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Stefanie Colella-Walsh is a Shareholder and member of the Stark & Stark Mass Tort Litigation Group where she concentrates her practice in complex litigation with a focus in mass tort and pharmaceutical litigation. Ms. Colella-Walsh is also a Shareholder in several of Stark & Stark's Litigation Teams. Ms. Colella-Walsh has extensive experience as a trial attorney throughout the state of New Jersey.

A federal judge in New Jersey recently granted summary judgment to Plavix drug makers Bristol Myers-Squibb Company (“BMS”), Sanofi-Aventis U.S., L.L.C., Sanofi-Aventis U.S., Inc., and Sanofi-Synthelabo, Inc. in a lawsuit alleging that plaintiff’s gastrointestinal bleeding was caused by defendants’ prescription drug Plavix.

Plaintiff alleged that she suffered injuries as a result of defendants’ design, development, manufacture, promoting, marketing, distributing, labeling, and sale of Plavix, an anti-clotting medication.

Plavix was initially approved by the FDA for individuals with recent heart attack, stroke (including Transient Ischemic Attack or “TIA”), or peripheral arterial disease. Plavix inhibits blood platelets from forming clots and therefore increases the risk of bleeding. Its labeling has included information about that risk.

Plaintiff’s complaint asserts product liability related causes of action under California state law, for defective design, manufacturing defect, failure to warn, and negligence.

Continue Reading Plavix Decision Raises Questions About Learned Intermediary Doctrine

On Thursday, October 26, 2017, President Donald Trump declared the opioid crisis a national health emergency.

What is the Opioid Epidemic?

From 2000 to 2015, more than half a million people died of drug overdoses across the country and most of those deaths involved opioids, according to the Centers for Disease Control and Prevention (CDC). The CDC estimates that 64,000 people died from drug overdoses in 2016 alone.

Continue Reading Trump Declares Opioid Epidemic a Public Health Emergency

Attorney General Christopher S. Porrino recently announced that New Jersey has filed a lawsuit against Insys Therapeutics, Inc. charging that the company engaged in a “greed-driven campaign of consumer fraud and submission of false claims to health insurers” to increase the market share for its opioid-fentanyl drug, Subsys.

What Does New Jersey’s Opioid Lawsuit Claim?

The complaint asserts that Subsys has Food and Drug Administration (FDA) approval only for the treatment of opioid-tolerant cancer pain, yet Insys unlawfully directed its sales people to “push Subsys for prescription to a broader patient population – patients suffering any type of chronic pain – and at higher doses.” The state’s lawsuit alleges that corporate decision-makers sought to expand the limited market for Subsys by aggressively pushing “off label” uses of the drug.

Continue Reading New Jersey Files Lawsuit Against Opioid Manufacturer

According to a study published by the Journal of the American Medical Association, from 2000 to 2015, opioid-involved poisoning deaths erased approximately two and a half months from overall life expectancy at birth in the United States. Other studies, news reports, government agencies, and medical journals are addressing opioid deaths as a public health crisis that cannot be ignored or discounted.

What is the Opioid Epidemic?

Many sources reiterate that the opioid epidemic is not about recreational drug use but rather originated from prescription drugs, manufactured by pharmaceutical companies, and distributed to doctors, who prescribed the drugs to patients.

Continue Reading Opioid Epidemic Lowers Overall Life Expectancy In U.S.

The number of cases involving the anti-psychotic drug Risperdal almost tripled in the first half of 2017, jumping from approximately 2,000 cases at the beginning of the year to more than 5,500 as of June 2017, comprising the largest mass tort litigation in Philadelphia.

The new filings in the Risperdal litigation were largely triggered when Johnson & Johnson terminated tolling agreements on thousands of cases, which had paused the statute of limitations deadline. A Johnson & Johnson subsidiary, Janssen Pharmaceuticals, Inc., manufactures Risperdal.

The Risperdal litigation mostly involves a condition called gynecomastia, which causes breast tissue enlargement in males. Risperdal was originally approved in 1993 to treat schizophrenia in adults. In 2006, clinical studies linked an increased risk of gynecomastia in male adolescents to Risperdal use. The Risperdal gynecomastia lawsuits allege the manufacturer did not sufficiently warn doctors and patients of the male breast growth problem, and that Johnson & Johnson and Janssen Pharmaceuticals failed to properly share information with the FDA.

Continue Reading Philadelphia Risperdal Docket Almost Triples in First Half of 2017

The sixth pelvic mesh product liability trial against Ethicon, Inc., a Johnson & Johnson subsidiary, is underway in the Philadelphia Court of Common Pleas. The lawsuit alleges that the plaintiff was injured by Ethicon’s TVT Secur pelvic mesh product, requiring her to undergo multiple corrective surgeries and removal of mesh fragments from her urethra. The plaintiff alleges that the defective pelvic mesh product has caused perforations to her urethra, incontinence, and pain. The complaint alleges design defect and a failure to warn.

