Articles Posted in Defective Drugs

A New Jersey jury recently awarded a substantial $1.59 million verdict to a victim who was prescribed the acne drug Accutane and developed Ulcerative Colitis. The jury found that Hoffman-LaRoche and Roche Laboratories, which manufactures Accutane “failed to provide Kamie Kendall Ries…with adequate warning of the health risks.” Ries’ winning verdict is a good sign for the thousands of victims who developed Colitis after taking the drug.

According to the American Osteopathic College of Dermatology, Accutane (generic name: Isotretinoin) is a powerful drug prescribed for severe acne. The potent medication is a natural derivative of Vitamin A and is only used in extreme cases where acne does not respond to any other treatment including creams and antibiotics. Over two million patients have consumed the drug since it first came on the market in the mid-1980s. Notably absent from the lengthy list of side effects is the risk for Colitis, which thousands of patients claim they developed after taking the drug.
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The $11 million ruling awarded by a jury in a Topamax birth defect case will stand, according to National Trial Lawyers. Court of Common Pleas Judge George W. Overton denied a motion by Johnson and Johnson subsidiary Janssen Pharmaceuticals for a new trial, upholding the original award for the family of Brayden Gurley.
The US Food and Drug Administration (FDA) has since issued a warning regarding serious birth defects in infants caused by expectant mothers using Topamax. Severe cases of cleft lip, cleft palate and other deformities have been widely reported. However, the Gurley family accused Janssen Pharmaceuticals of “operating in a culture of secrecy, intentionally withholding concerns about Topamax known to the company at the time, together with safety reports that suggested an association between Topamax and birth defects, dating back to 2003,” according to Bloomberg News. It is possible that the pharmaceutical company knew about the issues as far back as 1997, but kept these warnings private.
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According to several sources, a judge has been asked to approve a $100 million settlement to aid victims of last year’s Meningitis outbreak, which was traced back to New England Compounding Center. The Massachusetts Pharmacy is believed to have manufactured steroid injections that were tainted with black mold and caused a nationwide outbreak of the deadly disease. WBZ reports that “NECC’s owners, its insurers and one of its affiliates will contribute an aggregate amount estimated to exceed $100 million to a compensation fund to be distributed to NECC creditors, including those who died or suffered significant injuries” as a result of receiving the drug.

The outbreak quickly grew out of control and spread across 20 states. The New England Compounding Center surrendered its license in 2012, but the damage was already done. The Center for Disease Control and Prevention data shows that as many as 750 patients were sickened and 64 people died as a result of the contamination. The pharmacy then filed for bankruptcy.
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A multibillion-dollar trial involving the drug Actos, manufactured by Takeda Pharmaceuticals, resumes today in a Las Vegas court. Actos is a single-ingredient drug used in conjunction with diet and exercise to help manage blood sugar levels in patients with type-2 diabetes. In the lawsuit, Bertha Triana, 80, and Delores Cipriano, 81 claim that taking Actos led to bladder cancer in both women. According to an article published by Drugwatch, “their attorneys are expected to call experts who will testify about the number of warnings Takeda officials ignored or hid that indicated the drug could lead to bladder cancer.”

Delores Cipriano was diagnosed with bladder cancer in July 2012 after being prescribed Actos for about 14 months. So far, she has undergone 2 painful surgeries to remove tumors in her bladder. Bertha Triana was diagnosed with the disease after taking the drug for more than two years. According to her lawyers, Triana “had four operations to remove bladder tumors and is undergoing her third round of chemotherapy.”

During the trial, the plaintiff’s attorneys are expected to argue that Takeda Pharmaceuticals willingly and knowingly engaged in “spoliation of evidence” relating Actos to bladder cancer. In other words, the women believe the manufacturer was aware of the link between the drug and bladder cancer, and made an intentional or negligent effort to cover up the evidence.
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Jurors in a state court have awarded Kamie Kendall Rees $1,587,928 in her Accutane injury lawsuit against drug maker Hoffman La Roche Inc. The ruling comes in a retrial after an appeals court threw out the original verdict of $10.5 million on the grounds that a judge was improper in deciding to bar the manufacturer from presenting evidence about use of the drug.

