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A new follow up study by Øjvind Lidegaard found that compared to combined oral contraceptives containing levonorgestrel users of vaginal ring contraceptives (such as NuvaRing) were 1.9 times more likely to suffer venous thrombosis. The VTE risk of vaginal ring users was 6.5 times higher than women not taking hormonal birth control.

The study also found an increase  risk in transdermal patch birthcontrol as well, with women with 2.3 times more likely to have a VTE compared to users of combined oral contraceptives containing levonorgestrel and 7.9 times more likely than non users of hormonal contraceptives.

A copy of the article, which was published in the British Medical Journal in May 2012 can her found here.

Our firm represents hundreds of women who have suffered from injuries stemming from NuvaRing and other birth controls. If you have been injured after taking birth control please contact the attorneys at Rheingold, Valet, Rheingold, McCartney & Giuffra for a free consultation with an experienced drug injury attorney.

In May, 2012, Abbott Laboratories willingly plead guilty to illegal drug marketing. This is the highest fine ever paid by Abbott, but billion dollar fines are bcoming business as usual for drug companies: $3 bil against GlaxoSmithKline , and $2.3 bil against Pfizer.

As we often note, the victims of these civil and criminal for violating the Food, Drug, and Cosmetic Act are often women, children and the elderly. In this case Abbott heinously marketet a strong anti-seizure to disabled elderly people in nursing homes. Drug companies can only market drugs for FDA-approved conditions. Doctors ae allowed to prescribe drugs for "off-lable' use, but a company cannot do so. In this case, Abbott created special marketing crews who went to nursing homes and stated that the drug should be used for schizophrenia and dementia. Abbott created an entire campaign of using Depakote as a sedative. Federal law prevents intentional sedation, but Depakote had not yet been recognized by the federal government as an improper sedative.

Thankfully a brave and heroic whistleblower stepped forward, Meredith McCoyd. Her and three other whistleblowers should be commended for bringing an end to this methodical sedating of the elderly with dementia who had no idea about how they were being abused by Abbott for profits. To promote whistleblowing (federal laws were creating during the civil war to prevent profiteering), the whistleblowers will be handsomely rewarded-over $100 million will be split amongst them.

Medical devices can be an important part of patient care-but only if they work properly. According to patient safety advocates, more needs to be done to ensure that medical devices do not malfunction and lawmakers need to pass legislation that will enable the Food and Drug Administration (FDA) to accomplish this. Unfortunately, current legislation does not make this possible.

"Our system for overseeing medical implants and other high risk devices is clearly broken and allows too many dangerous devices on the market," Lisa McGiffert, Director of Consumers Union's Safe Patient Project, said in a statement. "Tens of thousands of patients have been injured or died in recent years because current law fails to ensure medical devices are safe."

A new bill introduce by Congressman Tom Green (R) from upstate New York would require the results from all clinical trials be disclosed regardless of the outcome of the trial. This bill comes after more research has shown that results from government funded clinical trials often go unreported despite the disclosure requirements already in place. The new bill would amend the Public Health Service Act, adding a stronger enforcement mechanism. The bill says once it has been verified that the results of a clinical trial haven't been reported, the grantee:

"shall not be eligible to recieve any remaining funding for the grant or funding for a future Federal grant until such time as the grantee comes into complicance with all applicable reporting requirements...and shall be liable to the United States for repayment of any amount provided under the grant for clinical trial for which the grantee failed to comply with such reporting requirements."

One study reported in the British Medical Journal reported less than 30% of trials registered with clinicaltrials.gov are in compliance with the requirements already in place.

An article recently published in Pediatrics reported that only 29% of 2,385 pediatric clinical trials registered with clinicaltrials.gov ever reported their results and on average the results weren't published for two years after the study had completed. Additionally, only 53% of the trials funded by the National Institute of Health were ever reported. Further, results from terminated or suspended clinical trial were rarely ever reported

Rheingold, Valet, Rheingold, McCartney & Giuffra is deeply involved in the pharmaceutical and device litigations we handle. This gives us the opportunity to uncover some of the hidden results of clinical trials never reported by the pharmaceutical companies that sponsor them. It is shocking what companies sometimes don't disclose, but through litigation much of this information is eventually made public and the world is a better place as a result.

In April, the Archives of Surgery published a major article on the risks of robotic surgery by Buchs and others at the University of Illinois. The doctors looked at the outcome of 884 cases of robotic surgery performed at their institution, to see what role was played by the condition of the patient before surgery, the type of surgery, the skill of the surgeon, and the stresses caused by the surgery. Not surprisingly they found greater complications occurred as the surgery got more complicated or the patient was more debilitated beforehand. Also there were more complications when the surgeon had less experience.

Of the cases studied, more than 16% had post operative complications, and 1 in 200 died. In 1 in 50 instances, the robotic surgery had to be abandoned and the doctors had to resort to open surgery to deal with the problem created. For whatever reason, the authors chose not to tell the type of complications.

Due to the expanding litigation with regard to several products, multiple new consolidations have been announced. Judge Goodwin in the Southern District of West Virginia will receive all federal cases involving vaginal slings (also known as transvaginal mesh) made by American Medical Systems, Boston Scientific and Ethicon, Inc. Judge William Duffey in the Northern District of Georgia will now manage all the Wright Medical Conserve metal-on-metal hips. To promote judicial economy, lawsuits involving the same products can be consolidated with one judge for pre-trial management. Transvaginal mesh has come under attack for poor designs which result in pain, erosion, infection and other injuries in many women. The Conserve hip has been linked to stem failure and metallosis, tissue necrosis, pseudo tumors and other problems.

Mayor Bloomberg has promoted cycling in New York City by adding hundreds of miles of cycling lanes. This has lead to a vast increase in people doing "green" commuting. However, vehicle drivers continue to flaunt driving regulations, causing tragic accidents with bicycles, including fatalities. A federal jury in the Southern District of New York (Manhattan, known as New York County) rendered a verdict totaling $1,251,853 against several drivers. Notably, an elevator maintenance company van was improperly parked in a bus lane when a passenger threw open the van's door into an oncoming cyclist who had no way to avoid the door. This was argued to be in violation of NYS Vehicle and Traffic Law Section 1214. The bicyclist suffered degloving and broken bone injuries which required multiple surgeries and resulted in functional loss and scarring. She had twenty days of hospitalization plus extensive outpatient physical therapy

Vivius Inc (Qnexa), Orexigen Therapeutics Inc. (Contrave), and Arena Pharmaceuticals Inc. (Lorcaserin) are the latest pharmaceutical companies moving for FDA approval of prescription weight-loss drugs. These companies are in the process of conducting clinical trials or actually close to producing data to federal agencies for approval.

Our firm represented hundreds of clients against American Home Products, which quietly changed its name to Wyeth during the litigation. The Mayo Clinic discovered and published medical reports that diet drug users developed heart valve injuries, many of which were irreversible. A fatal lung disease, now know as pulmonary arterial hypertension, was the worst problem. Wyeth was in possession of side effect data but denied its existence to the Mayo Clinic and the FDA, only later to actually file supplemental adverse event reports long after the fact, and after it was too late for many users.

Amazingly, Xenical and Meridia were subsequently approved and also later found to cause heart problems. Most shocking is that these costly diet pills have never proved to have significant, permanent weight loss in combination with provable reduction in obesity-related illnesses in those using the drugs.

Over the counter products that had ephedra and phenylpropanolamine were associated with heart attacks and strokes due to blood pressure spikes. Our firm had leadership positions in litigation committees and also litigated cases to verdict. In fact, our suits resulted in manufacturers halting sales long before the FDA removed these ingredients from the market.