Verdict Included Millions in Punitive Damages

The trial concluded Friday in the U.S. District Court, Northern District of Florida, following a little over one month of testimony. According to court documents, the jury hearing the lawsuit agreed that the 3M military earplugs were defective and responsible for three plaintiffs’ hearing loss.

Each was awarded $830,500 in compensatory damages and $2.1 million in punitive damages, bringing the total judgment against 3M to 7.1 million. Juries award punitive damages to punish defendants for wrongful conduct.

“The evidence is clear: 3M knew their earplugs were defective, yet they allowed our servicemembers to suffer these life-altering injuries,” the plaintiffs’ attorneys said in a statement issued after the verdict was rendered.

About 3M Combat Arms Earplugs

Combat Arms Earplugs, Version 2, were standard issue for all U.S. active-duty military personnel serving on combat deployments or taking part in live-fire training exercises from 2002 through 2015.  The devices were designed and developed by Aearo Technologies, which was granted an exclusive contract to supply protective earplugs to the U.S. Defense Logistics Agency in 2002. The 3M Company acquired Aearo in 2008, at which time it became responsible for the administration of the military contract.

The CAEV2 design was dual-ended and reversible depending on the level of protection a wearer required. When the green end was inserted into the ear canal, they blocked all sound in the manner of traditional earplugs. The yellow end was supposed to prevent eardrum damage from gunfire, explosions, and other concussive noises typically encountered during combat while allowing spoken commands and other low-level noises to be heard.

Over 229,000 3M Military Earplugs Lawsuits Still Pending

3M now faces more than 220,000 military earplugs lawsuits that have been centralized before a single judge in the Northern District of Florida.

All plaintiffs similarly allege that their use of CAEV2 while on active duty from 2003 through 2015 resulted in service-related hearing loss and tinnitus. Among other things, they assert that the earplugs were too short to fit properly in certain individuals and failed to form the necessary protective seal when in use. While these defects were allegedly known to the defendants as early as 2000, Aero and 3M falsely certified that the earplugs met all standards of the military contract and failed to instruct the military in their proper use.

The trial that concluded last week was considered a bellwether case and was intended to provide some insight into how other juries might rule in similar military earplugs lawsuits. The litigation’s next bellwether trial is scheduled to begin on May 21^st.

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Both studies were conducted by Valisure, the online pharmacy that first raised the alarm about the drug’s potential link to cancer.

What the Valisure Zantac Studies Revealed

The first study was published on January 29^th in the Journal of the American Medical Association (JAMA) Network Open and illustrated how ranitidine might be a significant source of N-Nitrosodimethylamine (NDMA) – a known carcinogen — under a range of physiologically-relevant conditions.

“Specifically, under simulated gastric conditions, NDMA yield from a standard tablet of ranitidine was seen to increase with both rising nitrite and decreasing pH, to levels up to three orders of magnitude beyond established limits of exposure,” Valisure said in a statement announcing the findings.

The second study was published in MedRxiv and involved evaluations of 10,347 cancer patients. The analysis found a significant association between the use of ranitidine and elevated diagnosis rates of breast, thyroid, bladder, and prostate cancers. The study’s chemical analysis also suggested that the rapid formation of NDMA might continue for extended periods of time when ranitidine remains exposed to gastric conditions. This is particularly concerning, as the use of Zantac has been associated with longer gastric emptying times.

“The data published today strongly supports decades of research that ranitidine is fundamentally unstable, can form NDMA in a variety of conditions including in the human body, and could be carcinogenic and toxic to humans,” said David Light, Founder & CEO of Valisure and an author on both studies. “These findings underscore the vital importance of additional quality assurance testing of on-market drug products.”

Hundreds of Zantac Lawsuits Allege NDMA in Ranitidine Caused Cancer

In 2019, Valisure warned that it had detected excessive levels of NDMA in every Zantac sample – including over-the-counter and generic versions – it had tested. The online pharmacy also asserted that the instability of the ranitidine molecule results in the production of NDMA when the drug is subjected to conditions that mimic human digestion.

Months later, Emery Pharma reported that its own testing suggested the carcinogen was produced when ranitidine products were exposed to high temperatures typically encountered during shipment and storage.

