The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
In October of last year, Terri wanted to become involved in her state’s special election in a real way. With each passing day, she became angrier about the TV ads the drug companies were constantly running to defeat real drug price reform…
Drugs & Medical Devices
Americans have suffered and lost their lives because they are not given ALL information about risks by either manufacturers or the FDA. Pharmaceutical companies should be accountable for safety problems, and not keep drug risks hidden from the public. Medical device companies should respond to malfunctioning implants.
Consumers Union Documents
- Consumers Union’s Safe Patient Project Recommendations for Strengthening Medical Device Safety Oversight
Improve review of devices before they enter the market.
- Consumers Union Testimony on Medical Device Safety Before U.S. House Committee on Energy and Commerce/Health Subcommittee
Consumers Union Testimony on Medical Device Safety before U.S. House Committee on Energy and Commerce/Health Subcommittee
- Improve the Safety of Medical Devices
An overview of Consumers Union’s Safe Patient Project Initiative
- Two pathways for approval of devices
Consumers Union background on device approval and recommendations to make it safer
- FDA Advisory Committee Members Should be Free of Conflicts-of-Interest
Several congressional bills have introduced bills that would relax conflict of interest rules for the Food and Drug Administration (FDA) advisory committee members.
- Consumers Union Letter to Congress Concerning the Medical Device User Fee Act (MDUFA)
Consumers Union Letter to Congress Concerning the Medical Device User Fee Act (MDUFA)
- Drug Safety: Managing Multiple Drugs
The more drugs you take, the more likely you are to have a problem. Read Consumer Reports’ guide to consumers on managing multiple drugs safely.
- Drug Safety: Reading Labels and Patient Information
Consumer Reports guide to consumers on reading drug labels.
- Drug Safety: Taking Drugs as Directed
Consumer Reports advice to consumers on taking drugs safely.
- Drug Safety: Side Effects
Consumer Reports advice to consumers about drug side effects.
Consumers Union News Releases
- CU testifies for stronger medical device oversight at House Hearing Today
Congress Shouldn’t Sacrifice Patient Safety In The Drive to Speed Up Medical Device Approvals, CU Says
- Consumers Union steps up campaign to improve medical device safety
Consumers Union’s Safe Patient Project teams up with eight patient safety activists from around the country to Washington, D.C. to meet with lawmakers in Congress and press for improvements in the Medical Device User Fee Act (MDUFA).
- Lax oversight of medical devices puts patients at risk, Consumers Union says
Consumers Union, the advocacy arm of Consumer Reports, urged Congress to strengthen the law governing approval of medical devices.
- Consumers Union Urges Congress to Strengthen Medical Device Oversight
Consumers Union urged Congress today to strengthen the law that governs the approval of medical devices to ensure
- Consumers Union Statement on IOM Medical Device Study
The medical device industry lobby has criticized a report on medical device regulation before it was published.
- Consumers Union: IOM Report Urges More Consumer Protection for Medical Devices
The report that found thousands of medical devices are allowed to go on the market without proper testing for safety.
- Consumer Reports Poll Finds High Levels of Concern About Medical Harm & Support For Public Ratings on Hospital Safety
A new poll released today by the Consumer Reports National Research Center found high levels of public concern about hospital-acquired infections and other forms of medical harm.
- Report Finds Medical Errors More Common
Consumers Union Calls For Public Reporting of Medical Errors
- Health Care Reform Law Poised to Make Health Care Safer
New Law Includes Important Patient Safety Provisions That Will Save Lives and Health Care Dollars
- CU Report: U.S. Health Care System Fails To Protect Patients From Deadly Medical Errors
Consumers Union Assesses Lack of Progress Ten Years After Institute of Medicine Found Up To 98,000 Die From Preventable Errors
Blog Posts
- Institute of Medicine report scrutinizes medical device approval process
The IOM released a report last week reviewing the 510(k) medical device approval process. The report finds that the current FDA process “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of devices.
- Video: Advice on staying safe in the hospital–from the experts
Hear advice from consumer advocates on patient safety.
- Recall Announcement Affects Consumers Union Employee
Medical recalls can indicate potential risk of serious injury or death to patients, but they often go unnoticed.
- Let’s talk about labels
A bill in California (SB 1390) would create a minimum of 12-point font for the most crucial information on medication labels and would require translation of medication label information into commonly used non-English languages.
- California Pharmacy Board Should Support Safer Medication Labels
Guest blog post written by Syed Sayeed, Policy Analyst at Consumers Union’s West Coast Office. CU is calling on California residents to submit comments to the Pharmacy Board by March 10th, in support of requiring all pharmacies to print important label information in at least a 12-point font size.
- Medical Mistakes show on Oprah
Did you catch the Oprah Winfrey Show on Tuesday about medical mistakes? She featured actor Dennis Quaid who recalled the series of hospital errors that nearly killed his newborn twins after they were given one thousand times the amount of the blood-thinning drug Heparin—twice.
