Archive for April, 2011
Government Accountability Office Criticizes FDA Fastrack Process
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on April 22, 2011
“The FDA is falling short in how it handles recalls of risky medical devices, a new report from the Government Accountability Office concluded, adding to the ever-mounting criticisms of the agency’s fast-track, 510(k) approval process.”
The Government Accountability Office (GAO) is known as “the investigative arm of Congress” and “the congressional watchdog.” GAO supports the Congress in meeting its constitutional responsibilities and helps improve the performance and accountability of the federal government for the benefit of the American people.
In a recent article, the GAO complained that the FDA failed to keep track of the reasons devices such as hip implants are recalled, and it doesn’t always follow up to make sure the recall was complete.
Click here to read the article: GOA Still Leary of Fast-Track Device Approvals
The GAO is only the most recent group to criticize the FDA for the 510(k) fast-track approval process for medical devices.
Click here to read a previous post about the high recall rate for fast-tracked medical devices.
International Bribery, Oil, Drugs…and Artificial Hips??
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on April 18, 2011
Johnson and Johnson has admitted that it bribed European doctors and paid kickbacks in Iraq to win contracts to sell drugs and artificial joints.
The late Warren Zevon sang “Send lawyers, guns, and money, the sh*t has hit the fan”. Is that what they are thinking these days at Johnson & Johnson?
J & J is the parent of DePuy, Inc., the manufacturer of the ASR, a metal on metal replacement hip system that doctors around the world believe is defective and was recalled in 2010. According to the SEC, Johnson & Johnson carried out a program since 1998 of using slush funds, sham contracts, and offshore companies to bribe hospitals and doctors in Europe and Iraq to sell drugs and install their artificial joints. The SEC also claims that Johnson & Johnson made illegal payments to Iraqi officials to win contracts under the United Nations Oil for Food Program.
Read the full story here: Johnson & Johnson Will Pay $70 Million Over Bribery Claims
Read the SEC’s filed complaint here: SEC Complaint against J & J
The SEC action follows up a United Kingdom action against British businessman Robert Dougall, then director of marketing at DePuy International (DPI), another subsidiary of Johnson & Johnson. He pleaded guilty in the regarding his involvement in £4.5m of payments to Greek surgeons to encourage them to use DPI products. From 1998 to 2006, J&J earned more than $24 million in profits by bribing Greek doctors to buy surgical implants including artificial knees and hips, the SEC said.
Read the full story here: SFO Whistleblower Robert Dougall is Spared Prison
What was the response from embattled Johnson & Johnson?
Johnson & Johnson is paying $70 million to resolve the bribery claims. J & J agreed to pay $48.6 million in disgorgement of profits and interest to settle the SEC’s claims, a $21.4 million fine to settle criminal charges filed by the Justice Department, and admitted the allegations of the charges filed by the Justice Department. J & J has recalled more than 50 products since the start of 2010 including the DePuy ASR replacement hip, which was affected thousands of people worldwide.
Click here to find out more about the Brandi Law Firm DePuy Hip Attorneys.
Drug Recalls Hit All Time High
Posted by The Brandi Law Firm Blog in Drug and Medical Device Litigation on April 12, 2011
There is good news and bad news in the statement “Drug Recalls Hit all Time high in 2009”
The fact that this occurred reflects some vigilance in protecting consumers and an absolute failure by companies to produce safe products.
As CNN Money reports, the number of recalls hit 1,742 in 2009–that’s an increase of 309 percent over 2008. While most of the recalls came from a now shut down drug repackager, separating those out still results in an over 50% increase over 2008. According to Bowman Cox, managing editor of the Gold Sheet, a trade pub that analyzes FDA data. “If we continue at this same rate, we could get 600 or more recalls by the end of the year,” he adds. “That’s still a very high rate of recalls.”
In their zeal to be first to market and obtain the biggest market share, some companies have clearly taken shortcuts on manufacturing controls, labeling, and poor packaging at the expense of consumer safety. Would this be happening if companies truly emphasized safety as they claim? It is way past time for the truth to match the rhetoric.
Read more here: Drug Recalls Hit All-Time High in 2009
The FDA has released a mobile phone app to track recalls, which can be downloaded here. While the access to recall information is a positive thing, does the need for a mobile phone app indicate that there are just too many recalls?
For more information please click here to learn more about Brandi Law Firm Drug Litigation Attorneys.
Is Your Doctor Also Working for a Drug Company?