In April 2020, the  U.S. Food & Drug Administration (FDA)  ordered all Zantac and generic ranitidine drugs recalled. By then, however, many pharmaceutical companies had already taken steps to withdraw their ranitidine-containing heartburn drugs from the market. Several major retailers, including Walmart, Walgreens, Rite-Aid, and CVS, had also stopped selling the medications.

More than 570 Zantac lawsuits are now pending in a multidistrict litigation underway in the U.S. District Court, Southern District of Florida, all of which allege the ingestion of ranitidine-containing medications contributed to the development of cancer. Plaintiffs further claim that the various defendants had long known that ranitidine could expose users to dangerous levels of NDMA but failed to disclose this risk to doctors and patients.

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The trial is intended to serve as a test case and could provide valuable insight into how other juries might resolve similar hearing loss claims involving the same 3M military earplugs.

Combat Arms Earplugs, Version 2: History and Background

Combat Arms Earplugs, Version 2, were standard issue for all U.S. active-duty military personnel serving on combat deployments or taking part in live-fire training exercises from 2002 through 2015.  The devices were designed and developed by Aearo Technologies, which was granted an exclusive contract to supply protective earplugs to the U.S. Defense Logistics Agency in 2002. The 3M Company acquired Aearo in 2008, at which time the Minnesota-based conglomerate became responsible for the military contract.

The CAEV2 design was dual-ended and reversible depending on the level of protection a wearer required. When the green end was inserted into the ear canal, they blocked all sound in the manner of traditional earplugs.

The yellow end was supposed to shield the eardrums from gunfire, explosions, and other damaging concussive noises typically encountered during combat. However, they also allowed the wearer to hear spoken commands and other low-level noises.

Veterans Allege 3M Military Earplugs Failed to Protect Their Hearing

Court documents indicate that at least 229,397 3M military earplugs lawsuits are now pending in the Northern District of Florida, where all federally filed claims of this nature have been consolidated for cordinated pretrial proceedings.

All of the pending cases are being pursued by U.S. military veterans who claim their use of CAEV2 while on active duty from 2003 through 2015 was responsible for causing their service-related hearing loss and tinnitus. Among other things, they assert that the earplugs were too short to fit properly in certain individuals and failed to form the necessary protective seal when in use. While these defects were allegedly known to the defendants as early as 2000, Aero and 3M falsely certified that the earplugs met all standards of the military contract.

In July 2018, the 3M Company entered into a $9.1 million settlement with the U.S. Department of Justice to resolve allegations that it knowingly sold defective Combat Arms Earplugs to the U.S. Defense Logistics Agency for over a decade. Although those charges echoed the claims put forth by veterans now suing 3M, the settlement agreement did not require the company to admit liability or compensate those who lost their hearing due to the alleged defects.

The trial set to begin on Monday will involve a consolidated lawsuit brought by three veterans. Two additional bellwether trials are scheduled to get underway on May 17^th and June 7^th.

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“We will evaluate the clinical trial results we have received to date and will work with the drug manufacturer to obtain further information as soon as possible,” the U.S. Food & Drug Administration (FDA) said in a communication issued on February 4^th. “We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

FDA First Approved Xeljanz in 2012

Xeljanz was first approved in 2012 to treat adults with rheumatoid arthritis who did not respond well to methotrexate. Five years later, the drug was approved to treat patients with psoriatic arthritis who did not respond well to methotrexate or other similar medicines. In 2018, the FDA approved Xeljanz to treat ulcerative colitis, a chronic, inflammatory disease affecting the colon.

Xeljanz belongs to a class of drugs called JAK inhibitors that work by suppressing the immune system. An overactive immune system is known to contribute to these three indications. Xeljanz is an oral medication available in either a 5mg twice-daily dose or a 10-mg twice-daily dose. Xeljanz XR is an 11mg extended-release tablet.

Xeljanz Black Box Warning for Blood Clots

When the FDA initially approved Xeljanz, Pfizer was ordered to conduct a post-market study comparing the rate of certain heart-related complications among rheumatoid arthritis patients receiving either the 5mg twice-daily dose, the 10-mg twice-daily regimen, or TNF blockers. Interim results from that study suggested patients taking the higher dose of Xeljanz were more likely to experience a pulmonary embolism – a life-threatening blood clot that travels to the lungs — or die compared to those taking either the lower dose or a TNF blocker.

