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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Category Archives: Legal Issues

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Beginning of the End for Monsanto?

Posted in Lawsuits, Politics, Public Health

A former farm worker named Enrique Rubio may just be the right “David” to take down “Goliath” chemical company Monsanto. Rubio filed suit against the manufacturer of Roundup® early last week, claiming that the company’s infamous herbicide is the cause of his bone cancer and inability to work. Roundup’s® safety has been hotly debated for… Continue Reading

Drugs Disapproved by the FDA Deserve Attention

Posted in Drug Studies, FDA Regulation, Public Health

Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”. Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press… Continue Reading

2014 – FDA Recalls DePuy Craniomaxillofacial Distraction System, Cites Fatal Risk

Posted in Devices, FDA Regulation, Recalls

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled.  This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic… Continue Reading

Understanding Federal Preemption

Posted in Preemption

What is federal preemption? It’s an easier concept to grasp than you might think. Think back to when you were a kid, and you asked your mom if you could go to a party. She clearly said, “no.” You then went to ask your dad if you could go to the party, and he clearly… Continue Reading

Proposed Class-Action Lawsuit Filed Against Manufacturer & Distributor of OxyElite Pro

Posted in FDA Regulation, Lawsuits, Safety Alerts

A man by the name of Sandeep Barot has filed a proposed consumer protection class-action lawsuit against the manufacturer and distributor of dietary supplements that allegedly cause liver damage. See Barot v. USPLabs LLC et al., No. 1:14-cv-00562, complaint filed (D.N.J. Feb. 3, 2014). The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition Center… Continue Reading

Our Comment in Support of the FDA’s Proposed Rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985)

Posted in Generic Drugs, Preemption

Janice L. Weiner Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Bldg. 51, Room 6304 Silver Spring, MD 20993-0002   Dear Ms. Weiner, We are grateful for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes… Continue Reading

Generic Drug Industry Pushback Over New FDA Regulations

Posted in FDA Regulation

A recent article in the Los Angeles Times discusses industry pushback against proposed federal legislation that would allow the manufacturers of generic pharmaceutical drugs the ability to “inform people about all known health risks” associated with various drugs produced.  The Generic Pharmaceutical Association was quoted saying that the new regulations “would create ‘dangerous confusion’ and… Continue Reading

AndroGel manufacturer stirs up undue concern over “low-T”

Posted in Androgel, Lawsuits

As lawsuits concerning the testosterone therapy drug AndroGel have recently been filed, a great deal of information has come to light concerning the marketing of that product. Here is an excerpt from one of the current AndroGel lawsuits: “In 2000, when the FDA approved AndroGel, the company announced that the market was ‘four to five… Continue Reading

February 2014 – AndroGel Lawsuit Filed in Federal Court

Posted in Androgel, Lawsuits

WARNING: Research shows AndroGel (AbbVie, Inc., Abbott Laboratories, Inc.) is overprescribed and can lead to “serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.” AndroGel is a topically-applied gel containing testosterone at concentrations of either 1% or 1.62% used by patients suffering from hypogonadism, or “low-testosterone”.  While this condition does persist in… Continue Reading

FDA Exerts New Authority over Compounding Pharmacies with Drug Quality and Security Act

Posted in FDA Regulation, Politics, Public Health

In the wake of the recent fungal meningitis outbreak that left 64 dead and infected some 751 Americans, traced back contaminated steroid injections from the New England Compounding Center (Framingham, MA), the United States Food and Drug Administration has sought greater oversight over the pharmacy compounding industry. To that end, Congress passed the Drug Quality… Continue Reading

FDA: Xarelto not to be approved for acute coronary syndrome

Posted in Drug Studies, FDA Regulation, Public Health

Yesterday (1/16/2014) Reuters reported that an FDA advisory panel rejected a call by Johnson and Johnson to approve their anticoagulant Xarelto (rivaroxaban) for acute coronary syndrome by a vote of 10-0 with one abstention. While Xarelto “is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of… Continue Reading

2013 – “FDA lifts constraints on Glaxo diabetes drug Avandia”

Posted in Drug Studies, FDA Regulation

A recent article by Bill Berkrot and Ransdell Pierson (published in Reuters) reports on restrictions being lifted from the use of the drug Avandia.  Avandia is a diabetes drug made by the company GlaxoSmithKline that was thought to increase the risk for heart attacks for people using the drug.  The U.S. Food and Drug Administration… Continue Reading

New Federal Efforts to Curb Salmonella Outlined by FSIS

Posted in FDA Regulation

Salmonella is a food-borne bacteria, typically present in meat and poultry products.  An estimated 1.3 million illnesses can be attributed to Salmonella every year.  To address outbreaks of salmonella, the US Department of Agriculture’s (USDA) Food and Safety Inspection Service (FSIS) has released its Salmonella Action Plan that outlines the steps it will take to… Continue Reading

Internet Privacy Lawsuit: Google v. United States

Posted in Lawsuits

On October 26th, a federal court in California allowed a lawsuit against Google Inc. to proceed in which it is alleged that Google has violated privacy laws by scanning the emails of persons who do not use Google’s email service, Gmail, for the purpose of advertisement optimization. While it is currently legal for Google and… Continue Reading

FBI Steps Up Defenses for Attacks on US Food Supply

Posted in FDA Regulation, Public Health

Ellen Beck recently wrote an article for the “Smart Blog on Food and Beverage” website titled “FBI Makes Threats to U.S. Food Supply a Bigger Priority”, that discusses the food industry’s vulnerability to intentional food contamination.  In light of all the terrorist attacks taking place throughout the world, the FBI is becoming increasingly concerned that… Continue Reading

FDA moves to ban trans fats – New York Times

Posted in FDA Regulation, Public Health

A November 7th New York Times article by Sabrina Tavernise discusses the recent FDA ruling surrounding trans fats. Nutrition is an ever-changing area of research.  Many of the guides to healthy cooking and eating methods once thought ideal are now seen to be quite unhealthy and harmful to our health.  During the 1950’s, 1960’s, and… Continue Reading

FDA finds Drug Quality and Security Act insufficient

Posted in FDA Regulation

Julian Hattem of RegWatch, a blog curated by TheHill, reports in a piece that the US Food and Drug Administration is “not sold” on a recent pharmacy compounding bill. The mixing and distributing of medications happens at various compound pharmacy clinics found all throughout the United States, and these compounding clinics have been the source… Continue Reading

FDA seeks more stringent controls for some pain medications

Posted in FDA Regulation, Public Health

According to a recent report by HealthToday.com, The U.S. Food and Drug Administration believes certain commonly-used drugs that should be more difficult to obtain.  Painkillers such as Lortab and Vicodin contain hydrocodone (a synthetic opiate) which is often abused and highly addictive; tighter controls on these types of prescriptions may be a good way to… Continue Reading

Johnson and Johnson $2.2B Settlement for Illegal Marketing, Corruption

Posted in Lawsuits

As of November 4th, Johnson & Johnson agreed to a $2.2 billion deal in the settlement of pending criminal and civil charges that “alleged the healthcare giant illegally marketed its Risperal antipsychotic [along with Invega and Natrecor], and also paid kickbacks to physicians and Omnicare, the largest nursing home/pharmacy [company in the US,] to boost… Continue Reading

PhRMA unhappy with Maine’s new drug import law

Posted in Legal Issues

As reported by FDA News, the state of Maine has passed a law that green lights the use of imported prescription drugs through internet pharmacies.  The new law goes against past federal restrictions on drug imports that were established in order to inhibit the sale and use of medication that did not meet the federal… Continue Reading