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Hernia Mesh Litigations Set to Begin After COVID-19 Delays

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After a delay due to COVID-19 restrictions, the lawsuits surrounding defective Hernia Mesh products are beginning to move forward around the country. Major manufacturers, including Bard, Ethicon, Atrium, and Covidien, are involved in separate litigations, although it’s likely that advances against one manufacturer will impact judiciary decisions against another. 

The Bard Hernia Mesh litigation is the biggest (based on market share) and focuses on the PerFix, 3DMax, Marlex, Kugel, Composix, Ventralex, Ventrio, Sepramesh, and Ventralight product lines. The primary state litigation is based in Rhode Island (where Bard is headquartered) and began on April 6, 2021, while the federal Multi-district Litigation (MDL) is occurring in the Southern District of Ohio and began on April 19, 2021. 

The Ethicon Hernia Mesh litigations primarily focus on Physiomesh and include claims against both the Proceed and Prolene product lines. Set to begin on June 7, 2021, the major state litigation will take place in New Jersey (home to the company’s headquarters), while the federal MDL is scheduled in the Northern District of Georgia. 

The Atrium Hernia Mesh litigations mainly focus on the C-Qur product line. The major state litigation will take place in New Hampshire (where the company’s former headquarters were located), while the federal MDL is scheduled for the District of New Hampshire. The first in-person federal trial will begin on July 7, 2021 with additional state and federal bellwether trials to follow.

The Covidien Hernia Mesh litigations, the smallest of the group, involve the Parietex and Gore-Tex product lines. The state litigation will occur in Massachusetts (where the company was previously headquartered), but no trial date is currently set.

Hernia Mesh

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Lung Injuries in Teens Linked to Vaping Marijuana

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A recent study reveals that teens are nearly twice as likely to report “wheezing or whistling” in the chest after vaping marijuana than after smoking cigarettes or e-cigarettes. While we know that cigarettes and e-cigarettes are unhealthy and damaging to the lungs, it appears that vaping marijuana has even worse health implications. 

Study author Carol Boyd, co-director of the Center for the Study of Drugs, Alcohol, Smoking & Health at the University of Michigan in Ann Arbor, was surprised by these results. “We thought we would find more negative respiratory symptoms in both cigarette and e-cigarette users,” she explains. “I recommend parents treat all vaping as risky behavior (just like alcohol or drug use).”

Vaping marijuana is also associated with a newly-identified lung disease called EVALI, which stands for e-cigarette or vaping product use-associated lung injury. This dangerous illness was first identified in August 2019 by the U.S. Centers for Disease Control and Prevention (CDC) after seemingly-healthy young people from around the country were hospitalized for severe and even fatal lung infections. 

A link between the condition and vaping was soon discovered with blame being placed on the use of vitamin E acetate. This sticky oil substance, which is added to thicken or dilute the oil in cartridges, is most often used in vaping products with THC, the primary psychoactive compound in marijuana. “According to the CDC, 84 percent of the EVALI cases were associated with cannabis-containing products,” Boyd says. 

Vaping and Juul

Update: Tort Lawsuit Against 3M Begins This Month in Pensacola

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Later this month, a mass tort lawsuit is set to begin in Pensacola, Florida, against 3M for the defective ear protection that the company made for the military, which led to hearing loss in servicemen and women. As of January 2021, there were more than 220,000 service members who have filed suit. 

WUWF News (NPR for Florida’s Great Northwest) spoke to Bryan Aylstock, an attorney at the law firm Aylstock, Witkin, Kreis, and Overholtz in Pensacola for more insight into the suit. “We now have a trial set for late March involving three service members,” he shares. “And then two subsequent trials involving single service members — what we call ‘bellwether trials,’ to help the parties and the court determine what the evidence is, what the facts show, and how to proceed following those trials.”

When looking at mass tort versus a class-action lawsuit, Aylstock explains that the two take very different approaches. “We’re signing up individual service members who have hearing loss or tinnitus following the use of these defective earplugs, and we’re individually filing their lawsuits. So there are an awful lot of them — probably too many to ever go to trial,” he says. “But they are treated individually; their cases rise and fall on their own merit.” In these instances, the attorneys are able to talk to the individuals involved and understand their experiences. This sort of interaction typically doesn’t occur in a class-action lawsuit, which is not an individualized process. 

