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Invokana Kidney & Heart Attacks

Invokana Black Box Warning – Leg & Foot Amputations

By | Invokana | No Comments

INVOKANA® BLACK BOX WARNING LEG, TOE & FOOT AMPUTATIONS

The Food & Drug Administration (FDA) is requiring a black box warning to appear for Invokana® and Invokamet® alerting users and physicians of the serious adverse event of an increased risk of Leg, Toes & Foot Amputations with Invokana use.  Black box warnings are reserved for the most serious adverse events.

Doubling of the Risk of Leg & Foot Amputations

Invokana® is manufactured by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson. The FDA warning is the result of two large clinical studies that found that Invokana users faced twice the risk of leg and foot amputations with Invokana® compared to placebo users.  The studies were CANVAS (Canagliflozin Cardiovasculare Assessment Study) and CANVAS-R.

According to the FDA, the CANVAS trial showed that over a 1 year period that the risk of amputation was

  •  5.9 out of every 1000 patients treated with Invokana®
  • 2.9 out of every 1000 patients treated with placebo

CANVAS R results showed that over a 1 year period that the risk of amputation was

  • 7.5 out out every 1000 patients treated with Invokana®
  • 4.2 out of every 1000 patients treated with placebo

This is not the first time the FDA has expressed concern over Inovkana®.  In May 2016 the FDA’s review of interim clinical data caused the FDA to further investigate the increased risk of lower limb amputations, mostly toes, with the diabetes medicine Invokana®

The most common type of amputations was of the toe and middle of the foot. Amputations involving the leg, below and above the knee, had occurred as well. In addition, some patients had more than one amputation, some of which involved both limbs.

The FDA warning provides further information about Invokana® in regard to its usage, methodology, and side effects. It’s a prescription medicine used primarily with diet and exercise in order to lower the level of blood sugar in adults with type 2 diabetes. It falls into the drug class of sodium-glucose cotransporter-2 (SGLT2) inhibitors. It reduces the blood sugar by triggering the kidneys to remove sugar in the body through urine.

The FDA recommends “patients taking Invokana® should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet.” This recommendation is further supplemented by emphasizing one shouldn’t stop their diabetes medication without first consulting their health care professional.

We Can Help You.

If you or a loved one has taken Invokana® and sustained an amputation of the foot, toes or leg we would like to help you.  Call for a confidential consultation at 1-800-745-4050.

Helpful link:

FDA

 

 

Invokana Kidney & Heart Attacks

Invokana Kidney Injuries – We Can Help

By | Invokana | No Comments
Invokana Kidney & Heart Attacks

Invokana Kidney Injury

Invokana® Lawsuit News!

A Invokana kidney injury case can proceed according to a federal judge. No preemption exists according to Judge Martin Feldman. The case concerns the plaintiff developing acute kidney damage while using Invokana a Janssen Pharamaceutical product. Janseen is a division of Johnson & Johnson.

The case involved Gloria Guidry who was prescribed Invokana to treat her Type II diabetes.  She took Invokana from approximately 6 months before she was hospitalized for acute kidney injury and acute kidney failure. Guidry alleged that Invokana caused her acute kidney failure.

In the Guidry, Janssen filed a motion to dismiss urging Judge Feldman to dismiss all of the plaintiff’s claims because of preemption.  The were many issues addressed in Judge Feldman’s 45 page opinion.  However, the key issue in the case was whether a defective design claim arising from use of a brand name prescription drug, Invokana®, is preempted.

Judge Feldman ruled that under Louisiana law that a defective design claim against a brand name prescription drug is not preempted. His rational seemed to be focus, in part, on providing Louisiana residents the right to go to court and have their claim heard by a jury.  Further, a key fact the plaintiff alleged was that Janssen knew Invokana’s design posed an unreasonably dangerous risk of kidney injury before it was approved by the FDA.

How Does Invokana Work?

As noted in our Current Investigations, Invokana is designed to help diabetics reduce excess blood sugar by blocking re-absorption of glucose in the kidneys.  Instead glucose is pushed out through urination.  In this process, it is alleged, sugar builds up in the tubes connecting the kidney to the bladder, forcing the kidneys to over work.  This causes the kidneys to stress leading to kidney injury and kidney failure.

Why You Should Select Us?

If you have a serious injury case you need an experienced product liability attorney.  At the James Esparza Law Group we only accept clients who have been harmed from defective products. We provide each client with the personal care and attention they deserve.  If you or a loved one would like to discuss your Invokana injury we are here to answer your questions. We will make no promises to you, but we will investigate your case and answer your questions as best as possible. Call now 1.800-745-4050. Experience law done differently!

 

 

J & J Baby Powder

Talcum Powder Lawsuit News – Baby Powder – Ovarian Cancer

By | Talcum Powder | No Comments

J & J Baby Powder

Talcum Powder Lawsuit News


TWO TALCUM POWDER LAWSUITS WERE DISMISSED

Talcum Powder Lawsuit filed by two women were dismissed.  The two women blamed Johnson & Johnson talcum powder for their ovarian cancer.  New Jersey State Court Judge Nelson Johnson ruled that the women could not produce sufficient scientific evidence that talc causes ovarian cancer.

The plaintiffs, Brandi Carl and Diana Balderrama alleged that their use of taclum poweder in Johnson & Johnson’ Baby Powder led to the development of ovarian cancer.

In these talcum powder lawsuits, baby powder lawsuits,  Johnson & Johnson filed a motion for summary judgment seeking dismissal of the two cases.  J & J argued that the plaintiffs’ experts were unable to link talcum powder use to ovarian cancer. Judge Johnson agreed ruling that the experts testimony suffered from multiple deficiencies.

