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.

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.

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.

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.”