Below is a representative sampling of G&E's complex pharmaceutical and medical device litigation cases.
California Superior Court, Alameda County
G&E director Elizabeth Graham was lead negotiator, served as Co-Liaison Counsel in California, and was a member of the Plaintiffs’ Executive Committee leading litigation on behalf of tens of thousands of women adversely affected by the permanent birth control device Essure, manufactured by Conceptus/Bayer HealthCare. Sold as a permanent, non-surgical contraception solution for women, Essure has been linked to severe complications and side-effects, including perforation of the uterus and other organs often requiring surgery to remove the failed device. In September 2016, all California product liability lawsuits brought against Bayer and its subsidiaries involving Essure were coordinated as a Judicial Council Coordinated Proceeding (JCCP) in the California court system. In August 2020, G&E helped reach a $1.6 billion settlement on behalf of thousands of women, including the almost 2,000 clients represented individually by G&E.
District of Massachusetts
G&E filed cases concerning alleged defects in Stryker-branded LFIT Anatomic CoCR V40 femoral heads, a prosthetic hip replacement device. Plaintiffs alleged that the defective femoral heads had caused catastrophic side-effects including separation of the femoral head from the hip stem, fracturing of the device, metallosis, tissue damage, and other complications that have led to painful hip revision surgeries. G&E served on the Plaintiffs’ Steering Committee in this litigation, which reached a confidential settlement in November 2018.
District of Kansas
G&E filed several cases against Ethicon in regards to their power morcellators. A power morcellator is a small tool with blades that rotate in order to break up tissue from the uterus or uterine fibroids during hysterectomy or myomectomy (surgery for the removal of fibroids) surgery. The tool was introduced as a means to facilitate less invasive surgeries. Unfortunately, evidence suggested the tool may spread previously undetected uterine cancers, some of them quite aggressive. Following the release of studies and an FDA recommendation against the use of the devices, Ethicon pulled three models of power morcellators from the market in a “voluntary recall,” designed to prevent further illness or loss of life. The cases were consolidated in a multi-district litigation (MDL) in front of the Honorable Kathryn H. Vratil, who oversaw the first MDL female majority leadership group. Two of G&E’s directors, Elizabeth Graham and Sindhu Daniel, served on the Plaintiffs’ Steering Committee in this litigation. The MDL was created in October 2015, and in likely one of the quickest resolutions of an MDL, was dissolved after only eight months. The cases reached a confidential settlement.
Eastern District of Louisiana
Bayer HealthCare and Janssen Pharmaceuticals, manufacturers of the anticoagulant drug Xarelto, reached a settlement agreement with plaintiffs in March 2019 for $775 million. The lawsuits brought by plaintiffs claimed that the drug was marketed as a safe blood thinner without warning consumers and patients about the dangerous side effects associated with the medication, including uncontrollable bleeding. G&E directors Elizabeth Graham and Sindhu Daniel held plaintiffs’ leadership positions on the PSC, leading the Law & Briefing, Administrative, and Privilege Log Review Committees, and as members of the Bellwether Selection Committee.
District of Maryland
G&E represents plaintiffs who have made product liability claims against medical technology manufacturer Smith & Nephew, Inc. concerning complications arising from the company’s Birmingham Hip Resurfacing (BHR) system. The BHR system uses a cobalt-chromium metal-on-metal design that, with wear, causes metal ions from the implants to migrate into surrounding tissues, resulting in injuries like metallosis and bone and tissue necrosis. The MDL, overseen by the Honorable Catherine C. Blake, encompasses 300 pending cases. G&E serves on the Plaintiffs’ Steering Committee in this litigation.
Northern District of Florida
G&E represents plaintiffs who have suffered hearing loss or tinnitus allegedly caused by 3M’s reversible Combat Arms Earplugs. The earplugs were issued by the U.S. military to protect soldiers during training and in combat between 2003 and 2015. 3M faces claims from over 200,000 U.S. military veterans alleging personal injuries from using these earplugs. These veterans accuse 3M of knowing, for many years, that the earplugs were defective but not issuing a product recall or warning. G&E serves on the Plaintiffs’ Steering Committee in this litigation.