Were You Issued 3M Combat Arms Earplugs and Now Suffer Tinnitus and/or Hearing Loss?

It’s important to note that this lawsuit is only against 3M, not the government or military. In 2018, 3M settled with the government for over nine million dollars in a case concerning the fraud they committed for selling defective earplugs to the military. “They were selling these products for a huge profit to the U.S. military for 15 years without telling them the truth about how the earplugs really worked and the defects that the company executives knew about,” Aylstock adds. 

In an e-mail statement submitted to WUWF News, 3M said: “We are confident in our case and look forward to defending against plaintiff’s claims at the upcoming trial. As we will demonstrate, the Combat Arms Earplugs Version 2 product was not defectively designed and did not cause injuries. The Combat Arms Earplugs Version 2 product is effective and safe to use, and its design reflected the direction and feedback of individuals acting on the military’s behalf.”

Additional Reading:

https://druglawjournal.com/dlj_legal/veterans-suing-3m-over-claims-of-defective-earplugs/
https://druglawjournal.com/dlj_device/3m-combat-arms-earplugs/

Seresto Flea and Tick Collars Linked to Nearly 1,700 Pet Deaths; Class-Action Lawsuit Filed Against Elanco Animal Health

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A class-action lawsuit has been filed against Elanco Animal Health (Elanco), the seller of Bayer’s Seresto flea and tick collars. Two pet owners claim that their dogs either died or developed problems as a result of the collars and argue that Elanco misrepresented the safety of its product. 

Days before the lawsuit was filed, a congressional subcommittee called for Elanco to voluntarily recall the collars due to reporting by the Midwest Center for Investigative Report and USA TODAY. Unfortunately, Elanco declined this request. 

These investigations revealed that the flea and tick collars, which are the top-selling collar of their kind on Amazon, have been linked to nearly 1,700 pet deaths. Moreover, since 2012, when the product first hit the market, the Environmental Protection Agency has received over 75,000 incident reports related to pet and human health issues following the use of the collar.

The Seresto collars have two active pesticide ingredients: imidacloprid and flumethrin. In a recent interview, Colleen Dekker, a spokesperson for Elanco, said that the company has looked into reports of deaths and illnesses after wearing the collar and found no evidence that either of these active ingredients is at fault. 

However, the two plaintiffs — Faye Hemsley from Huntingdon, Pennsylvania, and Aitana Vargas from Los Angeles, California — both blame the Seresto flea and tick collars for their pets’ ailments. Hemsley purchased the collar in January 2020 for her terrier mix, who suddenly died the following month. Vargas bought the collar for her Siberian Husky in November 2020, and two months later, a cancerous lump appeared on the dog’s neck near where the collar sits. 

Spencer Sheehan, a consumer liability attorney based in New York, believes that this lawsuit is likely the first of “dozens.”

Class Action Lawsuit and FDA Probe Against Real Water

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A recent class-action lawsuit filed by Milberg Coleman Bryson Phillips Grossman PLLC (Milberg) argues that Nevada-based Real Water causes liver failure and other side effects due to unidentified toxins. Real Water, a product of Affinity Lifestyles.com, Inc., calls its drinking water the “healthiest” available thanks to its alkaline properties and infusion with negative ions. The company argues that its water can “help your body restore balance and reach its full potential.” 

According to Milberg’s complaint, Real Water failed to disclose that its product is defective, causing health problems such as fever, fatigue, nausea, vomiting, jaundice, liver failure, and hospitalization. The lawsuit specifically states that Real Water has “caused liver damage to children due to non-viral hepatitis.” In November 2020, a two-year-old from Southern Nevada was taken to the hospital for liver malfunction. It was determined then that multiple children had had similar problems with the only common link being the consumption of Real Water. 

The Food and Drug Administration began an investigation on March 16th, and only five days later, on March 21st, they issued a warning that consumers, restaurants, and retailers should not drink, cook with, or serve Real Water. In concordance with the FDA’s statement, a company press release revealed that Real Water has asked stores to immediately stop selling its products. 

Johnson & Johnson Sets Aside Nearly $4 Billion for Talc Verdict

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A securities filing from late February shows that Johnson & Johnson (J&J) allotted $3.9 billion for litigation expenses in 2020 and that the funds were “primarily associated with talc-related reserves and certain settlements.” This figure is almost twice as much as the $2.1 billion that the company agreed to set aside in November. 

