Johnson & Johnson said its decision to stop selling the metal liners in the Ultamet Metal-on-Metal Articulation and Complete Ceramic-on-Metal Acetabular Hip System was because of decreased demand and not because of the safety concerns cited by the FDA regarding metal-on-metal hips or the more than 10,000 lawsuits pending against DePuy over the ASR hip implant system (In re: DePuy Orthopaedics Inc., ASR Hip Implant Products Liability Litigation, MDL-2197 (U.S. District Court for the Northern District of Ohio)), according to a May 16 Bloomberg report. The company will continue to sell its DePuy Pinnacle system, though.

“Although the company has said that it did not make this marketing decision because of lawsuits or regulations, the fact remains that there is a recent marked increase of scrutiny of metal-on-metal hips,” said Rochelle Rottenstein, principal of the Rottenstein Law Group LLP.

For those who believe their metal-on-metal hip implant has injured them, the Rottenstein Law Group LLP offers an in-depth look at hip replacement settlements for metal-on-metal hip implants manufactured by DePuy, Stryker, Smith & Nephew, Biomet and Wright Medical. Common alleged side effects the firm hears about include metallosis (metal poisoning) and the need for revision surgery. The first trial in the country in Los Angeles resulted in the plaintiff winning an $8.3 million damages award (Kransky v. DePuy; BC456086, Los Angeles Superior Court).

DePuy, citing recent state court hip trials, filed the motion stating that the recalls are not relevant to the trials, according to court documents for Dorney-Madgitz, et ux. v. DePuy Orthopaedics Inc., et al., No. 11-dp-20112 (U.S. District Court for the Northern District of Ohio); In re: DePuy Orthopaedics Inc., ASR Hip Implant Products Liability Litigation, MDL-2197 (U.S. District Court for the Northern District of Ohio). Plaintiff Faye Dorney-Madgitz is suing DePuy alleging ASR side effects, including metallosis (metal poisoning), the documents said. The ASR was recalled in 2010.

“DePuy recalled the ASR because the device was deemed defective. That information is relevant and the juries at these trials should be privy to it,” said Rochelle Rottenstein, principal of RLG.

This trial is scheduled to begin in September, according to court documents. Judge David A. Katz is presiding over the federal consolidation of DePuy ASR lawsuits. There are an additional 11,000 lawsuits pending against DePuy over the ASR hip implant in state and federal courts, according to Bloomberg. The first trial in the country in Los Angeles resulted in the plaintiff winning an $8.3 million damages award (Kransky v. DePuy; BC456086, Los Angeles Superior Court).

RLG represents clients in ASR hip lawsuits and notes that DePuy, according to a January 2012 Reuters story, has set aside at least $3 billion for DePuy ASR hip settlements. The firm encourages those who believe they have suffered from the ASR’s alleged side effects to visit the firm’s website for more information on how to file a lawsuit.

The results of a prospective randomized trial, which were reported by Dr. Robert E. Gutman at the annual meeting of the Society of Gynecologic Surgeons, showed that cure rates and patient satisfaction following pelvic prolapse repair were similar at three-year follow-up regardless of whether vaginal mesh or native tissue was used for the repair, according to the May 9, 2013, article in Ob.Gyn.News that reported on the study. That article further reports that, “subjects treated with mesh had more complications without experiencing benefit beyond that observed in the native tissue repair patients.”

There currently are transvaginal mesh cases pending in state courts and as part of federal multidistrict litigation actions (MDLs) in the U.S. District Court for the Southern District of West Virginia (MDL No. 2187; MDL No. 2387; MDL No. 2326; MDL No. 2327).

Unlike transvaginal mesh class actions, in which similar claims against one or more common defendants are grouped together and the claimants are required to split a single award, transvaginal mesh MDLs consolidate cases for the purpose of streamlining pretrial proceedings such as discovery. That is, the vaginal mesh lawsuits that are part of the MDLs will be tried separately and the plaintiffs in those cases will not be required to share an award.

The Rottenstein Law Group LLP urges all women who believe they have been hurt by vaginal mesh to contact the firm for a free evaluation of their chances of recovering monetary compensation for their injuries via a vaginal mesh lawsuit.

A cohort of Palm Beach County, Florida, surgeons reviewed data from procedures on adults over 18 years old who suffered different types of closed head injuries and then determined if the patients were using warfarin, Pradaxa (dabigatran), or were not using any anticoagulation drugs, according to the study published in the May 1, 2013, edition of the Journal of Neurosurgery.

