Recent Blog Posts in October 2009

A recent clinical trial shows that the cancer drug Gleevec (generic name Imatinib Mesylate) helps lessen the skin symptoms of Nephrogenic Systemic Fibrosis (NSF).

The study was conducted by Dr. Jonathan Kay of the University of Massachusetts Medical School, Worcester, MA.  Dr. Kay presented the results of his study on October 18, 2009, at the 2009 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals.

Participants in the clinical trial were given 400 mg of Imatinib Mesylate daily for four months.  The six subjects who completed the trial showed an improved modified Rodnan skin score (mRSS), which is a measurement of skin thickness at 17 different parts of the body.  But the improvements did not last after treatment stopped.  The mRSS scores of four of the six participants worsened after they stopped taking the drug.  The participants also experienced known side effects of Imatinib Mesylate, including nausea, vomiting and diarrhea.

A summary of the results of Dr. Kay’s study may be found HERE.

In May 2007, the FDA ordered all manufacturers of gadolinium-based contrast agents to warn of the risk of Nephrogenic Systemic Fibrosis (NSF) for people with kidney disease.  However, the FDA considered specifically targeting General Electric product Omniscan and recommending that it never be used on people with kidney failure.

The current warning required for gadolinium-based contrast agents applies to all brands of gadolinium-based contrast agents.  The warning does not state that gadolinium-based contrast agents should never be used for patients with renal failure, just that they only should be used if the diagnostic benefits outweigh the risk of developing NSF.

However, one FDA staff member recommended more.  In a recently released FDA document, FDA staff member Dr. Louis Marzella stated that “a contraindication for Omniscan is warranted in patients with severe renal insufficiency.”  The term “contraindication” means a recommendation against using a specific medical treatment under certain circumstances.

In the United States, GE’s product Omniscan has an approximately 30% market share of gadolinium-based contrast agents.  Bayer HealthCare’s product, Magnevist, is the market leader, with a 50% market share.  But despite Omniscan’s smaller market share, in the data reviewed by the FDA in 2007, there were nearly twice as many incidents of NSF among people treated with Omniscan as there were for people treated with Magnevist.

Today, the United States Court of Appeals for the Eighth Circuit heard oral argument on whether a failure to warn claim against a generic drug manufacturer is preempted.  We discussed this legal issue in a previous blog entry.

The case in which the 8th Circuit heard oral argument was Mensing v. Wyeth, Inc., et al., No. 08-3850.  Gladys Mensing took Metoclopramide, the generic version of Reglan.  She then developed Tardive Dyskinesia, an often permanent disorder that causes involuntary movements of the body, especially of the lower face.  Tardive Dyskinesia is now known to be caused by prolonged use of Reglan/Metoclopramide.  The district court dismissed Ms. Mensing’s claim on preemption grounds.

Gladys Mensing's attorneys are Michael K. Johnson and Lucia J.W. McLaren, both of Goldenberg & Johnson, P.L.L.C.  An audio recording of the complete oral argument is available HERE.

On October 1, 2009, the United States Judicial Panel on Multidistrict Litigation issued an order consolidating lawsuits involving YAZ, Yasmin and Ocella birth control pills.  The YAZ multidistrict litigation, or “MDL,” is assigned to the Honorable David R. Herndon, Chief Judge of the Southern District of Illinois.

All personal injury cases filed by women hurt by YAZ, Yasmin and Ocella in federal courts throughout the country will now be transferred to the Southern District of Illinois for coordinated or consolidated pretrial proceedings before Chief Judge Herndon.  This includes lawsuits brought by women who have suffered heart attacks, strokes, pulmonary embolism (PE), deep vein thrombosis (DVT), gallbladder disease, and death.  The YAZ MDL will also include a putative class action based on the advertising and marketing of YAZ.

An MDL is a special legal procedure used in United States Federal Courts.  It is designed to speed up the process of handling complex cases, including pharmaceutical litigation arising from dangerous drugs.  Cases included in an MDL are sent to a single federal court for pre-trial proceedings, but then sent back for trial to the courts in which they were filed.  For the many women injured by YAZ, Yasmin and Ocella side effects, this is a positive development, because it allows them and their attorneys to pool their resources against corporate giant Bayer, which manufactures YAZ and Yasmin.

We often hear that generic drugs are the same as name brand drugs, only they cost less.  But not according to drug manufacturers.  Drug companies are currently arguing to courts around the country that they have less of an obligation to warn of dangerous side effects for the generic versions of their drugs.  This means if you’ve been injured after taking a generic drug, you may have less rights than if you were injured after taking the brand name version of the same drug.

