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Eliquis, like Xarelto and Pradaxa, is part of a class of drugs known as New Oral Anticoagulants (NOACs). NOACs have entered the United States market in the past few years and have earned their respective manufacturers billions of dollars in sales in that short period of time.

dangerous-goods-labels-1190908-m.jpgThe reason for windfall sales is that patients who take conventional blood thinners like warfarin to reduce the risk of stroke and systemic embolism need to go their doctors frequently to have a blood test performed. This is needed because, while warfarin has been proven effective at treating patients at risk for these conditions, if medication levels are not checked often and adjusted when needed, serious side effects can occur.

Eliquis was marketed as new kind of treatment that does not require frequent monitoring and will let patients lead a normal life without the fear of developing serious side effects. While this is true for many patients, others will experience a severe internal bleeding condition, which can cause intracranial bleeding and hemorrhaging. If a patient develops one of these deadly conditions, there is not an approved cure to help those suffering from a bleeding disorder. In other words there is no antidote for the poisonous effects of Eliquis.
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Over the past decade, more and more people have started taking testosterone replacement therapy (TRT) drugs to treat the alleged symptoms of having a “low-t” count. Low-T is a term created by the marketing arm of drug companies intended to mean a person has a lower than average testosterone count. The symptoms of having a lower than average testosterone level, according to TRT drug manufacturers, are weight gain, tiredness, depression, loss of muscle definition, and other symptoms that are essentially the characteristics of normal male aging.

test-tubes-1-1416029-m.jpgAccording to a recent article from HCP Live, the American Urological Association has released a white paper warning physicians about problems with current practices in testosterone evaluation techniques. The first problem, as noted by the paper’s author, is there is no consensus among urologists and clinical pathologists as to what a low testosterone level is or means.

Many of the studies performed on testosterone levels involved research subjects who were over the age of 65. There is very little research on average testosterone levels of men with normal sexual and reproductive function. The definition of low testosterone levels used by the United States Food and Drug Administration (FDA) is a level below 300 ng/dl. However this is a definition used to establish when a patient suffers from hypogonadism.
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Each year over 330,000 hip replacement surgeries are performed in the United States. A total hip replacement surgery, known to doctors as arthroplasty, traditionally involves cutting through most of the patient’s muscle tissue, tendons, and bone surrounding the original hip joint. An artificial hip is then anchored to the bone using a long metal spike and possibly medical-grade cement.

untitled-1019029-m.jpgWhile elderly Americans and athletes may require a new hip due to their natural hip being broken, most patients are undergoing hip replacement surgery to alleviate the pain of arthritis. Doctors are telling prospective patients a new hip will allow them to essentially live as they did when they were years younger before experiencing any hip trouble.

The problem is many patients who undergo total hip replacement surgery will experience significant pain and suffering as result of defective artificial hip devices, which can loosen, deteriorate or completely fail within a short period of time following surgery.
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New drugs can yield billions of dollars for pharmaceutical companies. Because it takes many years to develop a drug, undergo clinical trials, and get it to market, drug companies will do virtually anything to get as much profit as possible for each new drug. This is especially true when considering that many proposed drugs will never make it through development, past clinical trials, or ever receive FDA approval. Some drugs are later found to be toxic or otherwise harmful to patients after being put on the market and then have to be withdrawn, while the manufacturer may be subjected to numerous lawsuits.
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Xarelto is a member of a class of drugs known as New Oral Anticoagulants (NOACs), along with Eliquis, and Pradaxa. These drugs were designed to replace older blood-thinning drugs such as warfarin, which requires frequent monitoring of a patient’s blood to prevent dangerous side effects. The problem with Xarelto and these other NOACs is they have been shown to cause serious bleeding disorders, including internal bleeding, intracranial bleeding, and hemorrhaging.

pills-1161455-m.jpgIf patient experiences a bleeding disorder after taking Xarelto, there is no approved cure for the disease, and the condition can be fatal. In other words, when a patient comes into the emergency with serious internal bleeding caused by Xarelto, there is not much doctors can do besides transfuse blood and try to make the patient comfortable.

