Yourlawyer.com (Stryker Hip Replacement News)

Orthopedic Docs Withheld Info About Industry Pay When Presenting Research

Thu, 08 Oct 2009 00:00:00 -0700

A new study has found that doctors who presented research last year at the annual meeting of the American Academy of Orthopaedic Surgeons weren't always as forthcoming as they should have been about their financial relationships with the manufacturers of artificial joints. The study appears this week in The New England Journal of Medicine.

The financial relationships between the medical industry and doctors have caused controversy in recent years. In 2007, a U.S. attorney in New Jersey filed criminal complaints alleging that some of the largest artificial-joint makers conspired to violate a federal anti-kickback statute by making payments to surgeons in an attempt to keep their business. As we reported the time, four of the companies, Biomet Inc., DePuy Orthopaedics, Smith & Nephew, and Zimmer Holdings Inc. – paid a total of $310 million, without admitting wrongdoing. A fifth manufacturer, Stryker Corp., cooperated with the probe and was not charged.

According to The Wall Street Journal, the New England Journal of Medicine study measured the accuracy of disclosures by orthopedic surgeons who presented research at the 2008 meeting. The authors of the study compared the doctors' disclosures against a similar list published by the five firms involved in the 2007 settlement. They found that the orthopedists did not disclose more than 20% of the payments they received from the artificial joint manufacturers when they were presenting research involving a the firms' products.

According to the article, of 344 payments disclosed by the companies, only 245 were disclosed by the recipients The study also found that only 165 of 208 payments "directly related" to the doctor's presentation were disclosed.

Critics of industry payments to doctors have long held that such relationships create conflicts-of-interest, and could unduly influence everything from research findings to prescribing practices. According to The Wall Street Journal, several states, including Massachusetts and Vermont, have enacted laws requiring medical companies to disclose the payments they make to doctors. On the federal level, the Physician Payment Sunshine Act would require similar disclosure. The legislation is currently part of the health reform being considered in the U.S. Senate, the Journal said.

Kickback Charges Against Orthopedic Device Makers Dropped

Tue, 31 Mar 2009 00:00:00 -0700

Criminal charges were dismissed yesterday against several orthopedic device makers because they have fulfilled the terms of deferred prosecution agreements they reached with U.S. prosecutors a year and half ago. According to Dow Jones News Wire, Zimmer Holdings Inc., Johnson & Johnson unit DePuy, Smith & Nephew PLC and Biomet Inc. had all been accused of violating federal anti-kick back laws.

According to Bloomberg News, the four companies supply 95 percent of hips and knees used annually in 700,000 replacement surgeries in the U.S. Prosecutors had accused the four firms of handing out excessive consulting agreements, lavish trips and other perks to reward surgeons who used their products. Investigators said physicians performed little or no consulting work, other than to exclusively use the products of whatever company was paying them, and also failed to disclose the relationships with the hospitals where they performed surgery, or to their patients.

In 2007, the government agreed to defer prosecution if the firms paid more than $310 million and made reforms. Under the deferred prosecution agreements, Zimmer paid $169.5 million; Johnson & Johnson, $84.7 million; Smith & Nephew, $28.9 million; and Biomet, $26.9 million, Bloomberg said.

"We are confident that the industry, which had been engaged in illegal kickback practices to secure market share, has made significant changes in their practices to strengthen compliance programs, increase compliance staffs and enhance internal compliance policies and procedures," said acting U.S. Attorney Ralph J. Marra Jr. in a statement Monday. "We expect they will continue these measures beyond the expiration of the agreements and commit to a continued culture of openness, accountability and compliance."

The Department of Justice statement said consulting payments to surgeons by the companies declined to $105 million in 2008 from $272 million in 2007, while the total number of physicians receiving payments from the companies declined to 628 in 2008 from 1,693 in 2007.

According to the New Jersey Star-Ledger, all four companies that entered into civil settlements remain subject to the terms of separate five-year Corporate Integrity Agreements entered into with the Office of Inspector General of the Department of Health and Human Services until September 2012.

A fifth company, Stryker Orthopedics Inc., voluntarily cooperated with the U.S. Attorney's office and executed a non-prosecution agreement, the Star-Ledger said. It also pledged to put reforms in place and had been operating as well under a monitor's supervision that also ended yesterday.

Stryker Corp. Says it Faces Federal Probe Over OP-1 and Calstrux Products

Wed, 11 Mar 2009 00:00:00 -0700

Stryker Corp. is facing a federal probe over some of its bone growth products. The news comes just a few weeks after a Stryker sales rep agreed to plead guilty to promoting the off-label use of the products, despite knowing that such use could lead to dangerous complications.

A second sales rep had also entered a guilty plea to a similar charge last November. As we previously reported, both employees had agreed to cooperate with the Justice Department's investigation as part of their plea deals.

According to Reuters, the Justice Department investigation focuses on Stryker's OP-1 and Calstrux products. The New York Times reported in February that the Food & Drug Administration (FDA) has only allowed limited use of the OP-1 products in patients whose broken shin or thigh bones had failed to heal properly.

These limited approvals are known as “humanitarian device exemptions.” Under such approvals, a device may only be used in up to 4,000 patients a year. The FDA grants such allowances when it believes a small group of patients may be helped by a device whose effectiveness has not been fully proven.

According to Reuters, federal prosecutors are looking into accusations that Stryker sold misbranded medical devices and submitted false reports to the FDA regarding the number of patients treated with the products under the humanitarian device exemptions.

As we reported last month, the plea agreements with the Stryker sales reps stated that they had encouraged medical professionals to combine Stryker’s bone products, even though they knew doing so was not approved by the FDA and had produced “adverse events in some patient." Prosecutors also said other Stryker employees distributed brochures giving instructions for mixing bone products in ways not approved by the FDA.

Calstrux was recalled in 2006 because of a “lack of labeling precautions.” At the time, the FDA warned that adverse reactions had been reported when Calstrux and other bone growth products had been mixed.

Last July, the FDA warned that Stryker Corp.’s OP-1 Implant and OP-1 Putty had been linked to potentially fatal complications when used in off-label procedures involving the cervical spine. According to the FDA warning, the complications involved swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. In many cases, the complications were life threatening and required further surgery.

Stryker Sales Reps Plead Guilty, Agree to Cooperate with Federal Probe

Fri, 20 Feb 2009 00:00:00 -0800

Two former Stryker sales reps will cooperate with a federal probe into the company's marketing of bone growth products after reaching plea agreements with U.S. prosecutors. According to The New York Times, the sales reps pled guilty to promoting the off-label use of the bone growth products even though they knew that such use could cause serious side effects in patients.

Three of the Stryker bone growth products under investigation are the OP-Implant, OP-1 Putty and Calstrux. The Justice Department has been trying to determine if Stryker abused humanitarian allowances for the OP-1 products. Its investigation is also focused on allegations that Stryker promoted off-label use of Calstrux and other bone growth products.

Neither the OP-1 Putty or the OP-1 Implant have been approved for widespread use. According to The New York Times, the Food & Drug Administration (FDA) has only allowed limited use of the OP-1 Implant for in patients whose broken shin or thigh bones had failed to heal properly. It has allowed a similar use of OP-1 Putty for patients who had failed spinal fusion procedures.

