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The U.S. Food and Drug Administration this week issued an order to immediately halt the sale and distribution of pelvic mesh product for treatment of pelvic organ prolapse.vaginalmesh-300x225

Boston Scientific and Coloplast are the only two companies in the U.S. still selling mesh to treat pelvic prolapse. The FDA order immediately prohibits the sale of Boston Scientific’s Uphold Lite and Xenform mesh products, as well as Coloplast’s Restorelle DirectFix.

Our medical device injury attorneys have been watching the issue closely as tens of thousands of women have been seriously injured by mesh implantation. Still, Boston Scientific and Coloplast have continued to market and sell the product 7 years after the FDA issued an emergency order mandating device makers prove their products are safer and more effective than traditional surgical repair.

In a landmark decision the Connecticut Supreme Court this week reinstated a lawsuit filed by Sandy Hook school-shooting victims against Remington, one of the nation’s largest gun manufacturers.

Families of nine victims and one survivor of the Newton, Connecticut school shooting sued Remington Outdoor Co. Inc. and other defendants, including a gun wholesaler and a local retailer, alleging wrongful marketing and unethical advertising under the Connecticut Unfair Trade Practices Act (CUTPA). In the narrow 4-3 ruling, justices dismissed a case against the defendants based on negligent entrustment.ar-15lawsuit-300x81

Some are hailing the decision as a landmark victory against gun violence. Since passage of the The Protection of Lawful Commerce in Arms Act (PLCAA)  (15 U.S.C. §§ 7901 through 7903,) gunmakers have enjoyed near complete immunity for liability over gun violence. With certain specific exceptions, the PLCAA immunizes firearms manufacturers, distributors, and dealers from civil liability for crimes committed by third parties using their weapons.

Our Massachusetts product liability attorneys note this claim illustrates the many ways in which a product liability lawsuit can hold manufacturers accountable. However, this particular lawsuit has a narrow, treacherous pathway to success as Remington will almost certainly appeal to the U.S. Supreme Court, which must decide whether to allow state consumer law to trump federal protections in place to protect gunmakers.

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The increasing number of dangerous, defective and deadly products being marketed to the American consumer continues to have a significant impact on our health and welfare.

Boston Products Liability

Property casualty insurance advisors continue to add exclusions even as they push corporations to increase coverage for product liability, noting adequate product liability insurance is not just for manufacturers. Under the law, any entity involved in the supply chain of a defective product, including suppliers, retailers and distributors, can be held liable for injury.

All makers and sellers of products sold to U.S. consumers, whether they be artificial hips or baby cribs, have an obligation under the law to ensure their products are safe when used as intended and are recalled in a timely fashion if they prove dangerous or defective. Common assertions in a Massachusetts product liability claim include dangerous design or poor manufacturing, lack of proper warnings, and breach of expressed or implied warranty.

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Prescription opioids have become the most dangerous drugs in America.

A growing body of evidence suggest the prescription drug epidemic was not an unforeseen health crisis in America, but rather a carefully orchestrated push for sales and profits by some of the nation’s largest drugmakers and pharmacies, which is now claiming more lives each year than either traffic accidents or gun violence.

The Massachusetts Attorney General’s Office has filed a lawsuit against Purdue Pharma, makers of OxyContin, and eight members of the Sackler family, which founded the company, claiming the company misled doctors about the risks of the potent opioid. More than 200,000 people have died of prescription opioid overdose since OxyContin came on the market in 1996. In 2007, three company executives pleaded guilty to federal charges that they misrepresented OxyContin’s dangers. The company paid $634 million in fines. It sold $1.7 billion in Oxo Contin in 2017, according to Reuters News Service. perscription-drugs-2-1319811-300x225

When the Food and Drug Administration approved OxyContin in 1995, the federal watchdog agency allowed drugmakers to claim OxyContin’s long-acting formulation was “believed to reduct” its potential for abuse, compared to Vicodin, Percocet and other more traditional narcotic painkillers. As we recently reported on our Product Liability Lawyer Blog, the FDA is under fire for inherent conflicts of interest, as it is charged with both approving drugs for market and pulling dangerous drugs off the market.

Our Massachusetts personal injury lawyers have written about many of the consequences of the opioid crisis, from work injuries, to the risk of becoming addicted while recovering from injury, to the responsibility and liability of doctors, pharmacists and drugmakers. We applaud the Massachusetts Attorney General’s Office for pursuing this case. As has been the case throughout history — from asbestos and mesothelioma, to lawsuits against big tobacco, to multi-district litigation involving dangerous drugs and medical products — pushing these cases into court often forces a treasure trove of documents from these companies, which will be invaluable to thousands of other lawsuits seeking justice for families.

