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Pharmaceutical & Medical DeviceView Industry as PDF

For over 30 years, BSCR has enjoyed nationwide success defending the interests of many of the world’s largest pharmaceutical and medical device companies. We have earned the trust of our clients by offering innovative solutions to the complex legal challenges encountered by the pharmaceutical and medical device industries. In doing so, we have gained a reputation for efficiently and cost-effectively managing and resolving matters in the industry.
 
We have served as national, regional and local counsel for a range of companies in mass tort cases and multi-district litigation.  We have successfully represented companies in multi-district, class action and consolidated litigations across the country, including in Arkansas, California, Florida, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, New Jersey, Ohio, Oklahoma, Pennsylvania, Texas, West Virginia and more.  With a staff of skilled trial attorneys and nurses, we have tremendous experience unearthing dispositive facts and dissecting complicated medical concepts and legal issues.

Our depth of experience enables us to identify the nuances of each legal problem and develop creative solutions to solve those problems in ways that support our clients’ business objectives.  In some instances, strategic settlements are the best approach, and in others hard-nosed litigation, trial, or another approach is a more effective means of achieving the legal and business goals of a client.  Our attorneys are experienced in identifying and executing the best approach for each litigated matter.

Our attorneys have successfully represented manufacturers of a number of pharmaceutical drugs, including those used for:

• Anxiety
• Arthritis
• Blood Pressure
• Cholesterol
• Contrast imaging
• Depression
• Diabetes
• Diagnostic imaging
• Hormone replacement therapy
• Migraines
• Psychosis

We have also defended companies that manufacture a wide variety of medical devices, including:

• Cardiac and uterine ablation devices
• Cardiac leads
• Cardiac resynchronization therapy devices 
• Catheters
• Feeding tubes
• Guidewires
• Heart valves
• Hip replacements
• Hysteroscopic microinsert devices
• Implantable cardioverter defibrillators
• Kidney stone retrieval systems
• Knee replacements
• Laparoscopic staplers
• Neurovascular devices
• Pacemakers
• Pelvic organ prolapse products
• Spinal cord stimulators and leads
• Stents
• Urinary devices

Although we are litigators, we also have significant experience guiding pharmaceutical and medical device companies through other legal and regulatory challenges.  Beyond litigation, our attorneys are experienced at providing advice to clients on crisis management, internal and external communications, quality-system controls and regulatory issues, including skillfully preparing witnesses for appearances before regulatory authorities and advising clients about product labeling, product marketing, product recalls, and returning products to the market.

Members of the practice group are active in the pharmaceutical and medical device committees of the ABA, DRI, FDCC and IADC, and have repeatedly been recognized for excellence in pharmaceutical and product liability work in publications such as Best Lawyers, Chambers USA, International Who’s Who, LMG Life Sciences and Super Lawyers. More importantly, our clients give us outstanding marks on the effectiveness, quality and efficiency of our services, as well as our overall value.  During client feedback interviews, they have commented:
 

“We wouldn’t consider using anyone else for future litigation and would definitely refer colleagues to the firm.
I’m a ‘big fan’ of the firm.”

-Vice President & General Counsel for Pharmaceutical Company

 “The team understood the company’s objectives and resolved the litigation accordingly.One of the best results in mass tort litigation the company has ever had from a value standpoint.”

-Corporate Counsel for Pharmaceutical Company

For more information about the services we provide to the Pharmaceutical & Medical Device industries contact Tom Sterchi, Kara Stubbs or Jeff Kruse at 816.471.2121.
 

News & Events

Join Baker Sterchi Attorneys at DRI's 2017 Drug and Medical Device Seminar

03.10.17 | Join attorneys from Baker Sterchi Cowden & Rice’s Drug and Medical Device Practice Group, including DRI Drug and Medical Device Steering Committee Member Jeffrey Kruse, at DRI’s Annual Drug and Medical Device Seminar being held May 11-12, 2017 at the...

Join Baker Sterchi Attorneys at DRI's 2016 Drug and Medical Device Seminar

02.11.16 | Join DRI Drug and Medical Device Steering Committee Member, Jeffrey Kruse, and other Baker Sterchi Cowden & Rice attorneys practicing in the firm’s Drug and Medical Device Practice Group, at DRI’s upcoming Drug and Medical Device Seminar being held May 19-20 at the...