These limited approvals are known as “humanitarian device exemptions", the Times said. Under such approvals, a device may only be used in up to 4,000 patients a year. The FDA grants such allowances when it believes a small group of patients may be helped by a device whose effectiveness has not been fully proven.

Last July, the FDA warned that Stryker Corp.'s OP-1 Implant and OP-1 Putty had been linked to potentially fatal complications when used in off-label procedures involving the cervical spine. According to the FDA warning, the complications involved swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. In many cases, the complications were life threatening and required further surgery.

According to the Boston Business Journal, another bone product involved in the probe is a bone-void filler called Calstrux. Calstrux was recalled in 2006 because of a “lack of labeling precautions.” At the time, the FDA warned that adverse reactions had been reported when Calstrux and other bone growth products had been mixed.

According to the Boston Business Journal, U.S. Attorney Michael Sullivan’s office reached plea agreements with the two Stryker sales reps in November 2008 and February 2009. The agreements said the sales reps had encouraged medical professionals to combine Stryker’s bone products, even though they knew doing so was not approved by the FDA and had produced “adverse events in some patient,” the Business Journal said. Prosecutors also said other Stryker employees distributed brochures giving instructions for mixing bone products in ways not approved by the FDA.

According to The New York Times, the Justice Department may be seeking to determine whether Stryker knew the products were being promoted for unauthorized use. Under the plea agreements, the sales reps will cooperate with the Justice Department's investigation. Each agreed to “testify truthfully and completely before any grand jury, and at any hearing or trial", the Boston Business Journal said.

Stryker Recalls Crania Implant Kits

Fri, 26 Dec 2008 00:00:00 -0800

Custom-made Cranial Implant Kits made by Stryker Corp. have been recalled over sterility issues. According to the Food & Drug Administration (FDA), the Cranial Implant Kits are used to correct defects in the jaw and face, or cranium and face.

The Stryker cranial implant kit recall has been deemed a Class I recall by the FDA. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death, the agency said.

According to a Stryker press release, the recall involves 322 Custom Cranial Implant Kits. The kits included in the recall are Small (Catalog no. 54-00101), Medium (Catalog no. 54-00102), Large (Catalog no. 54-00103), and Extra large (Catalog no. 54-00104) sizes. Stryker recalled all kits it distributed between Nov. 5, 2007, and Oct. 23, 2008, the release said.

Stryker issued the recall after determining that the sterilization validation of the product was not performed according to appropriate standards. Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly, Stryker said.

Physicians and hospitals should stop implanting the Cranial Implant Kits immediately and return them to Stryker. According to the Stryker press release, patients who have received these implants should be monitored by their physicians for signs of infection for at least six months post-implantation.

Stryker said it previously notified implanting surgeons, hospital risk managers and its sales representatives of the potential health risks associated with the kits via a letter dated Oct. 24, and requested that they return any remaining products. The company said it plans to repeat the notification.

Physicians and patients with questions related to this issue should contact Stryker at 800-962-6558, Monday – Friday, 8 a.m. to 7 p.m. ET. Patients with questions are encouraged to speak with their surgeon. Any adverse events relating to this product should be reported to Stryker.

Health care professionals and consumers may also report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online:www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178

Women Having Problems with Hip Device

Tue, 11 Nov 2008 00:00:00 -0800

Medical researchers internationally are concerned about the use of hip resurfacing techniques being used in women. Regardless, hip implant device makers and some American doctors have aggressively promoted hip resurfacing, since it became available in the U.S. in 2006, several years after it went into use overseas.

Hip resurfacing is targeted to physically active, middle-age patients, who are expected to outlive the normal 15-to-20-year life span of a full replacement joint. The procedure preserves more of a patient’s own thigh bone than traditional replacement; however, but, studies are emerging in countries where resurfacing has been used longer than in the U.S., such as Sweden and Australia, that indicate a higher failure rate for women over men who undergo the resurfacing procedure. Also, a British study revealed that those women are likelier to require a second corrective operation soon after the first as compared with women who underwent conventional full replacement hip surgery.

Researchers at Rush University Medical Center in Chicago found hip resurfacing complications were more frequent in women of all ages as well as men over the age of 55. “This procedure is not ideal for everyone,” said Dr. Craig J. Della Valle, who led that study. Meanwhile, doctors have long known that resurfacing retains more of a patient’s thigh bone, but that bone must remain strong for years, which is why the procedure is not advised for patients in their 60s. The drawback is particularly significant for younger women because of menopausal bone weakening.

The Rush findings were based on a review of short-term outcomes for the first group of patients in the U.S. to receive a resurfacing device known as the Birmingham hip resurfacing system made by Smith & Nephew. The study found of 32 of the first 537 hip resurfacing patients to receive the device after its approval in 2006, about six percent, suffered serious complications in the first year; 14 required corrective surgery. The most frequent cause involved femur fracture, which occurred in four of the 160 female patients reviewed. All four were between the ages of 42 and 59.

A study released in September by the Royal College of Surgeons of England found 3.7 percent of the 2,360 women who underwent resurfacing there required a second surgery to repair the same hip within three years as compared to 1.6 percent or less for women receiving traditional replacements. Dr. Della Valle at Rush said, “We have to be careful both on the patient side and the doctor side about adopting new technologies.” Australia, Sweden, and England operate databases, known as registries, which regularly track the outcomes of orthopedic procedures and are publicly available. The U.S. does not have such a national tracking system.

Some U.S. orthopedic specialists refuse to perform resurfacing on any patient, citing no long-term data on durability. Also, the rate of problems seen in short-term studies typically increases over time. With traditional replacement hips, “based on data, I know what the results will be in 10 to 20 years,” said Dr. Thomas P. Sculco of the Hospital for Special Surgery, in Manhattan, who performs only traditional replacements. “I can’t give you 10-to-20-year data for hip resurfacing.” Also, some doctors feel American surgeons are eager to profit on patient demand and are performing resurfacings after only minimal training. When a resurfacing fails, the patient must undergo a full hip replacement, the very procedure resurfacing is meant to defer.

Payments to Joint Implant Doctors Continue

Thu, 30 Oct 2008 00:00:00 -0700

About one million Americans will undergo joint replacement surgery in the next year. Given that, consumers might be interested to know how much money their orthopedic surgeon might be receiving from joint replacement makers. Although some physicians may not receive funding for using a specific maker’s device, some could receive kickbacks as large as a million dollars, despite that a recent federal anti-kickback case targeted such questionable payments.

Beginning in September 2007, a criminal investigation put a temporary halt on the paychecks of several thousand doctors who were also consulting for joint replacement device makers. In a settlement, in which they admitted no wrongdoing, the industry's “major players” paid $311 million and agreed to federal monitoring. The high-profile prosecution did not sever the financial ties between doctors and medical-supply companies and payouts continue. Some experts fear that between buying out old contracts and writing new contracts under stricter compliance standards, amounts could increase; critics expect patients will face more problems because there is no way in which patients can determine how back-door financing is affecting medical care and choices. Of deepest concern? Doctors using a specific device or procedure for the money they will make, not for the benefits of one device or procedure over another and not for what is in the patient’s best interest.

