January 2012 Archives

Type Two Diabetes Drug Bydureon Approved by FDA

January 30, 2012

A new diabetes drug has made it to the market after a long delay by the Food and Drug Administration (FDA). The FDA approved Amylin Pharmacuetical's drug Bydureon just a few days ago. Bydureon is a once a week injection medication created to improve glycemic control in adults with type 2 diabetes in multiple settings. In 2010, the FDA rejected the drugs approval twice, requesting more studies be done, but Bydureon has finally been approved. Amylin is hoping with the new drugs convenient once a week use, it will gain an advantage over competitors. The company plans to sell the new diabetes drug in both the U.S. and Europe, they are expected to hit $1 billion in annual sales. (read full article)

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According to the American Diabetes Association, type 2 diabetes is the most common form of diabetes; it affects millions of Americans every day. With type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin, and insulin is necessary for the body to be able to use glucose for energy. Untreated patients with type 2 diabetes may experience constant fatigue, weight loss, blurred vision, increased thirst and several other serious side effects. Over the past few years, pharmaceutical companies have tried to find alternative options for diabetic patients when it comes to injections or oral medication and as of now, Amylin's Bydureon is the only type two diabetic medication for adults with a once a week dose. The company has tested the drug for any side effects and has clearly posted all possibilities on the label.

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Pizza Delivery Man Attacked in Dallas

January 25, 2012

Around 7:30 p.m. on Tuesday evening, a Domino's pizza delivery man was attacked as he was making a delivery to a Dallas apartment complex. The address where the delivery was made was a vacant apartment. When he arrived to his destination at the Sienna Palms Apartments in northeast Dallas, the delivery man was immediately attacked. He tried running, but unfortunately, he was gunned down and shot in the back. The delivery man's condition is still unknown and is currently being treated at Baylor Hospital. The suspect is still at large and police are currently investigating the incident.
Our thoughts and prayers go out to the victim and his family during this tough time.
Borchardt Law Firm currently represents the family of a Domino's pizza delivery man who was assaulted while making a delivery. Unfortunately, the injuries that were inflicted ended his life. A claim has been brought against the local franchise and the national corporation of Domino's Pizza alleging that the company failed to implement security policies and procedures on the safe delivery of pizza, particularly in unsafe areas. The attorney on the case, Geno Borchardt, stated, "they have numerous policies in place to protect the safety of their driver, but many of these policies were ignored. The victim of this incident was a good man. He loved his wife deeply and their life together was ruined because Domino's failed to follow safe procedures. The purpose of this lawsuit is to ensure that nothing this tragic ever happens to anybody else." (read full story)

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FDA Puts Johnson & Johnson Back In The Headlines

January 23, 2012

A warning letter sent by the U.S. Food and Drug Administration (FDA) puts Johnson & Johnson back in the headlines. On December 8, 2011 the FDA disclosed new information in a warning letter stating one of the company's subsidiaries sold multiple types of orthopaedic devices with out the required approval from regulators. The letter was based on an inspection of DePuy Orthaepedics from May 10, 2011 to June 7, 2011. The inspection showed DePuy had cleared 14 devices, mostly knee or hip systems, with out receiving proper approval from the FDA.

Unfortunately for Johnson & Johnson, this isn't the first time for DePuy to make the headlines for negative publicity. In August of 2010 Johnson & Johnson issued a recall for their ASR XL Acetabular Hip Replacement System after receiving hundreds of lawsuits due to the failing device. Before the recall, the company believed the ASR XL Acetabular system was used in more than 90,000 patients, creating a large amount of concern for the majority of those patients.

Since the ASR XL Acetabular recall, Johnson & Johnson has been closely watched by the FDA. With the most recent warning, the company is striving to maintain a positive image. After the warning letter was sent out in December, DePuy responded by stating that the cleared devices were custom-made for certain patients and did not need the regular required approval. However, the FDA argued otherwise stating that, "the fact that the final specifications are tailored to match a patient's anatomy does not preclude a clinical study or submission of a marketing application for the devices." The FDA also stated that DePuy failed to obey with quality regulations for the devices. DePuy has currently discontinued all custom-made devices and is trying to answer all questions that raise concern in the warning letter.

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Johnson & Johnson View $158 Million Settlement as a Win in Texas Case

January 20, 2012

Johnson & Johnson, the world's eighth-largest pharmaceuticals company, has made the news again, unfortunately, not for positive reasons. After the company had to recall their DePuy ASR™ XL Acetabular Hip System and the ASR™ Hip Resurfacing System in 2010, they faced hundreds of lawsuits involving failed medical devices and have continuously received more cases. Though, their most recent lawsuit was for something different.

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Risperdal, an anti-psychotic medication, also known as an "atypical anti-psychotic," is used to treat schizophrenia and symptoms of bipolar disorder. It may also be used to treat symptoms of irritability for autistic children. Risperdal was created by Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson, and has been on the market for several years. After years of patient use, complaints began to pile up claiming Janssen Pharmaceuticals Inc. made false or misleading statements about the safety, cost and effectiveness of the expensive drug. Patients also worried that the pharmaceutical company had been improperly influencing doctors to market the drug. Risperdal is not a cheap drug and has earned Johnson & Johnson close to a billion in profit.

Just last year a South Carolina jury found Johnson & Johnson guilty of overstating the safety and effectiveness of Risperdal, settling the case at $327 million. Shortly after, a Louisiana jury found the company guilty for violating that state's Medicaid fraud act settling the case at $258 million. When a Texas attorney general heard of the two cases he added up all the money the state's Medicaid program has spent on Risperdal, the attorney proposed Johnson & Johnson pay $579 million to the state's Medicaid program and another $500 million in penalties. On January 19th Johnson & Johnson reached a settlement of $158 million in a Medicaid fraud lawsuit for the state of Texas. For the company, this settlement was considered a win compared to their previous settlements and also considering the fact that the company has made billions from Risperdal. Though Johnson & Johnson lawyers took this case as a win, the company's continuous appearance in the news has negatively impacted their sales and reputation.

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