defective medical device

[This is part of an ongoing series of articles we've reported on for the Depuy Hip Replacement Failure.  Bisnar|Chase has filed and is currently litigating these types of hip replacement failure lawsuits.]

A witness for Johnson & Johnson miscalculated when he testified that Loren Kransky’s metal hip replacement device failed because of the angle at which it was implanted, the plaintiff’s attorney said in cross-examination during the trial in Los Angeles.

According to a Bloomberg News report, expert Avram Edidin testified during the trial involving a product liability lawsuit filed by Loren Kransky, which claims that J & J defectively designed his metal hip device and failed to warn consumers about the risks. Kransky’s lawsuit is the first of 10,000 DePuy ASR hip device lawsuits to go to trial.

Discrepancy in Measuring Implant Angle

Edidin, a professor at Drexel University’s School of Biomedical Engineering in Philadelphia, testified that the ideal angle of the device’s placement is 45 degrees. He told jurors that Kransky’s surgeon placed the cup of the device at a 63- to 65-degree angle causing the metal to wear and cause complications. Edidin’s testimony was meant to convince jurors that the implant failure was the fault of the surgeon and not J & J. Read the rest »

Johnson & Johnson has been told to pay $7.76 million in punitive damages to a woman who has already won a $3.35 million compensatory award for serious injuries and complications blamed on the company’s transvaginal mesh device. The punitive damages were awarded by a New Jersey jury on February 28, 2013.

The verdict came in the first of 4,000 lawsuits to go to trial over the Gynecare Prolift mesh made by Ethicon, a subsidiary of Johnson & Johnson. The jury, comprising six men and three women, turned in the verdicts after a six-week trial that included expert testimony from both sides.

The plaintiff in this case, Linda Gross, alleged that she suffered constant pain after receiving the Gynecare Prolift mesh implant to shore up weakened pelvic muscles. She also testified that she underwent 18 surgeries to correct the problems caused by the mesh. Gross also told the jury that the company misled her when it came to the safety of the mesh and the procedure.

Read the rest »

A jury in Atlantic County, New Jersey, awarded $3.35 million to 47-year-old Linda Gross for damages stemming from a Gynecare Prolift mesh device made by Ethicon, a subsidiary of Johnson & Johnson.

According to a Reuters news report, the nine-member jury heard the case for six weeks before delivering the verdict on February 25, 2013.

The jury, comprised of  six women and three men, determined that Ethicon had failed to adequately warn Gross and her doctor about the potential complications and injuries related to the vaginal mesh implant.

Fraudulent Misrepresentations

Gross ended up undergoing 18 surgeries in an attempt to correct the problem. In fact, news outlets that covered the trial reported that Gross remained standing throughout the proceedings because it was too painful for her to even sit down.  She alleged in the lawsuit that she suffered from severe complications including mesh erosion, infections and nerve damage.  The jury found in this case that the product was not defectively designed, but that Ethicon had made fraudulent misrepresentations about the product. Read the rest »

Fresenius Medical Care, the manufacturer of dialysis products GranuFlo and NaturaLyte, has no problem communicating about lawsuit claims according to an article in Lawyers and Settlements. However, they were silent about alkali dosing errors that resulted in numerous tragic deaths. The article states that while Fresenius could have communicated this valuable information in a nanosecond with a tweet, they chose not to do so.

GranuFlo and NaturaLyte are two products manufactured by Fresenius, which also happens to be the largest manufacturer of dialysis machines and the largest operator of dialysis clinics in the country. According to The New York Times, an internal memo from Fresenius in November 2011 cautioned its own clinics to watch out for alkali dosing errors as a result of using GranuFlo and NaturaLyte.

In 2010, 941 people died after suffering cardiac arrest in Fresenius clinics during dialysis treatments. Too much bicarbonate in the blood can potentially lead to heart problems. Fresenius did not communicate the danger posed by the products to other clinics and doctors until the internal memo was leaked to the U.S. Food and Drug Administration (FDA). Read the rest »

Johnson & Johnson’s Ethicon unit properly designed a vaginal mesh implant and adequately warned consumers of its risks, a lawyer for the company told jurors who are about to decide on a lawsuit filed by a woman who blames the device for her 18 surgeries. According to a Bloomberg news report, the lawyer urged jurors in Atlantic City, New Jersey, to reject a product liability lawsuit filed by Linda Gross who maintains that Ethicon’s design of the Gynecare Prolift transvaginal mesh implant was defective. Gross also claims in her lawsuit that J & J failed to warn her and her doctor of the risks involved. Gross’s lawsuit is the first of 1,800 mesh lawsuits to go to trial.

Addressing jurors during her closing arguments, the company’s lawyer said that Prolift has been “studied and studied extensively.” She claimed that it was not a defective or dangerous product and that doctors and consumers were well informed regarding the risks involved with the mesh device.

Read the rest »

89 Percent of Mass. Pharmacies Fail Inspections

February 10, 2013—Boston, Massachusetts—According to a recent report from Boston.com, 89 percent of the so-called “specialty” pharmacies subjected to surprise inspection failed to meet safety standards.  This news comes in the wake of a fatal outbreak of fungal meningitis last year linked to  injections prepared by one Massachusetts pharmacy.

Compounding Pharmacies “Not Sterile”

Serious safety violations were found in almost half of the pharmacies, prompting an immediate shut down by the state.  Another 21 were cited for minor violations.  One pharmacy surrendered its license after inspectors found sterility issues in a room where injectable drugs were prepared.

The Department of Public Health began surprise inspections after a Framingham pharmacy was linked to an outbreak of fungal meningitis in steroid injections last fall.  That tainted medication issue caused nearly 700 cases of illness and 45 deaths.

Critics of the pharmacies are not surprised at the findings.  They have been advocating for stricter oversight for some time, saying that few of these compounding pharmacies observe safety precautions.  They also warn that similar inspections in other states would probably reveal similar results.  Many states do not even have safety guidelines for these manufacturers, resulting in a self-regulation that many feel is ineffective.

There is some evidence that unsterile conditions have led to the problems experienced by patients who are given injections and drugs from compounding pharmacies.  Inspectors have found that “sterile” environments in these facilities often do not meet sterility standards generally accepted by the medical community, leading to contamination of drugs before they leave the manufacturer.

New Rules and Money Needed

Massachusetts recently enacted a new regulation that all inspectors must be licensed pharmacists with five years’ experience prior to inspecting other facilities.  More money in the state budget, approved last year, also means that more inspectors are available to investigate complaints and conduct surprise inspections.

However, other states have not yet moved to upgrade their own inspection processes, nor have they budgeted more money to examine compound pharmacies.  Critics worry that this may have the effect of simply causing pharmacies with sloppy safety practices to relocate to states where they will be held under less scrutiny.  Since there is little federal oversight of these compounding pharmacies, patients in any state may not know that their medication is coming from a safe source and may be unknowingly exposed to the danger of infection.

What Should I Do If I Am A Victim of Tainted Medication?

Victims who have been injured by tainted medication have rights under product liability law.  They are entitled to payment of medical bills, recovery expenses, lost wages, and other costs associated with their illness.  Furthermore, they may also be able to receive compensation for their pain and suffering or for permanent disabilities caused by these medications.

However, it is difficult for an individual to recover these expenses without legal assistance.  A personal injury attorney can examine the victim’s case, discuss the injuries sustained, and determine the best way to collect damages from the manufacturer if there is a question of product liability.