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.”

“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.

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.

Agreement Reached in Novo Nordisk Diabetes Drug “Scheme”

Novo Nordisk illegal marketing allegations may now be resolved.

Novo Nordisk has reached an agreement with the Department of Justice in an alleged “white coat marketing scheme.” The drugmaker faced claims of intending to encourage doctors to prescribe three Novo Nordisk drugs to patients. Novo Nordisk

Since 2006, under a so-called “Changing Life with Diabetes Program,” illegally hired Certified Diabetes Educators (CDEs) and employed them as sales reps. These “sales reps” helped the company to pocket  $6 billion in the whole deal.

The lawsuit alleged that the NovoLog, Levimir, and Victoza salespeople, or educators, had an unfair advantage when meeting doctors. The Department of Justice became involved as all 3 drugs are covered by government health benefits.

The drugmaker is also in the middle of class action lawsuits over insulin pricing.

In an emailed statement Novo spokesman, Ken Inchausti, said that Novo Nordisk had “reached an agreement in principle to settle certain claims related to this investigation. The process is not finalized, and as such, we can’t provide further comment on this matter at this time.”

If you would like to speak with a lawyer, on behalf of yourself or a loved one, the Medical Claim Legal team is here to assist you. Don’t hesitate, contact us today.

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.