Mass Tort Institute Academy

10/01/2020

When the antacid drug Zantac (ranitidine) received FDA approval in 1983, GlaxoSmithKline (GSK) already knew the drug could be dangerous but continued to sell it without warning the public – raking in stunning profits at the expense of millions of people.

A 1983 study revealed that ranitidine when taken with food caused DNA fragmentation, a significant first step in cancer development in rats’ stomachs. Consumers could hardly anticipate that GSK was giving them the opposite directions for use than they should have been, considering the prevalence of medicine labels directing patients to take it with food. Also in 1983, two studies uncovered the potential link between ranitidine and the carcinogenic molecule NDMA (allegedly up to 3,000 times the FDA limit). Scientists at the time suggested including Vitamin C in Zantac to prevent cancer. GSK took no action.

After 36 years, the FDA requested that manufacturers withdraw all ranitidine drugs from the market. In February 2020, 140 cases alleging false advertising and failure to warn were consolidated in a Southern District of Florida MDL.

What part of mass tort history do you want us to focus on next week? Please comment below, like and share!

09/25/2020

Leigh O’Dell of Beasley Allen Law Firm currently serves as co-lead counsel on the talcum powder MDL. She is at the forefront of the battle against Johnson & Johnson, a corporate behemoth whose asbestos-tainted talcum powder has caused ovarian or uterine cancer in women who used the product for feminine hygiene.

O’Dell and co-lead Michelle Parfitt have recently achieved some impressive milestones in the talc MDL. In April 2020, they got their experts admitted as testifying witnesses, the first talc experts to survive a Daubert challenge in the litigation. A month later, J&J pulled their talc products off the shelves in North America in an apparent attempt to mitigate liability.

One medical expert calculates that this use of talcum powder leads to nearly 10 percent of the new ovarian cancer cases reported annually. Approximately 14,000 women die from talc-related ovarian cancer each year.

Do you know of anyone in the industry that you would like to nominate for a spotlight? If so, please comment below. And as always, don’t forget to share!

08/27/2020

- Ortho Evra

Johnson & Johnson introduced the first birth control patch, Ortho Evra, in 2002, knowing it was dangerous.

J&J failed to warn consumers of the extraordinarily high risks: blood clots, heart attacks, strokes, and pulmonary embolisms. Women were dying at a rate three times higher than those who used traditional birth control pills.

In 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained an invalid, which showed J&J had received nearly 500 reports of adverse events between 2002 and 2004.

The FDA approved updates to the Ortho Evra label in 2005, strengthened the warning in 2008, and made it a black box warning in 2011. J&J stopped making Otho Evra in 2014.

The MDL wound to a close in early 2015. Even after paying $68.7 million in verdicts and settlements, J&J was left with $1.6 billion in its pocket from the sale of a product that never should have been on the market.

Please comment down below what part of mass tort history you want us to focus on next week? Stop by every Thursday to find out.


Sources:
www.reliasmedia.com
www.classaction.org
westlaw.com
https://lnkd.in/dCfQ6aA
www.nbcnews.com
www.center4research.org

07/23/2020

– Zyprexa

Is gaining 10 pounds an acceptable side effect for a drug that alleviates the symptoms of schizophrenia or bipolar disorder? What if it was 100 pounds? And what if the weight gain raised blood sugar levels, leading to diabetes?

In 1996, pharmaceutical giant Eli Lilly and Company obtained FDA approval for the antipsychotic Zyprexa. It was later proved that Lilly was aware of the drug’s link to diabetes since 1995, but downplayed risks and hid information from the public in pursuit of profits.

By 2007, Lilly had paid $1.2 billion to settle more than 26,000 lawsuits filed by people who claimed in court documents they developed diabetes or related conditions after taking Zyprexa. The U.S. Department of Justice (DOJ) also brought criminal and civil charges against Lilly after the company promoted Zyprexa for treatments the FDA had not approved. These included the treatment of dementia and Alzheimer’s disease.

