Orthopedic Alerts for Patients - Implant Recalls

Alerts and implant recalls for patients with orthopedic bone and joint conditions.

  A Philadelphia jury has awarded a $20 million verdict in favor of a New Jersey woman who suffered complications after a June 2007 pelvic-mesh procedure. The award — $17.5 million of which was for punitive damages — is the latest against Ethicon, a subsidiary of Johnson & Johnson, which has faced thousands of lawsuits in connection with its vaginal-mesh products. In February 2015, the company settled more than 100 lawsuits filed by women who claimed the Mentor ObTape Transobturator Sling devices caused them permanent injuries. The company has maintained that the benefits of the devices outweigh the risks.

Read more ...

  A federal jury in New Orleans recently sided with drugmakers Bayer AG and Johnson & Johnson in the first bellwether trial from plaintiffs alleging they were harmed by the blood-thinning drug Xarelto. Joseph Boudreaux, 75, of Louisiana blamed the drugmakers for life-threatening bleeding after taking the drug. He is the first in a series of four Xarelto bellwether cases (test trials) set to take place this summer in a consolidated legal action called a multidistrict litigation that involves nearly 20,000 plaintiffs. The verdicts in these trials will assist other plaintiffs and the drug companies assess potential outcomes and values of similar claims in pending litigation.

Read more ...

A Texas man filed a lawsuit against Bristol-Myers Squibb and AstraZeneca claiming the Type 2 diabetes drug Onglyza (saxagliptin) caused heart failure, according to court documents. According to Wrendell Chester’s complaint for damages filed on Feb. 1, 2017 in the United States District Court for the Southern District of Texas, he took both Onglyza and Kombiglyze XR (saxagliptin and metformin extended release) between 2010 and 2015. After taking the drugs, he suffered congestive heart failure, heart failure and acute hypoxic respiratory failure — a condition where there is not enough oxygen in the blood.

Read more ...

  The first Xarelto bellwether trial began on April 24, 2017 in New Orleans, and the plaintiff accused Johnson & Johnson and Bayer of failing to warn that the blood thinner could cause serious or fatal bleeding. Joseph Boudreaux took Xarelto to help cut his stroke risk, but instead the drug caused serious gastrointestinal bleeding, according to his lawsuit. Boudreaux spent a week in the intensive care unit and needed several blood transfusions and heart procedures. He also claimed that the drug makers failed to warn patients and doctors that the drug had no antidote or a way to determine which patients were at higher risk for bleeding.

Read more ...

Changes in menstrual bleedingUnwanted pregnancyChronic painPerforation/migration of the deviceAllergy and sensitivity or immune-type reactionsANVISA issued Resolution RE 457, which suspends the importation, distribution, sale, and use of the product throughout the national territory of Brazil. This is a major victory for patient safety and women in Brazil. Essure Not Banned in U.S. However, despite a similar assessment of the device by the U.S. Food and Drug Administration (FDA), Bayer continues to market and sell Essure in the United States. The device works by causing scar tissue to build up in the fallopian tubes to prevent fertilization of eggs. Bayer claims the device is over 99 percent effective at preventing pregnancy.

Read more ...

  An additional 3,000 plaintiffs filed Risperdal (risperidone) gynecomastia lawsuits against Johnson & Johnson and Janssen Pharmaceuticals in 2017, bringing the total to more than 5,500, Forbes reported. According to reports from the Philadelphia Court of Common Pleas, plaintiffs filed the suits in the first three months of 2017. About 80 percent of cases in the CLC come from out-of-state plaintiffs. Philadelphia’s Complex Litigation Center Director Stanley Thompson told Forbes the CLC would “deal with [the lawsuits] in due course.” Claims against J&J and its Janssen subsidiary say the drug giant failed to warn the antipsychotic Risperdal can cause gynecomastia — a condition where young men and boys grow female breasts.

Read more ...

By E. Scott Sills, MD, PhD Not every woman with Essure contraceptive implants will have pelvic cramping, bleeding, painful sex, weight gain or other problems appear after this procedure. But, there is no clear consensus on what to do about women with Essure who subsequently develop symptoms associated with this device. It is understandable that symptomatic Essure patients would seek some kind of surgery to treat complications. But, our research unfortunately showed a surprisingly high reliance on hysterectomy to accomplish this. An earlier study looked at outcomes after thousands of Essure procedures in New York, and found the risk of undergoing reoperation was more than 10 times higher for Essure patients, compared to women who had standard laparoscopic tubal ligation.

Read more ...

  As Americans continue to file hernia mesh lawsuits, Canadians began their hernia mesh class action claiming they weren’t warned of the implant’s risks. The device at the center of the claims is Ethicon’s Physiomesh Hernia Mesh which Health Canada recalled in 2016. The Canadian agency’s action came after it learned that recurrence and reoperation rates with the device were higher than those of other meshes. After the recall, Canadians who received Physiomesh suffered severe pain and had to undergo additional surgeries to repair hernias that reoccurred. Canadian lawyer Jill McCartney is representing plaintiffs in the class action.

Read more ...

Popular heartburn drugs called proton pump inhibitors taken by millions of Americans may increase the risk of heart problems, kidney damage and death, according to two 2017 studies. The first study, published in PLoS One by Anna Maria Pello Lazaro and colleagues looked at 706 patients with coronary artery disease (CAD). About 431 of these patients took PPIs, most commonly Prilosec (omeprazole), to control stomach problems from CAD medications. But, patients who took PPIs had a higher risk of heart failure and death that those who did not, about 14.65 percent versus 5.45 percent.

Read more ...