Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.
Twitter: JjrkCh

Wednesday, April 23, 2014

RAND study: medical device PREVENTABLE harm & perverse incentives


No matter how it’s tallied—in total, per capita, or as a percentage of gross domestic product—U.S. spending on health care outstrips that of any other nation. Many experts identify costly new technology as the biggest driver of health care spending. Previous studies aimed at reining in spending on technology have focused on changing how existing medical technologies are used. But what about also encouraging the creation of technologies that could improve health and reduce spending, or that provide large-enough health benefits to warrant any extra spending? A recent RAND study focused on policies that could help change which medical products—drugs, devices, and health information technologies—get invented in the first place.
To spur inventors to create medical products that lower health care spending and promote health, policymakers need to address the perverse financial incentives that lead inventors and investors in the opposite direction. Currently, large profits are most often available from creating increasingly expensive products that boost spending, whether or not they also substantially improve health. In contrast, inventors face relatively weak incentives to create products that would help decrease spending.
The RAND research team developed ten high-priority policy options that could change the costs, rewards, and risks that inventors and investors face. We synthesized information from scientific, trade, and popular literature; conducted interviews with more than 50 national experts from a variety of fields; sought input from a panel of accomplished technical advisors; and developed illustrative case studies of eight medical products.
Illustrative Case Studies of Health Care Technology
         Avastin for Metastatic Breast Cancer
         A Cardiovascular Polypill
         Electronic Health Records
         Haemophilus influenzae Type b (Hib) Vaccine
         Implantable Cardioverter-Defibrillator
         Prostate-Specific Antigen
         Robotic Surgery
Who are the key players along the medical product innovation pathway?
In its simplest form, the innovation pathway for medical products has three stages—invention, regulatory approval, and adoption. Figure 1 shows key actors at each stage—the individuals and entities that make the most important decisions—as well as individuals and entities that seek to influence them. For example, inventors and investors obviously play key roles in the invention stage. The U.S. Food and Drug Administration (FDA) is the dominant player in the approval stage, and the physicians and hospitals deciding which technologies to use for which patients largely determine how quickly and broadly a product is adopted, thus determining a product’s success in the U.S. market.
Inventors and investors are strongly influenced by their expectations about the prospects and costs of gaining regulatory approval and the eventual adoption and use of their products. In turn, these expectations determine the anticipated costs, risks, and market rewards of pursuing their ideas for creating new medical products.
The decisions of key actors are influenced by others—for example, the National Institutes of Health (NIH), as the nation’s principal funder of basic biomedical research, provides fuel for invention by virtue of its investments in creating basic scientific knowledge. Manufacturers, patients, and payers all try to influence a product’s use for different reasons and with varying degrees of success.
Key actors

Key Influences
Fig. 1 The Medical Product Innovation Pathway
NOTE: ONC=Office of the National Coordinator for Health Information Technology.
What drives the costs, risks, and rewards of medical product invention?
The decisions of inventors and investors are largely driven by two considerations. The first is a technical assessment of whether the new product can be successfully brought to market and, if so, how much money and time it will take. The probability of success is influenced by perceptions of risks: scientific risk (will the technology work?) and regulatory risk (will the FDA approve it for use?).
The second consideration is financial: Are the anticipated rewards of bringing the product to market big enough to justify the associated costs and risks at all three stages?
We identified five features of the U.S. health care environment that substantially affect the costs, risks, and rewards of medical product invention for inventors and investors. The five are set forth below; to amplify the descriptions, we include paraphrases of comments from our expert interviews. The policy options that we developed were designed to address these features.
Roadblocks to High-Value Medical Product Innovation
Lack of Basic Scientific Knowledge
From the Experts
Knowledge gaps increase the risk of failure, the likely costs, and the time required to bring to market products that could help decrease spending.
When making decisions about where to invest R&D resources, developers consider the state of the basic science.
Costs and Risks of FDA Approval
The FDA approval process takes time and money; until FDA approval is granted, inventors and investors may receive no returns from the U.S. market to help recoup their investments.
The biggest impediment to high-value innovation—one that pushed developers to go in safer directions—is the difficult regulatory pathway.
Inadequate Rewards for Medical Products That Decrease Spending
Innovators who develop products that could reduce spending often cannot expect adequate market rewards for their efforts. Reasons include the facts that insured consumers do not pay the full price once they have exceeded their deductibles; many patients assume that newer, more expensive products must be better; and providers making decisions to use—or not use—a particular product often reap larger financial rewards from using a costlier alternative.
The reason that developers are deterred or discouraged from creating high-value technology that lowers overall spending revolves around reimbursement… There’s no market incentive.
Treatment Creep
Medical technologies that provide substantial health benefits to particular kinds of patients are often used for other kinds of patients, including many for whom there are small, or no, health benefits.
Companies will sometimes focus on one population to get over regulatory hurdles and then shift the focus for longer-term marketing.
Medical Arms Race
Health care providers such as hospitals often compete for business by offering the latest high-tech equipment or service rather than by offering greater value through larger health benefits and/or lower prices.
Marketing robotic surgery to hospitals for use in prostate surgery was “genius,” but there was no evidence that using the robot improved health outcomes.
In short, the medical innovation system is broken.

