Articles Posted in Dangerous Drugs

Following the discover of “foreign matters” in vials of drugs for injection, Pallimed Solutions, Inc., a Woburn, Massachusetts compounding pharmacy, had recalled over a dozen products. The decision comes after the state board ordered the company to stop making drugs that were supposed to have been manufactured with sterile processes.

So far, there have been no reports of related injuries or illnesses.

Among the products included in the voluntary recall are those used in eye treatments and hormone replacement therapy and for erectile dysfunction. In a press release, Pallimed Solutions said it made the decision to call back the products following an inspection by the Massachusetts Board of Registration in Pharmacy and the US Food and Drug Administration and to ensure patient safety. According to The Globe, late last year the state of Massachusetts told Pallimed to stop making sildenafil citrate, also known as Viagra, because it was manufactured using “improper components.”

At least 50 federal lawsuits have been filed in nine states seeking products liability compensation from the New England Compounding Center, the Framingham, Massachusetts pharmaceutical company that is the identified source of a tainted steroid injection that has made nearly 600 people ill with fungal meningitis, spinal infections, and/or other complications, including joint infections and stroke. At least 37 people have died. More drug injury cases against NECC are also being submitted in state court.

According to the drug defect lawsuits, the compound pharmacy made a dangerous and flawed product. Millions of dollars are being sought by the plaintiffs for their personal injuries, mental anguish, emotional trauma, lost wages, costly medical bills, and other related damages, as well as the wrongful deaths of loved ones. In Massachusetts, please contact our Boston fungal meningitis law firm to request your free case evaluation.

Because so many dangerous drug cases are in progress, attorneys are seeking to have one judge hear the pretrial and discovery portions of all the federal lawsuits via multidistrict litigation. The complaints would then go to a judge in the original district for trial.

We blogged last month about the nationwide outbreak of meningitis that originated in a Framingham, MA compounding pharmacy.

A consumer watchdog organization, Public Citizen, is now asking the Food and Drug Administration to re-inspect over a dozen specialty pharmacies with records of violations. Public Citizen sent a letter to the FDA on Thursday calling for the agency to re-examine 16 compounding pharmacies that received warnings from the FDA between 2003 and 2012.

Public Citizen decried what it says is the FDA’s recurring failure to follow up on warning letters to pharmacies. “By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens,” said Dr. Michael Carome, Deputy Director of Public Citizen’s health unit.

The fungal meningitis outbreak that has killed 36 people and made ill more than 500 has been linked to contaminated pain injections from the New England Compounding Center of Framingham, MA.

The FDA inspected the New England Compounding Center three times before the outbreak and issued a warning letter in 2006, according to Congressional investigators. The letter addressed numerous violations, such as repackaging FDA-approved drugs into smaller doses and mass producing drugs without prescriptions.

Public Citizen wants the FDA to look into warning letters sent to pharmacies in 15 states for a number of violations, including: producing drugs from non-FDA approved ingredients, making copies of already approved drugs, and making compounds without a prescription from a doctor.
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The CDC is reporting that the death toll in the ongoing fungal meningitis outbreak involving tainted steroid injections is now at 30, while the number of those afflicted is at 419 (those affected by related joint infections are also included in this number). The steroid shots were used for treating back pain, as well as joint problems.

According to the New York Times, doctors that have been treating patients afflicted in this outbreak are seeing certain worrying complications in some, including epidural abscess in the area of the spine where the shot was administered and arachnoiditis, involving spinal inflammation. In Massachusetts, please contact our Boston fungal meningitis law firm if you or someone you love became afflicted after receiving a methylprednisolone acetate injection.

The Boston Globe reports that right before the national outbreak erupted, the New England Compounding Center, which is based in Framingham, Massachusetts, had sent out a “Quality Assurance Report Card” to clients touting it’s labs’ cleanliness even though internal tests showed contamination that was widespread. Two of the three steroid lots involved in the outbreak were made during the period noted in the report card, which claims that the pharmacy’s “extensive” testing of products for microbial contaminants and sterility had a 100% success rate.

