Product Liability Archives

A Large Number of Vehicle Recalls Expected in 2015

There were an unprecedented number of vehicle recalls in 2014, prompting many experts to call it “The Year of the Recall.” While the number of recalls in 2015 isn’t expected to match the record 63.9 million vehicles recalled in 2014, a recent study presented at the Automotive Warranty and Recall Symposium predicts another above average year.

According to the study, the main reason for this continued increased number of vehicle recalls is that the federal government is becoming more effective at identifying vehicle issues that need to be fixed via recall. Overall, this is a good sign for the improvement of vehicle safety moving forward.

Based in the report, it’s unlikely that we’ll see another year where one or two large issues dominate the recalls. Last year, defective Takata airbags comprised nearly 30% of all recalls, while GM ignition switch defects accounted for 20% of recalls. Instead, it’s expected that 2015 will see a larger number of recalls issued, but for smaller numbers of vehicles per recall.

The head of the National Highway Traffic Safety Administration (NHTSA) mirrored the sentiments expressed by the report. “I think we could actually see an increase in the number of recalls. The reality is that means your system is working….I’d rather have people be preemptive than waiting too long and making a mistake, because you can’t save those lives after they’re gone.”

The NHTSA received $126 million in fines and penalties from vehicle manufacturers in 2014. This figure is more than the total amount they’ve collected in all other years combined, providing further evidence that the NHTSA is cracking down on vehicle safety issues.

If you’ve been injured a car accident caused by a defective auto, you may be entitled to recover compensation for your damages. The attorneys at Golomb & Honik have decades of experience handling defective auto claims, and we have the vast resources to hold negligent auto manufacturers accountable for their actions.

Please contact Golomb & Honik using the form at the left side of the page or call 855-889-5389 today to schedule your defective auto consultation. We serve clients nationwide from our offices in Philadelphia, Pennsylvania.

Filed Under: Defective Products, GM Recall, Product Liability, Takata Airbag Recall

Judge Upholds $1.75 Million Punitive Damage Award in Transvaginal Mesh Case

7:11 pm by golombhonik1

A federal judge denied a motion to reduce the $1.75 million punitive damage award against C.R. Bard Inc., the manufacturer of the Avaulta Plus transvaginal mesh device used to treat pelvic organ prolapse and stress urinary incontinence. The judge ruled to uphold the large punitive damage award since evidence demonstrated that Bard knew their transvaginal mesh product was dangerous, yet did nothing about it.

According to evidence presented in the trial, Bard knew that the polypropylene resin used to manufacture their transvaginal mesh device was dangerous because Phillips company, the makers of the resin material, explicitly warned Bard that it shouldn’t be used in permanently implanted medical devices. Phillips even refused to sell the material to Bard due to these risks. However, Bard purchased the resin from a different company and intentionally kept this fact a secret from Phillips.

Bard eventually stopped contacting the new supplier directly because the supplier refused to sell the resin material to Bard after learning it was being used in a dangerous way. In addition, evidence demonstrated that Bard:

Ignored recommendations from doctors and researchers stating that additional trials were needed before taking this product to market
Disregarded adverse results obtained on the tests that were conducted on their transvaginal mesh product, and failed to communicate these adverse results to doctors

Based on all of this evidence, the judge ruled that the high punitive damage award was appropriate due to Bard’s reckless disregard of information demonstrating their product’s potential to harm patients.

Bard is still facing several other class action lawsuits associated with their defective transvaginal mesh device. If you’ve suffered an injury due to this defective medical device, you may be entitled to compensation for your damages. The attorneys at Golomb & Honik have decades of experience handling these complex claims, and we have the vast resources necessary to achieve a successful outcome through litigation.

Please contact Golomb & Honik using the form at the left side of the page or call 855-889-5389 today to schedule your defective transvaginal mesh consultation. We serve clients nationwide from our offices in Philadelphia, Pennsylvania.

Filed Under: Class Action, Defective Products, Product Liability

Granuflo Lawsuits Rising

5:10 pm by Admin

As of February 2015, more than 2,575 lawsuits are pending against Fresenius in the District of Massachusetts federally-filed GranuFlo MDL. The lawsuits claim Fresenius knew—or should have known—about the increased risk of death and serious injury associated with GranuFlo, and that those risks were concealed and misrepresented by Fresenius Medical Care. Lawsuits seek punitive damages in addition to medical expenses and pain and suffering, claiming Fresenius knowingly exhibited a deliberate disregard for the value of human life.

