Products Liability
Massachusetts Compounding Pharmacy Recalls All 2013 Products
An unannounced inspection at a Massachusetts compounding pharmacy recently uncovered suspicious material on medication containers, leading the operation to order a voluntarily recall for all its 2013 products.
Pallimed Soluitions, Inc. of Woburn issued the recall after the visit from the Food and Drug Administration (FDA) and the Massachusetts Board of Registration in Pharmacy. The agencies found an unknown substance on sterile compounding products. Five affected vials were discovered and no illness has been reported. The recalled drugs include those used for erectile dysfunction treatment, testosterone replacement therapy, vitamin injections and ophthalmic preparations.
The Board of Registration has ordered the pharmacy to halt sterile compounding activities. In December, the compounding pharmacy was among three cited by the state pharmacy board during unannounced inspections. Pallimed was ordered to stop production of sildenafil citrate, which is sold as Viagra. The inspection found the medication was being prepared with improper components.
Medication involved in the recall was shipped to patients and medical offices in Massachusetts, New Hampshire, Rhode Island, Maine, Connecticut, Vermont and 15 other states. Recipients are advised to discontinue use of medications and return to Pallimed Solutions.
The FDA and Massachusetts Board of Registration in Pharmacy share regulation of compounding pharmacies in Massachusetts, which in contrast to large manufacturers, are allowed to dispense medications for individuals with prescriptions, often with conditions which cannot be met in regular pharmacies.
Both agencies are still responding to the aftermath of 2012, when the New England Compounding Center in Framingham was linked to a deadly fungal meningitis outbreak, which sickened over 650 people in 19 states and killed at least 39 others.
In January, Gov. Deval Patrick proposed new licensing requirements for compounding pharmacies, including to let the state assess fines for violating regulations, to protect whistleblowers and reorganize the state pharmacy board.
Along with federal regulations, compounding pharmacies in Massachusetts operate under 247 CMR. Under M.G.L. 94C, section 21 and 105 CMR 721.000, pharmacies and pharmacists must have a prescription for a specific patient before they dispense a medication.
Vaginal Mesh Case Results in $11.1 Million Award
In the first lawsuit associated with transvaginal mesh implants, a New Jersey jury has ordered Johnson & Johnson to pay $11.1 million to a South Dakota woman who suffered injuries.
Johnson & Johnson and its Ethicon division face 1,800 lawsuits in New Jersey over injuries involving surgical mesh products, which are used to treat pelvic organ prolapse and stress urinary incontinence. Last week, the plaintiff received $7.76 million in punitive damages and $3.35 million in other compensation in Atlantic City Superior Court.
The woman, who filed her lawsuit in 2008, alleged Johnson & Johnson failed to adequately warn her doctor of potential dangers from the vaginal mesh implants. It alleged the company was liable for defective design, manufacture and warnings and instructions.
In Massachusetts and other states, the law allows a consumer to bring a claim against a company which manufactures a defective product that causes them injury. A company has a responsibility to protect consumers from defective design, manufacturer error and to warn the consumer about possible harm. Companies and professionals involved in distribution and sale can also be held liable if they act negligently. There is a statute of limitation restricting how long someone can file a claim.
Surgical mesh is a Class II medical device regulated by the Food and Drug Administration (FDA). It has been used to treat pelvic organ prolapse and stress urinary incontinence (SUI) since the 1990s. In 1996, the FDA approved it as a treatment for SUI. In 2002, it was approved to treat pelvic organ prolapse.
In 2005, Johnson & Johnson introduced its Gynecare Prolift surgical implant, the product which was used by the plaintiff. It was one of several implants on the market, along with others by Johnson & Johnson and other manufacturers such as Boston Scientific and American Medical Systems. Johnson & Johnson discontinued its vaginal mesh implants in 2012 after reports of women suffering injuries and an FDA warning.
The FDA first issued a notification about surgical mesh implants in 2008 and upgraded its warning in 2011, saying research showed approximately 10 percent of women who had received transvaginal mesh surgery experienced mesh erosion within a year. Other complications included pain, infection, bleeding, organ perforation, urinary problems and neurovascular muscular problems. Many women suffered emotional problems.
Treatment of a second surgery or intensive medical care does not always alleviate the symptoms.
Related: Jury awards woman $7.76 million punitive damages for J&J mesh, Reuters.