According to The Wall Street Journal, scores of plaintiffs are lawyering up to begin their fungal meningitis litigation against the New England Compounding Center, which is located in Framingham, Massachusetts. Already, at least 10 drug defect lawsuits have been filed in the wake of the deadly outbreak that has afflicted at least 294 people in 16 states, killing 23.

Authorities are now saying that about 14,000 patients, if not more, were exposed to contaminated doses of methylprednisolone acetate. In Massachusetts, please contact our Boston fungal meningitis lawyers. Altman & Altman, LLP is experienced in handling Massachusetts products liability cases against pharmaceutical companies and other related parties. We would be happy to provide you with a free case evaluation.

While NECC, which produced the tainted steroid, is currently the sole defendant of the drug injury lawsuits that have been filed so far, more possible defendants, such as the medical facilities where the steroid was administered, doctors that gave the injection, suppliers, and others involved in the chain of distribution and sale of contaminated steroid, could be added to the mix.

Some of the plaintiffs contend that the shot caused them to develop meningitis, while others, who haven’t been afflicted, are seeking damages for “emotional distress” and other personal injuries. A class action is even being sought by some of the plaintiffs.

Fungal meningitis is not contagious. Only those that received the steroid shot are believed to be at risk during this current outbreak. Early symptoms may include stiff neck, fever, dizziness, headache, nausea, numbness, sensitivity to light, slurred speech, stiff neck, and swelling or redness in the area where the injection was administered. Symptoms can take more than 30 days after exposure to the fungus to appear. Serious side effects may include stroke, long-term disability, memory impairment, speech difficulties, physical impairment, and even death.

Lawsuits Mount as Meningitis Deaths Rise, Wall Street Journal, October 21, 2012

23 Dead in Meningitis Outbreak, ABC News, October 22, 2012

Fungal Meningitis, CDC

More Blog Posts:

Framingham, Massachusetts Compounding Pharmacy Linked to Fungal Meningitis Outbreak Had Settled Wrongful Death Lawsuit Over Similar Allegations in 2007, Boston Injury Lawyer Blog, October 12, 2012

Steroid Linked to Rare Fungal Meningitis Outbreak May Have Been Administered to About 13,000 People in 23 States, Drug Injury Lawyers Blog, October 8, 2012

Meningitis Outbreak Linked to Massachusetts Pharma Company, Drug Injury Lawyers Blog, October 16, 2012 Continue reading

According to the Associated Press, the New England Compounding Center had already settled a wrongful death lawsuit over similar allegations in 2007. The Framingham, Massachusetts compounding pharmaceutical company is considered the source of the tainted steroid shots that are believed to be the cause of this current fungal meningitis outbreak. Already, reports the CDC, over 185 people in 10 states have fallen ill and at least 14 people have died in this latest contamination.

Please contact our Boston defective medication lawyers if you believe that you have fallen ill because of a dangerous or contaminated medication. Altman & Altman LLP also represents drug defect clients throughout the US.

In the earlier case, the victim, 83, died about 18 months after getting a shot that New England Compounding Center had produced. His loved ones contended that the shot was contaminated and caused him to develop the bacterial meningitis, which led to his death in 2004. A settlement was reached with his widow.

Our Boston injury lawyers are offering free case assessments to women in Massachusetts who believe that they may have developed serious complications from taking Yasmin, YAZ, or Ocella birth control pills. These contraceptives all contain the progestin drospirenone, which has been linked to venous thromboembolic events, including heart attack, pulmonary embolism (PE), deep vein thrombosis (DVT), myocardial infarction (MI), and ischemic stroke (CVA). Yasmin and YAZ are made by Bayer AG. Ocella, which is Yasmin’s generic version, is distributed by Barr Laboratories.

As you can imagine, these are serious health complications to have from taking oral contraceptives that also have been used to treat moderate acne, menopause, and osteoporosis. Yet as of the April, Bayer AG had already paid $142 million to women contending that Yasmin or YAZ had caused their blood clots, which can lead to some of these more serious health complications and even death.

However, if JP Morgan Chase & Co. analyst Richard Vosser is to be believed (per Bloomberg.com, he thinks that Bayer may end up paying over $2.65 billion dollars to resolve all its YAZ and Yasmin lawsuits), the 500 dangerous drug lawsuits involving venous clot injuries that have already been settled do not comprise even half of the cases that will have to be resolved. (There have also been women who have stepped forward contending that Yasmin and YAZ can cause gallbladder damage and/or gall stones. Bayer is rejecting these claims.)