The two cases were set for trial in October, 2016.  Presently, there are over two hundred cases filed in New Jersey state court and the ruling will impact those two hundred cases.

Previously, Johnson & Johnson lost two trials in St. Louis where one jury awarded $72 million in damages and another jury awarded $52 milion.

The ruling will be scrutinized by attorneys for both sides.

Talcum Powder Lawsuit Evaluation

The James Esparza Law Group is focused solely on representing individuals and families that have been harmed by defective products. If you or a loved one has be diagnosed with ovarian cancer and regularly used  baby powder we can help. We have helped thousands. We can help you too. Call 1-800-745-4050.

 

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Testosterone Lawsuits and Generic Drug Preemption

By | Personal Injury Attorneys, Testosterone | No Comments

Generic Drug Preemption – Good For Consumers?

Attorneys involved in pharmaceutical product liability litigation such as Testosterone Lawsuits  have been living with a United States Supreme Court decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011). In this case, the United States Supreme Court ruled that lawsuits against generic drug manufacturers are preempted by federal drug regulations which require a generic drug label to match the brand warning label word for word regardless of mounting evidence that a generic drug carries a risk far greater than what is disclosed in the label. The case has essentially eliminated all claims form users of generic drugs from bring claims against generic manufacturers.

For consumers, often times, the first time they hear of preemption is when their attorney informs them they have no case because the product they used was a generic drug and not a branded drug. So what is preemption? Most pharmaceutical product liability are based on a failure to warn. This means the drug label failed to warn the user of the true risk or risks associated with the drug. Because Congress wanted to promote the generic drug industry they created a different path for approval of generic drugs and branded drugs. A company seeking approval of a generic drug must only show that the drug is a bioequivalent of the branded drug. On the other hand, the branded drug must show the drug is safe and effective as labeled. The branded drug creates the label and the generic manufacturer of the drug adopts the branded drugs label. The generic manufacturer has no control over the label.

This confusing issue reared its head in In Re Testosterone Therapy Products Liability Litigation, MDL 2545, where some of the defendants filed a motion to dismiss plaintiff’s state law claims arising out of use of certain prescription generic testosterone therapy drugs. They argued that federal law preempts state law claims. Plaintiff’s opposed the motion. Judge Matthew Kennelly granted defendants’ motion dismissing all claims against Pfizer, Inc. and Pharmacia & Upjohn Company, LLC and Auxillium Pharmaceuticals, Inc.

Plaintiffs then filed a motion for reconsideration and clarification of the order dismissing all of plaintiff’s claims, including those based on fraud. The issue whether fraud claims against manufacturers of generic drugs based on “off-label” promotion are preempted under Mensing. Judge Kennelly’s opinion focused on whether off-label promotion falls within the area of drug labeling. He concluded that “Defendants’ obligations under state fraud law to refrain from falsely promoting their drugs for unapproved use does not conflict with their obligations under federal law to maintain their warning labels.” Thus the fraud based claims are not preempted.

Questions About Testosterone Lawsuits?

For plaintiffs who used depo-testosterone, manufactured by Pfizer, Pharmacia & Upjohn, or Testopel®, manufactured by Auxillium, the court’s decision carves out a small avenue for hope that they may obtain compensation for injuries sustained by these products. However, without failure to warn, these cases are vulnerable.

If you have questions about bringing a testosterone lawsuit contact us.  We would like to help. We are representing select clients that used prescription testosterone and suffered life altering injuries.

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Androgel Lawsuit Update

By | Personal Injury Attorneys, Testosterone | No Comments

Androgel® Trial News

Eight Androgel lawsuits out of approximately 6,000 cases have been selected by Judge Matthew Kennelly in the Androgel® litigation for bellwether trials. The initial bellwether pool of cases consisted of 100 cases that were thought to be representative of the pool of 6,000. Four of the cases will be heart attack or stroke cases and the other four will involve claims of blood clot victims, deep vein thrombosis (DVT) or pulmonary embolism (PE). The initial group of eight bellwether trials are non-mixed use cases where the only prescription testosterone involved is Androgel®.

Cases for Axiron®, Testim®, Androderm®, Testopel® and Fortesta® will be addressed at a later date as well as mixed use cases.

If you are unfamiliar with Testosterone Replacement Product Liability Litigation, MDL No. 2545, the cases are about adult males who used prescription testosterone products and while using testosterone replacement therapy developed a heart attack, stroke (ischemic), deep vein thrombosis (DVT) or pulmonary embolism (PE).

What is a Bellwether Trial?

In selecting cases for bellwether trials it is important that cases selected are not atypical. The cases should not possess a unique set of facts. The over-riding criteria is selecting cases is that they should be representative of as many cases. Extremely unique cases do not further the goals of assessing the strengths and weakness of causation, both general and specific, core theories of liability, the adequacy of warnings, the role of marketing and promotion of Androgel and defense.

When is the Trial? 

The first Androgel® case is set to start on June 5, 2017. While this seems like a long time away much work needs to be completed by then. For example, Judge Kennelly has set the following deadlines:

* 9/19/2016 Deadline for completing additional fact discovery in bellwether trial cases
* 10/24/2016 Deadline for plaintiffs’ expert witness disclosures,
* 11/29/2016 Deadline for defendants’ expert witness disclosures,
* 12/9/2016 Deadline for plaintiffs to request to disclose rebuttal expert testimony,
* 12/21/2016 Deadline for plaintiffs’ disclosure of rebuttal expert testimony, if allowed,
* 1/20/2017 Deadline for completing depositions of expert witnesses,
* 2/17/2017 Deadline for motions for summary judgment or partial summary judgment,
* 2/17/2017 Deadline for motions challenging expert testimony,
* 3/20/2017 Deadline for responses to summary judgment / expert motions,
* 4/10/2017 Deadline for replies on summary judgment / expert motions, and
* 5/8/2017 Target date for Court’s ruling on summary judgment / expert motions.

