Articles Posted in defective products

Throughout the United States, there are hundreds of lawsuits pending against Stryker based on its Stryker Rejuvenate and Stryker ABG II hip implant products. The lawsuits have been brought by individuals who had Stryker hip implants used in procedures prior to the July 2012 recall of these defective medical devices.

Our Boston defective hip implant lawyers know that the outcome of pending cases are important because they can shape future litigation. While each of the different lawsuits will be resolved on their own merits if the cases proceed, verdicts or decisions that favor the plaintiff could make the company more likely to offer generous settlements to injured victims who have lawsuits pending.

Because the current litigation can have an impact on all plaintiffs, it is important to keep up-to-date with what is going on with Stryker cases, especially multi-district and multi-county proceedings. Recently, in one such proceeding in New Jersey, the court issued a new case management order.
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Those who have been negatively affected by the insertion of vaginal mesh to treat urinary incontinence and pelvic discomfort may have only a short time left to file a claim for compensation.

Our transvaginal mesh attorneys understand that victims in these cases may have a two-year window from the time they learned of widespread problems in which to file suit. The U.S. Food & Drug Administration had issued a warning on July 13, 2011, indicating that the mesh was often ineffective, but exposed patients to greater health risks and that surgery complications were widespread.

An earlier warning from the U.S. Food & Drug Administration in 2008 had downplayed the issues patients suffered and indicated that problems with the mesh material were rare. The agency may have been reluctant because the product has been so widely used since the 1990s, and had been touted as an advancement in medical treatment.

Today, we know that is clearly not the case. The FDA discovered that in about 1 out of every 10 women who had the transvaginal mesh inserted for purposes of pelvic repair had some degree of erosion within just one year of the implant. Other common complications noted from the devices were intense pain, bleeding, infection, organ perforation, urinary problems and painful sexual intercourse. Additionally, some patients reported experiencing vaginal scarring and shrinking, neuro-muscular problems and recurrent prolapse. Many of these woman also suffered deep emotional effects as well.

Several of the medical device companies targeted by this litigation are based in Boston, including Boston Scientific Corp. Since that 2011 warning from the FDA, Boston Scientific has been named as a defendant in some 6,300 lawsuits pertaining to transvaginal mesh.

More than half of those cases were filed this year. Some 1,600 of those were filed just in May and June of this year.

In all, it’s believed about 16,000 lawsuits have been filed on behalf of transvaginal mesh patients and their surviving family members. That’s quite a bit more than anyone initially expected, though it just goes to show how widespread the troubles have been.

Boston Scientific has held firm in its stance that transvaginal mesh products continue to be an “important treatment option” for women troubled by pelvic organ prolapse.

Many of the cases filed in federal court have been lumped into a multidistrict litigation action that is being handled in the U.S. District Court in the Southern District of West Virginia. The first of those cases is expected to proceed to trial by the end of this year. The next is on the docket for next spring.

These lawsuits allege that manufacturers failed in their duty to provide an adequate warning regarding the risks associated with these medical products.

Attorneys across the country will be closely watching how these cases unfold. They have been coined “bellweather cases,” in that they will give both plaintiffs and defendants a clearer sense of how juries are going to weigh these issues.
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DePuy hip implant devices are one of several brands of metal-on-metal hip implants that have proved to be dangerous to patients. DePuy Orthopaedics, a subsidiary of Johnson & Johnson, is currently defending itself against a number of lawsuits from patients harmed by their defective hip replacement and hip implant products. Recently, Harris Martin reported that the company asked the court in one of those cases to prevent two experts from testifying.

Our Boston DePuy injury attorneys know that DePuy lost a past case when an injured plaintiff was awarded $8.3 million in damages. The company is likely trying to prevent future large verdicts. The motion to the court to keep these two experts from testifying in the case is just another attempt to escape liability for the defective metal-on-metal devices.