Those findings prompted the FDA to order a new Black Box Warning – its strongest safety notice – to be added to the Xeljanz label.  The agency also limited the approved use of Xeljanz for ulcerative colitis to patients who are not treated effectively or who experience severe side effects with certain other medicines.  Doctors are now cautioned to prescribe the lowest effective dose possible and limit the 10mg twice-daily regimen to the shortest duration possible.

Cancer, Heart Problem Risks Seen with Both Xeljanz Doses

That trial is now complete. According to the FDA, the initial results show a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis patients treated with both the 5mg and 10mg doses of Xeljanz than patients treated with a TNF inhibitor. The agency is now awaiting additional results from the trial.

For now, patients should NOT stop taking Xeljanz without first consulting with their health care professionals, as doing so may worsen their condition. Health care professionals should consider the benefits and risks of Xeljanz when deciding whether to prescribe or continue patients on the medicine.

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According to a Practice and Procedure Order issued in the U.S. District Court, Northern District of Georgia, on January 7^th, the conference will be held over Zoom beginning at 10:00 a.m.

All outstanding disclosure and discovery deadlines related to the pending ParaGard lawsuits are currently stayed. The Order further directed attorneys to submit a brief statement outlining their preliminary understanding of the facts involved in the litigation by January 25^th.

ParaGard Lawsuit Conference: What’s on the Agenda?

Several issues will be addressed during today’s conference, including the appointment of the plaintiffs’ and defendants’ liaison counsel. Lawyers on each side were to meet and confer on possible candidates and file their proposals with the Court by February 2^nd.

“Appointment of liaison counsel will be made by the Court after full consideration of the proposals,” the January 7^th Order states. “At the Initial Conference, liaison counsel, if appointed, and/or the parties should be prepared to discuss any additional needs for an organizational and leadership structure or any additional matters consistent with the efficient handling of this matter.”

Finally, the Court will also consider the appointment of attorneys to a Plaintiffs’ Steering Committee. This committee will be tasked with conducting and coordinating the discovery stage of the ParaGard litigation with the Defendants’ representatives or committee.

ParaGard IUD Lawsuits: What’s the Problem?

ParaGard is a copper intrauterine device (IUD) implanted into the uterus to provide long-term birth control for up to 10 years. The device consists of a t-shaped plastic frame wrapped in copper wire coils and works by trigging an inflammatory reaction that is toxic to sperm and prevents pregnancy.

Although the manufacturer of ParaGard asserts that the IUD is easy to remove and will not impair fertility once explanted, women pursuing these lawsuits claim the device is prone to fracture during removal procedures. This occurrence can allegedly result in severe internal injuries and the need for a total hysterectomy or other invasive surgical procedure to retrieve the IUD’s broken fragments.

According to court records, just under 100 ParaGard IUD lawsuits were pending in the Northern District of Georgia as of January 19^th. However, in seeking to have the federal docket centralized in one jurisdiction for coordinated pretrial proceedings, plaintiffs’ attorneys had predicted that hundreds of similar cases would eventually be filed in courts around the United States.

ParaGard IUD lawsuits currently pending in the Northern District of Georgia and any transferred there in the future will undergo coordinated discovery and motions practice before a single federal judge. The multidistrict litigation process is intended to avoid conflicting pretrial rulings from different courts in cases that involve similar factual allegations, avoid duplicative discovery, and serve the convenience of common witnesses, parties, and the judicial system.

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According to an update issued earlier this month by the U.S. Judicial Panel on Multidistrict Litigation, a total of 207,702 3M military earplugs lawsuits were pending in the Northern District of Florida as of December 15^th. All of the claims were filed on behalf of former U.S. military personnel who developed hearing loss and/or tinnitus allegedly due to their use of CAEV2 while on active duty from 2002 through 2015.

CAEV2 Were Standard Issue for U.S. Active-Duty Personnel

Combat Arms Earplugs, Version 2, were standard issue for all U.S. active-duty personnel serving on combat deployments or participating in live-fire training exercises at domestic and overseas military installations during that time period. The military earplugs were designed and developed by Aearo Technologies, which was granted an exclusive contract to supply the devices to the U.S. Defense Logistics Agency in 2002. The 3M Company took over that contract when it acquired Aearo in 2008.