Such lucrative “side deals” cannot possibly occur with no conflict of interest and according to Rosamond Rhodes, ethicist at the Mt. Sinai School of Medicine in New York, these practices create the potential to distort the judgment of the most well-intentioned doctors. “It's just human nature," she said. "The money moves you."   Worse, while money is given to those surgeons who assist in developing new products, industry is augmenting their programs for training and education, which involves flying in doctors nationwide and paying them to teach each other. That's a glaring conflict, in the view of Dr. Brian Hurley, president of the American Medical Student Association, who believes medical professionals should pay training expenses out of their own pockets. "It's like going to a car salesman to learn about cars. The point is always, 'Use more of our product,'" he said. "Patients need to know they can trust that when a physician recommends something for them that it's in their interest, as opposed to the financial interest of the physicians themselves." 

Between 2002- 2006, Zimmer Holdings Inc. and three of its rivals paid over $800 million to 6,500 doctors, hospitals, and medical associations. In 2007, 48 doctor-consultants received $1 million or more each. Also, spine and heart devices makers have been accused of paying specialists with undeserved patent royalties and strip-club visits. Meanwhile, Zimmer owes nearly $100 million in back pay to doctor-consultants, and will spend millions to buy out old royalty contracts and broker new deals. Device makers paid a "large number of doctors" to increase sales and guarantee loyalty to particular implant brands, according to a spokesman for U.S. Attorney Christopher Christie of New Jersey, who brought the case. Investigators found money and perks, such as luxury trips, were given to surgeons who did little or no work. Prosecutors have said their investigation is ongoing and criminal charges against surgeons who solicited kickbacks are expected shortly.

Feds Seek to Have Stryker Lawsuit Dismissed

Tue, 28 Oct 2008 00:00:00 -0700

The Justice Department is trying to have a lawsuit filed by Stryker Corp. dismissed. The lawsuit, which was filed by the company against the federal government in August, is seeking to prevent the enforcement of a subpoena Stryker received in February.

The past year or so has been a rough one for Stryker. In January, Stryker recalled some of its hip implant components made under the popular Trident line because of possible contamination issues. The Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S. The recall came after Stryker received two FDA warning letters about conditions at the Ireland plant, as well as a factory in New Jersey that also makes hip implants.

The subpoena cited in the Stryker lawsuit was issued by the Justice Department and the Department of Health and Human Services’ Office of Inspector General. It was part of an investigation into allegations that Stryker submitted false or other improper claims for reimbursement under Medicare and Medicaid. Stryker says that since it was first subpoenaed in February, it has turned over “300,000 pages of hard copy, multiple compact discs and a DVD of myriad electronic information” to investigators.

In March, Stryker received a letter from investigators expanding the scope of the subpoena, which asks for documents pertaining to corporate structure, management, research, sales, marketing, personnel and consultants. Stryker’s lawsuit says the documents requested go “far beyond its orthopedic division and well outside any relationship to Medicare and Medicaid providers.”

In a brief seeking the dismissal of the Stryker lawsuit, lawyers for the government wrote: “The subpoena required production of all responsive documents by April 28, 2008. However, now - eight months after the subpoena was issued - Stryker still has not complied. Instead, Stryker asked the government to delay seeking judicial enforcement of the subpoena, and then filed this improper pre-enforcement action in an apparent attempt to frustrate the government’s investigation into the company’s conduct.”

In October 2007, Stryker settled with the U.S. Attorney’s Office an earlier investigation in which its orthopedics division was allegedly paying surgeons kickbacks for using Stryker products. At the same time, four other orthopedic-implant-makers also settled and paid $310 million in fines. Stryker cooperated in that earlier investigation and did not pay a fine.

While the settlement included a non-prosecution agreement, Stryker is not protected from further investigation by the Office of Inspector General.

Lifespan and Success of Artificial Hip, Knee Implants Unpredictable

Tue, 07 Oct 2008 00:00:00 -0700

A surprising number of people who receive artificial hips and knees will need to have their joints replaced, according to a recently-released study. What's more, another study has found that there is no way to predict what kind of activities might put too much wear and tear on a new hip or knee implant.

Knee and hip replacement surgery has become wildly popular. According to the Associated Press, Americans undergo 478,000 knee replacements and 234,000 hip replacements every year. But by 2030, hip replacements are expected to double, and knee replacements are expected to reach a whopping 3.4 million per year.

Such surgeries are popular because, when successful, they can relieve patients of their debilitating pain, and allow them to walk normally again. But joint implants have a finite lifespan, and will eventually need to be replaced. Often substandard implants - as illustrated by this year's recalls of Stryker Hip Implants and Zimmer Durom Cup Hip Implants - result in the need for early revision. But even quality implants won't last forever.

The first study, conducted by British researchers, found that one in 75 people who undergo hip or knee replacement surgery must undergo surgical revision within three years. Even with the best of care, such replacement surgery is not always avoidable.

The one-in-75 replacement figure cited by the British researchers is actually pretty good, but the study found that the number of revisions gets higher, depending on several factors. For example, hip resurfacing, a popular procedure, where rather than cutting away damaged bone, damaged hip ball and socket is covered with smooth metal, required revision at a higher rate than the traditional operation. According to the report, 2.6 percent of resurfacing patients got a redo in three years compared with just under 1 percent who got a cemented new hip.

Patients with a partial knee replacement called the unicondylar knee needed more revisions than those who undergo a more traditional procedure. The rate of a revision with that procedure was about 2.8 percent.

A second study, conducted by researchers at Massachusetts' Lahey Clinic found that there is no evidence available right now to enable doctors to advise patients on what activities might be safest for their new joint. While most doctors will tell their patients that low-impact activities, such as walking and jogging are fine, there is no agreement on more strenuous sports. There is also no evidence that hip resurfacing - typically offered to younger patients - will enable a return to more strenuous activities than traditional hip replacement.

"People do have very high expectations. They're not always getting those results," Thomas Barber of the American Academy of Orthopaedic Surgeons, told the Associated Press. "If you didn't play tennis before you got the operation, you're probably not going to play tennis afterwards."

Study: Newer Joint Replacements Require More Revisions

Wed, 03 Sep 2008 00:00:00 -0700

It seems that newer medical techniques that are used in hip and knee replacements require revisions at a greater rate that older, established methods. British researchers report that one in about 75 people required repeat hip and knee replacements in the three years following the original procedure. The study was published in the journal PLoS Medicine.

The revision rates were even higher for patients who had new surgical techniques called hip resurfacing and unicondylar knee replacements. Researchers said that these findings are raising concerns about the procedures. "On the basis of our data, consideration should be given to using hip resurfacing only in male patients and unicondylar knee replacement in elderly patients," Jan van der Meulen of the London School of Hygiene and Tropical Medicine and colleagues wrote.

The research involved an analysis of about 170,000 procedures that took place between 2003 and 2006. Nearly half of all of these surgeries were performed in England during this time frame and experienced an overall revision rate of 1.4 percent, which is about one in 75 people. Meanwhile, hip resurfacing, which is a newer technique in which doctors replace just the surface of the femur instead of the entire joint, saw a revision rate of 2.6 percent, the study found. Also, unicondylar knee replacement—which is a procedure in which the surgeon only replaces one side of the knee joint—saw a revision rate of 2.8 percent, van der Meulen said.

