When Medtronic recalled its Sprint Fidelis defibrillator because of faulty lead wires in October 2007, very little attention was paid to the history of the medical device in the first place. When Medtronic introduced its Sprint Fidelis defibrillator, the company touted the device’s thinner wires as an advance in defibrillator technology. What it didn’t tell the public was that these leads may be prone to fracture because they are thinner than the older defibrillator wires which had been functioning without problems. If the previous model of lead wires functioned without fracture problems, why create a new product that had the potential to cause grave harm and risk the possibility of extraction and further surgery? The answer lies in marketing and company profits rather than good medical science. Medtronic wanted to grow market share and increase company profits. In reality, there was no medical reason to introduce a new device to the market. This is an important issue that raises ethical questions about the behavior and marketing practices of pharmaceutical and medical device companies. A new medical device product or new drug may substantially increase company sales but does it benefit healthcare professionals in determining what is best for the patient? That’s the question that seems to get lost in the race for money and market share.
Sprint Fidelis Lead Recall Lawyer Resource
Defibrillator Lead Recall Lawsuit Information
Medtronic Sprint Fidelis Lead Recall Patient Check List
Defibrillator Leads Recall Lawyer / Attorney Clinical Overview

Some might dismiss the healdline of this blog post except for the fact that 13 of the 20 most popular drugs taken on the mainland are manufactured in Puerto Rico. According to an Associated Press report, the drug factories have consistently failed in terms of maintaining a sterile environment and have even shipped tainted pills to the US mainland. This in spite of the fact that even the modern facilities are failing. In one incident, an employee started covering exposed pills after noticing the blue specks of the pills matched the paint color of the factory walls! This is not a good sign for a pharmaceutical industry which plans to start manufacturing their drugs overseas where the FDA’s control is severely limited.
The problem is not isolated to pharmaceutical drugs. Medtronic’s recalled Sprint Fidelis defibrillator was manufactured in Puerto Rico and has experienced serious issues with faulty and breaking leads. At this point it appears that the faulty leads with the Sprint Fidelis are attributable to welding.
Yet, these pharmaceutical and medical device companies are always looking to cut costs and increase profits. They are trying to move their operations overseas to capitalize on the cheap labor pool. But this raises a serious consumer safety problem. If we can’t maintain quality standards in the US how do we plan to ensure safety when we’re exporting the drugs and have no regulatory authority?

A new study suggests babies may be exposed to toxic chemicals from such everyday products as baby powder, baby lotions, and shampoo. These potentially harmful chemicals are called phthalates and are found in ordinary pediatric products on the market today. Phthalates are used in plastics such as toys and baby bottles as well as personal hygiene products and medical equipment. The real danger is that parents may be exposing their children to this potentially toxic chemical without even knowing it since the government doesn’t require products to list phthalates as an ingredient.

The Kugel Mesh hernia patch lawsuits have expanded beyond the recalled patches. It appears that Davol hernia patches that were not part of the recall may have similar problems as the Kugel patch with the ring. The Kugel recall was based upon the failure of the rigid ring that was supposed to keep the patch in place. Once the ring failed, the sticky side of the patch made with marlex could move, fold up, and become bound up with the intestines, colon, and other organs. Some lawsuits have been filed alleging that other ringless Davol patches with the sticky marlex also have migrated and caused injuries to the colon and internal organs.
Hernia Mesh Class Action Lawyer Recall Attorney

Fosamax, manufactured by Merck, is undergoing more scrutiny after another lawsuit was filed against Merck. This time, however, the lawsuit involved a non-jawbone injury. According to the lawsuit, the plaintiff has suffered stress fractures due to Fosamax toxicity. Fosamax belongs to the bisphosphonates family of drugs which stays in the body for 10 years. The FDA has issued a statement about the possible dangers of Fosamax and other bisphosphonates, noting that there is “the possibility of severe and sometimes incapacitating bone, joint, and/or muscle [musculoskeletal] pain in patients taking bisphosphonates.” Fosamax has been linked to osteoporosis and necrosis of the jaw which is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures Fosamax is another of the drugs that have caused headaches for the giant pharmaceutical company Merck. Other problematic Merck drugs include: Vioxx, Gardasil and Vytorin.

In a shocking article published in the NY Times, the FDA is so far behind in monitoring the nation’s food supply, pharmaceutical drugs imported into the country, and medical devices that the problem won’t be rectified in any of our lifetimes! According to the article, “the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators.” This precarious situation presents a real threat to our public safety. Yet, our government is doing nothing substantial to address the dangers. That’s a real scandal and a clear and present danger to our future well being.

