Epipen

What the EpiPen Recall Might Mean for You

EpiPen and EpiPen Jr auto-injectors distributed between December 2015 through July 2016 are being recalled. 

In early April,  pharmaceutical company Mylan NV announced a recall of certain brand name EpiPen products. The flaw in the recalled devices means that in a case of emergency, patients could face serious health risks. EpiPen

In a public statement, Mylan stated that “this recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component.”

Mylan’s EpiPen, expanded its recall of the popular auto-Injectors to the U.S. In the recall announcement, Mylan made it clear that they would be readily available to replace the recalled devices. 

Epipen
Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions.

Further, the pharma giant stated that “there will be no additional replacement-related financial burden to them as a result of this recall.” 

Patients with the recalled auto-injectors could face serious consequences from anaphylaxis. Anaphylaxis is a life-threatening allergic reaction to things like insect bites, food, and medication. 

The recalled product was manufactured by Pfizer’s Meridian Medical Technologies and was distributed between December 2015 and July 2016 by Mylan Specialty.

If you or your loved one have been put at risk by the EpiPen or any other Mylan product, contact the legal professionals at Medical Claim Legal.

Chantix

Violations during Chantix Trial Lead to FDA Warning Letter

Physician faces FDA Warning after ignoring protocol during a clinical trial.

A Chantix trial has ruffled the feathers of the FDA. Dr. Cassandra Curtis, an Indianapolis-based physician received an FDA warning letter after failing to follow drug protocol at her clinic.Chantix

The approved plan for Chantixa smoking cessation drug, required that patients participating in a trial meet certain guidelines. The FDA accused the doctor several violations including keeping “inadequate records” of the amount of the drug being distributed.

Guidelines insisted that patients enrolled in the trial must “smoked an average of at least 10 cigarettes a day during the past year.” 3 of the patients did not meet this requirement.

Dr. Curtis also included a patient in the study with a pre-existing condition which should have disqualified them. One chronic obstructive pulmonary disease patient was enrolled.

Other accusations in the warning letter accused the doctor of failing to maintain adequate patient records, therefore compromising a collection of useful data.

These violations are serious ones as the FDA warning notes that they compromise “safety and welfare.”

Chantix Suicide Risks and Bizarre Behaviors

Chantix and it’s maker Pfizer have already had a share of controversy as the drug has been tied to increased suicide risk. Other bizarre behavior was documented when one user faked his death.

Business Insider documented other specific “changes in behavior” seen amongst Chantix users:

  • In July 2012, a plaintiff named Eric Hall sued Pfizer, claiming Chantix made him rob a toll collector, wreck his car, and land in jail, according to this personal injury blog.
  • In May 2011, MSNBC reported regulators were overlooking serious psychotic reactions to the drug, citing a study by the non-profit Institute for Safe Medication Practices.
  • That study found a 24-year-old woman on the drug started beating her boyfriend because he looked “peaceful,” MSNBC reported.
  • The study also found a 42-year-old man punched a stranger at a bowling alley.
  • In September 2007, The New York Times reported the late indie rocker Carter Albrecht – described by friends as even-tempered – had assaulted his girlfriend while on the drug.
  • And in February 2008, New York Magazine ran this first-person piece called “This Is My Brain On Chantix,” in which the author claimed the drug spurred “self-destructive fantasies.”

Chantix Legal Representation

Pfizer has fought tooth and nail to remove warnings about the suicide risks. The company has attempted to provide evidence to the FDA, in the form of clinical trials, that demonstrate that there is no connection between the treatment and a suicide risk. However, the money trail has presented a troubling pattern.

After performing a review of Pfizer’s financial disclosures, the FDA found that investigators at 32 sites where the trial was being performed were paid $25,000 or more by the Chantix drugmaker Pfizer.

If you or a loved one used Chantix and experiences adverse effects, you could be entitled to financial compensation. The Medical Claim Legal team could get you the help that you need.

pAXIL

FDA Refused Update to Suicide Risk on Paxil Label

Paxil suicide risk was disclosed, according to GlaxoSmithKline.