Earlier, drug manufacturers claimed that once the Food and Drug Administration (FDA) approved a brand name drug’s label, including its warning, a person injured by a drug side effect could not sue the manufacturer for failing to warn of the side effect.  The Supreme Court of the United States rejected this argument in a decision issued earlier this year.  Wyeth v. Levine, 129 S. Ct. 1187 (2009).

Despite this Supreme Court decision, drug manufacturers are now asking courts to bar similar claims brought by persons injured by generic drugs.  The drug companies argue that because the FDA has approved their generic versions of the drugs with labels that are the same as the labels first approved for the brand name version of the drug, they cannot change their labels without violating federal law.  They make this argument despite the fact that manufacturers of the brand name drug must keep their warnings up to date, and can still be sued when their warnings are inadequate and cause an injury.

At the moment, California residents are safe from this absurd argument.  Last September, a California Court of Appeal rejected the preemption argument made by a manufacturer of metoclopramide, the generic version of Reglan.  McKenney v. Purepac Pharmaceutical Company, No. F052606 (Sept. 25, 2008).  Ms. McKenney developed tardive dyskinesia from taking metoclopramide, after the risk of this side effect was downplayed in Purepac’s warning label.

Unfortunately, generic drug manufacturers are continuing their fight to take away the rights of consumers injured by generic drugs.  While federal courts in New Hampshire, Illinois, Oklahoma and Louisiana have ruled against the drug manufacturers, they have appealed, and the issue is now pending before federal appellate courts in the 5th, 6th and 8th Circuits.  Also, Senator John Cornyn (R-TX) has filed an amendment to the health care reform bill that would make the generic drug manufacturers’ argument federal law.

The optimistic sounding conclusion of a recent study on the safety of gadolinium-based contrast agents is misleading to the extent it fails to address the risk of Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD).  The study, published by members of the Department of Radiology at the Mayo Clinic, concludes that “gadolinium contrast agents are associated with a very low rate of adverse effects.”  Hunt, et al., Frequency and Severity of Adverse Effects of Iodinated and Gadolinium Contrast Materials: Retrospective Review of 456,930 Doses, AJR: 193, October 2009.

This conclusion masks the fact that occurrences of NSF were not counted as part of the study.  Incidents of NSF were not counted because the study defined “adverse effects” to only include side effects that occurred during or immediately after administration of the gadolinium-based contrast agent.

The study reports that of 158,439 doses of gadolinium contrast agents between 2002 and 2006, there were only 64 “cases of adverse effects” for gadolinium.  But the devil is in the details, in this case the study’s definition of “adverse effect”:  “Adverse effect was defined as a reaction occurring in the radiology suite during contrast administration or within 30 minutes of administration.” (Emphasis added)

This definition means that cases of NFS were not even considered in the study.  Why?  Because the symptoms of NSF appear later than 30 minutes after the administration of the gadolinium-based contrast agent.  Generally, NSF symptoms appear between several days and several months after injection of a gadolinium-based contrast agent.  Indeed, symptoms have been documented as appearing as long as 18 months later.

Even the cause of NSF does not occur within 30 minutes after administration of the gadolinium-based contrast agent.  This is because for a person with normal functioning kidneys, the contrast agent flushes out in approximately 90 minutes.  On the other hand, the people who contract NSF are those who still have the contrast agent in their system several hours later, when the gadolinium-based contrast agent begins breaking down.  It is only at this point, well after the 30 minute post-administration period considered in the study, that the toxic gadolinium is dispersed throughout the body.

An internet search for the phrase “MRI lawsuit” will pull up various law-firm and attorney-sponsored websites.  The term “MRI lawsuit,” however, is misleading.  Magnetic resonance imaging (MRI) itself does not cause nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD).

The real culprits are gadolinium-based contrast agents.  An injection of a gadolinium-based contrast agent  --  even just one  --  can cause NSF/NFD.  These contrast agents are used in some, but not all, MRIs.  If nothing was injected into you for your MRI, you did not receive a gadolinium-based contrast agent and therefore are not at risk of developing NSF.  Further, gadolinium-based contrast agents are also used in medical scans other than MRIs, despite the fact that the FDA has not approved their use in these treatments.  These unapproved uses include the following:  MRA, angiogram/angioplasty, CT scan (CAT scan), fistulogram, and venogram.