In 2009, Lilly pleaded guilty and agreed to pay more than $1.4 billion to resolve the case. This included an $800-million civil settlement with the DOJ and a criminal fine of $515 million – the largest ever in a health care case at the time.

Sources:
www.thejusticelawyer.com
www.drugwatch.com
www.biospace.com
https://lnkd.in/eQjmBMf

07/21/2020

Appeals court upholds groundskeeper’s Roundup cancer trial win over Monsanto

In yet another court loss for Monsanto owner Bayer AG, an appeals court rejected the company’s effort to overturn the trial victory notched by a California school groundskeeper who alleged exposure to Monsanto’s glyphosate herbicides caused him to develop cancer, though the court did say damages...

07/15/2020

was recalled for contamination with enalapril maleate, which can cause miscarriage, birth defects, and even death to newborns.

Read about:

Taro Pharmaceuticals voluntarily recalled one lot of Lamictal (lamotrigine) medication after tests showed some of the mental health drug was contaminated.

07/09/2020

- Fosamax

Fosamax is used to treat osteoporosis and bone disorders. Although Fosamax is intended to increase bone density, in some patients it does just the opposite. These patients can experience atypical femur fractures or Osteonecrosis of the Jaw (ONJ). In ONJ cases, the body is unable to supply blood to the jawbone, and the tissue begins to die. When this occurs, sections of the patient’s jaw may have to be surgically removed.

Plaintiffs in the Fosamax litigation claim Merck was aware of the risk of femur fractures in 1990 and the risk of ONJ in 1995. Yet, it took FDA intervention in 2005 before Merck placed a warning for ONJ on the product. The process to add a femur fracture warning didn’t begin until 2008 at the FDA’s request. In the interim, it seems little was done to advise doctors or patients about the risks. At least 4,000 lawsuits have been filed in this litigation, but there have been few settlements. In 2010, an $8 million verdict for one plaintiff was reduced to $1.5 million.

Do you have a historical mass tort case that you want to hear more about? Comment below, and don't forget to share it!


Sources:
www.drugwatch.com
www.drugdangers.com

07/04/2020

The Declaration of Independence was the culmination of over a decade of simmering tensions between the American Colonies and the British Empire. The colonists refused to accept oppression as a way of life, and they put everything on the line to obtain an American ideal—a promise—that life, liberty, and the pursuit of happiness was best achieved through self-governance.

Our founders’ overarching goal was to establish fair and just laws, fairly and justly applied. They declared on our first July 4th that we, the people, are entitled to trial by jury; to laws adopted by representative government; and to a judiciary empowered to enforce them.

There is no better protector of the rights promised by the Declaration of Independence than the legal profession. On this special day, the Mass Tort Institute celebrates our country and those of you who strive every day to achieve the American ideal. Here’s to the lawyers, judges, and those who support us in our persistent demand for justice.

06/04/2020

- IVC Filter

An IVC filter is a medical device meant to prevent pulmonary embolism caused by blood clots or deep vein thrombosis. In some cases, IVC filters cause more harm than good, by migrating and causing organ damage, or shifting and puncturing vein walls. Removing a failed IVC filter can cause additional injuries or even be impossible to accomplish.

A 2015 NBC News investigation revealed that Bard (one IVC filter manufacturer) had been aware of the risks for years but did nothing to correct the device’s defects. To the contrary, Bard went to great lengths to keep the defects a secret from everyone, including doctors. NBC News linked Bard’s intentional coverup to 39 deaths.

Plaintiffs have filed thousands of lawsuits and experienced varying degrees of success in IVC filter litigation. In October 2019, a Philadelphia plaintiff won a $33 million verdict against Rex Medical, but the defendants have won some verdicts as well. Given the mix of plaintiff and defense verdicts, it’s difficult to predict the future of the litigation.

What’s your take on IVC filter litigation? Please share your thoughts and this post!


Source:
www.drugwatch.com

05/25/2020

Celebrating Memorial Day

In honor of those service men and women who sacrificed themselves to protect our freedoms, and for those who stand strong for us today, we say thank you.