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Top 5 Big Pharma Verdicts and Settlements of 2015
Jan 21, 2016 | Drug Watch
By Michelle Llamas
...The two mesh manufacturers at the top of the list with the most lawsuits are Johnson & Johnson’s Ethicon division with more than 29,000 cases and Boston Scientific with close to 19,000. -
Urogynecologists speak: FDA reclassification welcome
Jan 22, 2016 | Contemporary Ob/Gyn News
A January 4th action by the US Food and Drug Administration (FDA) reclassified transvaginal mesh implants for pelvic organ prolapse (POP) as class III (or high-risk) medical devices requiring premarket approval application (PMA).
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Top 5 Big Pharma Verdicts and Settlements of 2015
Jan 21, 2016 | Drug Watch
By Michelle Llamas
Big Pharma paid out big settlements and got hit with some big jury verdicts in 2015. The year’s hardest hitcompanies include Johnson & Johnson, Takeda, Wright Medical and Boston Scientific. Lawsuits against the companies alleged the drug and device makers made false marketing claims, sold faulty products and failed to warn consumers about dangerous side effects, some fatal.
A number of highly prescribed drugs and popular medical devices were at the heart of the litigation, including Type 2 diabetes medication, antipsychotic drugs and a number of medical devices like hip implants. Here are highlights of some of 2015’s big settlements, verdicts and controversies surrounding dangerous drugs and medical devices.Multi-Billion Dollar Actos Settlement
In October 2015, Takeda Pharmaceuticals agreed to settle thousands of Actos bladder cancer lawsuits for$2.4 billion, and it is one of the largest settlements in drug and device history. In 2014, Takeda was hit with a massive $9 billion jury verdict in favor of one plaintiff who was diagnosed with bladder cancer after taking Actos.
Several studies, including Takeda’s own five-year study, linked the medication to a 41 percent increased risk of bladder cancer. Spurred by this data, plaintiffs who say they were diagnosed with bladder cancer after taking Actos filed lawsuits accusing Takeda of hiding the risk.
Over the span of several years, the Japanese drug company fought against allegations that its blockbuster Type 2 diabetes drug caused bladder cancer. It insists the settlement is not an admission of guilt.Millions Paid in Transvaginal Mesh Lawsuits
Transvaginal mesh remains one of the most controversial medical devices on the market and one of the largest mass torts in American history. Mesh ignited a social media firestorm with women whosuffered complications from the device taking to Facebook and Twitter to spread the word about the dangerous device. One victim called it “genocide on women.”
More than 70,000 lawsuits against seven companies are currently pending in federal multidistrict litigation before Judge Joseph R. Goodwin in West Virginia. Thousands more are pending in state courts. The two mesh manufacturers at the top of the list with the most lawsuits are Johnson & Johnson’s Ethicon division with more than 29,000 cases and Boston Scientific with close to 19,000.
Some of 2015’s mesh settlement and jury verdict highlights include:C.R. Bard agreed to pay $200 million to settle some of its cases. The company already faced a number of multi-million-dollar jury verdicts.A state jury in Delaware hit Boston Scientific with a massive $100 million verdict, ruling on behalf of one plaintiff who suffered constant pain and inability to have sex. According to Bloomberg, it is the 8th largest jury verdict in 2015.Coloplast announced it would add $448 million more to the settlement budget to close out more of its cases.
Johnson & Johnson quietly settled a handful of cases with undisclosed amounts but has yet to commit to a blanket settlement to resolve tens of thousands of federal and state cases against it.Stryker to Pay 1.4B to Settle Hip Implant Cases
Each year, the number of Americans receiving hip implants rises. According to a study presented at the 2014 annual meeting of the American Orthopaedic Association, about 2.5 million Americans currently live with a hip implant. Unfortunately, not all implants are created equal. Metal-on-metal implants in particular are known for causing a number of complicationsfrom infections to implant failures.
In 2015, several hip implant manufacturers faced lawsuits, including:The first Wright Conserve hip bellwether trial ended in an$11 million jury verdict for the plaintiff. According to the jury, Wright’s hip implant was faulty and unreasonably dangerous. The jury awarded $10 million for punitive damages because they said Wright acted with gross negligence. Hundreds more plaintiffs await their day in court.Zimmer lost $9.2 million over its Durom Cup hip implant. After only a few hours, the jury sided with the plaintiff and found Zimmer’s design was faulty and it failed to warn the public.Stryker Orthopaedics settled a number of its Rejuvenate and ABG II hip implant cases in 2014 for $1.4 billion. The company said it hoped to pay the last of the settlements by the end of 2015.Jury Rules Against J&J in Risperdal Lawsuits
Johnson & Johnson faced a number of trials and lawsuits linked to its blockbuster antipsychotic Risperdal. Parents of young men and boys filed lawsuits against J&J after their children took Risperdal and grew female breasts. One boy, Austin Pledger, has to live with 46DD-sized breasts because he cannot have surgery to remove them.
In addition to individuals suffering from complications, the Department of Justice and several states sued the company for marketing fraud. According to these lawsuits, J&J illegally marketed their drugs for uses not approved by the FDA.