While the outcomes of the bellwether trials in the MDL are not binding they will be closely watched by the parties involved as they may highlight successful trail strategies and influence negotiations to reach Androgel® settlements.

Question?

The James Esparza Law Group has been selectively evaluating and accepting cases where an adult male has used Androgel® and while using the product developed a heart, stroke, deep vein thrombosis (DVT) or pulmonary embolism (PE). If you have a question, we can help. Simply click the contact below. Phone calls work as well.

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The Need-To-Know Guide for Patients Undergoing Knee Revision Surgery

By | Personal Injury Attorneys | No Comments

Each year, approximately 700,000 Americans undergo knee replacement surgery. For those who suffer from advanced osteoarthritis and other painful joint diseases, a knee replacement offers a new chance for an active life. Before surgery, severe knee pain may have limited a patient’s activities. While there are some restrictions after knee replacement surgery, most patients are able to travel, exercise in moderation, and enjoy a full and active life not possible before the knee replacement.

Most people who receive knee replacements experience reduced pain and increased activity. However, for some, these benefits don’t last. Several knee replacement devices have been recalled because they are not sufficiently durable and early failure means an increased risk of expensive knee revision surgery.

Some recalled knee implant systems include:

  • DePuy LCS Knee Implant-Meniscal device: Recalled because label errors stated the wrong size.
  • DePuy LCS Duofix Femoral Component: Recalled because of pain, swelling and increased revision rates in patients who had received the implant.
  • DePuy PFC Sigma Knee Systems: Recalled after the FDA discovered the product did not have proper approvals.
  • Zimmer NexGen LPS, CR and MIS Knee Replacement Systems: Recalled because studies found these knee replacement components experience premature wear leading to early knee revision surgery.
  • Zimmer Natural Knee System: Recalled because newer models were experiencing early failure.
  • Stryker Scorpio CR and PS knee replacement components: Recalled due to mislabeling.

When a knee implant fails, the only option is knee revision surgery. During knee revision surgery, the defective artificial knee is removed and is replaced with a new prosthetic knee. As with all surgeries, there are risks, including blood clots, infection and bone damage. There is no guarantee that the new knee will last.

Patients who experience premature knee replacement failure have a right to expect the manufacturer of the artificial knee to cover the expense of the knee revision surgery, the new knee joint, follow-up care, lost income, and any pain and suffering or disability caused by the defective knee joint. Salt Lake City defective medical device attorney James Esparza can help. To learn more about Utah defective medical device lawsuits or to schedule a free consultation, contact the James Esparza Law Firm at 800-745-4050.

James Esparza Explains How Your Utah Dangerous Implant Lawsuit Will Proceed

By | Personal Injury Attorneys | No Comments

In recent years, the pharmaceutical industry has made incredible progress with drugs and devices that can help people live normal, healthy lives. Chronic pain and seemingly insurmountable medical challenges have been solved with a single surgical implant. With a brand new artificial joint, a simple shunt, or pelvic sling, millions of people have been able to enjoy a pain-free existence.

Because of mounting competition in the pharmaceutical device industry, many manufacturers often rush to get the “next big thing” on the market. This can often result in insufficient testing, faulty design, or other negligent oversights in the device. If these products cause harm to consumers, the manufacturers should be held accountable for the damage caused.

How a Defective Medical Device Lawsuit Typically Works

Unfortunately, when a medical device causes one person to be injured or become ill, it has likely had a similar effect on thousands of individuals that also trusted the device. Because of this, the courts could potentially be flooded with thousands of very similar cases.

This is why most defective medical device lawsuits go through multidistrict litigation. In this process, the Judicial Panel on Multidistrict Litigation—founded in 1968 in response to an antitrust suit involving nearly 2,000 similar cases—will review requests to consolidate similar lawsuits before these cases go to trial.

This allows things that would be shared by the cases—such as discoveries and depositions—to be gathered under a single federal judge. After these proceedings are complete, the individual cases are sent back, or remanded, to the federal court district in which the case originated. The benefit to these multidistrict litigations is that settlements often occur during the consolidated, pretrial period.

Hiring an Experienced Utah Defective Pharmaceutical Device Attorney

James Esparza has over twenty-five years of experience representing clients in defective medical device litigation, protecting their rights and fighting for the compensation that they deserve.

If you or a loved one has suffered complications from a defective medical implant in Utah, such as a hip implant or transvaginal mesh, contact the James Esparza Law Firm at 801-272-9100, or toll free at 1-800-745-4050.

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So, What’s Wrong with Invokana?

By | Personal Injury Attorneys | No Comments

INVOKANA INJURIES

The new wonder drug Invokana® was controversial from the inception. The drug was approved in March 2013 by a vote of 10 to 5 of the FDA Endocrinologic and Metabolic Drugs Advisory Committee with panel members expressing concern over the risk of kidney damage, heart attack and stroke associated with the drug. In addition, some members of the panel were concerned about the “small volume of data” to support use of the product. Invokana®is manufactured by Janssen Pharmaceuticals a subsidiary of Johnson & Johnson. Invokana is a new drug but it the sponsor Janssen never demonstrated that it is superior to more affordable older drugs such as metformin. Invokana is novel because it works by inhibiting a normal kidney function, which is to return glucose to the blood and discard other undesirable substances.  Instead, the drug increases the amount of undesirable sugar in the urine. In the first year of adverse event reporting data, serious injuries to kidney function were reported this according to Quarterly Weekly.

WHAT ARE THE SIDE EFFECTS AND PROBLEMS WITH INVOKANA?

