Pharmaceuticals Attorneys Blog

Published on: July 9, 2024

Settlement of Valsartan Lawsuit Nears for Some

blood-pressure-monitor-1749577_640-e1720474938721 Plaintiffs sued Hetero, the manufacturer of valsartan, a generic blood pressure medication, because it was contaminated with carcinogens, and they alleged it caused cancer. The lawsuits were consolidated in 2019. These cases are coming closer to settlement. Recently, the United States District Judge Renée M. Bumb who is presiding over the multidistrict litigation ordered both sides to finalize a settlement agreement in all of the plaintiff groups; there are three groups, one for personal injury, another for economic loss, and still another for medical monitoring. The deadline was June 30. If you were harmed by Valsartan, you should call the seasoned Chicago-based lawyers of Moll Law Group. Billions have been recovered in cases with which we’ve been involved.

Contact Moll Law Group About Your Valsartan Cancer Claim

Valsartan, manufactured safely by Novartis Pharmaceuticals Corp. under the brand name Diovan, functions by relaxing a patient’s blood vessels. This improves flow and reduces pressure. When the patent expired, various generic manufacturers in China and India began selling the drug, which they made with a different manufacturing process. The U.S. Food and Drug Administration investigated claims that drugs manufactured overseas contained NDMA or N-nitrosodimethylamine or NDEA (N-nitrosodimethylamine).

In 2018, the generic Valsartan was recalled around the world because of its unacceptable levels of carcinogenic toxins. Many patients, including around 3 million Americans, had not known they were taking contaminated drugs that could seriously harm them.

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Published on: December 12, 2023

Supreme Court Heard Arguments to Challenge OxyContin Settlement

By Moll Law Group

headache-1540220_640-e1702313969782 The Supreme Court heard arguments related to a challenge to the bankruptcy deal that’s intended to compensate victims of highly addictive pain killer OxyContin. Based on the questions judges asked, court watchers believe the Court is split. The manufacturer of Oxycontin, Purdue Pharma, entered into a deal to pay billions to people harmed by the opioids they made and sold. That deal protected members of the Sackler family from personal liability. If you were injured by Oxycontin or another highly addictive pain killer, you should call the seasoned Chicago-based dangerous drug lawyers of Moll Law Group. Billions have been recovered in product liability lawsuits with which we’ve been involved.

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The case that the Court is hearing arose from complex circumstances. The Sackler family took assets from the manufacturer of Oxycontin, Purdue Pharm and shifted those assets overseas, which then triggered the problem that the company no longer has enough money to pay its creditors, such as those injured by pain killer. Purdue Pharma pled guilty to three criminal charges by 2020. It agreed that it owed $8 billion in criminal and civil fines to state and local governments trying to address the opioid crisis.

Based on this, the company reached a deal in bankruptcy court that would reimburse victims of the epidemic along with the harmed by an amount less than it might have paid, had it not shifted its assets overseas.

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Published on: November 14, 2023

Eli Lilly Announces a Diabetes Drug Trial for Children

By Moll Law Group

woman-6532129_640-e1699049259188 Recently, Eli Lilly announced that it is planning a clinical trial of its diabetes drug Mounjaro in patients who are six years old or older that have obesity. In fact, according to a United States government registry, Eli Lilly is already underway with a Mounjaro trial on children as young as 10 years old who have type 2 diabetes. Meanwhile, the registry also indicates that the company Novo Nordisk, based in Germany, is also performing a late stage trial of the drug semaglutide, which is sold under the brand name Ozempic in kids who are only 6 years old. Ozempic has been reported to do harm, including gastroparesis. If you or your child is injured as a result of Mounjaro/Ozempic, please call the seasoned Chicago-based trial attorneys of Moll Law Group. We represent children nationwide.

Talk to Moll Law Group About Whether Your Claim is Viable

Both Mounjaro and Ozempic have surged in popularity and demand as treatments for diabetes and obesity. Ozempic is a brand name for semaglutide, which is a medication that manages patients’ blood sugar levels by copying the protein glucagon-like peptide 1 (GLP-1). It lowers your hunger cues and slows digestion in the gut, which can result in weight loss.

More than $1.5 billion in sales were generated by Eli Lilly in the first half of 2023, which is a year after it was approved in the United States. However, it is concerning that children will be subjected to clinical trials because there have been reports that these drugs cause harm, and lawsuits filed in connection with that harm. The Mounjaro lawsuits, which are in their infancy at the time, claim that the drug causes severe gastrointestinal trouble including intestinal blockage and gastroparesis and that Eli Lilly did not adequately inform of the risks associated with taking it.