DePuy Orthopaedics Seeks to Block Expert Testimony

The case against DePuy Orthopaedics is a product liability case and the plaintiffs have the burden of showing that the metal-on-metal hip implant products were dangerous and failed to live up to the promises made by the manufacturer. The plaintiffs do not need to demonstrate that DePuy Orthopaedics was negligent in not producing a safer product since strict liability rules apply. Experts have testified in past cases that the problems with DePuy’s products were well-known before the medical devices even came onto the market.

One of the two expert witnesses, a professor of biomedical engineering and surgery at McGill University, testified at a previous DePuy trial that the rate of adverse events associated with the metal-on-metal hip implants produced by DePuy should have caused alarm and raised “red flags” as far back as 2003. This was before the DePuy hip implants were even released on the market. The other expert criticized DePuy’s effect analysis and the company’s failure mode.

DePuy is likely seeking to prevent these two expert witnesses from testifying because it believes that the evidence presented significantly damages the defense case. DePuy is trying to prevent the testimony from being presented during a multi-district litigation and submitted supporting briefs barring the testimony on June 14, 2013.

The judge will now need to make a decision on whether these experts should be permitted to testify in the upcoming bellwether trial in September. If the judge permits the experts to testify, then it is likely that the information presented will once again be damaging to DePuy Orthopaedic’s case. Both DePuy Orthopaedics and the plaintiffs who wish to present testimony from the experts will have a chance to make arguments to the judge about whether the testimony should be allowed.

Determining what evidence is or is not admissible in a case against a drug manufacturer can be a complex and technical process. Responding to actions such as this one is just one of the many tasks that attorneys will do to help victims of defective metal-on-metal hip implants to get the justice they deserve.
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For women suffering from pelvic organ prolapse or stress urinary incontinence, transvaginal mesh manufacturers promised surgical solutions that would help to correct their health issues. Unfortunately, transvaginal mesh or TVM turned out to be a very dangerous product that caused a number of complications including significant pain; recurrent prolapse and breakdown of the mesh in the body.

Since transvaginal mesh not only failed to perform as promised but also caused harm, many patients have taken action against TVM manufacturers. In one lawsuit against a TVM manufacturer, plaintiffs are alleging that the manufacturer knowingly used a plastic that was not safe for use in people. Our Boston transvaginal mesh lawyers know that TVM from all manufacturers has generally proved to be dangerous. However, this new evidence indicates that at least one manufacturer may have gone beyond simply failing to disclose risks and instead intentionally acted in a way likely to cause harm.

Emails Show Transvaginal Mesh Manufacturers Intentionally Put Patients at Risk

According to a June 26 Bloomberg news article, CR Bard may have knowingly sold vaginal mesh devices that were made of a plastic material manufacturers had warned was not suitable for implantation in humans.

The plastic was made by a Chevron Phillips Chemical Co. unit and was resin-based. Chevron Phillips Chemical Co. had registered a warning that the mesh should not be permanently implanted in people and after this warning was issued, managers at Bard’s Davol unit knowingly used the plastic in mesh units intended for the treatment of hernias. Now, plaintiffs in a transvaginal mesh claim contend that this same unsafe mesh was also used not just in hernia products but in transvaginal mesh products as well.

Evidence indicates that CR Bard Inc. acted intentionally to use this unsafe plastic, rather than just simply using it by mistake. For example, two emails were sent in 2004 and in 2007 by Davol executives warning colleagues not to tell Chevron Phillips or other manufacturers of the resin-plastic that the plastics were being used in medical devices that were placed in people.

One of the e-mails sent by a top Bard executive, who is now a vice president at the company, expressly cautioned that Chevron Phillips would probably “not be interested in a medical application due to product liability concerns.” The same email indicated that Davol shouldn’t be mentioned to any of the manufacturers because the manufacturers likely were unaware of C.R. Bard’s implant applications.

These emails are extremely incriminating because they can be used to demonstrate that top executives in the company knowingly made the decision to use a plastic that was proven unsafe, despite an awareness that people could get hurt.

