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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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Medtronic Settles Charges Over Kickbacks To Doctors

Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a U.S. Justice Department announcement yesterday. The company was accused of seeking ...

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DeflateGate’s Effects Impact Legal Gambling and the Economy

DeflateGate’s Effects Impact Legal Gambling and the Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Lawsuits over DePuy ASR Metal-on-Metal Hip Implants Continue to Mount

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be hit with lawsuits over recalled metal-on-metal DePuy ASR hip implants. Just yesterday, the national law firm of Parker Waichman LLP announced it had filed yet another DePuy ASR hip implant lawsuit, this time on behalf of a Virginia resident ...

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Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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Research Suggest Fracking Chemicals Can Pollute Aquifers

A new study suggests fluids used during the hydraulic fracturing (fracking) process could migrate through underground fractures and contaminate water aquifers.

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FDA Allows Sales of 700 Generic Medicines Banned by European Medicines Agency

FDA Allows Sales of 700 Generic Medicines Banned by Europe

FDA Allows Sales of 700 Generic Medicines Banned by Europe


The European Medicines Agency (EMA) instituted a ban on about 700 generic medicines that were approved based in part on what were said to be flawed clinical studies conducted at GVK BioSciences, a contract research organization based in Hyderabad, India.

The U.S. Food and Drug Administration (FDA) said it found no systemic issues affecting the safety or efficacy of generic drugs tested at GVK BioSciences, but the FDA said it supports Europe’s ban, according to Outsourcing-Pharma.com. The banned medicines include different formulations and strengths. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals | Tagged , , , , , |

FDA Warns of Diabetes Drugs that Can Cause Disabling Joint Pain

FDA Warns of Diabetes Drug that Causes Disabling Joint Pain

FDA Warns of Diabetes Drug that Causes Disabling Joint Pain


On Friday, the Food and Drug Administration (FDA) warned diabetes patients that an entire class of diabetes drugs can cause severe and disabling joint pain.

The drugs include Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). They are all in the same class and work by making more insulin available to the body. Continue reading

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FDA is Using Whole Genome Sequencing to Stop Foodborne Illnesses

FDA is Using Whole Genome Sequencing to Stop Illnesses

FDA is Using Whole Genome Sequencing to Stop Illnesses


The U.S. Food and Drug Administration (FDA) is implementing whole genome sequencing to quickly detect and stop the spread of foodborne illnesses, Business Insider reports. The process offers huge advantages over the previous method, where samples from sick patients were tested to see if infections were caused by the same pathogen. Once enough matches appeared, the sick individuals were interviewed by epidemiologists to see if a common food was responsible for the outbreak. This method, however, does not conclusively find the cause and is time-consuming. “While all of this was going on, more contaminated product was getting out into the public,” said Dr. Steven Musser, deputy director for scientific operations at the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition, according to Business Insider.

The FDA is now having state and federal labs map out the exact genome of strains of foodborne pathogens such as Listeria and Salmonella. The National Institutes of Health houses a public database, known as GenomeTrakr where all the sequences are uploaded. Whole genome sequences allows scientists to distinguish a pathogen from related species, as well as slight mutations within the same strain. Continue reading

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FDA Takes Action Against Three Tobacco Companies over “Additive-Free” and “Natural” Marketing Claims

FDA Takes Action Against Three Tobacco Companies

FDA Takes Action Against Three Tobacco Companies

Three tobacco companies—ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd.—have received warning letters from the Food and Drug Administration (FDA) over “additive-free” and/or “natural” claims on their cigarette labels.

ITG Brands LLC makes Winston cigarettes, labeled additive-free; Santa Fe Natural Tobacco Company’s Natural American Spirit cigarettes are labeled additive-free and natural; and Sherman’s 1400 Broadway N.Y.C. Ltd.’s Nat Sherman cigarettes are labeled natural, WebMD reports. The companies may not represent “implicitly or explicitly . . . that the product presents a lower risk of tobacco-related disease,” the FDA news release says. Continue reading

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Stryker Recalls Orthopedic Devices that May Have Been Damaged in Shipping

Stryker Recalls Orthopedic Devices

Stryker Recalls Orthopedic Devices


Medical device maker Stryker Corporation is recalling nearly 17,000 orthopedic implant devices because of potential of damage during shipping.

