Democratic lawmakers from both houses of Congress have teamed up to introduce legislation limiting toxic heavy metals in baby foods and in foods for children up to age three.
The bill comes in the wake of a high-profile Congressional report released in February which found that leading baby food manufacturers knowingly sell baby foods contaminated with heavy metals, according to a review of the manufacturers’ internal documents. The report has generated widespread media attention, considerable concern among parents and the filing of more than 38 class action lawsuits.
The Food and Drug Administration first responded to the congressional report on…
The word “bellwether” refers to something that indicates or predicts trends or tendencies or is otherwise at the lead or forefront.
Bellwether trials are individual lawsuits hand-picked to be heard first, ahead of a “pack” of similar lawsuits grouped together in what’s known as multidistrict litigation. MDLs consolidate related cases before one federal judge in order to reduce costs and promote efficiency in legal proceedings.
However, no judge can hear hundreds or thousands of cases at once. In order to test the strength of the lawsuits, a handful of bellwether trials will be held. The number of bellwether trials is…
The U.S. Food and Drug Administration alerted patients and doctors last week that two brands of surgical mesh used in breast reconstruction surgery may present a higher risk of complications than similar brands.
Breast reconstruction surgeries are typically performed to rebuild the breast after mastectomy (breast removal) or lumpectomy (lump removal) during breast cancer treatment. Breast reconstructions can be performed with just breast implants or with the additional use of surgical mesh, which is used to reinforce weak tissues. Surgical mesh is made from biological tissues, from synthetic materials such as polypropylene, or a combination.
FDA Research Findings
Starting Monday all U.S. patients will have free, immediate electronic access to their doctors’ notes and many other types of medical records. Called “Open Notes,” the patient-friendly mandate is part of the federal 21st Century Cures Act that was signed into law in late 2016.
Open Notes was supposed to go into effect Nov. 2 but implementation was delayed due to the COVID-19 pandemic.
The law requires all health care organizations to create online portals where patients can access the following types of medical records: consultations, progress and procedure notes, discharge summaries, medical histories, physical exam findings, and reports from…
A recent New York Times investigation of the nation’s popular five-star nursing home rating system found that the system is “broken,” offering at best a “distorted” picture of nursing home quality.
Meticulous research revealed that nursing homes routinely game the star system in order to boost their ratings and hide their deficiencies. Nursing homes submit incorrect information that makes them look better, such as artificially increasing staff hours by including vacationers and underreporting patients with severe bed sores or taking controversial medications.
Nearly 70% of five-star nursing homes were cited for problems with patient abuse or infection control. Residents at…
Boston Scientific has agreed to settle transvaginal mesh claims from 47 states and the District of Columbia for $188.7 million. Last week’s settlement concludes a series of lawsuits accusing Boston Scientific of violating consumer protection laws by misrepresenting the safety and effectiveness of their transvaginal mesh products.
Boston Scientific agreed to change the way it markets transvaginal mesh, including disclosing significant complications and using everyday language to describe complications when marketing to consumers. The company agreed to stop making false safety claims, including:
- Surgical experience or technique can eliminate mesh risks
- Mesh does not increase the risk of infection or…
Baby food manufacturers including Gerber, Campbell’s, Beech-Nut Nutrition, Walmart, and others are facing a number of lawsuits, including 38 distinct class-action lawsuits, where a few parents are filing claims on behalf of many others. According to the lawsuits, each of these companies sold baby food that tested positive for heavy metals. Heavy metals can be devastating to the mental and developmental health of babies and there is no safe level of exposure.
On March 10, a group of parents requested the Judicial Panel on Multidistrict Litigation consolidate their cases in federal district court for the Eastern District of New York…
MedTruth recently reported a pandemic-related increase in fake “FDA Registration Certificates” being used to fraudulently promote medical products. As part of the Food and Drug Administration response to the growing problem, the agency published an online consumer guide entitled “Are There ‘FDA Registered’ or ‘FDA Certified’ Medical Devices? How Do I Know What Is FDA Approved?”
To set the record straight for consumers:
While companies that manufacture and distribute medical products in the U.S. are generally required to register with the FDA, the agency does not issue registration certificates. …
For the second time in less than two years, the Food and Drug Administration has warned Paragard IUD manufacturer CooperSurgical for running ads that fail to disclose Paragard’s safety risks as required by federal law.
The video of concern, “Paragard: Family Planning During The Pandemic,” ran on Boston NBC-affiliate WBTS’ “The Hub” webpage from Oct. 5, 2020 through at least Feb. 12, 2021, the date of the Paragard warning letter. The video has been removed. The FDA was alerted about the video by a complaint submitted through the agency’s Bad Ad Program.
“This misleading presentation is particularly concerning from a…
The U.S. Food and Drug Administration has taken action against a niche printing industry that has been misleading consumers about the safety and efficacy of certain medical devices. The FDA announcedlast week that it sent letters to 25 printing firms to stop producing fake “FDA registration certificates.”
“Medical devices” is a term used in specific ways by the FDA. It includes everything from consumer health care products such as bandaids, thermometers, and hydrogen peroxide to surgically implanted devices such as pacemakers, breast implants and artificial joints. …
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