District of New Jersey
G&E represents plaintiffs that have allegedly suffered vision problems after taking bladder pain drug Elmiron. Manufactured by Janssen Pharmaceuticals, long-term Elmiron use has been linked to vision impairment and potentially permanent vision loss. Lawsuits have been filed by Elmiron patients concerning these side-effects, and claiming Janssen failed to warn patients of these risks. In December 2020, the U.S. Judicial Panel on Multidistrict Litigation approved all Elmiron lawsuits to be consolidated in the District of New Jersey before the Honorable Brian R. Martinotti. G&E director Sindhu Daniel serves on the Plaintiffs Steering Committee in this litigation.
Northern District of Georgia
Hernia mesh is a screen-like surgical implant used to repair hernias, a condition that occurs when tissue or organs bulge through a weak spot or tear in abdominal muscle. Although mesh is generally effective at preventing hernia reoccurrence, a number of these products were recalled and patients report suffering from complications from allegedly defective mesh, which includes infections, adhesions and bowel obstructions that require removal or revision surgeries. G&E is currently representing numerous clients who have had Ethicon Physiomesh, Atrium C-Qur, Bard/Davol, and Covidien products.
State of California Superior Court, San Francisco County
G&E serves on leadership as co-liaison counsel in a coordinated proceeding involving more than 18,000 plaintiffs injured by harmful HIV medications manufactured by Gilead Sciences, Inc. The plaintiffs are patients who were prescribed antiretroviral medications containing tenofovir disoproxil fumarate (TDF), namely Viread, Truvada, Atripla, Complera or Stribild, which are approved to treat and/or reduce the risk of sexually transmitted HIV-1. These TDF drugs are linked to severe side-effects such as chronic kidney disease, bone density loss and fracturing. Plaintiffs allege that for over a decade, Gilead withheld another form of these medicines that it knew was safer and more effective than the TDF formulations it sold during that period.
Eastern District of Louisiana
Taxotere is a chemotherapy drug approved in the treatment of breast cancer along with other forms of cancer. In December 2015, the FDA required the maker of Taxotere, Sanofi-Aventis, to change the drug’s label to warn patients of the risk of permanent hair loss. G&E is actively representing women who have suffered permanent hair loss following chemotherapy with Taxotere for breast cancer.
District of New Jersey
There are over 18,000 filed cases claiming that regularly applying Johnson’s Baby Powder and/or Shower to Shower to the genital area can cause ovarian cancer. The litigation in these cases shows a positive trend, and recent jury verdicts in the Missouri state courts suggest that the volume of cases will continue to grow. G&E is representing women who consistently used Johnson’s Baby Powder for at least 5 years and were subsequently diagnosed with ovarian cancer. G&E serves on the Plaintiffs’ Steering Committee in this litigation.
Southern District of Florida
G&E represents plaintiffs alleging that the multiple pharmaceutical manufacturers that produce the antacid medication Zantac (ranitidine), concealed evidence that the drug was linked to certain types of cancers, including bladder, kidney, pancreatic, stomach, rectal, and colon cancer. The alleged deception occurred as companies accumulated substantial profits from Zantac, making it the first drug ever to generate $1 billion in sales. Lawsuits from around the country have been consolidated in the Southern District of Florida before the Honorable Robin L. Rosenberg.
District of Massachusetts
Centralized before the Honorable F. Dennis Saylor, IV, the Zofran (ondansetron) MDL encompasses over 400 cases against drugmaker GlaxoSmithKline (“GSK”) alleging that GSK marketed the anti-nausea drug “off label” for unapproved uses, and failed to warn doctors and patients that it could cause birth defects such as cleft palate and congenital heart defects. G&E filed many of the first cases in the litigation, and plays a significant role in leading the litigation. G&E director Elizabeth Graham serves as co-lead on the Plaintiffs’ Executive Committee and as Chair of the Law & Briefing Committee in the MDL.
G&E served as one of the four lead firms in negotiating the terms of the Essure JCCP settlement, achieving an overall $1.6 billion for thousands of women, including the almost 2,000 clients represented by G&E.
G&E directors lead the Law & Briefing, Administrative, and Privilege Log Review Committees, and served as members of the Bellwether Selection Committee.