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Published on: October 10, 2023

FDA Adds New Warnings to the Label of TEPEZZA

By Moll Law Group

eye-321961_1280-e1696438901920 The Food and Drug Administration recently updated the warning label on Horizon Pharmaceutical’s TEPEZZA. The label now includes that one of the “major recent changes” for warnings and precautions is “hearing impairment including hearing loss.” Hearing loss is just one of four warnings. The others are hyperglycemia, exacerbation of preexisting inflammatory bowel disease and infusion reactions. If you suffered hearing loss or other harm, you should call the trusted Chicago-based dangerous drug lawyers of Moll Law Group. Billions have been recovered in lawsuits around the country with which we’ve been involved.

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Tepezza is a drug prescribed to improve symptoms of thyroid eye disease, which is a rare condition in which fatty tissue and muscles located behind the eye become inflamed such that the eye is pushed to the front and bulge outwards. The drug is supposed to mitigate the effects of double vision, proptosis, and chronic bulging eye. Unfortunately it is a drug that carries significant risks.

The new Tepezza warning provides that it can cause serious hearing impairment including hearing loss that could be permanent. Doctors are advised to evaluate a patient’s hearing before, during and after treatment with the drug and also weight the risks and benefits of treating a patient with the drug. The warning came a little less than a month after the Brazilian Health Regulatory Agency approved its use as a thyroid eye disease treatment.

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Published on: September 28, 2023

FDA Advisory Panel Determines that Phenylephrine Doesn’t Get Rid of Congestion

By Moll Law Group

woman-698964_1280-e1695661666719 Phenylephrine is an ingredient in popular oral decongestants branded as Vicks Nyquil Sinex Nighttime Sinus Relief, Sudafed PE, and Benadryl Allergy Plus Congestion. It was believed that the drug worked to reduce blood vessel swelling in the nasal passages, and that this got rid of congestion. These decongestants generated nearly $1.8 billion in sales in 2022. A Food and Drug Administration (FDA) advisory panel has advised that data shows over-the-counter cold and allergy medications that contain phenylephrine don’t effectively eliminate nasal congestion. A unanimous vote by the panel declared that the drug is not useful.

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The FDA only started to review over-the-counter cold medicines in 1976. Over the last 30 years, Florida pharmacy professors have pressured the FDA to do something about the efficacy of phenylephrine. Back in 1993, Dr. Leslie Hendeles wrote a paper published in a medical journal that phenylephrine didn’t work because it was destroyed in the stomach and never made it to the bloodstream. Further research over the years determined the drug was not any better than a placebo. Pandemic legislation changes FDA staffing and procedures so that they’re more in line with the rules surrounding prescription drugs, and this caused the FDA to produce an 89-page review.

While the FDA makes final decisions about drugs, they sometimes use advisory committees to give them advice and recommendations. FDA considers a committee’s advice and recommendations when deciding; in this case the advisory committee’s opinion was based on the FDA’s 89-page review.

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Published on: August 23, 2021

FDA Notifies Amazon It Is Distributing Defective Drugs

By Moll Law Group

In spite of its efforts to stop the distribution of dangerous weight loss and sexual enhancement products, the Food and Drug Administration (FDA) continues to discover weight loss and sexual enhancement products that violate the federal Food, Drug, and Cosmetic Act at various online stores. Consumers in Chicago and elsewhere should be wary of purchasing these types of products online.

The FDA has warned consumers about dangerous products available at online retailers for a decade, but in spite of efforts to improve safety in these spaces, violations persist. On July 26, 2021, the FDA issued a letter to let Amazon know that it was distributing weight loss and sexual enhancement products that violate the federal Food, Drug, and Cosmetic Act. The distributed products include hidden ingredients that could have harmful medical consequences.

The FDA sampled 26 products it bought on Amazon. It also sampled 25 products it bought on eBay. Alarmingly, the FDA found that all 26 of the drugs bought on Amazon contained undeclared active ingredients. 20 of 25 products purchased on eBay also did. None of the potentially harmful ingredients in these products is declared in the product labeling so that consumers know to seek physician supervision and advice with regard to them. For instance, an FDA lab analysis confirmed that X Rated Honey for Men includes tadalafil, which is the active ingredient in the erectile dysfunction drug Cialis. Likewise, analysis found tadalafil, the active ingredient in the FDA-approved prescription drug Cialis, in Adam’s Secret Extra Strength 2000 sold through online retailers.

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Published on: April 6, 2020

The Food and Drug Administration Pulls Zantac from Pharmacy Shelves

By Moll Law Group

FDA Recall Earlier this week, the U.S. Food and Drug Administration issued a news release requesting manufacturers to withdraw all products containing the popular heartburn drug, ranitidine, the active ingredient in the medication, Zantac. The order applies to both prescription and over-the-counter medications. In light of the ongoing COVID-19 national emergency, those who have medicine containing ranitidine on hand are being asked not to return the product to the pharmacy, as is typically recommended. Instead, the FDA is recommending the medication be destroyed according to the disposal suggestion contained in the medication guide or package insert. All formulations of ranitidine are impacted, including pills, injections, and compounded medications that include ranitidine.