Dialysis concentrate GranuFlo was recalled by the FDA after it was determined the product could place patients at risk for cardiac arrest when administered or prescribed improperly. The manufacturer of GranuFlo, Fresenius Medical Care, has been charged with failing to adequately warn doctors or their patients that the product contains more of an ingredient which the body converts to bicarbonate than other brands. Overdoses of bicarbonate have been linked to heart problems, and while Fresenius warned its own clinic doctors about GranuFlo’s potential to cause cardiac arrest, they failed to warn outside clinics.

In fact, these outside clinics continued to use GranuFlo until an internal memo from the company was leaked. In early 2012, Fresenius voluntarily changed GranuFlo’s labeling, however they continued to market the product. The Class I recall for GranuFlo mandated by the FDA is the most serious type of recall available. A Class I recall indicates a reasonable probability that the use of the product could cause serious adverse health issues or even death.

Understanding the GranuFlo Recall

During hemodialysis, a medical machine filters waste and extra salt and water from the blood of the patient. This process involves neutralizing acid in the blood by supplying the patient with bicarbonate, an alkaline substance. Granuflo is a powder concentrate and NaturaLyte is its liquid counterpart. These two drugs are in a class known as dialysates, and are used during the dialysis process to neutralize the buildup of acids in the blood. The active ingredient in NaturaLyte and Granuflo is sodium dialysate, which is comprised of acetate and bicarbonate.

Reportedly, doctors failed to account for the additional bicarbonate contributed by GranuFlo when making the decision on how much bicarbonate to administer separately. High bicarbonate levels in the body can cause low blood pressure, cardiac arrhythmia, low potassium levels, and higher concentrations of carbon dioxide in the blood. According to a company memo, 941 patients treated at Fresenius Clinics experienced cardiac arrest during 2010 because of using GranuFlo.

Granuflo and NaturaLyte Lawsuits

The 2,575 lawsuits have been consolidated into an MDL in the District of Massachusetts. As the statutes of limitations grow near for those in some states, attorneys across the U.S. believe many more lawsuits will be filed. The first trial is scheduled for January 2016, with a second trial scheduled in February 2016. The currently filed lawsuits have in common the following allegations:

Fresenius knew of the dangers associated with Granuflo and NaturaLyte yet failed to warn consumers.
Fresenius intentionally placed patients in harm’s way through their refusal to warn health care providers of the risks of Granuflo and NaturaLyte.
Fresenius failed to warn consumers and health care providers of the significant risk of cardiac arrest and death associated with NaturaLyte and Granuflo.
Fresenius intentionally withheld risks of adverse cardiac events associated with NaturaLyte and Granuflo and did not report the risks to the FDA.
Fresenius failed to release adequate product-related warnings and instructions to health-care providers.

If you or a loved one has suffered injury or harm from the use of Granuflo or NaturaLyte, it can be beneficial to speak to a knowledgeable product liability attorney who can ensure you receive just compensation for your injuries.

Contact Our National Dangerous Drug Attorneys

If you suffered harm that you believe may have been caused by GranuFlo® and NaturaLyte® dialysis products, please contact the national dangerous medical device attorneys at Golomb & Honik, P.C. for a no-cost evaluation. Our lawyers have the resources to take on large pharmaceutical companies—and win. We believe in holding negligent drug companies responsible for their dangerous drugs and products and fight aggressively for justice.

To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

Filed Under: Blog, Drug Injuries, Product Liability

FDA Demands Cardiovascular Warnings on Xolair

12:38 am by Admin

The FDA has—once again—expressed concern over the potential cardiovascular risks associated with the drug Xolair. Xolair is an asthma drug, which has been on the market since it received FDA approval in 2003. The drug is manufactured and marketed by Genentech and Novartis, and currently makes over $1.5 billion each year. Xolair is administered via injection every other week, and used in place of steroid asthma inhalers.

Why is Xolair Still Being Marketed?