The results match findings from other countries that also reflected higher revision rates for the new procedures, according to van der Meulen. The new surgeries offer benefits because recovery time can be shorter because only a part of the joint is replaced, van der Meulen added. "That is an observation that is seen around the world," he said. "Our registry is the largest in the world, which allows us to look at the most recent results.

Hip and knee replacements are among the most frequently performed surgeries, and medical device makers like Britain's Smith & Nephew and U.S.-based Stryker Corp have looked to new techniques given the increasing aging population. van der Meulen noted that the researchers did not review or product types.

Earlier last month, we reported that the Food and Drug Administration (FDA) was in the early stages of developing a program to create a national surveillance registry for orthopedic device implants, enabling the FDA to look into independent public and private registries from which claim information would be fed into a central agency-regulated network.

According to an FDA spokesman, orthopedic device manufacturers would benefit from the program because it would “offer more timely, comprehensive assessment of the ‘real world’ experience of their devices and an alternative means to conduct mandated post-approval studies.” Advocates argue that such a system would quickly alert doctors and federal regulators to devices with high failure rates, possibly sparing tens of thousands of patients from severe, painful injuries. One such examples is with the hundreds of patients who received the Zimmer Durom Cup hip implants in the U.S. and experienced serious adverse reactions.

Stryker Corp. Sues Over Federal Subpoena

Thu, 28 Aug 2008 00:00:00 -0700

Stryker Corp., the maker of hip implant components recalled earlier this year, is claiming that it is being harassed by two government agencies. In a lawsuit filed in U.S. District Court in New Jersey on Aug. 15, the device maker claims that a subpoena served by the U.S. Department of Justice and the U.S. Department of Health and Human Services' Office of Inspector General represents an "abuse of process".

In October 2007, Stryker settled with the U.S. Attorney's Office an earlier investigation in which its orthopedics division was allegedly paying surgeons kickbacks for using Stryker products. At the same time, four other orthopedic-implant-makers also settled and paid $310 million in fines. Stryker cooperated in that earlier investigation and did not pay a fine.

While the settlement included a non-prosecution agreement, Stryker is not protected from further investigation by the Office of Inspector General. The subpoena the company is complaining about is part of an investigation into allegations that Stryker submitted false or other improper claims for reimbursement under Medicare and Medicaid. Stryker says that since it was first subpoenaed in February, it has turned over "300,000 pages of hard copy, multiple compact discs and a DVD of myriad electronic information" to investigators.

In March, Stryker received a letter from investigators expanding the scope of the subpoena, which asks for documents pertaining to corporate structure, management, research, sales, marketing, personnel and consultants. Stryker's lawsuit says the documents requested go "far beyond its orthopedic division and well outside any relationship to Medicare and Medicaid providers."

The past year or so has been a rough one for Stryker. In January, Stryker recalled some of its hip implant components made under the popular Trident line because of possible contamination issues. The Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.

The recall came after Stryker received two FDA warning letters about conditions at the Ireland plant, as well as a factory in New Jersey that also makes hip implants. The first, a seven-page letter dated March 15, 2007, cited several violations at the Ireland plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. The heavily redacted letter referred to an earlier voluntary recall of “hip fracture stems” which appeared to be related to the problems. It also cited several instances where the “root cause” of problems that caused that particular recall was not determined.

Lawsuit Alleges Medical Device Makers Paid Illegal Kickbacks to Doctors

Wed, 13 Aug 2008 00:00:00 -0700

A Pennsylvania medical supply company is suing six joint implant manufacturers over alleged illegal kickbacks to doctors. The lawsuit, filed in U.S. District Court in Pittsburgh on Monday, alleges that the defendants blocked Intermedics-McCullough out of the market despite selling inferior and more costly products by offering kickbacks "for the purpose of gaining exclusive access to the lucrative replacement hip, knee and joint industry and to the orthopedic industry in general."

According to the Pittsburgh Post-Gazette, the lawsuit names Zimmer Inc. and Zimmer Holdings Inc.; DuPuy Orthopedics; and Biomet Inc., all of Warsaw, Ind.; Smith and Nephew Inc. of Memphis, Tenn.; Stryker Orthopedics of Mahweh, N.J.; and Stryker Inc., of Kalamazoo, Mich. as defendants. The lawsuit also names dozens of local doctors as recipients of illegal payments.

Allegations of kickbacks by medical device makers are nothing new. A New Jersey based federal probe completed last year found that the manufacturers named in the Intermedics-McCullough suit made lucrative payments to U.S. physicians between 2002 and 2006 as a way to encourage doctors to favor their products. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

Since the settlements were reached, some members of Congress have pushed for laws that would require better disclosure of payments made to doctors. The Physician Payments Sunshine Act, for example, would require companies to disclose all gifts, fees or other compensation of more than $500 a year.

According to the Post-Gazette, Intermedics-McCullough sold replacement hip joints, knees, shoulder implants and other orthopedic and surgical products to local hospitals and orthopedic surgeons. The Intermedics-McCullough lawsuit claims that from 1988 to 2007, the defendants "paid illegal kickbacks and provided numerous forms of illegal payments" to doctors and hospitals, and that Intermedic's sales began to drop after 1996 as a result of those practices.

Among the alleged illegal payments listed in the lawsuit was one in excess of $8 million from Zimmer to Dr. Harry Rubash, formerly of the University of Pittsburgh Medical Center and now chief of orthopedic surgery at Massachusetts General Hospital. In total, the lawsuit lists more than 200 payments, ranging from a few hundred dollars, to the $8,073,997 paid to Dr. Rubash.

Reports of Squeaky Hip Implants Growing

Tue, 27 May 2008 00:00:00 -0700

More patients are complaining of squeaky hip replacement implants. As recently as 2006, the American Association of Orthopedic Surgeons called the recently emerging hip squeaking phenomenon an “underreported medical trend that has stumped the medical community.” “As a surgeon, hearing someone walk, hearing them squeak, it’s a little unsettling,” said Dr. Andy Star, chief of orthopedics at Abington Memorial Hospital. “We are a little anxious about it and we honestly don’t know what to tell the patients.”

Other than going through a second major surgery, there are virtually no options for dealing with the squeaking that doctors are reporting among some patients who received ceramic hip replacements. Reports of noisy joints following hip replacements were very rare before 2003 when the federal Food and Drug Administration (FDA) approved the first ceramic-on-ceramic implant for total hip replacements.

According to the American Academy of Orthopaedic Surgeons, about 235,000 total hip replacements were performed in 2005. The surgery involves substituting deteriorated hip joints with plastic, metal, and ceramic materials that can either be used together or in different combinations. Ceramic has been used in joint replacement surgery since the 1970s; modern medical grade ceramic is harder and scratch-resistant and lab tests indicate it produces less wear and tear and lasts longer. Durability tends to be why total ceramic hips are popular among younger, more active patients. Currently, no medical evidence links the noise to structural problems with the parts and patients complaining of noise report no pain or other physical problems with the implants.

Noise complaints are almost exclusively reported by patients with both ceramic ball and socket combinations and a 2006 study in the Journal of Arthroplasty found 10 out of 143 patients—seven percent—who underwent total ceramic hip replacement from 2003 to 2005 developed squeaking when walking, bending, and even during sexual activity. Another 31 patients reported their new hips made other noises, such as popping and grinding. No squeaks were reported among 48 patients who received hips made of metal and plastic. And, some doctors say they’ve heard of no noise reports from patients with ceramic and plastic or metal combination implants.

