FDA Drug Approvals Present Safety Risks About 1/3 of the Time

A significant number of FDA drug approvals eventually face safety issues.

If you even pay minimal attention to pharmaceutical news, you know that the industry seems to be plagued with recalls and legal disputes. New data mirrors this. Reports indicate that around 1/3  of FDA drug approvals have safety issues. That’s right 1 and every 3 FDA drug approvals put the consumer at risk. Drug approvals

With increased pressure to to shorten the drug approval process, 19 drugs have received FDA-approval this year. That number is almost as many drug approvals as in the entirety of 2016.

After the drug approval the impacted drugs were subject to recalls, added warning labels, and safety advisories. From the Mylan EpiPen recall to the phantom Motrin recall, consumers were put at risk unbeknownst to themselves or the FDA, apparently.

This is troubling as patients put their confidence in these FDA drug approvals. Although most of the concerns were not risky enough to warrant a recall, in the time period reported only 3 drugs required being removed from the market.

An author of the study, Dr. Nicholas S. Downing, elaborated on the findings. He noted that drug approvals typically come after a trial on 1,000 patients, often times it is difficult when the product is put up against real-world factors.

A patient’s race, gender, ethnicity, weight, and previous medical conditions can all be factors for the way in which drugs impact them.

Experts assert that there is not reason for alarm, but that the new study is a good argument for continuous monitoring of the safety of drugs “throughout their life cycle.”

More Pelvic Mesh Lawsuit Cases Follow $20M Ruling

Johnson & Johnson will likely continue to pay victims after $20 million pelvic mesh lawsuit.

More pelvic mesh lawsuit rulings could mean more than 100’s of millions of dollars in payouts for victims. Just last week, a woman who claimed injuries after a pelvic mesh implant was awarded $20 million in a lawsuit against Johnson & Johnson. Pelvic Mesh Lawsuit

The jury in the case out of a Philadelphia Common Pleas Court ruled that Johnson & Johnson and their subsidiary, Ethicon, concealed the risks that they were aware of when marketing of the TVT-Secur mesh. 

The awards included $2.5 million in compensatory damages and $17.5 million in punitive damages in the most recent pelvic mesh lawsuit.

The victim issued a public statement after the ruling. “I’m happy I could be a voice for other women…it’s been a nightmare, and I feel justice was truly served today.” 

This is ominous news for the company that’s set to face additional trials over claims of suffering from recipients of the the device. Johnson & Johnson’s subsidiary Ethicon Inc. made the Prolift mesh implant which has left more than 54,000 lawsuits.

In recent pelvic mesh lawsuit rulings, a Philadelphia jury found that the device had defective design.

In an emailed statement, Kristen Wallace, an Ethicon spokeswoman, said “we believe the evidence showed Ethicon’s TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff’s continuing medical problems,”

In 2015 the drug giant declined to disclose the amount of settlement reached with more than 100 plaintiffs in a U.S. District Court. The pelvic mesh suits are the largest of many product liability claims that Johnson & Johnson is facing. Nearly 55,000 claims are pending for legal compensation due to the implant. Claims assert that the pelvic mesh implants manufactured by Johnson and Johnson erode.

What is the Reason for the Pelvic Mesh Lawsuits?

The pelvic mesh lawsuits are flooding in from patients all over the country who have experienced severe side effects from the mesh. The claims are being made that Johnson & Johnson did not properly market the products, failing to cite the side effects that were caused by the product.

In a report by the Associated Press, Attorneys General Bob Ferguson of Washington and Kamala Harris of California accused the New Jersey-based health care giant of neglecting to tell patients and doctors about the risks and occurrences of dire, sometimes irreversible complications. Those include urinary dysfunction, loss of sexual function, constipation and severe pain. These side effects can make everyday activities such as walking up and down stairs, laying down, or exercising extremely painful.

In a Reuters article, it is stated that Johnson & Johnson sold more than 787,000 pelvic mesh devices in the United States from 2008 until 2014, including more than 42,000 in California. Also in that article, the Food and Drug Administration said it was reclassifying mesh used to treat pelvic organ prolapse trans-vaginally from class II, or moderate risk, to class III, for high-risk devices, which will require manufacturers to submit extensive data to establish the devices’ safety. Hopefully this increased scrutiny by the FDA will prevent something like this from happening again in the future.

Financial Compensation for Pelvic Mesh Implant Recipients

If you or a loved on believe suffered  pain, suffering, or death due to a pelvic mesh implant, you could be entitled to financial compensation.  The Medical Claim Legal team can connect you with the money that you deserve. Get connected with a dedicated attorney today.