In April, the US Food and Drug Administration ordered Bayer and the makers of other birth control pills containing drospirenone to strengthen their warning that these oral contraceptions cause blood clots. Researchers have said that drospirenone may up the risks of clots by three times.

Bayer Yasmin Lawsuit Settlements Climb To $142 Million, Bloomberg, April 26, 2012

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone, FDA, April 10, 2012


More Blog Posts:

Boston Products Liability: Yaz Birth Control Pill May Cause Serious Side Effects and Health Complications, Boston Injury Lawyers Blog, April 12, 2012

New FDA Report Suggests Exercising Caution About Using Fosamax Long-Term, Boston Injury Lawyers Blog, May 11, 2012

Pradaxa Lawsuit Claims Drug’s Side Effects Caused Woman to Bleed to Death, Boston Injury Lawyers Blog, April 30, 2012 Continue reading

The Food and Drug Administration has published an analysis in the New England Journal of Medicine about the long-term use of Fosamax. The bone-building drug has recently come under fire following reports that it has caused a number of women to develop weaker bones and other serious health complications, such as osteonecrosis of the jaw, atypical thigh fractures, and esophageal cancer. In recent years, the number of Fosamax lawsuits and other injury claims blaming bisphosphonates has grown. While the FDA isn’t recommending against the long-term use of bisphosphonates, it has voiced concerns about the potential risks involved from taking this type of medication for too long.

To investigate further, the federal agency looked at data from women who had been taking bisphosphonates for six to 10 years. Its analysis found that there wasn’t a lot of benefit from taking bone-building drugs after three to five years. However, rather than make a recommendation about whether long-term use is wise or necessary, the FDA’s report noted that this decision should be determined on an individual basis based according to the risks and benefits for each patient.

In its report, The FDA did say that women who have a bone density that is close to normal or have a low fracture risk might be good candidates to stop using bisphosphonates after three to five years. The federal agency also reported that older patients with a bone density that is in the osteoporotic range and are considered high risk for developing fractures could benefit from continuing to take these medications over a longer period of time.

Our Boston injury lawyers represent clients with Massachusetts dangerous drug cases with products liability claims against manufacturers. Medications are supposed to help, not hurt a patient. Serious side effects should be more the exception than the norm.

FDA Still Cautious About Bone Drugs, ABC News, May 10, 2012

Bisphosphonates for Osteoporosis – Where Do We Go from Here?, The New England Journal of Medicine, May 9, 2012

More Blog Posts:
Pradaxa Lawsuit Claims Drug’s Side Effects Caused Woman to Bleed to Death, Boston Injury Lawyer Blog, April 30, 2012

Another Boston Injury Lawsuit Blames DES Drug for Causing Newton Woman’s Breast Cancer, Boston Injury Lawyer Blog, January 30, 2012

Aspirin Causes Some People More Harm than Good, Says Study, Boston Injury Lawyer Blog, January 21, 2012 Continue reading

The estate of a woman who bled to death is suing pharmaceutical company Boehringer Ingelheim for her wrongful death. Gertrude Eubanks died on April 4, 2011 from internal bleeding just days after she started taking Pradaxa, an anticoagulant. The drug, which is supposed to prevent strokes in individuals with atrial fibrillation, was introduced in the US on October 2010 and offered as an alternative to Coumadin (warfarin).

However, Pradaxa, unlike Coumadin, lacks a reversal agent that can be used to stop bleeding problems. This lack of an antidote is reportedly causing a number of these people to die.

The US Food and Drug Administration has now received hundreds of reports about internal bleeding and hemorrhaging. For example, one man suffered a fatal massive brain hemorrhage after a fall accident. He too had been taking Pradaxa. Also earlier this year, the Institute for Safe Medication Practices issued a report confirming at least 505 Pradaxa-related bleeding events Compare that to the 176 bleeding incidents involving Warfarin reported. Federal regulators are now looking into whether Pradaxa is safe for use.