Nader Moussa/Wikimedia Commons/CC-BY-SA-3.0/GFDL
About 80 percent of all radical prostatectomies in the United States today are performed with robotic assistance, but there is no good evidence that robotically assisted radical prostatectomies produce better outcomes or have fewer serious side effects than manual radical prostatectomies.

The FDA approved the use of Avastin for metastatic breast cancer patients, but later withdrew that approval. Nonetheless, by law, Medicare continues to pay for Avastin used for those patients because this use is listed in major drug compendia.

A major limitation of today’s electronic health records is the lack of interoperability between systems.

Eldin Muratovic/Fotolia
A cardiovascular polypill, a multidrug combination that reduces blood pressure and cholesterol, could offer substantial health benefits per dollar spent, but development is slowed because inventors cannot justify the cost required to seek regulatory approval.
How can we redirect invention of medical products?
Our analysis led us to ten high-priority policy options that could alter the financial incentives driving medical-product innovation. Some options would directly affect inventor and investor decisions by lowering invention or approval costs and risks. Other options would indirectly influence inventor and investor incentives by altering the expected market rewards of an invention. Figure 1 highlights the stage of the innovation pathway at which each option operates. Policy options are described briefly on the pages that follow.
These options, individually or in combination, could redirect inventive efforts toward products that would help reduce health care spending and/or ensure that new products will provide health benefits that warrant any spending increases.
Ten Policy Options for Healing Medical Product Innovation
.                 Enable More Creativity in Funding Basic Science
NIH’s method for selecting which research to fund typically favors low-risk projects; if investigators fail to achieve their project goals, prospects for future NIH funding are greatly reduced. A different model is used by the Howard Hughes Medical Institute. It funds scientists rather than projects, encourages risk-taking, and seems more willing than NIH is to continue funding promising scientists whose past risky endeavors did not pan out.
.                 Offer Prizes for Inventions

Substantial prizes could be awarded to the first individual or group that invents a drug or device that satisfies pre-specified criteria. Prizes could be offered by public entities such as the Centers for Medicare & Medicaid Services (CMS) or NIH, by private health care systems, by philanthropists or charitable foundations, or by public-private partnerships. An alternative to an immediate cash prize is to offer a percentage of future savings to the Medicare program attributed to the invention.
Buy Out Patents
Purchasing the patents of products that have already been invented could ensure that a product is commercialized at a lower price, increasing the immediate reward for inventing products that decrease spending. Public agencies, private philanthropists, or public-private partnerships might be purchasers. A purchaser could put the patent in the public domain, generating price competition, or license the technology selectively,
specifying the highest price that licensees could charge. The best approach might be to offer patent sellers a share of the savings to the Medicare program attributed to the invention.
Establish a Public-Interest Investment Fund

Private investors often find the likely market rewards for inventing products that reduce spending too low to be attractive. When this is the case, a public-interest investment fund could provide the required investment capital. A private-public partnership could tap the expertise of private-sector investors who are most capable of assessing the promise of technical concepts and inventors. They could be motivated to participate by being allowed to invest in projects supported by the fund, with their financial returns coming from a share of Medicare savings attributed to the inventions.
Expedite FDA Reviews and Approvals for Technologies That Decrease Spending