It is not unreasonable to believe that the same plastic was used not just in mesh used to treat hernia injuries but also in patients undergoing surgical procedures with transvaginal mesh. Plaintiffs in TVM cases may thus be able to use the emails to strengthen their claim against the medical device company, by presenting the emails as proof that Bard intentionally took dangerous risks with patient health.
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Just a few short months ago, many people had never heard of a compounding pharmacy. Now, however, compounding pharmacies have been in the news many times in recent months, starting with headlines about a devastating outbreak of fungal infections allegedly caused by the New England Compounding Pharmacy (NECC).

Infections and issues related to compounding pharmacies have prompted discussions of changing regulatory laws and created nationwide concern as people throughout the United States were diagnosed with meningitis due to the NECC’s contaminated steroid medications. Unfortunately, our Boston injury attorneys know that the NECC case was not an isolated incident and that many compounding pharmacies are simply not producing drugs that are as safe as they should be. A recent incident involving a Tennessee compounding pharmacy has confirmed this and underscored the fact that compounding pharmacies can cause serious public health problems.

More Trouble at Compounding Pharmacies

According to Fox News, health officials are now investigating cases involving patients who were injected with medicines from a Tennessee compounding pharmacy called Main Street Family Pharmacy.

Main Street Family Pharmacy was creating injections with methylprednisolone acetate, which is the same drug that was produced by NECC and that caused the fungal infection throughout the entire United States. More than 55 people died and 740 more were injured by the fungal infection caused by NECC and this made patients and public health officials very nervous when news broke that a Tennessee pharmacy had sent out the same drug that was also contaminated.

As of now, however, authorities indicate that the current situation does not approach the level of severity of the fungal infections and meningitis outbreak prompted by NECC in 2012. However authorities also caution that it is still early and that investigation is still ongoing, which means that things could turn out to be much worse.

So far, seven cases of potential infection have been identified and traced back to drugs from the Main Street Family Pharmacy. Five of those cases are in Illinois and two more are in North Carolina. All five of the patients in Illinois had skin infections in the buttocks and hips. At least one of the North Carolina patients, on the other hand, is reported as having some type of fungal infection. However, a health-care epidemiologist leading the CDC investigation into the incidents reports that there is no current indication that the patient has meningitis or any other life threatening conditions.

As the CDC and other investigations continue into these infections, hopefully no more reports will surface of people developing complications or infections as a result of the injection of drugs from the Main Street Family Pharmacy.

In the meantime, until the investigations are concluded and cases resolved, the FDA has recommended that doctors stop using any sterile drugs distributed by Main Street Family Pharmacy. Main Street Family Pharmacy has indicated that it supports the FDA”s recommendation because in its 15 years of operation, “patient safety has always been and will always be,” their top priority. Unfortunately, it seems as if the company may not have lived up to its obligations and may have let patients down.
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According to the Centers for Disease Control and Prevention, infections from certain foodborne germs increased in 2012 as compared with prior years, with some infections occurring at the highest levels since 2000. While new standards aim to make food safer, some restaurants and food distributors are still not doing enough to protect the public from dangers of foodborne illness.

Our Boston injury attorneys know that foodborne germs can lead to devastating illness and even death. If you are made sick as a result of contaminated food sold in your supermarket or served to you in a restaurant, you may have a claim for damages. You will need to prove that someone was to blame and that the dangerous product or the negligence of the manufacturer, distributor, store or restaurant was the direct cause of your foodborne illness.

Foodborne Illness and Food Poisoning Lawsuits

According to the Centers for Disease Control and Prevention, infections from two germs that are commonly spread through food have significantly increased in 2012 when compared with the baseline period from 2006 to 2008. The two germs that have caused higher rates of infection include:

• Campylobacter, which can be found in raw milk, produce and poultry. Infections from this germ have increased 14 percent in 2012 as compared with 2006-2008 and infections are at their highest level since 2000.
• Vibrio, which is commonly linked to eating raw or undercooked shellfish. Infections from this germ are up 43 percent as compared with rates observed from 2006 to 2008.

Campylobacter infections can cause stomach pain, diarrhea and fever. The infections normally resolve themselves in around a week, but this is not always the case. Vibrio, on the other hand, is more rare but can cause more serious and potentially life threatening infections. Those who develop this infection who have liver disease are at the greatest risk.