Unfortunately, there are some serious problems associated with the use of Invokana®. Four serious health issues are:

  • KIDNEY DAMAGE – has been associated with the drug.
  • HEART ATTACK – has been associated with the drug. When the FDA approved Invokana® they required the manufacturer to study the association of between the drug and heart attacks. The study is a 4 year study know as CANVAS which should be concluded in 2017.
  • KETOACIDOSIS – has been diagnosed with the drug and can be life threatening. It occurs when ketones increase in a person’s blood or urine. The Food & Drug Administration (FDA) has issued warnings about this condition in May, 2015 and December, 2015
  • AMPUTATIONS–On May 18, 2016, the FDA issued a safety announcement alerting the public and physicians about clinical trial results that found an increased risk of leg and foot amputations, mostly affecting toes, with the diabetic medicine Invokana® and Invokamet®. The amputations occurred about twice as often in patients treated with Invokana compared to patients treated with placebo.

QUESTIONS

The James Esparza Law Group is evaluating Invokana injury cases for a select group of clients. If you have questions and would like to discuss your situation, please contact us.  Click contact or call us toll free at 1-800.745.4050. We are here to help you. 

 

 

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Rise in Diabetes Medication Litigation

By | Personal Injury Attorneys | No Comments

The James Esparza law Group, through its innovative approach to the law, has been succussfully helping injured people for over 30 years, seek justice and rebuild their lives.The James Esparza law Group, through its innovative approach to the law, has been succussfully helping injured people for over 30 years, seek justice and rebuild their lives.The James Esparza law Group, through its innovative approach to the law, has been succussfully helping injured people for over 30 years, seek justice and rebuild their lives.

What You Need to Know About Counterfeit Drugs and Protecting Your Health

By | Personal Injury Attorneys | No Comments

A counterfeit pharmaceutical is any drug that has been made, altered, or inappropriately labeled by an unauthorized source. It is possible for brand name, generic, over-the-counter, and prescription-only drugs to be counterfeited.

Common issues with counterfeit drugs include:

  • None of the listed active ingredients
  • Too much or too little of active ingredients
  • Substituted active ingredient
  • No oversight or quality control
  • Contaminants
  • Expired ingredients
  • Altered or fake packaging

Why are counterfeit pharmaceuticals dangerous?

Individuals take medications to deal with specifically targeted health issues. Without proper oversight and quality control, even a drug containing the ingredients the packaging describes could harm the individual taking them.

Some of the risks of taking counterfeit drugs:

  • Worsening of existing medical conditions
  • Incorrect dosages
  • Allergic reactions and side effects
  • Hazardous substitutions and contaminants
  • May build undesired resistance to drug, as with antibiotics
  • Death

How likely is it that a Utah consumer will encounter counterfeit drugs?

In general, due to stringent regulations, counterfeits are much less an issue here than they are in developing countries. However, there have recently been three well-known cases of counterfeit drugs in the American market:

  • Lipitor – used to lower cholesterol
  • Procrit – which treats anemia
  • Alli – aids in weight loss

Unfortunately, counterfeit medication is a growing problem all over the world. Because of these recent breaches and their resulting pharmaceutical injuries, the FDA has dialed up their efforts to protect consumers from dangerous counterfeits.

What can I do to protect my family from pharma fraud?

Always purchase prescription medications from state-licensed pharmacies in the United States. State-licensed pharmacies are subjected to scrutiny and regulations, as opposed to sources from out of the country or on the Internet.

Be sure you know your drug. Inspect packaging and container seals to be sure they haven’t been tampered with. If you notice any changes in the appearance or performance of the drug, follow up as soon as possible with your pharmacist. He or she will be able to tell you if there have been any known manufacturing or distribution changes that may be responsible for the differences, or if there is genuine cause for concern.

While breaches are rare, they do occur. In the rare event of counterfeit pharmaceuticals ending up in a state-licensed pharmacy, remember that:

  • You are more likely to hear about the problem through a recall or the news before you are affected.
  • It will be easier to trace the breach back to the responsible parties.
  • You are more likely to find out what prospective health risks were involved with the fraudulent drug so you can obtain necessary treatments as soon as possible.
  • You are more likely to find out who is liable for any Utah pharmaceutical injury resulting from defective drugs.

If you’ve been injured because of a counterfeit or defective drug, you may be eligible to take part in a Utah drug injury lawsuit. To learn more, schedule a no-cost case review with compassionate Salt Lake personal injury attorney James Esparza. Call our offices today at 800-745-4050.

Utah Car-Bicycle Collisions & How to Avoid Them – Part 2

By | Personal Injury Attorneys | No Comments

Summer is here and it seems more cyclists are on the road every day. Unfortunately, more time riding your bike increases your risk of a Salt Lake City bicycle collision. It’s enough to keep some cyclists off the roads entirely.

The greater understanding you have of what causes bicycle accidents in Utah and what kind of measures you can take to avoid getting hit, the more you will be able to identify a dangerous situation and take measures to protect yourself before coming to harm.

In part one of this three-part series, we told you about two common auto-bike collisions in Salt Lake City. In this article learn two more ways car-bike crashes occur and what you can do to prevent them.

Types of Bicycle Collisions and How Riders Can Protect Themselves

3. Left-Cross

What happens:  A driver turns left at an intersection, either driving immediately in front of or directly into a cyclist crossing the intersection.

How cyclists can protect themselves:  Again, riding further to the left in your lane will make you more visible. Drivers who are about to make a left turn may be overly focused on oncoming motor vehicles, so cyclists riding very far to the right may not visually register in time. If you coast, a driver may think you are coming to a stop, so keep pedaling as you approach and ride through the intersection. If you haven’t already, learn how to perform an emergency quick turn to avoid getting hit in this scenario. Wear brightly colored clothing, a visibility vest, and a flashing light to make yourself more visible.

