Partner Laura Pittner Appointed to PSC in Zimmer M/L Taper Hip MDL

GoldenbergLaw Partner Laura Pittner has been appointed to the Plaintiffs’ Steering Committee (PSC) in the Zimmer M/L Taper hip Multidistrict Litigation (MDL). This occurred on December 14, 2018, by the Hon. Jesse M. Furman, United States District Judge for the Southern District of New York.

About Laura PittnerPartner Laura Pittner

Laura has extensive experience in hip device litigations and has led GoldenbergLaw’s defective hip practice in the Depuy ASR, Depuy Pinnacle, Biomet M2A, Wright Profemur, Conserve and Dynasty Hip Systems, Zimmer Durom Cup, Smith & Nephew Birmingham Hip, Stryker Rejuvenate, and Stryker LFIT V40 cases. Her leadership has resulted in millions of dollars of settlements recovered for our clients.

Laura has also helped in the leadership of several other mass torts litigations, including in Benicar, a heart pressure medication alleged to cause gastrointestinal injuries, and Farxiga, a diabetes drug alleged to cause serious diabetic ketoacidosis.

Laura has been with GoldenbergLaw since 2010. She is a knowledgeable leader in mass tort and product liability cases. In addition, her practice includes motor vehicle, chemical exposure, and premises liability cases. She is also the proud mother of twin boys Cecil and Odin.

Zimmer M/L Taper Hip Prosthesis and Versys Femoral Heads

The Zimmer M/L Taper and Kinectiv hip systems are comprised of the femoral components of an artificial hip device. The devices are designed to be made of up two pieces, the neck and stem, not dissimilar to the Stryker Rejuvenate hip device that was previously the subject of consolidated litigations that resulted in substantial settlements. While the Zimmer M/L devices have not yet been recalled, there have been several reports of early failure associated with corrosion and metal wear at the neck-stem interface requiring revision.

In December 2017, a verdict was secured against Zimmer, the maker of the M/L Taper device in a case tried by another law firm in New Mexico. The plaintiff in that case was awarded over $2,000,000.

Several M/L Taper cases have been filed in various state and federal courts across the country. In October 2018, the Judicial Panel ofMultidistrict Litigation ordered that Zimmer M/L Taper cases throughout the United States be consolidated in the Southern District of New York before the Honorable Paul Crotty. The first case management conference occurred on December 6, 2018. At that time, the proposed Plaintiffs’ leadership committee was approved.

Contact Us

GoldenbergLaw is currently investigating Zimmer M/L Taper cases and other defective hip replacement cases. If you or a loved one has been fitted with a defective hip replacement, contact GoldenbergLaw.

Some Vaginal Rejuvenation Treatments Being Illegally Marketed, FDA Says

On July 30, 2018, the FDA released a safety announcement warning several companies to stop marketing their devices for vaginal rejuvenation procedures. The FDA is claiming they are “dangerous and deceptive treatments.” While the lasers and other energy-related procedures were intended for and approved to treat conditions like cancer and genital warts, manufacturers began to market the devices for symptoms related to vaginal rejuvenation procedures, such as vaginal atrophy, menopause, urinary incontinence, and sexual function.

What Is the Problem?

These manufacturers are illegally and deceptively marketing these lasers to be used for procedures that were never approved by the FDA. Any medical device or drug not approved by the FDA can be used off-label by a medical professional. However, the manufacturers of the device or drug cannot promote it off-label.

The FDA sent letters to several manufacturers regarding this off-label promotion. In some cases, the FDA even quoted the content on manufacturers’ websites that had false information. For example, BTL Industries, Inc. marketed the Exilis (Exilis Ultra 360), a radio frequency treatment, with “the Exilis Ultra 360 system is proven to increase elastin and collagen in the treatment area,” referring to vaginal rejuvenation procedures. The Exilis Ultra 360 was not approved for vaginal rejuvenation procedures, but rather for dermatology, including wrinkle treatment. BTL has removed the Exilis Ultra 360 page from their site following the FDA’s notice.

What Are the Injuries?

There have been 14 adverse events reported, including vaginal burns, scarring, and extreme pain following the procedure. Vaginal rejuvenation procedures can also cause bleeding, infection, adhesions, and numbness or loss of sensation.

What Are the Types of Vaginal Rejuvenation?

Vaginal rejuvenation surgery can have other names, including:

  • Cosmetic gynecology
  • Female genital plastic surgery
  • Female genital rejuvenation surgery
  • Re-virgination
  • G-spot amplification
  • Vulvovaginal plastic surgery
  • Designer vagina surgery

Who Are the Defendants?

The FDA sent letters to Immode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries, and Cynosure because of their deceptive advertising. The American College of Obstetricians and Gynecologists issued a statement that advises obstetrician-gynecologists and patients to be cautious with these procedures, as they are not approved by the FDA for the treatments they are being marketed for.

GoldenbergLaw Can Help

If you or a loved one underwent a vaginal rejuvenation procedure and experienced a serious side effect, contact GoldenbergLaw immediately. Our defective medical device lawyers have over 30 years of experience and are national leaders.

 

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Transvaginal Mesh Lawsuit

The first transvaginal mesh entered the market in 1996 when Boston Scientific released its ProteGen bladder sling to help women suffering from stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The product was recalled in 1999 after reports of complications with the mesh.

What Is the Problem?

Boston Scientific was able to fast-track the approval process for the transvaginal mesh by submitting a Premarket Notification 510(k) to the FDA. A Premarket Notification 510(k) explains that the product is similar to an existing product that already went through FDA approval. This 510(k) process expedites the process to get the product on the market because the pharmaceutical company does not have to pay for clinical trials to test the drug or device.

Boston Scientific claimed that the ProteGen bladder sling was equivalent to hernia meshes already on the market, including Trelex Natural Mesh and Gore-Tex Soft Tissue Patch.

What Are the Injuries?

Similar to hernia mesh complications, transvaginal meshes can cause mesh migration, infection, chronic pain, and mesh erosion. Because of the 510(k) process, transvaginal meshes were not tested in a vagina before they entered the market. One of the downsides of the 510(k) process is that it allows the flaw in the equivalent products to be used in the product.

The injuries associated with a transvaginal mesh include:

  • Mesh erosion
  • Painful sexual intercourse
  • Pelvic and vaginal pain
  • Urinary leakage

Perforation of bladder, intestines or bowels

GoldenbergLaw Can Help

GoldenbergLaw is committed to promoting safety through accountability. If you or a loved one suffered from a transvaginal mesh implantation, contact us for a free case evaluation. GoldenbergLaw has over 30 years of experience in defective drug and device litigation. Call us. You will sleep better.

 

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