The FDA could offer expedited—but not watered-down—review and approval processes for medical products with clear potential to substantially reduce health care spending. Creating such mechanisms could lower inventors’ regulatory costs and speed entry to market.
Reform Medicare Payment Policies

Currently, CMS is not allowed to consider cost in determining payment rates—if it were, the agency could set Medicare rates to save money in the short run and improve inventors’ incentives over the long run. One widely discussed possibility is for Medicare to move more swiftly to adopt approaches—such as bundled and capitated payment arrangements—that put providers at financial risk for costs not required to deliver high-quality care. Expanding the numbers of providers facing and circumstances involving such risks should boost demand for cost-saving drugs, devices, and other health care technologies.
Reform Medicare Coverage Policies
CMS could change its coverage determination policies in ways that would increase the health benefits per dollar of Medicare spending. For example, CMS could expand use of its existing “coverage with evidence” process. Medicare could also stop paying for tests, procedures, and products that clinical experts have deemed inappropriate or ineffective; many of these have already been identified by the American Board of Internal Medicine Foundation’s Choosing Wisely initiative. Medicare could also stop covering off-label use of some very expensive cancer and other specialty drugs in circumstances for which there is little or no evidence of effectiveness. Some of these policy changes would require new legislation.
Coordinate FDA and CMS Processes

For products that are likely to help reduce spending, CMS coverage and payment determination processes could be coordinated with FDA review and approval processes. Coordination could reduce the time required to obtain revenues from the Medicare market. Identifying the best approach might be informed by what is learned from current efforts involving parallel review by FDA and CMS.
Increase Demand for Technologies That Decrease Spending

Changing payer, provider, and patient incentives could increase demand for products that decrease spending. One promising approach is expanding use of value-based insurance designs (VBIDs), which require individual patients to pay more out of pocket to receive services that are less likely to benefit them. A major challenge in implementing VBIDs is determining which services are more and less likely to substantially benefit individual patients.
Produce More and More Timely Technology Assessments

Health technology assessments (HTAs) provide systematic evidence about the safety, efficacy, effectiveness, and cost of drugs, devices, and procedures. Because medical technology evolves quickly, HTAs are more useful when they are more current. An emerging commercial model may suggest a good way to produce more timely HTAs—namely, by keeping abreast of the literature through fairly frequent literature searches and revising HTAs when new findings warrant.
Several of these options are novel; thus, there are few precedents or existing analyses to help policymakers design and successfully implement them. Others have already been proposed but not implemented. In our view, the potential benefits of implementing specific policies could dwarf the costs of doing so. For example, the potential savings to the Medicare program alone that could result from implementing several of the options would generate a large pool of money that could be used to spur invention of products that reduce spending or provide substantial health benefits.
Because the stakes in reining in health care spending are so high, and the need to get more health benefits from the money we spend is so great, we believe all of these options should be considered—the sooner the better.
Technical Advisers
To help us achieve our project goals, we convened a panel of national experts to review our ideas and weigh the promise of various policy options suggested by our findings. The panel offered comments on our draft analytical framework, weighed the pros and cons of different case study topics, and suggested several policy options. However, the panel members do not necessarily endorse the study findings.
Donald M. Berwick, MD
President Emeritus and Senior Fellow, Institute for Healthcare Improvement, Cambridge, Massachusetts
Otis W. Brawley, MD, FACP
Emory University and American Cancer Society
Philippe Chambon, MD, PhD
Managing Director, New Leaf Venture Partners LLC
Delos M. Cosgrove, MD
CEO and President, Cleveland Clinic
Ezekiel J. Emanuel, MD, PhD
Vice Provost for Global Initiatives; Diane v.S. Levy and Robert M. Levy University Professor; Chair, Department of Medical Ethics and Health Policy, University of Pennsylvania
Atul Gawande, MD, MPH
Surgeon, Brigham and Women’s Hospital; Director, Ariadne Labs; Professor, Harvard School of Public Health and Harvard Medical School
Brent C. James, MD, MStat
Chief Quality Officer, Intermountain Healthcare
Dean Kamen
Founder and President of DEKA Research & Development Corporation
Karen Katen
Senior Advisor, Essex Woodlands
Larry Kessler, ScD
Professor and Chair, Department of Health Services, School of Public Health, University of Washington
Vinod Khosla
Partner, Khosla Ventures
Kenneth W. Kizer, MD, MPH
Distinguished Professor, University of California (UC) Davis School of Medicine and Betty Irene Moore School of Nursing; Director, Institute for Population Health Improvement, UC Davis Health System
Robert Langer, PhD
David H. Koch Institute Professor, Massachusetts Institute of Technology
Mark McClellan, MD, PhD
Senior Fellow and Director, Initiative on Value and Innovation in Health Care, The Brookings Institution
Arnold Milstein, MD
Professor of Medicine, Clinical Excellence Research Center Director, Stanford University
Trevor Mundel, MD, PhD
President, Global Health, Bill & Melinda Gates Foundation
Peter J. Neumann, ScD
Director, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center; Professor, Tufts University School of Medicine
Boris Nikolic, MD
Chief Advisor for Science and Technology to Bill Gates
Michael A. Peterson
President and Chief Operating Officer, Peter G. Peterson Foundation
Michael E. Porter

