Monthly Archives: January 2008

Kugel Hernia Mesh Recall Lawsuit

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 and Jaw Bone Death

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.

FDA Understaffed and Overwhelmed

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’s Final State of the Union Speech

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.

Stryker Settles Kickback Scheme and Trident “hip implant” recall lawsuit

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 Issues Heparin Recall

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.

Balloon Catheter Recall

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.

Stryker CEO One of Top Paid CEOs

In spite of all the problems the hip replacement manufacturer has had with the design and integrity of its manufacturing process, Stryker CEO Stephen P. MacMillan is one of the highest paid CEOs in the industry. He makes an annual salary of $2.84 million! In an age of corporate parachutes and malfeasance, I guess the salary shouldn’t surprise me. Hopefully, his salary will not shield him from answering questions about his faulty hip replacement product. A voluntary recall after two years of patient complaints will not suffice. Those who’ve suffered with the faulty hips will demand answers for what they’ve had to endure whil MacMillan was enjoying his fat salary. Stryker Recall Attorney Stryker Hip Implant Acetabular Cup Recall Lawsuit

Stryker Hip Recall Raises Ethical Questions

The Stryker recall of medical hip surgery products that followed the U.S. Food and Drug Administration warning last week has focused attention on this orthopedic product manufacturer. Stryker recalled its Trident PSL and Hemispherical Caps that were made in its Cork, Ireland plant. The company had received consumer complaints since 2005 about improper fitting of the hip implants that cause bone fractures. It is expected that civil lawsuits will be filed to determine the cause of the product failures.
Further investigation into this company reveals that Stryker Orthopedics, a division of Howmedica Osteonics Corp., based in Mahwah, N.J. entered into a nonprosecution agreement and a civil settlement with New Jersey U.S. Attorney Christopher Christies over charges that from 2002-2006 Stryker funneled money through consulting agreements to surgeons. The U.S. Attorney’s staff said that the payment provisions violated an anti kickback provision of the medicare fraud statute. As part of the settlement Stryker hired former U.S. Attorney General John Ashcroft as a monitor to supervise corporate reforms mandated by the settlement.
It will be interesting to see if there is any relation between the New Jersey U.S. Attorney’s investigation and the defective hip implant recall. I look forward to taking the depositions of the company officers on these questions.
Stryker Recall Attorney Stryker Hip Implant Acetabular Cup Recall Lawsuit

Stryker Hip Recall

Medical device maker Stryker Corporation will voluntarily recall its Trident PSL and Hemispherical Acetabular Cups after the FDA ordered the medical device company to fix a number of manufacturing defects in the hip replacement parts. Some patients who’ve received the Trident PSL and Hemispherical Acetabular Cups have had to have follow-up surgeries to fix the problems. The FDA has known about patient complaints since 2005 when improperly fitting hip implants caused bone fractures in some hip replacement patients.

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