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Legal Experts Say Recent Pelvic Mesh Verdicts May Suggest Johnson & Johnson Should Settle

Filed February 15th, 2016 Fran Kelley

After two jury awards exceeding $12 in the first pelvic mesh cases to go to trial, some legal experts have suggested that Johnson & Johnson should consider settling the estimated 150 cases remaining in the mass tort program and focus instead on the federal multidistrict litigation.

On February 10, 2016, a Philadelphia jury awarded $13.5 million to a plaintiff who brought suit against J&J’s Ethicon unit, which makes the Prolift pelvic mesh implant. The award included $10 million in punitive damages. This verdict closely follows a December verdict, awarding $12.5 million, $7 million of it in punitive damages, Law360 reports. An attorney told Law360 that two verdicts in a row in excess of $10 million “is a trend that’s worrying for Ethicon.” Continue Reading »

Woman Receives $13.5 Million in Damages in Johnson & Johnson Pelvic Mesh Trial

Filed February 11th, 2016 Fran Kelley

A Philadelphia jury awarded a woman $13.5 million in damages against Johnson & Johnson’s Ethicon division for pain and injuries she suffered because of in a case an Ethicon pelvic mesh implant.

The woman—who received the implant in 2005—alleges that the implant left her in near constant pain and discomfort and unable to have sex, Law360 reports. The jury agreed that the Ethicon transvaginal tape (TVT) was not reasonably safe, and, further, that the doctor would not have implanted the device if he had been adequately warned of the risks. Continue Reading »

Expert Witnesses Testify about DePuy Pinnacle Hip Injuries and Complications

Filed February 3rd, 2016 Fran Kelley

Expert testimony continues this week at the bellwether trial for injury claims by people implanted with DePuy Orthopaedics’ Pinnacle metal-on-metal hip replacement devices.

From among the Pinnacle cases consolidated in the federal court in the North District of Texas, five cases were chosen as representative of the injury claims in the Pinnacle hip litigation. These five are being heard in one proceeding. The outcome of the trial could play a key role in whether DePuy establishes a settlement program for Pinnacle injury claims. DePuy established a settlement program in 2013 for claims related to the similar ASR metal-on-metal hip implant, which was recalled in 2011. Continue Reading »

Medical Devices May be Vulnerable to Hackers, Security Expert Warns

Filed February 1st, 2016 Fran Kelley

Billy Rios, a cyber security expert, has warned that many medical devices—both personal devices and those used in hospitals—are vulnerable to hacking.

Rios, of the security consulting and assessment firm WhiteScope, told Dr. Max Gomez of television station CBS2, that when a device is connected wirelessly to a centralized computer network to make monitoring easier, the connection may also put the device at risk for hacking. “It’s a medical device, but the way this thing runs it’s really just a computer,” Rios said. “[S]omeone else can control this thing remotely and do things to the pump, or do things to the device or equipment. You have to understand what you’re doing before you do this.” Continue Reading »

Blood-Clot Filter Removal May Present Challenges in Young Patients

Filed January 28th, 2016 Fran Kelley

A team of doctors from the Children’s Hospital of Philadelphia, Perelman School of Medicine of the University of Pennsylvania, recently published a study in Pediatric Radiology on the challenges of removing inferior vena cava (IVC) filters in children. These filters are implanted to prevent blood clots from being carried into the heart and lungs.

Research studies have indicated increases in the rate of venous thromboembolism—the obstruction of a blood vessel by a blood clot dislodged from elsewhere—in children. An IVC filter is one of the treatments used to keep clots from reaching the heart and lungs, but doctors have concerns about the use of IVC filters in children.

IVC filters are typically used when the individual at risk for clots cannot take anticoagulant drugs or when anticoagulant drugs do not work well enough or fast enough, according to the Mayo Clinic. But complications can arise with long-term IVC filter implantation, including filter migration from the original site, clotting within the filter, and parts of the filter breaking off, which can lead to severe pain, bleeding, further clots, and other life-threatening complications. Broken-off parts of an IVC filter can penetrate the inferior vena cava, the aorta and the duodenum. For children, there is the additional concern that long-term filter placement in a child can negatively affect the growth of the child’s inferior vena cava.

C.R. Bard, the major manufacturer of IVC filters faces numerous lawsuits over deaths and injuries associated with IVC filters.