According to the GlaxoSmithKline court filing, the FDA refused four requests to change labels on the antidepressant Paxil to update a warning label to reflect that “there was a statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine.” pAXIL

As far back as 2006 the antidepressant and its controlled-release version, Paxil CR, added a warning about suicide risk in young adults. Facts such as this are of increasing importance as GlaxoSmithKline fights a complicated lawsuit.

The suit was brought on by the widow of Stewart Dolin, a Paxil user who at the time of his suicide was taking a generic version of the drug. The $12 million suit alleges that GlaxoSmithKline was negligent in not updating the warning label to demonstrate the risk for suicide while using.

The claim insists that the labeling did not provide enough information about the risk of suicide, which as a result led to the Chicago lawyer jumping in front of a train just 6 days into using a generic form of Paxil.

Dolin’s widow’s complaint notes that certain dangerous side-effects were listed on the label, but the labeling did not properly represent the risk posed. In fact, labeling only highlighted an increase in suicidal thoughts for users under the age of 24.

She further claims that doctors were not informed about the suicide risks in adults associated with the drugs, and had that information been clear, Mr. Dolin would have been prescribed the drug.

As the trial drags on in Illinois, GlaxoSmithKline a federal jury Wednesday that the U.S. Food and Drug Administration claims that the FDA rejected a label change to Paxil four times. The updated label would have addressed the increased risk of suicide on adult patients.

If you or someone that you love has been effected by the use of Paxil, connect with an attorney at Medical Claim Legal. You could be entitled to financial compensation, find out now.

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.

What’s BIA-ALCL? Rare Cancer Deaths Tied to Breast Implants

The FDA has linked BIA-ALCL deaths to a breast implants.

In 1997, The World Health Organization first made the link between the rare cancer and breast implants, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) occurs in a capsule of tissue that develops around the implant. The cancer typically surfaces around ten-year following the breast implantation. BIA-ALCL

The FDA was quoted this week saying that “…the available information suggests women with breast implants have a very low, but increased risk of ALCL compared to women who do not have breast implants.”

Women that have both silicone and saline-filled breast implants have been affected by ALCL.

The FDA says, it has received 359 reports of the lymphoma.

One recent study determined that 3.3 out of every 100,000 women with textured breast implants will develop BIA-ALCL. The textured breast implant variety seem to have the highest occurence of the cancer diagnosis according to FDA and the Australian government.

If you or a loved one has been diagnosed with BIA-ALCL, you may be entitled to compensation due to your pain and suffering. Let the Medical Claim Legal team help you through the process.

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.

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.

Pharmco Laboratories

SkinCare Co. Pharmco Laboratories Receives Warning From FDA

Pharmco Laboratories received a warning letter from the FDA citing 4 violations.

Pharmco Laboratories received a warning letter from the Food and Drug Administration. The letter to the Florida-based skincare manufacturer “summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

In the letter posted to the agencywebsite, four specific violation were referenced.

Pharmco Laboratories was accused of presenting an allergy risk to consumers. The FDA states that there has been insufficient evidence of the proper cleaning of equipment that came in contact with major allergens. Dietary supplements, for example, containing soybeans used the same dryer as the ingreditents in skincare items.

The FDA warning letter stated that “repeated lapses demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs.”

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.

Tecfidera

MS Drug Tecfidera Label Update Discloses Risk for Liver Injury

The Tecfidera label now reflects a possible side effect of liver injury.

Tecfidera, Biogen Inc’s multiple sclerosis (MS) drug,  has received label updates to  disclose a potential liver injury that could require hospitalization. Tecfidera

The world’s best selling oral MS drug experienced sales of $1.03 billion in the third quarter and accounts for about a third of the pharmaceutical company’s revenue.

Biogen reports that only 14 instances of liver injury have occurred around the 230,000 patients who have taken Tecfidera.

This isn’t the first time Tecfidera has had the spotlight. Just last week,  Biogen Inc. announced a settlement of a patient infringement lawsuit for $1.25 billion concerning the multiple sclerosis drug.

The label updates mention that abnormalities are resolved after use of  Tecfidera ends. A few cases required that the user be hospitalized. None of the cases have led to serious conditions including liver failure, liver transplant, or death.