COVID-19: Has Your Insurance Company Denied Your Business Interruption Claim?

COVID-19 has created unprecedented losses and trying conditions across the world. Loved ones have been lost to the disease, many lives have been upended, and the economy is suffering enormously.

Business owners in Minnesota and across the country are suffering substantially due to COVID-19 related losses. These losses are the result of both executive orders mandating closure of certain businesses and temporary business closures due to the risk of COVID-19 cases at the workplace.

Why Are Business Interruption Claims Being Denied?

Many business owners hold property insurance coverage to support them in times like these when their business experiences unexpected losses due to damage to the business. Property insurance policies are supposed to cover business monetary losses in the event of damage to property as well as the inability to operate a business related to executive orders.

Unfortunately, most insurance carriers in Minnesota and nationwide have been denying business owner claims for coverage after they sustained substantial income losses related to COVID-19. These carriers claim their policies were not meant to cover losses from a pandemic such as COVID-19 and that the pandemic does not constitute physical damage to property. However, the public policy and personal implications from such a conclusion could forever harm business owners and cause further damage to an already fragile economy.

Business Interruption Insurance Litigation Status

At this time, there are several individual actions filed in various state and federal courts across the country over claim denial issues related to business income loss coverage. There have also been several petitions filed before the Judicial Panel of Multidistrict Litigation [JPML] to consolidate such claims into a multidistrict litigation. The petitions argue that while insurance plan language may vary across carriers and plan-holders, that the issues at stake, what constitutes property damage to trigger coverage, are similar for every plaintiff.

The JPML will hear arguments on these petitions on July 30, 2020. Shortly thereafter, the JPML will issue an order deciding whether these types of claims are appropriate for consolidation, and if so, the location for such consolidated proceeding.

Let GoldenbergLaw Help

Partner Laura Pittner
Laura Pittner

GoldenbergLaw is representing business owners to further pursue these denials from their insurance carriers. If you have a claim or know someone who has a business income loss claim, please let us help. It is important to report and track losses and make a claim in a timely manner to preserve coverage opportunities. Time is of the essence.

Contact GoldenbergLaw Partner Laura Pittner today at lpittner@goldenberglaw.com or 612-436-5027 to discuss your potential claim. Let us deliver the Gold standard advocacy you deserve.

New Testing Finds Dangerous Levels of NDMA Contamination In Metformin

The online pharmacy Valisure recently announced that it found dangerously high levels of the probable human carcinogen N-nitrosodimethylamine (NDMA) in certain batches of the popular type-2 diabetes drug, Metformin. Valisure tested 38 batches of Metformin produced by a range of manufacturers and found levels of NDMA over the Food and Drug Administration’s (FDA) daily acceptable intake limit of 96 nanograms in 16 of these batches. Some of the NDMA levels were found to be over 10 times the daily acceptable limit!

On May 27, 2020, the FDA announced that it had also found high levels of NDMA in certain batches of Metformin and would be contacting the manufacturers of the contaminated medications to take appropriate action.

Valisure’s FDA Citizen Petition

Since this discovery, Valisure filed a Citizen Petition with the FDA and requested that the agency recall the contaminated batches of Metformin. In addition, Valisure implored the FDA to re-examine and modify testing methods to reduce the risk of underestimating NDMA levels.

Within the Citizen Petition, Valisure highlighted how they followed the FDA’s recommended testing protocols, but had also made some revisions to improve the accuracy of the tests.

Previous Valisure investigations and notifications to the FDA about NDMA contamination in the blood pressure medication Valsartan and the popular heartburn medication Zantac contributed to extensive recalls in the United States.

Background Information on Metformin and the FDA

On December 5, 2019, the FDA announced its investigation into the possibility of carcinogen contamination in Metformin. The statement came just one day after Singapore’s national health agency issued a recall of three Metformin medications due to NDMA contamination. Following the statement from Singapore, multiple global health agencies, such as Health Canada and the European Medicine Agency, announced similar investigations.

Just two months later, the FDA announced that it had found trace levels of NDMA contamination in Metformin. However, the FDA claimed that those levels did not exceed the acceptable daily intake limit of 96 nanograms.

New testing in May 2020 found levels of NDMA above the acceptable intake limit. It is possible Metformin recalls may be the agency’s next step in assessing the safety of the medication.

Valisure’s Testing Methods

The FDA used the Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) Method for determining the presence of NDMA in Metformin and published the details of their method on February 4, 2020. The method, which was developed and validated by the FDA, was used to determine the quantity of NDMA present in Metformin.

The method accomplishes its purpose by separating the NDMA impurity from Metformin by reverse phase chromatography (the process of separating hydrophobic moieties and those that do not have a dominant polar character) which is then detected by a high-mass accuracy (HRAM) mass spectrometer.

Quantitation is then performed by comparing the peak area of the NDMA impurity in the extracted ion chromatogram of the samples to the peak area of the NDMA reference standard using external calibration.

Valisure used the testing principle of the FDA’s method but also made modifications to achieve a lower limit of detection (LOD), which allows the tests to be alerted to lower levels of NDMA present in the samples. In addition, Valisure’s method allows for a lower limit of quantitation (LOQ) and a wider reportable range while using the same sample preparation method as the FDA.

