Glitch Found With Popular Medtronic’s Insulin Pump

Medtronic’s Insulin pump has issues with button.

In May, Medtronics issued a field safety notice.  insulinThe issue is related to the keypad on the MiniMed 640G Insulin Pump.  The button on the popular pump, is prone to get stuck in instances such as air travel or other times when there is a decrease in air pressure.

The danger with this sort of malfunction is that users may not be able to stop insulin delivery or program a bolus. The problem tends to last around 30 minutes.

Following this safety notice, it was announced that Aetna will pay Medtronic rebates for its insulin pump if patients’ health improves.

The company says that instances where the problem persists for more than ” the pump will begin to siren.” This disables the product.

“Phantom” Motrin Recall Lawsuit Resolved with Settlement

The “phantom” Motrin recall lawsuit against Johnson & Johnson has been resolved.

In the “phantom” Motrin recall in 2009, Johnson & Johnson hired a company to secretly purchase packets of defective Motrin from stores to avoid the public spectacle of a recall. This led to a lawsuit issued by the state of motrin recallOregon.

On Thursday, the Oregon Attorney General Ellen Rosenblum confirmed that a settlement had been reached. Johnson & Johnson is set to pay $400,000.

In 2008, Johnson & Johnson had discovered that some sets of Motrin were failing to dissolve properly. However, an official Motrin recall did not come until February of 2010.

The case was settled this week with no admission of wrong doing from the pharmaceuitcal giant.

In a statement, a Johnson & Johnson spokesperson insists “there was never a health or safety risk associated with the Motrin medicines at issue in the case, and we remain committed to providing consumers with safe and effective over-the-counter medicines.”

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.

Ventilators Recalled Over Shutdown Issues

Medtronic’s NewPort is recalling their ventilators following equipment failures.

Earlier this week the FDA released information on the recall of Medtronic’s NewPort ventilators. Ventilators help ease the breathing of individuals with respiratory problems. Typically the devices are used during procedures where general anesthesia is in use.Ventilators

The company is not new to controversy, particularly with their ventilators. The company recalled around 600 of their Puritan Bennett 980 ventilator systems in 2o15. This specific product was typically used in hospitals and aim to provide constant breathing support for adults, children, and premature babies.

According to the FDA notice, 7,576 devices in the US are being recalled. All the recalled ventilators were manufactured between March 2010 and January 2017 and were distributed between March 4, 2010 and Feb. 2, 2017.

Ensure patients on the Newport HT70 and HT70 Plus ventilators are appropriately monitored by trained caregivers as described in the Operator’s Manual.

Last month, the company announced a strategy for customers to maintain use of the product.

“A patient connected to the ventilators requires the constant attention of trained caregivers to the patient’s condition.

    • Always have an alternate power source and means of ventilation available when the ventilator is in use in case of a mechanical or system problem.
    • Always use appropriate monitors to ensure sufficient oxygenation and ventilation (such as a pulse oximeter and/or a capnograph) when the Newport HT70 or HT70 Plus ventilators are in use on a patient.
    • If able, use the appropriate remote alarm/nurse call cable (CBL3223 or 10104494) to project ventilator alarm states outside the patient room. This alarm will annunciate even with an unexpected reset. Consult the Operator’s Manual or call Technical Service for further information on this accessory.
    • If, at any time, the patient is not responding to ventilation appropriately, the patient should be taken off the ventilator immediately and connected to an alternate method of ventilation. Contact your health care provider or physician immediately.”

If you would like to speak with a lawyer, on behalf of yourself or a loved one who may have been impacted by the ventilator shutdown, the Medical Claim Legal team is here to assist you. Don’t wait,  contact us today.

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.