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What Prop. 46 Would Fix

The measure would reset California’s cap on noneconomic damages recoverable in medical malpractice cases based on inflation, meaning that the $250,000 cap, imposed in 1975, would become a cap of $1.1 million. 

Noneconomic damage caps— which restrict damages for pain, suffering and loss of enjoyment of life but not damages for lost wages, rehabilitation costs or medical bills— are admittedly complicated. Not surprisingly, then, misperceptions about 46 abound. Stanford law professors who study accident law and liability reforms, seek to clarify the issue surrounding Prop. 46.  


California Counties Sue Drug Manufacturers Over Narcotics Marketing

Orange and Santa Clara counties filed suit Thursday against five of the world's largest drug manufacturers, accusing them of creating a population of addicts to reap blockbuster profits on narcotic painkillers.

Drugs such as Oxycontin and Percocet are commonly prescribed for severe pain. The Orange County District Attorney filed a lawsuit against several pharmaceutical companies, claiming the companies are intentionally misrepresenting to doctors and patients just how addictive these prescription painkillers can be.

Orange County Health Care Agency officials say there were 291 deaths in 2012 related to overdoses. That's almost 40 percent of all the accidental deaths in the county.

One of the companies,
Janssen Pharmaceuticals, issued a statement: "Janssen is committed to ethical business practices and responsible promotion, prescribing and use of all our medications. We're currently reviewing the complaint."

Boehringer Ingelheim Settles Pradaxa Lawsuits for $650 Million

Pharmaceutical maker Boehringer Ingelheim agreed to settle lawsuits over the blood thinner drug dabigatran (Pradaxa). Under the terms of the settlement, the German company will pay $650 million to settle 4,000 suits brought by patients and survivors who claim "Boehringer failed to properly warn them that the drug, which is used to prevent blood clots, caused serious and sometimes fatal bleeding that could not easily be reversed." The Institute for Safe Medication Practices implicates the drug in "more than 1,000 deaths." The company stands by its medication, saying in a statement "Time and again, the benefits and safety of Pradaxa have been confirmed." 

The FDA approved Pradaxa in 2010 for use in patients at risk of stroke due to atrial fibrillation or other irregular rhythms. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011. The settlement follows a $931,000 fine assessed against the company in December for failing to preserve documents related to the drug's development. Pradaxa generated revenue of $1.63 billion last year.

Recent Verdict Good News for Accutane Ulcerative Colitis Victims

A recent $1.59 million verdict for a woman with ulcerative colitis is good news for thousands of Accutane victims who have filed Accutane lawsuits claiming the acne drug failed to warn of colitis risk.

A New Jersey jury found that the Accutane manufacturer, Hoffman-LaRoche and Roche Laboratories, failed to provide Kamie Kendall Ries from Salt Lake City with adequate warning of the health risks. Reis was prescribed Accutane in 1998, when she was just 12 years old and later had her colon removed after developing Accutane Ulcerative Colitis.

More good news for Accutane colitis victims is that the jury found the failure of adequate warnings extended to 1998, when Ms. Ries was prescribed Accutane. 

Roche intends to appeal the verdict. Buchanan said that plaintiffs (of which approximately 7,000 Accutane cases are pending in New Jersey and elsewhere) will seek to streamline the litigation through motion practice and trying more cases together in the future.

Accutane was pulled from the US market in 2009. Roche said its product was removed due to a low market share and the high cost of defending personal injury lawsuits by Accutane consumers. Accutane is still available in the UK and other countries, and the generic version of Isotretinoin is still available in the US.

Pfizer Recalling Effexor Due to Possible Contamination

Pfizer, Inc. is recalling the anti-depressant Effexor because it may have been contaminated with a heart drug. Interaction between the two could be fatal.

The recall affects 30-count and 90-count bottles of Effexor XR 150-milligram extended release capsules and 90-count bottles of Greenstone-branded Venlafaxine 150-milligram extended release capsules.

According to a press release, a pharmacist had reported that a bottle of Pfizer's Effexor XR contained one capsule of Tikosyn. There have been no other reports, but three lots that were packaged on the same line are being voluntarily recalled as a precaution.

The use of Tikosyn by someone taking Effexor or Venlafaxine could have "serious adverse health consequences that could be fatal," the press release states.

Patients should watch out for signs of abnormal heartbeat and contact their doctors if they have any problems.

Merck & Co. to Pay $100 Million in Contraceptive Settlement

Merck & Company, Inc. (the second-biggest U.S. drug maker) will pay $100 million to settle product liability lawsuits against its NuvaRing contraceptive devices.