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on April 7, 2011
How independent is your doctor when making a prescription choice for you?
On March 31, 2011 Merck revealed it paid $20.4 million to over 2088 physicians ($10,600 on average) in 2010 for speaking on its behalf. These figures do not include what Schering Plough, acquired by Merck in 2009, paid to doctors. This is the same Merck who spent millions on doctors who prescribed the withdrawn Vioxx and the embattled Fosamax that is the subject of numerous suits around the Country and studies showing its causal relationship to femur fractures in women.
Following up Merck’s doctor-payment disclosures, Pfizer and GlaxoSmithKline announced their payments:
The world’s largest drugmaker, Pfizer spent $177 million to doctors in support for clinical trials and speaking fees. 4,600 physicians collected a total of $34.4 million, or $7,400 on average. Broken down, that figure is comprised of $18 million in free meals for doctors, $8.9 million in advisory fees (paid to 1,400 doctors), $5.8 million for travel, and $1.7 million for education.
GSK’s (maker of the embattled Avandia) payments were only total of $85 million for trials and speaking.
Merck and Glaxo posted their numbers voluntarily, while Pfizer is required to disclose payments under its off-label marketing settlement with the U.S. Justice Department.
This office represents clients injured by Avandia (GSK) and Fosamax (Merck) and formerly represented numerous people injured by Vioxx (Merck).
Do you the patient have the right to know if your prescribing Doctor is working for the maker of the drug you are getting?
- read the Reuters article: Pfizer, GSK Paid $262 Million to U.S. Doctors in 2010
- or the article in the Wall Street Journal: Pfizer, Glaxo Disclose Fees to U.S. Doctors
- or in the Telegraph: GlaxoSmithKline Reveals Fees Paid to US Doctors
- or the Philadelphia Telegraph’s take: Big Pharma Reveals How Much it Paid Doctors
Other Related Articles:
Merck pays 2,000-plus docs $20.4M for speaking
Study: Fewer doctors report industry ties
Live From BIO: Biotech, Pharma are living in a fishbowl
Are pharma-doc links necessary or questionable?
Supreme Court Allows Defective Seat Belt Cases to Continue
Posted by The Brandi Law Firm Blog in Automobile Defects on April 5, 2011
In a recent decision, the U.S. Supreme Court addressed the following issue: Can a person bring a lawsuit alleging inadequate seatbelt design even if the company complied with the federal seatbelt safety regulations? The Court held that such claims were allowed and that compliance with federal standards did not excuse Mazda’s conduct.
This case concerned the tragic death in 2002 of Thanh Williamson. Ms. Williamson was riding in the rear of a 1993 Mazda minivan wearing the lap belt, which was the only restraint available, when it was struck head on by another vehicle. All other passengers in the van wearing combination lap/shoulder belts survived, but Ms. Williamson died as a result of her injuries.
Mazda argued that the lawsuit should have been dismissed because it complied with the Federal Motor Vehicle Safety Standard in effect at the time which allowed Mazda to pick either lap or lap and shoulder belts in some rear seats.
Ms. Williamson’s family argued that the Federal Regulations were merely minimum requirements, and that Mazda should have equipped the rear seats with lap and shoulder belts. A common claim in this instance is that, regardless of the existence of Federal Standards discussing this issue, Mazda had a duty to equip their vehicles with lap and shoulder belts for all passengers in light of the age of the Federal Regulation and the extensive studies that show they are much safer.
Essentially, Ms. Williamson’s family claimed that Mazda knew, or should have known, that lap and shoulder belt combinations greatly increase the safety of their consumers and the company was negligent for failing to install them in all seats in the vehicle.
Read the Supreme Court opinion here: Williamson v. Mazda, et al.
Read the New York Times article here: Supreme Court Allows Lawsuit Over Rear Seat Belts
At the Brandi Firm, this issue regarding the meaning and scope of Federal Motor Vehicle Safety Standards is a common one. More often than not a vehicle technically complies, but we believe that the standards represent the “floor” of compliance, or the absolute minimum required in order to sell cars in the United States. These standards don’t change often, but technical and scientific advances are common with regard to auto safety, and we believe that automobile manufacturers should make sure their products are up to date and as safe as possible, regardless of the minimum standards.
In our experience, automobile defects can either cause accidents or fail to provide adequate safety measures to prevent serious injury or death.
Click here to learn more about the types of Automotive Defects
-
You are currently browsing the archives for April, 2011