Stryker Orthopaedics-manufactured Trident implants account for the majority of complaints and the FDA issued a warning to Stryker last year for manufacturing and quality problems with its ceramic hips, including squeaking. Stryker maintains its product is safe and the FDA warning and a subsequent recall involving ceramic hip parts made at an Ireland plant were not related to squeaking, which it says occurs with less than one percent of its ceramic implants.

No one seems to be able to pinpoint the source of the squeaking; however, some believe decreased lubrication in the joint, mismatch of implant parts, and extreme flexing of the implants may be to blame. Doctors who’ve removed the ceramic implants report evidence of accelerated wear, but durability tests do not indicate pending joint failure.

One study suggests that squeaking occurring when patients bend forward could be managed with different bending techniques. For those who experience squeaking from walking, it seems a second surgery is the only option.

Stryker Corp. Trident Hip Replacement Blamed for Epidemic of Squeaky Hips

Mon, 12 May 2008 00:00:00 -0700

A growing number of hip replacement patients - especially those with Stryker Corp's Trident components - are experiencing squeaky hips. It seems that such artificial hips made with ceramic materials and touted as being more durable, are prone to squeaking, even during light walking. One study in the Journal of Arthroplasty found that 10 of 143 patients who received ceramic hips from 2003 to 2005 developed squeaking. No squeaks occurred in a control group of 48 who received metal and plastic hips. “There is something amiss here,” said Dr. Douglas E. Padgett, chief of adult reconstructive and joint replacement service at the Hospital for Special Surgery in Manhattan.

Most artificial hips consist of a socket implanted in the pelvis, into which a spherical head is fitted. The head is attached to a spike anchored into the thigh bone. Durability is critical as no one wants to outlive their artificial hips and undergo a second, more extensive surgery when older and less able to handle surgical trauma. Ceramics—which have been in use since the 1960s—were promoted as lasting longer than the 15 years for traditional steel and plastic joints; however, each joint type has known or suspected problems. Metal-on-metal devices slowly shed tiny ionized particles some feel promote cancer and the newest plastics are not as durable as other materials, raising worries that fragments can lead to bone-destroying inflammations.

Over 250,000 Americans receive total hip implants yearly in a procedure that costs close to $45,000. While any artificial hip can occasionally make any number of noises, it wasn’t until Stryker Corp. began marketing Trident ceramic hips in the United States in 2003 that the previously rare squeaking began. Tens of thousands of hips have been replaced by Stryker and other makers and now people are complaining that their squeaking hips are interfering with daily life. No one really understands why this is occurring, and now there are concerns the noises might be pointing to more serious problems and malfunctions.

Investigators reviewing the problem report that while the reason is unclear, squeaking appears to be linked with extreme flexing of the ceramic implants and some surgeons are afraid the ceramic material might shatter, leaving a patient with so many inflammatory shards that a doctor could never find them all. “Catastrophic failure has been a concern in the past, with older ceramic components,” said Dr. James M. Bried, a surgeon in Poway, California. Patients and surgeons are concerned squeaking points to premature wearing down, something that could force a second surgery and doctors who have removed ceramic hips say they find dark stripes indicating accelerated wear on the ceramic heads. Dozens are undergoing a second surgery and have sued Stryker.

Stryker was the pioneer and market leader in ceramic joint replacement, but now doctors say Stryker has not taken patients’ concerns seriously. Last fall, the Food and Drug Administration (FDA) issued a warning to Stryker, saying it had failed to take steps needed to prevent squeaking and other problems. Also, last year Stryker recalled ceramic hip parts made at its Cork, Ireland, factory when it determined some parts failed to meet its sterility specifications.

Stryker Gets Another FDA Warning Letter

Mon, 05 May 2008 00:00:00 -0700

Stryker Corp. has been hit with another Food & Drug Administration (FDA) warning letter, the medical device maker's second since last November, and the third in a little over a year. This time, the FDA took Stryker's biotech division to task for quality systems and compliance issues at its Hopkinton, Massachusetts, location. One of the issues cited by the FDA warning letter involves falsification of hospital-approval documents used under an FDA rule that allows device sales on a very limited basis.

The past year or so has been a rough one for Stryker. In January, Stryker recalled some of its hip implant components made under the popular Trident line because of possible contamination issues. The Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.

The recall came after Stryker received two FDA warning letters about conditions at the Ireland plant, as well as a factory in New Jersey that also makes hip implants. The first, a seven-page letter dated March 15, 2007, cited several violations at the Ireland plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. The heavily redacted letter referred to an earlier voluntary recall of “hip fracture stems” which appeared to be related to the problems. It also cited several instances where the “root cause” of problems that caused that particular recall was not determined.

Then Stryker received another letter regarding the New Jersey facility. That letter, dated November 28, 2007 said that the deficiencies uncovered during an inspection at the Mahwah, New Jersey facility had contributed directly to the manufacture of faulty hip implants. The FDA letter described a range of deficiencies, including “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections, that was found throughout the plant. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

This third warning letter involves the company's biotech division, a small segment of Stryker's business that makes products to promote bone growth. The letter concerns observations made during an inspection that began in September 2007. The letter cites issues relating to the division's handling of a past clinical study, its quality system, including medical device reporting procedures, and the falsification of hospital Institutional Review Board documentation used to approve implantation of Humanitarian Use Device. No products have been recalled as a result of the letter.

Stryker says it is taking the FDA warning "very seriously" and has already taken steps to deal with the problems. The small number of field sales employees behind the falsified documents are no longer with the company, Stryker said. The company said it also launched a company-wide 'quality action plan' aimed at strengthening oversight.

Stryker Corp. Reports Another Kickback Investigation

Thu, 13 Mar 2008 00:00:00 -0700

Stryker Corp., the medical device maker that recalled hip implants earlier this year, is the subject of yet another investigation regarding kickbacks it allegedly paid to physicians. This time, Stryker is being investigated by the Department of Justice for violations of the Foreign Corrupt Practices Act, which covers bribes made overseas.

Stryker informed investors in a Securities and Exchange Commission filing that the Justice Department requested documents from Jan. 1, 2000, to the present, regarding possible violations of federal criminal and antitrust laws. Stryker Orthopedics Inc. of Mahwah, N.J., one of five companies implicated in a $230 million kickback scheme in which physicians were paid consulting fees to endorse or prescribe their products, is being examined by the U.S. Justice Department.

A recently completed New Jersey Attorney General's Office probe alleged the companies paid U.S. physicians lucrative fees for nominal services between 2002 and 2006. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

In January, Stryker Corporation issued a recall of its Trident Hip Implants just days after the Food & Drug Administration (FDA) posted a warning letter on its website regarding serious deficiencies at its New Jersey plant. The Stryker hip implant components involved were manufactured at the company’s facility in Ireland, which was also the subject of an earlier FDA warning letter.

The FDA implemented a review of the Stryker plants after receiving an unusually high number of complaints from patients receiving Stryker hip implants. Since 2005, patients receiving Stryker hip implants have reported a wide range of disturbing problems, including pain, difficulty walking, and “squeaky” joints. Some patients have had pieces of the implant parts break off or wear down unevenly. Following these reports, the FDA inspected both the Mahwah, New Jersey and Cork, Ireland plants where most of the Stryker hip implants sold in the US are made.