4. Drive Out

What happens:  A motor vehicle exiting a side street drives into or in front of a passing cyclist.

How cyclists can protect themselves:  This kind of accident happens most where there are a lot of driveways, side streets, and alleys, so take extra care when riding in areas where these are present. Ride further left so drivers approaching from a side street will be better able to see you in the road. Definitely avoid riding on the shoulder or any area right of the street edge line, as you will be significantly less visible. Again, wear brightly colored clothing, a visibility vest, and a flashing light to make yourself more visible.

For more information about collisions and evasive steering techniques, contact a Utah bicycle advocacy group or the local police department’s public outreach division.

To learn more about what Salt Lake bike injury lawyer James Esparza can do for you and your loved ones after suffering the consequences of a negligent driver, call toll-free 800-745-4050 today.

Utah Defective Medical Device Lawyer Explains Recalls & Safety Alerts

By | Personal Injury Attorneys | No Comments

It’s terrifying to learn that a medical device you’ve been relying on to assist you with a health issue may actually be causing you harm. With so many stories in the news, it’s possible that you may be feeling somewhat overwhelmed with information about hidden dangers in the marketplace.

The right knowledge can help you negotiate fear.

To help you better understand the U.S. Food and Drug Administration’s recall system, we’re going to break down some of the terms you may commonly see in conjunction with safety alerts on healthcare products. Knowing more may help you protect yourself or a loved one from harm, and it may help you better establish your eligibility for a faulty medical device lawsuit.

A recall occurs when a product in the marketplace presents a hazard to consumers or is not up to the manufacturer’s quality standards. The original manufacturer may initiate a recall independently, but if there is any degree of safety risk it is likely that the FDA will become involved.

Types of Recalls and Safety Alerts

  • Class I recall – This signifies the highest degree of safety risk to affected consumers. Using this product, or possibly even handling it, could cause serious injury or death.
  • Class II recall – Here, use of or exposure to the recalled product could cause minor injuries, or there is a very slight chance of injuries that are more extreme.
  • Class III recall – The hazard presented by the recalled product is minimal.
  • Market withdrawal – This happens when there is a problem with a product that isn’t subject to FDA penalties toward the manufacturer. An example of this would be when a third party tampers with a batch of products that weren’t under the protection of the maker or distributor. Here, the problem is handled by removing the product from consumer access.
  • Medical device safety alert – This may be coupled with a classed recall. It happens when a medical device is discovered to potentially cause substantial harm.

However, please remember that in any recall initiated for safety reasons, there is always a chance of a victim sustaining a serious injury.

Have you been injured by a recalled medical device? Are you unsure how to take the next step in obtaining compensation for your suffering? Reach out to a Salt Lake City personal injury attorney at the James Esparza Law Firm. To set up a free consultation, call 800-745-4050 today.

Know the Statute of Limitations on Defective Drug Liabilities for Utah Drug Injuries

By | Personal Injury Attorneys | No Comments

Pharmaceutical injuries do more than hurt the body. They can also damage the trust you place in the healthcare system. Determining who is liable for your injury and holding them accountable for the suffering you’ve endured is just as important to your recovery process as obtaining compensation for medical expenses and lost wages.

If you have decided to investigate your options for a Utah defective drug lawsuit, one of the first things you should know about is the Utah statute of limitations on drug liability claims.

The clock starts ticking the moment an injury is discovered.

“Statute of limitations” refers to the amount of time an individual has to file a claim for damages against the maker of a defective product or drug. Every state has its own set of laws governing the statute. In Utah, depending on the circumstances surrounding your case, the window of opportunity for a defective drug lawsuit expires:

  • Two years after an injury is sustained
  • Two years after an injury is discovered
  • Two years after the injury should have been discovered.

Let’s look at each option in closer detail.

  • Two years after an injury is sustained: With some defective pharmaceutical injuries, evidence of harm is immediate and unambiguously linked to the drug in question. For example, the manufacturer of a prescription painkiller neglects to include a label warning consumers against operating heavy machinery while taking the drug. Because of this, an individual is severely injured in an automobile accident. In this case, the statue of limitations would begin at the point of the accident.
  • Two years after an injury is discovered: Especially when dealing with drug interactions and the long-term effects of chemicals on the body, it may not be possible to know that an injury was sustained for quite some time. For example, a hormone medication causes the victim to develop breast cancer, but they are not aware of this until the diagnosis three years after they stopped taking the drug. In this case, the time limit for filing a lawsuit would begin when the cancer is diagnosed.
  • Two years after the injury should have been discovered: Some victims may avoid going to the doctor even after the symptoms of a Salt Lake City drug injury begins to manifest. In this case, Utah law will begin the statute at the point at which it should have become obvious to the victim that they needed to pursue diagnosis. For example, an asthma patient developed a lung disease from the medication in her inhaler, but refused to go to the doctor even after she’d been dealing with a harsh and persistent cough for several months. In this case, the statute began when the victim should have sought treatment for the cough.

What it boils down to is this: if you have been injured by a defective drug, do not waste any time. You have less time to recover damages than you might think. Seek the guidance of a Salt Lake drug injury attorney right away. To set up a no-cost consultation, call our office at 800-745-4050 today.

Utah Car-Bicycle Collisions & How to Avoid Them – Part 3

By | Personal Injury Attorneys | No Comments

For the final installation in this three-part series, we’ll take a look at two collisions that can be considered at least partly the fault of the cyclist. Keep yourself safe by knowing the law!

