Gilman Law Investigating Recent Drug Recalls and Shortages of Critical Cancer Medications

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Gilman Law LLP Praises Recent FDA Actions to Mitigate Shortages of Doxil and Methotrexate, Calls on the U.S. Congress to Pass Legislation to Address Frequent Shortages of Critical, Life-Saving Medications

Gilman Law LLP, a national law firm with offices in Florida and Massachusetts, is investigating quality issues at drug manufacturing facilities operated by Ben Venue Laboratories and Novartis that have resulted in not only drug recalls, but shortages of methotrexate and Doxil, both critical drugs that cancer patients rely on to stay alive. The defective drug lawyers at Gilman Law LLP fear that many preventable and tragic injuries are likely to be the result of these medication recalls shortages. Even though federal regulators have taken steps to mitigate the Doxil and methotrexate shortages, the true consequences of this serious situation are still being assessed.

Unfortunately, the Doxil and methotrexate shortages were not isolated events, but rather represent a growing problem that has affected supplies of some critical, life-preserving medications. According to the U.S Food & Drug Administration (FDA), in 2011 it tracked more than 250 drug shortages, which it says have been increasing steadily over the past five years, tripling from 61 in 2005 to 178 in 2010. Drug shortages can create significant public health concerns because they often result in the delay or denial of life-saving treatments for hundreds of people. Other shortages force providers to prescribe second-line alternatives, which may not be as safe or effective as a first-line treatment.

Last week, the FDA issued draft guidance that instructs pharmaceutical companies on the specific procedures for notifying the agency when life-savings medications are discontinued and encourages them to voluntarily report any supply disruptions that could lead to a shortage. While the agency’s action is commendable, more needs to be done to ensure that life-saving drugs are available for the patients who need them. According to a recent Reuters report, legislation that would force drug companies to inform the FDA about looming shortages has been deadlocked in the U.S. Congress since last February. Gilman Law LLP calls on both parties in Congress to put aside partisan concerns, and pass this legislation immediately in the interest of public health.

Novartis and Ben Venue Laboratories Plant Shut-Downs
Last month, a Novartis facility in Lincoln, Nebraska was shut down after an FDA inspection uncovered serious safety issues, including products being contaminated with foreign tablets and foreign objects, suspected tampering, products missing labels, discolored tablets and partial or chipped and broken tablets. According to a Wall Street Journal report, the Novartis shut down resulted in recalls of several over-the-counter medications, as well as the prescription blood pressure drug DynaCirc CR.

In November 2011, Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim GmbH, announced it was shutting down a manufacturing plant in Ohio, after Ben Venue was cited by both the U.S. Food & Drug Administration (FDA) and European Medicines Agency for “serious deficiencies” at the facility. According to a report from MSNBC, the shut-down resulted in severe shortages of Doxil, a drug used to treat ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma. The nationwide supply of methotrexate, used in children with a treatable form of acute lymphocytic leukemia, was also severely strained. According to an FDA enforcement report, the problems at the Ben Venue facility also prompted a recall of 9,380 vials of the leukemia drug, Fludara, because of concerns that its sterility could not be assured, and the risk that patients could suffer hypersensitivity reactions from potentially contaminated vials.

Last week, the FDA announced that it had finally taken steps to ease the shortages of methotrexate and Doxil. According to the agency, pharmaceutical company Hospira agreed to rush 31,000 vials - enough to last a month - of preservative-free methotrexate from its Australian plant to the United States. Hospitals began receiving the drug last Tuesday. The FDA also hastened the approval of an application by APP Pharmaceuticals to manufacture methotrexate, an application that had languished since 2010. In regards to Doxil, the agency also announced that it had agreed to allow temporary shipments from India of a similar drug called Lipodox, made by Sun Pharma Global.

While the FDA’s action no doubt comes as an enormous relief to patients and their families who rely on Doxil and methotrexate to treat their cancer, little will comfort those who were not able to receive these vital treatments as a result of the shortages. According to the report from MSNBC, Doxil was virtually unavailable in the U.S. since June 2011. As a result, cancer patients who need Doxil to survive were placed on waiting lists, had treatments deferred or have been forced to utilize other, sometimes less effective, therapies.

Gilman Law LLP is offering free, no obligation lawsuit consultations to anyone injured by a drug recalled because of the quality issues at the Ben Venue and Novartis facilities, as well anyone impacted by the Doxil and methotrexate shortages. To learn what legal avenues may be available to you, please contact Gilman Law LLP today. Free case evaluations are available at or by calling Toll Free at 1-888-252-0048.

About Gilman Law LLP

Gilman Law LLP, a leading national law firm with offices in Florida and Massachusetts, has been recognized for delivering successful results to their clients across a broad range of claims stemming from consumer product injury, mass tort, and class action lawsuits. For over 32 years, the Gilman Law LLP team of highly experienced lawyers has earned renown for tireless work on behalf of their clients on many of today’s most challenging and important legal issues.

Gilman Law LLP
Beachway Professional Center Tower
Suite 307
3301 Bonita Beach Road
Bonita Springs, FL 34134


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Kenneth G. Gilman, Esq.