The recent recall is the latest step in an escalating investigation surrounding a contaminant known as N-Nitrosodimethylamine (NDMA), which is commonly found in ranitidine. Through its research, the FDA found that the impurities in some ranitidine products increase over time when stored at higher temperatures, potentially resulting in dangerous levels of NDMA.

In its official statement, the FDA explained that it didn’t see unacceptable levels of NDMA in the many samples they tested. Nevertheless, since they did not know how or for how long the product might have been stored they decided that it should not be available to consumers and patients unless its quality could be assured.

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Published on: October 17, 2016

FDA Issues Warning About Potentially Fatal Baby Teething Products

By Moll Law Group

The U.S. Food and Drug Administration recently issued a warning indicating that benzocaine, an anesthetic commonly used in over-the-counter teething gels for infants as well as liquid medications, can cause serious injuries and even death. Commonly found in products like Anbesol or Baby Orajel, the local anesthetic has in some cases led to a serious condition known as methemoglobinemia. This condition reduces the quantity of oxygen that travels through the patient’s bloodstream. Parents who have products containing benzocaine are promptly advised to stop using them on children younger than two and should seek a consultation with a health care official immediately.

In many instances, parents and other consumers presume that products marketed as homeopathic remedies are safe and pose fewer risks than pharmaceuticals and similarly derived products. A maker of such products, Hyland’s, which offers a benzocaine teething product, announced that it has discontinued making such products. According to a statement, the company stopped manufacturing the products due to the FDA’s warning. Major international drug store Walgreen’s has also discontinued its offering of products containing benzocaine.

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Published on: October 7, 2016

Cancer Patients File Lawsuit Against Taxotere Maker After Suffering Permanent Hair Loss

By Moll Law Group

A substantial number of breast cancer patients in the U.S. have received treatment using a drug called Taxotere, which is manufactured by a company called Sanofi. Unlike other cancer drugs that required weekly appointments, Taxotere required treatment only once every three weeks. For cancer patients who are still busy juggling other commitments, this was an appealing option. In addition to being used to treat breast cancer, the drug has also been employed to treat stomach cancer, non-small cell lung cancer, neck cancer, head cancer, and metastatic prostate cancer.

Soon after the drug became a popular treatment, numerous reports surfaced from patients claiming that they suffered permanent hair loss as a result of taking the drug. According to the slew of lawsuits that were filed after the reports became widespread, the plaintiffs largely alleged that the drug maker failed to provide appropriate warnings and disclosures regarding the drug’s potentially disfiguring side effects. Other allegations included failing to conduct appropriate investigations into the safety and potential side effects of the drug, concealing information from consumers, and failing to fully and accurately communicate the severity of the dangers that could arise from taking the drug.

In addition to the adverse reaction reports that surfaced, studies have shown that nearly 10 percent of breast cancer patients who took Taxotere suffered alopecia that persisted for 10 years or more. This caused a variety of injuries and consequences, including emotional distress, pain and suffering, social anxiety, and disfigurement.

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Published on: August 1, 2016

FDA Increases Warnings Associated with Fluoroquinolone Antibiotics, Including Cipro and Levaquin

By Moll Law Group

The U.S. Food and Drug Administration recently issued a new warning increasing the cautions associated with fluoroquinolone-based medications, concluding that this class of antibiotics may be too strong to address bronchitis, sinus infections, and urinary tract infections. The FDA has received a number of complaints regarding the drugs and has concluded that dangerous side effects include disabling and potentially irreversible tendon, muscle, joint, nerve, and central nervous system pain. The warning label for these drug products has been updated to reflect these new risks.

The agency also stated in its warning that fluoroquinolones should only be prescribed to patients who have no other medical recourse for acute bacterial exacerbation of chronic bronchitis, uncomplicated urinary tract infections, or acute bacterial sinusitis. More specifically, health care professionals should immediately stop prescribing these medications for patients who have any of these conditions and support any serious adverse reactions as soon as possible. The current Boxed Warning for fluoroquinolone medicines applies to a number of conditions like tendon rupture, myasthenia gravis, and tendinitis, as well as peripheral neuropathy and a variety of other conditions.

Patients who have been injured as a result of taking dangerous pharmaceuticals can file a product liability or negligence claim against the drug manufacturer. The FDA requires drug manufacturers to comply with extensive regulations regarding the development, testing, approval, and marketing of new drugs. In many instances, companies that manufacture and sell dangerous pharmaceuticals have failed to comply with some of the testing requirements or even hidden information from the FDA about adverse side effects associated with the drugs when seeking approval.

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