The diabetes drug Actos has a heightened risk of bladder cancer, especially among men. Men who developed bladder cancer after taking Actos may be able to file a lawsuit against the manufacturer of Actos to recover money damages for their injury.

There currently are three main venues where Actos lawsuits may be pursued, two in state courts, and one in federal court. The two state court venues for Actos bladder cancer lawsuits are Cook County, Illinois, and Los Angeles County, California. For Actos bladder cancer lawsuits filed in federal court, a multi-district litigation ("MDL") has been created, which means that all federal lawsuits will be transferred to the United States District Court for the Western District of Louisiana.

If you or a loved one developed bladder cancer after using Actos, the best place for your lawsuit to be filed will depend on a number of factors, including your state of residency. Because the litigation has just started, it is not clear which court will be best for your Actos bladder cancer lawsuit. You may call the Actos attorneys at DeCarli Law for a free, no obligation telephone consultation to discuss your legal options.

The Financial Times reported on Thursday that the United States Department of Justice is conducting a corruption probe of several major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Bristol-Myers Squibb, and Eli Lilly.  Specifically, the Department of Justice is investigating whether these and other companies have violated U.S. anti-bribery laws by making payments in other countries.

The Department of Justice is particularly interested in payments that may have been used to influence the reliability or integrity of clinical drug trials conducted in other countries.  This is significant because 80% of applications to the Food and Drug Administration for approval of drug marketing in the United States rely on at least one clinical drug trial conducted outside the U.S.

The FDA has issued a safety alert disclosing that Lamictal (lamotrigine) can cause aseptic meningitis.  Lamictal (lamotrigine) is a medication commonly used to treat seizures in children two years and older, and bipolar disorder in adults.  Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light.  In cases of meningitis, it is important to rapidly diagnose the underlying cause so that the correct treatment can be promptly begun.

The label change to disclose the risk of aseptic meningitis came after the FDA identified 40 cases of aseptic meningitis in patients who took Lamictal between December 1994 and November 2009.

The Food and Drug Administration (FDA) today ordered the recall of the male enhancement supplement Prolactis because it contains an undeclared drug ingredient.  Lab analysis has found that Prolactis contains Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED).  This makes Prolatis' an unapproved drug.  The Prolactis label does not disclose this ingredient.

Sildenafil is the active ingredient in Viagra.  Sildenafil's analogue, Sulfoaildenafil, may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Another favorable ruling was issued in the federal multi-district litigation (MDL), where the claims of some people suffering from nephrogenic systemic fibrosis (NSF) are being adjudicated.  On Friday, June 18, 2010, Judge Aaron Polster declined to change his earlier ruling on the admission of expert testimony, with one small exception.  We reported the earlier ruling in a previous blog entry.

Defendant GE Healthcare filed a motion asking the Court to reconsider its ruling on expert testimony issued on May 4, 2010.  GE Healthcare is the manufacturer of Omniscan, one of the most popular and dangerous brands of gadolinium-based contrast agents.  As Judge Polster explained in his order, GE Healthcare's motion for reconsideration challenged "every ruling by this Court that resulted in the partial or wholesale exclusion of the testimony or opinions of [GE Healthcare]'s expert witnesses."

Judge Polster declined to change his earlier ruling, with one narrow exception.  The previous order excluded in its entirety the testimony of Dr. Waymack, GE Healthcare's lone regulatory expert.  However, the plaintiffs had only sought to exclude a portion of his testimony.  The Court therefore modified its order to permit Dr. Waymack to testify on matters other than those that the plaintiffs asked to exclude.

Significantly, the Court observed that "the association between gadolinium-based contrast agents, severe renal impairment and NSF is virtually inescapable."  NSF, also known as Nephrogenic Fibrosing Dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues.  Gadolinium-based contrast agents are used in various medical procedures, including MRI, MRA, and CT scans (CAT scans).  As the Court's order observed, diabetics and others with severe kidney impairment are most at risk of developing NSF.

Important news for Californians suffering from nephrogenic systemic fibrosis (NSF):  California NSF lawsuits have been consolidated in Department 304 of the San Francisco Superior Court, with the Honorable Richard A. Kramer presiding.  This means if a case is filed anywhere in a California state court, and is not removed to federal court by the defendants, the case will be overseen by Judge Kramer.  You can learn more about California NSF Lawsuits HERE .

NSF is a progressive, debilitating disease caused by gadolinium-based contrast agents used in MRIs, MRAs, and other medical scans.  The people most likely to develop NSF are those on dialysis or with renal impairment, past kidney transplant recipients, or past liver transplant recipients.  Symptoms of NSF include:

• Swelling, thickening and tightening of the skin, especially on the legs or arms;
• Skin is hard, and feels "woody" or "leathery";
• The skin has an "orange peel" appearance;
• Hair loss on the affected area of the skin;
• Joints contract and become inflexible, especially the hands, wrists, elbows or feet, ankles, knees;
• Yellow papules in the whites of the eyes;
• Severely affected people may be unable to walk or close their hands.

• A warning that the elderly may be at particular risk of NSF due to impaired ability of their kidneys to clear gadolinium from the body.


• A statement that there is no evidence to support the initiation of hemodialysis to prevent or treat NSF in patients not already undergoing hemodialysis. 

• A statement that the type and dose of contrast agent used should be recorded.

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.