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1. Device lawsuits plague Cook Medical

   Jun 18, 2016 | Indianapolis Business Journal

   By John Russell
   
   
   The lawsuits against Cook Medical began four years ago with a trickle but have since turned into a gusher, now surpassing 500. Patients around the country say the company’s blood-clot filters—small, cage-like devices inserted into blood vessels to prevent blood clots from reaching the lungs—have broken apart, moved or poked through a vessel.
2. Women with pelvic mesh implants report painful, intractable infections

   Jun 19, 2016 | CTV News

   Canadian women say their quality of life has been destroyed by painful and seemingly intractable bacterial infections caused by pelvic mesh implants used to treat incontinence.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

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1. Device lawsuits plague Cook Medical

   Jun 18, 2016 | Indianapolis Business Journal

   By John Russell

   The lawsuits against Cook Medical began four years ago with a trickle but have since turned into a gusher, now surpassing 500.
   
   Patients around the country say the company’s blood-clot filters—small, cage-like devices inserted into blood vessels to prevent blood clots from reaching the lungs—have broken apart, moved or poked through a vessel.
   
   Some of the patients complain of pain, infections and the need for several surgeries to recapture the filter. At last count, 560 patients had sued—up sharply from about 100 last summer.
   
   The lawsuits are casting a harsh glare on Cook Medical, a pioneer in medical devices and one of Indiana’s largest privately owned companies, with annual sales of $2 billion and a global workforce of 12,000.
   
   The Bloomington-based manufacturer already has had its hands full dealing with product-quality issues.
   
   It has issued five recalls since 2014, the latest just last month, when it recalled more than 4 million cathetersafter receiving reports of tips splitting or breaking, requiring surgeons to retrieve them from inside the patient.
   
   Cook makes more than 16,000 products—from stents to hernia-repair devices. The company declined to say how big a percentage of sales the filters represent.
   
   For its part, Cook says its filters are safe and help save thousands of lives a year for patients who are at risk for pulmonary embolism, or blockage of an artery in the lungs.
   
   Nationally, 100,000 people die each year from pulmonary embolism, according to the Centers for Disease Control and Prevention.
   
   About 200,000 blood-clot filters—also known as inferior vena cava filters, or IVC filters, for short—are implanted nationwide each year. The market for IVC filters is $435 million, according to market research firm Axis Research Mind.

   “IVC filters are an important option for physicians trying to prevent this life-threatening condition,” said Marsha Lovejoy, Cook Medical’s global manager of corporate content strategy. “We are dedicated to providing life-saving treatment options for patients.”
   
   Cook is one of the nation’s largest makers of blood-clot filters, although it declined to say how many it sells a year.
   
   It is one of three leading firms in the industry, along with New Jersey-based C.R. Bard Inc. and the Cordis subsidiary of New Jersey based Johnson & Johnson. A separate series of suits against C.R. Bard has been consolidated in U.S. District Court in Arizona.

   The hundreds of lawsuits now sprouting up against Cook are sure to cost the company large sums to defend itself—and possibly millions of dollars more if a jury makes a big award, or the company decides to settle.
   
   And some plaintiff’s lawyers say Cook is showing signs that it plans to settle at least some of the claims. In February, Cook hired attorneys from Faegre Baker Daniels in Indianapolis as “settlement counsel”—a term used for attorneys who specialize in resolving disputes quickly and under favorable terms.
   
   “To me, that sends a strong signal that Cook is looking carefully at these cases, seeing which ones have the most merit, and separating the wheat from the chaff for a settlement,” said Moze Cowper, an attorney in Austin, Texas, who is representing a Utah woman who claims she was injured from a manufacturing defect in a filter implanted in 2015.
   
   But Cook said it has no plans to settle the cases. The company hired settlement counsel as a “routine response,” Lovejoy said.
   
   “Courts routinely require parties to participate in settlement conferences like this one early in the proceedings,” she said.

   
   She added: “Cook’s IVC filters are not defective in design or manufacturing. We will vigorously defend against those claims.”

   Legal onslaught
   
   It’s unclear how many more cases will be filed, and whether the numbers will rival other recent medical-device lawsuits in Indiana.
   
   Two years ago, Biomet Inc. in Warsaw agreed to settle for more than $100 million a case involving the company’s implanted hip replacement devices. More than 950 patients around the nation claimed they were harmed by the metal-on-metal ball-and-socket parts.
   
   In the most serious cases, the Biomet implant had to be replaced or a “revision” surgery was required to remedy injuries that ranged from shed metal that caused toxic reactions to dislocation or device failure.
   
   Some medical-law experts doubt that Cook’s cases, even as they continue to grow, will rival the nation’s largest medical-device litigation.

   “Five hundred lawsuits doesn’t strike me as a lot. You can get into the thousands,” said David Orentlicher, a physician, attorney and co-director of the Center for Law and Health at Indiana University’s McKinney School of Law in Indianapolis.
   
   “Having a device malfunction is not unusual, whether it’s an artificial joint or a defibrillator,” he said.
   
   Earlier this decade, more than 60,000 patients sued makers of transvaginal mesh, including Johnson & Johnson, C.R. Bard, Coloplast and American Medical Systems.
   