If you believe you have a Massachusetts Pradaxa case on your hands, our Boston injury lawyers want to hear from you.

According to the Eubanks estate’s dangerous drug lawsuit, she started taking Pradaxa in March 26, 2011. She began to experience internal bleeding, which led to her death nine days later. During the time she was on the anticoagulant, she experienced serious mental anguish.

Her wrongful death complaint contends that Pradaxa was defectively designed and that the manufacturer should have known that the warnings made available with the drug were insufficient. The inadequate warnings prevented Eubanks and her doctors from knowing the risks involved for her when taking the medication. The lawsuit accuses the defendants of negligence, breach of duty to Eubanks, not doing enough to notify medical professionals and consumers about the risks involved, and failing to take Pradaxa off the market even after all of the reports of serious bleeding side effects.

Other Pradaxa lawsuits are being filed.

Death magnifies Pradaxa hemorrhage concerns, Fox, March 7, 2012

Study: Higher heart attack risk from pradaxa, CBS News, January 11, 2012

More Blog Posts:
Another Boston Injury Lawsuit Blames DES Drug for Causing Newton Woman’s Breast Cancer, Boston Injury Lawyer Blog, January 30, 2012

Aspirin Causes Some People More Harm than Good, Says Study, Boston Injury Lawyer Blog, January 21, 2012

Adverse Reactions to Diabetes Meds, Antiplatelet Drugs, Blood Thinner, and Insulin Linked to Elderly Seniors Ending Up in the ER, Reports New Study, Boston Injury Lawyer Blog, November 26, 2011 Continue reading

50 years after her birth, Arline MacCormack believes that the DES drug that her mother took while she was pregnant has caused her to now develop breast cancer. MacCormack, a Newton resident, is one of more than 50 women in the US have filed products liability lawsuits against the drug manufacturers for marketing diethylstilbestrol to women who were expecting babies between 1938 and the early 70’s. Millions of women in different countries took the drug to prevent birth problems, include premature births and miscarriages.

It wasn’t until 1971, after a studied showed that taking DES increased the chances that the female babies might develop vaginal cancer years later, that the FDA told physicians to stop prescribing the drug to women who were pregnant. Since then, thousands of dangerous drug lawsuits have been filed by DES daughters who claim the drug caused their infertility issues, cervical cancer, and vaginal cancer. A lot of these products liability cases were settled before going to court.

MacCormack’s Boston DES lawsuit is considered the first significant lawsuit claiming a connection between breast cancer and DES in women over 40. She is blaming 14 drug manufacturers, including Bristol-Myers Squibb Co. and Eli Lilly and Co,. for not letting the FDA and doctors know that DES came with serious safety risks and actually did not stop miscarriages from happening.

The Newton woman was 44 when she was diagnosed with the disease. She says the type of breast cancer she has is more associated with women over 60.

MacCormack’s claims are supported by a recent study involving National Cancer Institute researcher Dr. Robert Hover. The study suggests that DES daughters older than 40 have a 1 in 25 risk of developing breast cancer, while other women in that age range (until they turn 55) have a 1 in 50 chance. Drug manufacturers have disputed this.

Earlier this month, a federal judge in Boston heard the drug makers’ motions claiming that the opinions of the experts the female plaintiffs’ have cited aren’t based on reliable science. They want any testimony from the experts excluded from the case. U.S. Magistrate Judge Marianne Bowler, however, turned down their motions and has told the drug manufactures to go into mediation with the women plaintiffs.

Boston lawsuit claims DES-breast cancer link, USA Today, January 10, 2012
Judge orders talks in DES-breast cancer case, MassLive, January 20, 2012

More Blog Posts:
Aspirin Causes Some People More Harm than Good, Says Study, Boston Injury Lawyer Blog, January 21, 2012
Adverse Reactions to Diabetes Meds, Antiplatelet Drugs, Blood Thinner, and Insulin Linked to Elderly Seniors Ending Up in the ER, Reports New Study, Boston Injury Lawyer Blog, November 26, 2011
Man Awarded $48.1M Dangerous Drug Verdict in Products Liability Lawsuit Over Motrin, Boston Injury Lawyer Blog, October 7, 2011 Continue reading

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