Philadelphia Personal Injury Lawyers Blog

Philadelphia patients taking the anti-seizure drug Lamictal may want to see their doctor about a different medication. The Food and Drug Administration in conjunction with the manufacturer, GlaxoSmithKline, have decided to add a warning and re-label the medication after reports of aseptic meningitis.

Lamictal is prescribed to patients with a high risk of seizure and has also been approved by the FDA to treat patients suffering from manic depression. In an effort to warn patients of the potential serious side effect, GlaxoSmithKline will add language to the medication guide distributed to patients. In addition doctors and others in the health community will be advised of this rare but serious side effect.

Aseptic meningitis is a dangerous inflammation of the spinal cord and brain. Those diagnosed with aseptic meningitis experience headache, fever, chills and vomiting. Most suffers of aseptic meningitis must be hospital for the majority of the illness.

Related Sources:
FDA warns of brain problem with Glaxo seizure drug

Thousands of people in the Philadelphia area and millions in the United States have taken the drug Rituxan over the past twelve years but the drug could leave you susceptible to untreatable infections.

Reports have surfaced that some patients taking the medication have developed serious untreatable viral infections. The infections have left some with complete loss of motor function and have killed others. In 2007, Genentech and Biogen Idec, manufacturers of the drug issued a warning that the drug could cripple or kill patients but took no further action. Patients and their attorneys are arguing that once again the pharmaceutical company put more effort into marketing the drug for profit than informing patients of the serious risks associated with the drug.

Rituxan is an immunosuppressant used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. Side effects of the drug include fatal reactions from infusion, kidney failure and serious brain infection. The drug is also prescribed off label for other auto immune diseases including thrombotic thrombocytopenic purpura.

Related Sources:
Lawsuit Says Rituxan Left Man A Quadriplegic

A federal investigation by the Food and Drug Administration at a plant in Lancaster, Pennsylvania operated by Johnson & Johnson found multiple violations that could harm the medications manufactured there.

The investigation found a pattern of inattention to detail. Equipment was found to be improperly cleaned and maintained. Problems at the plant were not investigated for significant periods of time and records were rarely maintained. Batches of medication manufactured during an equipment malfunction were not always quality checked. Popular over the counter medications such as Pepcid and Mylanta are manufactured at the plant.

This is the second plant shut down by J&J this year. A plant in Fort Washington, Pennsylvania was shut down after a massive recall was issued by J&J on many popular over the counter medications.

Related Sources:
New FDA report shows multiple lapses at J&J plant

The Food and Drug Administration is reviewing only a small percentage of drug testing sites that are not located in the United States. For the past ten years, major drug manufactures have moved testing overseas to cut costs. In 2008, the FDA reviewed only one percent of overseas drug testing sites.

The FDA is responsible for the safety of the drugs sold and prescribed in the United States. Without proper inspection and monitoring of drug trials, unsafe or defective drugs could reach the US market and harm unsuspecting patients. Over eighty percent of drugs approved in 2008 had data from foreign studies.

To remedy the situation the FDA has agreed to place more stringent requirements on companies testing drugs overseas. All companies must now submit trial data in a standardized electronic format to help the FDA identify trials and sites for inspections. The FDA will also work closer with foreign governments to oversee trials and ensure only safe drugs reach the US market.

Related Sources:
Where was that new drug tested?

Johnson & Johnson has expanded the recall of over the counter medications. The new recall is due to a foul odor that has made consumers nauseous. A chemical used to treat the wood pallets that transport and store the medication is the source of the odor.

Johnson & Johnson and McNeil Consumer Healthcare have issued three recalls in the last 8 months for over the counter medications. The foul odor recall includes four lots of Benadryl Allergy Ultratablets and one lot of Extra Strength Tylenol.

The recalls have lead to congressional hearings, fines by the Food and Drug Administration and a factory closing in Pennsylvania.

Related Sources:
J&J expands medicine recall linked to foul odor

More bad news for the over-the-counter medication manufactured by a Johnson & Johnson subsidiary, McNeil consumer products. A congressional investigation has revealed that in 2008, the company discovered problems with the Motrin formula but did not issue a recall. Instead the company hired an outside contractor to purchase the dangerous drugs.

In 2008, the company discovered a problem with their Motrin tablets. Johnson & Johnson was unsure if the tablet dissolved properly and appropriately administered the pain relieving ingredient, ibuprofen. In response, the company hired an outside contractor to buy samples of the medication and test the product to determine if a recall was an appropriate measure to take.

The outside company purchased lots of the medication and told employees specifically not to mention a recall and it never tested the medications for problems. In 2009, Johnson & Johnson recalled Motrin after the Food and Drug Administration confronted the company about the problems with the Motrin formula.

This revelation comes just a month after the massive recall of children's over the counter medication announced by Johnson & Johnson. Foreign particles were discovered in some batches of the medication and it is unknown if these particles could harm the children taking them. Since the recall the FDA has received hundreds of reports of injuries from the dangerous medications including seven deaths.