“Alleged excessive bleeding incidents are at the center of Pradaxa lawsuits in federal court,” said Rochelle Rottenstein, principal of RLG, referring to a multidistrict litigation formed in federal court in Illinois (In re Pradaxa Products Liability Litigation, MDL-2385, U.S. District Court for the Southern District of Illinois (East St. Louis)).

RLG LLP encourages those who were allegedly harmed by Pradaxa to visit the firm’s website to download a free brochure to help them determine if they have a case.

A 2011 study published in the Journal of the American College of Cardiology found that those at risk of getting diabetes were more likely to be diagnosed with the disease when they were using Lipitor, a statin prescribed to reduce high cholesterol in patients, according to Reuters. Another study, published in the January 2012 edition of JAMA: Internal Medicine, indicated that there is a potential link between statins and a type 2 diabetes risk in women.**

“There has been a sizable amount of news coverage centered on the link between Lipitor and an increased diabetes risk,” said Rochelle Rottenstein, principal of RLG. “As more people become aware of the connection, more of them are considering their legal options. We receive calls daily from women who believe Lipitor has put them at risk.”

Plaintiffs across the country are filing Lipitor lawsuits, many of which are under consideration for consolidation into a federal multidistrict litigation for efficient pretrial proceedings (In re Lipitor (Atorvastatin) Litigation, MDL No. 2459 (JPML)).

The device notification, according to CNBC, says that “micro-cracks” in some monopolar curved scissors can cause leaks that “may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause thermal injury.” In the notification statement, according to CNBC, Intuitive Surgical said that it had no evidence of any injuries actually caused by the micro-cracks.

“This is potential evidence that can be used in court to prove the serious alleged dangers associated with the da Vinci Surgical System,” said Rochelle Rottenstein, principal of RLG. “Medical technology can be a valuable part of a patient’s treatment, but a device must not do more harm than good.”

In other da Vinci robot news, Intuitive Surgical is currently a defendant in a trial in Washington State in which it is accused of improperly training surgeons in the use of the surgical robot (Estate of Fred E. Taylor v. Intuitive Surgical Inc.; 09-2-03136-5, Superior Court, Port Orchard, Wash.). It is the first of about a dozen da Vinci lawsuits in the United States to go to trial, according to Bloomberg. Intuitive Surgical asserts that it is fully committed to superior training opportunities for surgeons and surgical teams in the use of its products, but notes that it does not participate in determining when a surgeon is adequately prepared to operate using the da Vinci Surgical System. According to USA Today, the da Vinci surgical robot was used in about 400,000 surgeries in 2012.

Pfizer lost patent protection for Lipitor in 2011, which led to other manufacturers’ selling cheaper generic versions of the drug. Given the great number of Lipitor users, that switch to generic plays a large role in reduced spending, according to a May 9 Reuters report.

But despite the availability of inexpensive Lipitor, RLG principal Rochelle Rottenstein notes that studies have been released that indicate there could be some serious risks that go along with using Lipitor. She cites a January 2012 study in JAMA: Internal Medicine that indicated there is a potential link between statins and a Type 2 diabetes risk in women.

“Even though generics present a cheaper alternative, there are still some people buying name-brand Lipitor,” Rottenstein said. “Those people are at risk of suffering the alleged side effects that could make them eligible to file a lawsuit.”

Plaintiffs across the United States have filed lawsuits, many of which are under consideration for consolidation into a multidistrict litigation for efficient pretrial proceedings (In re Lipitor (Atorvastatin) Litigation, MDL No. 2459 (JPML)).

The most common side effects reported to the FDA include the expulsion of the device and the device dislocation (migration), according to a recent AdverseEvents report. This is supported by a 2008 FDA report that mentions those alleged side effects, in addition to perforation of the uterine wall and pelvic inflammatory disease as primary potential issues.

“We file Mirena lawsuits daily for those who believe their intrauterine devices have harmed them,” said Rochelle Rottenstein, principal of the Rottenstein Law Group. “These reports could be valuable evidence for Mirena plaintiffs during trials.”

Women across the United States have filed lawsuits that have been consolidated at the federal level (In re: Mirena IUD Products Liability Litigation, MDL No. 2434, U.S. District Court for the Southern District of New York) and in at least one state (In re: Application for Centralized Management of Certain Cases Involving Mirena, Morris County (N.J.) Superior Court) there has also been a consolidation.