Johnson & Johnson to Pay $110M to Plaintiff in 5th Talcum Powder Cancer Trial

Johnson & Johnson lost its 5th talc-powder trial.

This week, a Missouri jury ordered Johnson & Johnson to pay more than $110 million to a woman who says she developed ovarian cancer after decades of using the company’s talc-based products.Epipen

This is the largest settlement yet in a surge of suits accusing the world’s largest health-care company of withholding information about cancer risks.

Early last year, Johnson & Johnson made headlines when the company went up against a 72 million dollar lawsuit. The baby powder lawsuit was filed by the family of a deceased woman who’s ovarian cancer was linked to the use of the product for feminine hygiene.

As the year came to a close Product liability judgments against J&J totaled nearly $2B in the last year. J&J lost 6 out of 7 product liability claims in 2016. The cases have been noted as the largest jury verdicts over product defect claims in America.

Nearly $200m was set to go to judgments related to baby powder cases. In fact, Johnson & JohnsonJohnson lost three straight trials where a judge found that their talc-based products caused ovarian cancer.

J&J has argued that there is no such cancer risk.  Citing that comprehensive studies show link between the products and cancer.

Financial Compensation from Johnson & Johnson

As the number of legal cases again J&J continue to grow, the chances of you qualifying for compensation avails. If you or a loved may have endured pain, suffering, or death due to J&J’s Baby Powder and Shower to Shower products you could be entitled to financial compensation. The Medical Claim Legal team can connect you with the money that you deserve. Get connected with a dedicated attorney today.

Johnson & Johnson Hip Replacement Judgments totaled over $1.5B in 2016

Hip replacement judgments in 2016 cost the global brand more than $1.5B with more judgments pending.

Hip replacement issues have left many people in pain. Johnson and Johnson lost 6 out of 7 product liability claims in 2016. The cases have been noted as the largest jury verdicts over product defect claims in America.Hip replacement

Beyond these judgments, there are tens of thousands of potential cases against the brand. Potential legal issues are related to hip replacements, pelvic mesh, and baby powder among other products.

Bloomberg outlined Johnson & Johnson’s legal failures like so:

  • Hip implant, Dallas: for $1 billion
  • Hip implant, Dallas: $502 million
  • Talc, St. Louis: $72 million
  • Risperdal, Philadelphia: $70 million
  • Talc, St. Louis: $70 million
  • Talc, St. Louis: $55 million

2017, has not left the brand in the clear, hip replacement, baby powder, and other big settlements will continue to cost the company.

If you have suffered pain or suffering due a faulty Johnson & Johnson hip replacement product, you could be entitled to compensation.

New FDA Off-Label Marketing Rule Delayed by One Year

The FDA has delayed new rule for off-label uses of pharmaceuticals.

After interferences from Pharma, the Food and Drug Administration (FDA)   has delayed implementing a new rule that regulates off-label marketing. Off-label

The new rule regulates the way in which pharmaceutical manufacturers can discuss the unapproved uses of their products with health-care providers.

was delayed in an effort to recieve public comments. Device and pharma industry groups have accused the agency of ignoring proper rulemaking procedures.

The new rule would mean that drug makers must update a product label if there’s an indication that a company intends to use its medicine for an off-label or unapproved use.

Doctors sometimes prescribe drugs as a treatment for conditions outside of medications original purpose.

Companies can face criminal charges and liability if they tout their products to doctors and the public for off-label uses the FDA hasn’t specifically approved.

The FDA is pushing back the rule’s effective date to March 19, 2018.  Nearly one year after it’s original date.

Zimmer Biomet Receives FDA Class I Recall for Shoulder Device

The Zimmer Biomet shoulder device is facing a class 1 recall from the FDA.

Due to a “higher fracture rate than stated” the Food and Drug Administration (FDA) has issued a class one recall of the Zimmer BiometZimmer biomet reverse shoulder device. Such recalls are reserved for products that “will cause serious adverse health consequences or death.”

This medical device recall, the most serious recall category, was issued this February. The recall reportedly included 3,662 devices.

Zimmer Biomet
Notice that risk managers received related to Zimmer Biomet recall.

The company acknwledged that these shoulder trays, all manufactured prior to September 2011, would fracture easily.

Risks included a need for revision surgery. According to experts, such surgeries might lead to permanent loss of shoulder function, infection and even death.”

Patients that may have received the Zimmer Biomet device may be entitled to compensation for their pain and/or suffering. For more information about filing a claim through Medical Claim Legal, complete a claim form at this link.

