Contaminated Cubicin® May Cause Serious or Deadly Injury

Published On: 12th August 2014

According to its website, “Cubist Pharmaceuticals, Inc. is a bio-pharmaceutical company focused on the research, commercial­ization and creation of pharmaceutical products that address unmet medical needs in the acute care environment.”  www.cubist.com.  One of its products is Cubicin®  (daptomycin for injection) 500 mg in 10ml single use vials.  Cubicin® is an intravenously administered prescription product for the treatment of skin infections and certain blood stream infections.  See Link

Cubist Pharmaceuticals, with an office in Lexington, MA, manufactures the Cubicin® .  On August 6, 2014, Cubist Pharmaceuticals announced that it was recalling certain lots of Cubicin® (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer.  FDA Recall .  Cubist is notifying customers by letter and by phone. 

The glass particulate matter poses a safety risk to patients.  The glass can cause thromboembolism or life-threatening pulmonary embolism.  Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. 

Cubist Pharmaceuticals has identified 9 specific lots of Cubicin® subject to the recall.  The lots are identified at the following web site: LOT IDENTIFICATION

The law firm of Pearson Randall & Schumacher, PA has represented individuals hurt by pharmaceutical companies for over 15 years. If you were administered Cubicin®   (daptomycin for injection) 500 mg in 10 mL single use vials and suffered an adverse event please call our office at 612-767-7500 and ask for Steve Randall.

Johnson & Johnson Laproscopic Power Morcellator linked to uterine cancer

Published On: 1st August 2014

Earlier this year, Johnson & Johnson suspended sale of its power morcellators and asked doctors worldwide to return the devices.

The devices, which are used to treat uterine fibroids an estimated 50,000 times each year in the U.S, have been linked to uterine cancer.  The FDA estimated that 1 in 350 women who used the power morcellators during fibroid surgery developed a rare form of uterine cancer.  According to the FDA:

Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

The Washington Post reported that on July 31, 2014 the company will attempt to withdraw all of the problematic devices:

J&J will take the further step of reaching out to customers to ask them to return the devices they have already bought in what it is calling “a worldwide market withdrawal” of all Ethicon morcellation devices that remain on the market, an Ethicon spokesman said.

If you had fibroid surgery utilizing a Johnson & Johnson/Ethicon laproscopic power morcellator, we invite you to contact an attorney with the law firm of Pearson, Randall & Schumacher, P.A. for a free consultation.

Benicar/Olmesartan Drug Warning

Published On: 31st July 2014


 

The law firm of Pearson, Randall & Schumacher, P.A. is currently investigating the serious side effects of Olmesartan (sold under the names of Benicar, Benicar HCT, Tribenzor, or Azor).  These side effects include chronic diarrhea with substantial weight loss after prolonged ingestion of Benicar.

Benicar was approved in 2002 by the FDA for treatment of high blood pressure.  In June 2012, researchers from the Mayo Clinic released a study of 22 patients who presented for unexplained diarrhea while on Olmesartan.  The results of the Mayo study were alarming.  14 of the 22 study participants required hospitalization because of chronic diarrhea.  The average weight loss was 39 pounds for each person in the study and stool frequency was extremely high as well, with an average of 6 evacuations per day.  The average length of time that study participants were on Olmesartan was 19 months.

The Mayo study and subsequent studies concluded that Olmesartan caused villous atrophy and mucosal inflammation in biopsies of the small intestines of study participants.  The good news is that all of the study participants were able to control their diarrhea once Olmesartan was stopped.  In addition, there are numerous substitutes for medications to control high blood pressure and those other medications do not cause diarrhea.

After the Mayo Clinic study and other studies (including the American College of Gastroenterology) showed the definite link between Olmesartan and diarrhea, the FDA order the drug manufacturer to add a stronger warning label on the drug in July 2013.

If you suffered chronic diarrhea while on an Olmesartan drug (Benicar, Benicar HCT, Tribenzor, or Azor)), we encourage you to seek medical attention first.  Then, we invite you to contact an attorney with the law firm of Pearson, Randall & Schumacher, P.A. for a free consultation.