Liability for Foodborne Illness

Efforts are continually underway to try to prevent foodborne illness from occurring and to try to minimize the dangers that people are exposed to in their food products. For example, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) both have certain requirements that must be followed as well as best practices that are advised. In 2011, FSIS updated its industry performance standards for both campylobacter and salmonella to reduce the presence of these germs in turkeys and chickens.

Manufacturers are expected to comply with guidelines, and restaurants and stores that serve food must also comply with local Board of Health requirements. Typically, people get sick only whens something goes wrong somewhere along the way and someone doesn’t comply with the regulations. When this occurs, you may be able to sue if you were made ill due to foodborne bacteria or germs. For example, you could potentially sue:

• A food manufacturer or distributor that produced contaminated products.
• A grocery store that sold you tainted or contaminated food.
• A restaurant that served you undercooked or dangerous food that caused you to develop food poisoning.

The key in these lawsuits will be showing that the manufacturer; grocery store; distributor or other defendant did something wrong or careless or breached some legal safety obligation. Provided you can show that something went wrong, you should be entitled to receive monetary compensation for pain and suffering, lost wages and other losses.
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DePuy metal-on-metal hip replacement products have proved to have a very high failure rate and are causing significant complications for patients. Unfortunately, thousands of patients are suffering from problems due to DePuy’s hip replacement devices and are now suing its parent company, Johnson and Johnson, in order to try to recover compensation.

Our Boston defective hip attorneys know that DePuy may end up settling many cases with plaintiffs in order to resolve multiple claims at once. However, DePuy will settle cases only if the company accepts responsibility for the defective hip replacement products and if some determination can be made about how much each case should be worth. As such, the outcome of “bellwether” trials will play a major role in how cases against DePuy proceed.

Bellwether Trials Produce Mixed Results

Bellwether trials are the first legal actions that are being heard in court related to defective DePuy hip replacement products. The cases go before the court and a jury renders a verdict as to whether DePuy is responsible for causing harm and how much DePuy has to pay for the harm.

The outcome of these trials can shape how the company handles future litigation. If it becomes clear that DePuy is being held responsible in multiple trials, then this is an indicator that legal liability is clear and that DePuy will be blamed in most pending cases against it. As a result, DePuy may be more likely to negotiate a reasonable settlement with plaintiffs whose cases are outstanding. The compensation awarded to the victims in the bellwether trial can serve as a guide to help make clear how much cases should be worth.

Unfortunately, the two DePuy bellwether trials that have occurred so far have not produced any clear guides for how things should proceed going forward. This is because the results have been mixed.

In a Los Angeles trial, DePuy was held legally liable by the jury for an estimated $8.3 million in damages to a former prison guard who experienced pain and suffering due to design flaws in the DePuy ASR hip replacement system. No punitive damages were awarded, but the case still resulted in the plaintiff receiving a substantial monetary award. This boded well for others who had DePuy products implanted and who were experiencing complications.

In a second bellwether trial, however, a jury in Chicago rejected the claim of a plaintiff who said she had experienced complications as a result of a DePuy hip replacement system. The jury found that DePuy had not acted improperly in marketing the device and that the plaintiff was not entitled to damages.

The varied outcomes mean that DePuy is unlikely to definitively act in offering reasonably generous settlements to injured plaintiffs, at least not until there is a clear trend showing that DePuy trials will generally end in favor of injured patients damaged by the DePuy hip replacement systems.
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When transvaginal mesh products came on the market, manufacturers sold the products as a cure or treatment for pelvic organ prolapse and stress urinary incontinence. The hope was that the mesh products would make correcting these medical problems easier. Unfortunately, the products haven’t lived up to the promises made by manufacturers. In fact, transvaginal mesh products turned out to be very dangerous and to create many unpleasant side affects.

