News - Page 5 of 17 - Drug Law Journal

Proton Pump Inhibitors Linked to Serious Health Complications

Posted on June 24, 2021June 25, 2021

In recent years, Proton Pump Inhibitors (PPI) have been linked to serious health problems and all-cause mortality, suggesting that the acid reflux medication may do more harm than good. Studies show that PPIs cause damage to major organs and also lead to a higher risk of developing type 2 diabetes.

One study even argues that PPI usage increases mortality in COVID-19 patients. After testing nearly 300 hospitalized COVID-19 patients in Brooklyn, NY, researchers discovered that mortality was 2.3 times higher among PPI users. The authors of the study write that “severe acute respiratory syndrome coronavirus-2 may escape the inactivation by gastric acid because of hypochlorhydria caused by proton pump inhibitors,” predisposing the patients to severe cases of COVID-19 regardless of existing cardiovascular comorbidities.

Proton Pump Inhibitors and Skin Reactions

Additionally, PPI usage can lead to the development of life-threatening skin reactions. The Journal of Cosmetic Dermatology published data that revealed that the acid reflux medication increases the risk for skin issues, such as contact hypersensitivity and a form of lupus skin disease. More severe complications include Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Finally, regular PPI users are often less physically active. They more frequently struggle with high blood pressure and high cholesterol. Studies published in Physician’s Weekly also note that usage may result in weight gain, metabolic syndrome, and chronic liver disease. Over-usage is linked to bone fractures, kidney disease, and dementia.

For more information about health complications associated with Proton Pump Inhibitors, contact us today.

Additional Reading:

Proton Pump Inhibitors (PPIs) and Common Drug Interactions

Proton Pump Inhibitors (PPI) Commonly Asked Questions

Proton Pump Inhibitors (PPI’s)

North Carolina Takes Legal Action Against JUUL

Posted on June 21, 2021July 8, 2021

North Carolina Attorney General Josh Stein recently filed a lawsuit against e-cigarette company JUUL for its marketing tactics towards young people. Stein argues that these practices have played a role in creating “an epidemic among minors.” This statement is supported by, among other evidence, a 2017 report that revealed 17 percent of all North Carolina high school students had used an e-cigarette within the last 30 days.

Stein’s investigation, which began last fall, hopes to show that JUUL failed to highlight the potency and danger of nicotine. If found guilty, the e-cigarette company would be in violation of North Carolina’s Unfair and Deceptive Trade Practices Act.

Notable Increase in E-Cigarette Usage

“JUUL’s business practices are not only reckless — they’re illegal,” Stein shared. “We cannot allow another generation of young people to become addicted to nicotine.” He also revealed that the average potency of a JUUL pod is nearly three times the concentration allowed for sale for people of all ages in countries around the world.

Within the last year, e-cigarette use has increased among high schoolers across the country by 78 percent and middle-schoolers by 48 percent. North Carolina is the first state to come forward with allegations against JUUL.

For more information about the investigation into JUUL, contact us today.

Additional Reading:

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

Juul and Vaping Side Effects

The FDA’s Concerning Approval Of New Alzheimer’s Drug, Aduhelm

Posted on June 17, 2021July 8, 2021

Aduhelm, a new Biogen drug, received approval from the U.S. Food and Drug Administration (FDA) last week, with the hope that it will be a game-changer when it comes to caring for dementia patients. It is the first federally-approved drug that works to slow the biological process of Alzheimer’s instead of simply alleviate the symptoms.

Advocates believe that Aduhelm can slow disease progression, ultimately turning Alzheimer’s into a manageable chronic condition. Proponents, however, argue that the scientific evidence fails to support the claims of the drug. Considering this lack of evidence, they also balk at the $56,000 price tag on a year’s worth of treatment.

Scientists have expressed shock towards the FDA’s decision, especially because the agency ignored an outside advisory committee that voted almost unanimously against approval. Harvard Medical School Professor Aaron Kesselheim was one of three committee members who resigned in protest. He called the decision “probably the worst drug approval…in recent U.S. history.”