According to a recent news article from the Madison Record, the makers of Xarelto now are being sued over the drug’s inability to clot in a timely manner. Bayer AG is the manufacturer of Xarelto and Janssen Pharmacutica (a subsidiary of Johnson & Johnson) is the marketing partner in the United States.
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Our Boston product liability lawyers recently discussed the arrest of NECC owners and employees in connection with the meningitis outbreak that occurred in 2012. The outbreak, which left 64 dead and caused more than 750 people to contract meningitis, was traced to contaminated steroids from the New England Compounding Center. The contamination occurred because basic safety protocols were not followed when the drugs were being compounded and packaged. attorney.jpg

Following the public health crisis due to the contaminated steroids, NECC went bankrupt. This left many victims turning to suing sister companies of NECC to try to recover compensation for their monetary and non-economic damages. It also left the NECC owners and employees without any consequences to face for what they had done. Now, however, the arrest of the owners and of some high level employees at the pharmacy could change things.
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According to a recent news article from NJ.com, the president and founder of OtisMed Corp. recently admitted to shipping hundreds of artificial knee products without FDA approval and pleaded guilty to criminal charges.

prison-979960-m.jpgAuthorities are reporting defendant pleaded to guilty to three misdemeanor fraud counts related to a shipment of over 200 artificial knee devices to surgeons throughout the United States with full knowledge the United States Food and Drug Administration had not approved them. Prosecutors stated defendant will be sentenced in March of 2015 and faces up to three years in prison.

OtisMed, which has since been acquired by Stryker Corporation, plead guilty to felony charge of distributing an adulterated medical device into interstate commerce and must pay approximately $40 million in fines and restitution. The company will also be required to pay an additional $41.2 million in civil settlements related to false claims litigation.
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Brinkley v. Pliva, Inc., a defective drugs case from the United States Court of Appeals for the Eighth Circuit, involved plaintiff whose doctor prescribed the brand-name drug Reglan to treat her Gastro Esophageal Reflux Disease (GERD). Plaintiff’s pharmacist substituted the generic drug metoclopramide, which was manufactured by defendant. This occurred in 2002.

medication pills.jpgPursuant to Federal Food Drug, and Cosmetic Act (FDCA), manufacturers of generic medications are required to prove their drugs are the same as the brand-name equivalent in design and labeling. Generic drug makers are not permitted to add any additional warnings.

In 2004, the United States Food and Drug Administration (FDA) approved the Reglan maker’s request to add two additional bold statements to the labeling warning the product should not be taken for more than 12 weeks. Defendant did not add these additional warnings to its generic product.
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In 2012, a meningitis outbreak was traced to a New England compounding facility. As our Boston product liability lawyers wrote at the time, multiple drugs were linked to the meningitis outbreak. DWI Arrest.jpg

More than two years later, many of the victims and their family members are still trying to get justice from those responsible. Separate from the civil lawsuits, prosecutors have also been investigating what laws were broken and whether criminal charges were appropriate. Now, CBS Boston has announced that 14 people were arrested for their role in causing this devastating public health crisis that affected so many victims throughout Boston and the rest of the United States.
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According to a recent news article from CBS Boston, the founders of a Framingham compounding pharmacy and 12 other employees have been charged with racketeering and second-degree murder.

caduceus-1219484-m.jpgCourt papers indicated the compounding pharmacy was only licensed to manufacture small numbers of specific drugs for individual patients. This is the same pharmacy that was linked to a 2012 meningitis outbreak allegedly caused by tainted steroids made by defendants. In that incident, 64 people died and 750 more became seriously ill after taking the drugs.

As part of an investigation into this defective drug manufacturing incident, authorities found records filled with obviously fake names of patients such as “Bud Weiser,” “Filet O’fish,” and “Baby Jesus.” There were instructions by company founders that the names used in official logs should resemble real names and not be obviously false, though it appears employees did not follow this advice. The fake names are part of an alleged plan to defraud the FDA and avoid reporting requirements.
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Boston, MA 02110
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Disclaimer – The settlements above are only a sample of cases represented by our office. Each case is different and the amount of a potential resolution of your case will vary considerably depending on a substantial amount of factors. Some case results were worked in conjunction with partnering law firms.

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