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Weekly Roundup 3.23.18

In the herb garden, the chives have popped up, always a harbinger of Spring.
I tried to get in a posting this week, but being a short one the week got away from me.
Even the FDA blog – FDA Voices – has not been updated since February 7.
Still, all that said, things still occur here is a bit of what happened this week that caught my eye, but like the week and month, will be short: OPDP Issues First Letter of 2018 – The Office of Prescription Drug Promotion, which last year issued only a total of 5 regulatory action letters, eeked out their first for 2018.
The communications vehicle was an Exhibit Panel and the violation – only one cited – had to do with supplying incomplete risk information as well as there being issues of placement.
This week FDA announced the voluntary recall and destruction of supplies of the herbal supplement known as Kratom.
Earlier in the month, FDA Commissioner Gottlieb released a statement regarding a scientific examination of Kratom asserting that there were opioid compounds present in Kratom.
The effort included product under three brand names distributed by one company, but did not say whether there are other brands from other companies still that might be on the market.
Commissioner Gottlieb issued a long statement that details FDA’s involvement in the development of a vaccine each year and notes that the advisory committee meeting that will consider what strains go into the mix for the next season will be occurring shortly – in fact on March 1.
Have a good weekend!

Weekly Roundup 3.23.18

In the herb garden, the chives have popped up, always a harbinger of Spring.
I tried to get in a posting this week, but being a short one the week got away from me.
Even the FDA blog – FDA Voices – has not been updated since February 7.
Still, all that said, things still occur here is a bit of what happened this week that caught my eye, but like the week and month, will be short: OPDP Issues First Letter of 2018 – The Office of Prescription Drug Promotion, which last year issued only a total of 5 regulatory action letters, eeked out their first for 2018.
The communications vehicle was an Exhibit Panel and the violation – only one cited – had to do with supplying incomplete risk information as well as there being issues of placement.
This week FDA announced the voluntary recall and destruction of supplies of the herbal supplement known as Kratom.
Earlier in the month, FDA Commissioner Gottlieb released a statement regarding a scientific examination of Kratom asserting that there were opioid compounds present in Kratom.
The effort included product under three brand names distributed by one company, but did not say whether there are other brands from other companies still that might be on the market.
Commissioner Gottlieb issued a long statement that details FDA’s involvement in the development of a vaccine each year and notes that the advisory committee meeting that will consider what strains go into the mix for the next season will be occurring shortly – in fact on March 1.
Have a good weekend!

Plaintiff Blames Bayer for Mirena IUD Side Effects

Together, they are litigating because of alleged permanent injuries sustained from Latasha’s use of the Mirena intrauterine device system as a contraceptive.
Pseudotumor cerebri (PTC) or idiopathic intracranial hypertension (IIH) is a condition whereby there is increased pressure in the brain due to an excessive production of cerebro-spinal fluid (CSF).
PTC is called this because the symptoms of it can mimic that of a brain tumor.
It does occur in some people without the hormonal influences of an implanted IUD, but pseudotumor cerebri has been found as a side effect in Mirena IUD users.
While pseudotumor cerebri Mirena IUD side effects vary, symptoms of PTC include an unrelenting headache, known as a migraine, and disturbances in the visual field.
According to the facts section of the Mirena IUD side effects lawsuit, auditory symptoms can also arise with this condition and are frequently experienced as hearing whooshing sounds or ringing in one or both ears.
While Latasha M. is now 30 years old, she was implanted with the Mirena IUD system back in 2011 when she was just 23 years old.
The Mirena IUD side effects were so severe, however, the IUD was removed in 2012—just a year later, according to the narrative of the lawsuit.
The couple is asking for compensatory and punitive damages with a return of all court and attorney’s fees included.
The Mirena IUD Side Effects Lawsuit is Case No.