Widespread Reach of Aduhelm’s Approval

The cost of Aduhelm, coupled with the number of Americans who could end up using the drug, may have an even more widespread reach and play a role in the ongoing debate about reforming the FDA and enacting legislation to drive down the price of prescription drugs. Industry advocates worry that giving the government more power within the pharmaceutical industry will result in fewer medical breakthroughs. However, Aduhelm’s approval may show this line of thinking to be flawed. The FDA’s concerning approval of the drug may result in less productive future research, a longer wait for successful Alzheimer’s treatment, and more difficulties in funding programs that these patients and their families need.

For more information about the approval of Aduhelm, contact us today.

Additional Reading:

U.S. Food and Drug Administration Approval Process

Johnson & Johnson to Pay $2 Billion in Landmark Baby Powder Trial

Posted on June 15, 2021June 25, 2021

On June 1st, the Supreme Court rejected an appeal from Johnson & Johnson (J&J) without comment. In 2018, 22 women sued the company over its talc products, believing the asbestos in the products gave them ovarian cancer. Talc and asbestos are often found in the same mines, with asbestos being a known carcinogen. Jurors noted sufficient evidence to support the link between the talc, asbestos, and ovarian cancer diagnoses.

The plaintiffs won in a $4.7 billion verdict, which was later reduced to $2 billion by a Missouri appeals court. Ultimately, the women were each awarded $25 million in compensatory damages, and the company was fined.

Mesothelioma, a rare form of cancer, is also linked to asbestos exposure. J&J is currently fighting thousands of lawsuits linked to this cancer, having set aside almost $4 billion to cover the related expenses.

In 1976, J&J participated in an industry agreement to ensure asbestos-free products. However, in 2018, a Reuters investigation found mention of undisclosed asbestos contamination in over three decades of internal reports from the company. Just a year later, in 2019, the U.S. Food and Drug Administration (FDA) confirmed the presence of asbestos in J&J talc products.

In May 2020, U.S. and Canadian sales of baby powder ended due to “pandemic-related low demand and public safety misinformation.” Publicly, J&J maintains the safety of their products.

For more information about the link between J&J talc baby powder and asbestos exposure, contact us today.

Additional Reading:

Johnson & Johnson Sets Aside Nearly $4 Billion for Talc Verdict

Johnson & Johnson to Stop Selling Talcum Powder

Johnson & Johnson

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Posted on June 10, 2021July 8, 2021

In April 2020, the Food and Drug Administration (FDA) issued a recall of all prescription and over-the-counter (OTC) versions of ranitidine, more commonly known as Zantac, due to an increased cancer risk. Recently, the medication relaunched with a new name and ingredient: Zantac 360 (famotidine). The oral tablet is available in two strengths (10 mg and 20 mg) and without a prescription. It is only recommended for use by adults and children over the age of 12.

Famotidine and ranitidine are in the same class of medications. They are both H2 blockers and work equally well to combat heartburn, acid reflux, and other stomach ailments. After discovering that ranitidine contained a chemical called N-nitrosodimethylamine (NDMA), the FDA tested other H2 blockers for the carcinogen. Fortunately, famotidine has no traces of NDMA. Thus, these is no possible link to cancer, which means that Zantac 360 is a safer option for consumers.

Famotidine may look familiar: it’s the same active ingredient in Pepcid AC, another OTC heartburn medication, meaning Zantac 360 and Pepcid AC provide the same symptom relief without any benefits over the other. They both work within an hour and last for up to 12 hours.

This relaunch comes at a notable time. In addition to the hundreds of lawsuits that have already been filed against Zantac, a new study in The American Journal of Gastroenterology indicates that Zantac products may cause a 22 percent increase in the user’s risk of bladder cancer.

For more information about the Zantac recall and relaunch, contact us today.