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Medical Device Recall: Stryker Rejuvenate and ABG II Hip Implants
The year 2012 saw another major hip replacement recall which may require an intensive treatment plan for patients.
In July 2012, Stryker recalled two hip replacements, the Rejuvenate and ABG II modular-neck stems. Stryker initiated the voluntary recall due to the potential risks for fretting and corrosion at the junction of the metal stem and metal neck.
Several months later, product liability lawsuits have been filed in a few states and patients are still learning what the recall may mean for them. The recall came two years after DePuy Orthopedics recalled its all-metal hip implant, the ASR XL Acetabular System, in 2010. A study showed the DePuy hip implant failed in one of eight patients and required they undergo a second surgery within five years – compared to the industry standard of 15.
The DePuy hip implant caused friction between the metallic ball and socket components and injuries such as bone fractures, trouble walking and metallosis, a painful condition which occurs when metallic particles appear in a patient’s blood stream.
With the Stryker recall, the company states the incidence of complications is extremely low and that patients who experience pain and swelling should speak with their surgeon. If a patient does require a second surgery, it may be more complex than in the DePuy recall. The neck stem of Stryker’s hip implant was implanted tightly into the femur bone to stay permanently. There may be potential for complications such as bone fractures.
If you have a Stryker hip implant, you should have been contacted by your surgeon about the recall. If not, you should contact them now as well as an experienced medical device lawyer, who can represent your interests.
Contact an Experienced Hip Implant Recall Lawyer The Boston product liability lawyers at Breakstone, White & Gluck have over 100 years combined experience handling cases involving defective medical devices and pharmaceuticals. If you have been injured, it is important to learn your rights. For a free legal consultation, contact us today toll-free at 800-379-1244 or 617-723-7676 or use our contact form.
Related: Stryker Initiates Voluntary Product Recall of Modular-Neck Stems, Food and Drug Administration.
What to Know About Medical Device Recalls
Medical devices are supposed to improve the quality of a patient’s health. When they are surgically implanted, patients expect an extensive recovery and regular medical check-ups. But no patient should expect the medical device to cause new injuries or to be recalled.
Medical devices are supposed to undergo a rigorous approval process with the Food and Drug Administration (FDA) before going on the market, but some screening fails to identify defective devices. Here are some things every patient using a medical device should be aware of regarding product recalls.
Who is Responsible for a Medical Device Recall? The FDA can legally require a company to recall a medical device. In many cases, however, companies recall their own medical devices.
What Does a Recall Mean? A medical device is recalled when it no longer meets FDA requirements. A recall means a medical device is defective, poses a risk to a person’s health, or both.
A recall may mean the device needs to be removed and replaced. It may also mean the device needs repairs or monitoring.
There are three classes of medical device recalls. A Class I Recall is the most serious and indicates there is a reasonable chance the recalled medical device could cause serious illness or even death.
A Class II Recall means a product may cause temporary health problems. A Class III Recall is the least serious type and occurs when the FDA instructs a manufacturer to make a correction that violates FDA regulations.
What is the 510(k) Approval Process? The FDA approves 90 percent of medical devices under the 510(k) process, including many devices which have been recalled in recent years. These include hip implants, external heart defibrillators and transvaginal mesh.
The process – also called Premarket Notification – was designed to bring new treatments to patients faster. Manufacturers must notify the FDA of their intent to market a medical device at least 90 days in advance. Medical device manufacturers are required to submit premarket notification if they plan to introduce a device for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety could be affected.
How to Learn About a Medical Device Recall. Your doctor or the medical device manufacturer should notify you. You can visit the manufacturer’s website to check for recall notices. The FDA also maintains an online medical recall database. Finally, large medical device recalls may receive media coverage, which may answer some of your questions.
What to Do When a Medical Device Recall Occurs. You can expect to work with the manufacturer as well as your doctor or surgeon.
You should follow your doctor’s advice, except if he or she asks you to sign a form authorizing the release of your medical records before treatment is undertaken. This would allow your physician to release your medical records directly to the manufacturer. It is not in your best interest to sign the release before speaking to an attorney.
Contact a Boston Medical Device Recall Lawyer. If you have a medical device which has caused you injury – or which you suspect has caused you pain and injury – you should contact an experienced Boston product liability lawyer. You may be entitled to file a lawsuit to recover damages for pain and suffering, medical costs and other expenses. You may also be entitled to damages if a loved one has suffered illness or been killed as a result of a defective medical device.
