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Couple Files New Pinnacle Hip Implant Failure Lawsuit

A Wisconsin couple recently filed a Pinnacle hip implant failure lawsuit against DePuy, alleging that a DePuy hip implant caused serious defects leading to device failure and removal.
The plaintiff, Thomas B., was implanted with a Pinnacle device from DePuy in October 2009.
During surgery, doctors allegedly found that tissue in the area had reacted poorly to excessive metals released by the metal-on-metal hip implant.
Thomas filed his Pinnacle hip implant failure on May 2, 2018, in Texas.
The lawsuit was filed on multiple counts, including design defect, manufacturing defect, failure to warn, negligence, and several others.
The Pinnacle Hip Implant Device The specific device referred to in this lawsuit is the DePuy Pinnacle Acetabular Cup System, or Pinnacle hip.
Though DePuy markets its device as safe and effective, hip replacement lawsuits allege that the company is aware of the link between its Pinnacle device and a number of hip replacement problems, including metallosis, toxicity, muscle and tissue damage, and a high rate of Pinnacle hip implant failure.
Filing a Lawsuit Over Pinnacle Hip Implant Failure Lawsuits claim that the Pinnacle device’s manufacturers failed to adequately warn the public and the medical community about the defects associated with the DePuy Pinnacle device.
If you or someone you love has experienced hip replacement problems due to DePuy Pinnacle hip defects, you may be able to file a DePuy Pinnacle hip implant lawsuit.
The Pinnacle Hip Implant Failure Lawsuit is Case No.

Xarelto Bleeding Death Lawsuit Filed by Plaintiffs, Alleging Serious Injuries

A new Xarelto bleeding death lawsuit has been filed on behalf of a deceased woman who the family members claim was critically injured while taking this popular medication.
Many plaintiffs have come forward to file a Xarelto bleeding death lawsuit, alleging that themselves and their family members were subjected to critical and dangerous side effects while taking the drug.
Xarelto is often prescribed to reduce the risk of systemic embolism and stroke for prophylaxis of deep vein thrombosis and to treat pulmonary embolism or deep vein thrombosis.
However, as alleged in the Xarelto bleeding death lawsuit, patients may be exposed to serious internal bleeding risks.
The decedent in the Xarelto bleeding death lawsuit allegedly suffered dangerous and serious side effects, including fatal bleeding.
The Xarelto bleeding death lawsuit argues that the woman ultimately suffered a sudden Xarelto bleeding death on Jan. 28, 2016.
If internal bleeding is left too long, the patient could suffer life-threatening side effects.
Many patients have accused the manufacturers of failing to let people know about the dangerous internal bleeding risks associated with the medication.
Many of these patients have come forward to file a Xarelto bleeding death lawsuit.
The Xarelto Bleeding Death Lawsuit is Case No.

Lamictal Skin Rash Could Signal a Serious Immune System Reaction

Have you experienced a Lamictal skin rash or other side effects after taking the anti-seizure medication?
Lamictal (lamotrigine) was FDA-approved in December 1994 to treat epileptic seizures and in 2003 to treat bipolar disorder.
Among these reactions are Stevens Johnson Syndrome, Toxic Epidermal Necroloysis, Drug Reaction with Eosinophilia and Systemic Symptoms, Drug-Induced Hypersensitivity Syndrome, and Hemophagocytic Lymphohistiocytosis.
Lab tests often reveal an enlarged liver, enlarged spleen, enlarged lymph nodes, anemia, and low platelet count.
According to the FDA, HLH is commonly mistaken for Drug Reaction Eosinophilia and Systemic Symptoms (DRESS).
To help clarify the reaction, patients experiencing HLH will often exhibit a minimum of five of these symptoms: Lamictal skin rash accompanied by fever Enlarged spleen Cytopenias (reduced number of mature blood cells) Elevated levels of triglycerides or low blood levels of fibrinogen (a blood clotting component) High levels of blood ferritin (a protein that stores iron in human tissues) Bone marrow, spleen or lymph node biopsy that identifies hemophagocytosis Decreased or no Natural Killer (NK) Cell activity (cells that detect and kill cancer cells and viruses) Lamictal Skin Rash and DRESS Another potentially life-threatening Lamictal skin rash is a symptom of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a delayed immune system reaction that can appear two to eight weeks after the offending medication has begun.
DRESS includes a Lamictal skin rash, accompanied by inflammation of internal organs, including the liver, kidneys and lungs.
DRESS symptoms also include blood abnormalities, such as: Eosinophilia: An increased level of disease-fighting white blood cells called eosinophils.
Lymphadenopathy: Swollen lymph nodes.
If you have experienced a Lamictal skin rash that has progressed to a dangerous condition such as HLH or DRESS, you could be eligible for compensation through legal representation.