Protecting Yourself From Common Bike-Car Collisions

5. Against Traffic Crash

What happens:

  1. A cyclist, riding against traffic, is struck by a vehicle making a right turn onto the same street.
  2. A cyclist, riding against traffic, is struck head-on by a vehicle driving on the same road.

How cyclists can protect themselves: Know the law: never ride against traffic. It’s a blatant safety hazard and against Utah cycling laws. In other words, if you are injured while riding this way, it is very unlikely you will be able to win a bike injury lawsuit even if the driver was also breaking the law at the time of the collision.

6. Sidewalk Slam

What happens: A cyclist riding on the sidewalk comes to a crosswalk or entryway and isn’t seen by a driver turning right. The driver hits the cyclist at the crosswalk or entryway.

How cyclists can protect themselves: There are four basic ways to avoid getting hit this way:

  • Avoid riding on sidewalks! Though technically legal in the state of Utah, there are many exclusion areas, especially in Salt Lake City, where sidewalk riding is prohibited. Regardless, riding on the sidewalk is almost always a bad idea. There are always visibility problems for cyclists riding this way, in part because drivers don’t expect to see cyclists on the sidewalk. Keep in mind that many traffic safety studies have determined that riding on the sidewalk is at least twice as dangerous for the cyclist as riding in the street. You also pose a risk to pedestrians.
  • Know the area. If you know that a stretch of sidewalk doesn’t have many cross streets or driveways and doesn’t see a lot of pedestrian traffic, it might be good for occasional use. Just stay aware of any cross streets or driveways and check for traffic in all directions before crossing.
  • Maintain a low speed. Ride slowly enough to stop completely on short notice.
  • Visibility, visibility, visibility. Utah law requires you to ride with a white headlight and red tail light (or reflectors) that have a visibility distance of at least 500 feet from a half hour before sunset to a half hour after sunrise, as well as any time visibility is impared. Wear reflective gear and brightly colored clothing.

If you’d like to know more about Utah bike laws as well as effective safety techniques, connect with your local police department or a Salt Lake bike advocacy group.

A Salt Lake City bike crash is terrifying and potentially life altering. To learn more about obtaining justice for your injuries, contact the legal team of the James Esparza Law Firm. Call our offices now at 801-272-9100, or toll free 800-745-4050 to set up a no-fee consultation.

Loose Objects in Your Car Can Be Very Dangerous in a Utah Car Crash

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Moms carry a lot of stuff when they travel, and there is a good reason for this. Children need to be fed, entertained, cleaned, and kept happy – even when on the go. A typical mom-mobile may have a diaper bag, extra wipes, sports equipment, dance shoes, overdue library books, snacks, bottles, extra clothes, toys, etc.

Being prepared is great. But, the loose objects in your car have the potential to become dangerous projectiles if you and your children are involved in a Salt Lake City car crash.

According to the National Highway Transportation Safety Administration (NHTSA), everyday objects like cell phones, books, loose change, and toys are responsible for about 13,000 car accident injuries each year. Suppose your child’s backpack is sitting on the back seat. The average sixth-grader’s backpack weighs around 20 pounds. You are traveling at about 55 miles an hour when you crash. The backpack travels through the car with more than 1000 pounds of force. That is enough force to crush bones.

Even a lightweight object, like your spare change, can do significant damage at high speeds.

Obviously, you can’t store everything in the trunk. You need toys, snacks, and your cell phone handy.Salt Lake City car accident lawyer James Esparza offers these tips to help you and your children stay safe in the car:

  • Keep heavy items stowed in the trunk or under a cargo net.
  • Don’t forget that unsecured booster seats can also go flying. Keep the seat buckled in, even if your child isn’t in the car. Or, put it in the trunk.
  • When you choose items for your car, look for lightweight options. For example, instead of using wipes in a plastic case, use a soft, refill pack.
  • Give young children soft, light-weight toys like small stuffed animals and puppets to play with while you are driving.
  • If you use snack containers, attach them to the seat with short straps.
  • Any items that are not being used should be stowed away. Even your cell phone should be put in a storage compartment.

Keeping your family safe is important, but it’s hard to protect against reckless and irresponsible drivers. If you or your child is injured because of the negligence of another driver, you deserve justice and compensation. Contact the James Esparza Law Firm at 800-745-4050 to learn about Utah car accident lawsuits and your rights.

To Err Is Not Just Human: Robot Surgeons Make Deadly Mistakes

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We all make mistakes, but a mistake during surgery can have fatal consequences. This is one reason that doctors and hospitals have embraced robotic surgery.

Most robotic surgeries are done using the da Vinci Surgical System, which is manufactured by Intuitive Surgical. The da Vinci robot is used for hysterectomies, mitral valve repair, gastric bypass, gall bladder surgery, and the removal of thyroid and prostate cancers.

The da Vinci robotic system is made up of three components: a surgeon’s console with a joystick, a 3D vision system, and a robotic cart with four surgical arms. Three of the arms manipulate surgical instruments while the fourth holds a camera.

Robotic surgery is a lot like playing a video game – except there are real life consequences. The image from the camera is shown on the vision system. The surgeon then uses the console to control the arms. His movements are scaled down and any unintended wobble is filtered out. This allows the surgeon to make very precise cuts on a very small scale. Because the surgeon can operate on a smaller scale than is possible with the human hand, there is less blood loss, less scarring, and a faster recovery time.

Unfortunately, there is a problem with the system. In May 2013, Intuitive Surgical sent an urgent medical device notification to users of the da Vinci system. The notification warned that a defective part could cause tissue burns during surgery.

The defective pieces are the “-09” and “-10” versions of the EndoWrist Hot Shears Monopolar Curved Scissors. These instruments are used to cut and coagulate tissue during surgical procedures. The scissors may develop energy-leaking micro cracks when they are cleaned and sterilized. These micro cracks may be too small to be seen with the naked eye, but they can increase the risk of inadvertent burns.

