Minneapolis Personal Injury Lawyers, Attorneys - Pearson, Randall & Schumacher P.A.

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

Kenneth LaBore — Fri, 22 Oct 2010 21:50:20 +0000

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

Kenneth LaBore — Thu, 14 Oct 2010 19:11:32 +0000

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.

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)

FDA makes a decision on the fate of Avandia, restricting access to the drug

Kenneth LaBore — Fri, 24 Sep 2010 21:25:34 +0000

The United States FDA (the federal Food and Drug Administration) has announced that it will significantly restrict access to the diabetes drug Avandia for new patients. [1]

The pharmaceutical manufacturer of the drug, GlaxoSmithKline (GSK), is now required by the FDA to develop a “risk evaluation and mitigation strategy,” or “REMS” for to restrict access to Avandia. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications. Current users of Avandia can continue using the medication if they choose to do so, but should be aware of the significant risks involved.

The drug known as rosiglitazone, or by its brand name Avandia, or the combinations with Avandia of Avandamet or Avandaryl, used in managing and treating Type 2 diabetes mellitus has been the subject of personal injury lawsuits and continuing medical criticism across the United States. The use of this drug, Avandia (rosiglitazone), has been associated with an increased risk of serious cardiovascular events, such as heart attacks, congestive heart failure, stroke and resulting deaths.

The FDA has been continuing to investigate these adverse effects and evaluate the use of this medication. In July 2010, a joint advisory committee met with the FDA to further advise them about the effects of Avandia/Avandamet/Avandaryl (rosiglitazone) use, with the majority of the committee suggesting that federal action be taken to restrict or eliminate use of the drug due to the significant cardiovascular risks and death.

Now the FDA has made a decision to restrict access to that drug for only new patients and requires that these new patients be informed about the cardiovascular safety concerns associated with this drug. Physicians will also have to attest to and document their new patients’ eligibility for the medication and new patients will have to acknowledge they understand the risks and potential serious side effects.

If you or someone you know has taken this drug 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, 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. To contact the author, Attorney Nicole L. Kreklau directly, please send an email to nkreklau@prslegal.com, or call any of the attorneys at Pearson, Randall, Schumacher & LaBore, P.A. at 612-767-7500 or toll-free at 800-774-0757.

Footnotes/Links: [1] For the FDA press release announcing this decision, see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226975.htm

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)

Serious cardiovascular events and resulting deaths from Avandia (rosiglitazone), Avandamet or Avandaryl use continue as FDA considers removal of the drug from the pharmaceutical market

Kenneth LaBore — Thu, 02 Sep 2010 19:24:03 +0000

A drug known as rosiglitazone, or by its brand name Avandia, or the combinations with Avandia of Avandamet or Avandaryl, used in managing and treating Type 2 diabetes mellitus has been the subject of personal injury lawsuits and medical criticism across the United States.

The way Avandia (rosiglitazone) works is to help sensitize the body to insulin. At the time of its introduction to the market in 1999, Avandia (rosiglitazone) was considered a breakthrough medication for blood sugar/glucose level controls. Avandia (rosiglitazone) can also be combined with metformin, an anti-hyperglycemic agent that increases the effect of insulin. When metformin was combined with Avandia (rosiglitazone), it was sold as Avandamet. Another combination was Avandaryl, which contains the secretagogue, glimepiride, a substance that triggers insulin release.

The use of this drug, Avandia (rosiglitazone), has been associated with an increased risk of serious cardiovascular events, such as heart attacks, congestive heart failure, stroke and resulting deaths. These conclusions were based on concordant evidence from 3 independent metaanalyses performed.

Despite the known potential cardiovascular risks, Avandia (rosiglitazone) was kept on the market. In 2007, a study published in the New England Journal of Medicine, authored by Dr. Steven Nissen and Kathy Wolski [1], shows that patients on Avandia (rosiglitazone) had a 43% higher risk of a heart attack than those who took other drugs. The findings are based on the analysis of 42 clinical trials.

In November 2007, the FDA (the federal Food and Drug Administration) added a “black box” warning to the drug labels for Avandia, as well as Avandaryl and Avandamet, about potential cardiovascular risks, specifically the myocardial ischemia. Although the addition of a “black box” warning sounds impressive, the impact was relatively minimal. Avandia/Avandamet/Avandaryl (rosiglitazone) remained on many formulary drug lists and its use remained relatively stable.

Now in July 2010, a joint advisory committee met with the FDA to further advise them about Avandia/Avandamet/Avandaryl (rosiglitazone). The majority of the committee still agreed that the drug posed significant cardiovascular risk after analysis of 3 additional lines of evidence emerged through continued studies since 2007 and suggested that further federal action be taken by the FDA. [2] The ultimate decision about the fate of Avandia/Avandamet/Avandaryl (rosiglitazone) lies with the FDA in determining if the drug should be taken off the market. Any action by the FDA is expected to occur before the end of this year.

If you or someone you know has taken this drug 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, 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. To contact the author, Attorney Nicole L. Kreklau directly, please send an email to nkreklau@prslegal.com, or call any of the attorneys at Pearson, Randall, Schumacher & LaBore, P.A. at 612-767-7500 or toll-free at 800-774-0757.

Footnotes/Links:

[1] Nissen, Steven E., M.D., and Kathy Wolski, M.P.H. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. N Engl J Med. 2007;356:2457-2471. Click for link to June 14, 2007 volume: http://www.nejm.org/toc/nejm/356/24/

[2] Graham, David J., MD, MPH; Ouellet-Hellstrom, Rita, PhD; MaCurdy, Thomas E., PhD; et al. Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone. JAMA. 2010;304(4):411-418. Click for link to abstract of study: http://jama.ama-assn.org/cgi/content/abstract/304/4/411

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)

Improper Transfer in Nursing Home leads to Death of Priest

Kenneth LaBore — Thu, 27 Aug 2009 17:08:58 +0000

Minnesotan’s have seen in the news the loss of a local priest and victim of war injuries from Iraq, Father Tim Vakroc. Father Vakroc was critically wounded in a roadside bomb attack near Mosul in May 2004. Even though he survive the bomb blast he could not survive the poor care and treatment he received in a Minnesota Nursing Home, St. Therese whe he was injured in an improper transfer from his wheel chair to bed. Father Vakroc fell during the transfer and sustained an injury to his head, causing his death.
Unfortunately as an attorney that handles nursing home abuse and neglect cases in Minnesota I see this scenario too often. Most of the cases I see involved a fall from either transfer using less than the required number of people or from old and poorly maintained lift equipment. Both of these causes could be prevented. Nursing Homes need to invest in hiring the necessary numbers of well trained fully vetted staff. Nursing Homes also need to spend the necessary capital to maintain and purchase safe and modern transfer lifts for their residents.
The Father Vakroc case is so tragic and newsworthy due to his personal story and the completely avoidable nature of his accident.
For more information about the death of Father Vakroc at St. Therese see: August 25, 2009, WCCO: Nursing Assistants ‘Devastated’ in Vakroc Death and Star and Tribune: 2 Nursing Assistants Blamed for Priest’s Fall.This website is not to provide 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.
If you or a loved one has suffered an injury or abuse in a nursing home or other care facility that serves the elderly in Minnesota , please contact our firm for a free consultation and information regarding the obligations of the facility and your rights as a resident or concerned family member. To contact attorney Kenneth LaBore, directly please send an email to klabore@prslegal.com, or call Ken at 612-767-7503.