Medical device recalls are debilitating for patients who have often already suffered physical pain. Recall lawsuits are complex. If you have been injured by a defective medical device, Breakstone, White & Gluck has the experience, expertise and resources to obtain you results in your claim.
For a free legal consultation, contact us today toll-free at 800-379-1244 or 617-723-7676 or use our contact form.
Product Liability: Infant Recliner Recall Sought After 5 Deaths
A manufacturer of baby recliners involved in five infant deaths is now the target of a lawsuit filed by the Consumer Product Safety Commission (CPSC).
The CPSC filed a complaint against Baby Matters, LLC of Berwyn, Pennsylvania on Dec. 5 after the company refused to issue a voluntary recall of the Nap Nanny Generation One and Two and Chill models. The CPSC is aware of four infants who have died in Nap Nanny Generation Two recliners and one in a Chill model. It has received over 70 additional reports of children nearly falling out of the defective product.
The CPSC complaint alleges the company’s recliners contain defects in design, warnings and instructions, which pose a substantial risk of injury and death to infants. It seeks an order requiring the firm notify the public of the defect, remove it from store shelves and offer consumers a full refund. The company’s website and media reports state it has gone out of business as a result of its legal costs.
Some 155,000 of the recliners have been sold since 2009. The company sold 5,000 Nap Nanny Generation One models and 50,000 Nap Nanny Generation Two models between 2009 and early 2012. Both are now discontinued. A recall was issued in July 2010 announcing Generation One owners would receive an $80 coupon and improved instructions and warnings to consumers who owned the Generation Two Nap Nanny recliner.
The company developed the Nanny Chill model as an improvement. One hundred thousand Nap Nanny Chill models have been sold since January 2011. The recliners are priced about $130.
The 2010 recall came after the CPSC learned about one death that occurred in a Nap Nanny recliner and received 22 reports of infants hanging or falling out over the side, even though most had been harnessed in.
In a statement on the company’s website, owner/founder Leslie Gudel, said, “We do not believe the complaint has merit and stand behind the safety of our product when used as instructed.”
Later in the statement, she said, “No infant using the Nap Nanny properly has ever suffered an injury requiring medical attention. The Nap Nanny was designed and constructed for use only on the floor with the harness secured.”
Related:
Five infant deaths Prompt CPSC to Sue Manufacturer of Nap Nanny and Chill Infant Recliners, Consumer Product Safety Commission.
A message from Leslie Gudel – owner/founder Nap Nanny
Feds file suit against Nap Nanny maker after 5 infant deaths, 70 complaints, ABC News.
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Toy Safety: 10 Worst List Highlights Dangerous Toys
As the holiday shopping season begins, a watchdog organization is reminding consumers that not every toy on the shelves is safe.
The organization W.A.T.C.H., or World Against Toys Causing Harm, Inc., has released its annual list of 2012 “10 Worst Toys.” W.A.T.C.H. says the toys on the list can cause children to choke, have sharp parts and carry misleading labels. The defective toys can be found online and in stores, at major retailers such as Toys “R” Us, Walmart and Amazon.
Dangerous toys seriously injure and kill children every year in the United States. In 2010, 17 children were killed in toy-related accidents. The majority were related to choking on balloons, small balls and rubber balls. The same year, about 181,500 children younger than 15 were treated in hospital emergency departments for toy-related injuries.
If you are shopping for young children, take a look at this year’s “10 Worst Toys” list. We have also provided a list of websites to help you make safe purchases below.
The Avengers Gamma Green Smash Fists
Potential for blunt impact injuries and there are no warnings on the package.
Playful Xylophone
Potential for choking injuries.
Power Rangers Super Samurai Shogun Helmet
Potential for impact and puncture wound injuries.
Water Balloon Launcher
Potential for choking and facial injuries. Varying age recommendations online and on the package.
N-Force Vendetta Double Sword
Potential for Impact injuries.
Explore & Learn Helicopter
Potential for strangulation and entanglement injuries. Cord is twice the length allowed by law.
Spinner Shark 4-Wheel Kneeboard
Potential for impact injuries.
Dart Zone Quick Fire 12 Dart Gun
Potential for eye injuries.
Bongo Ball
Potential for impact and other serious injuries. Children are encouraged to climb inside the inflatable ball. The toy and the packaging have contradicting instructions about supervision.
Magnetic Fishing Game
Potential for choking injuries. Different age recommendations online and on the packaging.
Related:
Toy Safety Fact Sheet, Safe Kids.
