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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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On November 5, 2015, Michael A. Bottar completed the final leg of a six-city CLE tour for the New York State Academy of Trial Lawyers titled “Say What?  Using, Misusing and Abusing the Hearsay Rules.”  Bottar chaired the statewide CLE, which was attended by hundreds of attorneys in Syracuse, Albany, Rochester, Buffalo, New York City and Long Island.  

A DVD of the lecture and accompanying print materials may be obtained from the New York State Academy of Trial Lawyers members-only CLE library.  To join the New York State Academy of Trial Lawyers, click here.

CLE description:

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Formerly Samantha C. Robbins, Ms. Riggi’s practice focuses on cases sounding in medical malpractice, workplace accident, motor vehicle, product liability, wrongful death and severe personal injury matters.

Ms. Riggi is a graduate of Syracuse University College of Law, and Siena College, magna cum laude. She is a past member and Associate Editor of the Syracuse Journal of International Law and Commerce, which published her note “Who’s Your Daddy: The International Market for American Sperm.” In addition to the Journal of International Law and Commerce, she is a past member of the Syracuse University College of Law Moot Court Honor Society, and was inducted into The Order of Barristers.

While in law school, Ms. Riggi won a number of trial and appellate competitions, including the 42nd annual Mackenzie Hughes LLP, Edmund H. Lewis Appellate Advocacy Competition (winner; best final round advocate; highest-scoring brief), the 41st annual annual Mackenzie Hughes LLP, Edmund H. Lewis Appellate Advocacy Competition (winner; highest-scoring brief), and the 36th annual Lionel O. Grossman Trial Competition (winner)

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On October 16, 2015, Michael A. Bottar, a partner with Bottar Law, PLLC, received the New York State Academy of Trial Lawyers “ROCKSTAR” award for his commitment to providing high-quality continuing legal education to attorneys throughout the State of New York.

The Academy’s ROCKSTAR award has been issued to a handful of members who have provided legal instruction on at least thirty (30) occasions.  Since 2012, Bottar has lectured more than 1,000 attorneys at seminars held in Syracuse, Albany, Rochester, Buffalo, New York City, and Long Island, as follows:

  • Say What? Hearsay Rules In New York (Syracuse 2015)
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According to the United States Supreme Court, the two-year and six-month time limits in section §2401(b) of the Federal Tort Claims Act (FTCA) “are just time limits, nothing more. Even though they govern litigation against the Government, a court can toll them on equitable grounds.”

Under the FTCA, “the United States shall be liable . . . in the same manner and to the same extent as a private individual under like circumstances, but shall not be liable for interest prior to judgment or for punitive damages (28 U.S.C. §2674).”  The FTCA is a limited waiver of the United States’ immunity from tort liability and, therefore, the language of the Act is strictly construed.

Relevant to this summary update is the FTCA’s statute of limitations language which provides “a tort claim against the United States shall be forever barred unless it is presented in writing to the appropriate Federal agency within two years after such claim accrues or unless action is begun within six months after the date of mailing, by certified or registered mail, of notice of final denial of the claim by the agency to which it was presented (28 U.S.C. §2401(b)).”

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On January 15, 2015, Bottar Law, PLLC was among fifteen New York law firms (the only firm in upstate New York) to receive a 2014 Litigator Award for extraordinary achievement within the fields of medical malpractice, birth injury, products liability, catastrophic injury and personal injury litigation.

According to the Trial Lawyers Board of Regents™, the annual Litigator Awards stand as nation’s most coveted symbol of litigation Achievement, and recognize trial lawyers that have attained extraordinary litigation achievement within one or more of 72 pre-defined practice specialty categories.  To be award eligible, nominees must prove achievement of litigation performance benchmarks that includes not less than:

  • two verified verdicts or settlements of at least $1 million in any one practice specialty category within the preceding 5 year period prior to nomination, or
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On November 7, 2014, Aaron J. Ryder spoke in Syracuse and Albany for the New York State Academy of Trial Lawyers at a CLE titled “Cutting the Gordian Knot, Resolving Liens and Reimbursement Claims.”

CLE description:

Few things are more frustrating to litigators than a client’s Medicare, Medicaid or ERISA claimed right of lien or reimbursement.  Often the lien and reimbursement claims from third party providers derail settlements, and leave clients and their attorneys in limbo.  Attorneys frequently report that they spend as much time negotiating these claims as they do litigating the underlying case. This seminar will focus on this practical problem and the best way to avoid or surmount it. 

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