Lupron

Lupron, a Drug Used to Delay Puberty, Causes Problems in Women

Lupron was injected in thousands of women in an effort to inhibit puberty or increase height.

More than 10,000 adverse event reports have been filed with the FDA based on the experiences of women who’ve taken Lupron. The reports describe a variety of symptoms experienced by those who took the drug to grow taller or delay puberty. Lupron

Lupron, currently manufactured by AbbVie, is an injection designed to reduce testosterone in men or estrogen in women. The drug is also approved for use by men with prostate cancer.

The experiences of the women that used the drugs are varied but complex. Many women reported experiencing symptoms and conditions linked to older, even elderly people. According to the FDA reports:

A 20-year-old was diagnosed with osteopenia, a thinning of the bones. A 26-year-old in Massachusetts needed a total hip replacement. One 25-year-old woman from Pennsylvania has osteoporosis and a cracked spine. In Wisconsin, another woman in her 20’s  has chronic pain and degenerative disc disease.

Other women described depression and anxiety.

Additionally, the FDA is reviewing deadly seizures caused by the use of Lupron and similar drugs.

The drug has had success in the marketplace. In 2015, the drug-maker reportedly brought in $826 million in sales.

Monsanto

Monsanto Popular Weed Killer to Be Labeled a Cancer Risk

Monsanto, a major agricultural corporation, can now be required to label its popular weed-killer, as a possible cancer threat.

California can require Monsanto to label Roundup, its top-selling herbicide, as a possible cancer threat, a judge tentatively ruled Friday.

Monsanto has insisted that its product poses no risk to people. 

On Friday, a federal judge denied the corporation’s bid to overturn a 2015 state ruling to label it as a cancer risk.

The main criticism is Roundup’s main ingredient. The popular weed-killer includes Glyphosate, a chemical which was originally touted as a way to kill weeds while leaving crops and plants intact.

The U.S. Environmental Protection Agency, says it has ‘low toxicity.’ The agency considers Glyphosate safe when used correctly.
However, under California Proposition 65 label requirements in California, businesses are required to notify Californians about significant amounts of chemicals in the products that they purchase.

Chemicals that require labeling include ingredients or additives in pesticides, common household products, food, drugs, dyes, or solvents.

California regulators are waiting for the lawsuit to be resolved before deciding whether to require warnings, said Sam Delson, a spokesman for the state Office of Environmental Health Hazard Assessment.

Software

Medical Device Software Vulnerabilities a Huge Concern

Software vulnerabilities of medical devices may be difficult for health sector officials and manufacturers to manage.

As we reported last week, St. Jude implemented software updates that could protect pacemakers and other medical devices from being compromised by hackers. Oxycontin

Unfortunately, new information suggested that the public is not completely in the clear.

“Software is never perfect and all systems still will have these flaws,” says Joshua Corman, director of the Cyber Statecraft Initiative at the Atlantic Council and an expert on medical device security. “The question is how gracefully and collaboratively and quickly and safely can we respond to these flaws.”

In late 2016, there were reports that the Merlin@home transmitter used in monitoring certain St. Jude Medical implant devices could be hacked. These hacks could lead to deadly consequences for  the patient.

MedSec, a cybersecurity firm,  initially found the problems in the St. Jude devices. After which they “tipped off”- the activist investment firm Muddy Waters, which publicized the flaws and advised clients to bet against the health care firm’s stock.

Ever since the US government and St. Jude confirmed the one flaw, the VA has been “taking steps to be sure all our patients and providers are aware of this issue and take appropriate actions to be sure that all our patients get the update for their monitor,” said Merritt Raitt, acting director of the VA National Cardiac Device Surveillance Program.

Asbestos

The Risks of Asbestos Exposure and Your Legal Rights

The more a person breathes in tiny asbestos particles, the more likely that individual will develop a large variety of lung and breathing complications.

Asbestos was introduced to the construction industry over 100 years ago.  It was widely considered the standard for strengthening building materials in the construction of buildings.

The dangers of inhaling asbestos fibers began to surface around 1980.  It does not take extreme exposure to asbestos for it to be dangerous.  Most victims of asbestos exposure and asbestosis have worked or lived in an environment where there is asbestos in the building or home.

These effects range from wheezing and shortness of breath to mesothelioma and lung cancer.  Regardless of your condition, Medical Claim Legal can help you obtain compensation.

There are a large number of lawsuits involving asbestos exposure and asbestosis.  Do not let your case get passed over.  Medical Claim Legal will connect you with a lawyer who is experienced and successful in the asbestos lawsuit field.  To get the compensation that may be owed to you, contact Medical Claim Legal today.

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