   Those patients complained that the mesh, a medical implant used to treat conditions such as pelvic organ prolapse and stress urinary incontinence, had serious side effects, including piercing through organs.
   
   In several early trials, juries awarded more than $2 million in damages. Some of the other makers then began to settle, with some of the patients receiving tens of thousands of dollars.
   
   Injuries vary
   
   It’s too early to say how the lawsuits against Cook will turn out, or whether the company stands to be severely injured from possible jury awards or settlements.

   But some plaintiff’s attorneys in the Cook case say their clients have serious injuries and that even one case can result in a lot of misfortune.

   “The injuries vary from person to person,” said TaKeena Thompson, an attorney at Cohen & Malad in Indianapolis, which represents nine patients. “It will depend on whether a doctor is able to retrieve the filter, and do so quickly.”
   
   That doesn’t always happen, according to some adverse-event reports submitted to the U.S. Food and Drug Administration.
   
   In one report, a 50-year-old patient who was hospitalized with severe pneumonia said her doctor decided to implant a Cook IVC filter in her thigh. The filter broke, with part of it lodging in the lower lumbar of her spine, and the rest of it migrating toward the spine.
   
   “Saw doctor after doctor to conclude with five massive surgeries to remove embedded Cook filter,” she wrote. “[I] have an 11-inch scar, 1/4-inch width in abdominal exploration and retrieval operation. Near one-year anniversary coming up. I will never be the same inside or out.”
   
   Cook said “only a very small percentage” of its filters has resulted in complications and is subject to litigation.
   
   “We are committed to patient safety and intend to vigorously defend these products because we believe in their ability to save lives,” Lovejoy said.
   
   The cases have been consolidated in U.S. District Court in Indianapolis.
   
   The first trial is set for March 2017.•

   
   

   http://www.ibj.com/articles/59060-device-lawsuits-plague-cook-medical
   

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2. Women with pelvic mesh implants report painful, intractable infections

   Jun 19, 2016 | CTV News

   Canadian women say their quality of life has been destroyed by painful and seemingly intractable bacterial infections caused by pelvic mesh implants used to treat incontinence.

   The news comes as some U.S. states are suing a major mesh manufacturer, alleging thatthousands of women face complications, including a risk of chronic infection, sometimes years after surgery.

   There are thousands of lawsuits underway around the world.

   Chrissy Brajcic, 40, of Windsor, Ont., says she lies in bed all day “in agony” due to the nausea, vomiting and pain she still has more than a year after the removal of a polypropelene mesh implant.

   Doctors had recommended the mesh to stop incontinence following childbirth. It left her feeling like she had “barbed wire” in her abdomen, she said. The pain was so bad she couldn’t continue her work as an interior decorator and had difficulty walking.

   After the mesh was removed in February 2015, the pain continued and the intractable urinary tract infections began. “It feels like I’m dying from the inside and I’ve lost all sense of normalcy in my life,” she said.

   Brajcic’s infections don’t appear to be responding to a growing list of antibiotics. She says each subsequent infection is worse than the one before.

   “The future is very uncertain,” according to Brajcic. “We don’t know if anyone is able to kill these infections at this point because nothing has worked in the past year.”

   “I’m in a terrifying place,” she added.

   Brajcic said her goal is to get all pelvic mesh off the market until further studies are done.

   Diane Fichter, a B.C. woman among dozens who approached CTV News in 2012 to discuss painful complications, says doctors have run out of antibiotics to treat her latest infection, which began last September.

   Fichter’s implants were put in place for incontinence and organ prolapse seven years ago and, like Brajcic, she suffered so much pain that she had most of the mesh removed.

   “Physically it’s extremely hard,” she said. “Emotionally, it’s extremely hard.”

   The intravenous antibiotics Fichter has taken have caused anaphylactic shock, along with extreme nausea and vomiting, so she is afraid to take any more.

   Fichter encourages women considering mesh implants to educate themselves. One website,Mesh Problems, lists some of the research and women’s stories.

   Earlier this year, the U.S. FDA reclassified pelvic mesh to repair pelvic organ prolapse from the moderate-risk category to the high-risk category of devices. Mesh devices for stress incontinence were not reclassified.

   “The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation,” the FDA said at the time.

   Dr. Blayne Welk, a urologist and assistant professor of surgery at Western University in London, Ont., performs mesh removals several times a month at St Joseph’s Heath Care London.

   He has conducted studies showing that about five per cent of women in Ontario have the implants removed due to complications. Other studies have found much higher rates of complications, up to 30 per cent.

   Dr. Welk says the recurrent bladder and kidney infections in a “fairly small group” of patients are a concern, but he doesn’t think the mesh should be removed from the market.

   “It’s a tool that should be used for the right patients,” he said.

   Doctors are trying to figure out why a subset of women, such as Brajcic, are suffering from chronic infections even after the mesh is removed.

   Dr. Welk points to research that suggests the mesh may sometimes be “be colonized with bacteria at the time of implantation” that leads to chronic inflammation.

   “Those women should be followed by surgeons for a couple of years afterward to ensure they don’t develop complications,” he said, “… and to be able to treat and intervene in a timely manner if they do.”

   http://www.ctvnews.ca/health/women-with-pelvic-mesh-implants-report-painful-intractable-infections-1.2952614
   

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