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Strict liability rules stipulate that a drug manufacturer can be held legally responsible when patients experience side effects from medication use of which they were inadequately warned.
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TOPAMAX LITIGATION:
UNDERSTANDING YOUR RIGHTS
Strict Liability Rules Stipulate that a Drug
Manufacturer Can be Held Legally Responsible When Patients Experience Side Effects from Medication Use of
Which they Were Inadequately Warned
CAREY, DANIS & LOWE
PERSONAL INJURY ATTORNEYS
Topamax Litigation: Understanding Your Rights Carey, Danis and Lowe, Attorneys at Law 2
Topamax is a medication marketed for the prevention of migraine headaches and
for the treatment of the seizure disorder epilepsy. Topamax is manufactured by a
Johnson & Johnson subsidiary called Janssen Pharmaceuticals and it is one of
the most commonly prescribed anticonvulsant medications on the market. By
2008, the medication had U.S. sales exceeding $10 billion, and it accounted for
21 percent of all epilepsy medications taken by patients within the United States.
Unfortunately, Topamax has been linked to serious complications when taken
during pregnancy. Topamax can significantly increase the risk that a child will be
born with an oral cleft palate if their mothers take the drug during fetal
development.
Many women were unaware of this link between Topamax and oral cleft palate
and took the medication during pregnancy without the knowledge that their child
could be at risk. Janssen Pharmaceuticals and Johnson & Johnson may be held
legally liable for the harm that resulted to children and families, and an
experienced defective drug lawyer should be consulted for assistance in holding
the company accountable for damages.
Topamax Litigation: Understanding Your Rights Carey, Danis and Lowe, Attorneys at Law 3
TOPAMAX LITIGATION: YOUR RIGHT TO COMPENSATION
Drug manufacturers have certain obligations to the public. The manufacturers
must test the medications through clinical trials prior to releasing them in order
to ensure that the drugs are reasonably safe when used for their intended
purposes. Because almost all drugs have some types of side effects, the
medications do not need to be without side effects. However, the risks must
outweigh the benefits of the medication use. Further, when there are side effects
associated with the use of a drug or medical therapy, patients must be warned
about both common and rare complications so that the patient can make an
informed choice about
whether to continue to
take the drugs in
question.
If a drug manufacturer
fails to fulfill its
obligations in ensuring
that it warns patients
about risks of
medications, the
manufacturer can be
held responsible for
resulting complications, injuries and damages. There is no requirement that a
plaintiff demonstrate negligence to win a defective drug case. Strict liability rules
stipulate that a drug manufacturer can be held legally responsible when patients
experience side effects from medication use of which they were inadequately
warned.
Topamax Litigation: Understanding Your Rights Carey, Danis and Lowe, Attorneys at Law 4
Patients may also argue that the drug manufacturer breached express or implied
warranties; was negligent in the design or production of the drug; or failed to
provide adequate warning of
complications. There are myriad
legal arguments that a plaintiff can
make to successfully hold a drug
manufacturer accountable,
provided that the plaintiff can
prove the medication caused the
health problem.
In the case of Topamax, there have
been multiple studies demonstrating the risks associated with the medication
use. In 2008, for example, the Neurological Medical Journal warned of birth
defects resulting from Topamax.
In March of 2011, the data on Topamax complications prompted the Food and
Drug Administration to release a warning alert of the link between Topamax and
cleft palate in children whose mothers took Topamax. According to the FDA’s
warning, children exposed to Topamax during fetal development had a 20 times
increased risk of being born with an oral cleft palate as compared with children
whose mothers had not taken this medication during pregnancy.
Animal studies have provided information on this link between Topamax and
cleft palates as far back as 1997. Unfortunately, Janssen Pharmaceuticals did not
act to notify the public of this fact but instead the company continued to produce
and sell the medication without providing adequate warnings.
Janssen Pharmaceuticals did not just continue to sell the drug for epileptic
patients either. The company also launched an aggressive campaign to market
Topamax Litigation: Understanding Your Rights Carey, Danis and Lowe, Attorneys at Law 5
the medication for off-label use, which means use as a treatment method for
conditions for which it was not approved by the FDA. In 2010, more than $80
million in fines were assessed to the company because of this off-label marketing.
