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J&J Talcum Powder Ovarian Cancer Trial Underway
Feb 3, 2016 | The Legal Examiner
By Shezad Malik MD JD
...Plaintiffs have alleged in thousands of lawsuits that its DePuy line of ASR and Pinnacle metal on metal hip implants cause metallosis and fail prematurely requiring re-do surgery, that its line of Duragesic Pain fentanyl patches causes overdoses and death, that its Ethicon line of vaginal mesh and bladder sling inserts cause perforation and chronic pain, that its Risperdal antipsychotic medication causes gynecomastia (male breast growth) in young boys... -
FDA Increases Scrutiny on Transvaginal Mesh Products
Feb 3, 2016 | The Legal Examiner
By Dori Milner
On January 4, 2016, the FDA took action to address the safety risks of transvaginal mesh repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). -
Bard Mesh Patients Cite Slow MDL Pace In Bid To Move Suits
Feb 3, 2016 | Law360
By Jody Godoy
A Philadelphia-based firm representing women in cases against C.R. Bard Inc. over allegedly defective pelvic mesh implants argued on Wednesday that six dozen of the suits should be transferred to Pennsylvania federal court since they're not about to be resolved in the sprawling multidistrict litigation in West Virginia. -
Boston Scientific, Bard Escape Joint Pelvic Mesh Trial
Feb 3, 2016 | Mass Device
By Brad Perriello
Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR) yesterday won the 1st trial in a pelvic mesh lawsuit against 2 companies after a Kansas City jury voted 10-2 that their implants were not defective and didn’t cause plaintiff Eve Sherrer’s injuries.
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J&J Talcum Powder Ovarian Cancer Trial Underway
Feb 3, 2016 | The Legal Examiner
By Shezad Malik MD JD
Johnson & Johnson (J&J), the world’s largest pharmaceutical and medical device maker has been exposed to hundred of thousands personal injury and defective product liability lawsuits over the past 10 years.
Plaintiffs have alleged in thousands of lawsuits that its DePuy line of ASR and Pinnacle metal on metal hip implants cause metallosis and fail prematurely requiring re-do surgery, that its line of Duragesic Pain fentanyl patches causes overdoses and death, that its Ethicon line of vaginal mesh and bladder sling inserts cause perforation and chronic pain, that its Risperdal antipsychotic medication causes gynecomastia (male breast growth) in young boys, that its Tylenol causes liver failure, that its Ethicon Morcellator device spreads uterine cancer through out the abdomen and pelvis during laparoscopic hysterectomy and uncontrollable bleeding from its blood thinner Xarelto.
Johnson & Johnson also faced charges of illegal marketing. In 2013, J&J paid $2.2 billion to the federal government and several states for illegal promotion of drugs, including Risperdal and Invega.
Now J&J is facing claims that its world famous baby powder causes ovarian cancer in women.
J&J is under fire by the family of Jackie Fox, who died of ovarian cancer last year at the age of 62 after enduring many rounds of chemotherapy. In a Saint Louis Missouri state court, Fox alleges that talc in J&J’s products caused her disease and the company knew the risk and failed to warn customers. The St. Louis talc ovarian cancer trial is expected to last two to three weeks. There are about 1,200 talc ovarian cancer lawsuits pending in state and federal courts nationwide.
What is Talcum Powder?
Talcum powder is derived from talc, which is a hydrated magnesium silicate. Talc is most popular as Baby Powder, which used to prevent or treat rashes in babies. Also, many women use talc powder for personal hygiene and cosmetics. Many different products are marketed as body powder, such as “Shower to Shower” and other brand names.
Talc powder is generally recognized as safe, but it may cause serious and life-threatening ovarian cancer concerns when used for feminine hygiene.
Did J&J Hide Ovarian Cancer Risks from Women?
According to plaintiffs, J&J’s internal documents will show it knew of studies connecting talc use and ovarian cancer but continued to market it, particularly to African-American and Hispanic women.
J&J claims that Fox’s family cannot prove talc caused the ovarian cancer and that a warning label wouldn’t have stopped her from using it. The Fox family isn’t claiming that talc was the sole cause of her cancer, but that it was a contributing factor. The plaintiff doesn’t have to prove that talc is the only cause for J&J to be held liable.
J&J Talcum Powder
J&J marketed its Shower to Shower brand talc for feminine hygiene. One 1988 ad promised “just a sprinkle a day keeps odor away.” Fox said in a deposition about six months before she died that she was “raised on” Johnson’s Baby Powder and Shower to Shower talc and used it every morning until she was diagnosed with cancer.