Ventralight Mesh Lawsuit Claims That Bard And Davol’s Product Is Defective

Davol and Bard face a Ventralight mesh lawsuit alleging that the Ventralight hernia mesh product is defective and can cause serious complications.
Bard, alleging that their Ventralight ST Bard Mesh caused serious health problems and surgical complications.
The abdominal mesh was entirely removed.” The Ventralight mesh lawsuit claims that the hernia mesh was defectively designed and is therefore not safe for its intended use in hernia repair.
The complaint argues that possible adverse reactions to the mesh or its components include chronic pain, recurrence of hernia, foreign body response, rejection, infection, scarification, improper wound healing, excessive and chronic inflammation, allergic reaction, adhesions to internal organs, erosion, abscess, fistula formation, granulomatous response, seroma formation, nerve damage, tumor formation, cancer, tissue damage, death and other complications.
David claims that the coating on the hernia mesh prevents fluid from escaping which can result in seroma formation, infection, abscess formation and more.
The tendency to breed bacteria is allegedly caused by the mesh’s ethylene oxide (ETO) coating.
Moisture is needed to eliminate dry spores, and mesh products which are not properly sterilized can result in infections after the bacteria is exposed to the body.
However, once the coating is reabsorbed, the “naked” mesh can allegedly adhere to organs and cause fistula formation.
“As described above, there was an unreasonable risk that the ST Bard Mesh would not perform safely and effectively for the purposes for which it was intended, and Defendants failed to design against such dangers, and failed to provide adequate warnings and instructions concerning these risks,” the Ventralight mesh lawsuit states.
The Ventralight Mesh Lawsuit is Case No.

Alleged Mirena IUD Complications Lead to Lawsuit

A Mirena IUD complications lawsuit has been filed by a woman who alleges that the manufacturer failed to warn her about the serious side effects associated with using the popular birth control method.
In this Mirena IUD complications legal claim, the plaintiff alleges that the company knew or should have known about the unreasonably dangerous product and failed to warn consumers about the risks.
The plaintiff, a resident of Ohio, alleges that Mirena IUD complications were serious in nature but that the marketing materials provided to her doctor and herself did not fully explain the risks of using Mirena as a form of birth control.
Included inside the Mirena IUD complications lawsuit are allegations that the label does not warn about non-stroke neurological conditions that patients may develop such as pseudotumor cerebri.
This is also known as inter-cranial hypertension.
The Mirena IUD complications lawsuit says that the manufacturer is aware of the risk of pseudotumor cerebri in use of Mirena.
After the Mirena IUD was placed inside the patient’s body, the plaintiff says she began to experience unexplained side effects including pressure behind her eyes, dizziness, severe headaches and vision disturbances.
In 2010, the first Mirena IUD device was taken out of that plaintiff without any complications, but the plaintiff only became aware of the connection between pseudotumor cerebri and use of Mirena in 2016.
Any patient critically injured by Mirena or any other drug is within their rights to consider legal action.
The Mirena IUD Complications Lawsuit is Case No.

Side Effects of Onglyza May Include Heart Failure

Although Onglyza has quickly become a popular type-2 diabetes drug since its FDA approval in 2009, there are a number of serious side effects of Onglyza that patients may not have been adequately warned about, including heart failure.
In response to reports of side effects of Onglyza, the FDA has required the drug’s manufacturers to update its warning label with these risks.
A side effect of many diabetes drugs is weight gain, but weight gain has not associated with Onglyza.
This makes the drug highly attractive for type-2 diabetes patients.
Side Effects of Onglyza: Heart Failure Heart failure is a serious and potentially life-threatening medical condition in which the heart becomes so weak that it cannot adequately pump blood throughout the body.
These kinds of permanent changes may include improving their diet, reducing their level of salt intake, exercising, losing weight, and/or managing stress more effectively.
Onglyza manufacturers were warned by the FDA in April 2015 to include an increased risk of heart failure to their warning labels.
Filing a Lawsuit Over Side Effects of Onglyza A growing number of diabetes patients are coming forward, alleging that Onglyza directly led to major side effects, including heart failure.
Some patients choose to file lawsuits over side effects of Onglyza against the manufacturers, AstraZeneca and Bristol-Meyers Squibb, for failing to adequately warn and inform the medical community and consumers of potential heightened risk factors of their drug.
Free Onglyza Lawsuit or Kombiglyze Lawsuit Review Did you or a loved one suffer heart failure, cardiac failure, congestive heart failure or death after taking Onglyza or Kombiglyze XR?

Persona TM Tibial Plate Might Come Loose and Lead to Pain, Knee Instability

If you underwent knee replacement surgery between 2012 and 2015, your hardware might contain a recalled component, the Persona TM Tibial Plate.
Zimmer (now Zimmer Biomet) issued a voluntary recall of the Persona Trabecular Metal (TM) Tibial Plate in January 2015 after reports of device loosening.
Patients suffering from a variety of issues might be showing signs that the Persona TM Tibial Plate has failed to secure the implant.
Reasons for Persona TM Tibial Plate Problems The Persona TM Tibial Plate covered under the recall is a metal component that anchors the implant to the bone without the use of surgical cement.
Over time, the bone is supposed to grow in and around the pegs to fully secure the knee implant components.
Unfortunately, patients began to complain of two main issues with the Persona TM Tibial Plate: Radiolucent Lines: Patients underwent x-rays that indicated small gaps between the tibial plate and the bone, possibly indicating “poor seating.” Radiolucent means the evidence is visible on an x-ray.
Because the Persona TM Tibial Plate is not anchored with any surgical cement, the radiolucent lines are defined as the area between the bone and the plate.
Zimmer has said that loosened components are the most prevalent reason for knee implant revision surgeries.
According to Zimmer, 38 percent of patients who complained of the Persona TM Tibial Plate either had radiolucent lines that were causing problems or had undergone revision surgery to correct the issues.
In addition to experiencing pain, mobility issues, inflammation, knee instability, or a tight knee, patients complained of patella tracking issues, fractures, and loss of fixation of the knee implant.