Intuitive Surgical is not recalling the defective scissors because there is no suitable replacement. Instead, they are asking surgeons to be aware of the risk and take necessary precautions. These precautions include not applying electrical energy unless the instrument tip is in direct contact with tissue, and paying close attention to any tissue near the instrument shaft or wrist.

The defective part is not the only problem facing Intuitive Surgical. The medical device company is currently facing 26 da Vinci lawsuits filed by patients who were injured during robotic surgery.

Injuries associated with the da Vinci robotic surgery system include:

  • Surgical burns
  • Excessive bleeding
  • Punctured blood vessels or arteries
  • Punctured organs
  • Inflammation of the stomach lining
  • Intestinal tearing
  • Bowel injuries
  • Punctured or cut ureters
  • Vaginal cuff dehiscence
  • Sepsis

If you were injured during surgery with the da Vinci Surgical System, you may be eligible for compensation for your medical bills, pain, and other losses. To learn more about da Vinci surgical robot lawsuits in Utah, contact Salt Lake City defective medical device attorney James Esparza at 800-745-4050.

Good Night Sleep in Utah or Ambien Nightmare

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Imagine waking up in your car. You’ve been in an accident. Your last memory is taking an Ambien before going to bed. You have no idea where you are and how you got there.

According to the National Highway Transportation Safety Administration (NHTSA), Ambien is one of the 10 drugs most commonly found in impaired drivers. However, many of these drivers did not consciously intend to get behind the wheel. A side effect of Ambien is parasomnia, unusual behavior that occurs during deep sleep. Examples include sleepwalking, sleep eating, and sleep driving.

Ambien (zolpidem tartrate) is the most commonly prescribed sleep medication in the United States, and parasomnia is not the only side effect of the medication.

Side Effects of Ambien

  • Parasomnia: Parasomnia occurs when the patient engages in waking activities while in deep sleep. There have been instances of sleep eating, sleepwalking, sleep driving, and even sleep shopping in patients taking Ambien. There have been several reports of sleep sex. One man became violent and attacked his roommate. These behaviors can affect the safety of the patient and the safety of others. The patient has no memory of the behavior when he wakes up.
  • Hallucinations: Patients taking Ambien have reported vivid hallucinations. These hallucinations are both visual (seeing things that aren’t there) and auditory (hearing voices or sounds that don’t exist). As with parasomnia, there is a possibility that patients experiencing hallucinations could endanger themselves or others.
  • Dissociation: Patients taking Ambien have reported feeling a sense of physical dissociation or emotional detachment from everyday life.
  • Depression: Ambien is also linked to depression. Patients with no history of depression have suffered from severe depression after taking Ambien. Ambien may have been a factor in several suicide attempts.
  • Temporary insomnia: Although Ambien is a sleep medicine, patients have reported increased levels of insomnia when taking Ambien.
  • Ambien car accidents: In January, the US Food and Drug Administration warned that certain doses of Ambien may increase the risk of next-day car crashes, especially for women. Ambien is also linked to sleep driving crashes.
  • Addiction: Ambien can be addictive when taken on a regular basis.

These Ambien side effects have the potential to cause serious injury or death, especially in patients who are unaware of the risks associated with the drug.

If you have suffered an injury or accident as the result of taking Ambien, you may have a Utah dangerous drug claim against Sanofi-Aventis, the maker of Ambien. We urge anyone who has suffered serious Ambien side effects to contact a Salt Lake City pharmaceutical injury lawyer. To learn more about Utah Ambien lawsuits contact the James Esparza Law Firm at 800-745-4050.

Is Robotic Surgery Safe?

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Robotic surgery isn’t science fiction. Hospitals like Salt Lake Regional Medical Center, Ogden Regional Medical Center, and Intermountain Medical Center routinely use robotic systems to perform procedures such as hysterectomies, laparoscopies, and prostate removal. Doctors believe there are many benefits to using surgical robots. The robotic system allows the doctor to make small, precise movements. Even complex surgery can be performed through a tiny opening. This means less blood loss, less scarring, and a faster recovery time. The patient can return to normal activities much sooner than with traditional surgery.

The da Vinci surgical robot system is the only robotic surgery system used in the United States. It was approved for use by the FDA in 2000. In 2012, it was used for over 400,000 surgeries. Many of these surgeries were hysterectomies.

According to the American College of Obstetricians and Gynecologists, robotic surgery isn’t always the best option for patients and may not lower the risk of complications. However, hospitals pay over $2 million for a da Vinci system. They need to schedule surgeries in order to pay for their equipment. Because of this, women may be pressured to consider robotic surgery. Although most women do well after robotic surgery, serious complications can occur.

A California woman was hospitalized after her bowels fell out of her vagina following a robotic hysterectomy. A New York woman died after robotic surgery burned her artery and intestines. Other women have been left with perforated intestines or colons. The US Food and Drug Administration (FDA) shows more than 500 reports of adverse events, including death, associated with the da Vinci robotic surgical system since January 1, 2012.

The FDA is currently investigating the robotic surgery system in an attempt to determine if injuries are caused by defects in the machine or by surgeons who receive inadequate training.

Surgeons who use the da Vinci robotic system undergo online training to learn the vocabulary needed to run the machines. The machine consists of a surgeon’s console and a cart that holds four robotic arms.  One arm has a camera that gives the surgeon a stereoscopic view of the surgery. The other arms hold surgical instruments. The surgeon controls the arms using the console. The robot edits out any natural tremors, so the surgeon’s movements are translated into very small, very precise actions.