Attune Knee Problems Alleged Against DePuy Orthopaedics

DePuy Orthopaedics is facing a new product liability lawsuit alleging Attune knee problems forced the plaintiff to undergo revision surgery.
Plaintiff Robert L. filed this product liability claim soon after he experienced Attune knee problems, alleging the defective knee replacement system worsened his medical condition.
According to the prosthetic manufacturer, the DePuy Synthes Attune Knee System had taken six years to develop and release into the market.
According to numerous injury reports, issues with the tibial baseplate have resulted in early device failure and need for revision surgery.
Approximately 633 of these injury reports had resulted in revision surgeries, with DePuy continuing to receive complaints regarding Attune knee problems.
According to the FDA, the reasons for potential Attune knee replacement system failure includes but not limited to are: Failure to Bond Wear and Tear of Components Fracture Metallosis Implant loses Attachment with Bone (Osseointegration) It is important to note that revision surgery is considered riskier than the initial implant surgery, due to higher risk of infection.
Even though these Attune knee problems can be devastating to patients, DePuy allegedly failed to warn the public against these problems.
Robert alleges that neither he nor his physician were aware that the Attune knee replacement system may have contained defective components, or that it posed unreasonably dangerous risks to patients.
This Attune Knee Replacement Lawsuit is Case No.
In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions.

Sorin 3T Heater-Cooler May Cause Infection After Heart Surgery

The Sorin 3T heater-cooler is a popular warming system used in heart surgery, but many patients might not realize until after the fact that they’ve developed an infection because of it.
In recent years, more patients have come forward to allege that the Sorin 3T heater-cooler, as with other devices used during heart surgery, might cause patients to develop serious bacterial infections.
The device is used to keep the patient’s blood and organs warm during a bypass surgery.
The infection is most likely caused by Mycobacterium chimaera, which could have contaminated the Sorin 3T heater-cooler in Germany during the manufacturing process.
The FDA has stated that as of now, those affected by the issue are patients who went through surgery with a Sorin 3T heater-cooler developed before September 2014.
All surgeries come with a risk of infection and other complications, but those patients who developed an unexplained infection following their heart surgery may have grounds to pursue a lawsuit against the makers of the Sorin 3T heater-cooler.
Any patient who had a surgery with this device should be aware of the possible risks.
Currently, infections have been identified in several states, including Michigan, Iowa, and Pennsylvania.
These began in 2011 and include cases from at least 28 patients who developed this infection after a surgery using the Sorin 3T heater- cooler.
Patients should be aware of the side effects of this infection and should get help from their medical professional as soon as possible.

Heart Failure Linked to Side Effects of Onglyza

Class action investigators are reviewing injury claims describing side effects of Onglyza, a popular type-2 diabetes treatment medication.
A recent study analyzing the side effects of Onglyza found an increased risk of heart failure and being hospitalized for potentially fatal cardiac events.
However, Avandia was eventually recalled due to potential cardiac complications, which spurred concern in the medical community regarding the side effects of other type-2 diabetes treatment medications.
Even though this medication is supposed to improve the patient’s life and longevity, the side effects of Onglyza have been linked to heart failure and increased risk of hospitalization for cardiac events.
Also included in the investigation is Kombiglyze XR, another type-2 diabetes drug in the same family which contains the same core ingredient as Onglyza, saxagliptin.
Both Onglyza and Kombiglyze XR are typically prescribed to treat type-2 diabetes symptoms and are designed to help control high blood sugar levels in adult patients.
When used in conjunction with diet and exercise, these drugs are supposed to prevent severe diabetic symptoms and produce ideal insulin levels.
Bristol-Myers Squibb and AstraZeneca funded the study in question which analyzed patients prescribed Onglyza and Kombiglyze XR.
The study was conducted to help doctors evaluate the safety profiles of different type-2 diabetes treatment medications and help determine which medications are right for patients.
In addition to potentially fatal cardiac events, Onglyza has been linked to pancreatic problems allegedly due to the drug’s treatment mechanism.