Rees claimed that the manufacturer never warned consumers and healthcare providers about the health risks involved. Like a lot of Accutane patients, she started taking the medication when she was young to treat her acne. She developed Ulcerative colitis after taking the medication for two years. Because Rees’s condition was so severe, she eventually underwent surgery to get her large intestine removed.

Some 16 million people have taken Accutane. Roche discontinued the drug in 2009 after millions of dollars were awarded in drug injury verdicts to other plaintiffs in the US. To date, reports Bloomberg, Roche has lost 10 out of the 13 drug defect lawsuits brought over this medication since 2007, including a case in 2012 in which the manufacturer was ordered to pay two plaintiffs $18 million and $25 million verdict to another plaintiff in 2010.

Indian drug maker Ranbaxy Laboratories Ltd. is facing harsh criticism after issuing a recall for more than 60,000 bottles of its generic cholesterol-lowering drug Lipitor. The recall was issued because of a dosage mix-up. A pharmacist discovered a 20-milligram tablet in a bottle marked for 10-milligram tablets. The company confirmed a recall for only select batches of the medication, but it has not yet received any consumer complaints.

This recall is the latest of a series of issues for Ranbaxy. In the past year, Ranbaxy came under fire after its quality control and manufacturing practices came into question by the FDA. In November of 2012, It recalled certain batches of generic Lipitor after discovering it was contaminated with tiny glass particles. The company also found itself at the center of a whistleblower lawsuit last year stemming from a pharmaceutical fraud case in 2007 where it was accused and found to be selling “untested, spurious, and ineffective medication.” The company has since been banned from selling any of its drugs or ingredients in the United States; which was its largest market.

Quality control has not just been an issue for Ranbaxy, in fact other Indian drugmakers have come under closer scrutiny as the FDA, the guardian of the world’s most important pharmaceuticals market, has increased its presence in the country, reflecting India’s growing importance as a supplier to the United States. Indian generic drugmakers currently produce nearly 40 percent of generic drugs and over-the-counter products and 10 percent of finished dosages used in the United States.
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The Pennsylvania Supreme Court has ruled that drug maker Wyeth must deal with products liability claims alleging that the warning labels on a popular diet drug were defective. In a 4-2 vote in Lance v. Wyeth, the majority rejected the claim that inadequate warnings and manufacturing defects are the only claims against pharmaceutical companies that are viable. Now, the Pfizer subsidiary will face negligent design and marketing allegations over the popular diet pill linked to the Fen-Phen craze.

It was during the 1990’s that Redux and Pondimin, two diet pills, were prescribed by weight-loss clinics. While the US Food and Drug Administration approved Redux but included a warning that pulmonary hypertension was a possible risk, both pills were pulled from the market in 1997 as they became increasingly inked to the risk of heart problems.

The plaintiff in this drug injury lawsuit is Patsy Lance, who is the administrator of her daughter Catherine Lance’s estate. Catherine took the diet drug Redux for a few months in 1997 and then died from primary pulmonary hypertension-related complications-it was later that year that the drug was taken off shelves.

The next trial over a Fosamax femur fracture claim will start in May as part of Multidistrict Litigation in district court in New Jersey. Meantime, the drug’s manufacturer, Merck & Co., has agreed to a proposed $27.7 million to settle ONJ lawsuits filed by plaintiffs who say that the bisphosphonate caused their jaws to deteriorate.

The Fosamax settlement, if approved, would resolve a lot of the more than 5,200 drug injury cases. Fosamax was developed to help treat osteoporosis in women, Paget’s disease, and other bone diseases. Plaintiffs have until the end of March to opt out of the deal, while Merck has until mid-May to decide whether to definitely go ahead with it.

That said, the drugmaker noted that the settlement would not cover the approximately 4,115 femur injury cases that plaintiffs contend were caused from taking Fosamax.