Former Boston Scientific Corporation Chief Product Liability Litigation Officer Jeffery Kruse Joins Baker Sterchi Cowden & Rice

10.07.15 | Baker Sterchi Cowden & Rice LLC announces that Jeffery A. Kruse, former Chief Product Liability Litigation Officer at Boston Scientific Corporation, has joined the firm’s Kansas City office as a Member (partner)...

Higgins Comments on High Court's Generic-Drug Liability Ruling

06.26.13 | Angela Higgins' commentary on the significance of the U.S. Supreme Court's June 24 ruling in Mutual Pharmaceutical Co. Inc. v. Bartlett was included in a Law 360 article (Lawyers React To High Court's Generic-Drug Liability Ruling) regarding the significance of the ruling, which prohibits a user of a generic drug from bringing a state-law design defect claim against the manufacturer because the manufacturer cannot change a generic drug's design under federal law. . .

Stubbs and Tinsley Article on Preemption Under Mensing Published in IADC Newsletter

06.05.13 | BSCR Members Kara Stubbs and Caroline Tinsley's article entitled "A New Argument Against Preemption Under Mensing: The Different Manufacturers Exception" was published in the May 2013 issue of the International Association of Defense Counsel's Drug, Device and Biotechnology Committee Newsletter.

Stubbs Selected as Co-Chair of Medical Device Subcommittee

01.18.13 | Kara Stubbs has been selected to serve as the Co-Chair of the Medical Device Subcommittee of the ABA's Section of Litigation, Products Liability Committee. The Section of Litigation is the largest specialty section of the American Bar Association.

Baker Sterchi Sponsors ABA Pharmaceutical and Medical Device Litigation Meeting

11.19.12 | Baker Sterchi Cowden & Rice was a law firm sponsor of the ABA Current Issues in Pharmaceutical and Medical Device Litigation meeting held at Boston Scientific in Natick, Massachusetts on November 16, 2012. Co-sponsored by

Stubbs to Moderate Panel on Social Media Discovery

04.27.12 | BSCR attorney Kara Stubbs will be moderating a panel at Medmarc's Annual Meeting in June. Stubbs' panel will address practical issues related to the discovery of social media, including how to effectively discover valuable information from social media sources and how to effectively use the information that is located. . .

Stubbs Co-Chairs ABA Pharmaceuticals Subcommittee

12.19.11 | Baker Sterchi Cowden & Rice Member Kara Trouslot Stubbs served as a co-chair of the Pharmaceuticals Subcommittee of the ABA Products Liability Committee, which recenty partnered with the Medical Device Subcommittee to sponsor the Annual Pharmaceutical and Medical Device CLE Workshop held at GlaxoSmithKline in Philadelphia in November.

Tinsley Speaks at Pharmaceutical and Medical Device Workshop

12.19.11 | Caroline Tinsley was a panelist at the ABA Annual Pharmaceutical and Medical Device Workshop held in Philadelphia in November. Tinsley's panel addressed international issues arising in the litigation of pharmaceutical and medical device cases. . .

Tinsley Appointed DRI Committees Liaison

07.20.11 | Baker Sterchi Cowden & Rice Member Caroline Tinsley has been appointed to the position of Liaison between the DRI Drug and Device Committee and the DRI E-Discovery Committee.

Stubbs to Co-Chair ABA Drug & Medical Device Committee Meeting

10.04.10 | Kara Stubbs is co-chairing the annual CLE event of the Pharmaceutical and Medical Device Committees of the ABA Section of Litigation. The CLE event will take place on November 11 at Johnson & Johnson.

Tinsley Co-Authors DRI Drug and Medical Device Guide

06.01.10 | Caroline Tinsley is a co-author of "Epidemiology and Pharmaceutical Products Litigation: A Beginner's Guide (2010)" to be published by the Defense Research Institute, Drug and Medical Device Committee.

Tinsley Gives Presentation at DRI Drug and Medical Device Annual Meeting

06.01.10 | On May 20, Caroline Tinsley gave a presentation at the DRI Drug and Medical Device Annual Meeting in San Francisco, CA, entitled "Epidemiology 101: Its use in Pharmaceutical Litigation".