Taper Lock Failure Prompts Stryker Femoral Head Recall

However, some joint replacement systems, like the Stryker LFIT system, are connected with a series of complications that may result in early device failure or revision surgery.
These complications prompted the Stryker femoral head recall.
Stryker’s femoral head recall has affected over 42,000 units around the world, prompting lawsuits and legal actions taken by a multitude of affected patients.
The medical device company, Stryker, issued a voluntary LFIT Anatomic femoral head recall on Aug. 29, 2016.
This recall was terminated on May 2, 2017, but it was too late for many patients who had already been implanted with Stryker’s defective device.
A hip replacement system is made up of three basic parts: a stem implanted into the femur (the bone in the thigh), a ball that attaches to the top of femur (called the femoral head) and the cup that the ball rests in (which is attached to the pelvic bone).
The reason for the Stryker femoral head recall has to do with something known as a taper lock failure.
At the junction of the femoral stem (the part that is implanted into the femur) and the femoral ball, there is a “neck” or small metal rod.
This extends from the femoral stem and attaches the ball to the stem.
If you have undergone a hip replacement surgery and were implanted with a Stryker hip, your device may be subject to the Stryker femoral head recall.

Have You Suffered Side Effects After the DePuy ASR Hip Recall?

After a major DePuy ASR hip recall, more and more patients are coming forward with reports of serious side effects caused by defective DePuy hip implants.
In fact, thousands of Americans undergo hip replacement surgery each and every year.
Unfortunately, metal-on-metal implants like the DePuy ASR device have been connected with some significant complications.
According to lawsuits, certain side effects are serious enough to necessitate revision surgery.
In response to these reports of injuries, the FDA issued a DePuy ASR hip recall back in August 2010.
So far, thousands of hip implant surgery patients have filed lawsuits against DePuy over a slew of injuries.
Patients have reported suffering from side effects including a high rate of device failure, metallosis (metal poisoning), dislocation and device dissociation.
A massive settlement was reached for patients who had suffered from side effects of the DePuy device after the DePuy ASR hip recall in March 2015.
If you or someone you love has suffered complications from a DePuy ASR metal-on-metal hip implant or have had to undergo revision surgery due to complications, you may be able to file a lawsuit.
Though filing a DePuy hip implant lawsuit can be complicated, talking with a qualified DePuy ASR hip implant attorney can help.

Injured Patient Files Invokana Ketoacidosis Lawsuit

A patient prescribed a diabetes medication that he thought would help him ultimately experienced side effects and filed an Invokana ketoacidosis lawsuit.
He and other Invokana patients have come forward with claims of diabetic ketoacidosis and say that they were never warned about the substantial risk of this side effect.
Unfortunately, however, as alleged in the Invokana ketoacidosis lawsuit, some patients may face a risk of severe side effects that could cause additional pain and medical problems.
Chief among this Invokana lawsuit and other complaints is the development of diabetic ketoacidosis.
When the fats are broken down, ketones are put into person’s bloodstream.
The body typically disposes of excess ketones through a person’s urine.
Later that same year, the FDA also announced that Invokana may cause diabetic ketoacidosis.
An Invokana ketoacidosis lawsuit may be filed by any patient who developed this medical problem and has had to cope with the pain and other side effects because of it.
Serious Invokana side effects such as diabetic ketoacidosis can lead to hospitalization or other health complications.
The Invokana Ketoacidosis Lawsuit is Case No.

Essure Long Term Side Effects Prompt Lawsuit

Essure long-term side effects have prompted FDA action and several product liability lawsuits.
Over the span of three months, a scar tissue barrier forms around the inserts, resulting in permanent occlusion of the fallopian tubes.
Since its initial approval by the FDA in 2002, over 4,500 adverse events reports have been filed regarding Essure long-term side effects.
According to the FDA, some women have had surgical procedures to remove the device because of the severity of the symptoms.
The effectiveness of Essure has also been called into question, with reports of women getting pregnant after Essure placement.
“If a woman becomes pregnant with Essure, there may be a risk for the pregnancy to occur outside of the uterus (ectopic pregnancy), which may result in serious complications,” the FDA states.
In 2016, the FDA issued a new, mandatory clinical study for Essure to determine heightened risks.
“While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications.” Essure lawsuits have been filed against Bayer due to Essure long-term side effects, accusing the drug manufacturer of misleading consumers about the permanent birth control.
According to the Essure birth control lawsuits, Essure’s approval was based on unreliable studies, and the birth control should not have been put on the market without further study of Essure long-term side effects.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.