Articles Posted in Product Liability

Fresenius Granuflo and NaturaLyte lawsuits filed throughout the federal court system will now be consolidated before one Massachusetts’ judge for coordinated pretrial proceedings, as part of a multidistrict litigation (MDL).

This affects all product liability lawsuits filed over heart attacks or sudden deaths allegedly caused by the use of GranuFlo or NaturaLyte dialysate products during hemodialysis – including at least 119 complaints filed throughout 16 different U.S. District Courts. These complaints all involve similar allegations that plaintiffs’ hearts suddenly stop during or shortly after dialysis treatment involving the use of Granuflo Acid Concentrate or NaturaLyte Liquid Acid Concentrate manufactured and sold by Fresenius Medical Care.

The lawsuits allege that Fresenius failed to adequately research the side effects of their dialysate products or warn about the potential risks including the importance of monitoring bicarbonate levels of patients receiving the products to avoid sudden cardiac arrest and death.

We’ve known for some time that Pradaxa has problems—this drug, intended to replace the time-tested blood thinner Warfarin (Coumadin), has been shown to cause internal bleeding and hemorrhaging. Unlike Warfarin, the bleeding cannot be quickly countered, which can cause death in serious cases. There were at least 260 deaths of people on Pradaxa between October 2010 and November 2011, which were confirmed by the drug’s manufacturer.

But when a drug is not properly tested and evaluated for safety before it comes on the market, you often see more than one problem with the drug. Now, new information has come out showing that patients with artificial heart valves are particularly at risk for Pradaxa injuries.

The warning comes from the FDA, which advises that a European clinical trial called RE-ALIGN was stopped mid-study because people with mechanical heart valves were more likely to experience strokes, blood clots and heart attacks, as compared to Warfarin users. The FDA is going so far as to require a labeling change warning doctors and patients that Pradaxa is contraindicated for patients with prosthetic heart valves.

Importantly, the FDA is not recommending Pradaxa use in patients with other types of heart valves called bioprosthetic valves. Those are made with natural biological tissue, but the effects of Pradaxa have not been specifically studied for those patients.

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Statins are a group of drugs used to lower cholesterol by inhibiting the enzyme HMG-CoA reductase. HMG-CoA reductase plays a role in the synthesis of cholesterol in the liver. Increased blood levels of cholesterol are associated with cardiovascular diseases. Statins have shown benefit in treating people with hypercholesterolemia (high cholesterol), and they are also now being used in people at low risk of cardiovascular disease as prevention.

The benefits of statins are quite clear. They work, and they help a lot of people.  Any talk of the risk of statins has to be there. But there has been uncertainty regarding the safety of these drugs in recent years. The most common side effects reported with statins include increases in liver function tests, muscle aches, and rhabdomyolysis, a breakdown of muscle fibers. This would lead to questions of just what the drug companies should be telling doctors and end users about the risks of these drugs.

In recent years, there has been another concern: the possible relationship of the development of diabetes in patients taking statins. In 2008, a study on rosuvastatin (Crestor) to determine efficacy on vascular events suggested that statin use may result in the development of diabetes.

In 2010, an article published in The Lancet reviewed and analyzed 13 placebo-controlled trials to determine if the finding of the development of diabetes was consistent between trials. Results of this meta-analysis showed that there was a 9% increase in the risk of development of diabetes, mostly seen in patients over 60 years of age. Though this finding may seem odd, especially when statins have been shown to lower cholesterol in diabetic patients, other cardiovascular drugs such as thiazide diuretics, and beta-blockers have also been shown to lead to a higher risk of developing diabetes.

• Diabetes drug causes gastroparesis: new lawsuit in 2024

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This blog post is about defective Windows made by MI Windows and Doors. I am writing about this because I find it interesting. There are lawyers handling these cases all around the country. Our law firm is not handling these cases. So while you are always welcome to call us, we will not be of much help to you in these cases. I don’t think it is a terrible idea, however, to listen to some thoughts from a lawyer that does not have any chips on the table.