The Mirena IUD is a plastic contraceptive device that slowly releases a type of the hormone progestogen over the course of five years. It was first introduced in 2000 and is manufactured by Bayer.

A New England Journal of Medicine article dated May 2, 2013, states that physicians deciding whether to prescribe azithromycin—which is often sold under the brand names Zithromax and Z-Pak—should consider “data point[ing] to lethal arrhythmias as a potential consequence of QT-interval prolongation with use of azithromycin” and other medication. The possibility of azithromycin increasing a patient’s risk of lethal arrhythmias is especially important for physicians to consider when weighing the pros and cons of antibacterial drug therapy “for patients with preexisting cardiovascular risk factors or clinical conditions in which antibacterial drug therapy has limited benefits,” the article states.

As a law firm that represents thousands of clients in lawsuits seeking compensation for injuries allegedly caused by dangerous drugs and medical devices, RLG urges anyone who has suffered the alleged adverse side effects from Zithromax or any other prescription medication to speak to a qualified personal injury lawyer as soon as possible. The firm maintains a Zithromax Lawsuit Information Page that has features that allow for easy sharing, including links for automatic posting on Facebook and Twitter, specifically to enable visitors to spread the word about the dangers of Zithromax.

The new drug, Liptruzet, is found to lower cholesterol but does not lower the risk for cardiovascular disease, according to a May 3 New York Times article. Despite Lipitor’s popularity there is at least one study that shows it has its own share of risks. According to a study in JAMA: Internal Medicine, there is a potential link between statins and a Type 2 diabetes risk in women.***

“The FDA makes regulatory choices every day, but this one is troubling,” said Rochelle Rottenstein, principal of RLG. “This is especially true when considering the side effects we hear about daily from clients, in addition to the impact these choices can have on Lipitor lawsuits.”

Prompted by the drug’s potentially serious side effects, plaintiffs across the nation are filing Lipitor lawsuits, many under consideration for consolidation into a multidistrict litigation (In re Lipitor (Atorvastatin) Litigation, MDL No. 2459 (JPML)).

Attorneys for medical device manufacturers Merck and Organon USA argued that punitive damages could not be sought in New Jersey because the state’s Product Liability Act excludes punitive damages in prescription drug litigation, according to court documents in In re: NuvaRing Litigation (BER-L-3081-09, Superior Court of New Jersey, Bergen County). Judge Brian R. Martinotti said the cases are primarily concerned with what the companies revealed to the plaintiffs and their doctors in each of the respective states—not what was disclosed to the U.S. Food and Drug Administration in warning labels issued from the companies’ headquarters in New Jersey. This, he said, meant that each of those respective states had an interest in regulating punitive damages differently.

“The ruling does not guarantee any particular outcome after trial,” said Rochelle Rottenstein, principal RLG, “but it does mean that plaintiffs’ attorneys are allowed to seek punitive damages in addition to compensatory damages.”

This news comes as parties on both sides are also preparing for bellwether trials in the federal multidistrict litigation, a consolidation of federal NuvaRing lawsuits (MDL-1964, U.S. District Court for the Eastern District of Missouri), set to begin in October.

There are about 200 NuvaRing lawsuits pending in the MCL in New Jersey. There are currently more than 1,000 lawsuits pending as part of the federal MDL, according to court records. Among the side effects cited by plaintiffs is the risk of blood clots. The British Medical Journal published a study that found a six-and-a-half-fold to eightfold increase in the risk of clots in women who use vaginal ring contraceptives.

Salesman Damon Daniels’s territory covered the northwestern United States, according to an April 30 Bloomberg story. He said he would assist with console setup, the positioning of the operating table and the answering of questions, as part of his sales routine. Fred Taylor, whose family is the plaintiff, died of heart disease in 2012. His family attributes his death to a robotic surgery performed four years earlier by what they allege was an under-trained doctor.

“The testimony is important for the plaintiff,” said Rochelle Rottenstein, principal of RLG. “It could help prove the negligence the plaintiff alleges occurred with regard to the death of Mr. Taylor following a da Vinci robotic surgery.”

