Articles Posted in Products Liability

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Invokana (canagliflozin) lawsuits have been popping up around the country. According to the claims brought against Janssen Pharmaceuticals and parent company Johnson & Johnson, these companies failed to warn of the possible serious side effects associated with Invokana use.

According to one complaint filed in the Eastern District of California, a plaintiff was proscribed Invokana to treat her type 2 diabetes and she took as directed. Sometime after taking it, she was hospitalized for diabetic ketoacidosis (DKA) – a condition where the blood becomes too acidic, and can lead to serious health complications, including death.

After learning of at least 20 reports of patients with type 2 diabetes who were hospitalized for DKA after taking the drug, this past May the FDA warned doctors and patients about a possible link between Invokana and DKA. According to the FDA, DKA is a “type of acidosis that usually develops when insulin levels are too low or during prolonged fasting,” which is why DKA is most common in patients with type 1 diabetes, and is usually accompanied by high sugar levels. The FDA noted that the reports they received of patients with type 2 diabetes suffering from DKA “were not typical” because their blood sugar levels were only slightly increased compared to the greater increases normally seen in typical cases of DKA.

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The US Food and Drug Administration (FDA) recently ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to continued violations of federal law. The FDA also simultaneously issued a safety communication recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternate reprocessing methods.

Endoscopes are devices used to look inside a body cavity or organ. AERs are units used to wash and high-level disinfect flexible endoscopes and scope accessories between patients. According to the FDA, Custom Ultrasonics’ AERs could not adequately wash and disinfect the endoscopes, resulting in deadly germs becoming trapped inside the scope and then transmitted to the next patient.

The FDA’s order could not come at a more appropriate time, as the problem with the spread of antibiotic-resistant pathogens by dirty endoscopes topped the 2016 list of health technology hazards put out earlier this month by ECRI, a nonprofit organization. The order also comes amid concerns about infection outbreaks linked to improperly cleaned duodenoscopes – a type of endoscope used in endoscopic retrograde cholangiopancreatography procedures.

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Arguments will be heard in the District of Minnesota as to whether lawsuits involving the Bair Hugger Forced Air Warming Blanket will be consolidated. Sterile operating rooms are usually kept cool in order to help surgeons, nurses, and attending technicians remain alert, and also reduce the chance for infection. The Bair Hugger is a warming blanket thought to have a positive impact on healing by keeping a patient warm during an extended surgical procedure and reduce the risk of infections. It is heated with forced air, which travels up a hose connected to an external heater located at the floor. Though, according to various lawsuits, the Bair Hugger may actually be causing infections.

The allegation is that pathogens such as Methicillin-resistant Staphylococcus aureus (MRSA) are picked up from the floor by the heater and transferred to the sterile surgical site, resulting in the potential for severe infection. This is especially problematic for orthopedic procedures, where infection can be introduced deep into the joint.

Various plaintiffs have alleged an infection claimed to have originated with the blanket, resulting in serious health consequences, including additional surgery. In one case, a woman who went in for a routine knee replacement claims she left with a MRSA infection that resulted in 27 additional surgeries and eventually cost her her right leg, amputated just below the hip. Dr. Scott Augustine, the co-inventor of the Bair Hugger – who is now promoting a warming blanket that does not use forced air – claims the Bair Hugger is a risk to patients. The company that now owns the Bair Hugger, 3M Company/Arizant Healthcare, Inc., disagrees.

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This past month, the U.S. Judicial Panel on Multidistrict Litigation (“MDL”) consolidated lawsuits filed by families claiming that the anti-nausea drug Zofran (Ondansetron) caused birth defects in their children, including but not limited to, cleft lip, cleft palate, club foot, and heart defects.

According to the complaints, GlaxoSmithKline (“GSK”), Zofran’s manufacturer, concealed a known risk of harm related to Zofran which, on-label, is used to treat nausea and vomiting resulting from chemotherapy.  However, doctors have long prescribed the drug off-label for severe morning sickness or hyperemesis gravidarum.  Whether GSK will litigate or settle the product liability lawsuits, now consolidated as MDL 2657, is unknown.