Medical Studies Link Talc to Cancer
In the 1970s researchers began linking talc to ovarian cancer. According to Daniel Cramer, a doctor at Boston’s Brigham and Women’s Hospital, he noted that in 1982, women who reported genital-talc use faced a 92 percent increase in the risk of developing ovarian cancer.
Several studies and reports have confirmed that talc applied to a woman’s genital area may travel through the vagina and into the uterus, fallopian tubes and ovaries.
In June 2013, according to a study in the medical journal Cancer Prevention Research found that women who used talcum body powder as a feminine hygiene produce may face a 20% to 30% greater risk of ovarian cancer compared to those who do not apply talc.
Cramer, in a new study in the journal Epidemiology, found that talc was associated with a 33 percent rise in the risk of ovarian cancer, which increased the longer it was used.
The American Cancer Society advised in 1999 that women use corn starch-based products in the genital area.
The case is Fox v. Johnson & Johnson, Cause No. 1422-CC09012-01, Division No. 10, Missouri Circuit Court, Twenty Second Judicial District (St. Louis).
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FDA Increases Scrutiny on Transvaginal Mesh Products
Feb 3, 2016 | The Legal Examiner
By Dori Milner
On January 4, 2016, the FDA took action to address the safety risks of transvaginal mesh repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Transvaginal mesh has been the subject of controversy for years, as the FDA has received thousands of reports of problems, including organ perforation, infection, and bleeding.
Surgical mesh is a type of plastic-like netting that surgeons use to shore up weakened or damaged tissue. In women with POP, a condition in which the organ protrudes or “falls” into the wall of the vagina, surgeons use the mesh to support and hold the dropped organ and tissues back into place. Serious complications, however, have raised concerns that repair with mesh is more dangerous than traditional repair without it.
Thus, after much research and analysis, the FDA recently required manufacturers to conduct additional clinical studies on these products, and has reclassified the devices from class II (moderate risk) to class III, which indicates high-risk.
FDA Has Watched Mesh for Years
The FDA has been watching the developments with transvaginal surgical mesh for years, now. Back in 2008, they warned that they’d received over 1,000 reports of adverse events associated with these devices, identifying surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as “an area of continuing serious concern.”
In July 2011, they updated their previous warning to inform patients and physicians that complications associated with surgical mesh were not rare, and that it was not clear that repairing POP with mesh was more effective than traditional non-mesh repair. They noted that between 2008 and 2010, they received nearly 3,000 additional reports of complications with surgical mesh devices used to repair POP and SUI, with problems including erosion of the mesh through the vagina, pain, infection, bleeding, pain during intercourse, organ perforation and urinary problems.
In September 2011, the administration held a subcommittee meeting to discuss the safety and effectiveness of vaginal mesh. The panel concluded that the safety of these medical devices was not well established, that more clinical studies were needed, and that manufacturers should conduct more trials to better explain the risks and benefits.
FDA Raises Safety Requirements for Transvaginal Mesh
Progress has been slow, but the FDA has finally taken meaningful action to protect public safety. According to their press release, their first order was to reclassify mesh used for transvaginal repair from class II to class III. The FDA proposed this change back in May 2014, “based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device.”
They then issued a second order requiring that manufacturers submit a premarket approval (PMA) application to support the safety and effectiveness of their products. Many transvaginal mesh products were previously approved through the FDA’s fast-track 510(k) process, which didn’t require clinical studies—only that the companies prove their products were significantly similar to other devices already on the market.
This change will force companies to prove that their products are safe and effective through the FDA’s most rigorous vetting process. Manufacturers will have 30 months to comply with the new requirements.
According to the Wall Street Journal, companies that make transvaginal mesh kits have already faced losses in court as women seek compensation for serious injuries. In 2014, Endo International PLC settled 20,000 transvaginal mesh lawsuits for $830 million, and in April 2015, Boston Scientific Corp settled about 3,000 cases for $119 million. Johnson & Johnson stopped selling some of it’s transvaginal mesh products in 2012.
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Bard Mesh Patients Cite Slow MDL Pace In Bid To Move Suits
Feb 3, 2016 | Law360
By Jody Godoy
A Philadelphia-based firm representing women in cases against C.R. Bard Inc. over allegedly defective pelvic mesh implants argued on Wednesday that six dozen of the suits should be transferred to Pennsylvania federal court since they're not about to be resolved in the sprawling multidistrict litigation in West Virginia.