It is puzzling that Xolair is still on the market, still be used by asthma patients and still bringing in staggering amounts of money for the manufacturer, when as far back as 2009 the FDA indicated worry regarding the risks of heart attack and strokes in those taking Xolair. In September 2014, the FDA took further action, adding new warnings to Xolair’s product labeling which confirms the drug is associated with increased cardiovascular risks. While the warnings are not contained in a black box warning, they are listed in the adverse reaction section of the labeling, which is at least a step in the right direction. Xolair has a prior black box warning from 2007 that relates to the high risk of anaphylaxis, which can be extremely dangerous or even deadly. At least 48 adverse event reports related to anaphylaxis among those taking Xolair are documented.

Is Corporate Greed Trumping Patient Safety?

The source of the new warnings is data from a five-year study, along with twenty-five additional trials, which compared Xolair to a placebo. The trials and study determined Xolair raises the risk of heart attack, chest pain, pulmonary hypertension, heart attack, and blood clots. Unfortunately, due to the specific manner in which the five-year study was designed, the FDA is unable to say just how big those risks really are. While this, in itself, will certainly not make patients feel very secure about taking Xolair, the drug recently gained approval in Europe and the United States to treat chronic idiopathic urticarial—a skin condition marked by chronic hives. This latest approval for the use of Xolair prompted Novartis to predict its dermatology division would soon be bringing in more than $2 billion in annual sales.

Does Xolair Cause Cancer?

The risks of Xolair anaphylaxis was known prior to the drug’s FDA approval; in pre-marketing clinical trials, serious anaphylaxis occurred in approximately one out of every 1,000 patients, yet despite the risks, Xolair was allowed on the market. There has also been concern related to the correlation between Xolair and certain types of cancer. Prior to approving Xolair for use in the United States, the original FDA safety officer’s report included the wording, “Comparisons of malignancy rates suggest—but do not establish—an increased rate for Omalizumab (Xolair)-exposed subjects.” Apparently one clinical study showed the subjects taking Xolair experienced more malignancies than the control group. Cancers were seen in one out of every 200 subjects treated with Xolair—primarily breast cancer, skin cancer and prostate cancer.

National Dangerous Drug Lawyers

You have a right to seek justice if you or someone you love has sustained a heart attack or been diagnosed with cancer after taking Xolair. Drug companies who routinely put profits before people should pay for their negligence—and their unscrupulous behavior. To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

Filed Under: Blog, Product Liability

Sausages Recalled for Improper Labeling

6:12 pm by golombhonik1

Individuals with food allergies rely on accurate labeling to ensure that the food they eat is suitable for their diets. But when corporations fail to properly label products, the results can be disastrous. If you have suffered needlessly because a food company decided to prioritize profits over safety, Golomb & Honik can help you recover compensation for your damages.

According to Reuters, Interbay Food Co LLC is recalling nearly 5,000 pounds of pork sausages because they contain milk, but the labels did not include this information. The United States Department of Agriculture said that the Washington-based company is recalling one-pound refrigerated packages and five-pound logs of its British Pantry Ltd, British Style Bangers.

Food manufacturers have a legal responsibility to correctly label foods. The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2006 requires that foods containing major allergens declare these ingredients. Major allergens include:

Milk
Eggs
Fish
Crustaceans
Peanuts
Tree nuts
Wheat
Soy

The United States Food and Drug Administration (FDA) oversees food labeling and is responsible for ensuring the safety of the food we eat. About five percent of the American population suffers from a food allergy. If a company’s negligence has caused you harm, Golomb & Honik will fight aggressively to protect your rights and hold the negligent food manufacturer accountable.

Please contact Golomb & Honik today to arrange a free consultation. We serve clients nationwide from our offices in Philadelphia.

Filed Under: Product Liability

FDA Issues Warning over Dangerous Drugs in Weight Loss Supplements

6:06 pm by golombhonik1

Weight loss is a multi-billion dollar per year industry. While some products and services truly do help people lead healthier lifestyles, many are nothing more than modern day snake oil. And, in some cases, they are downright dangerous. If a dangerous drug or supplement has caused you pain and suffering, the attorneys at Golomb & Honik can help you recover the compensation you deserve.

The United States Food and Drug Administration (FDA) recently warned consumers to steer clear of three weight loss supplements that actually contain dangerous pharmaceuticals. The supplements LX1, Mezo, and Best Line Suplemento Alimenticio actually contain pharmaceutical ingredients, despite being labeled as herbal and all natural.