Results

Summary Judgment Obtained for Pharmaceutical Manufacturer

BSCR obtained summary judgment in a pharmaceutical product liability case pending in Kansas federal court. Plaintiff filed suit against our clients alleging...

BSCR Wins Motion to Dismiss Pharmaceutical Company in Product Liability Action Alleging Innovator Liability

BSCR obtained a dismissal of a pharmaceutical company client in a product liability case. In that case, plaintiff alleged...

Summary Judgment Obtained on Behalf of Medical Device Manufacturer Based on Preemption

BSCR obtained summary judgment in a medical device product liability case filed in Tenth Judicial District of Kansas (Johnson County). Plaintiff brought suit against our clients, the entities that designed, manufactured and sold the medical device implanted during plaintiff’s gastric bypass procedure, and...

Summary Judgment Obtained after Plaintiff's Experts Stricken under Daubert

BSCR obtained summary judgment in a medical device product liability case filed in the United States District Court for the Western District of Missouri following two successful motions striking plaintiff’s liability and causation experts. Plaintiff brought suit against our client, a manufacturer of a surgical suture, alleging...

BSCR Obtains Complete Dismissal of Cases Against Pharmaceutical Client

In 2007, Plaintiffs began filing lawsuits against four pharmaceutical manufacturers and sponsors of gadolinium based contrast agents ("GBCAs") alleging that the GBCAs caused or contributed to cause a rare disease now known as nephrogenic systemic fibrosis ("NSF"). Close to 1000 cases were filed in various state and federal courts over a period of four years. . .

Defense Verdict Obtained on Behalf of BSCR Client in Federal Court Pain Pump Trial

After a four week trial in the United States District Court for the District of Oregon (Portland), a nine-person jury returned a unanimous defense verdict in a case involving allegations of post-arthroscopic glenohumeral chondrolysis (PAGCL) after the infusion of local anesthetics via pain pump into the shoulders of plaintiffs following arthroscopic surgeries. The case involved the claims of three plaintiffs whose individual cases were consolidated for trial against the manufacturer and distributor of the pain pumps at issue, including BSCR client DJO, LLC, the pain pump distributor, a named defendant in two of the three cases being tried. . .

Blog Posts

Is It Necessary for an Expert Opinion to Take Into Account Obvious Alternative Explanations for an Injury? Eighth Circuit Weighs In.

08.07.17 | In Redd v. DePuy Orthopaedics, Inc., the Eighth Circuit Court of Appeals has reminded litigators of the importance of ensuring expert witnesses perform a thorough review of a matter, including apparent alternative causal explanations, prior to issuing their opinions.

Jurisdictional Discovery Is Not a Magical Incantation to Ward Off Timely Dismissal of a Case Filed in the Wrong Forum

07.14.17 | In the wake of Bristol-Myers-Squibb and other game-changing personal jurisdiction decisions from the U.S. Supreme Court and the Missouri courts this year, plaintiffs are chanting “jurisdictional discovery” as if it is a magical incantation to ward off the timely and necessary dismissal of claims improperly filed in the wrong forum. Definitive rulings in BMS, BNSF v. Tyrrell, and Dolan should not permit months of pointless discovery in cases that must, under the law, be dismissed for lack of personal jurisdiction.

FDA - Postmarket Management of Cybersecurity in Medical Devices

06.05.17 | It seems almost impossible in today’s world to escape our dependence on technology. From the minute we wake-up in the morning, we access news reports on our tablets, keep track of our health with fitness trackers, receive and respond to e-mails on our mobile phones, and many of us rely upon interconnected medical devices, such as insulin pumps, to safely navigate through a typical day. But such convenience is not without risk.

You've Got Mail - Service of Process by Mail is Satisfactory under the Hague Service Convention

05.30.17 | The United States Supreme Court ruled on May 22, 2017, that the Hague Convention, on the service of judicial documents abroad, permits service by mail if the receiving country has not objected to service by mail and service by mail is authorized under otherwise-applicable law.

Federal Judge Clobbers Claims in a Class III Medical Device Case

05.22.17 | A federal judge in North Carolina agreed with Bayer that federal law preempts all of plaintiff’s claims against Bayer in a medical device case. The judge then declined to exercise supplemental jurisdiction over the medical malpractice claims against the healthcare providers and dismissed those claims as well.