The FDA reports and letters cited several violations at the Ireland plant, including missed deadlines to fix failures, not following procedures for testing problematic products, and not documenting risk. Stryker received another letter from the FDA regarding the New Jersey facility that warned of deficiencies uncovered during an inspection that had contributed directly to the manufacture of the faulty Stryker hip implants. This FDA letter described a range of deficiencies that included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections. Staphylococcus bacteria was found throughout the plant and the warning letter stated repeatedly that Stryker had “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, regarding the bacterial contamination, the letter states that Stryker had ‘not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

Hip Implant and Joint Replacement Patients Hurt by Company Kickbacks to Docs

Fri, 29 Feb 2008 00:00:00 -0800

Kickbacks from the makers of hip implants and other joint replacements to orthopedic surgeons are so prevalent that it has become nearly impossible to eliminate the illegitimate practice, an assistant inspector general with the Health and Human Services Department told a Senate panel yesterday. Unfortunately, the practice of kickbacks is taking a toll on patients, who are often implanted with low quality devices because surgeons are influenced by such kickbacks.

Those allegations were part of testimony taken yesterday at a hearing of the Senate Special Committee on Aging. The hearing followed a probe of the orthopedic-device industry by U.S. prosecutors that resulted in a settlement for $311 million last September. The government said the companies handed out excessive consulting agreements, lavish trips and other perks to reward surgeons who used their products. Among the companies involved in that settlement was Stryker Corp., which recalled some of its hip implant components earlier this month. Stryker was also the recipient of two FDA warning letters in the past year, detailing contamination issues and other problems at its plants in New Jersey and Cork, Ireland.

Assistant inspector general Gregory Demske told lawmakers that four makers of artificial hips and knees paid doctors more than $800 million in royalties and fees in four years to influence their choice of implants. While he did not identify these companies, Demske said that together they controlled three-quarters of the $9.4 billion worldwide market for hip implants and knee replacements. Demske and other witnesses told the panel such payments have enriched doctors and distorted the market by bolstering sales of lower-quality devices. Demske said such payments are difficult to regulate, because it is hard for investigators to determine which are legitimate, and which are kickbacks.

Another witness, Charles Rosen, an Irvine, Calif., orthopedic surgeon, who started the Association for Ethics in Spine Surgery, said that so far, voluntary efforts to regulate payments to doctors have failed. "I don't believe the medical societies are capable of doing it, nor the industry," he said. "It is so embedded now among most of the people running these societies, including the educational foundations, that I don't think it's possible to change that without something from the outside happening." Rosen told the panel that he has been vilified by leaders of his medical specialty, including medical journal editors, because of his opposition to company payments.

Senator Herb Kohl (D-Wisc.), chairman of the panel, has proposed a so-called Sunshine Law that would require medical device makers with more than $100 million in annual revenue to disclose any money they give to doctors. Several medical device makers, including Medtronic Inc., said they would support Kohl's proposal if it covered every device maker rather than only those with more than $100 million in annual revenue. Larger device makers worry that physician consultants may be tempted to shift their allegiance to competitors that fall below that revenue threshold in order to keep taking excessive fees, according to Senate committee staffers.

Stryker Hip Implant Recall Creates Shortage in Canada

Fri, 15 Feb 2008 00:00:00 -0800

The Stryker hip implant recall has caused a world-wide shortage of these products and is prompting Health Canada to import equivalent products from the US. Stryker Orthopaedics recalled its Trident hemispherical and Trident PSL Shells from their Cork, Ireland facility on January 24th of this year. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version of this component is the most commonly used Stryker cup in the U.S. Stryker Canada claims that there is no increased health risk to patients that have been identified with the recalled products. But, the Stryker recall has caused some planned surgeries in Canada to be delayed.

To help manage the shortage, Health Canada has authorized the importation and sale of the Trident implant components manufactured in Stryker’s New Jersey facility. "These authorizations were based on information received by Health Canada that significant delays in scheduled and emergent hip implant surgery would occur if these implants were not made available," Health Canada said in a notice to hospitals published online Tuesday. The use of the New Jersey-made implants will be reviewed on a case-by-case basis.

Stryker Corporation issued its recall of its Trident Hip Implants just days after the Food & Drug Administration (FDA) posted a warning letter on its website regarding serious deficiencies at its New Jersey plant. The Stryker hip implant components involved were manufactured at the company’s manufacturing facility in Ireland, which was also the subject of an earlier FDA warning letter.

The FDA implemented a review of the Stryker plants after receiving an unusually high number of complaints from patients receiving Stryker hip implants. Since 2005, patients receiving Stryker hip implants have reported a wide range of disturbing problems, including pain, difficulty walking, and “squeaky” joints; some patients have had pieces of the implant parts break off or wear down unevenly. Following these reports, the FDA inspected both the Mahwah, New Jersey and Cork, Ireland plants where most of the Stryker hip implants sold in the US are made.

The FDA reports and letters cited several violations at the Ireland plant, including missed deadlines to fix failures, not following procedures for testing problematic products, and not documenting risk. Stryker received another letter from the FDA regarding the New Jersey facility that warned of deficiencies uncovered during an inspection that had contributed directly to the manufacture of the faulty Sryker hip implants. This FDA letter described a range of deficiencies that included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections. Staphylococcus bacteria was found throughout the plant and the warning letter stated repeatedly that Stryker had “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, regarding the bacterial contamination, the letter states that Stryker had ‘not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

Defective Medical Devices Show Need for More Regulation

Fri, 08 Feb 2008 00:00:00 -0800

Defective medical devices like Stryker hip implants, Medtronic Defibrillators and the Kugel Mesh Hernia Patch have injured countless people. Now researchers from the University of California, San Francisco (UCSF) have asserted that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes. The team analyzed the problem and proposed solutions in a "Perspectives" article in the January 2008 issue of the Journal of General Internal Medicine. UCSF researchers Mitchell D. Feldman, MD, MPhil, and Jeffrey A. Tice, MD, edited the issue.

The team found once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial. According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.” Feldman, professor of medicine at UCSF said, "These days, patients are asking their doctors for the newest technologies from genetic tests to specific radiation treatments and many physicians don't know where to turn for the latest evidence-based information. Sometimes, the only information out there is what the manufacturer provides."

The UCSF analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit. Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

"FDA approval should be the start of the process toward clinical application, not the end," Feldman said. "Physicians and patients just aren't aware of the limitations of the FDA process of initial assessment and oversight of new medical technologies. Assessments by objective entities are a necessary addition to FDA approval, so that deficiencies in clinical evidence, and patient safety issues that may arise after approval, are recognized before widespread adoption into clinical practice." The purpose of independent review organizations is to provide transparent, objective evaluations, Feldman said. Some, like the California Technology Assessment Forum (CTAF) conduct open, public meetings. Among others, their review board is filled with experts in medicine, representatives from medical professional societies, technology manufacturers, policy maker,s and insurance providers. The UCSF Division of General Internal Medicine currently subcontracts with CTAF to provide technology assessments.

"In order to be considered in an assessment, CTAF requires that information already be published or accepted by a peer-reviewed journal. This encourages companies to make their trial results available to the public," said Tice, attending physician in the Division of General Internal Medicine at UCSF. "CTAF also requires improvements in patient-oriented outcomes, not surrogate markers. For example, we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size."

