Lawsuit Update Center

Breast augmentation is the most prevalent cosmetic procedure in the United States, with estimates ranging that 1 to 3 million women have some type of breast implant. For years, there has been developing research about the possibility of implants increase the risk of certain cancers, but the evidence was considered too slim to create any action towards addressing the problem.

Now, the FDA has finally issued a safety warning about the risks of using breast implants manufactured by the company Allergan. The warning requested Allergan to recall all of their micro-textured implants in the United States, citing new sufficient evidence showing a link between their products and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This recall will most likely cause a significant increase in breast implant cancer lawsuits, including class action lawsuits for medical monitoring.

The warning is not without precedent, as there have been similar recalls for Allergan breast implants in Canada, Australia, and France within the past year. However, the FDA was hesitant to issue on their own recall due to “insufficient evidence” that indicated a connection between textured implants and the rare lymphoma cancer. Despite this, hundreds of women around the country have been taking Allergan to court based on claims that their breast implants were the cause of their illness.

A lawsuit recently filed in the U.S. District Court District of New Jersey alleges that someone received stomach cancer because of taking proton pump inhibitors (PPIs) Prilosec, Nexium, and the variations of both drugs.

PPIs are used to treat many stomach conditions but can create even worse problems in the stomach as well. Before informing yourself about these lawsuits, you must first inform yourself on PPIs, specifically Nexium and Prilosec. You must also inform yourself about their potential side effects.

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This page is about the Bair Hugger lawsuits that were filed claiming the product caused infections. But these suits did not go very far and I don’t know of any lawyers filing warning blanket lawsuits in 2021. Not all mass tort lawsuits work out and these Bair Hugger lawsuits certainly did not.

Let’s back up first to the start of this litigation.  I’m backfilling this first the original post…

As of September 2018, there are over 1,500 Bair Hugger warming blanket lawsuits pending in the MDL in Minnesota.

In one typical case, a New York couple claims that a surgical warming blanket used after the husband’s hip replacement operation caused severe infections, resulting in four additional surgeries. A man and his wife filed a lawsuit in New York on Nov. 25, 2015, against 3M, the manufacturer of the Bair Hugger forced-air warming system. Medical facilities commonly use this blanket during knee and hip replacement operations. In addition to 3M, the lawsuit lists Arizant Healthcare, Inc. and its subsidiaries as Defendants.

The value of surgical blanket lawsuits is still being determined, but many of these infection cases involve serious injury and death.

During the surgery on Oct. 24, 2012, medical personnel used a Bair Hugger on the man’s left hip, supposedly to help regulate body temperature. However, the warming blanket might have introduced bacteria into the surgical site, resulting in infection. Plaintiff received five surgeries within 16 months, including the original surgery, and he now struggles with mobility and needs crutches to walk.

Per the lawsuit: “Due to the infection, Plaintiff needed four additional surgical procedures to remove the implant and clean the infected area within sixteen months from the original implant surgery, and he continues to suffer limited mobility, requiring crutches to ambulate.”

According to diverse news reports, this Plaintiff is far from alone; many consumers across the nation have taken legal action after illnesses they’ve acquired after using the Bair Hugger, following hip and knee surgeries.

The Plaintiffs noted that 3M sent a letter to the FDA way back in June 1997, which warned of possible contamination issues with this product.

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The FDA has recently expressed concern about a certain group of medications called SGLT2 Inhibitors. This category of drugs includes popular prescription medications such as Invokana and Farxiga. Although these drugs have been, by all accounts, fairly successful when treating Type 2 diabetes. But they have produced their fair share of side-effects. Specifically, users of drugs such as Invokana are now reporting high levels of blood acid, the effects of which have landed some users in the ER.  While no deaths have been reported, there is no question that if these reports are accurate, these levels of blood acid could cause serious injury and death.  Accordingly, plaintiffs’ lawyers are investigating whether there is a connection between these drugs and these high acid levels and, if so, whether these drug makers knew about these risks and simply failed to inform patients and doctors.   If these dots are connected – and there is reason to think they might be – there are likely to be both serious injuries and lawsuits seeking compensation for those injuries.

The preceding paragraph was written some time ago.  In May 2017, there are 230 lawsuits pending in a federal MDL in New Jersey.

SGLT2 Inhibitors

Kugel hernia mesh lawsuits are settling, thanks in part to a change in defense counsel. The products, manufactured by Davol, are defective because the plastic ring can break off, causing perforation and infections. Left untreated, these injuries can be fatal. Davol has since eliminated the use of the plastic rings, in favor of a bio-absorbable ring.

Now represented by the New York firm Reed Smith, Davol has signaled a change in thinking to a more reasonable approach—these can be very meritorious cases worthy of settlement, and the expense of litigation is unnecessary. There are about 1,000 cases in the Rhode Island United States District Court MDL, and about 1,200 cases in Providence state court (the manufacturer, Davol, is a Rhode Island company). Right now, 4 federal suits have been settled, and one state claim has been settled. This looks to be the tip of the iceberg, as the parties move toward the first scheduled federal court trial in March 2010. That will be followed shortly thereafter by the first state court case in June 2010. The settlements will probably come in rapid numbers, now that discovery is coming to a close and the trials quickly approach.

For more on Kugel Mesh lawsuits and settlements, see our prior blog post.

The FDA is now requiring the makers of two prescription topical testosterone gel products to include a boxed warning on the labels. The move comes after reports of inadvertent exposure to eight children, aged nine months to five years. The drug is topically applied on the shoulders, arms, or abdomen. When transferred to children through secondary exposure (for example, children touching skin covered in the gel), the drug can cause enlargement of the genitalia, premature development of pubic hair, advanced bone age, and aggressive behavior.

The manufacturers of these products, Solvay Pharmaceuticals (AndroGel 1%) and Auxilium Pharmaceuticals (Testim 1%), already warn against exposure to the drug by children; however, the black box warning will enhance the visibility of the warning on the package inserts. Black box warnings are among the strongest safety measures the FDA can take, being reserved for medications with serious or life-threatening dangers.

There’s nothing to indicate that the companies did anything wrong—the dangers of secondary exposure are clearly noted in PDR guides, which warn against allowing others to come into contact with gel-covered skin. And of course, doctors who prescribe the medication should warn their patients about these risks.