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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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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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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

A Port Jefferson Station man was killed on Wednesday due to a single-vehicle crash on the Northern State Parkway in Dix Hills. Police are investigating the accident, Newsday reports. According to Newsday, the 81-year-old man was driving a Nissan Altima west in the right lane, west of Exit 42. He ...

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Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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Death in Those Taking Bactrim with ACE Inhibitors or ARBs

Sudden Death in Those Taking Bactrim Along with ACE Inhibitors or ARBs

Association between sudden death in those given Bactrim while already taking renin-angiotensin system blockers angiotensin receptor blockers (ARBs), heart medications.

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Western Pennsylvania Familes File Suit Over Alleged Fracking Pollution

Three families in western Pennsylvania believe a leading hydraulic fracturing (fracking) company and two water testing labs are conspiring to produce false results that show natural gas drilling is not contaminating their private water wells.

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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FDA Failed to Warn Public of Serious Side Effect Linked to Antibiotic Levaquin

FDA Failed to Warn Public of Levaquin Side Effect

FDA Failed to Warn Public of Levaquin Side Effect


The Food and Drug Administration (FDA) failed to disclose a serious side effect associated with the family of antibiotics known as fluoroquinolones identified in a 2013 agency report.

In an investigation, Cleveland television station ABC5 obtained a 2013 FDA report that raises concerns about possible “mitochondrial toxicity” associated with fluoroquinolones, which are marketed under brand names including Levaquin and Cipro and the generic form levofloxacin. These powerful antibiotics have been used to treat anthrax cases and are used for pneumonia and kidney infections. Continue reading

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

European Regulators Review Medtronic’s InductOs in Light of Contamination Issues

European Regulators Review Medtronic’s InductOs

European Regulators Review Medtronic’s InductOs


The European Medicines Agency (EMA) will be reviewing Medtronic’s InductOs following reports of contamination problems at a site that manufacturers one of the product’s components. InductOs is an implantable bone development product used in patients undergoing spinal fusion in the lower back and in surgeries to repair broken tibia. The kit InductOs is sold as contains its active ingredient dibotermin alfa and an absorbable collagen sponge (ACS) manufactured by Integra LifeSciences.

Regulatory Affairs Professionals Society (RAPS) reports that the contamination problems were from a site in the United States that manufactures the ACS in InductOs. In January 2014, inspectors identified “a number of major deficiencies” and Integra was issued a corrective action plan. Because of the contamination issues, the company was not allowed to import the sponge to the EU until inspectors could return and “assess the progress in eliminating the major deficiencies”. Continue reading

Posted in Legal News, Medtonic Infuse | Tagged , , , |

UPPAbaby Strollers and RumbleSeats Recalled for Choking Hazard

UPPAbaby Strollers and RumbleSeats Recalled

UPPAbaby Strollers and RumbleSeats Recalled


On July 23, the Consumer Product Safety Commission (CPSC) announced the recall of about 79,000 UPPAbaby strollers in the U.S. and Canada because the foam covering of the bumper bar could pose a choking hazard.

The recall includes the UPPAbaby 2015 CRUZ and 2015 VISTA strollers and 2015 RumbleSeats. The child can bite off and choke on the foam covering of the bumper bar. Continue reading

Posted in Defective Products, Product Recalls | Tagged , , , |

Children’s Breathing Difficulties Prompt Recall of Shiley Neonatal and Pediatric Tracheostomy Tubes

Children's Breathing Difficulties Prompt Recall

Children’s Breathing Difficulties Prompt Recall


Infants and children switched from older to newer models of Medtronic Shiley Neonatal and Pediatric Tracheostomy tubes developed breathing difficulties and this prompted Medtronic Inc. to recall 8,192 of the tubes in May.

In its recall announcement, the Food and Drug Administration (FDA) said there had been 12 reports of serious injuries associated with the Shiley tubes, but no deaths have been reported to date. Continue reading

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

Berkeley’s Cell Phone Radiation Warning is First in US

Berkeley’s Cell Phone Radiation Warning is First in US

Berkeley’s Cell Phone Radiation Warning is First in US


Berkeley’s cell phone ordinance, which requires retailers to warn consumers about the potential risk of radiation with cell phones, is the first measure of its kind to be passed. In May, the City Council unanimously passed the ordinance, titled Right to Know. The law goes into effect next month and warns consumers that “you may exceed the federal guidelines for exposure” to radiofrequency radiation by placing a cell phone into a bra or in a pants pocket. The warning also states that “The potential risk is greater for children” according to the New York Times.