Additional Reading:

Zantac Cancer Claims Invalid Under Federal Law

Zantac Lawsuits & Updates

Zantac (Ranitidine) Commonly Asked Questions

Zantac Cancer Risk

Bristol Myers Squibb Resolves False Claims Act Allegations

Posted on June 7, 2021June 7, 2021

Last month, Bristol Myers Squibb (BMS) reached an agreement with the United States and participating states to pay 75 million dollars plus interest in order to resolve False Claims Act allegations. The government contends that BMS underpaid the rebates owed under the Medicaid Drug Rebate Program (MDRP). Of the 75 million dollar payout, 41 million dollars will be paid to the United States and 34 million dollars will be paid to states involved in the settlement.

The MDRP makes it mandatory for drug manufacturers to pay quarterly rebates to state Medicaid programs in exchange for Medicaid coverage of their medications. The rebates are determined using the Average Manufacturer Prices (AMPs), which are reported to the government by the manufacturers. In general, the higher the AMP, the greater the rebate paid by the manufacturer to the Medicaid programs.

Between 2007 and 2013, BMS underreported the AMPs for various drugs by reducing the AMPs for service fees paid to wholesalers. Additionally, from 2014 to 2016, the company excluded additional value received based on price appreciation in contracts with wholesalers, also lowering the AMP. Thus, BMS underpaid quarterly rebates owed to participating states for nearly a decade, causing the United States to be overcharged for its payments to each state’s Medicaid program.

The case was presented under the whistleblower provisions of the False Claims Act. The whistleblower, a former head of healthcare industry trade group, first filed the lawsuit in 2013, but the government declined to intervene. Dan Miller of Walden Macht & Maran represented the whistleblower and believes the results speak for themselves: “We took this case to the brink of trial and prevailed.”

BMS, however, did not admit any guilt despite the settlement. A company spokesperson said, “Bristol Myers Squibb acted responsibly and in good faith in interpreting these regulations, and we deny that any wrongdoing occurred in this matter.”

For more information about this case, contact us today.

FDA to Reconsider Approvals for Unproven Cancer Drugs

Posted on June 4, 2021July 8, 2021

Annually, the United States approves multiple new uses for cancer drugs based on early evidence that they can shrink or slow the spread of tumors. How often do these initial results equate to longer, more robust lives for patients though? At the end of April, the Food and Drug Administration (FDA) met for the first time in a decade to determine if they should revoke the approvals for drugs that have failed to show they extend or improve life after use for cancer treatment.

During the three-day meeting, the FDA examined unproven cancer drugs from Merck, Roche, and Bristol-Myers Squibb. The schedule included presentations from drugmakers as well as opportunities to seek advice from cancer experts. The hope is that, through this examination, the FDA can remove expensive, unproven cancer drugs from the market. As Dr. Ezekiel Emanual, a cancer specialist and bioethicist at the University of Pennsylvania explains, “Doctors are using these drugs and patients are receiving them with all their toxicities and without knowing whether they are actually doing anything. We should not be in a situation where we’re endlessly uncertain.”

There has been an “unprecedented level of drug development” in recent years, with spending on cancer drugs more than doubling since 2013 to over 60 billion dollars annually. The U.S. spends more per person on prescription drugs than any other nation, and new medications can cost as much as 300,000 dollars per year. Unfortunately, the prices have risen faster than patient survival rates.

For more information about the potential withdrawal of cancer drugs from the market, contact us today.

Novo Nordisk Recalls Samples of Insulin Medication for Diabetes

Posted on June 2, 2021June 2, 2021

The Food and Drug Administration (FDA) announced that global healthcare company Novo Nordisk has voluntarily recalled samples of its insulin medication taken for diabetes, a health condition that affects over 34 million people in the United States alone.

The company recently recalled nearly 1,500 samples of Levemir®, Tresiba®, Fiasp®, NovoLog®, and Xultophy® — all insulin products that are prescribed to lower a diabetes patient’s blood glucose levels. It was also revealed that all recalled items “are packaged in cartons with either a vial, pen-injector (FlexPen® or FlexTouch®) or a cartridge (PenFill®).” The company stresses that use of a recalled product sample may not deliver the correct dosage, possibly leading to “hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening.”