Toy Safety, U.S. PIRG.
Dangerous Toy Report Details Lead, Choking Hazards, Breakstone, White & Gluck.
Meningitis Outbreak Prompts Federal and State Action on Compounding Pharmacies
A Massachusetts congressmen is proposing legislation that would give the Food and Drug Administration (FDA) greater authority over compounding pharmacies in the wake of a 19-state meningitis outbreak that has killed 29 people.
Rep. Edward Markey, (D., Mass.) last week announced the legislation, which would allow the FDA to inspect and regulate pharmacies partly based on their product volume.
Currently, states hold most of the authority over compounding pharmacies and the FDA is limited to inspections. It cannot require a compounding pharmacy to follow any operating standard.
Markey’s proposal aims to add oversight for compounding pharmacies which produce larger quantities. It does not target the traditional compounding pharmacy, which makes drugs for individual patients with a prescription.
The meningitis outbreak is being blamed on tainted steroid shots made by New England Compounding Center (NECC) of Framingham. As of Nov. 2, 395 people had contracted fungal meningitis, including the 29 deaths. Nine patients have fungal joint infections from steroid injections to the knee, hip, shoulder and elbow.
Officials say the defective drugs were shipped to 23 states and up to 14,000 patients may have been exposed. None of the contaminated product was distributed to Massachusetts healthcare providers or hospitals.
Markey’s proposal follows other attempts for regulation. In 1997, Congress passed a law giving the FDA authority to regulate large compounding pharmacies which advertised their products. But the U.S. Supreme Court struck down the law in 2002.
In Massachusetts, the Board of Registration in Pharmacy also moved to tighten controls last week, unanimously approving rules which allow the state to track drugs made by compounding pharmacies. The state’s goal is to determine whether a compounding pharmacy is violating its license and producing bulk quantities like a manufacturing facility. State officials say NECC was in violation of its license.
NECC has been shut down by the state and all of its products have been recalled. Another compounding pharmacy under the same ownership, Ameridose of Westborough, also recalled all of its drugs last week. On Oct. 10, Ameridose agreed to a temporary shutdown, which has been extended until Nov. 19.
State officials are seeking permanent surrender of NECC’s pharmacy license and permanent license revocation for NECC’s three pharmacists. The state has also started inspecting other compounding pharmacies, one of which has agreed to surrender its license after violations were found.
The Federal Bureau of Investigation (FBI) has launched a criminal investigation and at least three people have also filed personal injury lawsuits, reports USA Today.
Related:
Insight: How compounding pharmacies rallied patients to fight regulation, Reuters.
Harsh punishments rare for drug compounding mistakes, USA Today.
Pharmacy board adopts new rules, The Boston Globe.
Meningitis outbreak nears 400 infected as lawmakers push for tougher regulation, Associated Press/CBS News.
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Meningitis Outbreak: Over 300 Now Infected, 23 Dead as State Calls for Licenses
State officials have announced they will seek permanent surrender of New England Compounding Center’s (NECC) pharmacy license in the wake of a fungal meningitis outbreak which has infected more than 300 people and left 23 dead.
At a Tuesday press conference, state officials announced they will seek the pharmacy’s license and permanent license revocation for NECC’s three pharmacists. Recent state inspections of the closed-down Framingham facility found dirty and defective equipment and showed the company had failed to follow its own safety tests and properly sterilize tools.
Governor Deval Patrick said a federal criminal investigation has been launched, while Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality, said the company had been violating its state compounding license. The facility was licensed to produce medicine with a patient-specific prescription in hand, not manufacture large shipments.
As of this week, 304 people had contracted fungal meningitis or joint infections linked to the injectable steroid produced by NECC, reported The Boston Globe. Testing has found the fungus matches a type found in unopened vials of the steroid shipped from NECC, though they are still investigating how the fungus got into the vials. The injectable steroid is methylprednisolone acetate.
The 23 deaths linked to the defective steroid come from seven states. No one has been reported ill in Massachusetts. But federal officials say as many as 14,000 people may have been exposed to the contaminated drug between May 21 and Sept. 26, when it was recalled. The company went onto recall all its drugs.
The Food and Drug Administration released a list this week of more than 3,000 NECC customers who received products other than the injectable steroid blamed for the meningitis outbreak. They included 215 Massachusetts doctors, health centers and hospitals. The shipments fell within the time frame of when the defective steroids were produced at the facility.