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Biomet Hip Defect Lawsuits Have Many Chapters

Biomet is one of the manufacturers of the much-maligned metal-on-metal hip implants. It makes the M2A Magnum, an all-metal implant that plaintiffs and scientists believe causes serious medical problems, including failure and blood poisoning.

In late June 2012, plaintiffs in several federal Biomet hip implant lawsuits filed a motion with the Judicial Panel on Multidistrict Litigation, asking that all federal Biomet hip implant injury cases be grouped together in one court, before one judge. Specifically, the plaintiffs asked the court to move the cases to the Northern District of California, or the Southern District of New York.

This move is basically a request to open up a metal-on-metal hip implant class action lawsuit. In multidistrict litigation (MDL), all cases of the same type that are filed in federal courts are automatically sent to one judge. That judge oversees the cases and ensures that there is unified (and not duplicative) discovery. The judge may encourage early test trials (called bellwether cases), from which the parties can determine the relative strengths and weaknesses of their cases, as decided by a jury. Those test cases often allow the lawsuits to settle en masse. If they don’t settle, or if an individual plaintiff chooses not to settle with the group, the non-settling cases are sent back to their home federal court for further proceedings, including trial.

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People on dialysis have enough problems without having to worry about heart attacks. But it seems that the nation’s leading supplier of dialysis products (mostly through its own dialysis centers) may be causing an untold number of dialysis patients to have heart attacks and other cardiac problems.

Fresenius Medical Care creates two products for use in dialysis—GranuFlo (a dry acid dissolution system) and NaturaLyte (the liquid version). Patients who need dialysis have problems with kidney function. One of the side effects of kidney problems is that the body builds up acid in the bloodstream. To treat this, physicians often prescribe bicarbonate. If you remember your high school chemistry (I didn’t), bicarbonate can neutralize the acid.

The problem with GranuFlo and NaturaLyte is that some of the ingredients can be converted by the body into bicarbonate. If the physician doesn’t know that, then the patient can receive a double-dose of bicarbonate. Too much bicarbonate can cause cardiac problems, like heart attacks.

There is a growing concern there there is a compound in Teflon® that may cause cancer. No one is filing any lawsuits about this, at least not yet. Science has to dig a lot deeper into all of this. The purpose of this post is just to give you an overview of the concern about the possible.

Teflon® is the brand name for DuPont’s product, has been used as a non-stick coating surface for pans and cookware, as well as in other products such as fabric protectors since the 1940’s. Teflon® is the brand name for polytetrafluoroethylene (PTFE), a man-made chemical. C8, otherwise known as Perfluorooctanoic acid (PFOA), is another man-made chemical that is used during the manufacturing of Teflon® and other flurotelormers. C8 is not present in significant amounts in the end product, as it is burned off during the manufacturing process of Teflon®.

PTFE is known for its exceptional chemical resistance and non-stick properties, making it useful in a wide range of applications, including non-stick cookware, electrical insulation, industrial coatings, and biomedical implants. PTFE is also known for its low friction, high melting point, and excellent resistance to UV radiation and weathering, which makes it an ideal material for applications that require high performance under extreme conditions.

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I remember kids in elementary school in the ’70s with asthma. It seemed rare back then. Not anymore. Statistics seem to bear this out. The prevalence of asthma is increasing worldwide and in particular in the United States.

The one thing you have to keep in mind in this article is the conventional wisdom is that there is no connection between asthma medication and birth defects or other injuries to the fetus.  The use of albuterol and other asthma medications are often necessary to keep the fetus healthy. So keep a pin in that as you read on.  Also remember the best thing you can always do is talk to your doctor about the risks.

Pulmicort and Pregnancy

Asthma has risks for all who suffer from it, but people are paying a lot more attention to the issue of pregnancy and asthma and whether asthma medications can cause injury to the expectant mother or the unborn child. Specifically, people are questioning whether asthma drugs like budesonide (Pulmicort) that contained glucocorticoids increase the infant’s risk of developing metabolic and endocrine disorders.

Does this mean you should not ever use Pulmicort while pregnant? Of course not.  But you need to understand all the risks and talk to your doctor about them so you get on the path that causes the least risk.