A 2018 Reuters report first revealed that J&J has known for decades about asbestos in the talc. Internal records and trial testimony, among other evidence, show that their raw talc and finished powders sometimes tested positive for small amounts of asbestos from 1971 to the early 2000s. The pharmaceutical company now faces 25,000 lawsuits by former users of its baby powder who believe that the asbestos-laced talc caused their cancers.

The drugmaker is currently appealing to the Supreme Court against a $2.12 billion verdict in Missouri to women who believe their ovarian cancer developed due to asbestos in J&J products. Additionally, in November, a New York state judge ordered the company to pay $120 million to a Brooklyn couple after the woman argued that her cancer was a result of asbestos exposure from their baby powder.

Johnson & Johnson to Stop Selling Talcum Powder
Talcum Powder Lawsuits and Legal Updates
Talcum Powder

Update: Tort Lawsuit Against 3M Begins This Month in Pensacola

Posted on

Later this month, a mass tort lawsuit is set to begin in Pensacola, Florida, against 3M for the defective ear protection that the company made for the military, which led to hearing loss in servicemen and women. As of January 2021, there were more than 220,000 service members who have filed suit. 

WUWF News (NPR for Florida’s Great Northwest) spoke to Bryan Aylstock, an attorney at the law firm Aylstock, Witkin, Kreis, and Overholtz in Pensacola for more insight into the suit. “We now have a trial set for late March involving three service members,” he shares. “And then two subsequent trials involving single service members — what we call ‘bellwether trials,’ to help the parties and the court determine what the evidence is, what the facts show, and how to proceed following those trials.”

When looking at mass tort versus a class-action lawsuit, Aylstock explains that the two take very different approaches. “We’re signing up individual service members who have hearing loss or tinnitus following the use of these defective earplugs, and we’re individually filing their lawsuits. So there are an awful lot of them — probably too many to ever go to trial,” he says. “But they are treated individually; their cases rise and fall on their own merit.” In these instances, the attorneys are able to talk to the individuals involved and understand their experiences. This sort of interaction typically doesn’t occur in a class-action lawsuit, which is not an individualized process. 

 

Were You Issued 3M Combat Arms Earplugs and Now Suffer Tinnitus and/or Hearing Loss?

 

It’s important to note that this lawsuit is only against 3M, not the government or military. In 2018, 3M settled with the government for over nine million dollars in a case concerning the fraud they committed for selling defective earplugs to the military. “They were selling these products for a huge profit to the U.S. military for 15 years without telling them the truth about how the earplugs really worked and the defects that the company executives knew about,” Aylstock adds. 

In an e-mail statement submitted to WUWF News, 3M said: “We are confident in our case and look forward to defending against plaintiff’s claims at the upcoming trial. As we will demonstrate, the Combat Arms Earplugs Version 2 product was not defectively designed and did not cause injuries. The Combat Arms Earplugs Version 2 product is effective and safe to use, and its design reflected the direction and feedback of individuals acting on the military’s behalf.”

Additional Reading:

Veterans suing 3M over claims of defective earplugs

3M Combat Arms Earplugs

Zantac Cancer Claims Invalid Under Federal Law

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A federal judge recently threw out multiple claims by the plaintiffs in the Zantac cancer multi-district litigation (MDL) because the claims, which were filed under state laws, were barred by federal law.

MDL 2924, which now has more than 500 cases, was created in February 2020. These lawsuits focus on the belief that Zantac contains an undeclared carcinogen. Allegations made against the drug manufacturers include personal injury; negligence; violation of consumer protection laws; and design defects.

The recent ruling filed under state laws argued that the manufacturers of ranitidine (generic Zantac) created a flawed product and failed to notify consumers about it. The court ruled these claims invalid, effectively preventing manufacturers from addressing the defective design or the lack of consumer warning. Of course, the plaintiffs’ attorneys disagreed, arguing that the manufacturer could have changed the expiration date on the packaging without violating the law. Had the drug expired sooner, it would’ve been less harmful, as evidence shows that carcinogen levels in the drug increase over time. 

The federal judge also accused the plaintiffs of making conflicting Zantac claims within the same case (which is not allowed based on court precedent). The plaintiffs argued that the drug was defective at the time of manufacture, which opposes the claim about expiration dates. If the drug was in fact harmful on the production date, then an earlier expiration date would not make it safe. These claims, both under state law, were dismissed.