Berkeley’s ordinance brings up questions about whether or not other cities will adopt a similar law. The city is known for its progressive actions, and has passed legislation that are sometimes seen as radical but are later implemented in other places, including health benefits for domestic partners, smoking bans, Styrofoam bans and creating sanctuaries for illegal immigrants. “If you can get it passed in Berkeley, you have a beginning,” said Berkeley Council member Susan Wengraf, according to NYT. “If you can’t, forget it, or come back three years later.” Continue reading

Posted in Cellular Phone, Legal News | Tagged , , , , |

Stronger Warning Label Placed on Non-Aspirin NSAIDs

Stronger Warning Label Placed on Non-Aspirin NSAIDs

Stronger Warning Label Placed on Non-Aspirin NSAIDs


The warning labels on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) are being strengthened to reflect the the risk of heart attack and stroke, the U.S. Food and Drug Administration (FDA) announced. The agency already warned of this risk in 2005, but has updated the label after an expert panel reviewed new safety data. NSAIDs, which are available in many over-the-counter (OTC) products such as Advil, Motrin and Aleve, are widely used. Raising awareness about potential risks is important and wide-reaching.

The revised warning says that the painkillers may increase the risk of stroke or heart attack in the first few weeks and that the risk can increase when they are used for longer periods. The risk also increases with higher doses. The revised label will also reflect that patients with or without heart disease or other risk factors can face an increased risk of stroke or heart attack with NSAID use, although patients with risk factors or heart disease are more likely to experience these events. The FDA notification states that “A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.” Continue reading

Posted in Legal News | Tagged , , , , |

FDA Investigating Potential Health Risks of Brain Deposits of Gadolinium-Based MRI Contrast Agents

Health Risks of Brain Deposits of Gadolinium-Based MRI

Health Risks of Brain Deposits of Gadolinium-Based MRI


Recent studies have shown that gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI) deposit in the brain of some patients who have repeated scans. The Food and Drug Administration (FDA) is investigating possible health risks of such deposits.

Recent publications in the medical literature—including an article published in March in Radiology—have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration of the agent. The FDA says it is not known whether gadolinium deposits are harmful or can lead to adverse health effects. Continue reading

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

Study: Antibiotics Associated with Increased Risk of Juvenile Arthritis

Antibiotics Associated with Increased Risk of Juvenile Arthritis

Antibiotics Associated with Increased Risk of Juvenile Arthritis


The use of antibiotics was linked to an increased risk of cancer in a study conducted by researchers from Rutgers University, University of Pennsylvania and Nemours A.I. duPont Hospital for Children. Findings showed that children who were exposed to antibiotics were twice as likely to develop juvenile arthritis compared to those who were not. As additional courses of antibiotics were taken, the risk increased; the risk was strongest within one year of taking antibiotics. The study was published in the journal Pediatrics.

Researchers conducted the study in light of evidence suggesting that children may be more likely to develop chronic diseases, including inflammatory bowel disease, when exposed to antibiotics. “Antibiotics are one of the better known disruptors of human microbial communities,” said lead author Daniel Horton, a postdoctoral research fellow working in the Department of Pediatrics at Rutgers Robert Wood Johnson Medical School and biomedical informatics master’s degree candidate in the Rutgers School of Health Related Profession. Continue reading

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

Class 2 Recall Issued for Nearly 2,000 Medtronic MiniMed Insulin Pumps

Class 2 Recall for 2,000 Medtronic MiniMed Insulin Pumps

Class 2 Recall for 2,000 Medtronic MiniMed Insulin Pumps


Medtronic has recalled nearly 2,000 units of its MiniMed 640G insulin pumps, according to a notification posted on the U.S. Food and Drug Administration’s (FDA’s) website. The device was distributed in the following 10 European countries: Australia, Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the United Kingdom. Medtronic intends to submit the pump for PMA submission later this year, Fierce Medical Devices reports.

According to the recall notice, there may be instances where “the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.” The recall was designated as Class 2 by the FDA, meaning that exposure to the recalled device might lead to temporary or reversible adverse events or that there is a low risk of serious events. Continue reading

Posted in Defective Medical Devices, Health Concerns, Legal News | Tagged , , , , |

Chrysler Agrees to Record Fines and Penalties and Must Buy Back Defective Vehicles

Chrysler Agrees to Record Fines & Penalties

Chrysler Agrees to Record Fines & Penalties


Fiat Chrysler Automobiles could pay up to $105 million in fines and penalties and must buy back defective vehicles in an agreement with the federal government that will also require an independent monitor to oversee future vehicle recalls.

The automaker may have to buy back more than half a million vehicles with defective suspension parts if owners wish to sell those vehicles back to Chrysler, Fortune reports. Continue reading

Posted in Defective Products, Motor Vehicles | Tagged , , , , |

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