The CAEV2 design was dual-ended. When the green end was inserted, the devices blocked all sound in the manner of traditional earplugs. The yellow end ostensibly protected the eardrums from gunfire, explosions, and other damaging concussive noises typically encountered during combat. However, the wearer was still able to hear spoken commands and other low-level noises.

Currently, more than 1.7 million veterans receive compensation for tinnitus, and more than 1.1 million veterans get it for hearing loss. Even though military earplugs are standard issue in every branch of the service, veterans are 30% more likely to suffer from hearing loss or tinnitus than the general population. According to the Veterans Administration, those who served after Sept. 11, 2001, are four times more likely to develop hearing problems.

Vets Claim 3M Combat Arms Earplugs Failed to Protect Their Hearing

Veterans pursuing 3M Combat Arms Earplugs lawsuits claim the CAEV2 design was too short to fit certain individuals and failed to form a protective seal. They also assert that the earplugs’ manufacturers were aware of these defects as early as 2000, but manipulated test results and falsely certified Combat Arms Earplugs, Version 2, met all military contract standards.

In July 2018, the 3M Company entered into a $9.1 million settlement with the U.S. Department of Justice to resolve allegations that it knowingly sold defective Combat Arms Earplugs to the U.S. Defense Logistics Agency for over a decade. Although those claims echo the allegations put forth by veterans now suing 3M, the settlement agreement did not require the company to admit liability or compensate those who might have been harmed.

The multidistrict litigation underway in Florida was established in April 2019 to allow all federally-filed injury claims involving CAEV2 to undergo coordinated discovery and other pretrial proceedings. At that time, fewer than 700 cases were transferred to the consolidated proceeding.

3M Combat Arms Earplugs lawsuits could begin going to trial in April 2021.

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What This Latest Zantac Study Found

The study, which appeared this month in the medical journal Organic Process Research & Development, was conducted by scientists in the United Kingdom in cooperation with GlaxoSmithKline. Their root-cause analysis determined that rising levels of N-nitrosodimethylamine (NDMA) in Zantac were the result of degrading ranitidine hydrochloride molecules. The analysis also suggested that heat – including the heat generated by the human body’s digestive process –  was among the factors that can trigger the transformation of ranitidine into NDMA.

“Analysis using suitably isotopically labeled ranitidine hydrochloride confirmed the formation of NDMA solely from an intermolecular reaction of ranitidine hydrochloride without involvement of impurities,” the study authors wrote. “Factors that influence the rate of degradation include heat, humidity, and the crystal morphology of ranitidine hydrochloride with the material exhibiting a columnar habit showing a slower rate of degradation.

Discovery of NDMA Sparks Massive Zantac Recall

GlaxoSmithKline was just one of the numerous pharmaceutical companies to recall Zantac and other ranitidine-containing heartburn drugs in 2019 after the online pharmacy Valisure detected excessive levels of NDMA in every sample it tested. Valisure also asserted that the instability of the ranitidine molecule results in the production of NDMA when the drug is subjected to conditions that mimic human digestion.

Emery Pharma later reported that its own testing suggested NDMA was produced when ranitidine products were exposed to high temperatures typically encountered during shipment and storage.

The U.S. Food & Drug Administration (FDA) eventually confirmed those findings in April 2020 and ordered all Zantac and generic ranitidine drugs recalled. But by that time, many pharmaceutical companies had already taken steps to withdraw their ranitidine-containing heartburn drugs from the market. Several major retailers, including Walmart, Walgreens, Rite-Aid, and CVS, had also stopped selling the medications by the time the FDA acted.

Over 550 Zantac Lawsuits Pending in Federal Litigation

NDMA is an organic, environmental contaminant found in water and foods, including meats, dairy, and vegetables. However, animal testing suggests exposure to high levels of NDMA can increase the risk of cancer, especially kidney, liver, and gastrointestinal cancers. Both the World Health Organization and the U.S. Environmental Protection Agency have designated NDMA as a probable human carcinogen.