While it is unclear how the case will proceed, the plaintiffs now have 30 days to file new, narrower claims. Some reports suggest that they will focus on possible legal labeling changes that should’ve been made by the manufacturers. Additionally, there are still pending claims under federal law that have not yet been addressed by the judge. 

Additional Reading:

Keeping Up To Date On Potential Dangers of Medications

Zantac Lawsuits & Updates

Zantac (Ranitidine) Commonly Asked Questions

Zantac Cancer Risk

Penumbra Jet 7 Xtra Flex Catheter

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Last Updated March 4, 2021

The Penumbra Jet 7 Xtra Flex Catheter is a medical device that, until recently, was billed as part of a fully-integrated system for aiding with the removal of blood clots in patients suffering from acute ischemic stroke. Cleared for the U.S. market through the Food and Drug Administration’s (FDA) abbreviated 510(k) device clearance process, the Jet 7 Xtra Flex Catheter was designed to “vacuum” clots from arteries in the brain with minimally invasive procedures.  

On December 15, 2020, Penumbra initiated a voluntary recall of the Jet 7 Xtra Flex Catheter after consultation with the FDA. The recall came on the heels of more than 200 medical device reports associated with the Jet 7 Xtra Flex which included deaths, serious injuries, and malfunctions. Further testing by Penumbra demonstrated that the device was not able to withstand previously assured operational pressures causing injuries and death.

What Is the Jet 7 Xtra Flex Catheter and How Does it Work?

The Jet 7 Xtra Flex is a “reperfusion” catheter which was coupled with specialized suction or “aspiration” devices manufactured by medical device company, Penumbra, Inc.  Based in Alameda, California, Penumbra was established in 2004 to focus on devices tied to therapies that treat conditions such as stroke or aneurysm. The Jet 7 Xtra Flex was designed as a key component of a larger Penumbra Jet-Engine system which provides physicians with a complete package of tools for minimally invasive mechanical removal of cranial blood clots by vacuuming them out. This type of procedure is known as a thrombectomy and is a preferred method of extraction in acute ischemic stroke patients.

Traditionally, deep-vein thrombosis (DVT) and similar clotting conditions are approached with first-line drugs, known as lytics, which attempt to break down a clot over several hours or days. In recent years, lytic therapies have been combined with catheters to attempt to remove clots more effectively. Aspiration catheters such as the Jet 7 Xtra Flex, are maneuvered through the human vascular system through a small insertion in the groin. Once doctors approach the clot with the catheter, they use its suction to safely restore blood flow.

Aspiration catheters are touted as simple, low-cost options for removing small and relatively newer clots in a single session. However, larger and more cemented clots can overwhelm the suction potential of these devices and require additional follow-up procedures.

Are There Medical Issues and Side Effects Associated with the Jet 7 Extra Flex Catheter?

According to Penumbra, its Jet 7 Catheters have been associated with the following possible complications:

  • Allergic Reactions with Contrasting Agents
  • Acute Occlusion
  • Air Embolism
  • Arteriovenous Fistula
  • Distal Embolization
  • False Aneurysm Formation
  • Hematoma or Hemorrhage at Access Site
  • Infection
  • Intracranial Hemorrhage
  • Ischemia
  • Kidney Damage from Contrast Agent
  • Stroke
  • Vessel Spasm
  • Thrombosis
  • Perforation
  • Radiation Exposure Leading to Cataracts
  • Skin Reddening
  • Burns
  • Alopecia
  • Neoplasia from X-Ray Exposure
  • Sudden Death

Why Is the Jet 7 Xtra Flex Being Recalled?

Penumbra announced an “urgent recall” of the Jet 7 Xtra Flex in December 2020 following consultation with the FDA. The recall advised that all medical providers should immediately cease using the Jet 7 Xtra Flex and remove them from inventory. Specifically, the devices cited in the recall are:

  • Jet 7 Xtra Flex Catheter 
  • Jet 7Max Configuration

The recall does not apply to the Penumbra Jet 7 Repurfusion Catheter with Standard Tip.

The Jet 7 Xtra Catheter was approved for the U.S. market after review through the FDA’s abbreviated 510(k) device clearance process. However, post-market surveillance conducted by Penumbra and furnished to the FDA indicated a number of reports associating the Jet 7 Xtra Flex Catheter with deaths, serious injuries, and malfunctions at an alarming rate. Patient injuries described are as serious as vessel damage, hemorrhage, and cerebral infarction.

