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failure to warn 117 articles

PA judge allows Essure lawsuit to proceed

A federal judge in Philadelphia is allowing a lawsuit filed by five women suing Bayer over injuries caused by the company’s permanent birth control device Essure to proceed. U.S. District Judge John Padova rejected some of the women’s claims but ruled that two were reasonable to stand trial – negligent misrepresentation and negligent failure to warn of the risks. The women claim that the controversial contraceptive device migrated from its intended position in the fallopian tubes and punctured organs. Bayer had asked that the case be dismissed claiming the device was protected under a pre-market approval provision. Essure was approved ... Read More

NY new advertising campaign promotes IUD for birth control

The New York Health Department is hoping a new advertising campaign will encourage women to consider getting intrauterine devices, or IUDs. The ads, which feature all five boroughs, are produced in English and Spanish. They feature bright colors with eye-catching designs. One of the ads reads, “You spent the night in Brooklyn. But you left your birth control in Staten Island. Maybe the IUD is right for you.” The ads will run for three months citywide, with 1,000 appearing on subway stations and 20 big posters at bus stations. They also feature the social-media hashtag, #MaybeTheIUD. IUDs are small devices ... Read More

Even normal weight, underweight people can get type 2 diabetes

Nine out of 10 people diagnosed with type 2 diabetes are overweight, with a body mass index, or BMI, of 25 to 29.9. About half of the newly diagnosed are obese, with a BMI of 30 or higher, according to a Diabetes UK analysis. Weight gain, unhealthy diets and sedentary lifestyles increase one’s risk of developing the chronic disease. However, more than 10 percent of type 2 diabetics have normal weight and a handful are even underweight, which means no one is immune. Type 2 diabetes is growing in epidemic proportions. People with the condition must follow a strict diet ... Read More

Abbott, AbbVie face varying lawsuits with AndroGel

Abbott Laboratories and AbbVie skirted racketeering claims alleging the companies made health plans pay unnecessarily for the arthritis drug Humira and the testosterone replacement AndroGel instead of less expensive generics. U.S. District Judge Robert Dow said plaintiffs New England Carpenters Health and Welfare Fund failed to show that the defendants teamed up with pharmacies and intermediaries to illegally increase sales of the drugs by offering savings cards or coupons to reduce copayments. The fund also accused Abbott and AbbVie of insurance fraud, alleging the companies instructed pharmacies to hid subsidies by processing them as secondary insurance rather than discounts. “While ... Read More

New Jersey man blames heart attack on Axiron testosterone treatment

New Jersey resident Patrick Miller was 54 when he started using Axiron, a testosterone replacement product used to treat men who have low levels of the hormone in their blood. A month later, on Oct. 3, 2012, he had a heart attack. Thirteen months later, the Journal of the American Medical Association (JAMA) published a study that found men who used testosterone treatments have a 30 percent increased risk of having a heart attack, stroke or dying. And, in January 2014, the journal PLOS One found a two-fold increased risk of heart attack among older men in the first 90 days ... Read More

Plaintiff claims Actos bladder cancer warnings were not strong enough to convey risks

Takeda Pharmaceutical Co., attempted to convince a Philadelphia jury that it adequately warned of bladder cancer risks on the label of its type 2 diabetes drug Actos by presenting testimony from a former senior official with the Food and Drug Administration (FDA) David Feigal Jr., an expert witness for the drug company, said that Takeda had funded several studies to gauge the cancer risks with its once-blockbuster drug and had included that information on the drug’s insert. However, plaintiff Frances Wisniewski claims differently. She took Actos for seven years and developed tumors in her bladder. Her lawsuit alleges that Takeda ... Read More

Breast reduction third most common cosmetic surgery for men

In 2013, nearly 23,000 procedures – including liposuction and mastectomies – were performed on men to remove enlarged breast tissue, a condition known as gynecomastia. The procedure is the third most common cosmetic surgery performed for men behind rhinoplasty (nose reshaping) and blepharoplasty (eye lift). Gynecomastia can be embarrassing leaving lingering emotional scars. It can also be painful, causing breasts to become swollen and tender. In some cases, the breasts can lactate. The condition may go away after a few months or years, or symptoms may persist for a lifetime, in which case surgical intervention may be considered. “Surgical treatment ... Read More

Risperdal with stimulant often prescribed off-label to treat children with ADHD

A combination of two medications – a stimulant and the antipsychotic Risperdal – may be a helpful treatment for children with attention-deficit/hyperactivity disorder (ADHD) and severe aggression, but the amount of additional benefit appears to be moderate, according to new research published in the Journal of the American Academy of Child and Adolescent Psychiatry. Risperdal, also known as risperidone, is approved to treat adults and children with schizophrenia, bipolar disorder, and autism with irritability. It is not approved as a treatment for ADHD or ADD, but it is often prescribed by doctors off-label for those conditions and in many cases ... Read More

Lawsuit filed against Pfizer related to testosterone replacement drug

Pfizer’s testosterone replacement treatment Depo-Testosterone has become the subject of lawsuits questioning the safety and efficacy of the drugs after reports of heart attacks, strokes and blood clots in patients treated with the hormone. The lawsuit filed on behalf of Alvaro Roman Gutierrez alleges that Pfizer and its unit Pharmacia & Upjohn Co. LLC, conducted a “disease mongering” campaign to exaggerate the problem of low testosterone levels in men in order to boost sales of Depo-Testosterone. Gutierrez claims that Pfizer and Pharmacia & Upjohn spent millions of dollars to promote its drug to consumers and, along with other drug companies not ... Read More

Pfizer skirts patent lawsuit but Lipitor diabetes lawsuits continue to mount

A U.S. District judge has dismissed an antitrust lawsuit accusing drug makers Pfizer and Ranbaxy Laboratories of conspiring to delay sales of generic versions of their best selling cholesterol-lowering statin drug Lipitor. Judge Peter Sheridan said that the plaintiffs, retailers and distribution companies that bought Lipitor from Pfizer did not provide enough details to convince him that Pfizer and Ranbaxy had violated patent agreements. The lawsuit stems from a 2008 settlement of a patent settlement reached between Pfizer and Ranbaxy regarding Ranbaxy’s plan to make generic versions of Lipitor. Under that agreement, Pfizer agreed to drop damage claims against Ranbaxy, ... Read More