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When it comes to health care in the United States, it’s consumer beware.

A look at medical device and pharmaceutical drug recalls issued by the U.S. Food & Drug Administration in 2018 illustrates the consequences of a lax regulatory and approval process run largely by the drug companies and medical device manufacturers: A primary focus of the watchdog agency task with the nation’s safety must be warning consumers about the dozens of dangerous drugs and medical devices that it has approved for market.Boston Products Liability

Experienced Massachusetts product liability attorneys know too well that the nation’s healthcare system is a primary offender when it comes to consumer harm caused by dangerous or defective products.

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Several blood-pressure medications containing Valsartan are being recalled. The recent announcements are the latest in a rash of dangerous and defective drugs and medical products to be recalled in 2018.

Pharmacy Times reports Teva Pharmaceuticals has issued a voluntary recall in the United States of all lots of amlodipine/valsartan tablets and
amlodipine valsartan/hydrochlorothiazide combination tablets. The action comes after similar recalls have been announced by other manufacturers, after an active ingredient was found to be tainted with a known carcinogen.Products Liability cases Boston

Impurities found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. Miami Herald reports Mylan recalled 15 lots of the blood pressure and heart attack medication, which is used as the active ingredient in a variety of medications sold be various manufacturers.

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Lawyers for Civil Justice reported this month that nearly half of all cases pending before federal district court judges involve Multidistrict Litigation (MDLs) — more than 124,000 cases at the end of 2017.balance-1172800-300x204

About 90 percent of MDL cases involve product liability claims, which means, according to the study, that consolidated product liability cases – such as those alleging defects in drugs or medical devices – account for about 42 percent of the civil caseload before federal district judges.  The 18 largest MDLs contain 107,000 individual cases pending before just 15 federal judges, according to the report.

Multi-district litigation is a special federal legal procedure in the U.S. federal court system, which is designed to speed up the litigation process by combining many similar cases. The MDL statute is 28 U.S.C. § 1407 in the United States Code. Section 1407. Most MDLs involve a few dozen to a few hundred cases. The notable exception is MDL No. 875, based in the Eastern District of Pennsylvania, which is the largest and longest-lasting MDL. It was created in 1991 by the JPML to manage all asbestos personal injury and wrongful death cases in the federal courts. As of 2011, over 121,000 cases had been transferred into MDL No. 875, and over 108,000 cases had been settled, dismissed, or remanded, leaving about 13,000 pending.

Recent drug recalls of numerous common heart medications illustrate the growing risks faced by American consumers.

CNN reports the FDA has found another impurity in valsartan, Torrent Pharmaceuticals’ recalled heart drug.perscription-drugs-2-1319811-300x225

The generic ingredient is found in several pills that have been under voluntary recall since July. The U.S. Food and Drug Administration keeps an updated list of valsartan recalls, as not all pills containing the drug are currently subject to recall.

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This month’s $289 million jury award in a product- liability lawsuit against Monsanto is a historic and important victory for consumers that will likely have a watershed impact on billions of similar claims pending across the nation.

In this case, plaintiff was awarded $39 million in compensatory damages and $250 million in punitive damages after developing non-Hodgkin’s lymphoma. As CBS News reported, a California jury found the former school groundskeeper’s repeated use of Monsanto’s popular RoundUp product, a glyphosate-based weedkiller, was a substantial factor in causing plaintiff’s rare cancer.

It was the first of thousands of similar lawsuits Monsanto faces across the country. Plaintiff took a job as pest control manager for a Bay-area school district in 2012, where he sprayed the weedkiller 20 to 30 times per year. Jurors deliberated for three days following the eight-week trial.

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With over 1,000 cases already filed and climbing, the first of the Bellwether trials for the Invokana multidistrict litigation (MDL) is slated to begin in September 2018.  Bellwether trials, collectively, often set the standard for how the rest of the MDL will transpire.  For example, in majority, if the trials go well (i.e. for the injured consumers), the defendants may have increased the incentive to settle some or all of the cases.  If the trials do not go well (i.e. for the defending corporations), the cases may be taken back to start court for trial, or the plaintiffs may close their cases.  Invokana was approved to market in 2013 to treat Type 2 (adult onset) diabetes brought by Janssen Pharmaceuticals, a division of Johnson & Johnson.  Essentially, the function of this drug is to reduce glucose in the body by blocking a key component of the kidney that allows glucose to reenter the bloodstream.  This results in frequent urination to help discharge the glucose that has been separated from the system.  Continue reading