As a result of the improvements, Valisure’s methods generates increased chromatographic resolution and sharper peaks demonstrating increased NDMA contamination in Metformin samples.

These optimizations allow Valisure’s testing methods to extract more detail about the amount of NDMA within Metformin samples. Without these improvements, Valisure claims the FDA’s method may have underestimated the NDMA concentration in the Metformin.

Risks of Metformin NDMA Contamination

Valisure’s findings reveal that the danger of NDMA contamination in Metformin may be even more severe than previously estimated by the FDA. The impact of this discovery is compounded by the fact that Metformin is one of the most prescribed drugs in the United States.

Metformin is sold under brand names: Glucophage, Glucophage XR, Fortamet, Riomet and Glumetza, in addition to being sold as a generic. There are dozens of manufacturers who produce and distribute Metformin products in the United States.

Exposure to NDMA beyond the daily acceptable intake limit has been linked to various cancers, such as:

  • Stomach cancer
  • Bladder cancer
  • Intestinal cancer (in both the large and small intestine)
  • Colon cancer / Colorectal cancer
  • Esophageal cancer
  • Liver cancer
  • Prostate cancer
  • Pancreatic cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Kidney cancer
  • Multiple Myeloma

How GoldenbergLaw Can Help You

If you or a loved one has been diagnosed with cancer after taking metformin, contact GoldenbergLaw for a free consultation on a metformin lawsuit today. Our Minnesota Cancer Attorneys have over 30 years of experience fighting pharmaceutical corporations and will deliver the Gold standard advocacy you deserve.

J&J Discontinues Sales of Talc-Based Baby Powder

Johnson & Johnson announced today it was discontinuing sales of its talc-based baby powder products in the United States and Canada amid a firestorm of lawsuits claiming its signature product contains asbestos. The announcement comes just weeks after US District Judge Freda Wolfson ruled to allow testimony from plaintiffs’ experts in the New Jersey-based Multidistrict Litigation. Thousands of claimants have argued that regular exposure to the baby powder has caused them to develop ovarian cancer and mesothelioma.

Was Decision To Pull Talcum Powder Related To 2019 Recall?

In October 2019, J&J issued its first ever recall of talc-based baby powder after FDA testing found trace amounts of asbestos in the product. The company claims that this is a “commercial decision” due to a 60% decline in sales since 2017 as consumer habits change due in large part to lawsuits filed over the safety of the product.

As to the timing of discontinuing the talc-based Baby Powder, Professor of Marketing at Georgetown, Christie Nordhielm, claims that it appears Johnson & Johnson decided to withdraw from the market while consumers are concerned with the COVID-19 pandemic: “It’s a nice time to quietly do it, it will eliminate reputational hit.”

Thousands of lawsuits from consumers and survivors claim that Johnson & Johnson’s talcum powder products caused cancer due to contamination with asbestos—a known carcinogen to humans. Internal company records and trial evidence demonstrate that from at least 1971 to the early 2000s, J&J’s raw talc and finished powders sometimes tested positive for small amounts of asbestos.

Johnson & Johnson has also been the target of a federal criminal investigation into their lack of forthrightness about their talc products’ safety. 41 states have investigated Johnson & Johnson’s Baby Powder in addition to an investigation being launched by a Congressional subcommittee about the health of asbestos in talc-containing consumer products.

The pharmaceutical giant will continue to sell its cornstarch-based powder.

Ruling Clears Plaintiffs For Bellwether Trials

Judge Wolfson ruled on April 27, 2020 that five plaintiffs’ experts in the Talcum Powder litigation against Johnson & Johnson could appear before juries.

This is the first ruling by a federal judge on the reliability of plaintiffs’ experts testifying about whether or not talcum baby powder causes ovarian cancer. Of the five plaintiff experts that Judge Wolfson allowed to testify before juries in talcum powder litigation, two of those experts have testified before Congress on talcum powder safety.

Based on epidemiological studies, the plaintiffs’ experts will be able to testify that J&J’’s talc-based products can contribute to the development of ovarian cancer cancer due to contamination with asbestos and heavy metals. J&J wanted to prevent the plaintiffs’ experts from testifying in order to effectively eliminate all of the cases overseen by Judge Wolfson.

A handful of the more than 16,000 talcum powder lawsuits that have been consolidated under the MDL overseen by Judge Wolfson will now be selected for early “bellwether” trials which can help determine the strength of each side’s case and aid in a potential settlement process.

The decision opens the path for bellwether trials to begin in the MDL sometime in 2021.

Let Us Help

GoldenbergLaw is currently litigating cases where individuals have been diagnosed with ovarian cancer or mesothelioma after long term talcum powder exposure.  To get in touch with us regarding any potential talcum powder cases we may investigate on your behalf, please contact our Senior Partner Stuart Goldenberg at slgoldenberg@goldenberglaw.com or by phone at 612-335-9960, or our Partner Noah Lauricella at nlauricella@goldenberglaw.com or by phone at 612-335-9977.

Contact us today, and let us deliver the Gold standard advocacy you deserve.