Product Liability Lawyer Blog

December 29, 2014

What Does the Arrest of NECC Executives Mean For Victims of Meningitis Outbreak?

Our Boston product liability lawyers recently discussed the arrest of NECC owners and employees in connection with the meningitis outbreak that occurred in 2012. The outbreak, which left 64 dead and caused more than 750 people to contract meningitis, was traced to contaminated steroids from the New England Compounding Center. The contamination occurred because basic safety protocols were not followed when the drugs were being compounded and packaged.

Following the public health crisis due to the contaminated steroids, NECC went bankrupt. This left many victims turning to suing sister companies of NECC to try to recover compensation for their monetary and non-economic damages. It also left the NECC owners and employees without any consequences to face for what they had done. Now, however, the arrest of the owners and of some high level employees at the pharmacy could change things.
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December 26, 2014

Artificial Knee Manufacturer Pleads Guilty to Fraud

by Jeffrey S. Glassman

According to a recent news article from NJ.com, the president and founder of OtisMed Corp. recently admitted to shipping hundreds of artificial knee products without FDA approval and pleaded guilty to criminal charges.

Authorities are reporting defendant pleaded to guilty to three misdemeanor fraud counts related to a shipment of over 200 artificial knee devices to surgeons throughout the United States with full knowledge the United States Food and Drug Administration had not approved them. Prosecutors stated defendant will be sentenced in March of 2015 and faces up to three years in prison.

OtisMed, which has since been acquired by Stryker Corporation, plead guilty to felony charge of distributing an adulterated medical device into interstate commerce and must pay approximately $40 million in fines and restitution. The company will also be required to pay an additional $41.2 million in civil settlements related to false claims litigation.
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December 23, 2014

Brinkley v. Pliva, Inc.: Defective Generic Drug Lawsuits

by Jeffrey S. Glassman

Brinkley v. Pliva, Inc., a defective drugs case from the United States Court of Appeals for the Eighth Circuit, involved plaintiff whose doctor prescribed the brand-name drug Reglan to treat her Gastro Esophageal Reflux Disease (GERD). Plaintiff’s pharmacist substituted the generic drug metoclopramide, which was manufactured by defendant. This occurred in 2002.

Pursuant to Federal Food Drug, and Cosmetic Act (FDCA), manufacturers of generic medications are required to prove their drugs are the same as the brand-name equivalent in design and labeling. Generic drug makers are not permitted to add any additional warnings.

In 2004, the United States Food and Drug Administration (FDA) approved the Reglan maker’s request to add two additional bold statements to the labeling warning the product should not be taken for more than 12 weeks. Defendant did not add these additional warnings to its generic product.
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December 20, 2014

Two Years After NECC Meningitis Outbreak, the Aftermath of The Tragedy Continues

by Jeffrey S. Glassman

In 2012, a meningitis outbreak was traced to a New England compounding facility. As our Boston product liability lawyers wrote at the time, multiple drugs were linked to the meningitis outbreak.

More than two years later, many of the victims and their family members are still trying to get justice from those responsible. Separate from the civil lawsuits, prosecutors have also been investigating what laws were broken and whether criminal charges were appropriate. Now, CBS Boston has announced that 14 people were arrested for their role in causing this devastating public health crisis that affected so many victims throughout Boston and the rest of the United States.
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December 17, 2014

Framingham Compounding Pharmacy Owners Charged with Murder

by Jeffrey S. Glassman

According to a recent news article from CBS Boston, the founders of a Framingham compounding pharmacy and 12 other employees have been charged with racketeering and second-degree murder.

Court papers indicated the compounding pharmacy was only licensed to manufacture small numbers of specific drugs for individual patients. This is the same pharmacy that was linked to a 2012 meningitis outbreak allegedly caused by tainted steroids made by defendants. In that incident, 64 people died and 750 more became seriously ill after taking the drugs.