President Bush is about to deliver his final State of the Union address to Congress and the nation this evening. This is a President who had campaigned 7 years ago as a uniter not a divider and now finds his approval ratings hovering around a dismal 30%. He even admits that he has failed as a unifying force for the country.
In matters that are important to average consumers, Bush has allowed large pharmaceutical companies to get away with employing overyly aggressive marketing tactics for drugs that have been harmful if not lethal. These same companies have been less than forthright when revealing their effectiveness and scope of use. In another area of public concern, the food supply continues to be a source of worry. Each month, we hear of more foods contaminated with salmonella, E.coli, and other harmful contaminants. Yet, President Bush is not expected to discuss either issue in tonight’s State of the Union.

On September 27, 2008 Stryker announced a resolution with the US Attorney’s office in Newark, New Jersey over concerns that companies may have paid kickbacks to orthopedic surgeons in return for favoring their product. The U.S. Department of Justice had issued a subpoena in March 2005, requesting documents for the period January 2002 through the present relating to “any and all consulting contracts, professional service agreements, or remuneration agreements between Stryker Corporation and any orthopedic surgeon, orthopedic surgeon in training, or medical school graduate using or considering the surgical use of hip or knee joint replacement/reconstruction products manufactured or sold by Stryker Corporation.”
Christopher Christie, US attorney in Newark, oversaw the settlement and concluded that Stryker and four other companies – who together account for nearly 95% of the market in hip and knee implants – violated federal anti-kickback laws by paying doctors “to exclusively use their products.” Doctors often did “little or no work for the financial inducements but did agree to exclusively use the paying company’s products.”
Christie stated that surgeons typically received “tens to hundreds of thousands of dollars per year for consulting contracts and were often lavished with trips and other expensive perquisites,” failing to disclose the payments to their hospitals or patients.
Gary Heuer, special agent in charge of the U.S. Department of Health and Human Services’ Office of Inspector General’s New York office, stated that patients “deserve the best available treatment from physicians and surgeons without the corrupting influence of kickbacks from the medical device companies.”
Michael Drewniak, public affairs officer for US Attorney Christie, stated the payments were contrary to ethical standards, federal law and health care trends demanding transparency and accountability by businesses.
Stryker, along with four other makers of medical device implants – who together account for nearly 95% of the market in hip and knee implants — made agreements with the U.S. government to resolve fraud concerns over industry practices. Because Stryker voluntarily cooperated with the US Attorney’s Office, the company was exempted from paying fines to settle the case, but agreed to be monitored for 18 months. Stryker hired former U.S. Attorney General John Ashcroft to supervise corporate reforms mandated by the settlement. Biomet will pay $26.9 million; DePuy, $84.7 million; Smith & Nephew, $28.9 million; and Zimmer will pay $169.5 million.
The resolution required the companies to publish the names and sums paid to consultants and the terms of the settlement on their websites and to comply with certain standards and procedures in connection with the retention and payment of orthopedic surgeon consultants related to reconstructive products and the provision of certain benefits to such surgeons. The settlements released the companies from civil liabilities and prevented them from being banned from Medicare reimbursements.
While the American Academy of Orthopaedic Surgeons supports financial disclosures to patients about industry relationships, the organization took issue with the U.S. Attorney’s Office not to separate compensation into royalties and other categories.
Did your orthopedic surgeon receive payments from Stryker in 2007? Go to http://www.stryker.com/meetourconsultants/consultants/consultants_location.php to find out.
On October 12, 2007, Stryker disclosed that the United States Securities and Exchange Commission had made an informal inquiry regarding possible violations of the Foreign Corrupt Practices Act in connection with the sale of medical devices in certain foreign countries. The Company indicated that it was fully cooperating with the U.S. Securities and Exchange Commission regarding the informal investigation.
On November 14, 2007, Stryker agreed to pay $16.6 million to settle charges that a former outpatient therapy subsidiary – Physiotherapy Associates — fraudulently billed Medicare, Medicaid, and a Department of Defense health care program for services not covered by the programs. Stryker had recently announced the sale of Physiotherapy Associates to a pair of private equity firms, including Water Street Healthcare Partners. The case stems from two whistleblower lawsuits by former Physiotherapy employees who will receive nearly $3 million from the settlement.
Hip Implant Recall
Stryker Hip Implant Recall Information
Stryker CEO Paid

Baxter’s blood thinner Heparin is being recalled due to scores of allergic reactions and one possible death linked to the popular blood thinning drug. The recall affects thousands of doses and the company has stated that nine lots of Heparin are affected by the recall. The units in question are called “1,000 units/mL 10mL and 30mL multi-dose vials. Heparin is primarily used as an anti-coagulant. Symptoms of the allergic reaction include: nausea, vomiting, dizziness, fainting, throat swelling and low blood pressure.

Johnson & Johnson is recalling approximately 132, 000 of its Dura Star RX” and “Fire Star RX PTCA balloon catheters. Johnson & Johnson’s subsidiary Cordis is responsible for the manufacture of the catheters which may fail causing severe injury or even death. Apparently, there are no issues with the Johnson & Johnson cardiac stent.