The company at the time was called Orth-McNeil.
The $80 million settlement resolved the claims under the Federal False Claims
Act as well as other government allegations related to illegal off-label marketing.
However, the company was still responsible to the thousands of families affected
by birth defects caused by the Topamax medication.
TOPAMAX LITIGATION
With evidence suggesting a link between Topamax and cleft palates, families of
infants born with cleft palates began to file lawsuits against Janssen
Pharmaceuticals seeking compensation for losses and damages. More than 134
cases were pending in Philadelphia alone with plaintiffs seeking monetary
damages to cover the costs of corrective surgery and other damages. Many of
those cases have been settled.
Some Topamax claims have been decided already, with juries finding for
plaintiffs. For example, a Philadelphia case resulted in a $3 million award in
March of 2014. The jury determined that Janssen Pharmaceuticals had failed to
warn the mother about the risks of Topamax. Her daughter was born with a cleft
palate and although the child is just five-years-old, she has already undergone 14
procedures including four surgeries.
In another October case, a Virginia resident was awarded $4.02 million in
compensation for Topamax complications.
Plaintiffs who were harmed by Topamax can bring their own claims to obtain
compensation from Janssen Pharmaceuticals for damages. An experienced
Topamax Litigation: Understanding Your Rights Carey, Danis and Lowe, Attorneys at Law 6
defective drug lawyer can help victims affected by birth defects to pursue their
case and prove that the drug company should be held accountable for the
consequences of its dangerous medications.
Topamax Litigation: Understanding Your Rights Carey, Danis and Lowe, Attorneys at Law 7
About Carey, Danis & Lowe, Attorneys at Law
Carey, Danis & Lowe exclusively represents plaintiffs in litigation. The firm practices a wide area of personal injury law including trucking accidents, medical malpractice, auto accidents,
motorcycle accidents, product liability, burn injuries, defective prescription drugs, and defective medical devices. Currently approximately 50% of the practice is devoted to prescription drug litigation, including drugs such as Yaz, Pradaxa, Zoloft, Prozac, Lexapro,
Paxil, Celexa, Effexor, Wellbutrin, and defective medical devices including Mirena, Transvaginal Mesh, Depuy ASR Hips, and Nextgen Knees. The remainder of the practice is devoted to
trucking accidents, auto accidents, motorcycle accidents, medical malpractice, and other serious personal injuries.
The firm is headquartered in St. Louis, Missouri, but practices throughout the nation. We have successfully handled cases from coast to coast.
The law firm prides itself on personally handling all cases it takes in, and has the expertise to,
if necessary, try the case to a jury no matter how complex or lengthy. The firm has a successful track record in obtaining large jury verdicts for their injured clients as well as
substantial settlements.
The firm has obtained multi-million dollar verdicts and settlements in personal injury cases, including a $105 million jury verdict involving the explosive separation of a multi-piece wheel
against Firestone which was the largest verdict in Missouri that year, a $13 million verdict against a hotel where a boxing match was held for not having an ambulance on site, a $4.5
million jury verdict against Medical Engineering Corporation for a defective breast implant, a $2 million jury verdict in a medical malpractice case, a $2.1 million settlement involving a
trucking accident, a $1.1 million verdict in a motorcycle accident case, a $1,050,000 verdict in a trucking accident case, a $1 million judgment in underinsured motorist case, and many others.
The firm has also represented thousands of clients in pharmaceutical and medical device cases and recovered over a billion dollars. Some of the settlements and judgments involve Fen
Phen, Baycol, Vioxx, Bextra, Avandia, Paxil, Smith & Nephew Macrotextured Knees, and Depuy ASR metal on metal hips. The firm is dedicated to providing excellent legal representation for
people injured by defective products or in a variety of accidents.
Carey, Danis & Lowe, Attorneys at Law 8235 Forsyth Blvd, Suite 1100
St. Louis, Missouri 63105 http://www.cdlinjurylaw.com
Practice Areas Trucking Accidents / 18-Wheeler Crashes
Pharmaceutical Liability Motor Vehicle Accidents Personal Injury
Medical Malpractice Defective Medical Devices
Topamax Litigation: Understanding Your Rights Carey, Danis and Lowe, Attorneys at Law 8
Commercial Litigation