Professor, Harvard Business School

Wednesday, April 16, 2014

Implant Manufacturers Have Overwhelming Control of AAOS? Choosing Wisely!

KHN Staff Writer
APR 14, 2014

This KHN story was produced in collaboration with the Chicago Tribune.
When America’s joint surgeons were challenged to come up with a list of unnecessary procedures in their field, their selections shared one thing: none significantly impacted their incomes.
The American Academy of Orthopaedic Surgeons discouraged patients with joint pain from taking two types of dietary supplements, wearing custom shoe inserts or overusing wrist splints after carpal tunnel surgery. The surgeons also condemned an infrequently performed procedure where doctors wash a pained knee joint with saline. 

Scott Weingarten, chief clinical transformation officer at Cedars-Sinai Health System in Los Angeles, says his hospital has embraced the Choosing Wisely recommendations by adding them to the computerized patient record system. When doctors order something on the list, they are warned by the computer about the procedure (Photo by Jeff Lewis/AP Images).
"They could have chosen many surgical procedures that are commonly done, where evidence has shown over the years that they don't work or where they're being done with no evidence," said Dr. James Rickert, an assistant professor of orthopedic surgery at Indiana University. "They chose stuff of no material consequence that nobody really does."
The medical profession has historically been reluctant to condemn unwarranted but often lucrative tests and treatments that can rack up costs to patients but not improve their health and can sometimes hurt them. But in 2012, medical specialty societies began publishing lists of at least five services that both doctors and patients should consider skeptically. So far, 54 specialty societies have each offered recommendations and distributed them to more than a half-million doctors.