Indiana Judge Relies on Bausch to Bounce Preemption Motion

05.15.17 | A federal judge in Indiana relied on the Seventh Circuit’s decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) to reject a medical device maker’s argument that federal law preempts plaintiff’s claims, including plaintiff’s negligence per se claim.

Court Muzzles Counsel: Says Defendants Cannot Ask Plaintiffs if Their Attorneys Referred Them to Treating Physicians

04.27.17 | The Florida Supreme Court recently ruled that the attorney-client privilege protects a party from being required to disclose that her attorney referred her to treating doctors.

The Daubert Standard - Coming Soon to a Missouri Court Near You

03.31.17 | Earlier this week, Governor Eric Greitens signed Missouri HB 153 into law. HB 153, which supplants Missouri’s existing expert witness standard with that set forth in Federal Rules of Evidence 702, 703, 704 and 705, effectively submits expert testimony in most civil and criminal case to the analysis set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

Federal Judges Blow Their Stacks Over Boilerplate Objections

03.27.17 | Within a two-week period, two federal judges issued strongly worded orders denouncing the common practice of asserting boilerplate objections to written discovery.

Employees: Yes, You Can Owe Duties To Your Co-Employees

03.22.17 | The Missouri Court of Appeals rules that a worker may owe an independent duty of care to a co-worker, which is separate and distinct from her employer’s non-delegable duties.

Reports of the Death of Litigation Tourism in Missouri Have Been Greatly Exaggerated

03.01.17 | A recent Missouri Supreme Court decision is good news for out-of-state defendants, rejecting the theory that appointing a registered agent in the state to accept service of process equated to consent to personal jurisdiction, and explicitly adopting Daimler and Goodyear. The decision probably creates more turmoil than it resolves on the “general jurisdiction” front, however, and does not directly stamp out the multi-plaintiff litigation tourism that is presently bedeviling the state.

Rationale Underlying Missouri's Runaway Supplemental Jurisdiction Theory to be Tested by U.S. Supreme Court

01.30.17 | The U.S. Supreme Court has accepted certiorari in Bristol-Myers Squibb Co. v. Superior Court of California, a pharmaceutical product liability case in which some 600 out-of-state plaintiffs sued in a California court, arguing that the defendant had “contacts” with the state even though their individual claims did not arise out of those contacts. Because Missouri’s long-arm personal jurisdiction test...

Effectively Addressing Cybersecurity Breaches in Medical Devices (Part 3 of 3)

01.24.17 | Continuing from our two prior posts in this three-part series on effectively addressing cybersecurity breaches in medical devices, this third and final post will focus on best practices to prepare, mitigate and otherwise manage vulnerabilities and potential cyber-attacks.

Effectively Addressing Cybersecurity Breaches in Medical Devices (Part 2 of 3)

01.11.17 | Continuing from our prior post in a three-part series on effectively addressing cybersecurity breaches in medical devices, this second post will focus on specific examples of cybersecurity attacks on medical devices.

Effectively Addressing Cybersecurity Breaches in Medical Devices (Part 1 of 3)

12.14.16 | We will explore in a series of three blog posts: (1) the specific vulnerabilities and risks inherent with embedded and interconnected medical devices, (2) cybersecurity and attacks on medical devices, and (3) practical approaches companies may employ both before and after a device is marketed. This first post in the series serves as an introduction to navigating the medical device field...

Mere Designation of an Expert Witness Does Not Waive the Work Product Doctrine Protections

11.02.16 | A Missouri plaintiff did not irrevocably waive the protections of the work product doctrine simply by designating an expert witness and then withdrawing the designation without disclosing the expert’s analysis or conclusions.

FDA Launches Webpage Allowing Anonymous Reports of Regulatory Misconduct Regarding Medical Devices

10.25.16 | One week before Halloween 2016 and the FDA just launched a new webpage titled “Reporting Allegations of Regulatory Misconduct” which allows anyone to report alleged misconduct on the part of medical device manufacturers or individuals marketing medical devices.

Forum Non Conveniens - When Home Isn't Always Convenient

07.05.16 | In civil litigation, the practice of “forum shopping” refers to the deliberate examination of multiple courts or jurisdictions in order to file or transfer the case to one that is most likely to treat that party’s claims most favorably. Often, this forum shopping is blatant – where plaintiffs deliberately attempt to...