Our Boston transvaginal mesh lawyers know that many different manufacturers produced transvaginal mesh products that have been causing harm to patients. One such manufacturer is Boston Scientific. Boston Scientific had its first transvaginal mesh product approved in 1996 and has numerous products on the market, many of which are causing problems and leading to lawsuits.

The Boston Scientific Transvaginal Mesh Products

While a lot of attention is given to transvaginal mesh products by big name manufacturers such as Johnson & Johnson, Boston Scientific too is being sued by many patients and played an important role in bringing the dangerous mesh products to widespread use within the U.S. market. In fact, it was a Boston Scientific product that paved the way for other transvaginal mesh devices to be sold.

Boston Scientific’s first transvaginal mesh product approved in 1996 was called Protegen. Protegen was intended as a treatment for stress urinary incontinence, which is a condition wherein the weakening of the bladder muscles make it difficult for a woman to control her urination.

Prior to the release of Boston Scientific’s transvaginal mesh product, stress urinary incontinence was treated by using sutures to lift sagging organs. No implants or mesh products were used. Protegen changed that and doctors began to adopt the use of the Protegen product because of a belief that it would provide additional support and allow for better outcomes for patients.

Boston Scientific subsequently followed up its original release of Protegen with other bladder sling and pelvic mesh products including the:

• Prefyx PPS Pelvic Sling System.
• Soloynx SIS Vaginal Sling System.
• Lynx Suprapublic Mid-Urethra Sling
• Advantage Fit Transvaginal Mid-Urethral Sling System.
• Pinacle Pelvic Floor Repair Kit.

Unfortunately, problems soon began to develop. In 2003, Boston Scientific was sued based on complications and side effects developing as a result of Protegen. Boston Scientific decided to settle 738 of the lawsuits arising from Protegen problems.

Even after settling, however, Boston Scientific did not pull all of is transvaginal mesh products nor was much additional investigation done into whether TVM products were safe for use. Instead, not only did Boston Scientific keep right on enticing patients to use Transvaginal Mesh but also other manufacturers jumped on the bandwagon and started selling mesh products of their own.

Many of the manufacturers who came out with transvaginal mesh products did so with minimal testing of their own medical devices. The manufacturers got away with this because the FDA has an expedited approval process called 501(k) clearance that allows a product to be released without the normal rigorous clinical testing that is usually required.

Products can be released using 501(k) clearances provided that there is an existing product that is substantially similar. The Boston Scientific product, Protegen, was the product that was used by the manufacturers seeking 501(K) clearance. It was the basis, therefore, of the approval of a class of TVM products that have caused untold harm to patients worldwide.
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The job of a compounding pharmacy is pharmaceutical compounding, which essentially means creating a specific pharmaceutical product in order to meet the medical needs of a specific patient. The industry’s initial role was to combine or to process appropriate ingredients in order to meet a medical need. For example, if a patient required a specific dose or combination of medications, if flavors needed to be added to a drug, or if medication needed to be changed from a solid to a liquid, a compounding pharmacy would do this job.

Compounding pharmacies, when they first began, operated on a relatively small scale. A doctor might prescribe a specific drug to a patient that did not already exist in the specific necessary form or dose. The compounding pharmacy met that need. This was especially common for parenteral medications or intravenous medications.

The industry, however, evolved over time into something much different than a small pharmacy meeting the needs of specific patients. Unfortunately, our Boston defective drug attorneys know that the regulatory system did not evolve with the industry. As a result, compounding pharmacies weren’t properly regulated, pharmacies got negligent or careless, and people started dying.

Compounding Pharmacy Problems

As the number of medications grew and as drug shortages and rising costs started to become problems, compounding pharmacies morphed from small retail or boutique pharmacies to major manufacturing operations. Instead of just mixing drugs for specific patients or to meet a specific need, compounding pharmacies started to manufacture drugs on a massive scale and to sell those drugs across state lines. The compounding pharmacies weren’t pharmacies at all but were drug manufacturers by another name.

