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.

1. 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

2. 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.

3. 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.

4. 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

5. 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

6. 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.

7. 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

8. Topamax Litigation: Understanding Your Rights Carey, Danis and Lowe, Attorneys at Law 8
Commercial Litigation