Hospitals that have deployed the lists, including Cedars-Sinai Medical Center in Los Angeles, report that the frequency of superfluous procedures has dropped. Consumer Reports, AARP and Univision are some of the influential organizations that have been part of a broad campaign to educate patients about the questionable items. Dr. Donald Berwick, a former head of Medicare, heralded the "Choosing Wisely" campaign as "a game-changer" because the "advice comes not from payers or politicos, but from pedigreed physician groups."
Yet some of the largest medical associations selected rare services or ones that are done by practitioners in other fields and will not affect their earnings. "They were willing to throw someone else’s services into the arena, but not their own," said Dr. Nancy Morden, a researcher at the Dartmouth Institute for Health Policy & Clinical Practice in New Hampshire.
Some specialists did target their own money-makers. Gastroenterologists, radiologists and clinical pathologists all placed their own tests on their lists. The Society of General Internal Medicine recommended against the annual physical exam, a mainstay of American health care.
Other specialty groups said they did not include their own procedures where there are concerns of overuse, such as stents for heart patients and spine surgery, because the evidence is murky and the procedures are right for some patients. "What we did when we made up the list was to start with more straightforward situations and hopefully expand that later," said Dr. F. Todd Wetzel, a member of the board of directors of the North American Spine Society.
Those societies tended to focus on limiting testing that others do. In an article in the New England Journal of Medicine, Morden examined all the items on the first 26 Choosing Wisely lists. She found that 83 percent of the items targeted radiology, medications and cardiac and lab tests—not physician services.
Stenting Gets A Pass
The American College of Cardiology opted to list the use of cardiac testing in four circumstances. But the college did not tackle what studies suggest is the most frequent type of overtreatment in the field: inserting small mesh tubes called stents to prop open arteries of patients who are not suffering heart attacks, rather than first prescribing medicine or encouraging  a healthier lifestyle. As many as one out of eight of these stent procedures should not have been performed, according to a study in Circulation, the journal of the American Heart Association.  At hospitals where stenting was most overused, 59 percent of stents were inappropriate, the study found.
"Let's face it, angioplasty and stenting is a big business, it's highly profitable for hospitals, and it's highly remunerative for physicians," said Dr. William Boden, a New York cardiologist who oversaw the first large trials that found no advantage for stents for patients who are not in acute distress. "There's a tremendous impetus to not rock the boat and not to call attention to the fact that we do too many procedures in stable patients for whom outcomes would be the same if not even better if treated medically."
Dr. William Zoghbi, a Houston cardiologist who was president of the college when the list was announced in 2012, rejected the suggestion that stenting procedures should have been more broadly questioned, saying "the vast majority" of stents "are quite appropriate for the condition." He said cautious choices for the initial list made sense because a campaign like Choosing Wisely is unfamiliar to doctors. "You have to walk before you run," Zoghbi said.
The cardiologists did discourage one specific use of stenting, where doctors opening a clogged artery place additional stents in other places where screenings have spotted the starts of blockage. Dr. Vikas Saini, a Massachusetts cardiologist and president of the Lown Institute, which advocates for more restraint in treatments, said, "in 20 years of practice that’s not something I would have thought is standard and if people are still doing it, that’s a shame."
Stents are a profit center for the group of cardiologists who perform procedures, often known as invasive cardiologists. They earned a median salary of $488,000, according to the Medical Group Management Association. Orthopedic surgeons do even better: half earned more than $538,000 in 2012, according to the MGMA’s income survey.
The orthopedic academy defended its Choosing Wisely selections, writing in a statement that "our recommendations are limited by the existing evidence regarding the effectiveness of various treatment options for musculoskeletal conditions, which we are seeking to improve." It noted that its recommendation against the dietary supplements could save patients $750 million a year spent on these drugs.
The orthopedists' selections did not impress critics. Rickert, the Indiana orthopedist, noted that discouraging dietary supplements affects revenue for health stores and other retail outlets, not surgeons. Both he and Morden said saline injections to treat knee pain are seldom done. Morden said when she searched 2011 Medicare billing records for the procedure, "I found zero claims."
"That's how pathetic that item is," she said.
Dr. Augusto Sarmiento, a former president of the academy and retired chairman of orthopedics at the University of Miami Miller Medical School, said there were more significant overused procedures the academy omitted, including replacing hips and knees when the patient’s pain is minimal and can be managed with medicine.

In addition, Sarmiento said too many surgeons operate on simple fractured collarbones, inserting metal plates, rather than letting the injury heal with the help of a sling. "The abuse of surgery is due to the overwhelming control of the profession by the implant manufacturing companies," he said.