Eventually, the authors suggest, independent review boards should summarize their findings into uncomplicated take-home messages that patients can easily find on their own.

Stryker Hip Implant Recall, Warning Letters Point to Serious Problems

Tue, 05 Feb 2008 00:00:00 -0800

Stryker Corp. issued a recall of its Trident Hip Implants last month, just days after the Food & Drug Administration (FDA) posted a warning letter on its website chastising Stryker for deficiencies at its New Jersey manufacturing plant. The Stryker hip implant components involved in the January recall were manufactured at the company’s manufacturing facility in Ireland, which was also the subject of an FDA warning letter earlier this year.

The FDA decided to take a hard look at Stryker after receiving an unusually high number of complaints from recipients of Stryker hip implants. Since 2005, Styker hip implant patients have reported a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had pieces of implant parts break off or wear down unevenly. Those complaints prompted the FDA to inspect both the Mahwah, New Jersey and Cork, Ireland plants where most of the Stryker hip implants sold in the US are made. Those inspections resulted in the FDA issuing Stryker two warning letters.

The first, a seven-page letter dated March 15, 2007, cited several violations at the Ireland plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. The heavily redacted letter refers to an earlier voluntary recall of “hip fracture stems” which appears to be related to the problems. It also cited several instances where the “root cause” of problems that caused that particular recall was not determined.

Then Stryker received another letter regarding the New Jersey facility. That letter, dated November 28, 207 said that the deficiencies uncovered during an inspection at the Mahwah, New Jersey facility had contributed directly to the manufacture of faulty hip implants. The FDA letter described a range of deficiencies, including “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections, that was found throughout the plant. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

Stryker’s problems came to a head on January 22, 2007, when the company issued a recall for more hip implant components made in the Cork, Ireland plant. The latest Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.

The Trident Hip Implant cup recall was implemented by Stryker amid concerns that the components could be contaminated with “manufacturing residuals” at levels that exceed company standards. However, Stryker maintained that the problems did not affect the sterility of the components, and claimed that patients who have received the recalled Trident components will not need to have them replaced.

Just a few days after the Stryker hip implant recall, Stryker President and CEO, Stephen P. MacMillan assured investors that there was no clinical evidence to suggest safety problems with the company’s products. In his remarks, MacMillan did not mention all of the complaints Stryker received from its hip implant recipients. Still, even he had to concede there are serious problems at Stryker. “You don’t get two letters in nine months and feel good,” MacMillan told his audience.

Stryker CEO Talks of Work to Do Following FDA Warning, Hip Implant Component Recall

Fri, 25 Jan 2008 00:00:00 -0800

The head of Stryker Corp., the manufacturer of defective hip implants and other joint replacement components, told analysts on Wednesday that the company “has work to do”. That might qualify as the understatement of the year. Stryker has been receiving complaints about its defective hip implants since at least 2005. In a short 9 month period, Stryker received two Food & Drug Administration (FDA) warning letters, and just this week, the company recalled some of its Trident Hip Implant components.

The fact that Stryker has work to do won’t come as a surprise to many recipients of the company’s defective hip implants. These patients have complained about problem hip implant components for years, to no avail. Patients have reported a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had pieces of implant parts break off or wear down unevenly.

All the complaints led the FDA to conduct inspections of the company’s manufacturing plants in New Jersey and overseas in Cork Ireland. Just last week, a warning letter Stryker received from the agency dated November 28 was posted on the FDA website. The FDA warning letter said that the deficiencies uncovered during an inspection at the Mahwah, New Jersey facility had contributed directly to the manufacture of faulty hip implants. The FDA letter described a range of deficiencies, including “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections, that was found throughout the plant. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

Shockingly, this was not the first warning letter Stryker received in 2007 from the FDA. Dated March 15, 2007, another seven-page letter cited several violations at the Ireland plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. The heavily redacted letter refers to an earlier voluntary recall of "hip fracture stems” which appears to be related to the problems. It also cited several instances where the "root cause" of problems that caused that particular recall was not determined.

But two warning letters in nine months was not the worst of it. Stryker added to its woes earlier this week when it issued a recall for more hip implant components made in the Cork, Ireland plant. The latest Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.

The Trident Hip Implant cup recall was implemented by Stryker amid concerns that the components could be contaminated with “manufacturing residuals” at levels that exceed company standards. However, Stryker maintained that the problems did not affect the sterility of the components, and that patients who have received the recalled Trident components will not need to have them replaced.

While stressing that there was no clinical evidence to suggest safety problems with the company’s products (apparently 3 years of complaints from hip implants do not count as “clinical evidence”) Stryker President and CEO , Stephen P. MacMillan told investors and analysts during a conference call that the company was doing its best to fix its quality control issues. ``This is really frustrating and disappointing,'' MacMillan said of two FDA warning. ``You don't get two letters in nine months and feel good."

Stryker Trident Hip Implant Component Recall Latest Bad News for Company since FDA Warning Letter

Tue, 22 Jan 2008 00:00:00 -0800

Stryker Hip Implant components, made under the company’s popular Trident line, are being recalled today, just months after Stryker Corp. received a Food & Drug Administration (FDA) warning letter about poor conditions at the Stryker plant in Mahwah, New Jersey. While the Stryker Hip Implant components covered in this recall where not made at the New Jersey facility, the action does little to inspire confidence in the quality controls Stryker employs in the manufacture of such defective medical devices.

The Stryker Hip Implant component recall involves two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.

The Trident Hip Implant cup recall was implemented by Stryker amid concerns that the components could be contaminated with “manufacturing residuals” at levels that exceed company standards. However, Stryker maintains that the problems do not affect the sterility of the components, and that patients who have received the recalled Trident components will not need to have them replaced.

Both of the recalled Trident Hip Implant cups where among the Stryker components mentioned in the FDA warning letter Stryker received on November 28, 2007. The warning letter was issued to Stryker after FDA officials had spent 6 weeks inspecting its New Jersey plant over the summer. During that inspection, the FDA found a range of problems. Among the most serious where instances of bacterial contamination at the Stryker plant. The contamination included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections.

The letter marked the second time that Stryker was warned by the FDA as a result of the inspection that took place last summer. The most recent FDA warning letter chastised Stryker for sending the FDA inadequate responses to the initial warning between August 1 and November 1, 2007. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

According to the FDA warning letter, Stryker has been receiving complaints about components made at the New Jersey factory, including hip joints that did not fit properly, since 2005. Patients had been complaining about a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had pieces of implant parts break off or wear down unevenly. The FDA warning letter said that the deficiencies uncovered at the Mahwah facility had contributed directly to the manufacture of faulty hip implants.

The Trident Hip Implant cup recall and the FDA warning letter are not the only problems Stryker has faced this year. According to the Associated Press, Stryker was among five companies that make joint replacements in the US that agreed in September to pay a $310 million fine and accept federal monitors to settle allegations they gave doctors kickbacks to use their products.