Highlights from 2015’s Risperdal litigation include:A jury awarded Austin Pledger $2.5 million against J&J. Pledger’s lawsuit claimed Risperdal caused him to grow 46DD breasts.South Carolina’s Supreme Court ordered J&J to pay $136 million for misleading doctors about Risperdal’s benefits and risks. According to court documents, the company sent 7,000 letters to doctors downplaying the risks of the drug and concentrating on the benefits.A Philadelphia jury ordered J&J to pay $1.75to another plaintiff, Nicholas Murray, who took Risperdal and developed female breasts.Power Morcellator Death Case
Last year another controversial mass tort made headlines: the power morcellator. Surgeons use power morcellators — drill-like devices with sharp blades that chop up large pieces of tissue — to remove fibroids from the uterus and perform hysterectomies. The selling point of these devices is that they are less invasive and allow women to recover faster.
But in 2014, the FDA warned that laparoscopic power morcellators may spread undiagnosed uterine cancer in 1 out of 350 women. One type,leiomyosarcoma, is especially aggressive. Johnson & Johnson, one of the biggest manufacturers of power morcellators, removed its Ethicon devices from the market.
While morcellator lawsuits are still in the beginning stages of trial and settlement, they are poised to move more quickly because many plaintiffs with cancer are on limited time. Lawsuits claim the devices were defective and companies failed to warn about the risk of upstaging cancer.
Activity on power morcellator litigation in 2015 included:LiNA Medical settled its first morcellator death case for an undisclosed amount. Donna Burkhart had a hysterectomy with a power morcellator and was later diagnosed with myelosarcoma. She died less than a year after the hysterectomy. Burkhart also sued J&J and Blue Endo.The Judicial Panel on Multidistrict Litigation consolidated a number of morcellator lawsuits against J&J’s Ethicon unit in the U.S. District Court for the District of Kansas in October 2015.In November 2015, the first plaintiff’s steering committee made up of a majority of female lawyers will head the morcellator litigation before U.S. District Judge Kathryn Vratil.
Morcellators are involved in about 60,000 procedures a year and could seriously impact a number of women. Once cancers are upstaged by morcellators, they are difficult to treat and prognosis is typically poor.
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Urogynecologists speak: FDA reclassification welcome
Jan 22, 2016 | Contemporary Ob/Gyn News
A January 4th action by the US Food and Drug Administration (FDA) reclassified transvaginal mesh implants for pelvic organ prolapse (POP) as class III (or high-risk) medical devices requiring premarket approval application (PMA). The action followed numerous warnings from the FDA about the implants’ safety over the past 8 years. Transvaginal mesh implants were previously classified as class II (moderate risk) devices. Notably, the change applies only to surgical mesh marketed for transvaginal treatment of POP, and not the device’s use for indications such as stress urinary incontinence or abdominal repair of POP. Specifically, the change does not apply to full-length retropubic and transobturator midurethral slings or sacral colopopexy meshes, all of which have extensive clinical data showing safety and efficacy. Manufacturers of surgical mesh already on the market for the transvaginal indication will have 30 months to submit a PMA, and a PMA must be submitted for any new mesh proposed for use for transvaginal repair of POP.
Experts in urogynecology welcomed the change. “It is very challenging for the FDA to keep up with the thousands of new medical procedures that are developed each year across hundreds of disciplines and the rapidly changing technologies,” noted John O DeLancey, MD, Professor of Gynecology and Fellowship Director in Female Pelvic Medicine and Reconstructive Surgery, University of Michigan Medical School, Ann Arbor, and a member of the Contemporary OB/GYN editorial board. “Thirty years ago, when the original regulations were developed, saying something was substantially similar to existing products was something that surgeons welcomed and that allowed rapid progress. However, new complex surgical technologies have unique risks and change rapidly, and it is time to make sure that there are adequate safety and efficacy data before approving new techniques, devices, and products. It is what the public expects from the FDA and what all of us would want for our own health care.”
Douglass S Hale, MD, FACOG, FACS, is President of the American Urogynecologic Society (AUGS) and Director of Female Pelvic Medicine and Reconstructive Surgery at IU Health and a Clinical Professor at Indiana University School of Medicine. He commented on the reclassification in his blog at AUGS.org, writing, “Prior to [January 4th], transvaginal mesh devices were approved by the FDA through the relatively simple 510(k) process, which required only that a prior similar device had been approved and did not require laborious and expensive new clinical trials. Transvaginal mesh implants for POP were originally approved using full-length midurethral slings as the prior approved device. However, the FDA can require more detailed information be provided should excess complications arise from new 510(k)-approved devices through a process known as Section 522, and can also require post-market surveillance of such 510(k) approved devices.
Thus, the FDA now requires:
1. New transvaginal mesh POP devices be moved from class II to class III devices and do through the more rigorous PMA process; and
2. Existing transvaginal mesh POP devices to complete Section 522 studies.”
Surgical mesh was first approved as a class II device for transvaginal repair of POP in 2002. Since then, the FDA has received thousands of reports about complications associated with its use, including pain during intercourse, infection, and erosion into surrounding tissues. The agency issued safety communications about the device beginning in 2008 and proposed orders for the reclassification and PMA requirement in May 2014.
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