New Essure Injuries Lawsuit Filed Against Manufacturers Bayer and Conceptus

A new Essure injuries lawsuit has recently been filed against the device’s manufacturers Bayer and French company Conceptus over adverse side effects and complications suffered by dozens of plaintiffs claiming negligence and fraud.
The 62 plaintiffs filing this suit are in addition to those in a similar lawsuit filed by 10 others in February.
However, they did maintain that “We will vigorously defend the continued availability of Essure, which is an important option for the many women who are seeking permanent birth control.
As FDA has repeatedly determined, Essure is a safe and effective medical device that benefits women by providing them with a valuable contraception option.” The FDA limited the distribution and sale of Essure earlier this month.
A black box warning was also mandated to be placed on Essure labels, in 2016, along with a patient checklist listing severe adverse side effects that must be filled out by patients and doctors acknowledging their understanding of device risks.
Essure became approved by the FDA in 2002.
It is a permanent contraceptive device that becomes implanted into a woman’s fallopian tubes and features two metal coils.
Once implanted, the coils expand, causing tissue in the fallopian tubes to grow thus blocking sperm from being able to enter.
In a recent news release by the FDA, they discussed their added restriction of sales of Essure.
They maintained that “The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.” In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.

Weekly Roundup 5.18.18

It has also been raining FDA -related actions this week, of which many blog posts could be written.
Aimovig works as a calcitonin gene-related peptide receptor (CGRP-R) thought to play a role in migraine.
An interesting side note in the wake of the national discussion on pricing that took place this week, the release from the company names the list price for the drug, outlines a rationale for the price set and discusses the patient assistance program.
FDA Approves New Treatment for Opioid Addiction – A priority of FDA and of the Commissioner has been to make new treatments available for opioid withdrawal symptoms.
Only approved for use for a fourteen day period, the release from FDA cautions that it may not prevent withdrawal symptoms but may lessen severity of symptoms and is not a treatment for opioid use disorder, but is part of a broader treatment plan.
Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist reducing the release of nopinephrine which is believed to play a role in the symptoms.
On a related note, Commissioner Gottlieb posted on the FDA Voice blog an entry regarding actions and upcoming plans to address concerns that a balanced approach to the opioid misuse with respect to the needs of patients who require pain control.
Trump Speech on Pharma Pricing and Aftermath – Technically last week, but continued into this week.
Despite the anticipation and build up to the speech by Administration officials, the actual speech resulted in a rise in pharma industry stocks.
Things to Keep an Eye on This Week May 22 – Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee with Drug Safety and Risk Management Advisory Committee – consider NDA for buprenorphine sublingual spray for treatment of moderate to severe pain where an opioid analgesic is appropriate May 22 Senate HELP Committee Hearing – The Healthcare Workforce: Addressing Shortages and Improving Care May 23 Senate HELP Committee Hearing – S.2852 Pandemic and All-Hazards Preparedness Innovation Act of 2018 Regulatory Developments in Pharma/Biotech/Devices

Can Prilosec Cause Stomach Cancer?

A recent study has reported a link between proton pump inhibitors like Prilosec and stomach cancer, among other side effects and complications.
There are number of heartburn drugs tied to stomach cancer risks, reports are now warning.
Researchers in the study reported that heartburn medications, also known as PPIs or proton pump inhibitors, double the risk for developing stomach cancer.
Some of the medications that fall under the class of PPI heartburn meds includes: • Nexium, Nexium IV, Nexium 24 HR • Prilosec, Prilosec OTC • Prevacid, Prevacid IV, Prevacid 24-Hour • Protonix • Zegerid, Zegerid OTC Patients who developed stomach cancer after taking Prilosec or other PPI heartburn meds may be eligible to file a Prilosec and stomach cancer lawsuit to pursue compensation for bills, pain and suffering, and other damages.
Overview: Prilosec and Stomach Cancer According to a New York Times article, a new study suggests of a link between heartburn meds, such as Prilosec and Prevacid, and stomach cancer.
Although there is an increased risk for stomach cancer development for those who carry the stomach bacteria known as Helicobacter pylori, even when the bacteria has been eradicated through heartburn meds, stomach cancer may still develop.
According to the study, 63,397 people were evaluated in Hong Kong for treatment of an H. pylori infection.
These numbers reflect more than twice the incidence of cancer among those who had been treated with H2 blockers.
Prilosec and other heartburn meds have also been linked to kidney problems and kidney failure, according to recent studies.
Persons diagnosed with stomach cancer after taking Prilosec or other PPI heartburn meds may be eligible to file a legal claim.