Constructive Discharge Claims: When Does the 45-Day Period for Initiating Contact with the EEOC Begin to Run?

06.08.16 | On May 23, 2016, the U.S. Supreme Court decided the case of Green v. Brennan in order to resolve a split among the Circuits on whether, in an action for constructive discharge, the 45-day limitation period for the employee to initiate contact with the EEOC begins to run after the employer’s last discriminatory act, or at the time of the employee’s resignation.

Third Circuit Affirms Dismissal Opining No Physical Injury Equals No Ascertainable Loss

03.15.16 | On February 12, 2016, a panel of the U.S. Court of Appeals for the Third Circuit affirmed dismissal of a lawsuit accusing GlaxoSmithKline (“GSK”) of violating the Missouri Merchandising Practices Act (“MMPA”) by failing to adequately warn of the risks associated with the use of a prescription drug, Avandia.

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 4 of 4)

02.26.16 | The Proper Elements of an Effective Postmarketing Cybersecurity Program - The most practical portion of the FDA’s proposed guidelines is found in the Appendix. In this Section, the agency attempts to bring together all of the concepts from their recommendations into a cohesive summary of the necessary components of a proper cybersecurity program. The section discusses five broad concepts drawn from the NIST Framework...

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 3 of 4)

02.22.16 | Remediating and Reporting Cybersecurity Vulnerabilities - Manufacturers are required to determine if the residual risk of a cybersecurity vulnerability is “controlled” (acceptable) or “uncontrolled” (unacceptable). Following this initial determination of the seriousness of the risk to “essential clinical performance”, the FDA has recommended a variety of both remediation and reporting requirements...

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 2 of 4)

02.17.16 | Risk Assessment and Management in a Dangerous World - Manufacturers of medical devices are faced with ever-increasing cyberattacks that could impact patient safety and the efficacy of useful devices. One insurance group identified cyberthreats to medical devices as “open and growing”, describing a difficult “real world” scenario involving implantable defibrillators.

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 1 of 4)

02.15.16 | Background and Overview of Essential Concepts - As part of the increase in cybersecurity issues in an increasingly networked society, the FDA has decided to provide medical device manufacturers with structure and specificity in its quest to counter threats to patient safety. Although most of the recommendations offer industry a chance to self-police relatively minor security issues, the agency has proposed that a small subset of vulnerabilities...

"Excusable neglect" is a real standard requiring real evidence (Updated 01.04.2016)

01.04.16 | While a Kansas court may grant relief from a final judgment based on excusable neglect, it is an abuse of discretion to grant that relief when the party seeking that relief has failed either to explain what facts constituted excusable neglect or to provide any evidence to support that claim.

Forget the Pitchers - The H.E.A.T. Team Brought the Real Heat in October

11.10.15 | In October, the Department of Justice’s special health care fraud prevention team announced settlements of more than $719 million. The settlements involved allegations of illegal kickbacks, unnecessary medical treatments and premature implantations of medical devices.

FDA's New Draft Guidance Concerning Animal Studies for Medical Devices Makes 'Strong' Recommendations

10.22.15 | On October 14, 2015, the FDA issued a draft guidance to the medical device industry in which the FDA is expanding the scope of its guidance about animal testing and making some strong recommendations to industry.

Kicking the Can Down the Road: The U.S. Supreme Court Denies Certiorari in Failure to Update Labeling Case Against Generic Drug Manufacturer

05.20.15 | Manufacturers of Generic Pharmaceuticals bask in uncertainty after the United States Supreme Court denied certiorari in Pliva, Inc. v. Huck, leaving all to wonder whether or not state law “failure to update labeling” are preempted.

The Eighth Circuit Provides Clarity on Outside Sales Exemption and Waiver Requirements under FLSA

04.01.15 | The Eighth Circuit recently analyzed the application of the “outside sales” and “administrative” exemptions under the Fair Labor Standards Act in the context of promotional workers. Also, the Court was asked to decide, for the first time, what constitutes a valid waiver of an employee’s rights under the FLSA.

State's "Right to Try" Legislation Hangs Drug and Device Manufacturers Out to Dry.