This is the first da Vinci case (Estate of Fred E. Taylor v. Intuitive Surgical Inc.; 09-2-03136-5, Superior Court, Port Orchard, Wash.) of about a dozen lawsuits in the United States to go to trial. The family of Fred Taylor alleges that Taylor’s eventual death was the result of complications associated with a procedure conducted by an inadequately trained surgeon, according to an April 15 Bloomberg story. Intuitive Surgical asserts that it is fully committed to superior training opportunities for surgeons and surgical teams in the use of its products, but notes that it does not participate in determining when a surgeon is adequately prepared to operate using the da Vinci Surgical System. According to an April 9 USA Today article, the da Vinci surgical robot was used in about 400,000 surgeries in 2012.

RLG encourages people to visit this page to download a free brochure to help them determine if they have a case.

What Is the Zilver PTX Drug Eluting Peripheral Stent?

A stent is a tube inserted into a blood vessel to expand it and ensure proper blood flow. They are usually used in people who have some kind of heart or circulatory ailment. Cook Medical’s Zilver PTX Drug Eluting Peripheral Stent is made of a metal mesh and is meant for insertion in one of the primary arteries along the thigh bone in people who have peripheral artery disease (PAD). The stent is coated with the drug Paclitaxel, which prevents the blood vessel from narrowing again (a condition called “restenosis”). The drug coating is what gives the Zilver PTX its “drug eluting” quality because the Paclitaxel dissolves into the blood once the stent is inserted.

The Zilver PTX Drug Eluting Peripheral Stent Might Cause Life-Threatening Side Effects

The U.S. Food and Drug Administration (FDA) approved the Zilver PTX Drug Eluting Peripheral Stent in November 2012 via its premarket approval process. However, by December 2012, Cook Medical had received 13 complaints from patients all over the world that the stent’s delivery system could separate at the tip of the inner catheter. Two adverse events were reported in the United States, and one of the American patients died. Cook Medical initiated a worldwide recall of the stents.

Symptoms that can result from a separated tip can include:

• Surgery to remove the catheter tip;
• Vascular occlusion caused by an unretrieved catheter tip;
• Thrombosis;
• Amputation;
• Cardiac arrest; and
• Death.

The side effects are specific to the stent’s delivery system, so patients who were implanted with the stent and had the delivery system removed are not at risk of tip separation side effects. Cook Medical determined that the cause of the tip separation was due to a component within the delivery system not being manufactured according to its design criteria.

RLG’s Zilver PTX Drug Eluting Peripheral Stent Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Zilver PTX Drug Eluting Peripheral Stent lawsuit on your behalf if necessary. RLG will also keep you up to date on any Zilver PTX Drug Eluting Peripheral Stent class action lawsuits, FDA Zilver PTX Drug Eluting Peripheral Stent warnings, and Zilver PTX Drug Eluting Peripheral Stent FDA recall announcements. If you or a loved one was implanted with a Zilver PTX Drug Eluting Peripheral Stent and believe it caused an injury, contact RLG today.

What Is Potiga and What Is It Prescribed For?

Potiga is an anti-seizure medication manufactured by the British pharmaceutical giant GlaxoSmithKline plc. The FDA approved it in June 2011 to treat partial-onset seizures in people aged 18 and up. Potiga works differently from other anticonvulsants because it opens potassium channels in brain cells, which stabilizes the brain’s electrical system and thus reduces seizures.

According to the FDA, between April 2012 and February 2013, roughly 2,900 people purchased 10,900 Potiga prescriptions at retail pharmacies in the United States.

Potiga Might Cause Eye and Skin Side Effects

On April 26, 2013, the FDA issued a Potiga warning in the form of a drug safety communication advising the public that Potiga had been found to cause previously undocumented side effects. Some users reported blue skin discoloration in the following areas:

• Lips;
• Nail beds;
• Fingers or toes;
• Legs; and
• Face.

Some patients also reported that Potiga changed the color of their sclera and conjunctiva—the whites of the eyes and inner eyelids, respectively. Sometimes eye discoloration occurred without skin discoloration.

So far, the only reports of Potiga side effects have come from participants in the first Potiga clinical trials, and most cases occurred in people who had used Potiga for more than four years. Approximately 38 out of 605 (6.3 percent) study participants reported discoloration side effects, but the FDA doesn’t know if more were affected and didn’t report it. The FDA states it does not yet know if the discoloration is reversible.

RLG’s Potiga Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Potiga lawsuit on your behalf if necessary. RLG will also keep you up to date on any Potiga class action lawsuits, additional FDA Potiga warnings, and Potiga FDA recall announcements. If you or a loved one has taken Potiga, and you believe it caused an injury, contact RLG today.