More than 550 Zantac lawsuits are now pending in a multidistrict litigation underway in the U.S. District Court, Southern District of Florida, all of which allege the ingestion of ranitidine-containing medications contributed to the development of cancer. Plaintiffs further claim that Glaxo and other manufacturers had long known that ranitidine could expose users to dangerous levels of NDMA but failed to disclose this risk to doctors and patients.

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New York Law Targets Norlite Incinerator in Cohoes

Last month, Governor Andrew Cuomo signed legislation that prevents incineration of firefighting foams that contain perfluoroalkyl and polyfluoroalkyl substances, chemicals known collectively as PFAS. While the new law applies to cities designated as environmental justice areas and with 16,000 to 17,000 residents, its actual target is Cohoes, New York. Cohoes is home to the Norlite hazardous waste incinerator, the only facility in the state – and among just a few nationwide – known to have processed PFAS-containing firefighting foams.

The state Department of Environmental Conservation ordered Norlite to cease disposal of the material in 2019, and the city of Cohoes enacted a one-year moratorium on PFAS incineration last April. But a permanent ban was sought by environmentalists, local officials, and residents after it was revealed as incinerated more than 2 million pounds of foam through contracts with the Pentagon that have since been canceled. The company had also incinerated foam shipped from firehouses across the East Coast.

“This establishes a national precedent that other states should follow,” Judith Enck, former Region 2 administrator for the U.S. Environmental Protection Agency, said in a statement.

About PFAS-Containing Firefighting Foams

Aqueous film-forming foams (AFFF) made with PFAS were routinely used at military bases and civilian airports to extinguish fires driven by jet fuel and other flammable liquids.  Although PFAS are resistant to heat, grease, stains, and water, studies conducted since the late 1960s have linked exposure to these human-made chemicals to toxic effects that can impact the liver, testicles, and other organs. PFAS are also known as the “forever chemicals” because they never break down once they’ve accumulated in the human body or environment

The EPA currently classifies two specific PFAS used in AFFF —  PFOA and PFOS — as “emerging contaminants,” and has established a “Lifetime Health Advisory” setting a recommended lifetime limit for exposure from drinking water. The U.S. Department of Veteran Affairs has also issued a warning regarding increased risks of breast cancer, pancreatic cancer, prostate cancer, testicular cancer, and kidney cancer related to the use of firefighting foam at U.S. military installations.

Last December, the U.S. Congress mandated that PFAS-containing firefighting foams be phased out by 2024. The prior year, legislators directed the Federal Aviation Administration to modify its regulations to allow municipal airports to use PFAS-free alternatives.

Over 900 Firefighter Foam Lawsuits Pending in Federal Court

Hundreds of plaintiffs who developed cancer following exposure to AFFF are now pursuing firefighting foam lawsuits in federal courts around the United States. In December 2018, the U.S. Judicial Panel on Multidistrict Litigation consolidated these clams before a single federal judge in the District of South Carolina, allowing the cases to undergo coordinated discovery and other pretrial proceedings.  As of December 15, 2020, the litigation had grown to include 910 filings.

Plaintiffs generally allege that firefighter foams made with PFOA and PFOS contaminated groundwater near various military bases, airports, and other industrial sites where AFFF was used. They seek compensation for personal injury, a need for medical monitoring, property damage, and other economic losses.

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Metformin Recalls: What’s the Problem?

The FDA began investigating contaminated metformin late last year after Singapore authorities discovered that some tablets contained excessive levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen. Although the agency’s own tests did find NDMA in metformin sold in the United States, the regulator maintained that the levels detected were far below its recommended daily limit of 96 nanograms.

That all changed this past April when the online pharmacy Valisure reported that its own testing program had detected excessive levels of NDMA in 16 of 38 metformin samples tested. Because Valisure is the same company that discovered high levels of NDMA in Zantac, its metformin findings caused quite a stir.

Two months later, further FDA testing confirmed excessive levels of NDMA in some extended-release metformin product and initially asked five drug makers to remove their medications from the market. Since then, metformin ER recalls have been announced by the following companies:

• Amneal Pharmaceuticals
• Apotex Corp.
• Bayshore Pharmaceuticals
• Granules Pharmaceuticals
• Lupin Pharmaceuticals
• Marksans Pharma Limited
• Nostrum Pharmaceuticals
• Teva Pharmaceuticals

Other Medications Contaminated with NDMA

NDMA is classified as a probable human carcinogen based on animal tests that suggest exposure to high levels may increase the risk for cancer, including kidney, liver, gastrointestinal, and breast cancer.