Related Sources:

Tylenol Manufacturing Plant Closed in Pennsylvania

FDA docs: J&J knew of problems with Motrin in 2008

A children's medication manufacturing plant in Fort Washington, Pennsylvania has been closed by McNeil Consumer products in the wake of the massive children's medication recall. The plant in suburban Philadelphia will not be allowed to resume manufacturing until deemed safe by the Food and Drug Administration.

An investigation by the FDA uncovered more than twenty manufacturing problems associated with the plant. The report noted that some machines were covered in dust and others were held together with duct tape. For the last year the FDA had been pressuring the plant to correct its problems and finally shut it down after the recall was issued. The report also mentions that McNeil's parent company, Johnson & Johnson failed to investigate over three dozen consumer complaints of quality issues associated with their products.

Health regulators at the manufacturing facility failed to test the raw ingredients for contaminants in the over the counter medication it was producing. An inspection from the FDA discovered there was no site in the plant to test the ingredients and bacteria was in fact found. It is unclear whether the bacteria reached the finished product in the recalled medications but health officials are still urging parents and care givers to refrain from giving the potentially dangerous medications to their children.

Related Sources:

Tylenol plant in Ft. Washington closed in wake of recall

FDA Found Bacteria In Lots For Recalled Tylenol

McNeil Product Recall Information

Parents and caregivers of children in Philadelphia may want to check their medicine cabinet for recently recalled medications. McNeil Consumer Healthcare has issued a recall of over 40 over-the-counter infant's and children's liquid medications because they do not meet quality standards.

Children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl are among the medications recalled by McNeil in cooperation with the Food and Drug Administration. Some of the medications recalled contain higher concentrations of the active ingredient than listed on the bottle. Other medications contain inactive ingredients and other particles that have not been subject to internal testing requirements.

Although no adverse effects of injuries have been reported, McNeil and the FDA are advising that consumers stop using the products immediately and discard of them appropriately.

For a complete list of the medications recalled please visit this website.

Related Sources:
Children's Liquid Cold, Allergy Medicines Recalled

McNeil Product Recall

The Supreme Court will decide if a manufacturer can be sued by parents of children who suffered side effects from a vaccine. The 3rd U.S. Circuit Court of Appeals in Philadelphia ruled that the manufacturer could not be sued because a 1986 federal law prevents the suit. The suit is being ushered to the Supreme Court by President Obama and even the defendant in the case, Wyeth, which is now owned by Pfizer, Inc.

The National Childhood Vaccine Injury Act in 1986 set up a special court to hear vaccine disputes and was created to insure a stable supply of childhood vaccines by shielding companies from lawsuits. A concern over mercury-based thimerosal in vaccine and its link to autism has seen a recent rise in the number of lawsuits against drug manufacturers. As a result, thimerosal has been removed from childhood vaccines but further studies have shown that there is no link between thimerosal and autism. The vaccine court has rejected all claims against manufacturers and only one high court, The Georgia Supreme Court has ruled that families can sue drug manufacturers over vaccines.

Related Sources:
Court will hear case about vaccine side effects

The United States Consumer Product Safety Commission has recalled over a half a million units of Vicks DayQuil cold medicine because the packaging was found not to be child proof.

The 700,000 units were sold between September 2008 and December 2009 as Vicks DayQuil Cold & Flu 24-Count Bonus Pack Liquicaps. The packaging is marketed as child-resistant but the blister packs inside are not.

The UPC for this product is 3 23900 01087 1.

If a child was to open the medicine and ingest several of the pills they could suffer from serious health problems and death. Thankfully there have yet to be any reports of a child swallowing the medication.

This latest recall comes at not the most opportune time for Vicks and its parent company Proctor & Gamble. The company has already had 120,000 bottles of Vicks Sinex nasal spray recalled after bacteria were found in the spray. The Food & Drug Administration has also sent Vicks a letter warning them about the marketing of their products with Vitamin C.

Related Web Sources:

Red Orbit News

The drug manufacturers Pfizer and Wyeth (which is now part of Pfizer) were ordered by two Philadelphia juries to pay over $100 million in punitive damages to two women who were prescribed the hormone replacement drug (HRT) Prempro. Attorneys for plaintiffs alleged that this dangerous drug caused their clients to develop breast cancer and as a result had mastectomies performed. The defendants were found negligent in failing to warn patients and their doctors of the serious health risks while taking HRT.

Donna Kendall of Decatur, Illinois was awarded $6.3 million in compensatory damages and an additional $28 million in punitive damages. Connie Barton, also of Illinois was awarded $3.5 million in compensatory damages and an additional $75 million in punitive damages. Plaintiffs proved that Pfizer/Wyeth knew of the serious risks of its drug but failed to disclose these risks to patients and their prescribing doctors.

There are over one thousand hormone replacement therapy cases in the Philadelphia court system and all five that have gone to trial in the past three years have resulted in plaintiff's verdicts. Philadelphia juries are clearly outraged that Pfizer/Wyeth put profits over the safety of women's health. Plaintiffs assert that the drug manufacturer did not conduct adequate studies that would have revealed the breast cancer risk because the HRT drugs were producing revenues in excess of $2 billion annually.