In 2012, GSK pleaded guilty and agreed to pay $3 billion for unlawful promotion of several drugs, including Zofran.  As part of the settlement agreement, GSK conceded that it knowingly promoted the sale and use of Zofran for conditions other than those for which its use was approved as safe and effective by the FDA, including hyperemesis or pregnancy-related nausea.  Since then, several studies have raised concerns about the risk of Zofran causing congenital malformation (birth defects), resulting in a growing number of families pursuing a Zofran lawsuit against GSK.

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According to an FDA announcement titled “Mars Chocolate North America Issues Allergy Alert Voluntary Recall On Undeclared Peanut Butter In M&M’s® Brand Milk Chocolate Theater Box,” there may be unlabeled allergens in two Mars brand products. Specifically, Twix Brand Unwrapped Bites Stand Up Pouch and its M&M’s Brand Milk Chocolate Theater Box.

On September 5, 2014, Mars Chocolate recalled its Twix Brand Unwrapped Bites Stand Up Pouch for reportedly containing undeclared peanuts and egg. Specifically, the affected product is Twix Unwrapped Bites in a 7 ounce, metallized golden package, with code date 421BA4GA60 and an expiration date of 03/2015. This lot was shipped and distributed to customers’ warehouses in Indiana, Texas, Oregon, Tennessee, and Connecticut, which then redistribute products for retail sale nationwide.

Mars Chocolate North America recalled the second product, the M&M Brand Milk Chocolate Theater Box, on September 19. The affected M&M’s boxes contain peanut butter M&M’s inside an M&M’s Brand Milk Chocolate Theater Box. The affected M&M’s theater boxes are 3.40 ounce brown, 3 inch by 6.5 inch cardboard boxes stamped on the right-hand side panel with a lot number and best before date. The affected boxes are identified by UPC #40000294764, and were shipped and distributed to several states, including New York, between May 8 and July 1, 2014.

People with allergies to peanuts and egg run the risk of serious or life-threatening allergic reactions if they consume these products and may have a product liability claim against the manufacturer for damages caused by improper labeling.
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According to, Goodyear Tire & Rubber Company has recalled approximately 41,000 tires manufactured in 2009. The recall covers Wrangler Silent Armor tire sizes LT235/80R17 LRE, LT325/60R18 LRE, LT275/70R18 LRE, LT265/70R17 LRE, LT245/75R17 LRE and LT285/70R17 LRD.

Apparently, some of the tires may experience partial tread area separation. In its letter to the National Highway Traffic Safety Administration, Goodyear said that “[u]se of these tires in severe conditions could result in partial tread separation which could lead to vehicle damage or a motor vehicle crash.”

If a tire’s tread were to separate while the vehicle was in motion, there could be a blow-out or loss of control, followed by injury to the vehicle’s occupants. If this happened in the State of New York, an injured driver passenger may have a claim against the manufacturer. This type of claim, for a dangerous or defective product, is known as a product liability lawsuit.
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According to, the body of Richard G. Fesko was found on Friday afternoon in a manure pit off of East Lake Road in Skaneateles, New York. The circumstances of Mr. Fesko’s death are under investigation. The family told police that Mr. Fesko was spreading manure the day he died.

Generally, manure is spread by a tractor equipped with a manure spreader. Customarily, the spreader is either attached to or pulled behind the tractor. Tractor attachments, including manure spreaders, can cause tractors to become unstable and tip or roll depending upon the terrain. If a tractor that does not have ROPS (roll over protection systems) flips or rolls, the driver can be thrown from the equipment and suffer serious injury and/or be crushed underneath the weight of the machine.

