Photo of Stefanie Colella-Walsh

Stefanie Colella-Walsh is a Shareholder and member of Stark & Stark’s Litigation, Insurance Coverage & Liability, Intellectual Property and Mass Torts Groups where she concentrates her practice in complex litigation with a focus in mass tort and pharmaceutical litigation. She is currently involved in representing numerous plaintiffs in federal and state environmental and pharmaceutical mass tort cases, as well as state and federal class action litigations based upon commercial, employment, civil rights, investments/securities and consumer fraud claims. Ms. Colella-Walsh frequently writes about timely legal and legislative developments impacting plaintiffs in mass tort and product liability actions for Stark & Stark’s Mass Tort Law Blog.

On October 24, 2019, the United States Food and Drug Administration (“FDA”) issued a draft guidance addressing textured breast implants that have been linked to breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”).”

Continue Reading FDA Recommends New Warnings for Breast Implants Alleged to Cause Cancer

On October 3, 2019, Plaintiffs in several pending class actions made a motion before the Judicial Panel on Multidistrict Litigation, to centralize related Allergan Biocell textured breast implants lawsuits in a Multidistrict Litigation. The Judicial Panel on Multidistrict Litigation (“JPML”) is a panel of appellate and district court judges that determine whether or not to create an MDL. A Multidistrict Litigation (“MDL”) is a procedure whereby qualifying cases filed in federal district courts throughout the nation are consolidated in one federal district court, before a single judge. If an MDL is created, the JPML then selects the district court and assigns a judge to preside over the litigation.

Continue Reading Allergan Breast Implants Alleged to Cause Cancer

We have already written at length about the nationwide litigation alleging contamination of Valsartan, Losartan, and Irbesartan, with carcinogenic substances. Basically, the claims are that generic versions of those drugs were being made overseas using poor manufacturing processes that caused the drugs to be tainted with impurities.

That contamination included the probable human carcinogen N-nitrosodimethylamine (NDMA), prompting mass recalls by the Federal Drug Administration (FDA). Those pending lawsuits point out that NDMA is the substance actually used in research facilities to induce cancer in lab rats. Accordingly, individual claims in those cases allege serious injuries such as liver damage and various cancers (including liver, kidney, colorectal, and gastric cancers).


Continue Reading First Valsartan, Now Zantac: Cancer Causing Impurities in Foreign-Made Drugs

How Do I Know If I Have a Hernia Mesh Claim?

STEP 1: Obtain Medical Records

hernia mesh lawsuitThe first step in figuring out whether you have a potential hernia mesh claim is to confirm which type of hernia mesh you had implanted. There is a simple way to do that. Whenever doctors use a medical implant or device, like hernia mesh, it comes in its own shiny new box (as you can imagine, a lot of marketing goes into the packaging of these expensive products). The box has stickers on it that specifically identify everything about the mesh (manufacturer, model, lot number, etc.). The surgeon takes the sticker off of the box and attaches it to the Operative Report. Consisting of only a few pages, the Operative Report is a basic summary of your hernia mesh implant operation. The stickers are usually attached to the last page of the Operative Report. You can go to your medical provider and ask for your Operative Report (this should only take you a couple of days), or you can retain an attorney to formally request your operative report (this will take a few weeks).


Continue Reading A Simple Guide to Hernia Mesh Lawsuits and Settlements

Gilead Sciences, Inc. (“Gilead”) manufacturers the HIV drugs: Truvada, Atripla, Viread, Stribild, and Complera. After being named as a defendant in multiple lawsuits in 2018, Gilead filed a motion to dismiss all of the plaintiffs’ claims in the lawsuits, arguing that they were preempted by federal law, including the design defect allegations. Plaintiffs allege that these HIV drugs, which contain tenofovir disoproxil fumarate (“TDF”), cause kidney damage, such as chronic kidney disease, and bone damage, such as osteoporosis or osteopenia.

Continue Reading Plaintiffs’ Claims Against Gilead Permitted to Proceed in HIV Drug Lawsuits

The U.S. Food and Drug Administration (FDA) has announced that they are requiring a new black box warning on three drugs commonly prescribed to treat insomnia and sold under various brand names. The warning has been added after serious, deadly side effects were reported from individuals sleepwalking, or performing other tasks while sleeping or otherwise not fully awake.

Continue Reading FDA Adds “Black Box” Warning Label to Sleep Drugs Including Ambien, Lunesta

You have seen a lot of commercials and have probably been searching the internet for some straightforward explanations about Xeljanz Lawsuits.

Very simply, Xeljanz (aka tofacitinib) is a drug made by Pfizer used to treat arthritis. Because Xeljanz has to essentially suppress the patient’s immune system to treat arthritis inflammation, the drug has a lot of bad side effects that are clearly displayed on the drug’s label.

However, one of the side effects not specifically warned about is blood clots. A recent FDA safety alert has warned that Xeljanz, taken in certain doses, can cause an increased risk of blood clots in the lungs and death.


Continue Reading What Is the Deal With Xeljanz Lawsuits?

On April 17, 2019, Judge Sargus, who is overseeing the Bard Hernia Mesh MDL in the Southern District of Ohio, held a Case Management Conference. At the time of the conference, the Court noted that there were just over 1,700 cases filed in the MDL, with approximately 80-100 new cases being filed each week. The parties advised that the protocol and schedule for conducting various depositions were still being discussed, including the depositions of the treating physicians, corporate designees, and company witnesses. Paper discovery from defendants is also still being produced and reviewed by Plaintiffs’ leadership. Another conference is scheduled for early June.

Continue Reading Bard Hernia Mesh Litigation Continues in Federal and State Courts

Currently, there are more than 10,000 IVC filter cases filed across the country, in state and federal courts, with a majority being filed against manufacturers, Bard Medical and Cook Medical. IVC filters are small devices surgically implanted into the inferior vena cava in an effort to catch blood clots (where they should naturally dissolve) before they travel to the lungs, causing a potentially fatal pulmonary embolism. The Bard MDL (multidistrict litigation) is venued in the District of Arizona, while the Cook MDL is venued in the Southern District of Indiana. Additionally, lawsuits are being filed against Boston Scientific for its Greenfield Vena Cava Filter in Ohio; as well as Rex Medical and Argon Medical for their Option and Option Elite IVC Filters in Pennsylvania.

Continue Reading IVC Filter Cases Continue to Move Forward

On March 27, 2019, the initial Case Management Conference for the Valsartan MDL was held in the District of New Jersey before the Honorable Robert B. Kugler. At the time that the cases were consolidated before Judge Kugler, for pretrial purposes, in February 2019, there were approximately 40 cases filed, but we expect thousands of cases to be filed over the next couple years.

Continue Reading Initial Court Conference Kicks Off Valsartan Litigation in New Jersey