Ben Venue and Novartis Plant Shutdown | Drug Recalls and Drug Shortages for Critical Cancer Drugs

Drug Recall | Ben Venue, Novartis Shutdown | Cancer Drug Shortage

Gilman Law LLP, a leading national law firm with over 40 years of experience protecting the rights of victims, is investigating serious quality problems that have resulted in the closure of pharmaceutical manufacturing facilities operated by Ben Venue Laboratories and Novartis.  In the case of Ben Venue Laboratories, the shut-down of its Ohio manufacturing plant has resulted in the recall of the Fludara leukemia drug, as well as shortages of vital medications, including the life-saving cancer drugs, methotrexate and Doxil.  Quality problems at a Novartis plant in Nebraska are behind a recent recall of the DynaCirc CR blood pressure drug, possible shortages of prescription pain drugs, and recalls of various over-the-counter medications, including Excedrine and No-Doz.

The damage caused by the shortages of crucial medications and recalls of other drugs is yet to be disclosed.  However, the defective drug lawyers at Gilman Law LLP fear that many preventable and tragic injuries are likely to be the result.  If you or someone you love was injured as a result of contaminated or defective drugs made at the troubled Ben Venue or Novartis facilities, or if you have been impacted by the critical shortages of methotrexate, Doxil or other vital medications, we urge you to contact Gilman Law LLP to discuss what legal avenues might be open to you and your family.

Ben Venue Manufacturing Problems

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.  The Ben Venue shut down has impacted several critical, life-saving drugs that thousands of cancer patients must depend to stay alive.  These include:

• Doxil:  Doxil is a used to treat ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma. Prior to the Ben Venue shut-down, the Ohio plant was the world’s sole supplier of Doxil.  Since June 2011, the drug was virtually unavailable in the U.S., and 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.  To relieve the shortage of Doxil, the FDA announced in February 2012 that it had agreed to allow temporary shipments from India of similar drug called Lipodox, made by Sun Pharma Global.
• Methotrexate: Among other things, methotrexate is used to treat acute lymphocytic leukemia in children.  This form of leukemia is highly treatable with the proper medication.  The Ben Venue Ohio facility was one of only four major producers of this important, life saving drug. By early February 2012, some estimates said that only a week’s supply of methotrexate remained to meet U.S. demand for the drug. To help ease the shortage, 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. The FDA also hastened the approval of an application by APP Pharmaceuticals to manufacture methotrexate, an application that had languished since 2010.
• Fludara: Genzyme, a unit of Paris-based Sanofi, announced it was issuing a recall of 9,380 vials of the leukemia drug, Fludara, because of manufacturing deficiencies at Ben Venue’s Ohio facility, where it was produced.  The recall was issued because of concerns about the drug’s sterility, and while no adverse events had been reported in relation to the recalled Fludara, Genzyme said there was a “possibility for hypersensitivity reactions.”

Novartis Manufacturing Issues

In January 2012, Novartis voluntarily suspended operations and shipments from its Lincoln, Nebraska plant, after FDA inspectors issued a scathing review of the facility.  The problems cited by the inspectors included products being contaminated with foreign tablets and foreign objects, suspected tampering, products missing labels, discolored tablets and partial or chipped and broken tablets.  Like the Ben Venue situation, the Novartis shut-down resulted in drug recalls and shortages of important medications, including:

• Prescription Painkillers: The FDA warned healthcare professionals and patients that mix-ups may have occurred with opiate products manufactured and packaged for Endo Pharmaceuticals at the Novartis facility, including Opana, Opana ER, Oxymorphone hydrochloride tablets, Percocet, Percodan, Endocet, Endodan, Morphine Sulfate extended release tablets, and Zydone.  It was also anticipated that this situation would result in a shortage of these pain drugs.
• DynaCirc CR: In February 2012, GlaxoSmithKline recalled more than 394,200 bottles of DynaCirc CR, a blood pressure drug that was packaged at the Novartis facility citing the potential for tablet mix-ups at the plant.  As a result of the recall, the drug would no longer be available to patients, who would have to seek alternate treatments.
• OTC Medicines:  The problems at the Novartis facility also prompted the recall of four over-the-counter medications made there, including Excedrin, NoDoz, Bufferin and Gas-X Prevention.  There were concerns that recalled bottles might contain stray pills of other medicines, or broken or chipped pills.

Legal Help for Victims of Ben Venue, Novartis Drug Recalls and Drug Shortages

If you or someone you love was injured as a result of contaminated or defective drugs made at the troubled Ben Venue or Novartis facilities, or if you have been impacted by the critical shortages of life-saving drugs like methotrexate and Doxil, the Defective Drug Attorneys and Drug Recall Attorneys at Gilman Law LLP are here to help.  For a free evaluation of your case, please fill out our free consultation form or call us direct to speak with a drug recall attorney at (239) 221-8401.