The samples were not stored within the correct temperature ranges, which can cause diminished product efficacy. Fierce Pharma reports that the issues occurred during the winter storm power outages in Texas earlier this year as well as due to human error in physician offices. With about 1.5 million samples in-market, this recall affects 0.1 percent of samples from Novo Nordisk.

For more information about this recall, contact us today.

New Class Action Brought Against Ethicon and Johnson & Johnson

Posted on May 27, 2021July 8, 2021

New proceedings have been launched against Ethicon and Johnson & Johnson for manufacturing defective mesh implants. Women implanted with the pelvic floor repair systems after July 4, 2017, may have experienced complications such as chronic pain, painful intercourse, and incontinence. As a result, Shine Lawyers filed a second class action in the Federal Court in early April.

According to Shine, the first class action was “the largest women’s health class action in Australia’s history”. In November 2019, Justice Anna Katzmann declared that the mesh implants from Ethicon and Johnson & Johnson were “not fit for purpose” and of “unmerchantable quality.”

Shine practice leader Rebecca Jancauskas shares, “We have seen firsthand the terrible impact these products can have on women’s lives, and [these repercussions] drive our team to pursue all available avenues to seek reparations.”

The new proceedings, headed up by Jancauskas, will include women who did not meet the cut-off date for the first class action. She adds, “We know there are thousands of women who were implanted with these defective products or who have developed complications… That’s why we’ve continued to fight for justice for these women, so none are left behind.” Hundreds of women who expressed interested in the earlier trial are potentially eligible to participate in the second lawsuit.

A separate lawsuit was recently filed against Boston Scientific Corporation and Boston Scientific Pty Ltd by AJB Stevens Lawyers, also on behalf of women who have suffered due to unacceptable mesh implants.

For more information about these proceedings, contact us today.

Hernia Mesh | Lawsuits and Legal Update

Johnson and Johnson seeks to dismiss thousands of talc baby powder lawsuits

Extra Strength Acetaminophen Nationwide Recall

Posted on May 18, 2021May 29, 2021

A-S Medication Solutions, LLM has voluntarily recalled nearly 200,000 bottles of extra-strength acetaminophen 500mg tablets due to a mislabeling issue. According to the Food and Drug Administration (FDA), the bottles have “an incomplete prescription drug label rather than the required OTC Drug Facts label.”

If the safety warnings on the OTC label are not considered, acetaminophen could be potentially harmful. The correct label includes warnings about liver damage if the recommended dose is exceeded; if users combine with excessive consumption of alcohol; or if consumers are allergic to the active ingredient.

Humana included the 100-count bottles as part of Health Essentials Kits for its members. The impacted bottles were likely distributed nationwide between January 14, 2021, and March 15, 2021, with expiration dates of either July 31, 2022, or August 31, 2022.

So far, there have been no reports of adverse events concerning the recalled product. However, the FDA is requesting that all affected bottles be returned.

1.800.597.1870

Free Case Evaluation

Proton Pump Inhibitors Linked to Serious Health Complications

Proton Pump Inhibitors and Skin Reactions

Additional Reading:

North Carolina Takes Legal Action Against JUUL

Notable Increase in E-Cigarette Usage

Additional Reading:

The FDA’s Concerning Approval Of New Alzheimer’s Drug, Aduhelm

Widespread Reach of Aduhelm’s Approval

Additional Reading:

Johnson & Johnson to Pay $2 Billion in Landmark Baby Powder Trial

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Additional Reading:

Bristol Myers Squibb Resolves False Claims Act Allegations

FDA to Reconsider Approvals for Unproven Cancer Drugs

Novo Nordisk Recalls Samples of Insulin Medication for Diabetes

New Class Action Brought Against Ethicon and Johnson & Johnson

Related Articles:

Extra Strength Acetaminophen Nationwide Recall

Stay Informed

Free Drug and Medical Device Case Review