A surgeon will learn to operate the machine by practicing using the tools on inanimate objects. He will then perform a practice surgery on a cadaver or animal in order to receive his training certificate. However, there are no standards for how many procedures must be completed before a surgeon does a real operation. In addition, a surgeon is not required to practice every possible procedure.

Injuries may be a mixture of both inadequate training and mechanical defects. In May 2013, Intuitive Surgical recently advised doctors that a defective part on the EndoWrist Hot Shears Monopolar Curved Scissors could cause tissue burns. The FDA recently recalled 30 surgical robotic devices because the systems may not have been adequately tested before being sent to US hospitals.

Want can you do if you suffered serious injury as a result of robotic surgery? Contact a Salt Lake City defective medical device attorney. You may be eligible for compensation for your medical bills, pain and suffering, lost wages, and other losses. To learn more about da Vinci surgical robot lawsuits in Utah, contact the James Esparza Law Firm at 800-745-4050.

Dangerous Diabetes Drugs: Part 2, Januvia

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Controlling diabetes is a challenge. Sometimes diet and exercise are not enough, and medication is needed. Januvia (sitagliptin) is a once-a-day pill that helps lower blood-sugar levels in patients with Type-II diabetes.

Januvia is an incretin mimetic. This means that the medication is an artificial version of the natural hormone incretin. Incretin is the hormone that tells your body to release insulin after you eat. Other incretin mimetics include Janumet, Victoza, Byetta, and Bydureon.

In May, the US Food and Drug Administration announced that the agency was looking into new evidence that Januvia and other incretin mimetics can increase the risk of pancreatitis and pancreatic cancer.

Researchers looked at samples of pancreas tissue from deceased patients with diabetes who took medications like Januvia. They found that a significant number of patients showed evidence of inflammation from pancreatitis and pancreatic-duct metaplasia, a cell change that often precedes pancreatic cancer.

The study has not been published.

This is not the first evidence linking Januvia to pancreatic cancer. A 2002 study in the journalGastroenterology was the first of several studies to link Januvia to an increased risk of cancer. That study linked Januvia to a 2.7-fold increased risk of pancreatic cancer.

The risk occurs because of the way Januvia works. As Januvia lowers blood-sugar levels, it suppresses the production of the DPP-4 protein. DPP-4 prevents the production of insulin, but it also helps the body fight cancer by limiting tumor growth. Januvia may also be associated with other cancers, such as thyroid cancers.Cancer is not the only dangerous side effect associated with Januvia. Januvia may cause kidney damage and pancreatitis.

The FDA has already added information about pancreatitis to Januvia’s warning labels. Pancreatitis is an inflammation of the pancreas that can cause malnutrition, kidney failure, and pancreatic cancer and may be fatal if untreated. Patients taking Januvia are six times more likely to develop pancreatitis than the general population.

Patients with existing kidney problems are advised not to take Jauvia.

Patients who suffer pancreatic cancer, pancreatitis, or kidney failure after treatment with Januvia may be eligible for monetary compensation through a Utah Januvia injury lawsuit. To learn more about Januvia injury lawsuits, please contact the James Esparza Law Firm at 800-745-4050, and ask to schedule a free consultation with a Salt Lake City medication injury attorney.

Utah Patient’s Guide to Insulin Pump Lawsuits

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Insulin pumps are wearable medical devices that deliver a continuous dose of insulin to patients suffering from Type-1 or Type-2 diabetes. Diabetics who use insulin pumps are able to work, go to school, and enjoy daily activities without having to stop for an insulin injection.

Because they are convenient, insulin pumps are very popular. However, these medical devices are not without risk. If the patient does not use the machine correctly, there is a risk that he will receive too much or too little insulin. Most insulin pump injuries are the result of:

  • Lack of education or training on the correct use of the device
  • Failure to follow device instructions
  • Failure to monitor blood glucose during periods of high activity
  • Inappropriate patient selection by a healthcare provider
  • Mistakes in calculating insulin dose
  • Lack of medical follow-up
  • Lack of support during emergencies

A patient who receives too much or too little insulin may suffer from ketoacidosis, hypoglycemia (too low blood sugar), or hyperglycemia (too high blood sugar).

Insulin pumps, like all medical devices, can malfunction. There have been several medical device recalls associated with defective insulin pumps produced by the Animas Corporation or by Medtronic, Inc.

  • In November 2008, Animas issued a nationwide recall of insulin pumps after learning that a defect in the battery cap could cause the machine to reset and deliver the wrong dose of insulin.
  • In July 2009, Medtronic recalled the MiniMed Paradigm insulin pump. Defects in the tube delivering insulin could interrupt the flow of insulin to the patient.
  • In February 2011, Animas recalled a batch of malfunctioning cartridges that could leak and deliver the wrong dose of insulin.
  • In April 2013, the FDA recalled the Animas 2020 insulin pump because a defective component could trigger a false alarm or warning.
  • The FDA also warned that the Animas 2020 insulin pump has a software malfunction that will prevent the pump from working after December 31, 2015.
  • In July 2013, the FDA recalled MiniMed Paradigm Insulin Infusion Sets because fluid in the tubing connector could temporarily block the vents that allow the pump to properly prime, causing too much or too little insulin to be delivered.

Diabetics who were injured or experienced diabetic ketoacidosis, hyperglycemia, or hypoglycemia after using an insulin pump should discuss their case with a Salt Lake City defective device lawyer. They may be eligible for compensation for medical expenses, pain and suffering, and other damages through a Utah insulin pump lawsuit.

Salt Lake City personal injury attorney James Esparza takes defective medical device claims on a contingency basis. This means that you don’t pay unless he wins your case. To learn more, contact the James Esparza Law Firm at 800-745-4050.

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