01.20.15 | Kansas has joined a short, but growing, list of states introducing legislation purporting to give terminally ill patients the option to try drug treatments not yet approved by the FDA, but which have passed Phase One FDA testing. However, the legislation does not incentivize any manufacturer to provide such drugs and in fact potentially exposes a manufacturer who does provide access to additional risk of lawsuits.

The Supreme Court's Jurisdictional Stretch in Resolving the Evidence Needed to Support a CAFA Removal

01.06.15 | A defendant removing a case to federal court under the Class Action Fairness Act need not provide evidence proving the jurisdictional amount in controversy in the notice of removal. A “short and plain statement of the grounds for removal” is sufficient.

Failure-to-Update Claims Against Generic Manufacturers Remain Viable

10.16.14 | In Franzman v. Wyeth, Inc., et al., the Missouri Court of Appeals for the Eastern District recently reversed the trial court’s judgment in favor of the manufacturers of the generic form of Reglan (the “Generic Defendants”) on the portion of Franzman’s failure-to-warn claim relating to the Generic Defendants’ failure to update their warning labels to reflect the 2004 brand-name label revision.

Weeks II: Alabama bucks the trend and accepts the Innovator-Liability Theory

10.10.14 | On August 15th, the Alabama Supreme Court endorsed the theory of “innovator liability” and held for the second time in Wyeth, Inc. v. Weeks, 2014 Ala. LEXIS 109 (Ala. Aug. 15, 2014) that a plaintiff who took only the generic version of a medication could still make a claim against the brand-name manufacturers. While this position remains the minority view, the Weeks case demonstrates that the innovator-liability theory remains an important and contested issue for brand and generic drug manufacturers.

FDA proposes a new layer of regulation for laboratory developed tests.

08.21.14 | The Food and Drug Administration (FDA) announced its intention to expand the regulation of laboratory developed tests (LDTs). LDTs identify patients’ individual reactions to pharmaceutical treatments, so medical providers can prescribe the best treatment for the particular patient.

Frying the Frye Test and Increasing the Caps: New Amendments to Kansas Civil Actions and Civil Procedure

07.11.14 | K.S.A. 60-19a02 has been amended, increasing Kansas's long-standing cap on non-economic damages (pain and suffering) recoverable in personal injury. K.S.A. 60-456(b) has also been amended to mirror the requirements for the admissibility of expert testimony set forth in Fed. R. Evid. 702.

FDA Proposes Social Media Guidelines for Pharmaceutical and Medical Device Companies

07.03.14 | In a draft guidance issued on June 17, 2014, the FDA proposed that pharmaceutical and medical device companies must be sure to disclose the benefits and main risks associated with a product when posting on social media platforms with character space limitations. The FDA also proposed guidelines for companies seeking to correct misinformation posted about their products on social media by third-parties.

In a differential etiology, experts need not rule out all possible causes

06.23.14 | Experts are not required to rule out all possible causes when performing the differential etiology analysis if the experts have properly ruled in the alleged cause.

Punitive Damages Part 1: Don't Get Caught Flat-Footed

04.29.14 | A Kansas plaintiff may amend their pleadings to assert punitive damages up until the day of the pretrial conference.

Kansas abolishes assumption of the risk defense.

04.21.14 | Based on its adoption of a statutory scheme of comparative negligence, Kansas has abolished common law assumption of the risk as a bar to recovery. Simmons v. Porter, 298 Kan. 299, 312 P3d 345, 355 (Kan. 2013).

A mundane lesson from an important decision, or, the importance of presenting evidence

03.20.14 | The plaintiff has the burden of proving standing, which is a jurisdictional issue that can be raised at any time.

No Signed Settlement Necessary, Except When It Is

02.25.14 | In Kansas, the parties bind themselves to an enforceable settlement, even though the parties contemplate subsequent execution of a formal instrument. However, when the parties specifically condition a contract on it being reduced to writing and signed, there is no enforceable contract until such act is accomplished.

Drager v. PLIVA USA, Inc.: Fourth Circuit Explicitly Rejects Stop Selling Attempt to Avoid Generic Preemption

02.19.14 | Drager is a well-reasoned opinion on preemption issues. The opinion also presents a clearly-articulated analysis of the implications of plaintiffs' claims against generic manufacturers, correctly noting that the essence of these claims is that the manufacturer should exit the market, an argument that the court emphatically rejected.

