DePuy Hip Recall Due to FDA Loophole?

As DePuy hip recall attorneys, we have heard many disturbing reports which place the blame for the DePuy hip recall squarely at the doorstep of the United States .

FDA “Approves” Implants by Default

Although most hip implant patients assumed that their hip replacement manufacturer (e.g., DePuy, Zimmer, Johnson & Johnson, Stryker, etc.) received approval from the FDA for their device, this assumption is not entirely accurate. new jersey philadelphia medical malpractice lawyers careless FDA approvalFor years, the FDA has permitted a regulatory loophole under FDA 510(k) which permits the release of new medical devices like the DePuy hip implant, Zimmer NexGen knee implant, and other medical devices, to be placed onto the market without first receiving a comprehensive review by the FDA. How? Because this loophole permits implant manufacturers, like DePuy, to obtain FDA approval if a medical device manufacturer shows that its device is “substantially equivalent” in safety and effectiveness to another FDA approved device.

Ironically, although DePuy claimed its ASR XL Acetabular or Resurfacing implants were “substantially equivalent” to other hip implants, DePuy was not required to make its product out of the same metals as already existing marketed hip implants. As such, reports have shown that the FDA never considered the effects of the chromium and cobalt metals used in DePuy’s hip implants. As a result, consumer advocates have argued that the FDA allowed DePuy to use – without any FDA testing- potentially hazardous metals in a medical device without proper oversight.

DePuy Hip Recall Attorneys in New Jersey and Philadelphia

The DePuy hip recall shows the potential danger in this process. What is the lesson? All potential hip implant patients should specifically ask whether their hip implant device has received formal FDA approval or was approved through the FDA 510(k) loophole. As a New Jersey and Philadelphia DePuy hip recall lawyer, we strongly encourage and current recipients of a DePuy hip replacement to contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Let the team at the Mininno Law Office earn you the compensation you need and deserve.

DePuy Hip Recall Attorneys Discuss Brief History of Hip Implants

As DePuy hip recall attorneys in New Jersey and Philadelphia, we have been posting topical information for potential DePuy hip recall patients interested in the “goings on” of how some 93,000 DePuy hip implants have been recalled. Today’s DePuy hip recall post discusses the history of not just DePuy hip implants, but hip implants in general. We’ll briefly trace the evolution of joint replacement surgery up and through the present day where we have many many different manufacturers (i.e, DePuy, Zimmer, Stryker, etc.) making artificial joint replacement parts for nearly every joint in the body.

Joint Replacements From 1960 to Present

Research shows that the first hip replacement surgery was performed in 1960. Back then, hip replacement surgery was considered somewhat controversial as many patients and doctors believed that a body’s own bones and joints could not be improved by using artificial implants. However, improvements in surgical techniques and advances in the medical technologies have dramatically improved over the last 50 years. Now, nearly all orthopaedic surgeons and patients acknowledge that total hip replacement surgery is a safe, effective, and common method to help patients with hip, knee, and other debilitating joint problems.

new jersey philadelphia depuy hip recall lawyers discuss brief history implantsIn fact, some hip replacement surgeons have argued that hip implant and joint replacement surgery is one of the most important surgical advances over the last century. Because of its popularity, and potential profitability, hip manufacturers such as DePuy, Johnson & Johnson, Zimmer, and others have been competing to capture this potentially lucrative market. Unfortunately, as has been suggested with DePuy, sometimes manufacturers are in such a rush to roll out a “new and improved” implant device, they fail to properly test whether the hip, knee, or other joint implant is better than those that already existed on the market.

In addition, manufacturers such as DePuy have the economic incentive to prematurely push a product on the market to prevent its competitors from either putting an identical product on the market, or putting a product they claim to be better. Here, there are some studies that suggest DePuy’s chromium on cobalt design was not fully studied and perhaps rushed to market. As a result, the failure rate for the DePuy hip implants is much greater than its competitors. Now, DePuy has to recall nearly 93,000 defective hip implants that were placed in patients. These DePuy hip recall patients will likely require revision surgery and blood monitoring to determine whether or not the chromium and cobalt metals are being leeched into their bloodstream.

DePuy Hip Recall Attorneys in New Jersey and Philadelphia

Although 50 years of medical advances have gone into making hip replacement surgery a benefit to patients, we continue to urge these manufacturers to put safety over profitability when introducing the “new and improved” implant devices.

If you are the recipient of a defective DePuy hip implant, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
Our team is a ready and willing to work as hard as needed to earn you the compensation you need and deserve.