Actavis (Fentanyl) Transdermal Pain Patch Recall Due to Dangerous Defects

Published On: 22nd October 2010

On October 21, 2010, the FDA notified healthcare professionals, directing a recall after laboratory testing identified an Actavis fentanyl patch that released its active ingredient faster than the approved specification. An accelerated release of fentanyl can lead to adverse events for patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), suspension of breathing and most seriously, death. The FDA recall includes several lots of fentanyl pain patches manufactured by Actavis.

These patches look similar to a medium sized, square band-aid, and contain a powerful prescription painkiller called fentanyl. Fentanyl pain patches are used to treat persistent, moderate to severe chronic pain, that requires continuous, around the clock delivery of medication, not managed by other means. The recalled fentanyl patches subject to the October 21, 2010 notice, is manufactured for Actavis by Corium International in the United States.

This is not the first time concerns with fentanyl pain patches have caught the attention of the FDA. In December 2009, the FDA put out its second warning in two years about the dangers of misusing the powerful drug and warned of defects in patches of other manufacturers such as Mylan and Johnson and Johnson (Durgesic). At that time, it was estimated that two patches out of every million sold and included in a recall have a defect that causes the leak. Now on October 21, 2010, the FDA issued a new recall on additional patches.

If you know someone has died as the result of using a fentanyl pain patch sold by Actavis, Mylan, Johnson and Johnson (Duragesic) or others, please contact our firm for a free consultation and information regarding a potential claim. Pearson Randall, Gempeler, Schumacher & LaBore, P.A. is a law firm that practices in the areas of personal injury, consumer protection and national pharmaceutical litigation, and is working on issues relevant to this case. Contact Attorney Gale D. Pearson at gpearson@prslegal.com or call 612-767-7500 or toll free at 800-774-0757.

This website information is not intended to provide medical or legal advice, as each situation is different and specific factual information must be obtained before an attorney is able to assess the legal questions relevant to your situation. In addition to providing related information, this blog may also be considered an advertisement for legal services.

Pearson, Randall, Gempeler, Schumacher & LaBore, P.A.

AGGRESSIVE AND COMPASSIONATE ATTORNEYS HELPING FAMILIES RECOVER
FROM BAD ACCIDENTS, BAD DRUGS AND BAD PRODUCTS.

612-767-7500 or 800-774-0757 (toll free)

RECALL OF OCTAGAM IGIV (Immune Globulin Intravenous) USED IN IMMUNODEFICIENCY INJECTIONS

Published On: 14th October 2010

On August 20, 2010, Octapharma USA Inc. recalled ALL lots of OCTAGAM (Immune Globulin Intravenous (human) 5% Liquid Preparation) currently in the United States. This voluntary market withdrawal was performed pending determination of the cause of strokes and death following use of this product. The FDA reported an unacceptable increase in the number of strokes during or following an injection of the defective lots of IGIV.

Octagam IGIV (Immune Globulin Intravenous) is a sterilized solution made from human plasma. It contains the antibodies to help the human body protect itself against infection from various diseases. Immune globulin is used to treat primary humoral immune deficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies, and to reduce the risk of infection in individuals with poorly functioning immune systems.

If you or someone you know has received this injection and suffered an injury or death as a result, please contact our firm for a free consultation and information regarding a potential claim. Pearson Randall, Gempeler, Schumacher & LaBore, P.A. is a law firm that practices in the areas of personal injury, consumer protection and national pharmaceutical litigation, and is working on issues relevant to this case. Contact Attorney Gale D. Pearson at gpearson@prslegal.com or call 612-767-7500 or toll free at 800-774-0757.

This website information is not intended to provide medical or legal advice, as each situation is different and specific factual information must be obtained before an attorney is able to assess the legal questions relevant to your situation. In addition to providing related information, this blog may also be considered an advertisement for legal services.

Pearson Randall, Gempeler, Schumacher & LaBore, P.A.

AGGRESSIVE AND COMPASSIONATE ATTORNEYS HELPING FAMILIES RECOVER

FROM BAD ACCIDENTS, BAD DRUGS AND BAD PRODUCTS.

612-767-7500 or 800-774-0757 (toll free)

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