While the Food and Drug Administration tightly regulates pharmaceuticals, labeling on supplements is considerably looser and can seriously mislead consumers.

Mezo and Best Line Suplemento Alimenticio contain benzylsibutramine, a substance that was marketed as the weight loss drug Meridia until it was found to be especially dangerous for individuals with heart conditions.

LX1 contains a similar substance, known as 1.3-dimethylamylamine or methylhexanamine, which can raise blood pressure and cause cardiovascular problems, including heart attack.

The pharmaceutical injury attorneys at Golomb & Honik stand up to big drug companies every day. If you believe that a supplement or drug has caused you harm, let us fight for your rights.

Please contact Golomb & Honik today to arrange a complimentary case evaluation. We serve clients nationwide from our offices in Philadelphia.

Filed Under: Drug Injuries, Product Liability

FDA Goes Head-to-Head With Uncooperative Compounders

5:34 pm by Admin

Just this month, the FDA has been forced to ask yet another company to issue a recall for products which create significant safety risks to consumers due to sterility issues. The FDA issues between ten and thirty recalls each months, with about one per month for pharmaceutical drugs. According to an ABC news report in 2012, many believe the system in place for communicating these recalls may not sufficiently warn unsuspecting consumers. In fact, only about half of these recalls—those deemed the most serious, and known as Class I recalls—have official public notices issued.

Sterility Safety Issues Revealed

A Dallas compounding pharmacy is the target of the recent FDA mandate, which included an official public notice. NuVision Pharmacy, operated by Downing Labs, has received three FDA warnings over the past fifteen months regarding the safety of its compounded drugs. FDA officials are concerned that the medications from NuVision Pharmacy, which are currently in circulation, could be contaminated, presenting a significant safety risk of illness or injury. An inspection early this summer revealed a litany of problems associated with potential contamination.

The formal request letter sent by the FDA to Downing Labs and NuVision Pharmacy cites numerous manufacturing issues including:

Lack of scientific data supporting explanations for prior sterility failures
An inability to properly identify the reason for the failures
“Sterile” vials containing fibers and particles found by visual examination

NuVision Refuses to Comply with FDA Requests

The FDA issued two alerts last year regarding NuVisions’s sterility problems, prompting NuVision to recall HcG 5000 IU compounds. The alert stated that “in the event a sterile product is compromised, patients are at risk for serious and possible life-threatening infections.” Following the first alert, the FDA attempted (unsuccessfully) to persuade NuVision to recall additional products. NuVision essentially thumbed their noses at the FDA on their company website, stating they were not a drug manufacturer, therefore were not required to follow prescribed FDA manufacturing standards. Compounded drugs are not required to go through the FDA approval process, resulting in potential safety hazards to patients.

What is Compounding?

Compounding is a practice in which a pharmacist, physician (or a person under the supervision of a licensed pharmacist or physician) mixes, combines or alters the ingredients of a specific drug in order to specifically tailor the medication to a patient. Compounded drugs may be necessary when the health needs of a patient are unable to be met by an FDA-approved medication. An example would be a patient who was allergic to certain dyes typically used in a required medication. The compounding pharmacy would mix the drug without those dyes in order to avoid allergic reactions. An elderly patient who might be unable to swallow his or her medication in pill form could have it compounded as a liquid.

What Prompted the 2012 Drug Quality and Security Act?

In 2012, an outbreak of fungal meningitis causing dozens of deaths was tied to a compounded product, leading the FDA to ask Congress for legislation allowing the agency to bolster its regulatory oversight when dealing with noncompliant compounders. This request led to the Drug Quality and Security Act which created two classes of compounders—those who comply and those who refuse. The act requests that entities which compound sterile drugs register with the FDA as an outsourcing facility. This facility must meet certain conditions in order to be exempt from the FDCA’s approval requirements.

Further, the drugs must be compounded under the direct supervision of a licensed pharmacist. The second group is comprised of those compounders who refuse to register with the FDA. The compounders who fail to register (such as NuVision) are still subject to warning letters, product seizures and the possibility of criminal violations for distribution contaminated products. Such uncooperative compounders may see revenues drop due to consumer worry about drug safety, while the FDA continues to struggle under insufficient resources which would allow them to offer the protection consumers want and deserve.