Citing the recent United States Supreme Court decision in Bristol-Myers Squibb v. Superior Court of California (BMS), Ethicon, Inc. argued that the company’s lack of tangible links to Pennsylvania prevented the Philadelphia County Court of Common Pleas from hearing pelvic mesh cases. Ninety of the cases filed in the Philadelphia court that alleging injuries caused by defective pelvic mesh implants were filed by out-of-state residents.

Continue Reading Johnson & Johnson Argues that Pelvic Mesh Cases Belong in New Jersey

In case you missed it, Stark & Stark has garnered a significant amount of local, regional, and national press attention for our recent $20 million pelvic mesh verdict against Johnson & Johnson in Philadelphia, PA. In the case, plaintiff Peggy Edelman alleged that a Johnson & Johnson pelvic mesh device implanted to relieve stress urinary incontinence in 2007 failed due to defect. Subsequent attempts to surgically remove the mesh after Ms. Engleman began experiencing pain and discomfort were unsuccessful. Nationally, Johnson & Johnson is facing tens of thousands of additional pelvic mesh lawsuits, including nearly 200 more in Philadelphia.

Below are some of the local, regional, and national press mentions for Stark & Stark and this very important verdict: Continue Reading Stark & Stark Gaining Press Attention for $20 Million Pelvic Mesh Verdict

The New Jersey Supreme Court recently reinstated a $25 million jury award for an Alabama man who suffered from severe inflammatory bowel disease after taking Accutane. Accutane is a prescription medication used for the treatment of acne.

In June 1995, while living in Alabama, the plaintiff was prescribed Accutane by his dermatologist and took the drug daily for four months. In November 1996, the plaintiff was diagnosed with inflammatory bowel disease in Alabama and was treated in that state. Ultimately, after multiple surgeries and complications, the plaintiff’s colon and rectum were removed and replaced with a “J-pouch.” He later underwent an ileostomy and had a colostomy bag for four years, followed by another “J-pouch” surgery. He continues to suffer residual pain and other symptoms.

Continue Reading Ruling May Open the Door in New Jersey for Otherwise Time-Barred Cases

A Multidistrict Litigation (“MDL”) against 3M and Arizant Healthcare, alleging the manufacturers’ Bair Hugger surgical warming blankets were the cause of deadly post-surgical infections, has progressed to the bellwether pretrial stage. The more than 800 cases were recently consolidated in Minnesota under the purview of the Honorable Joan N. Ericksen. Bellwether case selection will begin on December 23, 2016, with final case selection to be completed on or before March 8, 2017.

The Bair Hugger forced air blankets are used to keep patients warm during surgery. The Master Complaint adopted by the Plaintiffs in the pending MDL alleges that “scientific studies have shown that as the warmed air rises against the downward airflow in the operating room, it deposits bacteria from the non-sterile portions of the operating theater to the surgical site.” The Master Complaint further alleges that “scientific studies have also shown that the inadequate air filtration system of the Bair Hugger allows pathogenic-carrying cells, including but not limited to isolates of S aureus, coagulase-negative staphylococci (“CoNS”), and methicillin-resistant staphylococcus aureus (“MRSA”), to penetrate the intake filter of the device and colonize inside the device.” Accordingly, it is alleged that without an adequate filtration system at the distal hose outlet, the device releases contaminants into the operating theater and directly onto the surgical site itself. Plaintiffs contend that Defendants have known, for over two decades, that “the Bair Hugger emits significant levels of internally generated airborne contaminants into the operating theater and that the exhaust generated thereby creates convective airflow patterns that disrupt the unidirectional airflow of the operating theater, dramatically increasing the risk of infection for patients undergoing lengthy surgeries, especially hip and knee replacement surgeries.”

If you or someone you love has been affected by the use of a Bair Hugger warming blanket and/or has suffered from a serious infection after surgery, you should consult an attorney with experience in litigation involving mass tort injuries related to medical devices and associated products. The attorneys at Stark & Stark are currently accepting clients with cases against 3M and Arizant Healthcare and can provide you with a free consultation to help ascertain if you are eligible for assistance.

The third DePuy Pinnacle bellwether trial got off to a roaring start this week as Hon. Ed Kinkeade, District Judge for the United States District Court, Northern District of Texas, took control of his courtroom to set the tone for the trial. According to reports, he flatly denied both a continuance and a motion for a mistrial delivered by defendant, Johnson & Johnson, in the first few minutes of the proceedings. After lunch, Judge Kinkeade penalized both sides for wasting time over a witness objection. Later, Judge Kinkeade called a break with a warning to Johnson & Johnson’s lawyer that if he did not stand while objecting, he would be chastised in front of the jury.

Continue Reading Sparks Fly in DePuy Pinnacle 3rd Bellwether Trial