Second Stryker Warning Letter Cites Bacterial Contamination, Other Problems at Hip Replacement Plant

Thu, 17 Jan 2008 00:00:00 -0800

Stryker Corp., a maker of hip and other joint replacement components, has received a second warning from the Food & Drug Administration (FDA) to correct bacterial contamination issues and other problems at its New Jersey manufacturing facility. In a warning letter dated November 28, 2007, the FDA said that deficiencies at the plant had led to the manufacture of defective hip replacement components and other medical devices. Those problems had resulted in injuries to patients who had received the faulty components, and in some cases forced them to undergo additional surgeries.

According to the FDA warning letter, Stryker has been receiving complaints about components made at the New Jersey factory, including hip joints that did not fit properly, since 2005. Patients had been complaining about a range of problems, including pain, difficulty walking and "squeaky" joints, and some have had pieces of implant parts break off or wear down unevenly.

The warning letter was issued to Stryker after FDA officials had spent 6 weeks inspecting the plant over the summer. During that inspection, the FDA found a range of problems. Among the most serious where instances of bacterial contamination at the Stryker plant. The contamination included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections.

This is the second time that Stryker has been warned by the FDA as a result of the inspection that took place last summer. The current FDA warning letter chastises Stryker for sending the FDA inadequate responses to the initial warning between August 1 and November 1, 2007. The latest warning letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems." For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

The November 28 FDA letter warns Stryker that if it does not provide an adequate response to the problems cited by the agency, the FDA could act without notice and seize property, levy fines and seek injunctions. The letter also notes that the FDA will not approve sale of certain new Stryker medical devices until the violations are fixed and that it will notify federal agencies about the warning letter, so they can consider it when awarding contracts.

For its part, Stryker insists that it is working to fix the deficiencies uncovered by the FDA. In a statement released to the Associated Press, Stryker said “We have been working diligently for the past several months to respond to the FDA and will continue to work closely with them to address these matters."

The recent FDA warnings have not been Stryker’s only brush with federal regulators this year. According to the Associated Press, Stryker was among five companies that make joint replacements in the US that agreed in September to pay a $310 million fine and accept federal monitors to settle allegations they gave doctors kickbacks to use their products.

Stryker Corp. Gets FDA Warning Letter Following Inspection, Hip Implant Complaints

Wed, 16 Jan 2008 00:00:00 -0800

Stryker Corp., the maker of the Trident Hip Implant and other hip replacement parts, received a warning letter from the Food & Drug Administration (FDA) after problems where found at the company’s Mahwah, New Jersey plant during an FDA inspection. The inspection at the Stryker facility, which took place June 12 and July 1, 2007, uncovered problems that led to the manufacture of defective medical devices, including the Trident Hip Implant.

According to the FDA warning letter, which was dated November 28, 2007, the medical devices made at the Stryker Corp. plant in New Jersey included the Trident Hip Implant components, as well as the ReUnion Plasma Spray Humeral Stem, Solar Plasma Purefix HA Shoulder Stems, Trident PSL Acetabular Shells, Duracon Toatal Knee Modular Femoral Component, hip implants with ceramic bearing components, and Global Modular Hip Stems. In its letter, the FDA said Stryker had received complaints from January 2005 to April 2007 "for squeaking noises of hip implants with ceramic bearing components." According to the letter, some of the hip replacement component problems resulted in additional surgeries for implant failures such as fractures and pain.

According to the company's most recent financial report, Stryker's hip, knee and shoulder implants are a major generator of revenue for the company, with worldwide sales of $2.6 billion for the first nine months of 2007.

The FDA warning letter said that problems found during an inspection of the Stryker Facility were directly linked to the defective implant components. Those problems included failing “to establish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problem” related to complaints the company received between January 2005 and April 2007, and “verifying or validating the corrective and preventive action to ensure that such action is effective .” The FDA letter also said that previous responses it had received from Stryker regarding problem found during the 2007 inspection of the New Jersey facility were inadequate.

In a written statement, Stryker officials responded to the letter, saying: "We take these matters very seriously, and are committed to developing, manufacturing and marketing medical products that are safe and effective and that comply with applicable laws and regulations, including those administered by the U.S. FDA and regulatory bodies in other countries in which Stryker conducts business. We have been working diligently since July 2007 to respond to the FDA and will continue to work closely with them to address these matters."

According to Reuters, the FDA sends dozens of warning letters each year. Most are resolved without further action. In rare cases, the letters can result in product seizures or hold up approval of new products.

Squeaky Hip Lawyer Squeeky Lawsuit Attorney

Wed, 16 Jan 2008 00:00:00 -0800

Defective Stryker Hip Replacement Lawyer

Keywords: Squeaky Hip Lawyer Squeeky Lawsuit Attorney

On November 28, 2007, Stryker Corp., a leading maker of hip replacements and other joint replacement components, received a warning letter from the Food & Drug Administration (FDA) regarding deficient and unsanitary conditions at the Stryker manufacturing facility in Mahwah, New Jersey. The FDA warning letter resulted from an inspection of the Stryker plant that occurred in the summer of 2007, and marked the second time the FDA had told Stryker to correct the deplorable conditions at the New Jersey manufacturing facility.

In responding to the FDA warning letter, Stryker maintained that it did not “believe there is any clinical evidence to indicate that the products mentioned in the Warning Letter present a safety issue to patients.” However, the FDA warning letter had stated that Stryker had received complaints about hip implant components made at the Mahwah facility dating back to 2005. Outrageously, in the same press release in which Stryker defended the quality of its products, the company announced a recall of two defective Trident hip implant components. Though they were not made at the plant cited in the FDA warning letter, the recall of the Trident components raised serious questions about the quality controls employed by Stryker.

Stryker FDA Warning Letter
According to the November 28, 2007 FDA warning letter, Stryker had been receiving complaints about components made at the Mahwah, New Jersey factory since 2005. Those complaints included hip joints that did not fit properly, an issue which caused recipients to experience a range of problems, including pain, difficulty walking and “squeaky” joints. Some patients even reported that pieces of their implants had broken off , and others had worn unevenly. The FDA warning letter said that the deficiencies uncovered at the Mahwah facility had contributed directly to the manufacture of these faulty hip implants.

During its 2007 inspection, the FDA found a range of problems at Stryker’s New Jersey plant. Among the most serious where instances of bacterial contamination at the Stryker plant. The contamination included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections. The November 28 letter marked the second time Stryker was warned by the FDA about these problems. The warning letter faults Stryker for sending the FDA inadequate responses to the initial warning between August 1 and November 1, 2007. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.

Trident Hip Implant Component Recall
On January 22, 2008, Stryker Corp. announced that it was recalling two hip implant components made under the company’s popular Trident line. Ironically, the recall announcement was made in the same press release Trident used to respond to allegations in the November 28, 2007 warning letter. The Stryker Hip Implant component recall involved two hip replacement cups made at the company’s plant in Cork, Ireland. The recall involved the Trident Acetabular PSL Cup and the Trident Hemispherical Cups. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S. The Trident Hip Implant cup recall was implemented by Stryker amid concerns that these components could be contaminated with “manufacturing residuals” at levels that exceeded company standards.

Legal Help
Parker Waichman Alonso LLP is currently evaluating possible product liability lawsuits against Stryker Corp. for the defective hip implants and other joint implant components manufactured at its New Jersey plant. If you or a loved one were seriously injured as a result of a defective Stryker Hip Implant, you may have valuable legal rights. Please fill out our online form or call our office a 1-800-529-4636 for a free case evaluation by a qualified medical device attorney.