As part of an investigation into this defective drug manufacturing incident, authorities found records filled with obviously fake names of patients such as “Bud Weiser,” “Filet O’fish,” and “Baby Jesus.” There were instructions by company founders that the names used in official logs should resemble real names and not be obviously false, though it appears employees did not follow this advice. The fake names are part of an alleged plan to defraud the FDA and avoid reporting requirements.
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December 15, 2014

New Studies Examine the Appropriateness of Total Knee Replacement Surgery

by Jeffrey S. Glassman

A new article from the New York Times suggests that patients should be careful before agreeing to undergo total knee replacement. Patients who suffer from sore knees and have trouble getting around may give in too quickly to the temptations of having an artificial knee implanted.

The device manufacturers have created a series of computer animations and physical models to show how a new knee will change everything. After a quick operation and somewhat longer recovery, the patient is told he or she will feel years younger and be able to do all of the activities possible before having any knee trouble.
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December 12, 2014

Scott v. C.R. Bard, Inc.: On Transvaginal Mesh Injuries

by Jeffrey S. Glassman

Scott v. C.R. Bard, Inc., an appeal from the Court of Appeal for the State of California, involved a plaintiff who was injured by a polypropylene mesh kit designed to treat women who suffer from a condition known as pelvic organ prolapse (POP). POP occurs when a female patient has weak vaginal walls that allow the uterus and bladder or rectum to enter the vaginal canal. POP can cause serious organ dysfunction, incontinence, pelvic pressure, and extreme pain, even to the point of becoming physically disabled.

Many patients will try less invasive treatment such as pelvic exercise, however, transvaginal mesh (TVM) manufacturers have convinced many POP sufferers that implanting a sling or other device designed to hold a piece of surgical mesh can solve the problem and allow the patient to lead a normal life.
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December 8, 2014

Risks of Testosterone Replacement Therapy

by Jeffrey S. Glassman

Over the past decade, there has been a huge increase in the number of patients taking testosterone replacement therapy (TRT) drugs. A recent news article from IndyStar examines whether TRT drugs are a virtual fountain of youth or simply an increased risk for a having a heart attack.

Drug companies who manufacture testosterone replacement therapy products have created numerous ads targeting people who feel tired, have a lowered sex drive, feel depressed, gained weight, have thinning hair, and other characteristics of normal male aging and have convinced many of these men that they suffer from a condition known as “Low T.” Low T is a term created by drug companies to mean having a lower than average testosterone level, despite it not being an accepted medical condition.
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December 4, 2014

Xarelto Plaintiffs Push For Consolidation of Numerous Lawsuits

by Jeffrey S. Glassman

Xarelto is a member of class of drugs known as New Oral Anticoagulants (NOACs) and has been the subject of many recent dangerous drug lawsuits. The makers of Xarelto (Bayer AG and Johnson & Johnson) produced a drug linked to serious clotting disorders, internal bleeding, and intracranial bleeding. Patients were not sufficiently warned of these dangerous side effects and were not given a chance to make an informed decision before taking the drug.

According to a recent news article from Bloomberg, Xarelto manufacturers are fighting a push to consolidate the many lawsuits that have been filed. Plaintiffs have requested all cases be consolidated and heard in the U.S. District Court in Illinois by Judge David Herndon. Plaintiffs have specifically alleged 65 Xarelto deaths have already occurred.
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November 29, 2014

FDA Delays Rule on Generic Drug Warnings

by Jeffrey S. Glassman

Drug manufacturers have an obligation to alert patients to any potential side effects associated with a particular medication. However, because of the way the laws are written, those who make and distribute generic drugs are actually prevented by law from alerting the public to potential problems.

The U.S. Food and Drug Administration (FDA) has been considering making a change to remove this limitation and allow generic drug manufacturers to issue warnings. This could also mean these entities might face liability if those warnings are later shown to be inadequate.

However, according to the Wall Street Journal, the FDA ultimately decided to delay its new final rule addressing the issue.

A Boston dangerous drug lawyer knows consumers deserve to understand the risk they assume when they take any medication. Drug warning labels should provide comprehensive data on potential side effects that could present a risk to patient health. Additionally, there needs to be accountability when drugs cause dangerous side effects.
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