Thompson v. Allergan: Further Eroding "Alternative Feasible Design" in Drug Cases?

02.12.14 | The U.S. District Court for the Eastern District of Missouri has recently issued an opinion, relying on Mutual Pharmaceutical Co. Inc. v. Bartlett, that arguably takes us a step closer to the eradication of "alternative design" claims directed at branded drugs.

A Winning Strategy: Using Publicly Available FDA Documents in a 12(b)(6) Motion to Dismiss is Advantageous

02.10.14 | In Poll v. Stryker Sustainability Solutions, Inc., et al., the U.S. District Court for the District of Arizona notably held that courts may take judicial notice of documents on the FDA's website when considering a motion to dismiss. 2014 U.S. Dist. LEXIS 6309 (D. Az. Jan. 17, 2014).

Size Matters: New Guidance from FDA Governs Size and Shape of Generic Drugs

01.06.14 | On December 9, 2013, the Food and Drug Administration (FDA) released a draft guidance recommending that the size, shape, and physical attributes of generic drugs be of a similar size to the corresponding Reference Listed Drugs (RLD) .

FDA Orders Google-Backed Home Genetic Test Service 23andMe to Halt Marketing

12.26.13 | The U.S. Food and Drug Administration (FDA) ordered Google-backed home genetic test maker 23andMe to "immediately discontinue" its Personal Genome Service (PGS) after failing to undergo proper agency approval for its marketing claims.

The Eighth Circuit Paves the Way for More Removals under CAFA's "Mass Action" Provision

12.04.13 | The Eighth Circuit's recent opinion in Atwell v. Boston Scientific Corporation is bound to have an impact on mass action litigation nationwide. Atwell involves the interpretation of the Class Action Fairness Act of 2005 ("CAFA"), which provides for the removal from state to federal court of certain actions, including mass actions.

Proposed FDA Rule Effectively Abrogates Pliva v. Mensing and Mutual Pharmaceutical v. Bartlett and Opens Up Liability for Generic Drug Manufacturers

11.15.13 | On November 13, 2013, the U.S. Food and Drug Administration proposed a new rule allowing generic drug manufacturers to independently change their product's labeling to reflect newly discovered safety information.

Mutual Pharmaceutical v. Bartlett: Hope for an End to "Alternative Feasible Design" in Drug Cases?

07.24.13 | While Bartlett is expressly limited to the generic drug context, it presents a tantalizing glimpse of the Court's potential receptiveness to similar arguments regarding supposed feasible safer alternative design in the context of branded pharmaceuticals.

The Effect of Recall on PMA Medical Device Preemption

07.02.13 | Recalls (and manufacturers' unwillingness to issue them) are frequently in the news these days. We are often asked to analyze the effect of a product recall upon claims and liability. It is apparent that a recall (or, perhaps, a refusal to conduct one) tends to lead to increased litigation. But does a recall result in increased liability?

Buckman Preemption & State Safe-Harbor Presumptions of Non-Liability for Approved Warnings

12.27.12 | In an attempt to insulate drug and device manufacturers from the flood of tort liability in the latter half of the twentieth century, many states adopted "safe-harbor" statutes. These safe-harbor provisions created the presumption that a drug or device manufacturer was not liable for injuries in tort if the FDA approved the drug or device as "safe and effective" and the drug or device and labeling complied with the FDA's approval. . .

Solely Updating Package Insert is Insufficient to Warn Prescriber

12.06.12 | More plaintiffs' attorneys have adopted the recent trend of alleging that pharmaceutical companies must distribute "Dear Doctor" letters or otherwise affirmatively call attention to label changes to satisfy their duty to warn prescribers besides merely updating the package insert with new warnings. . .

Free-speech Protections May Alter Off-Label Promotions

12.04.12 | The FDA has historically prohibited pharmaceutical companies from engaging in "off-label" promotion of its products. The Food, Drug, & Cosmetic Act also criminalizes misbranding by pharmaceutical companies. . .

Supreme Court to Consider Preemption of Design Defect Claims

12.03.12 | Plaintiff Karen Bartlett was prescribed the generic drug, sulindac, to treat shoulder pain. In 2005, Ms. Bartlett developed a sever skin reaction knows as Stevens Johnson Syndrome or Toxic Expidermal Necrolysis. . .