The Food and Drug Administration (FDA) notice lists five devices included in the recall: the rHead lateral stem and Recon radial implant, both for replacement of the proximal end of the forearm’s radius bone; the uHead ulnar implant and Sigmoid Notch radial plate, both for replacement of the distal radioulnar joint; and the Radio-Capitellum to improve elbow function, Medscape reports. Continue reading

Posted in Defective Medical Devices | Tagged , , , , |

FDA Strengthens Heart Attack and Stoke Warnings for Nonsteroidal Anti-inflammatory Drugs

 FDA Strengthens Heart Attack & Stoke Warnings for NSAIDs

FDA Strengthens Heart Attack & Stoke Warnings for NSAIDs


The Food and Drug Administration (FDA) has strengthened existing warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) Drug Facts labels to indicate that the drugs can increase the risk of a heart attack or stroke, which can lead to death.

These side effects can occur as early as the first weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Aspirin is also an NSAID, but the revised warning does not apply to aspirin.) The OTC drugs covered by the revised warning in this group are used for the temporary relief of pain and fever and the prescription drugs are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple medicines with the same active ingredient. Continue reading

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FDA Warns of Danger of Giving Codeine Cough-and-Cold Medicines to Children

FDA Warns of Giving Codeine Medicines to Children

FDA Warns of Giving Codeine Medicines to Children


The Food and Drug Administration (FDA) is investigating the potential risks of using medicines with codeine to treat coughs and colds in children and has issued a Drug Safety Communication about such medicines. There is a potential for serious side effects, including slowed or difficult breathing.

Codeine is a type of opioid used to treat mild to moderate pain and reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines, according to the FDA. In April, the European Medicines Agency (EMA) announced that codeine must not be used to treat coughs and colds in children younger than 12. The EMA also said codeine is not recommended for children and teens between 12 and 18 who have breathing problems, such as asthma. The FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Continue reading

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CarMax Accused of Selling Cars with Lethal Safety Defects; Senator Seeks Tighter Regulation

CarMax Accused of Selling Cars with Defects

CarMax Accused of Selling Cars with Defects


U.S. Sen. Richard Blumenthal has proposed new legislation to regulate the sale of used cars with unrepaired recalls with what he says can be lethal safety defects.

Blumenthal, the senior senator from Connecticut, is concerned about cars sold by CarMax. “CarMax advertises that all its vehicles must pass a rigorous ‘125 point inspection,’ but no inspection that routinely ignores outstanding safety recalls can be called ‘rigorous,'” Blumenthal said, according to television station WFSB. “Regardless of whether they are buying a new or used car, all consumers deserve to know they are buying a safe car.” Continue reading

Posted in Defective Products, Motor Vehicles, Product Recalls, Recalled Vehicles | Tagged , , , , |

U.S. Representative Says CDC Withheld Data Linking MMR Vaccine and Autism

CDC Withheld Data Linking MMR Vaccine & Autism

CDC Withheld Data Linking MMR Vaccine & Autism


Florida U.S. Rep. Bill Posey recently presented evidence to Congress that the Centers for Disease Control and Prevention (CDC) destroyed data linking the MMR vaccine, (measles, mumps and Rubella) and autism.

Posey based his charges on the allegations from Dr. William Thompson, a 17-year veteran of the CDC, who became a whistleblower and charged that he was pressured to manipulate data in order to conceal possibly harmful side effects of the MMR vaccine, WND (WorldNetDaily) reports. Continue reading

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Congresswoman Calls for FDA Regulation after Veteran is Injured by Exploding E-Cigarette

Congresswoman Calls for E-Cigarette FDA Regulation

Congresswoman Calls for E-Cigarette FDA Regulation


The use of electronic cigarettes has been on the rise in their short time on the market. While they are touted as being a safer alernative to traditional cigarettes and as a cessation tool, there are still public health and safety concerns surrounding the products, especially given the lack of oversight from the U.S. Food and Drug Administration (FDA). The agency is currently planning on issuing regulations, and as that process moves forward a congresswoman is calling for the devices to be regulated the same as normal cigarettes.

According to Plymouth-Canton Patch, Michigan Congresswoman Debbie Dingell (D-Dearborn) is asking the FDA to place the same restrictions on e-cigarettes as regular cigarettes. The congresswoman was prompted by a veteran who was seriously injured by an exploding vapor pen. “Your natural thought is, is it safe to inhale? But second, is it safe to light up? Could it explode? And most people … didn’t think they had to worry about it exploding and I was actually stunned to hear of the number of incidents that have occurred across the country,” Dingell said to WWJ/CBS Detroit. Continue reading

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