Over six million women take HRT drugs to treat their menopause symptoms such as mood swings, night sweats, and hot flashes. Currently Pfizer is not seeking a global settlement. Plaintiff attorneys have been working hard to consolidate cases to ensure that all clients have their day in court.

Our firm has filed another lawsuit involving the drug reglan. Reglan is a drug prescribed for gastrointestinal upset, and when given for an extended period of time has been known to cause serious side effects and especially a neurological condition known as tardive dsykinesia. Our client used the drug for years without being told of the potential for developing tardive dyskinesia. The lawyers at Eisenberg, Rothweiler, Winkler, Eisenberg, and Jeck, P.C., particularly our mass tort team of lawyers, have extensive experience in handling individual drug product liability lawsuits for patients who were not warned of these side effects by the drug makers of reglan as well as the duragesic fentanyl pain patch. We welcome the opportunity to serve those who have suffered needlessly. If you or a loved one use reglan please be aware of the potential leaking of the patch which can cause serious injury or death in your family.

A Philadelphia mother recevied $2.5 million judgment against GlaxoSmith-Kline because a jury ruled that Paxil was responsible for her son's heart problems. The jury ruled 10-2 in favor of the mother citing that the drug manufacturer was negligent because they failed to warn doctors and patients of the risk to pregnant mothers.

The lawsuit is the first of hundreds to be filed in Philadelphia Court and many plaintiff lawyers are optimistic that their suits will have similar results. This particular case was difficult to prove in court because there are birth defects in 3 to 5 percent of all live births and it is hard to prove that a drug caused a birth defect in a child.

The jury's decision did not award the plaintiff compensatory damages because the jury did not find any evidence that GlaxoSmith-Kline knew about the potential side effects. Had documents surfaced that drug manufacturer knew of potential dangerous side effects but neglected to warn consumers or pull the drug off the market then compensatory damages would have been awarded.

GlaxoSmith-Kline is also battling law suits across the United States, Canada, and the United Kingdom for a different reason. There is evidence that Paxil users have a higher tendency to commit homicidal and suicidal acts. Already the drug manufacturer has settled cases outside of court and has had to deal with accusations of suppressing research that showed Paxil can lead to suicide.

If you believe you have been harmed by Paxil please do not hesitate to contact our experienced pharmaceutical litigation attorneys today to discuss your potential case.

The Food and Drug Administration is investigating the safety of the popular asthma medication Xolair. The five year observational study of the long term effects of the drug have found that patients using the injectable drug may lead to strokes, heart attacks, irregular heartbeats, hypertension and other heart problems.

Xolair is manufactured by Genetech and marketed by Novartis and was approved in 2003 by the FDA for patients with moderate to severe asthma in which inhalable treatments do not work. There is no recall yet on the product and the FDA is telling patients to continue to use the medication. The current observational health study is set to end in 2012 but the FDA is working to conduct a new study that will be better able to evaluate the risks associated with the drug.

Continue reading "FDA Examining the Safety of the Asthma Medication Xolair" »

It seems like anytime you turn on the TV these days you will see a commercial with an allergy sufferer skipping through a field of daisy's after taking an allergy medication, a sad man who is suddenly cheery after being prescribed an anti-depressant, or maybe the Nasonex bee. Big pharma is a $289 billion dollar industry and big pharma spends big bucks to make sure that consumers like you want to take their new drugs. Commercials and print advertisements aggressively push drugs with catchy images, jingles or celebrity spokespersons but fail to educate patients about the risks of the new drug. In fact, when a new drug hits the market, all the drugs long-term effects are not yet known. As direct-to-consumer advertising has sharply increased over the years, Congress has taken notice. Bart Stupack of Michigan, chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations is calling for a moratorium on direct-to-consumer ads during the drugs first two years on the market. Chairman of the House Energy and Commerce Committee, Henry Waxman of California supports the two year moratorium as well. "It is in these first few years of a drug's life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood," Waxman said.

As we wait to see how Congress moves on this issue, big pharma continues to expand their reach to consumers by utilizing all available mediums. For instance, on March 11, 2009, Schering-Plough launched "Don't Blow it - The Nasal Allergy Game" an online interactive game featuring Ronnie Nose, a cartoon nose. There is also a Facebook and Twitter component to this advertising campaign. As big pharma continues to pump billions of dollars a year into direct-to-consumer marketing, remember that these advertisements do not tell the whole story. Whether direct-to-consumer advertisements encourage patients to request prescriptions from their doctors, minimize harmful risks of a particular drug, or both, the progression of advertising to social media outlets such as Facebook or Twitter will only buttress misconceptions that the American consumer may have about a particular drug. The products that these advertisements are promoting are pharmaceutical drugs, not Coca-Cola, they should be presented as the former, not the latter.

Continue reading "Consumer Health and Safety or Pharma's Bottom Line?" »