- Old Blood for Halloween
Patients given blood transfusions of blood stored 29 days or longer are twice as likely to get a hospital-acquired infection as those receiving newer blood, according to researchers at Cooper University Hospital in New Jersey.
- You Score Higher Marks than Doctors
According to new FDA data, consumers like you make up the majority of drug adverse event reports submitted, replacing physicians.
- What you should ask your doctor
Consumer Reports Health continues its AdWatch series, with this analysis of those ubiquitous Cialis ads.
- Common sense shouldn’t take two years – unless it’s the FDA
Should it really take two years to study a common-sense proposal to make drug ads better for consumers? Not unless it’s the Food and Drug Administration, which has taken foot-dragging to new heights
News Articles
- Consumer Advocates Push House Panel For Stronger Oversight of Device Approvals Source: Bloomberg (Wednesday February 22, 2012)
Consumer advocates told a House panel Feb. 15 that stronger medical device safety oversight is needed, especially now that the Food and Drug Administration has a potential new user fee agreement with industry. Includes quotes by Lisa Swirsky, senior health policy analyst for Consumers Union.
- Hip Maker Discussed Failures Source: New York Times (Tuesday February 21, 2012)
Flawed Depuy hip implant had early FDA notice
- How dirty medical devices expose patients to infection Source: iWatch News (Wednesday February 22, 2012)
An outbreak of infections at a Texas hospital prompted an investigation of the surgical tools used and raised concerns about dirty devices, including possible design flaws that make them difficult to clean.
- Consumer group clashes with medical device industry on Capitol Hill Source: Cardiovascular Business (Tuesday February 21, 2012)
Some coverage of the medical device U.S. House hearing. Features quotes by Consumers Union and Jim Shull, who told about his experience as a patient harmed by synthetic mesh used for a hernia operation.
- Controversy over medical device safety Source: WOAI (Wednesday February 15, 2012)
San Antonio’s WOAI reports on the medical device debate in Congress, including the story of Mike McReynolds who can barely walk these days, because the hip implants he received in 2009 are causing excruciating pain. He recently learned those implants, made by a company called DePuy, were never subjected to clinical trials to prove their safety.
- Consumer Groups: Medical Devices Need More Oversight Source: Fowler Tribune (Monday February 20, 2012)
Colorado publication: Patient safety advocates are asking Congress to step up the regulation of such medical devices as hip replacements and heart stents. Comments by Lisa McGiffert, Director of Consumers Union’s Safe Patient Project.
- St. Jude Device Exposes Safety Monitoring Failures, Doctor Says Source: Bloomberg Businessweek (Thursday February 16, 2012)
Bloomberg story on a defective cable used in heart defibrillators. It is based on an article in the New England Journal of Medicine, which says that the cable is the latest example of a defective medical device that wasn’t spotted quickly enough because U.S. surveillance systems are lacking.
- Hip Implant U.S. Rejected Was Sold Overseas Source: New York Times (Tuesday February 14, 2012)
Background info on the Johnson & Johnson ASR metal hip implant. In March 2010, The Times disclosed that F.D.A. records showed that the agency had received 300 complaints about the ASR, virtually all of them involving patients who had to undergo replacement operation just a few years after getting the device. That number has since reached into the thousands.
- Faulty hip implants may cause long-term health, joint damage Source: USA TODAY (Wednesday February 8, 2012)
Faulty hip joints implanted in tens of thousands of Americans pose adverse health effects in some patients even after removal, according to new research.
- Austin woman, injured by device, lobbying Congress on law Source: Austin American-Statesman (Tuesday February 7, 2012)
Lana Keeton, an Austin woman injured by a medical device, went to Washington DC to meet with her Congress members asking for safety improvements for medical devices. Lana had a synthetic mesh bladder sling implanted in 2001 and has had 17 surgeries and procedures to remove the mesh and has had ongoing medical problems,
Research and Reports
- NEJM: Regulation of Medical Devices in the United States and European Union Source: New England Journal of Medicine (Tuesday February 14, 2012)
“In our view, the greatest challenge facing U.S. device regulation is the evaluation of high-risk devices through pathways intended for lower-risk devices, such as the 510(k) process.”
- NEJM: Postmarketing Surveillance of Medical Devices — Filling in the Gaps Source: New England Journal of Medicine (Tuesday February 14, 2012)
- Substantially Unsafe: Medical Devices Pose Great Threat to Patients
Public Citizen report on dangers of poorly regulated medical devices.
- Testimony of James Shull Before U.S. House Committee on Energy and Commerce/Subcommittee on Health
James Shull of Brown Mills, NJ testifies before U.S. House Energy and Commerce Committee, Health Subcommittee on medical devices
- FDA Should Enhance Its Oversight of Recalls Source: GAO (Tuesday June 21, 2011)
GAO report on medical device recalls
- FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process Source: GAO (Thursday January 1, 2009)
GAO report on Class III medical devices and the 510(k) process.