Spinal Fusions Spared
The median compensation of a spine surgeon is more than $730,000, according to MGMA's survey. It is unclear how many spine surgeons are still performing a procedure the North American Spine Society placed on its list: using bone growth material in spinal fusion in the neck. The Food and Drug Administration issued a safety alert against this in 2008, noting that the procedure had led to the swelling of neck tissue that compressed patients' airways, making it hard to breathe or speak.
"I think the use for that purpose has already fallen off substantially," said Dr. Richard Deyo, a professor at Oregon Health & Science University and spine researcher. "They've taken on the easy things."
The only other procedure the society mentioned was spinal injections, but it was to expand, not restrict their work: They encouraged doctors to do their injections with the help of imaging, which would tack on another expense. The group also did not address spinal fusion, which has more than doubled in frequency between 1998 and 2008, faster than most procedures, one study showed.  Other research found that patients with back pain were increasingly likely to get a physician referral, "presumably for consideration of treatments such as injections and surgery" while referrals for physical therapy stayed flat over a decade.
Wetzel, the spine society official and an orthopedic surgeon at Temple University Medical School in Philadelphia, said that since spinal fusion has been shown to be useful "under very specific circumstances," the society "didn't feel comfortable making any kind of blanket statement."
The importance of which items are included is not just an academic debate, because where the lists have been actively embraced, the rate of those services has dropped. Last year, the Cedars-Sinai Health System in Los Angeles added 120 Choosing Wisely recommendations into its computerized patient records so that they would pop up on a screen whenever a clinician tried to authorize one.
"The alerts fire about 100 times a day," said Dr. Scott Weingarten, Cedar-Sinai's chief clinical transformation officer. For example, he said, there has been a decrease in the use of benzodiazepines and other sedative-hypnotics to treat the elderly, as they result in more falls, following a recommendation from the American Geriatrics Society for Choosing Wisely.
"We've got a bunch of other countries knocking on our door," said Dr. Richard Baron, president of the ABIM Foundation, which solicited the Choosing Wisely lists from the specialties. "There's a Choosing Wisely Canada.  There are health systems using it, insurers are using it."
Dr. John Santa, medical director for Consumer Reports, said reducing tests is a worthy goal because test results often prompt patients to get procedures. He cited electrocardiograms, which are used to measure the heart’s electrical activity to diagnose heart disease.  "Some people would say, it’s a $50 test, it's harmless," Santa said. "The false positives you get from EKGs can cause significant downstream problems. You may think you may have just been brilliant in detecting some abnormality. That's how stents get put in."
In Annapolis, Md., the Anne Arundel Medical Center broadcasts "Choosing Wisely" lists on hospital television screens, places posters on the walls of doctors' offices and discusses the lists in its magazine that it mails to county residents. The lists are also embedded as links in electronic patient records so physicians can easily review them.
Dr. Barry Meisenberg, an oncologist in charge of the hospital's quality efforts, said the lists are helpful when he is trying to explain to disappointed patients why he is not ordering a particular test. "It does help that’s not just this guy’s opinion, it actually has the imprimatur of a society," he said.

Monday, April 7, 2014

Plaintiff awarded $1.2M by Texas jury for defective surgical mesh product

 April 04, 2014 at 11:38 AM

Johnson & Johnson was ordered by a Texas jury to pay $1.2 million to a woman who alleged one of the company’s lines of vaginal-mesh implants to treat incontinence was defectively designed, in the first verdict against the company over those devices.
Jurors in state court in Dallas concluded the design of the TVT-O mesh sling implanted in Linda Batiste was flawed and the 64-year-old woman deserved $1.2 million in compensatory damages, her lawyers said. They argued Batiste suffered pelvic pain when the device eroded inside her.
J&J, based in New Brunswick, faces more than 12,000 lawsuits accusing its Ethicon unit of making improperly designed vaginal inserts, such as the slings, that damaged women’s organs and made sex painful. Most of the cases have been consolidated before a federal judge in West Virginia for pretrial information exchanges while other cases are being heard in state courts.
The U.S. Food and Drug Administration has ordered J&J, C.R. Bard Inc. and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of lawsuits over the devices.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.
Appeal Planned
J&J officials noted the Dallas jury rejected Batiste’s claims that Ethicon didn’t provide proper warnings about the slings’ health risks and declined to award punitive damages.
“The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal,” Matthew Johnson, an Ethicon spokesman, said yesterday in an e-mailed statement.
J&J officials decided in 2012 to stop selling some lines of vaginal-mesh implants after being hit with a wave of lawsuits over the devices. The TVT-O sling Batiste, a former nurse, received is still on the market, Thomas Cartmell, one of her lawyers, said in a phone interview.
“This verdict represents the first time an impartial jury had the opportunity to decide whether Ethicon’s sling products are defective and they found exactly that,” Bryan Aylstock, a plaintiffs’ lawyer helping to oversee cases gathered before U.S. District Judge Joseph Goodwin in West Virginia, said in a phone interview. “We believe this is the first of many more verdicts to come over this dangerous product,” he added.
NJ Verdict
Last year, a New Jersey jury ruled J&J must pay $11.1 million in damages to a woman who blamed a Prolift device for her injuries in the first case over any of the company’s implants to go to trial. The Prolift implants help support sagging organs.
Lawyers for J&J, the world’s biggest maker of medical products, argued in court papers that the TVT-O slings are safe and effective and the company properly warned consumers about their risks.
In February, Goodwin threw out a woman’s claims that another line of the company’s sling inserts was def