At present, there are have been over 40 lawsuits filed against 3M over the Bair Hugger warming blanket, and I expect that number to grow. All of the complaints share similar allegations that after joint replacement surgery in which the device was used, patients developed catastrophic injuries, including infections, repeated joint surgeries, immobility and in severe cases amputations of knees and legs. According to the lawsuits, 3M knew about the hip and knee surgical infection risk for many years, but failed to make design changes or warn the doctors and hospitals. Continue reading
Johnson & Johnson is once again in the crosshairs of another medical device investigation. Ethicon, a division of J&J, is the largest maker of a highly controversial surgical instrument known as a power morcellator. The FBI has launched an investigation to determine if J&J continued to market the devices even after it was discovered they could spread a type of cancer.
The power morcellator was designed to be used in minimally invasive surgeries and is often used to remove the uterus. The tool has rapidly spinning blades that cut tissue into small pieces that can be removed from the body through small slits made during surgery. But it has been discovered that when the morcellator is used in women with undetected cancers, during removal of the uterus malignant cells are sprayed around the abdomen and can actually speed the progression of the disease. Continue reading
The first few settlement payments were made over the last two weeks from the DePuy ASR Settlement Trust. It had been hoped that more payments would have been made by this point. Brown Greer which is the law firm that is administering the settlement listed June on its website as the anticipated starting month for payments. Apparently, reviewing the claims and documents submitted turned out to be more time consuming than they had anticipated.
As of the second week of July, Brown Greer has doubled its team members on this project so that they now have 85 attorneys, project managers, analysis, and claim reviewers. Brown Greer has a good track record, in my experience, in administering large complex settlements such as this one and I am confident that they will be able to speed up the processing and payment of these claims.
Brown Greer reviews the claims submitted and then issues either a Notice of Eligibility or a Deficiency Notice if documents submitted are not complete. If an Eligibility Notice is issued, it provides a detailed breakdown of how much is proposed to be paid on the claim and why. The attorney receiving the Notice of Eligibility can either accept the claim or contest the claim. If the attorney receiving the Notice of Eligibility does not agree that the payment amount is correct he or she can submit a written description of why the claim is not correct and can upload documents to support the contest of the claim.
Zimmer Holdings has agreed to include Biomet’s “net debt” in the purchase. In the meantime, Biomet is being sued nationally and globally over its Magnum M2a Hip Replacement System. The pending sale may be one reason Biomet agreed to a $56 million settlement of all its U.S. Magnum M2a lawsuits in an effort to reduce its net debt.
In a recent medical study released by the Cleveland Clinic, drug coated stents manufactured by such companies as Boston Scientific and Johnson & Johnson have shown an increased risk for clots. With the older bare metal stents, tissue grows around and reclogs bare metal stents. Drug-eleuting stents prevent this growth but are now believed to increase the risk of blood clots.
After the third day of Transcather Cardiovascular Therapeutics show, the results are still mixed regarding the safety of drug coated heart stents. The stents, manufactured by Boston Scientific’s Taxus and Johnson & Johnson’s Cypher, many experts agreed, there appears to be a long-term clotting risk compared with the use of older bare metal stents. Even some physicians have been reluctant in employing the medical devices out of fear of clotting complications. According to the NY Times article, “Reporting surprising findings from one of those studies, Dr. Alaide Chieffo, a researcher from Milan, said that Italian and German doctors who tracked more than 3,000 patients with drug-coated stents from 2002 through the end of 2004 found that the drug therapy widely thought to protect such patients from clotting had no beneficial effect after the first six months.”
A leading stent manufacturer has admitted that there is an increased clot risk for those with Boston Scientific’s cardiac stent. It is the first acknowledgment by a stent maker of an increased risk of the dangerous side effect of stents, which are small wire-mesh tubes used to keep previously clogged arteries open. Drug-coated stents, which are coated with medicine to prevent the growth of tissue after implantation, have sales exceeding $5 billion a year in a market dominated by Boston Scientific and Johnson & Johnson.
Boston Scientific warned doctors that close to 1,000 of its cardiac implantable defibrillators may short circuit and fail to work properly leaving its patients vulnerable to cardiac problems. The company said that it learned of the failures after purchasing Guidant in April for $27.5 billion. U.S. regulators imposed sanctions on Guidant in December because of quality-control flaws after the recall last year of 109,000 defibrillators linked to at least seven deaths. Many recalled devices were sold years after Guidant learned of the flaws and began making models free of the problem.
A group that represents doctors, The Heart Rhythm Society, will publish guidelines to help doctors determine how to respond when a heart defibrillator malfunctions. The publication comes in response to problems experienced by cardiac defibrillator manufacturers,Guidant (recently acquired by Boston Scientific Corp.) and Medtronic. The guidelines call on device manufacturers to develop and use wireless and remote monitoring technology to identify possible malfunctions or problems earlier.