Was a DePuy Sales Rep Watching You Sleep?

If you have been following our series of DePuy hip recall posts, we hope they have been informative, interesting, and educational. Our previous DePuy hip recall posts have provided information about the actual implant that has been recalled, about signs and symptoms that patients can expect if their implant is fails; and about the bad faith settlement practices of Johnson & Johnson and DePuy claims adjusters. However, this particular post is unique because today we discuss a topic that most DePuy hip recall patients have never considered. Was a DePuy sales representative watching you while you had your implant surgery performed?

Sales Reps Guiding Surgeons Through Procedures

new jersey philadelphia depuy hip recall lawyers shocking sales repRecently, the prestigious Washington Post reported on a fairly widespread yet rarely discussed practice of medical device sales representatives to lurk in operating rooms, without patient knowledge or approval, and guide surgeons in the surgical procedure. According to the Washington Post, this practice of sales rep “assistance” is common among medical device companies including Johnson & Johnson, Stryker, Zimmer, and DePuy.

Unfortunately for most DePuy hip replacement patients, there really is no way to learn whether or not one of DePuy’s sales reps was actually in the operating room. Why? Because most current hospital policies do not require a sales rep to be identified in the patient’s medical chart. They also don’t require consent from the patient, and have not prohibited photography. There have been reports that sales reps have taken pictures of their company’s implant as its being implanted into the patient! These photographs are taken without first advising the patient that a sales representative will even be present.

Imagine that! A DePuy sales representative is allowed to walk into a sterile operating room and observe a patient having surgery, and the patient would never be the wiser.

Frankly, this widespread practice is kind of creepy. As New Jersey and Philadelphia DePuy hip recall lawyers, we urge that legislation be drafted which specifically requires that any medical sales representative obtain permission from a patient before they attend their surgery. If a surgeon is not comfortable performing a hip implant surgery without having a sales representative present, perhaps that surgeon should not perform the surgery in the first place.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

If you are the recipient of a DePuy hip replacement and are experiencing increasing pain and reduced functionality, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

DePuy owes you compensation for pain, suffering, and monies paid for any additional treatments associated with the correction of your hip replacement. Make sure you get the help of an attorney in earning this compensation.

DePuy Hip Recall Lawyers Fight for Full and Fair Compensation

As a New Jersey and Philadelphia DePuy hip implant recall firm, we have posted information regarding the recent market withdrawal of the DePuy ASR hip implant systems. On its web site, the Johnson & Johnson subsidiary claims that it will cover medical costs for the victims of these defective hip implants. Specifically, it states

“DePuy intends to cover reasonable and customary costs of treatment if you need services associated with the recall of ASR including revision surgery if it is necessary.”

This sounds good, right? But what does this promise really mean?

Depuy Hip Recall Attorneys Clarify Empty Promises

depuy hip recall attonrneys new jersey philadelphia full compensationAs a DePuy recall lawyer, we tell our clients that it means nothing. Why? Because before any claims for compensation are considered, DePuy, who admittedly designed, manufactured, and sold for profit a defective hip implant to 93,000 patients, is requiring those patients to first pay for their medical expenses upfront. That’s right, if your hip implant has failed, and you need treatment or surgery, you first have to send your bills to your own health insurance company and, if you don’t have private insurance, Medicaid or Medicare. DePuy will only then consider a claim for reimbursement for any out of-pocket expenses and deductibles that are not being covered by your health insurance, Medicaid, or Medicare.

Imagine that! DePuy is passing off the cost of its own wrongdoing to working folks whose wages go to fund the Medicaid and Medicare health insurance systems.

DePuy Hip Recall Attorneys against Corporate Wrongdoers

Time and time again, corporate wrongdoers fail to take responsibility and pay fair prices on all of the harm that they cause. As we posted previously, DePuy also refuses to fairly compensate its victims for pain or disability, or for the loss of the activities that many of them enjoyed before their hip implant failed. As defective product attorneys, we will demand that DePuy Orthopaedics make up for all of the harm caused by their wrongdoing. As it stands, DePuy refuses to pay a fair price for harm caused and is trying to push the cost of its harm on to insurance companies and the U.S. taxpayers. As a defective products firm, we can make sure that a DePuy implant victim is properly and fully compensated to the full extent of the law.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

If you are the recipient of a defective DePuy implant, you will need the assistance of a defective products lawyer from the Mininno Law Office. DePuy is trying to pull the wool over the eyes of the victims of their faulty and defective manufacturing. Contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Let the team at the Mininno Law Office earn you the compensation you need and deserve.