Unfortunately, the regulations didn’t change as compounding pharmacies did. The pharmacies were originally regulated by state boards responsible for overseeing pharmacies. The Food and Drug Administration (FDA), which regulates drug manufacturers, didn’t have authority over the compounding pharmacies. State boards, however, also didn’t really have any control over the major compounding manufacturers who were producing drugs on a massive scale. Further, state pharmacy boards weren’t really qualified to handle regulating and overseeing these massive drug manufacturers.

The result of this was that no one was really watching what was going on in these compounding pharmacies. Some Democratic lawmakers tried to change that in 2007 but weren’t successful and compounding pharmacies just continued to produce drugs with little oversight.

Then, however, the problems started. According to the American Society of Health-System Pharmacists:

• Five patients developed an eye infection after being administered bevacizumab that Clinical Specialties Compounding Pharmacy had repackaged.
• More than 50 people died and another 700 or so were injured when New England Compounding Center sent out drugs to more than 20 different states that had been contaminated with a fungus.
• A compounding pharmacy called Med Prep Consulting sent out 50-mL bags of magnesium sulfate in a five percent dextrose injection that contained mold. Fortunately, an employee at the Connecticut hospital that received the drugs noticed the mold floating at the top.

These problems will be just the tip of the iceberg if someone doesn’t step up and start overseeing what compounding pharmacies are doing. The Senate has introduced another bill to vest authority in the FDA, but it is not yet clear if this bill will actually pass or if compounding pharmacies will be free to continue wrecking havoc on unsuspecting patients.
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DePuy is one of several manufacturers who produced and sold metal-on-metal hip implant products to patients who needed a hip joint replaced or resurfaced. Unfortunately, the DePuy metal-on-metal hip implant product did not live up to expectations. The metal-on-metal replacement joints have a high fail rate that necessitates surgical correction for many patients within five years or less from the original surgery, and the implants also are causing complications including metal toxicity and significant pain.

Our Boston medical malpractice attorneys know that DePuy Manufacturing has been under fire in the United States for a long time with thousands of lawsuits filed against the company, many of which are moving forward in multi-district litigation in federal court. However, what people in the U.S. may not know is that they aren’t alone. DePuy hip implant products were sold not just in the United States but throughout the world. As such, DePuy is facing litigation on many fronts.

DePuy Hip Implants Causing Global Problems

DePuy, a unit of Johnson & Johnson, has been waging legal battles in the United States and NJ.com recently reported that more than 10,750 lawsuits have been filed based on the DePuy ASR XL hip replacement product. The lawsuits have been filed in state courts throughout the U.S., and there are both individual lawsuits ongoing and federal lawsuits including consolidated multi-district litigation cases.

The news has been up-and-down for DePuy with the ongoing lawsuits, with the plaintiff winning the first bellwether trial and Johnson & Johnson winning the second. The bellwether trials are essentially test trials, the outcomes of which can determine whether DePuy settles other pending cases and for how much. The bellwether trials are important as they may be determinative of the outcome of U.S. cases pending against Johnson & Johnson as a result of the DePuy hip replacement products.

These trials, however, are not the only thing for DePuy to worry about. The company did not restrict its sales of hip replacement devices to the United States and there are people in multiple locations throughout the world who are experiencing problems as a result of trusting the DePuy products.

Recently, for example, ENCA revealed that there are thousands of South African residents who are coping with problems caused by defective DePuy hip replacement devices. Those in South Africa who have been affected by the defective medical device want their day in court too and now there is a good chance they will get it.

This is made possible because lawyers have been given the go-ahead to sue the British company that made the implants. Now, nearly 200 South Africans are already demanding damages from DePuy due to botched hip replacements that are causing complications including almost constant pain.

DePuy will have to respond to the lawsuits brought by the 200 South Africans who are suing, along with responding to the claims made in the United States and elsewhere in the world. Hopefully, DePuy will accept responsibility for its actions as people throughout the world suffer the consequences, and will step up, do the right thing and fairly compensate victims for their injuries.

Unfortunately, DePuy doesn’t seem eager to right the wrongs caused by its dangerous products and injured victims will need to do everything possible to protect their rights and get their money from DePuy for their losses.
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