National Dangerous Drug Lawyers

If you or a loved one has suffered any serious side effects from the use of a compounded medication, you have a right to seek justice. To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national class action lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

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Filed Under: Blog, Class Action, Product Liability

Johnson & Johnson Recalls Hysterectomy Device Due to Cancer Concerns

9:27 pm by golombhonik1

Medical product and device manufacturer Johnson & Johnson decided to recall a medical device that is utilized during hysterectomies and other uterine procedures after it received reports that the device might spread undetected cancer in patients.

The device is one that shaves tissue into small pieces that can be removed without the need for open surgery. The Food and Drug Administration (FDA) warned healthcare providers that the popular device may disperse malignant cancer cells. The FDA found that about 1 in 350 women who go into surgery and have the devices used may have some type of cancer that the medical device can cause to spread past the uterus. Additionally, the spread of these cells into the abdomen and pelvis can substantially decrease a woman’s chance of surviving the cancer.

The Ethicon unit of Johnson & Johnson is the largest manufacturer of the devices. It decided to recall these defective medical devices from the market due to the concerns over the potential to spread cancer. The company decided to pull the product until medical guidelines were created or new technologies were established to decrease this serious health risk.

If you have been injured by a defective Johnson & Johnson hysterectomy device, you may be entitled to receive compensation through a product liability lawsuit. The attorneys at Gomom & Honik have more than 30 years of experience handling these complex cases, and we will fight aggressively to protect your rights.

Please contact Golomb & Honik today to schedule a free consultation with our defective medical device lawyers. We serve clients nationwide from our offices in Philadelphia, Pennsylvania.

Filed Under: Defective Products, Drug Injuries, Product Liability

Common Acne Medications may cause Severe Allergic Reactions

2:59 pm by golombhonik1

Late last month, the US Food and Drug Administration warned American consumers that common over-the-counter acne treatments contain ingredients that may cause severe and possibly life-threatening allergic reactions in some people. Currently, most of these topical treatments do not warn of these risks. Under certain circumstances, a failure to warn can become the subject of a defective drug case.

The FDA cited a number of different acne treatments, including:

Proactiv
Neutrogena
Oxy
Aveeno
Clean & Clear
MaxClarity
Ambi

The FDA says since these products and others contain salicylic acid and benzoyl peroxide, they may cause a severe allergic reaction. The FDA isn’t currently certain whether the severe allergic reactions are caused by these ingredients or others in the acne treatments, but the agency says that, between 1969 and the beginning of last year, they have received about 130 reports from people who suffered a severe allergic reaction after using one of these products. No fatalities have been reported, but hospitalizations have.

A severe reaction to acne treatment may cause symptoms of throat tightness, facial swelling, fainting and shortness of breath.

If you believe you suffered an injury because of a defective drug, please contact Golomb & Honik for a free case evaluation and to learn about our experienced attorneys serving the areas of New Jersey and Philadelphia.

Filed Under: Product Liability

Group urges FDA to insist on Energy Drink Warning

9:51 pm by golombhonik1

The defective product attorneys at Golomb & Honik have handled many types of cases related to certain products and medications that failed to warn consumers of serious risks. When you don’t know of certain risks posed by a product you use, you could be left seriously injured as a result.

Earlier this month, a consumer advocacy group called the Center for Science in the Public Interest asked the US Food and Drug Administration to require warnings on energy drinks. According to Reuters, the CSPI believes this warning is necessary because certain high-caffeine energy drinks have been linked to 17 deaths since the fall of 2012, although there isn’t any evidence showing that these deaths were caused by the drinks for sure. Reuters does say that 34 people have died in the last 10 years after drinking 5-hour Energy, Monster or Rockstar.

As this issue develops, we’ll continue to evaluate whether the makers of these energy drinks and others may be liable for failing to warn consumers of the serious risks posed by certain ingredients and for people with certain health conditions. The FDA says its continues to study energy drinks as it has for several years.

If you or a loved one has been injured by a dangerous, defective drug, please contact Golomb & Honik for a free case evaluation. Our experienced product liability attorneys represent people from all over, including Philadelphia and New Jersey.

Filed Under: Product Liability

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