Kline & Specter PC told U.S. District Judge Joseph Goodwin that it had negotiated with the medical device maker but had not come close to settling the 72 cases it now seeks to transfer to Pennsylvania.
The suits seek to hold the company liable for marketing and selling what the patients allege is a defective mesh product that caused them internal injuries.
Last summer, the firm sought to move 155 of its cases against Bard and hundreds more against Johnson & Johnson’s subsidiary Ethicon Inc. to Pennsylvania federal court, pointing to similar concerns with timing in the MDL.
According to court records, there are some 10,000 cases pending against Bard in the MDL in West Virginia.
But those cases are only a part of the giant jigsaw of litigation against mesh device manufacturers including Ethicon, Bard and Boston Scientific Corp.
Seven separate MDLs comprising some 70,000 cases are pending in West Virginia over alleged pelvic mesh implant injuries. Ethicon is facing about 23,000 as part of its MDL, according to court records.
Bard faced the first jury trial in the seven multidistrict litigation suits over the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. It was hit with a $2 million verdict in August 2013.
The U.S. Food and Drug Administration recently reclassified pelvic mesh devices like those at issue in the suits as high-risk devices that must undergo the agency's most stringent safety evaluation before being put on the market.
Counsel for the parties did not immediately reply to requests for comment after hours on Wednesday.
The plaintiffs are represented by Thomas Kline, Shanin Specter, Lee Balefsky and Michelle Tiger of Kline & Specter PC.
Bard is represented by Lori G. Cohen of Greenberg Traurig LLP and Michael K. Brown ofReed Smith LLP.
The case is In Re: C.R. Bard Inc. Pelvic Repair Systems Product Liability Litigation, case number 2:10-md-02187, in U.S. District Court for the Southern District of West Virginia. -
Boston Scientific, Bard Escape Joint Pelvic Mesh Trial
Feb 3, 2016 | Mass Device
By Brad Perriello
Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR) yesterday won the 1st trial in a pelvic mesh lawsuit against 2 companies after a Kansas City jury voted 10-2 that their implants were not defective and didn’t cause plaintiff Eve Sherrer’s injuries.
Sherrer alleged that Bard’s Align and Boston Scientific’s Solyx products used a polypropylene mesh that reacts to tissue by becoming brittle, and that the companies failed to warn patients about the products’ attendant risks, seeking $28 million in damages.
Manufacturers of pelvic mesh products, designed to treat female urinary incontinence and pelvic organ prolapse, face some 70,000 lawsuits spanning 3 multi-district litigations. Only a few have made it to trial, with juries recording 17 wins for plaintiffs and 5 for the defendant companies.
After the failure of the Solyx mesh Sherrer had implanted in 2010 to treat her pelvic organ prolapse, she was implanted with the Align product. Solyx, most of which was explanted after 67 days, caused her to become incontinent, her lawyer told the jury Dec. 2, and the Align implant’s stiffness allegedly led to chronic pain.
Boston Scientific’s attorney argued that Sherrer’s prior hysterectomy, osteoarthritis and an abdominal hernia could have caused her pain. The implant failed because it was not positioned correctly, he argued. Bard’s counsel told the jury that the material safety data sheet for the Marlex polypropylene mesh, indicating that the mesh is not suitable for permanent implantation, was included to cover liability, rather than safety issues.
After the 62-day trial – the longest-running pelvic mesh trial to date – the jury deliberated for less than 2 days before reaching a verdict for the defendants, according to Courtroom View Network. The case was also the 1st time a case involving either the Solyx or Align has gone to trial.
A Boston Scientific spokesman told the network that the company is pleased with the verdict and “believes the jury reached the right decision based on the facts and the law.” A representative for Bard and attorneys for Sherrer did not immediately respond to requests for comment, according to CVN.
In October, a Texas state jury used a plaintiff’s prior medical history as the basis for ruling that Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon’s Gynecare Prosima device was not defectively designed and that Ethicon’s risk warnings were adequate.
For Bard, Sherrer’s case is its 2nd to be heard in state court. In 2012 a California state jury awarded a plaintiff $5.5 million for injuries she attirbuted to the company’s Avaulta Plus mesh. Last year Boston Scientific won a pair of cases in Massachusetts state courts, but lost a $74 million case in Texas state court.
A Delaware state jury awarded a plaintiff $100 million last May, but a judge later slashed that judgment to $10 million. In October a North Carolina state jury found for the company.
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