For more than twenty years, farm equipment manufacturers have known that ROPS save lives. While most manufacturers build their machines with ROPS, some have refused to do so — primarily because ROPS make equipment more expensive. In these circumstances, the manufacturer of the equipment may be liable for personal injury and/or wrongful death. Other equipment was manufactured and sold before ROPS became standard operating equipment. Even so, manufacturers have a duty to notify existing customers that safety devices have become available and can be retrofit to old machines. We discussed ROPS subsidies in our prior post entitled “New York Tractor Rollover Injury and Death To Decline With ROPS Subsidy.”

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“New York has more than 7,000,000 acres of farmland and almost 25,000 farm families. And farming in New York, especially on our hilly landscape, can be challenging,” said Syracuse personal injury lawyer Michael A. Bottar, Esq., of Bottar Law, PLLC, a team of New York product liability attorneys.

According to the National Safety Council, the leading cause of farmer death over the past 40 years has been tractor rollovers or overturns. Many of the tractors involved in incidents leading to serious injury or death were brought into the country long ago. Some of the tractors were imported through intended channels, including authorized United States dealers and distributors. However, some of the equipment is “gray market.” Gray market equipment is equipment manufactured for another market, such as Asia, but imported into the United States through private channels for resale and use.

However tractors made their way into the United States, and into the possession of New York farmers, many are not equipped with rollover protection systems (also known as ROPS). ROPS include seatbelts, as well as cabins or cages to protect an occupant from a crush injury should the equipment flip during use. “These machines may be unreasonably dangerous and, in turn, defective,” Bottar said.

This year, New York State will spend as much as $100,000.00 to equip tractors with ROPS by offering a discount or subsidy to farmers of $600.00 for a ROPS system to update equipment manufactured by, e.g., Kubota, Yanmar and Caterpillar. The telephone number for the ROPS hotline is: 1-877-ROPS-R4U.
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Topamax is a very popular antiseizure medication prescribed around the country to treat epilepsy and migraine headaches. Topamax also goes by the generic name, Topiramate.

On March 4, 2011, the Food and Drug Administration issued an official Safety Alert about Topamax. The Safety Alert entitled “Topamax (topiramate): Label Change – Risk For Development of Cleft Lip and/or Cleft Palate In Newborns,” provided that the FDA had changed Topamax from a Category “C” to a Category “D” pregnancy drug. Category “D” pregnancy drugs have the potential to harm a developing fetus.

Prior to March of 2011, the Topamax package insert did not expressly mention cleft palate in newborns as a potential side effect the drug. The newly revised package language provides that “TOPAMAX use during pregnancy can cause cleft lip and/or cleft palate,” “[p]regnancy: increases risk of cleft lip and/or palate,” and “[d]ata from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts).” Additional information can be found in our entry entitled “Syracuse New York Topamax Birth Defect Lawyers Report Risk of Cleft Palate.”

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“Bottar Law, PLLC will be investigating Topamax birth defect cases,” said Anthony S. Bottar, Esq., a New York product liability lawyer.

On March 7, 2011, the Food and Drug Administration announced a change in the pregnancy class of Topamax (Topiramate) from a category “C” drug to a category “D” drug. Category “D” drugs may present a risk of harm to a human fetus. The “Safety Announcement,” entitled “FDA Drug Safety Communication: Risk of Oral Clefts In Children Born To Mothers Taking Topamax (Topiramate)” provided that “[i]f you take topiramate during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their healthcare professionals about other treatment options.”

The FDA press release was based upon data reported by the North American Antiepileptic Drug Pregnancy Registry. According to the NAAED data, 1.4% of children born to mothers taking Topamax developed a cleft palate, as compared to 0.38 to 0.55% of children born to mothers taking different antiepileptic drugs, and 0.07% of children born to mothers without epilepsy treatment. Based upon this data, the risk of a developing a cleft palate while on Topamax is 2-3 times higher than the risk associated with similar drugs, and roughly 20 times the risk faced by the general population.

In May of 2010, Ortho-MacNeil was fined for illegally promoting Topamax. Read more in our entry entitled “Topamax Manufacturer Fined $6M By FDA For Illegal Promotion of Topiramate.
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