The FDA began testing drugs for the compound shortly after NDMA turned up in generic versions of valsartan and other “sartan” blood pressure medications, resulting in dozens of recalls.

Last fall, the agency began investigating the presence of NDMA in brand-name and generic versions of Zantac. The agency ultimately requested that all versions of the heartburn medication be removed from the market entirely after confirming that the amount of NDMA in Zantac can increase over time.

What to Do if Your Metformin ER was Recalled

Only extended-release metformin tablets in doses of 500 to 750 mg are affected by these recent recalls. Immediate-release tablets have not been found to contain high levels of NDMA.

Even if you have metformin tablets that appear on the recall list, it’s important to keep taking them until you can get a new prescription or alternative form of treatment for glucose management from your doctor. It could be dangerous for patients with Type 2 diabetes to stop taking their metformin without first talking to their health care professional.

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According to separate filings with the U.S. Securities and Exchange Commission (SEC), federal prosecutors are trying to determine if the companies violated the federal False Claims Act by failing to disclose the presence of a probable carcinogen in their ranitidine-containing heartburn drugs.

“On 18 June 2020, the Group received a Civil Investigative Demand (CID) from the US Department of Justice (DOJ) seeking information related to Zantac pursuant to the False Claims Act,” GlaxoSmithKline wrote in its Q3 report to the SEC. “The Group is cooperating with the DOJ to provide this information.

Both companies must now submit information and documents to the DOJ, including applications and communications with the U.S. Food and Drug Administration (FDA) related to the development and marketing of Zantac.

Zantac and Ranitidine Products Recalled for NDMA

For decades, millions of people have used Zantac and generic versions of ranitidine, believing the medications were safe and effective treatments for heartburn. Zantac was first brought to market by GlaxoSmithKline in the 1980s, but Sanofi later acquired the rights to market name-brand versions in the United States. Multiple generic drug makers were also approved to sell their own over-the-counter and prescription versions of ranitidine.

In September 2019, the online pharmacy Valisure informed the FDA that it had detected high levels of N-Nitrosodimethylamine (NDMA) in every sample of Zantac and ranitidine it had tested. NDMA is designated a probable human carcinogen by both the U.S. Environmental Protection Agency and the World Health Organization. Animal studies have linked the compound to various cancers, including kidney cancer, liver cancer, gastrointestinal cancer, and breast cancer.

At the time, Valisure suggested the contamination was a consequence of the ranitidine molecule’s instability, which resulted in the production of NDMA when the drug was subjected to conditions that mimicked human digestion. Emery Pharma later reported that its own testing suggested NDMA was produced when ranitidine products were exposed to high temperatures typically encountered during shipment and storage.

The FDA confirmed those findings in April and ordered all Zantac and generic ranitidine drugs recalled. By that time, many pharmaceutical companies had already taken steps to withdraw their ranitidine-containing heartburn drugs, and several major retailers, including Walmart, Walgreens, Rite-Aid, and CVS, had already pulled the products from store shelves.

Over 500 Zantac Lawsuits Pending in Federal Litigation

More than 500 Zantac lawsuits are now pending in a multidistrict litigation underway in the U.S. District Court, Southern District of Florida, all of which allege the ingestion of ranitidine-containing heartburn drugs caused users to develop various forms of cancer. Plaintiffs further claim that Sanofi, Glaxo, and other manufacturers had long known that ranitidine could expose users to dangerous levels of NDMA but failed to disclose this risk on the product labels or through any other means.

Despite the FDA’s actions, the recent recalls, and the DOJ investigation, Sanofi and Glaxo continue to deny the allegations put forth in Zantac lawsuits.

“We stand by the long-standing science that supports the safety of Zantac OTC products, which have been used by consumers for over two decades. We are not going to comment on the specifics of ongoing litigation,” a Sanofi spokesperson recently told S&P Global Market Intelligence.

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