Ameridose, a Westborough pharmacy with the same owners as NECC, has also been closed down since Oct. 10 in an agreement with state officials. It is scheduled to remain closed until Nov. 5 for state inspections.
Related:
- CDC: 10 more people have fungal infections linked to Framingham pharmacy, The Boston Globe.
- New England Compounding did not follow sterility procedures, investigators find; state orders regular inspections of similar pharmacies, The Boston Globe.
- Corrected list of New England Compounding customers includes 215 in Massachusetts, The Boston Globe.
Contaminated Steroid Injections Trigger Outbreak in 23 States, 5 Deaths
Five people have died and at least 35 have fallen ill after being injected with a steroid which was contaminated with fungus from a Massachusetts compounding pharmacy.
The steroid was shipped to 75 health centers in 23 states, not including Massachusetts, according to media reports. Patients treated with the steroid in six states have fallen ill and died from aspergillus meningitis. Symptoms of this rare infection include headache fever, nausea and pain at the injection site.
The steroid was produced at New England Compounding Center of Framingham, Massachusetts. The company first recalled three lots of methylprednisolone acetate last week. This week, the Food and Drug Administration (FDA) has expanded the recall to include all injectable spinal drugs made by New England Compounding Center. The FDA is further urging health care providers to discard all products from the company as a precaution.
The 35 people who were stricken ill were treated with epidural injections of methylprednisolone acetate for lower back pain between July and September. The infected patients are from Tennessee, Virginia, Maryland, Florida, North Carolina and Indiana. Patients are still being notified. No Massachusetts facilities received the defective steroid injections, but there were shipments within New England to health care providers in Connecticut, Rhode Island and New Hampshire.
Nine Massachusetts health facilities did receive methylprednisolone acetate from other lots made by New England Compounding Center, but no cases of fungus meningitis have been reported.
New England Compounding Center has voluntarily given up its state license and ceased operation. Investigators this week found a contaminated sealed vial of steroid at the company, the FDA reported, and testing is being performed to determine if it is the same fungus as the outbreak.
The Boston Globe reported a state official said the Massachusetts Board of Registration in Pharmacy received complaints about the company in 2002 and 2003. The board worked with the company to improve conditions, but the official did not share details. The board is still investigating another complaint received in March about eye medications.
In 2006, the FDA sent the company a letter stating concerns including its splitting and repacking of the injectable colorectal cancer drug Avastin.
The case shines a light on regulations regarding pharmacies which prepare custom medications, often for patients who have allergies to other medications or for treatments which are no longer commercially available.
New England Compounding Center was not accredited by the Pharmacy Compounding Accreditation Board, which conducts a site visit and review of pharmacy every three years. The accreditation is voluntary.
Related:
5 deaths now tied to rare fungal meningitis possibly contracted from steroids prepared by Massachusetts pharmacy, Boston Globe.
Hundreds seen at risk in meningitis outbreak, Associated Press.
Massachusetts Board of Registration in Pharmacy.
Recalled Bicycles Have Defective Fork
A bicycle distributor has recalled about 12,000 high-end bicycles because the front forks can break, posing a fall and injury hazard.
Specialized Bicycle Components, Inc. of Morgan Hill, California has recalled the bikes in cooperation with the Consumer Product Safety Commission (CPSC). The recalled bikes were manufactured by Kinesis of China. Specialized has received four reports of the front forks breaking. The front fork is the part of a bike which holds the front wheel up and allows the rider to steer. The four reports involved facial fractures, head and shoulder injuries and cuts.
The product recall spans a number of 2008 and 2009 men’s and women’s Global model bicycles. The models come in multiple colors and were sold nationwide at authorized Specialized retailers from July 2007 to July 2012. They sold for between $550 and $1,100. The recalled bikes include:
- Globe Elite
- Gloe Sport
- Globe Sport Disc
- Globe Centrum Comp
- Globe Centrum Elite
- Globe City 6
- Globe Vienna 3
- Globe Vienna 3 Disc
- Globe Vienna 4
- Globe Vienna Deluxe 3
- Globe Vienna Deluxe 4
- Globe Vienna Deluxe 5
- Globe Vienna Deluxe 6
Consumers are advised to immediately stop using the defective bikes and return them to an authorized Specialized retailer for a free installation of a free replacement fork.
Related:
- Specialized Bicycle Components Recalls Bicycles Due to Fall and Injury Hazards, CPSC.