The FDA reported that Jet 7 Xtra Flex catheter failures included: ballooning; expansion; rupture; breakage or complete separation; and “exposure of internal support coils near the distal tip region of the [catheter]”. Internal post-market testing conducted by Penumbra indicated that the distal tip of the catheter is not able to withstand similar pressurization as Penumbra’s other catheters.

Are There Lawsuits Being Filed?

Following the recall announcement, attorneys for several stroke victims have begun thorough research into potential claims for injury resulting from the Jet 7 Xtra Flex Catheter.

Sources Cited (20)

1. “At FDA’s request, Penumbra recalls catheter device after 14 patient deaths” https://www.medtechdive.com/news/Penumbra-recalls-catheter-stroke-device-after-14-deaths/592338/

2. “Utilization of the large-bore Penumbra JET 7 reperfusion catheter in thrombectomy for acute ischemic stroke: A single-center experience” https://pubmed.ncbi.nlm.nih.gov/32693662/

3. “URGENT VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATIONIMMEDIATE ACTION REQUIRED” https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf

4. “JET 7 XTRA Flex reperfusion catheter related complications during endovascular thrombectomy” https://www.semanticscholar.org/paper/JET-7-XTRA-Flex-reperfusion-catheter-related-during-Majidi-Bageac/b564ae8beec12c7a473472b3aa535aad8ae6a316

5. “Urgent Recall for Penumbra JET 7 Xtra Flex Reperfusion Catheters” https://www.medscape.com/viewarticle/942732

6. “Penumbra Launches Jet 7 Reperfusion Catheter With Xtra Flex Technology in U.S.” https://www.dicardiology.com/product/penumbra-launches-jet-7-reperfusion-catheter-xtra-flex-technology-us

7. “Frontline Contact Aspiration Treatment for Emergent Large Vessel Occlusion: A Review Focused on Practical Techniques” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6372892/

8. “Direct thrombus retrieval using the reperfusion catheter of the penumbra system: forced-suction thrombectomy in acute ischemic stroke” https://pubmed.ncbi.nlm.nih.gov/21087940/

9. “Catheter-Based Clot Busting Therapies” https://www.dicardiology.com/article/catheter-based-clot-busting-therapies

10. “Penumbra Announces Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology Voluntary Recall” https://investors.penumbrainc.com/investors-relations/press-releases/press-release-details/2020/Penumbra-Announces-Penumbra-JET-7-Reperfusion-Catheter-with-Xtra-Flex-Technology-Voluntary-Recall/default.aspx

11. “Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers” https://www.fda.gov/medical-devices/letters-health-care-providers/penumbras-urgent-voluntary-recall-jet-7-catheters-xtra-flex-technology-due-increased-risk-mortality

12. “Penumbra JET® 7 Reperfusion Catheter with Standard Tip” https://www.penumbrainc.com/neuro-device/penumbra-jet-7/

Democratic Lawmakers Blast Pharmaceutical Executives Over Drug Prices and Charitable Donations

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During a House Oversight Committee hearing at the end of September, Democratic representatives harshly criticized pharmaceutical executives at Celgene, a Bristol Myers Squibb subsidiary, and Teva over drug prices and charitable contributions. 

Rep. Katie Porter (D-CA) noted the disturbing similarities between bonuses that former Celgene CEO Mark Alles received in recent years and the price increases for Revlimid, a cancer therapeutic that cost 215 dollars in 2005 and 763 dollars today. Alles could not confirm that the higher price correlated with drug improvements, to which Porter responded, “To recap here: The drug didn’t get any better. The cancer patients didn’t get any better. You just got better at making money. You just refined your skills at price gouging.” 

Rep. Rashida Tlaib (D-MI) considered internal documents from Teva that calculated the return on investment from charitable contributions and called out the drugmaker, saying, “Your pharmaceutical company makes these so-called charitable donations so you look like you give a shit about sick people.” Teva’s CEO Kare Schultz was so underprepared for the virtual hearing that one lawmaker told him he “might as well get off the screen,” while Rep. John Sarbanes (D-MD) said, “It would have been nice to come, maybe, equipped a little bit better.” 

Further Reading:

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