No. 2:14-07315, 2:14-07316, 2:14-07317, 2:14-07318, 2:15-00384, U.S. District Court, Eastern District of Pennsylvania)

"Our law firm is currently representing women from around the country in product liability lawsuits, so we wait in anticipation for the rulings in these complaints," says Dr. Francois Blaudeau, founder of Southern Med Law.

Dr. Blaudeau possesses a unique understanding of the medical and legal fields as he is also practicing obstetrician/ gynecologist and can answer questions relating to Essure. If you or a woman you love are believed to have suffered complications from the Essure birth control device, contact Southern Med Law to learn more about your legal rights. You can arrange for a free, no obligation legal consultation by calling Southern Med Law today, at 205-547-5525 or you can visit https://www.southernmedlaw.com to fill out a contact for and receive more information.

As stated by the FDA and court documents, Essure is a form of long-term birth control. During the implant procedure, two bendable metal coils are inserted into the fallopian tubes, passing through the vagina, cervix and uterus. The process causes scar tissue to form around the coils over several months, which blocks the tubes and prevents conception. The FDA stated in June that the agency has received 5,093 adverse event reports over Essure from the time the device was approved in November 2002 to May 31, 2015. According to the FDA, migration of the device or one of its components and device breakage were among the most frequent problems reported, while abdominal pain, menstrual irregularities and headache were among the most frequently reported side effects. The federal regulator also received five reports of fetal deaths in women who became pregnant following an Essure implant.

[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm, June 24, 2015]

The FDA announced in June that it will hold a meeting in September to discuss the risks of the birth control implant, such as unintended pregnancies, miscarriages and perforation of the uterus and fallopian tubes. The FDA has scheduled the meeting for September 24 so its Obstetrics and Gynecology Devices Panel can discuss data regarding Essure's safety and effectiveness. The federal regulatory agency said that it was soliciting feedback from its panel members, presenters and the public to help the agency form "recommendations and next steps about Essure."

[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm, June 24, 2015]

About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. Francois Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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Birmingham, AL -- (ReleaseWire) -- 07/15/2015 -- The attorneys at Southern Med Law have settled the first federally filed morcellator cancer lawsuit against LiNA Medical APS. Kebomed AG & LiNA Medical US, the makers of power morcellators. The lawsuit was filed in March 2014 in the U.S. District Court, Eastern District of Pennsylvania by Southern Med Law on behalf of Scott Burkhart, a Pennsylvania widower whose wife died of disseminated leiomyosarcoma in February 2013, which she developed after undergoing a power morcellator hysterectomy. The terms of the settlement are not being disclosed at the moment, but could prove positive for other power morcellator lawsuits that may be consolidated into a multidistrict litigation (MDL) in Kansas. Scott Burkart stated in this lawsuit that there was no evidence of disseminated cancer in his 53-year-old wife, Donna Burkhart, prior to having a robot-assisted hysterectomy in March 6, 2012. She was diagnosed with the aggressive uterine cancer just 9 days after having surgery. (No. 5:14-cv-1557)

Southern Med Law's Founder, Dr. Francois Blaudeau, an attorney and obstetrician-gynecologist who is representing the Burkart family, said power morcellators are used in about 10 percent of the 600,000 hysterectomies that are performed in the U.S. annually. Power morcellators shred uterine tissue into small pieces so that the fragments can be removed through small incisions in the abdomen. The undetected cancer cells spread into the peritoneal cavity as the uterine tissue is being removed. Power morcellators are used more commonly in less invasive laparoscopic procedures, which require a much smaller abdominal incision than traditional open-surgery hysterectomies.

Dr. Blaudeau and Southern Med Law are currently representing numerous women in morcellator lawsuits and urge women who have been diagnosed with uterine cancer following a hysterectomy using power morcellation to contact the firm. The firm offers free legal evaluations and you can speak with Dr. Blaudeau or one of his associated by calling 205-515-6166 or 205-547-5525. You can also visit www.southernmedlaw.com for all of the current news on morcellator cancer lawsuits and other medical litigation.

Power Morcellator News

In the wake of the filing of power morcellator lawsuits and the U.S. Food and Drug Administration's (FDA) warning against using the surgical devices because of the cancer risk, some insurance carriers are forgoing coverage of this procedure. In September, Highmark Inc., one of the largest Blue CrossBlue Shield plans in the country, was the first health care insurer to announce that it would stop power morcellation in gynecological procedures. The health insurer stopped coverage in its service area of Pennsylvania, West Virginia and Delaware. Aetna, the nation's third largest insurer, announced in May that it will no longer cover morcellation "in most circumstances because the safety and efficacy of this approach has not been demonstrated." Aetna now requires doctors to "precertify" a myomectomy (removal of fibroids) or hysterectomy (removal of the uterus) and is encouraging doctors to talk to their patients about the risks and benefits of uterine morcellation and its alternatives.

In addition to the FDA warning and drop in insurance coverage, the FBI announced the launch of an investigation into power morcellators where the bureau's probe includes the largest morcellator manufacturer, Johnson & Johnson's Ethicon unit, which stop selling its morcellators after the FDA's warning in April 2014. The FBI will examine what Johnson & Johnson knew about the cancer risk before the company took its morcellators off the global market.

Morcellator Cancer Lawsuits

According to court records there are currently 22 power morcellator lawsuits pending against Ethicon Inc. in 16 different federal courts nationwide. The 22 plaintiffs recently filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) and asked the panel to transfer their complaints as well as other subsequent federally filed power morcellation lawsuits, to the U.S. District Court, District of Kansas for coordinated pretrial proceedings. The plaintiffs requested a multidistrict litigation because all of the complaints allege that laparoscopic power morcellators that are used during a hysterectomy or a myomectomy to remove uterine fibroids can spread and upstage cancer or the development of recurrent parasitic fibroids, according to the petition. The JPML is scheduled to hear oral arguments on the request on October 1. (In Re: Power Morcellator Litigation, MDL Case No. 78)

About Southern Med Law
Southern Med Law and Dr. Francois Blaudeau possess a unique understanding of the medical and legal questions at issue in power morcellator cancer lawsuit claims. It is this in-depth knowledge that is tantamount to a successful legal representation that protects the rights of the injured. The staff at Southern Med Law is not only trained in successfully handling your legal needs but also understand the pain and suffering and treatment from a medical point of view, and is committed to protecting the rights of all individuals.

Southern Med Law
Francois M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm