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.

Abbott Labs Receives Stern FDA Warning About Heart Devices

Abbott Laboratories recieved a FDA warning letter after failing to investigate and resolve risks related to its implanted heart devices.

In a warning letter, the FDA critiziced Abbott Laboratories for failing to resolve issues related to its  cardiovascular devices.Abbott

Battery and cybersecurity problems with the heart devices seemed to be a dominant issue.

Concerns about the safety of several implantable defibrillators and its Merlin@home monitor, which allows doctors to care remotely for patients with cardiac devices.

In February, we covered complicatipons with the HeartMate PHP catheter. During procedures to unclog blood vessels, the HeartMate PHP is inserted in the heart to keep blood flowing. The device is used inside the heart with no need for open-chest surgery.
The most recent  investigation showed that lithium batteries in the devices weredraining and that the company had “underestimated the occurrence of the hazardous situation.”

As recently as September, the device received praised from the medical community.

Now, the Lab is putting an end to the commercially successful blood pumps use in the United States and Europe after several malfunctions and a patient death.

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

The devices in question are several cardiovascular devices acquired in Abbot’s $25 billion purchase of St. Jude Medical.

In an email to the FDA, the company said that it was looking into the matter.

The FDA has publicly noted that Abbott had failed to provide evidence that the actions had actually been implemented.

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.

FDA Warning Issued Regarding Glaucoma Med Latanoprost

Latanoprost manufacturer received an FDA warning letter.

Latanoprost, a glaucoma medication manufactured by Indoco Remedies, received an FDA warning. The popular medication apparently has experience leakage issues that conflict with FDA standards. Latanoprost

The warning letter was specifically in regards to Latanoprost solutions leaving their  Goa, India facility. The warning letter does not specifically call for a halt of shipments from the plant.

The FDA warning letter highlights  issues with product leakage when Latanoprost is shipped as well as communication practices between the Goa plant and thier American counterpart.

Many FDA Form 483 observations have been issued to Indian drug makers for failing to meet US FDA standards.

According to the FDA, Form 483 is issued when investigators have observed conditions that they believe may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The company plans on responding to the FDA in the- next 15 days regarding the warning letter. So far there has been no indication of a fall in sales of the drug.

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.

Product Liability Judgments Near $2B for J&J More Rulings to Come

Product liability judgments against Johnson & Johnson totaled nearly $2B in the last year.

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. Product liability

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 product liability claims.

5 products have the company facing 100,000 claims with Johnson and Johnson admitting that the numbers are continuing to increase.

Johnson & Johnson Product Liability Judgments

Bloomberg outlined Johnson & Johnson 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

Baby/ Talc Powder Product Liability Lawsuits

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

Pelvic Mesh Lawsuits

The pelvic mesh suits are the largest of the product liability claims. 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.

Hip Replacement Lawsuits

Later on in 2016, the company received a judgment to pay 6 plaintiffs $1B in compensation for their Pinnacle hip implants. Their woes are still lingering in 2017, there are currently more than 8,000 suits for the products.

Risperdal Lawsuits

The number of Risperdal cases has grown to 18,500. The treatment for schizophrenia, bipolar disorder, and irritability caused by autism cause Johnson and Johnson $70 million in product liability last year.

Financial Compensation from Johnson and Johnson

As the number of legal cases again Johnson and Johnson continue to grow, the chances of you qualifying for compensation avails. If you or a loved on believe suffered  pain, suffering, or death due to pelvic mesh, talcum powder, a pinnacle hip replacement, Xarelto, or Risperdal, 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.

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.

High Fracture Rate – Zimmer Biomet Shoulder Replacement Device

Zimmer Biomet Shoulder replacement device was found to have a higher risk of fracturing than it was earlier believed, consumers at risk.

Labeling of the Zimmer Biomet Shoulder replacement failed to adequately disclose fracture risks. Those who received the shoulder replacement may experience substantial pain and suffering.

The Biomet Comprehensive Reverse Shoulder recall, was issued as Class I. Class I recalls are reserved for some of the most serious recalls issued by FDA.  

Risks include:

  • Death
  • Infection
  • Loss of shoulder movement

In December, Zimmer Biomet sent a recall notice and a Certificate of Acknowledgement to all affected customers.

Those with adverse events or side effects related to the use of these products are urged to report such problems.

If you or a family member have received the Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340, you may be entitled to compensation. Connect with an attorney at Medical Claim Legal.