The Philadelphia researchers studied IVC filter removal in pediatric patients and they noted two major causes of retrieval failure — tip embedding and tilt, which are likely to worsen the longer the filter remains in place. Prolonged embedding may lead to tissue formation around the filter hook within the wall of the inferior vena cava, and this may make retrieval difficult or imprudent. With prolonged implantation time, the child may experience acute abdominal and leg pain.

The researchers performed a retrospective 10-year review of 20 children who underwent IVC filter retrieval. The subjects were 13 males and 7 females, ranging in age from 12-19 years. The mean implantation time for the IVC filter was 63 days, with a range of 20 to 270 days. Standard retrieval was performed in 17 of the 20 patients (85%). Additional (adjunctive) techniques were required for 3 patients (15%) and included the double-snare technique, balloon assistance, and endobronchial forceps retrieval. Median procedure time was 60 minutes (range: 45-240 min). Pre-retrieval cavogram demonstrated filter tilt in 5/20 patients (25%) with a mean angle of 17° (range: 8-40). Pre-retrieval CT demonstrated strut wall penetration and tip embedment in one patient each. There were two procedure-related complications: IVC mural dissection noted on venography in one patient and snare catheter fracture requiring retrieval in one patient. The authors say there were no early or late complications.

In their conclusion, the researchers said, “IVC filter retrieval can be performed safely but may be challenging, especially in cases of filter tilt or embedding.” Doctors may need to employ adjunctive techniques to safely remove the filters.

FDA Places Most Serious Recall Status on Brainlab Cranial IGS System Recall

Filed January 20th, 2016 Lillian Chiu

The U.S. Food and Drug Administration (FDA) has given a Class I designation to Brainlab’s recall of its Image-Guided Surgery (IGS) System. The Brainlab Cranial IGS System shows surgeons where their instruments are relative to the patient’s anatomy during minimally invasive surgeries. The recall was issued because the display may be inaccurate, potentially leading to serious or life-threatening consequences.

“Brainlab is recalling the Cranial IGS System due to potential inaccuracies in the display by the navigation system compared to the patient anatomy. This could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death.” the notification states. Class I recalls are the most serious type of recall indicating that the recalled device may present risk of serious injury or death. Continue Reading »

Lawsuit Against 3M Claims Bair Hugger Surgical Warming Device Caused Devastating Infection

Filed December 16th, 2015 Fran Kelley

A Texas woman has filed suit against 3M, alleging the company’s Bair Hugger surgical warming blanket was responsible for a drug-resistant infection that led to her leg amputation.

This case is one among dozens of cases claiming the Bair Hugger’s defective design leads to dangerous infections, Law360 reports. The Texas woman contracted the devastating infection after knee-replacement surgery during which the Bair Hugger was used. Continue Reading »

Boston Scientific’s Chariot Guiding Sheaths Under FDA Class 1 Recall over Risk of Shaft Separation

Filed December 14th, 2015 Fran Kelley

Boston Scientific, the manufacturer of Chariot Guiding Sheath, a device used in peripheral vascular procedures, has initiated a worldwide recall of the devices because of the risk of shaft separation, which could cause patient injury or death.

The recall was initiated on November 19, 2015 and affects all lot numbers of the Chariot Guiding Sheaths. A full list of lots numbers can be found on the FDA web site. Continue Reading »

Faulty Battery Prompts Medtronic Pacemakers to be Recalled

Filed December 4th, 2015 Lillian Chiu

Medtronic recalled nearly 100,000 InSync III pacemakers due to a potential battery defect. The problem, Qmed reports, is that the battery may have an unexpectedly high impedance, which may impair proper functioning if there is inadequate current. According to Qmed, the battery defect could lead to loss of pacing capture, erratic behavior, fluctuations in longevity estimates, and inaccurate lead impedances. More than 9,300 units in the United States are affected. A total of roughly 96,800 pacemakers were recalled. At least 22,000 patients worldwide have the pacemaker implanted.

There was a report of one patient death where the faulty battery may have been a contributing factor, Medtronic said. Continue Reading »

Texas Appeals Court Rules Medical Device Claims not Barred under Tort Reform Law

Filed November 20th, 2015 Fran Kelley

In a ruling earlier this month, the Third Court of Appeals in Austin, Texas ruled that personal injury claims against a medical device manufacturer accused of promoting off-label uses of one of its devices are not subject to the same requirements imposed on health care liability claims.

The court said Verticor Ltd., which manufactures the Eclipse Sphere device used in the plaintiff’s spinal surgery, cannot avoid the man’s claim that the company solicited a doctor to implant the Eclipse Sphere into his spine in an unapproved use, Law360 reports. Continue Reading »

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