- GAO: FDA Should Enhance Its Oversight of Recalls
Government Accountability Office; June 21, 2011
- Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments Source: GAO (Wednesday February 18, 2009)
GAO found that FDA does not review all class III devices through its most stringent premarket review process.
- FDA's Premarket Review and Postmarket Safety Efforts Source: GAO (Wednesday April 13, 2011)
Government Accountability office report
- Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years
IOM report: Thousands of medical devices are allowed to go on the market without proper testing for safety. FDA should develop a new framework for ensuring the safety and effectiveness of these devices.
Activists
We first contacted Laurie Yorke of Clark, NJ last year after we saw her on-line support group for those that have suffered from the side effects of Paxil and other anti-depressants. Three years ago, Laurie almost lost her then 15 year old son, Ryan due to a reaction to a off label use of Paxil. When Ryan started taking Paxil there were no warnings about suicide, aggression or personality changes. After a year on this drug she watched him change into someone she didn’t recognize. He had gone from a social, A student to a lethargic, confrontational, failing student. It was during that time that Ryan attempted to take his own life. Desperate to find out what was happening to her son, Laurie started doing her own research on the Internet…
Laurie of Clark, New Jersey
Kim Witczak and Eric Swan take the fight for good information about prescription drugs very seriously.
In 2003, Kim’s husband and Eric’s brother-in-law, Woody, filled a new prescription from his family doctor for the antidepressant, Zoloft to reduce insomnia and “help manage the stress of a new job.” Woody had just taken a position as Vice President of Sales with a start up company about 2 months prior.
After 5 weeks of being on the drug–Woody took his own life. He had no history of mental illness, depression or any other problem. Woody was not warned about the need to be closely monitored when first going on the drug or when the dose was increased…
Kim of Minneapolis, Minnesota
Cathy’s son, Stephen died due to a drug side effect that its maker knew about, but did not disclose to the public.
Cathy of Troy, Ohio
Ellen has always cared about health care issues, but last November’s Special Election in California really pushed her to get more involved. Ellen worked closely with Consumers Union and other community activists to reduce drug costs by supporting Prop 79.
Ellen has firsthand experience dealing with high prescription drug costs, as her husband pays a lot for his medications every month. With a full-time job, Ellen found the time to connect Consumers Union to local community activists, who together distributed 3,000 “Yes on 79″ doorhangers in her neighborhood.
Although Prop 79 was defeated at the polls, good prescription drug legislation will likely move in the legislature this year and Ellen will continue to work with Consumers Union online and offline to get a good bill passed.
Ellen of Los Osos, California
Stories about Drugs & Medical Devices
In January 2007 I underwent cabx5, an aneurysm repair in left ventricle of my heart, where a bi-ventricular pacemaker was inserted. According to my medical records, my doctor found the aneurysm in the left ventricle in 2004, and in 2005 in the stress test, and never told me about it. I am permanently disabled.
Glen of Paris, Texas
My mother had hip surgery during which the doctor, unbeknownst to my mother or her rehab crew, severed a nerve. After several months of my mother not getting the mobility or correct walking gait back, the doctor insisted it would only take more rehab.
Gary of Reno, Nevada
My mother had hip surgery during which the doctor, unbeknownst to my mother or her rehab crew, severed a nerve. After several months of my mother not getting the mobility or correct walking gait back, the doctor insisted it would only take more rehab.
Gary of Reno, Nevada
The surgeon in California, who originally did a hip replacement on my right hip, used a laser to assure that both my legs were the same length. When the liner broke (13 years later), the orthopedic surgeon replaced the ball with a larger ball. This resulted in my right leg (where hip replacement was) being longer than left leg. I now limp because the left leg is approximately 3/4″ shorter.
Leslie from Berryville, Virginia
My family experienced a surgical error in 2007. We filed a complaint with the state department of public health over this incident. In the single issue of exposing an IgE latex allergic patient to a medical device containing latex, it should have been very easy for DPH to find that the surgeon and hospital provided our daughter with negligent care. The device was clearly labeled as containing latex, the hospital and surgeon identified our daughter, Kelly, as a latex allergic patient before surgery, standard of care at the hospital was the strict avoidance of all latex products in an surgical/medical procedure for an identified latex allergic patient, and the Informed Consent for this procedure does not give the hospital or surgeon permission to treat our daughter with a medical device containing latex.
Lesley of Stamford, Connecticut
To Delay is Deadly
98,000 people die each year needlessly because of preventable medical harm. Efforts to reduce this are few and fragmented. With little transparency and no public reporting (except where hard fought state laws now require it), scarce data does not paint a picture of real progress.
In this report (PDF) we give the country a failing grade on progress on select recommendations we believe necessary to create a health-care system free of preventable medical harm.