U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the House Oversight and Government Reform Committee, recently introduced legislation in the House that will reverse a U.S. Supreme Court decision earlier this year involving medical devices. A companion bill will soon be introduced in the Senate by U.S. Sens. Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor, and Pensions Committee, and Patrick Leahy (D-VT), Chairman of the Senate Judiciary Committee.
In February, the U.S. Supreme Court immunized medical device companies from state lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc. the Court found that the product liability claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision was wrong. It ignored both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks.
Because of the Court’s decision, seriously injured people are without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings. It also removes one of the industry’s most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians.
The Medical Device Safety Act of 2008 protects patients from dangerous and defective devices by correcting the Court’s flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved. People should contact thier elected Congressmen and Senator to voice support of this legislation to ensure that injured people have a right to compensation for injuries caused by dangerous and defective medical devices.
A Dallas County jury recently awarded a man who was partially paralyzed in a moving-truck accident with $87 million. Talmadge Waldrip rented a U-Haul truck in September 2006 to help his daughter move. The 6-ton truck rolled over him, crushing his bladder and pelvis. “When I stopped the truck and got out of it, the truck started rolling backwards, and it knocked me down,” Waldrip said. The gravely injured man has gone through 14 surgeries and can still not properly walk. He requires around the clock medical care.
U-Haul’s response to the jury’s verdict: “While the plaintiff’s injuries are extremely regrettable, the final verdict is another example of abuse of the legal system against corporate citizens in America.” No, U-Haul, the jury’s verdict is not an example of the abuse of the legal system. The jury’s verdict is a message to your company that allowing your trucks to be rented by consumers with faulty emergency brakes will not be tolerated by the community. And when your gross negligence causes serious injury, you will compensate the injured.
The FDA reports additional patient deaths are possibly linked to the blood thinner heparin so the company is mounting a recall of all of the drug.
Baxter International Inc. will recall the remaining lots of single and multi-dose injection and it will recall HEP-LOCK products.
Last month, Baxter recalled nine lots of heparin multi-dose after the drugs use was linked to four deaths and hundreds of mysterious allergic reactions.
Most of those adverse events were attributed to the multi-dose vial of heparin.
Now 17 other deaths are being investigated because of a link to heparin, although the FDA reminds reporters that those patients were already very sick so a definitive cause-effect at this time has not been established.
The Connecticut�personal injury lawyers of Sabatini and Associates, LLC provide quality legal representation to clients in Hartford, Connecticut, and surrounding cities including: West Hartford, Newington, New Britain, Avon, Canton, Wethersfield, Glastonbury, East Hartford, Norwich, Granby, Rocky Hill, Bristol, Manchester, East Hartford, Plainville, Berlin, Farmington, Windsor, South Windsor, Bloomfield, Enfield and counties including New Haven County, Tolland County, Hartford County, New London County, Litchfield County and Fairfield County..
More lawsuits have been filed over bacteria-tainted syringes. Sierra Pre-Filled of Angier, North Carolina makes the syringes, filled with heparin or saline are used to flush IV or catheter lines. In December, bacteria-contaminated pre-filled syringes sickened 20 outpatients of Rush University Medical Center in Chicago. 14 of those patients required hospitalization from five to nine days. All already have compromised immune systems from cancer and other ailments and many were undergoing chemotherapy. Quick investigative work linked the syringes to the bacteria,�Serratia marcescens. On December 20, 2007, the FDA announced AM2 PAT, Inc., initiated a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. Then the FDA in January expanded the recall to include all lots and sizes the company makes of heparin and saline pre-filled syringes after finding they too were contaminated with Serratia marcescens. The heparin IV flush syringe contamination was later confirmed by the CDC after checking several unopened syringes of this product.
The FDA recently approved additional changes to the label of the Ortho Evra birth control patch to include results from a new epidemiology study that suggests that users of the patch are at higher risk for developing serious blood clots than those taking birth control pills. These dangerous blood clots are known as venous thromboembolism (VTE), which can lead to pulmonary embolism. The findings support earlier studies further reinforcing elevated risks of VTE associated with the patch.
The Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson, the makers of the patch, conducted the study that prompted the labeling changes. In September of 2006 the FDA advised the label of Ortho Evra to warn an elevated risk of VTE based on two studies.