The lawsuits were from women who allegedly were harmed by using Merck and Company’s NuvaRing. Under the settlement, “Merck will be paying a fraction of what at least one company has paid in a similar settlement.” Last year, Bayer AG (a German drug maker) paid $1.6 million to settle lawsuits against its Yaz and Yazmin birth control pills, which allegedly were causing women to have clots, strokes, and heart attacks.

FDA issues recall for unlabeled drug ingredient in catheterization set

The FDA has issued a Class I recall for the Arrow multi-lumen venous catheterization set with a blue FlexTip ARROWg+ard catheter.  These catheters are used to administer drug therapy after being inserted into a large vein.  The label of the product incorrectly states that the catheter “contains no medication.”

The catheterization sets actually contain silver sulfadiazine as well as chlorhexidine.   If a patient with an allergy or sensitivity, known or unknown, to either substance is exposed, they risk the possibility of adverse health consequences or even death.  An allergic reaction to either can present as a delayed rash or hives or more immediately as Type 1, IgE mediated anaphylaxis. Such anaphylaxis manifests as loss of blood pressure, broncospasm, and vascular collapse. 

Arrow sent out a letter on May 3rd, 2012 to all distributors of the sets urging them to quarantine the entirety of the designated product supply.  The distributors were then to alert their Arrow sales representatives to replace the labels in order to properly warn potential patients.

Multiple Sclerosis drug Ampyra linked to risk of seizure

A new drug safety communication by the FDA has updated risks of the drug Ampyra (dalfampridine) which is approved to improve walking in those with Multiple Sclerosis. Currently, the drug label lists seizures as a side effect but the FDA is now in the process of updating the label to clarify recommendations. 

Based on post-market adverse event reports, the FDA has found that most seizures happen within days to weeks of beginning the recommended dosage of Ampyra- even in those with no history of seizure.  Because the drug is eliminated from the body through the kidneys, kidney impairment may develop higher blood levels of the drug.  Higher blood levels would then lead to an increased risk for seizures. 

The update of the drug label will note that Ampyra should not be used by those who have a history of seizures or who have moderate to severe renal impairment.  Before being prescribed the drug, health care professionals should assess renal function of the patient by estimating their creatine clearance.  Moderate to severe kidney impairment is measured as less than or equal to 50 mL/min. 

If you think you have been injured by a defective drug or device, contact one of our experienced products liability attorneys at Arias Ozzello & Gignac for important legal advice.

Baldness drug Propecia may lead to long-lasting sexual dysfunction

Recent studies have linked the drug finasteride, marketed by Merck and Co. to treat male pattern baldness (Propecia) and enlarged prostate (Proscar), to a host of sexual side effects including problems with libido, ejaculation, and orgasm.  These side effects, recently added to the FDA’s warning for the drug, have the potential to last for months or even years after discontinuing use, according to a study newly published in the Journal of Sexual Medicine.

Dr. Michael Irwig‘s study surveyed 54 men under the age of 40 who, after stopping Propecia, reported experiencing side effects lasting for three months or more that included erectile dysfunction, low libido, trouble having an orgasm, and shrinking and painful genitals.The study reported that 96% of the men surveyed had these sexual problems for more than a year.  While it is true that the sample size of the survey was small and perhaps only included those men who were negatively affected by the drug, the authors maintain that the findings may signal significant risk for men using finasteride.

The FDA updated the warning labels for finasteride after reviewing several hundred post-marketing reports.  Despite the updated warnings, however, both the FDA and Merck maintain the safety and efficacy of the drug.

The defective drug attorneys at Arias, Ozzello & Gignac are currently researching claims against Merck for Propecia’s adverse side effects. If you or someone you know has experienced complications from taking Propecia, call our experienced attorneys today for a free consultation. You may be entitled to compensation for your damages.

Stricter Regulations Likely for Vicodin and Other Hydrocodone-Combination Drugs

In the aftermath of increasing reports of addiction and abuse, Vicodin and other hyrdrocodone-combination painkillers may soon face stricter regulation by the Food and Drug Administration. The agency announced on June 7, 2012 that its advisers will meet in October to discuss the various applications of hydrocodone drugs vis-à-vis the risks associated with these drugs' use. Hydrocodone’s current status as the second-most abused drug in the United States, only marijuana exceeds it in terms of the rate of misuse, coupled with the fact that emergency room visits related to hydrocodone misapplication and recreational use more than doubled between 2004 and 2010, prompted the FDA to reconsider its categorization of the class of drugs. The FDA’s October conference seeks to change the drugs' classification to a level that requires increased oversight by doctors, thus making hyrodcodone-combination painkillers more difficult to obtain. Under current classifications, the DEA lists the opioid hydrocodone as a Schedule II controlled substance, the second-highest level on a five-stage scale that takes into account the potential for addiction. Hydrocodone combinations, such as Abbott Laboratories’ Vicodin, rank one class lower and, as a result, have fewer restrictions on sales.

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