Many Women Use Asthma Medication During Pregnancy

Between 4 and 12% of pregnant women have asthma and 3% use asthma medications during pregnancy. Women with asthma are at an increased risk of complications during pregnancy due to inadequacy in controlling asthma and/or some medications used to manage asthma.

A Fetus Needs Oxygen

Certainly, doctors are in a Catch 22. Poorly controlled asthma can result in an inadequate supply of oxygen to the fetus. Asthma during pregnancy can lead to preterm labor, cesarean section, and hypertensive disorders, including preeclampsia and placental previa. Severe asthma can result in maternal mortality, fetal mortality, or both.

The Key Is Understanding the Risk

Therefore, management of asthma during pregnancy may be necessary to improve the mothers’ asthma, even if risks are present with the use of such medications. It is always important to weigh the potential risks to the fetus against the benefit of the mother. To do this accurately, drug companies have to tell us what the risks of asthma and pregnancy are. What are they? We don’t know what the drug companies know, but what we do know is mixed.

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Plavix (clopidogrel) is a prescription anti-platelet medication used to prevent stroke and heart attack in patients with cardiovascular disease. Plavix works by making blood platelets less likely to form clots.

It is generally taken in tablet form, once per day by mouth. Plavix is one of the best selling drugs worldwide, with over $8 billion dollars in annual sales.

As with many medications, Plavix may cause serious side effects, including:

Common Side Effects of Plavix

1. Bleeding: This is the most common side effect and can range from minor bruising to more severe bleeding.
2. Bruising: Increased tendency to bruise due to reduced blood clotting ability.
3. Nosebleeds: More frequent or prolonged nosebleeds.
4. Gastrointestinal Issues: Including stomach pain, diarrhea, indigestion, or heartburn.
5. Headaches: Mild to moderate headaches.
6. Dizziness: Feelings of lightheadedness or vertigo.
7. Itching or Rash: Skin reactions such as itching or rashes.

Serious Side Effects of Plavix

1. Severe Bleeding: Including gastrointestinal bleeding, brain hemorrhage, or bleeding within the eyes.
2. Thrombotic Thrombocytopenic Purpura (TTP): A rare blood condition involving blood clots forming throughout the body.
3. Hemorrhagic Stroke: Bleeding in the brain, especially in patients who have had a recent brain injury or surgery.
4. Ulcers or Holes in the Stomach or Intestines: Manifesting as severe stomach pain, bloody stools, or vomit that looks like coffee grounds.
5. Allergic Reactions: Symptoms may include rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
6. Liver Problems: Symptoms such as yellowing of the skin or eyes, dark urine, or persistent nausea/vomiting.
7. Low White Blood Cell Count: Leading to increased susceptibility to infections.

Drugs come with side effects. We all get that. So that is not the question. Instead, the question is whether the maker of Plavix knew that people who are unable to metabolize Plavix adequately were at greater risk for a heart attack. Since Plavix will not work until it is metabolized in the body, these individuals are at a greater risk for heart attack and stroke.

This increased risk is so great that in March of 2010, the FDA added what is known as a “Black Box Warning” to Plavix to alert both patients and physicians that the drug can be less effective in those patients who are unable to metabolize it into the active form. It is estimated that as many as 14% of the U.S. population are poor metabolizers of Plavix.

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The Food and Drug Administration (FDA) is urging Healthcare professionals to remain vigilant about reporting cases of malignancy in patients treated with TNF blockers to MedWatch. This comes after the FDA has continued to receive reports of a rare cancer of white blood cells, known as Hepatosplenic T-Cell Lymphoma or HSTCL.

The FDA updates on Tumor Necrosis Factor (TNF) blockers

HSTCL is an aggressive cancer and is usually fatal. The majority of the reported cases were in patients that are being treated for Crohn’s disease or ulcerative colitis, but also include a patient that is being treated for psoriasis and two patients that are being treated for rheumatoid arthritis. The FDA is now updating the number of reported cases of HSTCL. Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.