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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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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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Actos, Avandia May Up Risk for Diabetic Macular Edema

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

A Louisiana man has become the latest to claim that his taking the type 2 diabetes drug Actos resulted in developing bladder cancer. He has filed a lawsuit against the Japanese manufacturer of the drug and the marketer of it in the U.S., claiming they failed to warn about this ...

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Lawsuit Alleges Plavix Caused Oklahoma Man to Suffer Multiple Stomach Bleeds

Another lawsuit has been filed over adverse Plavix side effects. The lawsuit, filed by national law firm Parker Waichman LLP, alleges that the blood thinner, Plavix (clopidogrel), caused an Oklahoma man to suffer from multiple stomach bleeds.

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Birth Control Shot Depo-Provera may Increase HIV Risk

Birth Control Shot Depo-Provera may Increase HIV Risk, Study Suggests

A new study has linked the use of Depo-Provera (medroxyprogesterone acetate), an injectable type of birth control, to an increased risk of HIV infection.

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Boston Scientific Transvaginal Mesh

Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries

More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.

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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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System for Tracking Prescription Drug Side Effects Flawed

Study Finds System for Tracking Prescription Drug Side Effects Flawed

System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.

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Lawsuit Alleges Pentax was Negligent with Scope Design, Liable for Patient Death

A lawsuit has been filed in state court in Cook County, Illinois alleging that Pentax Medical, a division of Pentax of America, is liable for the death of a woman who died of a superbug infection after underoing a procedure with a duodenoscope. The August 31 lawsuit alleges that the scope was defectively designed, making it difficulty to sterilize. Duodenoscopes are snaked down the esophagus and into the small intestine to diagnose and treat gastrointestinal conditions. The devices have come under scrutiny following several outbreaks of infection from antibiotic-resistant bacteria.

The lawsuit was filed on behalf of the estate of a woman who died of infection with carbapenem-resistant Enterobacteriaceae (CRE) after undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) at Advocate Lutheran General Hospital in the Chicago suburb of Park Ridge, Illinois. The suit alleges that the hospital failed to adequately clean the scopes, leading to infections in 43 other patients. Continue reading

Posted in Legal News |

Covidien Bennett 980 Ventilator System under FDA Class 1 Recall

A number Covidien Puritan Bennett 980 Ventilator System units have been recalled because a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician.

Lots with product codes 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, and 980N3ENDIUUS are affected by the recall. These ventilators were manufactured March 2014 to June 2015 and were distributed from March 1, 2014 to June 17, 2015. A total of 657 ventilators were recalled in the U.S. Continue reading

Posted in Defective Medical Devices, Health Concerns |

Judge Issues Order in Conserve Hip Implant Bellwether Case

The first of the consolidated multidistrict litigation (MDL) cases over Wright Medical Conserve metal-on-metal hip implants continues to move forward. United States District Judge William S. Duffrey, Jr. issued a 123-page order in the case on August 31. Wright Medical had claimed that the design-defect claims were preempted by the Medical Device Amendment to the Food Drug & Cosmetic Act, but this argument was rejected by the Court. The Court also denied motion for summary judgement related to the plaintiff’s claims for defective design, fraudulent misrepresentation, concealment and punitive damages.

Plaintiffs in the MDL allege that Wright’s Conserve hip implant caused serious injuries as a result of its metal-on-metal design. All-metal hip implants have come under increased scrutiny in recent years in light of multiple recalls and high failure rates. The devices were first marketed as being more suitable for younger, more active patients. However, the implants have a risk of shedding or fretting metal particles into the bloodstream and nearby tissues when the surfaces of the implant rub together. This can lead to a host of complications, including metal poisoning. In some patients, it was necessary to perform a revision surgery to remove and replace the implant. Continue reading

Posted in Legal News |

Knee or Hip Replacement Increases Risk of Heart Attack and Blood Clots

A team of researchers based in Boston found that osteoarthritis patients who had total knee or hip joint replacement surgery (arthroplasty) were at increased risk of heart attack (myocardial infarction) in the early post-operative period.

The findings, published this week in Arthritis & Rheumatology, a journal of the American College of Rheumatology (ACR), indicate that long-term risk of heart attack did not persist, but the risk for venous thromboembolism—blood clot in veins and lungs—remained years after the procedure, News-Medical.net reports. Continue reading

Posted in Defective Medical Devices, Health Concerns |

FDA Renews Warnings of the Dangers of Pure Powdered Caffeine

Because pure powdered caffeine products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers,” the Food and Drug Administration (FDA) issued warning letters to five distributors of pure powdered caffeine and the agency has renewed warnings to consumers about this substance.

A teaspoon of pure caffeine is roughly equal to 28 cups of coffee. A tablespoon of pure caffeine can be lethal. A 100-gram package (which is about 3.5 ounces) can have as much caffeine as 400 “tall” cups of Starbucks coffee, 1,250 cans of Red Bull or 3,000 cans of Coke, the New York Times reports. In 2014, two otherwise healthy young men died after using too much pure caffeine, prompting the FDA to issue a safety warning. Continue reading

Posted in Health Concerns |

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

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

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

Posted in Legal News | Tagged , , , , |

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

Posted in Health Concerns | Tagged , , , , |

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 , , , , |

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